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Fonseca C, Baptista R, Franco F, Moura B, Pimenta J, Moraes Sarmento P, Cardoso JS, Brito D. Worsening heart failure: progress, pitfalls, and perspectives. Heart Fail Rev 2025; 30:715-734. [PMID: 39976853 PMCID: PMC12165898 DOI: 10.1007/s10741-025-10497-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/11/2025] [Indexed: 03/28/2025]
Abstract
For most patients with chronic heart failure (HF), the clinical course of the disease includes periods of apparent clinical stability punctuated by episodes of clinical deterioration with worsening signs and symptoms, a condition referred to as worsening heart failure (WHF). Over time, episodes of WHF may become more frequent, and patients may enter a cycle of recurrent events associated with deterioration in their quality of life and functional capacity, hospitalizations, and ultimately death. WHF is apparently an old concept but seems to have acquired new boundaries in terms of definition and clinical and prognostic value due to the fast-paced evolution of the HF treatment landscape and the emergence of new drugs in this setting. As a result, the management of WHF is being reshaped. In the present paper, a group of HF experts gathered to discuss the concept, prevention, detection, and treatment of WHF.
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Affiliation(s)
- Cândida Fonseca
- Heart Failure Clinic, Hospital S. Francisco Xavier, Unidade Local de Saúde Lisboa Ocidental, Lisbon, Portugal.
- Internal Medicine Department, Hospital de S. Francisco Xavier, Unidade Local de Saúde Lisboa Ocidental, Estrada Forte Do Alto Do Duque, 1449-005, Lisbon, Portugal.
- NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.
| | - Rui Baptista
- Cardiology Department, Unidade Local de Saúde de Entre Douro E Vouga, Santa Maria da Feira, Portugal
- Faculty of Medicine of the University of Coimbra, Coimbra, Portugal
- Center for Innovative Biomedicine and Biotechnology (CIBB), University of Coimbra, Coimbra, Portugal
- Clinical Academic Center of Coimbra (CACC), Coimbra, Portugal
| | - Fátima Franco
- Advanced Heart Failure Unit, Cardiology Department, Unidade Local de Saúde Coimbra, Coimbra, Portugal
| | - Brenda Moura
- Hospital das Forças Armadas, Porto Campus, Porto, Portugal
- Faculty of Medicine of the University of Porto, Porto, Portugal
| | - Joana Pimenta
- Internal Medicine Department, Hospital Eduardo Santos Silva, Unidade Local de Saúde Gaia e Espinho, Vila Nova de Gaia, Portugal
- Cardiovascular R&D Centre - UnIC@RISE, Department of Medicine, Faculty of Medicine of the University of Porto, Porto, Portugal
| | - Pedro Moraes Sarmento
- Heart Failure Clinic, Hospital da Luz, Lisbon, Portugal
- Centro de Investigação Clínica, Hospital da Luz Learning Health, Lisbon, Portugal
- Faculdade de Medicina, Católica Medical School, Universidade Católica Portuguesa, Lisbon, Portugal
| | - José Silva Cardoso
- Department of Cardiology, Unidade Local de Saúde São João, Porto, Portugal
- Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of the University of Porto, Porto, Portugal
- RISE-Health, Faculty of Medicine of the University of Porto, Porto, Portugal
| | - Dulce Brito
- Department of Cardiology, Unidade Local de Saúde Santa Maria, Lisboa, Portugal
- Lisbon Academic Medical Center (CAML), Lisbon, Portugal
- Centro Cardiovascular da Universidade de Lisboa (CCUL@RISE), Faculty of Medicine of the University of Lisbon, Lisbon, Portugal
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2
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de Jong MBL, Allach Y, Kamar SA, Clephas PRD, Brunner-La Rocca HP, Handoko ML, van de Halm VP, Kok WEM, Asselbergs FW, van Kimmenade R, Beeres SLMA, Rienstra M, Szymanski MK, de Boer RA, Kardys I, Brugts JJ. The Association between Serially Measured Circulating Biomarker Patterns and Pulmonary Artery Pressures measured by Invasive Hemodynamic Monitoring. J Card Fail 2025:S1071-9164(25)00236-2. [PMID: 40414277 DOI: 10.1016/j.cardfail.2025.04.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2025] [Revised: 04/17/2025] [Accepted: 04/21/2025] [Indexed: 05/27/2025]
Abstract
AIMS Invasive hemodynamic monitoring devices provide relevant insights into the remote hemodynamic status of heart failure (HF) patients. Additionally, circulating biomarkers have been advocated as additive in HF management by offering prognostic information and therapeutic targets. However, limited data exist correlating serially measured biomarkers to hemodynamic pressures provided by invasive sensors. This study aims to investigate the association between serial biomarker patterns and pulmonary artery (PA) pressure dynamics in HF patients. METHODS AND RESULTS This study is a sub study of the MONITOR-HF trial (NTR7673), a prospective investigator-initiated multicenter randomized clinical trial conducted in chronic HF (CHF) patients. Blood samples were collected at baseline and 3, 6 and 12 months follow up, and 92 proteins (OLINK CV-III panel) were measured. The primary endpoint was the average mean PA pressure (mPAP) during the week preceding blood sample collection, in patients who received an invasive PA pressure sensor. Linear mixed models were used to evaluate the association between serial biomarker levels and mPAP, adjusting for sex and age, and correcting for multiple testing. This study included 165 patients who had a median age of 68 [IQR 61 - 75] years and were predominantly male (78%). Fifteen biomarkers were significantly associated with the 7-day average mPAP, with thirteen biomarkers maintaining consistent associations across different lag-times. The strongest associations were found between mPAP and N-terminal pro b-type natriuretic peptide (NT-proBNP), pulmonary surfactant protein D (PSP-D), insulin like growth factor binding protein 7 (IGFBP-7) and matrix metalloproteinase-2 (MMP-2). CONCLUSION We found a consistent association between invasive hemodynamic pressures and thirteen serially measured blood biomarkers in CHF patients. These results, which use unique information obtained from PA pressure sensors, could deepen the understanding and therapy guidance of congestive HF.
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Affiliation(s)
- M Barry Loncq de Jong
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - Y Allach
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - S Abou Kamar
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - P R D Clephas
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - H P Brunner-La Rocca
- Department of Cardiology, Maastricht University Medical Centre, Maastricht, Netherlands
| | - M L Handoko
- Department of Cardiology, Utrecht University Medical Centre, Utrecht, Netherlands; Department of Cardiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - V P van de Halm
- Department of Cardiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - W E M Kok
- Department of Cardiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - F W Asselbergs
- Department of Cardiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - R van Kimmenade
- Department of Cardiology, Radboud University Medical Centre, Nijmegen, Netherlands
| | - S L M A Beeres
- Department of Cardiology, Leiden University Medical Centre, Leiden, Netherlands
| | - M Rienstra
- Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands
| | - M K Szymanski
- Department of Cardiology, Utrecht University Medical Centre, Utrecht, Netherlands
| | - R A de Boer
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - I Kardys
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands
| | - J J Brugts
- Department of Cardiology, Cardiovascular institute, Erasmus University Medical Center, Rotterdam, Netherlands.
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Mace MI, Lala-Trindade A, Fendler TJ, Sauer AJ. Emerging use of pulmonary artery and cardiac pressure sensing technology in the management of worsening heart failure events. Heart Fail Rev 2025:10.1007/s10741-025-10513-2. [PMID: 40343668 DOI: 10.1007/s10741-025-10513-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/19/2025] [Indexed: 05/11/2025]
Abstract
Unplanned admissions for worsening heart failure (WHF) are the largest resource cost in heart failure (HF) management. Despite advances in pharmacological agents and interventional therapy, HF remains a global epidemic. One crucial-and costly-gap in HF management is the inability to obtain objective information to identify and quantify congestion and personalize treatment plans to effectively manage WHF events without resorting to expensive, invasive methods. Although the causes of WHF are varied and complex, the universal effect of HF decompensation is the significant decline in quality of life due to symptoms of hypervolemic congestion and the resultant reduction in cardiac output, which can be quantified via increased pulmonary venous congestion due to high intracardiac filling pressures. Accessible and reliable markers of congestion could more precisely quantify the severity of WHF events and stabilize patients earlier by interrupting and reversing this process with timely introduction or modification of evidence-based treatments. Pulmonary artery and cardiac pressure sensing tools have gained evidential credence and increased clinical uptake in recent years for the prevention and treatment of WHF, as studies of implantable hemodynamic devices have iteratively and reliably demonstrated substantial reductions in WHF events. Recent advances in sensing technologies have ranged from single-parameter invasive pulmonary artery monitors to completely non-invasive multi-parameter devices incorporating multi-sensor concept technologies aided by machine learning or artificial intelligence, although many remain investigational. This review aims to evaluate the potential for novel pulmonary artery and cardiac pressure sensing technology to reshape the management of WHF from within the hospitalized and ambulatory care environments.
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Affiliation(s)
- Matthew I Mace
- Academy for Health Care Science (AHCS), 6 The Terrace, Rugby Road, Lutterworth, Leicestershire, LE17 4BW, UK.
- , 54 State St, STE 804 #13308, Albany, NY, 12207, USA.
| | - Anuradha Lala-Trindade
- Zena and Michael A. Wiener Cardiovascular Institute and Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA
| | - Timothy J Fendler
- Saint Luke's Mid America Heart Institute, Kansas City, MO, USA
- University of Missouri-Kansas City, Kansas City, MO, USA
| | - Andrew J Sauer
- Saint Luke's Mid America Heart Institute, Kansas City, MO, USA
- University of Missouri-Kansas City, Kansas City, MO, USA
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Teixeira AR, Barbas de Albuquerque F, Pereira-da-Silva T, Gonçalves AV, Ilhão Moreira R, Timóteo AT, Alves J, Barquinha S, Mata R, Dias M, Cacela D, Cruz Ferreira R. Hemodynamic effect of outpatient levosimendan infusion assessed daily using the CardioMEMS™ invasive remote monitoring system. Rev Port Cardiol 2025; 44:281-288. [PMID: 40058409 DOI: 10.1016/j.repc.2024.11.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/12/2024] [Revised: 07/14/2024] [Accepted: 11/06/2024] [Indexed: 04/17/2025] Open
Abstract
INTRODUCTION AND OBJECTIVES Levosimendan infusion in the outpatient setting improves the clinical status of heart failure (HF) patients, although its hemodynamic effects are not entirely known. Remote monitoring using the CardioMEMS™ system enables daily assessment of pulmonary artery pressure (PAP) and estimation of cardiac output (CO). We aimed to assess the hemodynamic effects of outpatient levosimendan infusion using CardioMEMS™. METHODS All patients admitted for 6-hour levosimendan infusion (performed every 14 days) and using the CardioMEMS™ remote monitoring system were included in a prospective single-center registry. Clinical and laboratory data were recorded. Systolic, diastolic, and mean PAP, heart rate, CO, and stroke volume (SV) were assessed daily. RESULTS A total of 25 sessions were performed in three patients. There were no adverse events or significant therapy adjustments. There was a significant reduction in diastolic PAP the day after levosimendan infusion compared to baseline (day prior to infusion) (24.1±4.1 mmHg vs. 21.6±2.9 mmHg, p=0.006). Thereafter, diastolic PAP stabilized and remained significantly lower than baseline up to day 10. There were no significant differences in systolic PAP, mean PAP, heart rate, CO, or SV at any timepoint analyzed, although there was a nonsignificant increase in CO with a peak at day 6. CONCLUSION Outpatient levosimendan infusion was associated with an early reduction in diastolic PAP, which was maintained for 10 days. The CardioMEMS™ system may enable a better understanding of outpatient hemodynamics in advanced HF. To our knowledge, there are no published data on this subject.
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Affiliation(s)
- Ana Rita Teixeira
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal.
| | | | - Tiago Pereira-da-Silva
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal; NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisbon, Portugal
| | - António Valentim Gonçalves
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Rita Ilhão Moreira
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Ana Teresa Timóteo
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal; NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisbon, Portugal
| | - João Alves
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Sofia Barquinha
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Rita Mata
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Mariline Dias
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Duarte Cacela
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
| | - Rui Cruz Ferreira
- Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
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Yee R, Love CJ, Kaiser DW, Birgersdotter-Green U, Cha YM, Singh JP, Liu S, Zhang Y, Chung ES. Rationale and Design of the Personalized Therapy Study: Evaluating Real-World Performance of Two Automated Defibrillation Therapy Algorithms. J Card Fail 2025; 31:824-832. [PMID: 39694452 DOI: 10.1016/j.cardfail.2024.11.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2024] [Revised: 11/05/2024] [Accepted: 11/06/2024] [Indexed: 12/20/2024]
Abstract
BACKGROUND Barriers to maximizing patient benefit with implantable defibrillation devices include limited ability to tailor antitachycardia pacing (ATP) therapy in real time and identify patients at risk of heart failure (HF) events early on. The Personalized Therapy study aims to evaluate the performance of 2 algorithms, intrinsic ATP (iATP) and TriageHF, to address these barriers in routine clinical practice. METHODS AND RESULTS The Personalized Therapy Study was designed as a prospective, multicenter, post-market registry study expected to enroll approximately 2200 patients meeting the following criteria: (1) implanted with a study-eligible device regardless of procedure type, (2) Medtronic CareLink Network enrolled, (3) TriageHF enabled within CareLink and High-Risk Alert notifications turned ON, and (4) iATP enabled. The primary study objectives are to demonstrate iATP effectiveness in the fast ventricular tachycardia zone and estimate the positive predictive value of TriageHF high-risk status for worsening HF. Additionally, objectives include characterizing iATP effectiveness in all ventricular detection zones and characterizing TriageHF-based clinical actions and related HF hospitalizations. CONCLUSION This study is expected to generate real-world evidence on the performance of the iATP and TriageHF algorithms, which aim to improve clinical practice by tailoring arrhythmia and HF therapies to individual patient disease states.
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Affiliation(s)
- Raymond Yee
- Department of Medicine, Western University, London, Ontario, Canada
| | - Charles J Love
- Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Daniel W Kaiser
- Department of Cardiology, St Thomas Heart, Nashville, Tennessee
| | - Ulrika Birgersdotter-Green
- Department of Medicine, Cardiovascular Institute, University of California San Diego, La Jolla, California
| | - Yong-Mei Cha
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
| | - Jagmeet P Singh
- Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
| | | | - Yan Zhang
- Medtronic, Inc, Mounds View, Minnesota
| | - Eugene S Chung
- The Heart and Vascular Center at The Christ Hospital, Cincinnati, Ohio.
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6
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Granot Y, Meir Y, Perl ML, Milwidsky A, Sadeh B, Sapir OR, Trabelsi A, Banai S, Toplisky Y, Havakuk O. Prediction of recurrent heart failure hospitalizations and mortality using the echocardiographic Killip score. Clin Res Cardiol 2025; 114:609-615. [PMID: 38829411 PMCID: PMC12058936 DOI: 10.1007/s00392-024-02473-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Accepted: 05/24/2024] [Indexed: 06/05/2024]
Abstract
AIM Examine the performance of a simple echocardiographic "Killip score" (eKillip) in predicting heart failure (HF) hospitalizations and mortality after index event of decompensated HF hospitalization. METHODS HF patients hospitalized at our facility between 03/2019-03/2021 who underwent an echocardiography during their index admission were included in this retrospective analysis. The cohort was divided into 4 classes of eKillip according to: stroke volume index (SVI) < 35ml/m2 > and E/E' ratio < 15 > . An eKillip Class I was defined as SVI ≥ 35ml/m2 and E/E' ≤ 15 and was used as reference. RESULTS Included 751 patients, median age 78.1 (IQR 69.3-86) years, 59% men, left ventricular ejection fraction 45 (IQR 30-60)%, brain natriuretic peptide levels 634 (IQR 331-1222)pg/ml. Compared with eKillip Class I, a graded increase in the combined endpoint of 30-day mortality and rehospitalizations rates was noted: (Class II: HR 1.77, CI 0.95-3.33, p = 0.07; Class III: HR 1.94, CI 1.05-3.6, p = 0.034; Class IV: HR 2.9, CI 1.64-5.13, p < 0.001 respectively), which overall persisted after correction for clinical (Class II: HR 1.682, CI 0.9-3.15, p = 0.105; Class III: HR 2.104, CI 1.13-3.9, p = 0.019; Class IV: HR 2.74, CI 1.54-4.85, p = 0.001 respectively) or echocardiographic parameters (Class II: HR 1.92, CI 1.02-3.63, p = 0.045; Class III: HR 1.54, CI 0.81-2.95, p = 0.189; Class IV: HR 2.04, CI 1.1-3.76, p = 0.023 respectively). Specifically, the eKillip Class IV group comprised one-third of the patient population and persistently showed increased risk of 30-day HF hospitalizations or mortality following multivariate analysis. CONCLUSION A simple echocardiographic score can assist identifying high-risk decompensated HF patients for recurrent hospitalizations and mortality.
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Affiliation(s)
- Yoav Granot
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel.
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
- Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
| | - Yuval Meir
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Michal Laufer Perl
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Assi Milwidsky
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Ben Sadeh
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Orly Ran Sapir
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
- Division of Preventive Cardiology, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA
| | - Adva Trabelsi
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Shmuel Banai
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Yan Toplisky
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Ofer Havakuk
- Department of Cardiology, Tel Aviv Medical Center, 6 Weizmann Street, 6423906, Tel Aviv, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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Ye L, Chang AJ, Chioncel O, Antohi EL, Geavlete O, Abdelhamid M, Adamo M, Biegus J, Chopra V, Cotter G, Grupper A, Lainscak M, Mebazaa A, Palazzuoli A, Rosano G, Savarese G, Collins SP, Hamilton SA, Ambrosy AP. A spotlight on congestion in acute heart failure: a joint session with the Romanian Society of Cardiology (part I). Heart Fail Rev 2025:10.1007/s10741-025-10515-0. [PMID: 40299252 DOI: 10.1007/s10741-025-10515-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/17/2025] [Indexed: 04/30/2025]
Abstract
Heart failure (HF) is a leading cause of hospitalizations, with over 1 million admissions annually in the USA and Europe due to signs and symptoms of congestion. Congestion in HF is now understood to result from both an absolute increase in total body fluid volume and a relative redistribution of fluid from capacitance vessels to the effective circulation. While guideline-directed medical therapy (GDMT) has greatly improved the outlook for stable HF patients, there has been little progress in managing acute HF (AHF) over the past 50 years. To address this unmet need, a group of expert clinicians met at the 63rd Annual Romanian Society of Cardiology Meeting on September 20th, 2024. They critically evaluated current evidence and identified knowledge gaps in three key areas of AHF management: (1) enhancing diuresis beyond standard therapy; (2) targeting fluid redistribution with intravenous vasodilators; and (3) applying hemodynamic profiling for personalized care. The first part of the discussion centered on enhanced diuresis strategies, covering contemporary real-world practice patterns, the relationship between residual congestion and hospital readmissions, findings from clinical trials of diuretic strategies, and recent insights into the role of GDMT in the acute setting. The panel also highlighted the limitations of existing evidence and proposed a research roadmap to optimize diuretic strategies in conjunction with GDMT in AHF, with the ultimate goal of facilitating decongestion in order to restore euvolemia and improve post-discharge outcomes.
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Affiliation(s)
- Linda Ye
- Department of Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA
| | - Alex J Chang
- Department of Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA
| | - Ovidiu Chioncel
- Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', Bucharest, Romania
| | - Elena-Laura Antohi
- Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', Bucharest, Romania
| | - Oliviana Geavlete
- Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', Bucharest, Romania
| | | | - Mariana Adamo
- Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy
| | - Jan Biegus
- Institute of Heart Diseases, Wrocław Medical University, Wrocław, Poland
| | - Vijay Chopra
- Max Super Speciality Hospital, Saket (Max Saket), New Delhi, India
| | | | - Avishay Grupper
- Faculty of Medical & Health Sciences, Tel-Aviv University, Tel-Aviv, Israel
| | - Mitja Lainscak
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
- General Hospital Murska Sobota, Murska Sobota, Slovenia
| | - Alexandre Mebazaa
- Université Paris Cité, Unité MASCOT Inserm, APHP Hôpitaux Saint Louis and Lariboisière, Paris, France
| | - Alberto Palazzuoli
- University San Raffaele of Rome - Uniroma 5 , Rome, Italy
- San Raffaele Cassino Hospital, Cassino, Italy
| | | | - Gianluigi Savarese
- Department of Medicine, Division of Cardiology, Karolinska Institutet, Stockholm, Sweden
| | - Sean P Collins
- Department of Emergency Medicine, Vanderbilt University Medical Center and Geriatric Research and Education Clinical Care, Tennessee Valley Healthcare Facility VA Medical Center, Nashville, TN, USA
| | - Steven A Hamilton
- Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA
| | - Andrew P Ambrosy
- Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.
- Division of Research, Kaiser Permanente Northern California, 4480 Hacienda Drive, Pleasanton, CA, 94588, USA.
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8
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Cheema B, Tibrewala A. SEISMIC-HF 1: key findings from AHA24 and implications for remote cardiac monitoring. Heart Fail Rev 2025:10.1007/s10741-025-10514-1. [PMID: 40268799 DOI: 10.1007/s10741-025-10514-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/15/2025] [Indexed: 04/25/2025]
Abstract
While there is continued progress in developing therapies for patients with heart failure, the condition results in significant morbidity and a sizeable economic impact on our society. Recent advances in wearable sensors combined with machine learning algorithms give hope that heart failure can be better managed remotely and allow for improved clinical outcomes. This is a focused review of the key findings of the SEISMocardiogram In Cardiovascular Monitoring for Heart Failure I (SEISMIC-HF 1) study, presented at the American Heart Association's Scientific Sessions 2024 in Chicago, Illinois. This study showcased the ability of a machine learning algorithm to estimate pulmonary capillary wedge pressure in patients with heart failure with reduced ejection fraction, utilizing seismocardiography, photoplethysmography, and electrocardiography signals obtained non-invasively through a wearable sensor patch (CardioTag) for model input. The authors showed a significant correlation between model-predicted pulmonary capillary wedge pressure and the gold standard pressure measurement obtained from right heart catheterization. Future investigations should assess the implementation of this technology as a part of a treatment strategy for outpatient heart failure care and explore its performance in additional study populations including those with heart failure with preserved ejection fraction and in patients outside of the clinical environment.
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Affiliation(s)
- Baljash Cheema
- Center for Artificial Intelligence, Bluhm Cardiovascular Institute, Northwestern Medicine, 676 N. Saint Clair Street Arkes Pavilion, Suite 600, Chicago, IL, 60611, USA.
- Feinberg School of Medicine, Northwestern University, 676 N. Saint Clair Street Arkes Pavilion, Suite 600, Chicago, IL, 60611, USA.
| | - Anjan Tibrewala
- Center for Artificial Intelligence, Bluhm Cardiovascular Institute, Northwestern Medicine, 676 N. Saint Clair Street Arkes Pavilion, Suite 600, Chicago, IL, 60611, USA
- Feinberg School of Medicine, Northwestern University, 676 N. Saint Clair Street Arkes Pavilion, Suite 600, Chicago, IL, 60611, USA
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Jalandhra GK, Srethbhakdi L, Davies J, Nguyen CC, Phan PT, Och Z, Ashok A, Lim KS, Phan HP, Do TN, Lovell NH, Rnjak-Kovacina J. Materials Advances in Devices for Heart Disease Interventions. ADVANCED MATERIALS (DEERFIELD BEACH, FLA.) 2025:e2420114. [PMID: 40244561 DOI: 10.1002/adma.202420114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/20/2024] [Revised: 03/07/2025] [Indexed: 04/18/2025]
Abstract
Heart disease encompasses a range of conditions that affect the heart, including coronary artery disease, arrhythmias, congenital heart defects, heart valve disease, and conditions that affect the heart muscle. Intervention strategies can be categorized according to when they are administered and include: 1) Monitoring cardiac function using sensor technology to inform diagnosis and treatment, 2) Managing symptoms by restoring cardiac output, electrophysiology, and hemodynamics, and often serving as bridge-to-recovery or bridge-to-transplantation strategies, and 3) Repairing damaged tissue, including myocardium and heart valves, when management strategies are insufficient. Each intervention approach and technology require specific material properties to function optimally, relying on materials that support their action and interface with the body, with new technologies increasingly depending on advances in materials science and engineering. This review explores material properties and requirements driving innovation in advanced intervention strategies for heart disease and highlights key examples of recent progress in the field driven by advances in materials research.
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Affiliation(s)
- Gagan K Jalandhra
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Lauryn Srethbhakdi
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - James Davies
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Chi Cong Nguyen
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Phuoc Thien Phan
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Zachary Och
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Aditya Ashok
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
- School of Mechanical and Manufacturing Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Khoon S Lim
- School of Medical Sciences, University of Sydney, Sydney, NSW, 2006, Australia
| | - Hoang-Phuong Phan
- School of Mechanical and Manufacturing Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Thanh Nho Do
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
| | - Nigel H Lovell
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
- Tyree Institute of Health Engineering (IHealthE), University of New South Wales, Sydney, NSW, 2052, Australia
| | - Jelena Rnjak-Kovacina
- Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW, 2052, Australia
- Tyree Institute of Health Engineering (IHealthE), University of New South Wales, Sydney, NSW, 2052, Australia
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10
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Wattanachayakul P, Kittipibul V, Fudim M. Radiofrequency-based wearable sensor patch in heart failure management: a focused review. Heart Fail Rev 2025:10.1007/s10741-025-10511-4. [PMID: 40205273 DOI: 10.1007/s10741-025-10511-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/27/2025] [Indexed: 04/11/2025]
Abstract
ZOLL Heart Failure Management System (ZOLL HFMS) is a non-invasive, remote monitoring device that employs radiofrequency signals transmitted through an adhesive patch embedded with integrated sensors to evaluate lung fluid levels. By analyzing trends in lung fluid status and related parameters, ZOLL HFMS may facilitate the early detection of heart failure (HF) decompensation and enable timely interventions. Insights from the recent BMAD trial (Impact of heart failure management using thoracic fluid monitoring from a novel wearable sensor: Results of the Benefits of Microcor [µCor™] in Ambulatory Heart Failure) highlight its promise in those with recent HF hospitalization, demonstrating a reduction in time to first HF readmission and improvement in quality of life. In this review, we summarize data on the ZOLL HFMS, with a focus on its lung fluid analysis mechanism for early HF decompensation detection and the accuracy of its measurements compared to other modalities. Then, we examine key outcomes from the recent BMAD trial, highlighting their clinical relevance and identifying gaps that warrant further investigation in future clinical trials. Lastly, we outline potential directions for integrating this technology into routine HF management.
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Affiliation(s)
- Phuuwadith Wattanachayakul
- Department of Medicine, Jefferson Einstein Hospital, Philadelphia, PA, USA
- Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA
| | - Veraprapas Kittipibul
- Division of Cardiology, Department of Internal Medicine, Duke University School of Medicine, 2301 Erwin Road, Durham, NC, USA
- Duke Clinical Research Institute, Durham, NC, USA
| | - Marat Fudim
- Division of Cardiology, Department of Internal Medicine, Duke University School of Medicine, 2301 Erwin Road, Durham, NC, USA.
- Duke Clinical Research Institute, Durham, NC, USA.
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11
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ZHANG SY. Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024. J Geriatr Cardiol 2025; 22:277-331. [PMID: 40351394 PMCID: PMC12059564 DOI: 10.26599/1671-5411.2025.03.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/14/2025] Open
Abstract
In the past 6 years, significant breakthroughs have been achieved in the treatment of heart failure (HF), especially in drug therapy. The classification of chronic HF and the treatment methods for HF and its complications are also constantly being updated. In order to apply these results to the diagnosis and treatment of patients with HF in China and further improve the level of diagnosis and treatment of HF in China, the HF Group of Chinese Society of Cardiology, Chinese Medical Association, Chinese College of Cardiovascular Physician, Chinese HF Association of Chinese Medical Doctor Association, and Editorial Board of Chinese Journal of Cardiology have organized an expert group and update the consensus and evidence-based treatment methods in the field of HF based on the latest clinical research findings at home and abroad, combined with the national conditions and clinical practice in China, and referring to the latest foreign HF guidelines while maintaining the basic framework of the 2018 Chinese Guidelines for Diagnosis and Treatment of HF.
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Affiliation(s)
- Shu-Yang ZHANG
- Chinese Society of Cardiology, Chinese Medical Association; Chinese College of Cardiovascular Physician; Chinese Heart Failure Association of Chinese Medical Doctor Association; Editorial Board of Chinese Journal of Cardiology;This guideline was first published in the Zhonghua Xin Xue Guan Bing Za Zhi 2024; 52(3): 235–275.
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12
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Gąsecka A, Siniarski A. Addressing 'Residual Congestion' to Improve Prognosis After Acute Heart Failure Decompensation. Card Fail Rev 2025; 11:e06. [PMID: 40171551 PMCID: PMC11959577 DOI: 10.15420/cfr.2024.24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Accepted: 01/26/2025] [Indexed: 04/03/2025] Open
Abstract
Congestion is the hallmark and the main therapeutic target in patients with decompensated heart failure (HF). Residual clinical congestion is defined as a high left ventricular diastolic pressure associated with signs and symptoms of HF, such as dyspnoea, rales and oedema, persisting despite guideline-directed medical treatment. Residual congestion in the predischarge and early post-discharge phase is the major risk factor for HF readmission and mortality. Therefore, prompt recognition of congestion and rapid optimisation of medical and device therapy are crucial to induce remission in this malignant process. In this paper we discuss the definitions, prevalence and prognosis of HF decompensation; the significance of assessing residual congestion in HF patients; the results of observational and randomised clinical trials to detect and treat residual congestion; and the current guidelines to prevent recurrent HF decompensation in the context of residual congestion. Strategies to detect and address residual congestion are crucial to stopping readmissions after an acute HF hospitalisation and improving long-term prognosis.
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Affiliation(s)
| | - Aleksander Siniarski
- Department of Coronary Artery Disease and Heart Failure, Institute of Cardiology, Jagiellonian University Medical CollegeKraków, Poland
- St John Paul II HospitalKraków, Poland
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Kačar P, Tamborrino PP, Iannaccone G, Butera G, Brida M, Prokšelj K, Gatzoulis MA, Montanaro C. Hypoplastic left heart syndrome (HLHS) becomes of age: Assessing the young adult with HLHS including the neoaorta/aortic arch. INTERNATIONAL JOURNAL OF CARDIOLOGY CONGENITAL HEART DISEASE 2025; 19:100555. [PMID: 39926123 PMCID: PMC11803127 DOI: 10.1016/j.ijcchd.2024.100555] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2024] [Accepted: 11/28/2024] [Indexed: 02/11/2025] Open
Abstract
Hypoplastic left heart syndrome (HLHS) is one of the most complex congenital heart defects (CHD), characterized by a hypoplastic left ventricle (LV), dominant right ventricle (RV) and small left-sided heart structures. The introduction of the Norwood operation has significantly improved outcomes, with 5-year survival reported up to 65 %. Despite these advances, post-operative morbidity and mortality remain high, and the long-term complications in adult survivors represent a challenge. The number of HLHS patients with Fontan circulation is expected to double in the next 20 years, leading to a growing population requiring specialized care from adult congenital heart disease (ACHD) teams. This article reviews current management strategies for HLHS, outlines potential long-term complications, and highlights existing knowledge gaps. Specific considerations in this population include the assessment of the neo-aorta and aortic arch, and systemic RV dysfunction in the setting of a Fontan circulation. The proposed surveillance strategy emphasizes the need for vigilant monitoring and timely intervention to treat the complications unique to this population, ensuring better outcomes for HLHS patients reaching adulthood.
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Affiliation(s)
- Polona Kačar
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- Department of Cardiology, University Medical Centre Ljubljana, Zaloška 2, Ljubljana, Slovenia
| | - Pietro Paolo Tamborrino
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- University of Pisa and Cardiovascular Division 1, Pisa University Hospital, Pisa, Italy
| | - Giulia Iannaccone
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy
| | - Gianfranco Butera
- Department of Cardiac Surgery, Cardiology and Heart Lung Transplant, Bambino Gesu‵ Children's Hospital IRCCS, Rome, Italy
| | - Margarita Brida
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- National Heart and Lung Institute, Imperial College, London, United Kingdom
- Medical Faculty, University of Rijeka, Croatia
| | - Katja Prokšelj
- Department of Cardiology, University Medical Centre Ljubljana, Zaloška 2, Ljubljana, Slovenia
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Michael A. Gatzoulis
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- National Heart and Lung Institute, Imperial College, London, United Kingdom
| | - Claudia Montanaro
- Adult Congenital Heart Disease Centre, Royal Brompton & Harefield, Guy's St Thomas's NHS Foundation Trust, London, United Kingdom
- Department of Cardiac Surgery, Cardiology and Heart Lung Transplant, Bambino Gesu‵ Children's Hospital IRCCS, Rome, Italy
- National Heart and Lung Institute, Imperial College, London, United Kingdom
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14
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Böhm A, Lucka J, Jajcay N, Segev A, Jankova J, Kollarova M, Holly O, Sebenova Jerigova V, Stevkova J, Spilak M, Skorec F, Guzma K, Johanesova L, Hanesz Z, Karolcik S, Remak A, Sobotka PA, Bezak B. A Noninvasive System for Remote Monitoring of Left Ventricular Filling Pressures. JACC Basic Transl Sci 2025; 10:256-258. [PMID: 40139862 PMCID: PMC12013836 DOI: 10.1016/j.jacbts.2025.01.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2025] [Accepted: 01/18/2025] [Indexed: 03/29/2025]
Affiliation(s)
- Allan Böhm
- Seerlinq Ltd, Trnava, Slovakia; Premedix Academy, Bratislava, Slovakia; Third Department of Internal Medicine, Faculty of Medicine, Comenius University in Bratislava, Bratislava, Slovakia.
| | - Julia Lucka
- Seerlinq Ltd, Trnava, Slovakia; Department of General Cardiology, The National Institute of Cardiovascular Diseases, Bratislava, Slovakia
| | - Nikola Jajcay
- Seerlinq Ltd, Trnava, Slovakia; Department of Complex Systems, Institute of Computer Science, CAS, Prague, Czech Republic
| | - Amitai Segev
- Seerlinq Ltd, Trnava, Slovakia; The Leviev Cardiothoracic and Vascular Center, Chaim Sheba Medical Center, Israel
| | | | - Marta Kollarova
- Seerlinq Ltd, Trnava, Slovakia; Premedix Academy, Bratislava, Slovakia
| | | | | | - Jana Stevkova
- Seerlinq Ltd, Trnava, Slovakia; Department of General Cardiology, The National Institute of Cardiovascular Diseases, Bratislava, Slovakia
| | | | | | - Kristian Guzma
- Seerlinq Ltd, Trnava, Slovakia; Premedix Academy, Bratislava, Slovakia
| | | | | | | | | | - Paul A Sobotka
- Seerlinq Ltd, Trnava, Slovakia; Clinical Research, Sensible Biotechnologies, Cambridge, Massachusetts, USA
| | - Branislav Bezak
- Seerlinq Ltd, Trnava, Slovakia; Premedix Academy, Bratislava, Slovakia; Department of Cardiac Surgery, The National Institute of Cardiovascular Diseases, Bratislava, Slovakia
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15
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Zalawadiya SK, Kiernan M, Borlaug BA, Stevenson LW, Desai AS, Bennett M, Mullens W, Hiivala NJ, Owens MM, Klein L. Changes in Seated Pulmonary Artery Pressure in Response to Titration of Heart Failure Medications During Ambulatory Monitoring. J Card Fail 2025:S1071-9164(25)00052-1. [PMID: 39947425 DOI: 10.1016/j.cardfail.2025.02.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2025] [Revised: 02/01/2025] [Accepted: 02/03/2025] [Indexed: 03/08/2025]
Abstract
INTRODUCTION Ambulatory hemodynamic monitoring (AHM) of heart failure (HF) using pulmonary artery pressure (PAP) is marked by frequent changes in HF medications. We are beginning to learn how medication titrations during AHM affect mean PAP (mPAP) measured in the seated position, which reflects most waking hours. METHOD We analyzed the 12-month data from the PROACTIVE-HF trial of the Cordella Cordella, Endotronix Inc, Naperville, Illinois, United States) PAP sensor system. Seated mPAP was examined in the 14-days before and after isolated changes in medications; only those medications with ≥10 titrations were analyzed. Dependent sample Wilcoxon-signed rank test was used to compare changes in mPAP with titrations. RESULTS We analyzed 456 subjects (age: 64 years, females: 40%, Black: 18%, HF with reduced ejection fraction: 46%). Loop diuretics (LD) were up-titrated 176 times in 133 patients and down-titrated 113 times in 96 patients. Before LD up-titration, mPAP increased by 1.6 ± 1.0 mm Hg; afterwards, it decreased by 2.3 ± 1.0 mm Hg (P < 0.001), with most reduction occurring within 1 week. Down-titration of LD was followed by an increase of 1.8 ± 1.3 mm Hg (P = 0.004) over the next several days. Similar trends were observed across categories of ejection fraction (≤40% and >40%). Angiotensin receptor neprilysin inhibitor (ARNI) up-titration decreased mPAP by 1.8 ± 1.9 mm Hg (P = 0.042), whereas down-titration increased mPAP by 1.5 ± 1.4 (P = 0.094). Mineralocorticoid receptor antagonist (MRA) up-titration tended to decrease mPAP (1.6 ± 2.5 mm Hg, P = 0.286,) whereas down-titration was followed by a significant increase in mPAP of 3.2 ± 1.6 mm Hg (P = 0.001). CONCLUSION The AHM platform using seated mPAP data provided valuable insights into its short-term responses to isolated changes in HF medications. The seated mPAP changed expectedly in response to the titration of LD, whereas the degree of response varied for ARNI and MRA. Ongoing investigation will further characterize the timing and variability of responses to inform algorithms for ambulatory management of PAP.
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Affiliation(s)
- Sandip K Zalawadiya
- Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee.
| | - Michael Kiernan
- Division of Cardiology, Tufts University, Boston, Massachusetts
| | - Barry A Borlaug
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
| | | | - Akshay S Desai
- Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts
| | - Mosi Bennett
- Minneapolis Heart Institute, Minneapolis, Minnesota
| | | | | | | | - Liviu Klein
- Advanced Heart Failure Comprehensive Care Center and Division of Cardiology, University of California San Francisco, California
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16
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Paudyal V, Thapa R, Basnet S, Sharma M, Surani S, Varon J. Updates on Pulmonary Hypertension. Open Respir Med J 2025; 19:e18743064344024. [PMID: 40322494 PMCID: PMC12046238 DOI: 10.2174/0118743064344024250203101417] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2024] [Revised: 12/06/2024] [Accepted: 01/01/2025] [Indexed: 05/08/2025] Open
Abstract
Pulmonary Arterial Hypertension (PAH) is an uncommon condition with high mortality. It is an underrecognized condition both in developing and developed countries, especially in developing countries, due to a lack of advanced healthcare facilities and resources for timely diagnosis. More than half of the individuals diagnosed with PAH live less than five years after diagnosis. In recent years, tremendous advancements have been made in diagnostic and therapeutic strategies for PAH patients. Phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists, and prostacyclin inhibitors in various forms (oral, inhaled, intravenous, or subcutaneous) have been the cornerstone of medical treatment. Atrial septostomy, heart and lung transplant, balloon pulmonary angioplasty, and pulmonary thromboendarterectomy are existing therapeutic options currently available. There has been a continuous effort to introduce newer therapies to improve life expectancy and modify disease. Newer therapies have shown promising results but require future data to guarantee long-term safety and efficacy. We aim to discuss a few of these critical updates in the constantly evolving field of PAH.
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Affiliation(s)
- Vivek Paudyal
- Department of General Practice and Emergency Medicine, Karnali Academy of Health Sciences, Jumla, Nepal
| | - Rubi Thapa
- Department of General Practice and Emergency Medicine, Karnali Academy of Health Sciences, Jumla, Nepal
| | - Sagarika Basnet
- Department of Internal Medicine, Kathmandu Medical College and Teaching Hospital, Kathmandu, Nepal
| | - Munish Sharma
- Department of Medicine, Baylor College of Medicine, Texas, TX, United States
| | - Salim Surani
- Department of Medicine, Texas A & M University, Texas, TX, United States
| | - Joseph Varon
- College of Medicine, University of Houston, Houston, United States
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17
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Griné M, Guerreiro C, Moscoso Costa F, Nobre Menezes M, Ladeiras-Lopes R, Ferreira D, Oliveira-Santos M. Digital health in cardiovascular medicine: An overview of key applications and clinical impact by the Portuguese Society of Cardiology Study Group on Digital Health. Rev Port Cardiol 2025; 44:107-119. [PMID: 39393635 DOI: 10.1016/j.repc.2024.08.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2024] [Revised: 07/26/2024] [Accepted: 08/01/2024] [Indexed: 10/13/2024] Open
Abstract
Digital health interventions including telehealth, mobile health, artificial intelligence, big data, robotics, extended reality, computational and high-fidelity bench simulations are an integral part of the path toward precision medicine. Current applications encompass risk factor modification, chronic disease management, clinical decision support, diagnostics interpretation, preprocedural planning, evidence generation, education, and training. Despite the acknowledged potential, their development and implementation have faced several challenges and constraints, meaning few digital health tools have reached daily clinical practice. As a result, the Portuguese Society of Cardiology Study Group on Digital Health set out to outline the main digital health applications, address some of the roadblocks hampering large-scale deployment, and discuss future directions in support of cardiovascular health at large.
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Affiliation(s)
- Mafalda Griné
- Serviço de Cardiologia, Hospitais da Universidade de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
| | - Cláudio Guerreiro
- Serviço de Cardiologia, Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, Portugal
| | | | - Miguel Nobre Menezes
- Structural and Coronary Heart Disease Unit, Cardiovascular Center of the University of Lisbon, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal; Serviço de Cardiologia, Departamento de Coração e Vasos, CHULN Hospital de Santa Maria, Lisboa, Portugal
| | - Ricardo Ladeiras-Lopes
- UnIC@RISE, Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculdade de Medicina, Universidade do Porto, Porto, Portugal; Hospital da Luz, Lisboa, Portugal
| | - Daniel Ferreira
- Serviço de Medicina Intensiva, Hospital da Luz, Lisboa, Portugal; Hospital da Luz Digital, Lisboa, Portugal
| | - Manuel Oliveira-Santos
- Serviço de Cardiologia, Hospitais da Universidade de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal; Faculdade de Medicina, Universidade de Coimbra, Coimbra, Portugal
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18
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Gingele AJ, Beckers F, Boyne JJ, Brunner-La Rocca HP. Fluid status assessment in heart failure patients: pilot validation of the Maastricht Decompensation Questionnaire. Neth Heart J 2025; 33:7-13. [PMID: 39656355 PMCID: PMC11695504 DOI: 10.1007/s12471-024-01921-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/21/2024] [Indexed: 01/04/2025] Open
Abstract
BACKGROUND eHealth products have the potential to enhance heart failure (HF) care by identifying at-risk patients. However, existing risk models perform modestly and require extensive data, limiting their practical application in clinical settings. This study aims to address this gap by validating a more suitable risk model for eHealth integration. METHODS We developed the Maastricht Decompensation Questionnaire (MDQ) based on expert opinion to assess HF patients' fluid status using common signs and symptoms. Subsequently, the MDQ was administered to a cohort of HF outpatients at Maastricht University Medical Centre. Patients with ≥ 10 MDQ points were categorised as 'decompensated', patients with < 10 MDQ points as 'not decompensated'. HF nurses, blinded to MDQ scores, served as the gold standard for fluid status assessment. Patients were classified as 'correctly' if MDQ and nurse assessments aligned; otherwise, they were classified as 'incorrectly'. RESULTS A total of 103 elderly HF patients were included. The MDQ classified 50 patients as 'decompensated', with 17 of them being correctly classified (34%). Additionally, 53 patients were categorised as 'not decompensated', with 48 of them being correctly classified (90%). The calculated area under the curve was 0.69 (95% confidence interval: 0.57-0.81; p < 0.05). Cronbach's alpha reliability coefficient for the MDQ was 0.85. CONCLUSIONS The MDQ helps identify decompensated HF patients through clinical signs and symptoms. Further trials with larger samples are needed to confirm its validity, reliability and applicability. Tailoring the MDQ to individual patient profiles may improve its accuracy.
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Affiliation(s)
- Arno J Gingele
- Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands.
| | - Fabienne Beckers
- Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Josiane J Boyne
- Department of Cardiology, Maastricht University Medical Centre, Maastricht, The Netherlands
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19
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Gregório C, Agostinho JR, Rigueira J, Santos R, Pinto FJ, Brito D. From Wristbands to Implants: The Transformative Role of Wearables in Heart Failure Care. Healthcare (Basel) 2024; 12:2572. [PMID: 39765999 PMCID: PMC11727849 DOI: 10.3390/healthcare12242572] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Revised: 12/06/2024] [Accepted: 12/13/2024] [Indexed: 01/15/2025] Open
Abstract
BACKGROUND Heart failure (HF) management increasingly relies on innovative solutions to enhance monitoring and care. Wearable devices, originally popularized for fitness tracking, show promise in clinical decision-making for HF. This study explores the application and potential for the broader integration of wearable technology in HF management, emphasizing remote monitoring and personalized care. METHODS A comprehensive literature review was performed to assess the role of wearables in HF management, focusing on functionalities like vital sign tracking, patient engagement, and clinical decision support. Clinical outcomes and barriers to adopting wearable technology in HF care were critically analyzed. RESULTS Wearable devices increasingly track physiological parameters relevant to HF, such as heart rate, physical activity, and sleep. They can identify at-risk patients, promote lifestyle changes, facilitate early diagnosis, and accurately detect arrhythmias that lead to decompensation. Additionally, wearables may assess fluid status, identifying early signs of decompensation to prevent hospitalization and supporting therapeutic adjustments. They also enhance physical activity and optimize cardiac rehabilitation programs, improving patient outcomes. Both wearable and implanted cardiac devices enable continuous, non-invasive monitoring through small devices. However, challenges like data integration, regulatory approval, and reimbursement impede their widespread adoption. CONCLUSIONS Wearable technology can transform HF management through continuous monitoring and early interventions. Collaboration among involved parties is essential to overcome integration challenges and validate most of these devices in clinical practice.
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Affiliation(s)
- Catarina Gregório
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
| | - João R. Agostinho
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
| | - Joana Rigueira
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
| | - Rafael Santos
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
| | - Fausto J. Pinto
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
| | - Dulce Brito
- Department of Cardiology, Hospital de Santa Maria (ULSSM), 1649-028 Lisbon, Portugal; (J.R.A.); (J.R.); (R.S.); (F.J.P.); (D.B.)
- Centro Académico de Medicina de Lisboa (CAML), 1649-028 Lisbon, Portugal
- Cardiovascular Center of the University of Lisbon (CCUL@RISE), 1649-028 Lisbon, Portugal
- Faculdade de Medicina, Universidade de Lisboa, 1649-028 Lisboa, Portugal
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20
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Spethmann S, Hindricks G, Koehler K, Stoerk S, Angermann CE, Böhm M, Assmus B, Winkler S, Möckel M, Mittermaier M, Lelgemann M, Reuter D, Bosch R, Albrecht A, von Haehling S, Helms TM, Sack S, Bekfani T, Gröschel JW, Koehler M, Melzer C, Wintrich J, Zippel-Schultz B, Ertl G, Vogelmeier C, Dagres N, Zernikow J, Koehler F. Telemonitoring for Chronic Heart Failure: Narrative Review of the 20-Year Journey From Concept to Standard Care in Germany. J Med Internet Res 2024; 26:e63391. [PMID: 39631073 DOI: 10.2196/63391] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2024] [Revised: 08/13/2024] [Accepted: 09/26/2024] [Indexed: 12/07/2024] Open
Abstract
BACKGROUND Chronic heart failure (CHF) is a major cause of morbidity and mortality worldwide, placing a significant burden on health care systems. The concept of telemedicine for CHF was first introduced in the late 1990s, and since 2010, studies have demonstrated its potential to improve patient outcomes and reduce health care costs. Over the following decade, technological advancements and changes in health care policy led to the development of more sophisticated telemedicine solutions for CHF, including remote patient management through invasive or noninvasive telemonitoring devices, mobile apps, and virtual consultations. Years of public funding in Germany have generated evidence that remote patient management improves outcomes for patients with CHF, such as quality of life, and reduces hospital admissions. Based on these data, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) decided, independently of the current European Society of Cardiology recommendations, to incorporate telemedicine as a standard digital intervention for high-risk patients with reduced left ventricular ejection fraction in Germany in 2020. OBJECTIVE This review aims to illustrate the journey from the initial concept through pioneering studies that led to telemedicine's integration into standard care, and to share current experiences that have positioned Germany as a leader in cardiovascular telemedicine. METHODS We review and discuss existing literature and evidence on the development and implementation of telemonitoring for CHF in Germany over the past 20 years. Relevant studies, reports, and guidelines were identified through a comprehensive search of electronic databases, including PubMed, Google Scholar, and specialized journals focused on CHF telemonitoring. RESULTS Pioneering studies, such as the TIM-HF2 (Telemedical Interventional Management in Heart Failure II) and IN-TIME (Influence of Home Monitoring on Mortality and Morbidity in Heart Failure Patients with Impaired Left Ventricular Function) trials, demonstrated the effectiveness of remote patient management applications for patients with CHF in Germany and their applicability to current practices involving both invasive and noninvasive methods. Collaborations between researchers and technology developers overcame barriers, leading to sustainable improvements in patient care. Ongoing research on artificial intelligence applications for prioritizing and interpreting individual health data will continue to transform digital health care. CONCLUSIONS The establishment of telemedical care for patients with HF across Europe is likely to benefit from experiences in Germany, where significant improvements have been achieved in the care of patients with HF.
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Affiliation(s)
- Sebastian Spethmann
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany
| | - Gerhard Hindricks
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Kerstin Koehler
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Stefan Stoerk
- Department Clinical Research & Epidemiology, Comprehensive Heart Failure Centre, Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany
| | - Christiane E Angermann
- Comprehensive Heart Failure Centre, University Hospital Würzburg, Würzburg, Germany
- Department for Internal Medicine I, University Hospital Würzburg, Würzburg, Germany
| | - Michael Böhm
- Department of Internal Medicine II, Cardiology, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany., Herne, Germany
| | - Birgit Assmus
- Department of Cardiology and Angiology, University of Giessen, Giessen, Germany
- DZHK (German Centre for Cardiovascular Research), Partner Site Rhein/Main, Kerckhoff Heart Center, Bad Nauheim, Germany
| | - Sebastian Winkler
- Department of Internal Medicine and Cardiology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany
| | - Martin Möckel
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Department of Emergency and Acute Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Mirja Mittermaier
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | | | | | - Ralph Bosch
- Cardio Centrum Ludwigsburg-Bietigheim, Ludwigsburg, Germany
| | - Alexander Albrecht
- Kardiologische Gemeinschaftspraxis Wilmersdorfer Strasse 62, Vivantes Klinikum Am Urban, Berlin, Germany
| | - Stephan von Haehling
- Department of Cardiology and Pneumology, University of Göttingen Medical Center, Göttingen, Germany
- German Center for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany
| | - Thomas M Helms
- German Foundation for the Chronically Ill, Berlin, Germany
- Peri Cor Cardiology Working Group / associated UCSF, Hamburg, Germany
| | - Stefan Sack
- Department of Cardiology, Pneumology, and Internal Intensive Care Medicine, Schwabing Hospital, Academic Municipal Hospital Munich, Munich, Germany
| | - Tarek Bekfani
- Department of Cardiology and Angiology, Universitätsklinikum Magdeburg, Magdeburg, Germany
| | - Jan Wolfgang Gröschel
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- ECRC Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
- Working Group on Cardiovascular Magnetic Resonance, Experimental and Clinical Research Center, a joint cooperation between Charité Medical Faculty and the Max-Delbrück Center for Molecular Medicine, Berlin, Germany
| | - Magdalena Koehler
- Department of Preventive Sports Medicine and Sports Cardiology, University Hospital 'Klinikum rechts der Isar', School of Medicine, Technical University Munich, Munich, Germany
- Department of Acute Medicine, Donauspital Wien, Wien, Germany
| | - Christoph Melzer
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Jan Wintrich
- Department of Internal Medicine II, Cardiology, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany., Herne, Germany
| | | | - Georg Ertl
- Department for Internal Medicine I, University Hospital Würzburg, Würzburg, Germany
| | - Claus Vogelmeier
- Department of Internal Medicine, Pulmonary and Critical Care Medicine, Member of the German Center for Lung Research (DZL), University of Marburg, Marburg, Germany
| | - Nikolaos Dagres
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Jasmin Zernikow
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Friedrich Koehler
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Berlin, Germany
- Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
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21
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Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC. HEART FAILURE 2024; 12:2011-2022. [PMID: 39387771 DOI: 10.1016/j.jchf.2024.07.022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/18/2024] [Revised: 07/29/2024] [Accepted: 07/30/2024] [Indexed: 10/15/2024]
Abstract
BACKGROUND There is an unmet need for early detection of heart failure decompensation, allowing patients to be managed remotely and avoid hospitalization. OBJECTIVES The purpose of this study was to compare a strategy utilizing data from a wearable HF sensor for management following a HF hospitalization to usual care. METHODS Eligible subjects were discharged from the hospital within the previous 10 days and had a HF event in the previous 6 months. The concurrent control study was divided into 2 arms; a control arm, BMAD-HF and an open-label intervention arm, BMAD-TX. The HFMS (Heart Failure Monitoring System) was worn by subjects for up to 90 days. Device data was blinded to investigators and subjects in the BMAD-HF control arm but provided proactively in the BMAD-TX intervention arm. The impact of HF management with the HFMS was evaluated by Kaplan-Meier analysis of time to first HF hospitalization. RESULTS A total of 522 subjects were enrolled in the study at 93 sites. A total of 245 subjects in BMAD-HF and 249 in BMAD-TX were eligible for intention-to-treat analysis. There were 276 hospitalizations in 189 subjects at 90 days, of which 108 events were determined to be heart failure related in 82 subjects. The subjects in the arm managed using HFMS data to direct HF therapy had a 38% lower HF hospitalization rate during the 90 days following a HF hospitalization compared to subjects in the control arm (HR: 0.62; P = 0.03). CONCLUSIONS In patients with a recent HF hospitalization, a strategy of using HFMS data for HF management is associated with a 38% relative risk reduction in 90-day HF rehospitalization. (Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-TX]; NCT04096040; Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF]; NCT03476187).
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Affiliation(s)
- John P Boehmer
- Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
| | - Sebastian Cremer
- Department of Medicine, Cardiology, Goethe University Hospital, Frankfurt, Germany
| | | | | | - Azam Hadi
- Allegheny Health Network, Pittsburgh, Pennsylvania, USA
| | | | - Ashley E Burch
- Department of Health Services and Information Management, Department of Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA
| | - Diana Bonderman
- Medical Department of Cardiology and Emergency Medicine, Favoriten Clinic, Vienna, Austria
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22
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Hernández-Sebastián N, Diaz-Alonso D, Barrientos-García B, Renero-Carrillo FJ, Calleja-Arriaga W. Fabrication of an Integrated, Flexible, Wireless Pressure Sensor Array for the Monitoring of Ventricular Pressure. MICROMACHINES 2024; 15:1435. [PMID: 39770189 PMCID: PMC11676487 DOI: 10.3390/mi15121435] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/01/2024] [Revised: 11/23/2024] [Accepted: 11/26/2024] [Indexed: 01/11/2025]
Abstract
This work presents the design, fabrication, and rigorous validation of a flexible, wireless, capacitive pressure sensor for the full-range continuous monitoring of ventricular pressure. The proposed system consists of an implantable set and an external readout device; both modules were designed to form an RCL resonant circuit for passive, wireless pressure sensing and signal retrieving. Using surface micromachining and flexible electronics techniques, a two-variable capacitor array and a dual-layer planar coil were integrated into a flexible ergonomic substrate, avoiding hybrid-like connections in the implantable set. The proposed arrangement (capacitor array and dual-layer coil) allows us to optimize the operation pressure range and sensing distance. The use of polyimide as both the flexible substrate and the passivation material is a key feature, ensuring a biocompatible, implantable set that is mechanically flexible and can be folded to a compact size to achieve minimally invasive implantation. An external readout device has also been developed using a discrete printed circuit board (PCB) approach to support pressure measurements. The pressure responsivity of the sensor was validated to the laboratory level using a controlled pressure chamber. The results obtained show that the capacitance value of the sensor changed from 5.68 pF to 33.26 pF as the pressure varied from 0 to 300 mmHg. Correspondingly, the resonance frequency of the implantable set shifted from 12.75 MHz to 5.27 MHz. The sensitivity of the capacitive sensor was approximately 0.58 pF/mmHg and the typical response time was 220 ms. The wireless system performance was evaluated in both air and synthetic biological tissue using a Maxwell-Wien bridge circuit. The results showed a sensing distance longer than 3.5 cm, even under moderate misalignment conditions (up to 1.5 cm). The output voltage was successfully measured, ranging from 502.54 mV to 538.29 mV, throughout the full pressure range, with a measurement error of ±2.2 mV.
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23
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Peled Y, Ducharme A, Kittleson M, Bansal N, Stehlik J, Amdani S, Saeed D, Cheng R, Clarke B, Dobbels F, Farr M, Lindenfeld J, Nikolaidis L, Patel J, Acharya D, Albert D, Aslam S, Bertolotti A, Chan M, Chih S, Colvin M, Crespo-Leiro M, D'Alessandro D, Daly K, Diez-Lopez C, Dipchand A, Ensminger S, Everitt M, Fardman A, Farrero M, Feldman D, Gjelaj C, Goodwin M, Harrison K, Hsich E, Joyce E, Kato T, Kim D, Luong ML, Lyster H, Masetti M, Matos LN, Nilsson J, Noly PE, Rao V, Rolid K, Schlendorf K, Schweiger M, Spinner J, Townsend M, Tremblay-Gravel M, Urschel S, Vachiery JL, Velleca A, Waldman G, Walsh J. International Society for Heart and Lung Transplantation Guidelines for the Evaluation and Care of Cardiac Transplant Candidates-2024. J Heart Lung Transplant 2024; 43:1529-1628.e54. [PMID: 39115488 DOI: 10.1016/j.healun.2024.05.010] [Citation(s) in RCA: 22] [Impact Index Per Article: 22.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Accepted: 05/14/2024] [Indexed: 08/18/2024] Open
Abstract
The "International Society for Heart and Lung Transplantation Guidelines for the Evaluation and Care of Cardiac Transplant Candidates-2024" updates and replaces the "Listing Criteria for Heart Transplantation: International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates-2006" and the "2016 International Society for Heart Lung Transplantation Listing Criteria for Heart Transplantation: A 10-year Update." The document aims to provide tools to help integrate the numerous variables involved in evaluating patients for transplantation, emphasizing updating the collaborative treatment while waiting for a transplant. There have been significant practice-changing developments in the care of heart transplant recipients since the publication of the International Society for Heart and Lung Transplantation (ISHLT) guidelines in 2006 and the 10-year update in 2016. The changes pertain to 3 aspects of heart transplantation: (1) patient selection criteria, (2) care of selected patient populations, and (3) durable mechanical support. To address these issues, 3 task forces were assembled. Each task force was cochaired by a pediatric heart transplant physician with the specific mandate to highlight issues unique to the pediatric heart transplant population and ensure their adequate representation. This guideline was harmonized with other ISHLT guidelines published through November 2023. The 2024 ISHLT guidelines for the evaluation and care of cardiac transplant candidates provide recommendations based on contemporary scientific evidence and patient management flow diagrams. The American College of Cardiology and American Heart Association modular knowledge chunk format has been implemented, allowing guideline information to be grouped into discrete packages (or modules) of information on a disease-specific topic or management issue. Aiming to improve the quality of care for heart transplant candidates, the recommendations present an evidence-based approach.
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Affiliation(s)
- Yael Peled
- Leviev Heart & Vascular Center, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Faculty of Medical & Health Sciences, Tel Aviv University, Tel Aviv, Israel.
| | - Anique Ducharme
- Deparment of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
| | - Michelle Kittleson
- Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
| | - Neha Bansal
- Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Josef Stehlik
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah, USA
| | - Shahnawaz Amdani
- Department of Pediatric Cardiology, Cleveland Clinic Children's, Cleveland, Ohio, USA
| | - Diyar Saeed
- Heart Center Niederrhein, Helios Hospital Krefeld, Krefeld, Germany
| | - Richard Cheng
- Division of Cardiology, University of Washington, Seattle, WA, USA
| | - Brian Clarke
- Division of Cardiology, University of British Columbia, St Paul's Hospital, Vancouver, British Columbia, Canada
| | - Fabienne Dobbels
- Academic Centre for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium
| | - Maryjane Farr
- Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX; Parkland Health System, Dallas, TX, USA
| | - JoAnn Lindenfeld
- Division of Cardiovascular Medicine, Vanderbilt University, Nashville, TN, USA
| | | | - Jignesh Patel
- Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
| | - Deepak Acharya
- Division of Cardiovascular Diseases, University of Arizona Sarver Heart Center, Tucson, Arizona, USA
| | - Dimpna Albert
- Department of Paediatric Cardiology, Paediatric Heart Failure and Cardiac Transplant, Heart Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
| | - Saima Aslam
- Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, California, USA
| | - Alejandro Bertolotti
- Heart and Lung Transplant Service, Favaloro Foundation University Hospital, Buenos Aires, Argentina
| | - Michael Chan
- University of Alberta Hospital, Edmonton, Alberta, Canada
| | - Sharon Chih
- Heart Failure and Transplantation, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
| | - Monica Colvin
- Department of Cardiology, University of Michigan, Ann Arbor, MI; Scientific Registry of Transplant Recipients, Hennepin Healthcare Research Institute, Minneapolis, MN, USA
| | - Maria Crespo-Leiro
- Cardiology Department Complexo Hospitalario Universitario A Coruna (CHUAC), CIBERCV, INIBIC, UDC, La Coruna, Spain
| | - David D'Alessandro
- Massachusetts General Hospital, Boston; Harvard School of Medicine, Boston, MA, USA
| | - Kevin Daly
- Boston Children's Hospital & Harvard Medical School, Boston, MA, USA
| | - Carles Diez-Lopez
- Advanced Heart Failure and Heart Transplant Unit, Department of Cardiology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
| | - Anne Dipchand
- Division of Cardiology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
| | | | - Melanie Everitt
- Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA
| | - Alexander Fardman
- Leviev Heart & Vascular Center, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Faculty of Medical & Health Sciences, Tel Aviv University, Tel Aviv, Israel
| | - Marta Farrero
- Department of Cardiology, Hospital Clínic, Barcelona, Spain
| | - David Feldman
- Newark Beth Israel Hospital & Rutgers University, Newark, NJ, USA
| | - Christiana Gjelaj
- Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA
| | - Matthew Goodwin
- Division of Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, USA
| | - Kimberly Harrison
- Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Eileen Hsich
- Cleveland Clinic Foundation, Division of Cardiovascular Medicine, Cleveland, OH, USA
| | - Emer Joyce
- Department of Cardiology, Mater University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland
| | - Tomoko Kato
- Department of Cardiology, International University of Health and Welfare School of Medicine, Narita, Chiba, Japan
| | - Daniel Kim
- University of Alberta & Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada
| | - Me-Linh Luong
- Division of Infectious Disease, Department of Medicine, University of Montreal Hospital Center, Montreal, Quebec, Canada
| | - Haifa Lyster
- Department of Heart and Lung Transplantation, The Royal Brompton and Harefield NHS Foundation Trust, Harefield Hospital, Harefield, Middlesex, UK
| | - Marco Masetti
- Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
| | | | - Johan Nilsson
- Department of Cardiothoracic and Vascular Surgery, Skane University Hospital, Lund, Sweden
| | | | - Vivek Rao
- Division of Cardiac Surgery, University of Toronto, Toronto, Ontario, Canada
| | - Katrine Rolid
- Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
| | - Kelly Schlendorf
- Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN, USA
| | | | - Joseph Spinner
- Section of Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA
| | - Madeleine Townsend
- Division of Pediatric Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada
| | - Maxime Tremblay-Gravel
- Deparment of Medicine, Montreal Heart Institute, Université?de Montréal, Montreal, Quebec, Canada
| | - Simon Urschel
- Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada
| | - Jean-Luc Vachiery
- Department of Cardiology, Cliniques Universitaires de Bruxelles, Hôpital Académique Erasme, Bruxelles, Belgium
| | - Angela Velleca
- Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
| | - Georgina Waldman
- Department of Pharmacy, Massachusetts General Hospital, Boston, MA, USA
| | - James Walsh
- Allied Health Research Collaborative, The Prince Charles Hospital, Brisbane; Heart Lung Institute, The Prince Charles Hospital, Brisbane, Australia
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24
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Efremov S, Zagatina A, Filippov A, Ryadinskiy M, Novikov M, Shmatov D. Left Ventricular Diastolic Dysfunction in Cardiac Surgery: A Narrative Review. J Cardiothorac Vasc Anesth 2024; 38:2459-2470. [PMID: 39069379 DOI: 10.1053/j.jvca.2024.06.042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/04/2024] [Revised: 06/19/2024] [Accepted: 06/27/2024] [Indexed: 07/30/2024]
Abstract
Cardiac relaxation is a complex process that involves various interconnected characteristics and, along with contractile properties, determines stroke volume. Perioperative ischemia-reperfusion injury and left ventricular diastolic dysfunction (DD) are characterized by the left ventricle's inability to receive a sufficient blood volume under adequate preload. Baseline DD and perioperative DD have an impact on postoperative complications, length of hospital stay, and major clinical outcomes in a variety of cardiac pathologies. Several baseline and perioperative factors, such as age, female sex, hypertension, left ventricle hypertrophy, diabetes, and perioperative ischemia-reperfusion injury, contribute to the risk of DD. The recommended diagnostic criteria available in guidelines have not been validated in the perioperative settings and still need clarification. Timely diagnosis of DD might be crucial for effectively treating postoperative low cardiac output syndrome. This implies the need for an individualized approach to fluid infusion strategy, cardiac rate and rhythm control, identification of extrinsic causes, and administration of drugs with lusitropic effects. The purpose of this review is to consolidate scattered information on various aspects of diastolic dysfunction in cardiac surgery and provide readers with well-organized and clinically applicable information.
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Affiliation(s)
- Sergey Efremov
- Saint-Petersburg State University Hospital, Saint-Petersburg, Russian Federation.
| | - Angela Zagatina
- Cardiology Department, Research Cardiology Center "Medika", Saint Petersburg, Russian Federation
| | - Alexey Filippov
- Saint-Petersburg State University Hospital, Saint-Petersburg, Russian Federation
| | - Mikhail Ryadinskiy
- Saint-Petersburg State University Hospital, Saint-Petersburg, Russian Federation
| | - Maxim Novikov
- Saint-Petersburg State University Hospital, Saint-Petersburg, Russian Federation
| | - Dmitry Shmatov
- Saint-Petersburg State University Hospital, Saint-Petersburg, Russian Federation
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25
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Clephas PRD, de Boer RA, Brugts JJ. Benefits of remote hemodynamic monitoring in heart failure. Trends Cardiovasc Med 2024; 34:468-476. [PMID: 38109949 DOI: 10.1016/j.tcm.2023.12.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2023] [Revised: 11/28/2023] [Accepted: 12/13/2023] [Indexed: 12/20/2023]
Abstract
Despite treatment advancements, HF mortality remains high, prompting interest in reducing HF-related hospitalizations through remote monitoring. These advances are necessary considering the rapidly rising prevalence and incidence of HF worldwide, presenting a burden on hospital resources. While traditional approaches have failed in predicting impending HF-related hospitalizations, remote hemodynamic monitoring can detect changes in intracardiac filling pressure weeks prior to HF-related hospitalizations which makes timely pharmacological interventions possible. To ensure successful implementation, structural integration, optimal patient selection, and efficient data management are essential. This review aims to provide an overview of the rationale, the available devices, current evidence, and the implementation of remote hemodynamic monitoring.
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Affiliation(s)
- P R D Clephas
- Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands
| | - R A de Boer
- Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands
| | - J J Brugts
- Department of Cardiology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands.
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26
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Tabrizchi R. Adequacy of Ambulatory Hemodynamic Assessments for Reducing All-Cause Mortality in Individuals With Heart Failure. INTERNATIONAL JOURNAL OF HEART FAILURE 2024; 6:149-158. [PMID: 39513021 PMCID: PMC11538721 DOI: 10.36628/ijhf.2024.0021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Revised: 08/27/2024] [Accepted: 09/18/2024] [Indexed: 11/15/2024]
Abstract
Heart failure (HF) as a syndrome which is normally associated with significant reduction of cardiac output has evolved to include conditions such those of moderate and preserved ejection fraction. While the prevalence of HF in the population is increasing, it is not HF with reduced ejection fraction that is driving the trajectory upward for mortality. There is some evidence to suggest that a better understanding of the pathophysiology, novel pharmacological strategies, devices, as well as remote monitoring of the hemodynamics seem to account for a reduction in the cardiovascular mortality and re-hospitalization in some cohorts with HF. However, the all-cause mortality associated with HF has not been reduced significantly by the current interventions. To explore the potential approaches needed for the strategies and avenues to reduce all-cause mortality in patients with HF, it would be helpful to evaluate the evidence in the literature directed at the care of patients with chronic/acute decompensated HF. It is evident that ambulatory measurements of pressures and volume are pivotal in a better management of HF but unless the interventions extend to an improvement in the renal function, the chances of reducing all-cause mortality seems modest. Therefore, future directions of interventions must not only be directed at close monitoring of pressures and volume simultaneously in HF patients but also at improving renal function. Moreover, it is clear that venous congestion plays a detrimental role in the deterioration of renal function and until measures are in place to reduce it, all-cause mortality will not decrease.
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Affiliation(s)
- Reza Tabrizchi
- Division of BioMedical Sciences, Faculty of Medicine, Memorial University of Newfoundland, St. John’s, NL, Canada
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Krittanawong C, Britt WM, Rizwan A, Siddiqui R, Khawaja M, Khan R, Joolharzadeh P, Newman N, Rivera MR, Tang WHW. Clinical Update in Heart Failure with Preserved Ejection Fraction. Curr Heart Fail Rep 2024; 21:461-484. [PMID: 39225910 DOI: 10.1007/s11897-024-00679-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/02/2024] [Indexed: 09/04/2024]
Abstract
PURPOSE OF REVIEW To review the most recent clinical trials and data regarding epidemiology, pathophysiology, diagnosis, and treatment of heart failure with preserved ejection fraction with an emphasis on the recent trends in cardiometabolic interventions. RECENT FINDINGS Heart failure with preserved ejection fraction makes up approximately half of overall heart failure and is associated with significant morbidity, mortality, and overall burden on the healthcare system. It is a complex, heterogenous syndrome and clinical trials, to this point, have not revealed quite as many effective treatment options when compared to heart failure with reduced ejection fraction. Nevertheless, there is an expanding amount of data insight into the pathogenesis of this disease and the potential for newer therapies and management strategies. Heart failure with preserved ejection fraction pathology has been found to be linked to abnormal energetics, myocyte hypertrophy, cell signaling, inflammation, ischemia, and fibrosis. These mechanisms also intricately overlap with the significant comorbidities often associated with heart failure with preserved ejection fraction including, but not limited to, atrial fibrillation, chronic kidney disease, hypertension, obesity and coronary artery disease. Treatment of this disease, therefore, should focus on the management and strict regulation of these comorbidities by pharmacologic and nonpharmacologic means. In this review, a clinical update is provided reviewing the most recent clinical trials and data regarding epidemiology, pathophysiology, diagnosis, and treatment of heart failure with preserved ejection fraction with an emphasis on the recent trend in cardiometabolic interventions.
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Affiliation(s)
| | - William Michael Britt
- Department of Internal Medicine, Emory University School of Medicine, Atlanta, GA, 30322, USA
| | - Affan Rizwan
- Baylor College of Medicine, Houston, TX, 77030, USA
| | - Rehma Siddiqui
- Department of Internal Medicine, University of Mississippi Medical Center, Jackson, MS, 39216, USA
| | - Muzamil Khawaja
- Division of Cardiology, Emory University School of Medicine, Atlanta, GA, 30322, USA
| | - Rabisa Khan
- Department of Internal Medicine, University of Mississippi Medical Center, Jackson, MS, 39216, USA
| | - Pouya Joolharzadeh
- John T Milliken Department of Medicine, Division of Cardiovascular Disease, Barnes-Jewish Hospital, St Louis, United States
| | - Noah Newman
- Department of Internal Medicine, Emory University School of Medicine, Atlanta, GA, 30322, USA
| | - Mario Rodriguez Rivera
- Advanced Heart Failure and Transplant, Barnes-Jewish Hospital Washington University in St Louis School of Medicine, St.Louis, MO, USA
| | - W H Wilson Tang
- Kaufman Center for Heart Failure Treatment and Recovery, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH, 44195, USA
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Reed GW, Harmon EK, Harb S, Yun J, Krishnaswamy A, Abraham WT, Kapadia S. Design and Rationale of the V-Wave Shunt MitraClip Study. Am J Cardiol 2024; 227:29-36. [PMID: 38950689 DOI: 10.1016/j.amjcard.2024.06.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/01/2024] [Revised: 06/03/2024] [Accepted: 06/10/2024] [Indexed: 07/03/2024]
Abstract
Heart failure (HF) and moderate-to-severe mitral regurgitation (MR) with residual elevations in left atrial pressure (LAP) after MitraClip may remain symptomatic and experience subsequent HF readmissions. The V-Wave interatrial shunt system is a permanent interatrial septal implant that shunts blood from the left-to-right atrium and serves to continuously unload the left atrium. Although the V-Wave shunt has previously been studied in patients with HF, the safety and feasibility of its deployment at the time of the MitraClip procedure is unknown. The V-Wave Shunt MitraClip Study (NCT04729933) is an early feasibility study that aims to demonstrate the safety and efficacy of implantation of the V-Wave shunt device at the time of MitraClip procedure. Patients with moderate-to-severe secondary MR with left ventricular ejection fraction 20% to 50% and New York Heart Association functional class III/IV symptoms despite optimal medical therapy, residual mean LAP ≥20 mm Hg after MitraClip, and mean LAP-right atrial pressure difference ≥5 mm Hg are included. The primary safety end point is a composite outcome of all-cause death, stroke, myocardial infarction device embolization, cardiac tamponade, or device-related re-intervention or surgery at 30 days. Patients will be followed up to 5 years. Enrollment is ongoing, with 30-day results expected by the end of 2024. The V-Wave Shunt Mitraclip Study aims to demonstrate the safety and efficacy of the implantation of the V-Wave interatrial shunt device at the time of index MitraClip placement which may serve as an adjunctive method by which continuous left atrial unloading may be achieved.
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Affiliation(s)
- Grant W Reed
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
| | - Evan K Harmon
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Serge Harb
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - James Yun
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - Amar Krishnaswamy
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
| | - William T Abraham
- Division of Cardiovascular Medicine, Ohio State University, Columbus, Ohio
| | - Samir Kapadia
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
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Lin CY, Lin SI, Lee YH, Chen CY. Left Atrial Hemodynamics and Clinical Utility in Heart Failure. Rev Cardiovasc Med 2024; 25:325. [PMID: 39355585 PMCID: PMC11440442 DOI: 10.31083/j.rcm2509325] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Revised: 05/03/2024] [Accepted: 05/16/2024] [Indexed: 10/03/2024] Open
Abstract
Comprehensive knowledge of the left atrium (LA) and its pathophysiology has emerged as an important clinical and research focus in the heart failure (HF) arena. Although studies on HF focusing on investigating left ventricular remodeling are numerous, those on atrial structural and functional changes have received comparatively less attention. Studies on LA remodeling have recently received increasing attention, and LA pressure (LAP) has become a novel target for advanced monitoring and is a potential therapeutic approach for treating HF. Various devices specifically designed for the direct measurement of LAP have been developed to optimize HF treatment by reducing LAP. This review focuses on LA hemodynamic monitoring and effective LAP decompression.
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Affiliation(s)
- Chang-Yi Lin
- Cardiovascular Division, Department of Internal Medicine, Mackay Memorial Hospital, Mackay Medical College, 104217 New Taipei City, Taiwan
| | - Shu-I Lin
- Cardiovascular Division, Department of Internal Medicine, Mackay Memorial Hospital, Mackay Medical College, 104217 New Taipei City, Taiwan
- Department of Nursing, Mackay Junior College of Medicine, Nursing and Management, 104217 New Taipei City, Taiwan
| | - Ying-Hsiang Lee
- Cardiovascular Division, Department of Internal Medicine, Mackay Memorial Hospital, Mackay Medical College, 104217 New Taipei City, Taiwan
- Department of Nursing, Mackay Junior College of Medicine, Nursing and Management, 104217 New Taipei City, Taiwan
| | - Chun-Yen Chen
- Cardiovascular Division, Department of Internal Medicine, Mackay Memorial Hospital, Mackay Medical College, 104217 New Taipei City, Taiwan
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Fernandez Valledor A, Moeller CM, Rubinstein G, Oren D, Rahman S, Baranowska J, Lee C, Lorenzatti D, Righini FM, Lotan D, Sayer GT, Uriel N. Durable left ventricular assist devices as a bridge to transplantation: what to expect along the way? Expert Rev Med Devices 2024; 21:829-840. [PMID: 39169616 DOI: 10.1080/17434440.2024.2393344] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Revised: 07/28/2024] [Accepted: 08/13/2024] [Indexed: 08/23/2024]
Abstract
INTRODUCTION The scarcity of donors coupled with the improvements in left ventricular assist devices (LVAD) technology has led to the use of LVAD as a bridge to transplantation (BTT). AREAS COVERED The authors provide an overview of the current status of LVAD BTT implantation with special focus ranging from patient selection and pre-implantation optimization to post-transplant outcomes. EXPERT OPINION The United Network for Organ Sharing 2018 policy amendment resulted in a significant reduction in the number of LVADs used for BTT in the US. To overcome this issue, modifications in the US allocation policy to consider factors such as days on device support, age, and type of complications may be necessary to potentially increase implantation rates.
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Affiliation(s)
- Andrea Fernandez Valledor
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Cathrine M Moeller
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Gal Rubinstein
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Daniel Oren
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Salwa Rahman
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Julia Baranowska
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Changhee Lee
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Daniel Lorenzatti
- Division of Cardiology, Montefiore Medical Center. Albert Einstein College of Medicine, New York, NY, USA
| | - Francesca Maria Righini
- Division of Cardiology, Department of Medical Biotechnologies, University of Sienna, Toscana, Italy
| | - Dor Lotan
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Gabriel T Sayer
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
| | - Nir Uriel
- Division of Cardiology, Advanced Cardiac Care, Columbia University Irving Medical Center, New York, NY, USA
- Division of Cardiology, Weill Cornell Medicine, New York, NY, USA
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Clephas PRD, Zwartkruis VW, Malgie J, van Gent MWF, Brunner-La Rocca HP, Szymanski MK, van Halm VP, Handoko ML, Kok WEM, Asselbergs FW, van Kimmenade RRJ, Manintveld OC, van Mieghem NMDA, Beeres SLMA, Post MC, Borleffs CJW, Tukkie R, Mosterd A, Linssen GCM, Spee RF, Emans ME, Smilde TDJ, van Ramshorst J, Kirchhof CJHJ, Feenema-Aardema MW, da Fonseca CA, van den Heuvel M, Hazeleger R, van Eck M, van Heerebeek L, Boersma E, Rienstra M, de Boer RA, Brugts JJ. Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial. Eur Heart J 2024; 45:2954-2964. [PMID: 38733175 PMCID: PMC11335373 DOI: 10.1093/eurheartj/ehae323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Revised: 05/03/2024] [Accepted: 05/09/2024] [Indexed: 05/13/2024] Open
Abstract
BACKGROUND AND AIMS In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.
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Affiliation(s)
- Pascal R D Clephas
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Victor W Zwartkruis
- Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands
| | - Jishnu Malgie
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Marco W F van Gent
- Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, Netherlands
| | | | - Mariusz K Szymanski
- Department of Cardiology, University Medical Center Utrecht, Utrecht, Netherlands
| | - Vokko P van Halm
- Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - M Louis Handoko
- Department of Cardiology, University Medical Center Utrecht, Utrecht, Netherlands
| | - Wouter E M Kok
- Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Folkert W Asselbergs
- Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | | | - Olivier C Manintveld
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Nicolas M D A van Mieghem
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Saskia L M A Beeres
- Department of Cardiology, Leiden University Medical Centre, Leiden, Netherlands
| | - Marco C Post
- Department of Cardiology, University Medical Center Utrecht, Utrecht, Netherlands
- Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands
| | | | - Raymond Tukkie
- Department of Cardiology, Spaarne Hospital, Haarlem, Netherlands
| | - Arend Mosterd
- Department of Cardiology, Meander Medical Centre, Amersfoort, Netherlands
| | | | - Ruud F Spee
- Department of Cardiology, Maxima Medical Centre, Veldhoven/Eindhoven, Netherlands
| | - Mireille E Emans
- Department of Cardiology, Ikazia Hospital, Rotterdam, Netherlands
| | - Tom D J Smilde
- Department of Cardiology, Scheeper Hospital TREANT, Emmen, Netherlands
| | - Jan van Ramshorst
- Department of Cardiology, Noordwest Hospital Group, Alkmaar, Netherlands
| | | | | | - Carlos A da Fonseca
- Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, Netherlands
| | | | | | - Martijn van Eck
- Department of Cardiology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, Netherlands
| | | | - Eric Boersma
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Michiel Rienstra
- Department of Cardiology, University Medical Centre Groningen, Groningen, Netherlands
| | - Rudolf A de Boer
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
| | - Jasper J Brugts
- Department of Cardiology, Thorax Centre, Cardiovascular Institute, Erasmus University Medical Center, Dr. Molewaterplein 40, 3015GD Rotterdam, Netherlands
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Patel M, Tated RCP, Maheta DK, Agrawal SP, Frishman WH, Aronow WS. Exploring Atrial Shunt Therapy for Heart Failure: A Comprehensive Review of the Atrial Coronary Sinus Shunt. Cardiol Rev 2024:00045415-990000000-00312. [PMID: 39145658 DOI: 10.1097/crd.0000000000000775] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/16/2024]
Abstract
Heart failure is a prevalent and severe medical condition characterized by the heart's inability to pump blood efficiently, leading to poor circulation and symptoms such as pulmonary congestion. Despite advancements in medical treatments, many patients continue to experience significant symptoms with reduced quality of life. This article explores the left atrial coronary sinus shunt as an innovative interventional strategy to address hemodynamic issues in heart failure. The shunt aims to decrease left atrial pressure and alleviate pulmonary congestion by creating a connection between the left atrium and the coronary sinus.
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Affiliation(s)
- Manav Patel
- From the Department of Medicine, Smt. NHLMMC, Ahmedabad, India
| | | | | | - Siddharth Pravin Agrawal
- Department of Internal Medicine, New York Medical College/Landmark Medical Center, Woonsocket, RI
| | | | - Wilbert S Aronow
- Department of Medicine, New York Medical College, Valhalla, NY
- Departments of Cardiology and Medicine, Westchester Medical Center and New York Medical College, Valhalla, NY
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Ilonze OJ, Ebong IA, Guglin M, Nair A, Rich J, McLaughlin V, Tedford RJ, Mazimba S. Considerations in the Diagnosis and Management of Pulmonary Hypertension Associated With Left Heart Disease. JACC. HEART FAILURE 2024; 12:1328-1342. [PMID: 38970588 DOI: 10.1016/j.jchf.2024.04.031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/03/2023] [Revised: 03/04/2024] [Accepted: 04/08/2024] [Indexed: 07/08/2024]
Abstract
Pulmonary hypertension associated with left heart disease (PH-LHD) remains the most common cause of pulmonary hypertension globally. Etiologies include heart failure with reduced and preserved ejection fraction and left-sided valvular heart diseases. Despite the increasing prevalence of PH-LHD, there remains a paucity of knowledge about the hemodynamic definition, diagnosis, treatment modalities, and prognosis among clinicians. Moreover, clinical trials have produced mixed results on the usefulness of pulmonary vasodilator therapies for PH-LHD. In this expert review, we have outlined the critical role of meticulous hemodynamic evaluation and provocative testing for cases of diagnostic uncertainty. Therapeutic strategies-pharmacologic, device-based, and surgical therapies used for managing PH-LHD-are also outlined. PH-LHD in advanced heart failure, and the role of mechanical circulatory support in PH-LHD is briefly explored. An in-depth understanding of PH-LHD by all clinicians is needed for improved recognition and outcomes among patients with PH-LHD.
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Affiliation(s)
- Onyedika J Ilonze
- Division of Cardiovascular Medicine, Krannert Cardiovascular Research Center, Indiana University, Indianapolis, Indiana, USA.
| | - Imo A Ebong
- Division of Cardiology, University of California Davis, Sacramento, California, USA
| | - Maya Guglin
- Division of Cardiovascular Medicine, Krannert Cardiovascular Research Center, Indiana University, Indianapolis, Indiana, USA
| | - Ajith Nair
- Winters Center for Heart Failure Research, Michael E. DeBakey VA Medical Center, Texas Heart Institute, Baylor College of Medicine, Houston, Texas, USA
| | - Jonathan Rich
- Division of Cardiology, Bluhm Cardiovascular Institute Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Vallerie McLaughlin
- University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, USA
| | - Ryan J Tedford
- Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA
| | - Sula Mazimba
- Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia, USA; AdventHealth, Orlando, Florida, USA
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Scacciavillani R, Koliastasis L, Doundoulakis I, Chiotis S, Kordalis A, Narducci ML, Kotoulas S, Pinnacchio G, Bencardino G, Perna F, Comerci G, Gatzoulis KA, Tsiachris D, Pelargonio G. Remote Monitoring of Cardiac Implantable Electronic Devices in Very Elderly Patients: Advantages and Specific Problems. J Cardiovasc Dev Dis 2024; 11:209. [PMID: 39057629 PMCID: PMC11277150 DOI: 10.3390/jcdd11070209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2024] [Revised: 06/24/2024] [Accepted: 06/27/2024] [Indexed: 07/28/2024] Open
Abstract
Cardiac implantable electronic devices (CIEDs) offer the benefit of remote monitoring and decision making and find particular applications in special populations such as the elderly. Less transportation, reduced costs, prompt diagnosis, a sense of security, and continuous real-time monitoring are the main advantages. On the other hand, less physician-patient interactions and the technology barrier in the elderly pose specific problems in remote monitoring. CIEDs nowadays are abundant and are mostly represented by rhythm control/monitoring devices, whereas hemodynamic remote monitoring devices are gaining popularity and are evolving and becoming refined. Future directions include the involvement of artificial intelligence, yet disparities of availability, lack of follow-up data, and insufficient patient education are still areas to be improved. This review aims to describe the role of CIED in the very elderly and highlight the merits and possible drawbacks.
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Affiliation(s)
- Roberto Scacciavillani
- Department of Cardiovascular & Pulmonary Sciences, Catholic University of the Sacred Heart, 00168 Rome, Italy; (R.S.); (G.P.)
| | - Leonidas Koliastasis
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Ioannis Doundoulakis
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Sotirios Chiotis
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Athanasios Kordalis
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Maria Lucia Narducci
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
- Cardiology Unit, Cardiothoracic Department, Azienda Ospedaliera Universitaria Santa Maria della Misericordia, 33100 Udine, Italy
| | - Sotiris Kotoulas
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Gaetano Pinnacchio
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
| | - Gianluigi Bencardino
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
| | - Francesco Perna
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
| | - Gianluca Comerci
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
| | - Konstantinos A. Gatzoulis
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Dimitris Tsiachris
- First Department of Cardiology, National and Kapodistrian University, “Hippokration” Hospital, 11527 Athens, Greece; (L.K.); (S.C.); (A.K.); (S.K.); (K.A.G.); (D.T.)
| | - Gemma Pelargonio
- Department of Cardiovascular & Pulmonary Sciences, Catholic University of the Sacred Heart, 00168 Rome, Italy; (R.S.); (G.P.)
- Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy; (M.L.N.); (G.P.); (G.B.); (F.P.); (G.C.)
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Adamson PB, Echols M, DeFilippis EM, Morris AA, Bennett M, Abraham WT, Lindenfeld J, Teerlink JR, O'Connor CM, Connolly AT, Li H, Fiuzat M, Vaduganathan M, Vardeny O, Batchelor W, McCants KC. Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations. JACC. HEART FAILURE 2024; 12:1212-1222. [PMID: 38530702 DOI: 10.1016/j.jchf.2024.02.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/25/2023] [Revised: 01/31/2024] [Accepted: 02/26/2024] [Indexed: 03/28/2024]
Abstract
BACKGROUND Inadequate inclusion in clinical trial enrollment may contribute to health inequities by evaluating interventions in cohorts that do not fully represent target populations. OBJECTIVES The aim of this study was to determine if characteristics of patients with heart failure (HF) enrolled in a pivotal trial are associated with who receives an intervention after approval. METHODS Demographics from 2,017,107 Medicare patients hospitalized for HF were compared with those of the first 10,631 Medicare beneficiaries who received implantable pulmonary artery pressure sensors. Characteristics of the population studied in the pivotal CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) clinical trial (n = 550) were compared with those of both groups. All demographic data were analyzed nationally and in 4 U.S. regions. RESULTS The Medicare HF cohort included 80.9% White, 13.3% African American, 1.9% Hispanic, 1.3% Asian, and 51.5% female patients. Medicare patients <65 years of age were more likely to be African American (33%) and male (58%), whereas older patients were mostly White (84%) and female (53%). Forty-one percent of U.S. HF hospitalizations occurred in the South; demographic characteristics varied significantly across all U.S. regions. The CHAMPION trial adequately represented African Americans (23% overall, 35% <65 years of age), Hispanic Americans (2%), and Asian Americans (1%) but underrepresented women (27%). The trial's population characteristics were similar to those of the first patients who received pulmonary artery sensors (82% White, 13% African American, 1% Asian, 1% Hispanic, and 29% female). CONCLUSIONS Demographics of Centers for Medicare and Medicaid Services beneficiaries hospitalized with HF vary regionally and by age, which should be considered when defining "adequate" representation in clinical studies. Enrollment diversity in clinical trials may affect who receives early application of recently approved innovations.
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Affiliation(s)
- Philip B Adamson
- Heart Failure Division, Abbott Laboratories, Austin, Texas, USA.
| | - Melvin Echols
- Division of Cardiology, Morehouse School of Medicine, Atlanta, Georgia, USA
| | - Ersilia M DeFilippis
- Division of Cardiology, Columbia University Irving Medical Center, New York, New York, USA
| | | | - Mosi Bennett
- Allina Health Minneapolis Heart Institute, Minneapolis, Minnesota, USA
| | | | | | - John R Teerlink
- Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco, California, USA
| | - Christopher M O'Connor
- Inova Heart and Vascular Institute, Falls Church, Virginia, USA; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA
| | - Allison T Connolly
- Global Data Science and Analytics, Abbott Laboratories, Santa Clara, California, USA
| | - Huanan Li
- Global Data Science and Analytics, Abbott Laboratories, Santa Clara, California, USA
| | - Mona Fiuzat
- Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA
| | - Muthiah Vaduganathan
- Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Orly Vardeny
- Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA
| | - Wayne Batchelor
- Inova Heart and Vascular Institute, Falls Church, Virginia, USA
| | - Kelly C McCants
- Norton Heart & Vascular Institute, Norton Healthcare, Louisville, Kentucky, USA
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Awad M, Colantonio M, Liriano MM, Santer M, Shepherd K, Haleem A. CardioMEMS monitoring device migration: A rare complication. Radiol Case Rep 2024; 19:2596-2599. [PMID: 38645959 PMCID: PMC11026698 DOI: 10.1016/j.radcr.2024.03.049] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2024] [Revised: 03/08/2024] [Accepted: 03/20/2024] [Indexed: 04/23/2024] Open
Abstract
We present a rare case of CardioMEMS device migration six years post-implantation. Much is still being learned about endothelization of pulmonary vasculature and this case highlights the importance of device surveillance and device-related complications.
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Affiliation(s)
- Maan Awad
- Department of Medicine, West Virginia University, Morgantown, WV 26506, USA
| | - Mark Colantonio
- Department of Medicine, West Virginia University, Morgantown, WV 26506, USA
| | | | - Matthew Santer
- Department of Medicine, West Virginia University, Morgantown, WV 26506, USA
| | - Katherine Shepherd
- Department of Medicine, West Virginia University, Morgantown, WV 26506, USA
| | - Affan Haleem
- Heart and Vascular Institute, West Virginia University, Morgantown, WV 26506, USA
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Teixeira AR, Barbas de Albuquerque F, Pereira-da-Silva T, Cacela D, Cruz Ferreira R. A rare case of CardioMEMS™ sensor migration. Future Cardiol 2024; 20:453-458. [PMID: 38899747 PMCID: PMC11485755 DOI: 10.1080/14796678.2024.2363717] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2023] [Accepted: 05/31/2024] [Indexed: 06/21/2024] Open
Abstract
The CardioMEMS™ system remotely monitors changes in pulmonary artery pressures, which allows for early detection of heart failure worsening. It is a safe and reliable invasive monitoring system. We report a case in which there was a late migration of the device at 6 months of follow-up to the contralateral pulmonary artery. The mechanisms, consequences, and management of device migration are discussed. To our knowledge, there are very few published data on late sensor migration.
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Affiliation(s)
- Ana Rita Teixeira
- Department of Cardiology, Hospital de Santa Marta, Unidade Local de Saúde de São José, Lisbon, Portugal
| | | | - Tiago Pereira-da-Silva
- Department of Cardiology, Hospital de Santa Marta, Unidade Local de Saúde de São José, Lisbon, Portugal
| | - Duarte Cacela
- Department of Cardiology, Hospital de Santa Marta, Unidade Local de Saúde de São José, Lisbon, Portugal
| | - Rui Cruz Ferreira
- Department of Cardiology, Hospital de Santa Marta, Unidade Local de Saúde de São José, Lisbon, Portugal
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38
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Urban S, Szymański O, Grzesiak M, Tokarczyk W, Błaziak M, Jura M, Fułek M, Fułek K, Iwanek G, Gajewski P, Ponikowski P, Biegus J, Zymliński R. Effectiveness of remote pulmonary artery pressure estimating in heart failure: systematic review and meta-analysis. Sci Rep 2024; 14:12929. [PMID: 38839890 PMCID: PMC11153505 DOI: 10.1038/s41598-024-63742-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Accepted: 05/31/2024] [Indexed: 06/07/2024] Open
Abstract
Heart failure (HF) poses a significant challenge, often leading to frequent hospitalizations and compromised quality of life. Continuous pulmonary artery pressure (PAP) monitoring offers a surrogate for congestion status in ambulatory HF care. This meta-analysis examines the efficacy of PAP monitoring devices (CardioMEMS and Chronicle) in preventing adverse outcomes in HF patients, addressing gaps in prior randomized controlled trials (RCTs). Five RCTs (2572 participants) were systematically reviewed. PAP monitoring significantly reduced HF-related hospitalizations (RR 0.72 [95% CI 0.6-0.87], p = 0.0006) and HF events (RR 0.86 [95% CI 0.75-0.99], p = 0.03), with no impact on all-cause or cardiovascular mortality. Subgroup analyses highlighted the significance of CardioMEMS and blinded studies. Meta-regression indicated a correlation between prolonged follow-up and increased reduction in HF hospitalizations. The risk of bias was generally high, with evidence certainty ranging from low to moderate. PAP monitoring devices exhibit promise in diminishing HF hospitalizations and events, especially in CardioMEMS and blinded studies. However, their influence on mortality remains inconclusive. Further research, considering diverse patient populations and intervention strategies with extended follow-up, is crucial for elucidating the optimal role of PAP monitoring in HF management.
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Affiliation(s)
- Szymon Urban
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Oskar Szymański
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wrocław, Poland
| | - Magdalena Grzesiak
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wrocław, Poland.
| | - Wojciech Tokarczyk
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wrocław, Poland
| | - Mikołaj Błaziak
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Maksym Jura
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wrocław, Poland
- Department of Physiology and Pathophysiology, Wroclaw Medical University, Wrocław, Poland
| | - Michał Fułek
- Department and Clinic of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Katarzyna Fułek
- Department and Clinic of Otolaryngology, Head and Neck Surgery, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Gracjan Iwanek
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Piotr Gajewski
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Piotr Ponikowski
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Jan Biegus
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
| | - Robert Zymliński
- Institute of Heart Diseases, University Clinical Hospital in Wroclaw, Wroclaw Medical University, Wrocław, Poland
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Aslan U, Beeres SLMA, Feijen M, Mulder GM, Jukema JW, Egorova AD. Efficacy of the Cardiac Implantable Electronic Device Multisensory Triage-HF Algorithm in Heart Failure Care: A Real-World Clinical Experience. SENSORS (BASEL, SWITZERLAND) 2024; 24:3664. [PMID: 38894453 PMCID: PMC11175325 DOI: 10.3390/s24113664] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/26/2024] [Revised: 05/23/2024] [Accepted: 05/31/2024] [Indexed: 06/21/2024]
Abstract
Heart failure (HF) admissions are burdensome, and the mainstay of prevention is the timely detection of impending fluid retention, creating a window for medical treatment intensification. This study evaluated the accuracy and performance of a Triage-HF-guided carepath in real-world ambulatory HF patients in daily clinical practice. In this prospective, observational study, 92 adult HF patients (71 males (78%), with a median age of 69 [IQR 59-75] years) with the Triage-HF algorithm activated in their cardiac implantable electronic devices (CIEDs), were monitored. Following high-risk alerts, an HF nurse contacted patients to identify signs and symptoms of fluid retention. The sensitivity and specificity were 83% and 97%, respectively. The positive predictive value was 89%, and negative predictive value was 94%. The unexplained alert rate was 0.05 alerts/patient year, and the false negative rate was 0.11 alerts/patient year. Ambulatory diuretics were initiated or escalated in 77% of high-risk alert episodes. In 23% (n = 6), admission was ultimately required. The median alert handling time was 2 days. Fifty-eight percent (n = 18) of high-risk alerts were classified as true positives in the first week, followed by 29% in the second-third weeks (n = 9), and 13% (n = 4) in the fourth-sixth weeks. Common sensory triggers included an elevated night ventricular rate (84%), OptiVol (71%), and reduced patient activity (71%). The CIED-based Triage-HF algorithm-driven carepath enables the timely detection of impending fluid retention in a contemporary ambulatory setting, providing an opportunity for clinical action.
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Affiliation(s)
- Ugur Aslan
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
| | - Saskia L. M. A. Beeres
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
| | - Michelle Feijen
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
| | - Gerlinde M. Mulder
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
| | - J. Wouter Jukema
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
- Netherlands Heart Institute, Morseelsepark 1, 3511 EP Utrecht, The Netherlands
| | - Anastasia D. Egorova
- Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands; (U.A.); (S.L.M.A.B.); (G.M.M.); (J.W.J.)
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40
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Zinno C, Agnesi F, D'Alesio G, Dushpanova A, Brogi L, Camboni D, Bernini F, Terlizzi D, Casieri V, Gabisonia K, Alibrandi L, Grigoratos C, Magomajew J, Aquaro GD, Schmitt S, Detemple P, Oddo CM, Lionetti V, Micera S. Implementation of an epicardial implantable MEMS sensor for continuous and real-time postoperative assessment of left ventricular activity in adult minipigs over a short- and long-term period. APL Bioeng 2024; 8:026102. [PMID: 38633836 PMCID: PMC11023704 DOI: 10.1063/5.0169207] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2023] [Accepted: 04/01/2024] [Indexed: 04/19/2024] Open
Abstract
The sensing of left ventricular (LV) activity is fundamental in the diagnosis and monitoring of cardiovascular health in high-risk patients after cardiac surgery to achieve better short- and long-term outcome. Conventional approaches rely on noninvasive measurements even if, in the latest years, invasive microelectromechanical systems (MEMS) sensors have emerged as a valuable approach for precise and continuous monitoring of cardiac activity. The main challenges in designing cardiac MEMS sensors are represented by miniaturization, biocompatibility, and long-term stability. Here, we present a MEMS piezoresistive cardiac sensor capable of continuous monitoring of LV activity over time following epicardial implantation with a pericardial patch graft in adult minipigs. In acute and chronic scenarios, the sensor was able to compute heart rate with a root mean square error lower than 2 BPM. Early after up to 1 month of implantation, the device was able to record the heart activity during the most important phases of the cardiac cycle (systole and diastole peaks). The sensor signal waveform, in addition, closely reflected the typical waveforms of pressure signal obtained via intraventricular catheters, offering a safer alternative to heart catheterization. Furthermore, histological analysis of the LV implantation site following sensor retrieval revealed no evidence of myocardial fibrosis. Our results suggest that the epicardial LV implantation of an MEMS sensor is a suitable and reliable approach for direct continuous monitoring of cardiac activity. This work envisions the use of this sensor as a cardiac sensing device in closed-loop applications for patients undergoing heart surgery.
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Affiliation(s)
- C. Zinno
- The BioRobotics Institute, Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy
| | - F. Agnesi
- The BioRobotics Institute, Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy
| | - G. D'Alesio
- The BioRobotics Institute, Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy
| | | | - L. Brogi
- Bio@SNS, Scuola Normale Superiore, Pisa, Italy
| | - D. Camboni
- The BioRobotics Institute, Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy
| | - F. Bernini
- BioMedLab, Interdisciplinary Research Center “Health Science,” Scuola Superiore Sant'Anna, Pisa, Italy
| | - D. Terlizzi
- Fondazione Toscana “G. Monasterio,” Pisa, Italy
| | - V. Casieri
- Unit of Translational Critical Care Medicine, Laboratory of Basic and Applied Medical Sciences, Interdisciplinary Research Center “Health Science,” Scuola Superiore Sant'Anna, Pisa, Italy
| | - K. Gabisonia
- BioMedLab, Interdisciplinary Research Center “Health Science,” Scuola Superiore Sant'Anna, Pisa, Italy
| | - L. Alibrandi
- Unit of Translational Critical Care Medicine, Laboratory of Basic and Applied Medical Sciences, Interdisciplinary Research Center “Health Science,” Scuola Superiore Sant'Anna, Pisa, Italy
| | | | - J. Magomajew
- Department of Chemistry, Fraunhofer Institute for Microengineering and Microsystems, 55129 Mainz, Germany
| | | | - S. Schmitt
- Department of Chemistry, Fraunhofer Institute for Microengineering and Microsystems, 55129 Mainz, Germany
| | - P. Detemple
- Department of Chemistry, Fraunhofer Institute for Microengineering and Microsystems, 55129 Mainz, Germany
| | - C. M. Oddo
- The BioRobotics Institute, Department of Excellence in Robotics & AI, Scuola Superiore Sant'Anna, Pisa, Italy
| | | | - S. Micera
- Author to whom correspondence should be addressed:
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Labrandero C, Deiros L, Abelleira C, Arreo V, Balbacid EJ, Gutiérrez-Larraya F. Hemodynamic Monitoring of Pediatric Patients With Heart Failure and Pulmonary Hypertension Using CardioMEMS. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:101933. [PMID: 39132597 PMCID: PMC11307819 DOI: 10.1016/j.jscai.2024.101933] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Revised: 03/03/2024] [Accepted: 03/08/2024] [Indexed: 08/13/2024]
Abstract
Background The CardioMEMS is an implantable device for hemodynamic monitoring approved by the US Food and Drug Administration for adult patients with heart failure. It has been used in the adult population without structural heart disease and with congenital heart diseases, but we do not have data in the pediatric population. Methods We report the initial single-center experience of the CardioMEMS implantation in children. Feasibility of device implantation, procedural outcomes, and clinical utility in the pediatric population were evaluated. Results The CardioMEMS device was implanted without technical complications in 8 pediatric patients (mean age 7 years and mean weight 27.9 kg) with pulmonary hypertension (6/8, 75%) and heart failure (2/8, 25%). The device was delivered via femoral access in 7 (85%) patients and implanted in the left pulmonary artery in 7 (85%). The noninvasive recording of pulmonary pressures in patients with pulmonary hypertension allowed the monitoring of the evolution of mean pulmonary artery pressure, intensifying vasodilator treatment, and avoiding control cardiac catheterizations. In patients with heart failure, pulmonary hemodynamic monitoring guided the decongestive treatment prior to heart transplantation. Conclusions The implantation of CardioMEMS in the pediatric population is a feasible procedure that allows the noninvasive hemodynamic monitoring of patients with heart failure and pulmonary hypertension. Its implementation in selected patients aids in outpatient follow-up and therapeutic management of patients with complex cardiac conditions, avoiding invasive procedures that require hospitalization. Further large-scale studies in the pediatric population are recommended.
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Affiliation(s)
- Carlos Labrandero
- Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain
| | - Lucía Deiros
- Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain
| | - César Abelleira
- Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain
| | - Viviana Arreo
- Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain
| | - Enrique J. Balbacid
- Department of Pediatric Cardiology, Hospital Universitario La Paz, Madrid, Spain
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Ciotola F, Pyxaras S, Rittger H, Buia V. MEMS Technology in Cardiology: Advancements and Applications in Heart Failure Management Focusing on the CardioMEMS Device. SENSORS (BASEL, SWITZERLAND) 2024; 24:2922. [PMID: 38733027 PMCID: PMC11086351 DOI: 10.3390/s24092922] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Revised: 04/28/2024] [Accepted: 04/30/2024] [Indexed: 05/13/2024]
Abstract
Heart failure (HF) is a complex clinical syndrome associated with significant morbidity, mortality, and healthcare costs. It is characterized by various structural and/or functional abnormalities of the heart, resulting in elevated intracardiac pressure and/or inadequate cardiac output at rest and/or during exercise. These dysfunctions can originate from a variety of conditions, including coronary artery disease, hypertension, cardiomyopathies, heart valve disorders, arrhythmias, and other lifestyle or systemic factors. Identifying the underlying cause is crucial for detecting reversible or treatable forms of HF. Recent epidemiological studies indicate that there has not been an increase in the incidence of the disease. Instead, patients seem to experience a chronic trajectory marked by frequent hospitalizations and stagnant mortality rates. Managing these patients requires a multidisciplinary approach that focuses on preventing disease progression, controlling symptoms, and preventing acute decompensations. In the outpatient setting, patient self-care plays a vital role in achieving these goals. This involves implementing necessary lifestyle changes and promptly recognizing symptoms/signs such as dyspnea, lower limb edema, or unexpected weight gain over a few days, to alert the healthcare team for evaluation of medication adjustments. Traditional methods of HF monitoring, such as symptom assessment and periodic clinic visits, may not capture subtle changes in hemodynamics. Sensor-based technologies offer a promising solution for remote monitoring of HF patients, enabling early detection of fluid overload and optimization of medical therapy. In this review, we provide an overview of the CardioMEMS device, a novel sensor-based system for pulmonary artery pressure monitoring in HF patients. We discuss the technical aspects, clinical evidence, and future directions of CardioMEMS in HF management.
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Affiliation(s)
| | | | | | - Veronica Buia
- Medizinische Klinik I, Klinikum Fürth, Academic Teaching Hospital of the Friedrich-Alexander-University Erlangen-Nürnberg, Jakob-Henle Str. 1, 90766 Fürth, Germany; (F.C.); (S.P.); (H.R.)
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43
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Medhi D, Kamidi SR, Mamatha Sree KP, Shaikh S, Rasheed S, Thengu Murichathil AH, Nazir Z. Artificial Intelligence and Its Role in Diagnosing Heart Failure: A Narrative Review. Cureus 2024; 16:e59661. [PMID: 38836155 PMCID: PMC11148729 DOI: 10.7759/cureus.59661] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/04/2024] [Indexed: 06/06/2024] Open
Abstract
Heart failure (HF) is prevalent globally. It is a dynamic disease with varying definitions and classifications due to multiple pathophysiologies and etiologies. The diagnosis, clinical staging, and treatment of HF become complex and subjective, impacting patient prognosis and mortality. Technological advancements, like artificial intelligence (AI), have been significant roleplays in medicine and are increasingly used in cardiovascular medicine to transform drug discovery, clinical care, risk prediction, diagnosis, and treatment. Medical and surgical interventions specific to HF patients rely significantly on early identification of HF. Hospitalization and treatment costs for HF are high, with readmissions increasing the burden. AI can help improve diagnostic accuracy by recognizing patterns and using them in multiple areas of HF management. AI has shown promise in offering early detection and precise diagnoses with the help of ECG analysis, advanced cardiac imaging, leveraging biomarkers, and cardiopulmonary stress testing. However, its challenges include data access, model interpretability, ethical concerns, and generalizability across diverse populations. Despite these ongoing efforts to refine AI models, it suggests a promising future for HF diagnosis. After applying exclusion and inclusion criteria, we searched for data available on PubMed, Google Scholar, and the Cochrane Library and found 150 relevant papers. This review focuses on AI's significant contribution to HF diagnosis in recent years, drastically altering HF treatment and outcomes.
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Affiliation(s)
- Diptiman Medhi
- Internal Medicine, Gauhati Medical College and Hospital, Guwahati, Guwahati, IND
| | | | | | - Shifa Shaikh
- Cardiology, SMBT Institute of Medical Sciences and Research Centre, Igatpuri, IND
| | - Shanida Rasheed
- Emergency Medicine, East Sussex Healthcare NHS Trust, Eastbourne, GBR
| | | | - Zahra Nazir
- Internal Medicine, Combined Military Hospital, Quetta, Quetta, PAK
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Alfieri M, Bruscoli F, Di Vito L, Di Giusto F, Scalone G, Marchese P, Delfino D, Silenzi S, Martoni M, Guerra F, Grossi P. Novel Medical Treatments and Devices for the Management of Heart Failure with Reduced Ejection Fraction. J Cardiovasc Dev Dis 2024; 11:125. [PMID: 38667743 PMCID: PMC11050600 DOI: 10.3390/jcdd11040125] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2024] [Revised: 04/13/2024] [Accepted: 04/18/2024] [Indexed: 04/28/2024] Open
Abstract
Heart failure (HF) is a growing issue in developed countries; it is often the result of underlying processes such as ischemia, hypertension, infiltrative diseases or even genetic abnormalities. The great majority of the affected patients present a reduced ejection fraction (≤40%), thereby falling under the name of "heart failure with reduced ejection fraction" (HFrEF). This condition represents a major threat for patients: it significantly affects life quality and carries an enormous burden on the whole healthcare system due to its high management costs. In the last decade, new medical treatments and devices have been developed in order to reduce HF hospitalizations and improve prognosis while reducing the overall mortality rate. Pharmacological therapy has significantly changed our perspective of this disease thanks to its ability of restoring ventricular function and reducing symptom severity, even in some dramatic contexts with an extensively diseased myocardium. Notably, medical therapy can sometimes be ineffective, and a tailored integration with device technologies is of pivotal importance. Not by chance, in recent years, cardiac implantable devices witnessed a significant improvement, thereby providing an irreplaceable resource for the management of HF. Some devices have the ability of assessing (CardioMEMS) or treating (ultrafiltration) fluid retention, while others recognize and treat life-threatening arrhythmias, even for a limited time frame (wearable cardioverter defibrillator). The present review article gives a comprehensive overview of the most recent and important findings that need to be considered in patients affected by HFrEF. Both novel medical treatments and devices are presented and discussed.
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Affiliation(s)
- Michele Alfieri
- Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital “Umberto I-Lancisi-Salesi”, 60121 Ancona, Italy; (M.A.); (F.G.)
| | - Filippo Bruscoli
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Luca Di Vito
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Federico Di Giusto
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Giancarla Scalone
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Procolo Marchese
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Domenico Delfino
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Simona Silenzi
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
| | - Milena Martoni
- Medical School, Università degli Studi “G. d’Annunzio”, 66100 Chieti, Italy;
| | - Federico Guerra
- Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital “Umberto I-Lancisi-Salesi”, 60121 Ancona, Italy; (M.A.); (F.G.)
| | - Pierfrancesco Grossi
- Cardiology Unit, C. and G. Mazzoni Hospital, AST Ascoli Piceno, 63100 Ascoli Piceno, Italy; (F.B.); (F.D.G.); (G.S.); (P.M.); (D.D.); (S.S.); (P.G.)
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45
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Manavi T, Zafar H, Sharif F. An Era of Digital Healthcare-A Comprehensive Review of Sensor Technologies and Telehealth Advancements in Chronic Heart Failure Management. SENSORS (BASEL, SWITZERLAND) 2024; 24:2546. [PMID: 38676163 PMCID: PMC11053658 DOI: 10.3390/s24082546] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/22/2024] [Revised: 03/21/2024] [Accepted: 04/11/2024] [Indexed: 04/28/2024]
Abstract
Heart failure (HF) is a multi-faceted, complex clinical syndrome characterized by significant morbidity, high mortality rate, reduced quality of life, and rapidly increasing healthcare costs. A larger proportion of these costs comprise both ambulatory and emergency department visits, as well as hospital admissions. Despite the methods used by telehealth (TH) to improve self-care and quality of life, patient outcomes remain poor. HF management is associated with numerous challenges, such as conflicting evidence from clinical trials, heterogeneity of TH devices, variability in patient inclusion and exclusion criteria, and discrepancies between healthcare systems. A growing body of evidence suggests there is an unmet need for increased individualization of in-hospital management, continuous remote monitoring of patients pre and post-hospital admission, and continuation of treatment post-discharge in order to reduce re-hospitalizations and improve long-term outcomes. This review summarizes the current state-of-the-art for HF and associated novel technologies and advancements in the most frequently used types of TH (implantable sensors), categorizing devices in their preclinical and clinical stage, bench-to-bedside implementation challenges, and future perspectives on remote HF management to improve long-term outcomes of HF patients. The Review also highlights recent advancements in non-invasive remote monitoring technologies demonstrated by a few pilot observational prospective cohort studies.
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Affiliation(s)
- Tejaswini Manavi
- Cardiovascular Translational Research & Innovation Centre, University of Galway, H91 TK33 Galway, Ireland; (T.M.); (F.S.)
- Lambe Institute for Translational Research, School of Medicine, University of Galway, H91 TK33 Galway, Ireland
| | - Haroon Zafar
- Cardiovascular Translational Research & Innovation Centre, University of Galway, H91 TK33 Galway, Ireland; (T.M.); (F.S.)
- Lambe Institute for Translational Research, School of Medicine, University of Galway, H91 TK33 Galway, Ireland
- College of Science and Engineering, University of Galway, H91 TK33 Galway, Ireland
| | - Faisal Sharif
- Cardiovascular Translational Research & Innovation Centre, University of Galway, H91 TK33 Galway, Ireland; (T.M.); (F.S.)
- Lambe Institute for Translational Research, School of Medicine, University of Galway, H91 TK33 Galway, Ireland
- Department of Cardiology, University Hospital Galway, H91 YR71 Galway, Ireland
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46
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Scardovi AB, Boccanelli A. Remote monitoring of severe heart failure. Eur Heart J Suppl 2024; 26:i108-i112. [PMID: 38867862 PMCID: PMC11167985 DOI: 10.1093/eurheartjsupp/suae026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/14/2024]
Abstract
Patients with advanced heart failure, due to the instability of their clinical conditions, need close surveillance to avoid dangerous exacerbations or sudden events. Digital technology can be of great help in this contest, thanks to remote monitoring, made possible with the use of wearable or implantable instruments. The latter are currently generally inserted inside defibrillators or resynchronization systems, or inserted inside the pulmonary circulation for monitoring pulmonary pressure. Parameters such as thoracic impedance, physical activity, heart rate variability, atrial and ventricular arrhythmias, blood pressure, and O2 saturation can be controlled remotely. The data relating to the actual benefit in terms of avoidable events (death and hospitalizations) are not definitive, but certainly from an organizational point of view, the benefit is evident, both on the part of the patient and of the organization of care. The latter, provided in the form of televisits, requires a re-modulation of the system, making use of trained personnel, a well-structured network, and digital technologies (platforms, electronic health records) that are not yet perfectly developed. The evolution of the solutions offered by artificial intelligence guarantees a rapid and progressive refinement of telemedicine in this sector.
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Affiliation(s)
| | - Alessandro Boccanelli
- Department of Medicine, UniCamillus—Saint Camillus International University of Health Sciences, Rome, Italy
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Wan J, Nie Z, Xu J, Zhang Z, Yao S, Xiang Z, Lin X, Lu Y, Xu C, Zhao P, Wang Y, Zhang J, Wang Y, Zhang S, Wang J, Man W, Zhang M, Han M. Millimeter-scale magnetic implants paired with a fully integrated wearable device for wireless biophysical and biochemical sensing. SCIENCE ADVANCES 2024; 10:eadm9314. [PMID: 38507494 PMCID: PMC10954204 DOI: 10.1126/sciadv.adm9314] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Accepted: 02/13/2024] [Indexed: 03/22/2024]
Abstract
Implantable sensors can directly interface with various organs for precise evaluation of health status. However, extracting signals from such sensors mainly requires transcutaneous wires, integrated circuit chips, or cumbersome readout equipment, which increases the risks of infection, reduces biocompatibility, or limits portability. Here, we develop a set of millimeter-scale, chip-less, and battery-less magnetic implants paired with a fully integrated wearable device for measuring biophysical and biochemical signals. The wearable device can induce a large amplitude damped vibration of the magnetic implants and capture their subsequent motions wirelessly. These motions reflect the biophysical conditions surrounding the implants and the concentration of a specific biochemical depending on the surface modification. Experiments in rat models demonstrate the capabilities of measuring cerebrospinal fluid (CSF) viscosity, intracranial pressure, and CSF glucose levels. This miniaturized system opens the possibility for continuous, wireless monitoring of a wide range of biophysical and biochemical conditions within the living organism.
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Affiliation(s)
- Ji Wan
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
- School of Integrated Circuits, Peking University, Beijing, China
| | - Zhongyi Nie
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
| | - Jie Xu
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
| | - Zixuan Zhang
- School of Electronic and Computer Engineering, Peking University, Shenzhen, China
| | - Shenglian Yao
- School of Materials Science and Engineering, University of Science and Technology Beijing, Beijing, China
| | - Zehua Xiang
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
- School of Integrated Circuits, Peking University, Beijing, China
| | - Xiang Lin
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
| | - Yuxing Lu
- Department of Bigdata and Biomedical AI, College of Future Technology, Peking University, Beijing, China
| | - Chen Xu
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
- Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, China
| | - Pengcheng Zhao
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
- School of Integrated Circuits, Peking University, Beijing, China
| | - Yiran Wang
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
| | - Jingyan Zhang
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
| | - Yaozheng Wang
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
- School of Integrated Circuits, Peking University, Beijing, China
| | | | - Jinzhuo Wang
- Department of Bigdata and Biomedical AI, College of Future Technology, Peking University, Beijing, China
| | - Weitao Man
- Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China
| | - Min Zhang
- School of Electronic and Computer Engineering, Peking University, Shenzhen, China
| | - Mengdi Han
- National Key Laboratory of Science and Technology on Micro/Nano Fabrication, Department of Biomedical Engineering, College of Future Technology, Peking University, Beijing, China
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Marshall V WH, Mah ML, DeSalvo J, Rajpal S, Lastinger LT, Salavitabar A, Armstrong AK, Berman D, Lampert B, Wright LK, Hickey J, Metzger R, Nandi D, Gajarski R, Daniels CJ. Novel uses for implanted haemodynamic monitoring in adults with subaortic right ventricles. Heart 2024; 110:491-499. [PMID: 37935570 DOI: 10.1136/heartjnl-2023-323206] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2023] [Accepted: 10/10/2023] [Indexed: 11/09/2023] Open
Abstract
BACKGROUND Pulmonary hypertension (PH) is a common complication in patients with complete dextro-transposition of the great arteries (TGA) after atrial switch (D-TGA/AS) and congenitally corrected TGA (ccTGA). In this population with subaortic right ventricles (sRVs), echocardiography is a poor screening tool for PH; implantable invasive haemodynamic monitoring (IHM) could be used for this purpose, but data are limited. The aim of this study is to report on novel uses of IHM in patients with sRV. METHODS This retrospective study describes the uses of IHM, impact of IHM on heart failure hospitalisation (HFH) and device-related complications in adults with sRV from a single centre (2015-2022). RESULTS IHM was placed in 18 patients with sRV (median age 43 (range 30-54) years, 8 female, 16 with D-TGA/AS, 2 with ccTGA); 16 had moderate or severe sRV systolic dysfunction, 13 had PH on catheterisation. IHM was used for (1) Medical therapy titration, (2) Medical management after ventricular assist device in patients with transplant-limiting PH and (3) Serial monitoring of pulmonary artery pressures without repeat catheterisations to help identify the optimal time for heart transplant referral. In follow-up (median 23 months), HFHs/year were similar to the year prior to IHM (median 0 (IQR 0-1.0) before vs 0 (0-0.8) after, p=0.984). Device migration occurred in one, without long-term sequelae. CONCLUSIONS Uses of IHM in patients with sRV are described which may minimise the need for serial catheterisations in a population where PH is prevalent. HFHs were low overall but not impacted by IHM. One device-related complication occurred without long-term consequence.
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Affiliation(s)
- William H Marshall V
- Internal Medicine, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - May Ling Mah
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Jennifer DeSalvo
- Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Saurabh Rajpal
- Internal Medicine, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Lauren T Lastinger
- Internal Medicine, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Arash Salavitabar
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Aimee K Armstrong
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Darren Berman
- Heart Institute, Children's Hospital Los Angeles, Los Angeles, California, USA
| | - Brent Lampert
- Internal Medicine, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Lydia K Wright
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Jenne Hickey
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Rachel Metzger
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Deipanjan Nandi
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Robert Gajarski
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
| | - Curt J Daniels
- Internal Medicine, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
- The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA
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Lindenfeld J, Costanzo MR, Zile MR, Ducharme A, Troughton R, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Johnson N, Henderson J, Adamson PB, Desai AS, Abraham WT. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol 2024; 83:682-694. [PMID: 38325994 DOI: 10.1016/j.jacc.2023.11.030] [Citation(s) in RCA: 28] [Impact Index Per Article: 28.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Revised: 11/17/2023] [Accepted: 11/20/2023] [Indexed: 02/09/2024]
Abstract
BACKGROUND Trials evaluating implantable hemodynamic monitors to manage patients with heart failure (HF) have shown reductions in HF hospitalizations but not mortality. Prior meta-analyses assessing mortality have been limited in construct because of an absence of patient-level data, short-term follow-up duration, and evaluation across the combined spectrum of ejection fractions. OBJECTIVES The purpose of this meta-analysis was to determine whether management with implantable hemodynamic monitors reduces mortality in patients with heart failure and reduced ejection fraction (HFrEF) and to confirm the effect of hemodynamic-monitoring guided management on HF hospitalization reduction reported in previous studies. METHODS The patient-level pooled meta-analysis used 3 randomized studies (GUIDE-HF [Hemodynamic-Guided Management of Heart Failure], CHAMPION [CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients], and LAPTOP-HF [Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy]) of implantable hemodynamic monitors (2 measuring pulmonary artery pressures and 1 measuring left atrial pressure) to assess the effect on all-cause mortality and HF hospitalizations. RESULTS A total of 1,350 patients with HFrEF were included. Hemodynamic-monitoring guided management significantly reduced overall mortality with an HR of 0.75 (95% CI: 0.57-0.99); P = 0.043. HF hospitalizations were significantly reduced with an HR of 0.64 (95% CI: 0.55-0.76); P < 0.0001. CONCLUSIONS Management of patients with HFrEF using an implantable hemodynamic monitor significantly reduces both mortality and HF hospitalizations. The reduction in HF hospitalizations is seen early in the first year of monitoring and mortality benefits occur after the first year.
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Affiliation(s)
- JoAnn Lindenfeld
- Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
| | | | - Michael R Zile
- Medical University of South Carolina, Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Caroline, USA
| | - Anique Ducharme
- Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada
| | - Richard Troughton
- Christchurch Heart Institute, University of Otago, Christchurch, New Zealand
| | - Alan Maisel
- University of California San Diego, La Jolla, California, USA
| | - Mandeep R Mehra
- Center for Advanced Heart Disease, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Sara Paul
- Catawba Valley Health System, Conover, North Carolina, USA
| | - Samuel F Sears
- East Carolina University, Greenville, North Carolina, USA
| | - Frank Smart
- Louisiana State University School of Medicine, New Orleans, Louisiana, USA
| | | | | | | | - Akshay S Desai
- Center for Advanced Heart Disease, Brigham and Women's Hospital, Boston, Massachusetts, USA
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50
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Botto GL, Sinagra G, Bulava A, Gargaro A, Timmel T, Giacopelli D, D’Onofrio A, Guédon-Moreau L. Predicting worsening heart failure hospitalizations in patients with implantable cardioverter defibrillators: is it all about alerts? A pooled analysis of nine trials. Europace 2024; 26:euae032. [PMID: 38291778 PMCID: PMC10858640 DOI: 10.1093/europace/euae032] [Citation(s) in RCA: 6] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/23/2023] [Accepted: 01/25/2024] [Indexed: 02/01/2024] Open
Abstract
AIMS To predict worsening heart failure hospitalizations (WHFHs) in patients with implantable defibrillators and remote monitoring, the HeartInsight algorithm (Biotronik, Berlin, Germany) calculates a heart failure (HF) score combining seven physiologic parameters: 24 h heart rate (HR), nocturnal HR, HR variability, atrial tachyarrhythmia, ventricular extrasystoles, patient activity, and thoracic impedance. We compared temporal trends of the HF score and its components 12 weeks before a WHFH with 12-week trends in patients without WHFH, to assess whether trends indicate deteriorating HF regardless of alert status. METHODS AND RESULTS Data from nine clinical trials were pooled, including 2050 patients with a defibrillator capable of atrial sensing, ejection fraction ≤ 35%, NYHA class II/III, no long-standing atrial fibrillation, and 369 WHFH from 259 patients. The mean HF score was higher in the WHFH group than in the no WHFH group (42.3 ± 26.1 vs. 30.7 ± 20.6, P < 0.001) already at the beginning of 12 weeks. The mean HF score further increased to 51.6 ± 26.8 until WHFH (+22% vs. no WHFH group, P = 0.003). As compared to the no WHFH group, the algorithm components either were already higher 12 weeks before WHFH (24 h HR, HR variability, thoracic impedance) or significantly increased until WHFH (nocturnal HR, atrial tachyarrhythmia, ventricular extrasystoles, patient activity). CONCLUSION The HF score was significantly higher at, and further increased during 12 weeks before WHFH, as compared to the no WHFH group, with seven components showing different behaviour and contribution. Temporal trends of HF score may serve as a quantitative estimate of HF condition and evolution prior to WHFH.
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Affiliation(s)
- Giovanni Luca Botto
- U.O. Electrophysiology, ASST Rhodense, 95 Viale Carlo Forlanini, 20024 Garbagnate Milanese (MI), Italy
| | - Gianfranco Sinagra
- Cardiothoracovascular Department, Cattinara Hospital, ASUGI and University of Trieste, Trieste, Italy
| | - Alan Bulava
- Faculty of Health and Social Sciences, Ceske Budejovice Hospital, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic
| | - Alessio Gargaro
- Clinical Unit, Biotronik Italia S.P.A., Cologno Monzese (MI), Italy
| | - Tobias Timmel
- Center for Clinical Research, Biotronik SE & Co. KG, Berlin, Germany
| | | | - Antonio D’Onofrio
- Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie, Monaldi Hospital, Naples, Italy
| | - Laurence Guédon-Moreau
- CHU Lille, University of Lille, Lille University Hospital Center, Lille, Hauts-de-France, France
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