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Kontogiannis V, Goromonzi F, Both B, Semrau F, Branagan-Harris M, Atkinson J, Roberts PR, Javanbakht M. Cost-Utility Analysis of LifeVest® in Post-Myocardial Infarction Patients at Risk of Sudden Cardiac Death in England. PHARMACOECONOMICS - OPEN 2025; 9:301-312. [PMID: 39849296 DOI: 10.1007/s41669-024-00553-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 12/22/2024] [Indexed: 01/25/2025]
Abstract
BACKGROUND Patients with a left ventricular ejection fraction ≤ 35% are at increased risk of sudden cardiac death (SCD) within the first months after a myocardial infarction (MI). The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution which can protect patients from SCD during the first months after an MI, when the risk of SCD is at its peak. This study aimed to evaluate the cost-effectiveness of WCD combined with guideline-directed medical therapy (GDMT) compared to GDMT alone, after MI in the English National Health Service (NHS). METHODS A multi-state Markov model, with a hypothetical cohort of 1000 patients, was developed to evaluate WCD + GDMT compared with GDMT alone, over a lifetime time horizon. Model input parameters were obtained from the pivotal randomised controlled trial and literature. The outcomes were costs and quality-adjusted life-years (QALYs), discounted at 3.5% annually, with overall results presented as an incremental cost-effectiveness ratio (ICER). RESULTS The cost-effectiveness analysis demonstrated that WCD + GDMT is potentially a cost-effective option with an ICER of £23,024 per QALY gained, which is in the acceptable willingness to pay threshold (WTP) range of £20,000-£30,000 set by the National Institute for Health and Care Excellence (NICE) in England. Results of probabilistic sensitivity analysis (PSA) indicated that WCD + GDMT has 89.3% and 23% probability of being cost-effective at WTP thresholds of £30,000 and £20,000, respectively. CONCLUSIONS Implementation of WCD in patients post-MI is potentially a cost-effective use of resources for the NHS and improves clinical outcomes amongst adherent patients and in circumstances where implantable cardioverter defibrillators are not indicated by the guidelines.
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Affiliation(s)
- Vasileios Kontogiannis
- Optimax Access Ltd, Kenneth Dibben House, Enterprise Rd, Chilworth, Southampton University Science Park, Southampton, UK.
| | | | | | | | - Michael Branagan-Harris
- Device Access UK Ltd., Kenneth Dibben House, Enterprise Rd, Chilworth, Southampton University Science Park, Southampton, UK
| | - Jowan Atkinson
- Device Access UK Ltd., Kenneth Dibben House, Enterprise Rd, Chilworth, Southampton University Science Park, Southampton, UK
| | - Paul R Roberts
- University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, Hampshire, UK
| | - Mehdi Javanbakht
- Optimax Access Ltd, Kenneth Dibben House, Enterprise Rd, Chilworth, Southampton University Science Park, Southampton, UK
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Dang PL, Lacour P, Parwani AS, Baehr FL, Primessnig U, Schoeppenthau D, Dreger H, Dagres N, Hindricks G, Boldt LH, Blaschke F. False Alarms in Wearable Cardioverter Defibrillators-A Relevant Issue or an Insignificant Observation. J Clin Med 2024; 13:7768. [PMID: 39768691 PMCID: PMC11728023 DOI: 10.3390/jcm13247768] [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: 11/08/2024] [Revised: 12/15/2024] [Accepted: 12/17/2024] [Indexed: 01/16/2025] Open
Abstract
Background: The wearable cardioverter defibrillator (WCD) has emerged as a valuable tool used for temporary protection from sudden cardiac death. However, since the WCD uses surface electrodes to detect arrhythmias, it is susceptible to inappropriate detection. Although shock conversion rates for the WCD are reported to be high for detected events, its efficacy in clinical practice tends to be degraded by patient noncompliance. Reasons for this include wearer discomfort and frequent false alarms, which may interrupt sleep and generate anxiety. Up to now, data on the incidence of false alarms emitted by the WCD and their predictors are rare. Objectives: The aim of our study was to assess the relationship between both artifact sensing and episode misclassification burden and wearing compliance in patients with a WCD (ZOLL LifeVest™ 4000 system, ZOLL CMS GmbH, Cologne, Germany). Methods and Results: We conducted a single-center retrospective observational study, analyzing patients with a WCD prescribed at our institution. A total of 134 patients (mean age 51.7 ± 13.8 years, 79.1% male) were included. Arrhythmia recordings were analyzed and categorized as non-sustained ventricular tachycardia, sustained ventricular tachycardia or fibrillation, artifact sensing or misclassified episodes. Indication for WCD prescription was both primary and secondary prophylaxis. A total of 3019 false WCD alarms were documented in 78 patients (average number of false alarms 38.7 ± 169.5 episodes per patient) over a mean WCD wearing time of 71.5 ± 70.9 days (daily WCD wearing time 20.2 ± 5.0 h). In a total of 78 patients (58.2% of the study population), either artifact sensing (76.9%), misclassified episodes (6.4%), or both (16.7%) occurred. Misclassified episodes included sinus tachycardias, atrial flutter, atrial fibrillation, premature ventricular contractions (PVCs), and intermittent bundle branch block. A multiple linear regression identified loop diuretics (regression coefficient [B] -0.11; 95% CI -0.21-(-0.0001); p = 0.049), angiotensin receptor-neprilysin inhibitors (ARNIs) (B -0.11; 95% CI 0.22-(-0.01); p = 0.033), and a higher R-amplitude of the WCD baseline electrocardiogram (ECG) (B -0.17; 95% CI -0.27-(-0.07); p = 0.001) as independent predictors for a lower number of artifact episodes per day. In addition, atrial fibrillation (B 0.05; 95% CI 0.01-0.08; p = 0.010), and calcium antagonists (B 0.07; 95% CI 0.02-0.12; p = 0.012) were independent predictors for increased numbers of misclassified episodes per day, while beta-blockers seemed to reduce them (B -0.06; 95% CI -0.10-(-0.01); p = 0.013). Patients terminated 61.0% of all false alarms manually by pressing the response button on average 1.9 times per false alarm with overall 3.6 manual terminations per affected patient per month. Conclusions: In conclusion, false alarms from the ZOLL LifeVest™ system were frequent, with artifact sensing being the most common cause. Hence, the occurrence of false alarms represents a significant side effect of WCD therapy, and efforts should be made to minimize false alarms.
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Affiliation(s)
- Phi Long Dang
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
| | - Philipp Lacour
- Study Center Berlin, IB University of Health and Social Sciences, 12683 Berlin, Germany
| | - Abdul Shokor Parwani
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Felix Lucas Baehr
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Uwe Primessnig
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Doreen Schoeppenthau
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Henryk Dreger
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Nikolaos Dagres
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany
| | - Gerhard Hindricks
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Charité Mitte, Charitéplatz 1, 10117 Berlin, Germany
| | - Leif-Hendrik Boldt
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
| | - Florian Blaschke
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany; (P.L.D.); (A.S.P.); (D.S.); (H.D.); (L.-H.B.)
- DZHK (German Centre for Cardiovascular Research), 10785 Berlin, Germany (G.H.)
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Kazberuk M, Pogorzelski P, Kuźma Ł, Kurasz A, Róg-Makal M, Matys U, Tokarewicz J, Kralisz P, Dobrzycki S. Wearable Cardioverter Defibrillator as a Treatment in Patients with Heart Failure of Various Aetiologies-A Series of Ten Cases Within the BIA-VEST Registry. J Clin Med 2024; 13:7686. [PMID: 39768607 PMCID: PMC11677621 DOI: 10.3390/jcm13247686] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2024] [Revised: 12/12/2024] [Accepted: 12/15/2024] [Indexed: 01/11/2025] Open
Abstract
Background/Objectives: Sudden cardiac death (SCD) remains a major global health concern and represents one of the most common causes of mortality due to cardiovascular diseases. The wearable cardioverter-defibrillator (WCD) is an innovative, non-invasive medical device designed to provide continuous heart monitoring and immediate defibrillation in patients at risk for SCD. The study aimed to assess the efficacy of WCD usage in patients awaiting decision on therapy with implantable cardioverter-defibrillators (ICDs). Methods: We explored the clinical applications, benefits, and limitations of WCD usage within the BIA-VEST registry in Poland over the years 2021-2023. The study included 10 patients with a mean age of 49.1 ± 12.02 years. Results: All patients demonstrated good tolerance and compliance with the LifeVest WCD, wearing it for an average of 93.1 days, about 22.8 h per day (95.7% of the time). No interventions from LifeVests were recorded, and there were no effective, ineffective, or inadequate discharges. After the first follow-up echocardiography, five patients still required ICDs. Due to improved LVEF and overall condition in six out of ten patients undergoing WCD bridge therapy, ICD implantation was finally waived. Conclusions: The WCD acts as a bridge to therapy, such as ICD implantation or cardiac surgery, and may be particularly beneficial for patients with transient or evolving conditions, such as structural heart diseases and life-threatening ventricular arrhythmias.
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Affiliation(s)
- Małgorzata Kazberuk
- Department of Invasive Cardiology, Medical University of Białystok, 15-089 Białystok, Poland
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Dell'Era G, Caimmi P, Spinoni EG, Battistini E, Porcellini S, De Vecchi F, Santagostino M, Ghiglieno C, Degiovanni A, Leigheb F, Kozel D, Capponi A, Patti G. Wearable defibrillator to improve accuracy in selecting candidates to implantable defibrillator: A real-world experience. ESC Heart Fail 2024; 11:3993-3999. [PMID: 39091044 PMCID: PMC11631226 DOI: 10.1002/ehf2.14840] [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: 07/14/2022] [Revised: 12/24/2022] [Accepted: 04/26/2024] [Indexed: 08/04/2024] Open
Abstract
AIMS The indication for implantable cardioverter defibrillator (ICD) for sudden cardiac death (SCD) prevention relies mostly on left ventricular ejection fraction (LVEF) ≤ 35%. The use of a wearable cardioverter defibrillator (WCD) in the case of dynamic alterations of LVEF may help avoid an improper early ICD implant when a favourable evolution in the post-acute phase is observed and may help reduce costs. METHODS This parallel cohort retrospective study included patients with heart failure with reduced ejection fraction (HFrEF) at high risk of arrhythmias recruited in the acute phase and divided into an early ICD cohort and a WCD cohort for primary prevention during the waiting period established by European Society of Cardiology guidelines. RESULTS A total of 41 consecutive patients were enrolled: 26 in the WCD group and 15 in the early ICD group. Age, LVEF at baseline, causes of HFrEF and drug therapy in the two cohorts were similar. During the waiting period after the inclusion, three patients (11.5%) in the WCD cohort and four (26.7%) in the early ICD cohort developed relevant ventricular arrhythmias (P = 0.22); none of them had subsequent LVEF recovery. At the end of the waiting period, 13 patients (50%) in the WCD group and 7 (46.7%) in the early ICD group experienced LVEF recovery (P = 0.84). The average cost per patient at the end of the waiting period was €23 934 in the early ICD cohort versus €19 167 in the WCD cohort (-19.9%). This cost savings from WCD use appears even higher when projected over a 10 year period (-41.2%). CONCLUSIONS WCD may represent a cost-effective strategy to more accurately select candidates for the primary prevention ICD implant among high-risk patients with HFrEF. ICD use provides effective protection from SCD and reduces costs compared with an extensive early ICD implant.
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Affiliation(s)
| | | | - Enrico Guido Spinoni
- Cardiology UnitMaggiore della Carità Hospital of NovaraNovaraItaly
- Department of CardiologyUniversity of Eastern PiedmontNovaraItaly
| | - Eleonora Battistini
- Cardiology UnitMaggiore della Carità Hospital of NovaraNovaraItaly
- Department of CardiologyUniversity of Eastern PiedmontNovaraItaly
| | | | | | | | - Chiara Ghiglieno
- Department of CardiologyUniversity of Eastern PiedmontNovaraItaly
| | - Anna Degiovanni
- Cardiology UnitMaggiore della Carità Hospital of NovaraNovaraItaly
| | | | | | | | - Giuseppe Patti
- Cardiology UnitMaggiore della Carità Hospital of NovaraNovaraItaly
- Department of CardiologyUniversity of Eastern PiedmontNovaraItaly
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Kutyifa V, Burch AE, Aßmus B, Bonderman D, Bianco NR, Russo AM, Erath JW. Sex differences in achieving guideline-recommended heart rate control among a large sample of patients at risk for sudden cardiac arrest. Heart Rhythm O2 2024; 5:274-280. [PMID: 38840767 PMCID: PMC11148490 DOI: 10.1016/j.hroo.2024.04.008] [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] [Indexed: 06/07/2024] Open
Abstract
Background Despite known clinical benefits, guideline-recommended heart rate (HR) control is not achieved for a significant proportion of patients with HF with reduced ejection fraction. The wearable cardioverter-defibrillator (WCD) provides continuous HR monitoring and alerts that could aid medication titration. Objective This study sought to evaluate sex differences in achieving guideline-recommended HR control during a period of WCD use. Methods Data from patients fitted with a WCD from 2015 to 2018 were obtained from the manufacturer's database (ZOLL). The proportion of patients with adequate nighttime resting HR control at the beginning of use (BOU) and at the end of use (EOU) were compared by sex. Adequate HR control was defined as having a nighttime median HR <70 beats/min. Results A total of 21,440 women and a comparative sample of 17,328 men (median 90 [IQR 59-116] days of WCD wear) were included in the final dataset. Among patients who did not receive a shock, over half had insufficient HR control at BOU (59% of women, 53% of men). Although the proportion of patients with resting HR ≥70 beats/min improved by EOU, 43% of women and 36% of men did not achieve guideline-recommended HR control. Conclusion A significant proportion of women and men did not achieve adequate HR control during a period of medical therapy optimization. Compared with men, a greater proportion of women receiving WCD shocks had insufficiently controlled HR in the week preceding ventricular tachyarrhythmia/ventricular fibrillation and 43% of nonshocked women, compared with 36% of men, did not reach adequate HR control during the study period. The WCD can be utilized as a remote monitoring tool to record HR and inform adequate uptitration of beta-blockers, with particular focus on reducing the treatment gap in women.
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Affiliation(s)
- Valentina Kutyifa
- Department of Cardiology, Clinical Trial Enrolling Unit, University of Rochester Medical Center, Rochester, New York
| | - Ashley E. Burch
- Department of Health Services and Information Management, East Carolina University, Greenville, North Carolina
| | - Birgit Aßmus
- Department of Cardiology and Angiology, UKGM Gießen, Justus-Liebig University, Gießen, Germany
| | - Diana Bonderman
- Department of Internal Medicine, Medical University of Vienna, Vienna, Austria
| | - Nicole R. Bianco
- Department of Medicine, Cooper Medical School of Rowan University, Camden, New Jersey
| | | | - Julia W. Erath
- Department of Cardiology, Goethe University Hospital, Frankfurt am Main, Germany
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Block M, Klein HU. [History of the implantable cardioverter-defibrillator in Germany]. Herzschrittmacherther Elektrophysiol 2024; 35:55-67. [PMID: 38421401 PMCID: PMC10923992 DOI: 10.1007/s00399-024-01001-5] [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] [Accepted: 02/06/2024] [Indexed: 03/02/2024]
Abstract
The implantable cardioverter-defibrillator (ICD) was a breakthrough in the prevention of sudden cardiac death. After years of technical development in the USA, Michel Mirowski succeeded in proving reliable automatic defibrillation of ventricular tachyarrhythmias through initial human implantations in 1980, despite many obstacles. Nearly 4 years later, the first patients received ICDs at multiple centers in Germany. Subsequently, outside the USA, Germany became the country with highest implantation rates. The absolute number of implantations remained small as long as implantations required epicardial defibrillation electrodes and therefore thoracotomy by cardiac surgeons. Pacemaker-like implantation using a transvenous defibrillation electrode with a pectoral ICD became feasible in the early 1990s pushing implantation rates to the next level. Technical advancements were accompanied by clinical research in Germany, and often, the first-in-human studies were conducted in Germany. In 1991, the first guidelines for indications were established in the USA and Germany. Several randomized studies on indications were published between 1996 and 2009, mostly led by American teams with German participation, but also under German leadership (CASH, CAT, DINAMIT, IRIS). The DANISH study in 2016 questioned the results of these long-standing studies. Instead of providing ICDs to patients using a broad indication, future efforts aim to identify patients who, despite optimal medical therapy, cardiac resynchronization therapy (CRT), and/or catheter ablation, need protection against sudden cardiac death. Risk scores incorporating myocardial scars in magnetic resonance imaging (MRI) and genetic information are expected to contribute to more individualized and effective indications.
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Lenormand T, Bodin A, Fauchier L. The Role of the Wearable Defibrillator in Heart Failure. Curr Heart Fail Rep 2024; 21:33-42. [PMID: 38236485 DOI: 10.1007/s11897-023-00641-x] [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: 12/29/2023] [Indexed: 01/19/2024]
Abstract
PURPOSE OF REVIEW Wearable cardioverter defibrillators (WCDs) have been developed as a temporary measure for protecting patients at risk for sudden cardiac death that do not meet the indication for implantable cardioverter defibrillator (ICD), most notably in the early stages of heart failure with reduced ejection fraction before reassessment of their left ventricular ejection fraction. In this review, we report available evidence in the literature and guidelines regarding WCD use in order to try to define the role WCDs may have in heart failure. RECENT FINDINGS In the last decade, most observational studies found WCDs to be both safe and effective in terminating ventricular arrhythmias in various indications, mostly centered around heart failure with reduced ejection fraction. The only available randomized controlled trial using WCD did not however show a benefit on patients' survival. Hence, recent guidelines only recommended its use in limited indications. Recent data also suggest a possible interest of WCD in monitoring patients, a finding that may prove useful in the context of new-onset heart failure. Data regarding WCD benefit is scarce, and definitive conclusions on its utility are hard to draw. In the context of heart failure, and particularly new-onset heart failure, WCD might find a role in a global comprehensive management of the disease, both acting as an educational tool, a monitoring tool, and, most importantly, a safe and effective tool in preventing sudden cardiac death. The low level of evidence however invites caution, and the decision of prescribing a WCD needs to be individualized and thoroughly discussed with the patient whose compliance is key with this device.
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Affiliation(s)
- Thibault Lenormand
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France
| | - Alexandre Bodin
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France
| | - Laurent Fauchier
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France.
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Nürnberg M, Semrau F. Critical appraisal of "Goetz G, Wernly B, Wild C (2023) Wearable cardioverter defibrillator for preventing sudden cardiac death in patients at risk: An updated systematic review of comparative effectiveness and safety. IJC Heart & Vasculature 45 (2023) 101189". IJC HEART & VASCULATURE 2023; 48:101258. [PMID: 37680548 PMCID: PMC10480618 DOI: 10.1016/j.ijcha.2023.101258] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/05/2023] [Revised: 08/16/2023] [Accepted: 08/16/2023] [Indexed: 09/09/2023]
Affiliation(s)
- Michael Nürnberg
- Hospital Ottakring/Wilhelminenspital, 3. Med. Div. of Cardiology with ICU, Vienna, Austria
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El‐Battrawy I, Koepsel K, Tenbrink D, Kovacs B, Dreher TC, Blockhaus C, Gotzmann M, Klein N, Kuntz T, Shin D, Lapp H, Rosenkaimer S, Abumayyaleh M, Hamdani N, Saguner AM, Kowitz J, Erath JW, Duru F, Mügge A, Akin I, Aweimer A, Beiert T. Use of the Wearable Cardioverter-Defibrillator Among Patients With Myocarditis and Reduced Ejection Fraction or Ventricular Tachyarrhythmia: Data From a Multicenter Registry. J Am Heart Assoc 2023; 12:e030615. [PMID: 37681569 PMCID: PMC10547297 DOI: 10.1161/jaha.123.030615] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2023] [Accepted: 08/18/2023] [Indexed: 09/09/2023]
Abstract
Background Data on the use of the wearable cardioverter-defibrillator (WCD) among patients with myocarditis remain sparse. Consequently, evidence for guideline recommendations in this patient population is lacking. Methods and Results In total, 1596 consecutive patients were included in a multicenter registry from 8 European centers, with 124 patients (8%) having received the WCD due to myocarditis and reduced left ventricular ejection fraction or prior ventricular tachyarrhythmia. The mean age was 51.6±16.3 years, with 74% being male. Patients were discharged after index hospitalization on heart failure medication: Angiotensin-converting enzyme inhibitors (62.5%), angiotensin-receptor-neprilysin inhibitor (22.9%), aldosterone-antagonists (51%), or beta blockers (91.4%). The initial median left ventricular ejection fraction was 30% (22%-45%) and increased to 48% (39%-55%) over long-term follow-up (P<0.001). The median BNP (brain natriuretic peptide) level at baseline was 1702 pg/mL (565-3748) and decreased to 188 pg/mL (26-348) over long-term follow-up (P=0.022). The mean wear time was 79.7±52.1 days and 21.0±4.9 hours per day. Arrhythmic event rates documented by the WCD were 9.7% for nonsustained ventricular tachycardia, 6.5% for sustained ventricular tachycardia, and 0% for ventricular fibrillation. Subsequently, 2.4% of patients experienced an appropriate WCD shock. The rate of inappropriate WCD shocks was 0.8%. All 3 patients with appropriate WCD shock had experienced ventricular tachycardia/ventricular fibrillation before WCD prescription, with only 1 patient showing a left ventricular ejection fraction <35%. Conclusions Patients with myocarditis and risk for occurrence of ventricular tachyarrhythmia may benefit from WCD use. Prior ventricular arrhythmia might appear as a better risk predictor than a reduced left ventricular ejection fraction <35% in this population.
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Affiliation(s)
- Ibrahim El‐Battrawy
- Department of Cardiology and AngiologyBergmannsheil University Hospital, Ruhr University of BochumBochumGermany
- Department of Molecular and Experimental CardiologyInstitut für Forschung und Lehre (IFL), Ruhr University BochumBochumGermany
| | - Katharina Koepsel
- Department of Cardiology and AngiologyBergmannsheil University Hospital, Ruhr University of BochumBochumGermany
| | - David Tenbrink
- Department of Cardiology and AngiologyBergmannsheil University Hospital, Ruhr University of BochumBochumGermany
| | - Boldizsar Kovacs
- Department of CardiologyUniversity Heart Center, University Hospital ZurichZürichSwitzerland
| | - Tobias C. Dreher
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive CareUniversity Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg UniversityMannheimGermany
| | - Christian Blockhaus
- Department of CardiologyHeart Centre Niederrhein, Helios Clinic KrefeldKrefeldGermany
- Faculty of Health, School of MedicineUniversity Witten/HerdeckeWittenGermany
| | - Michael Gotzmann
- Cardiology and RhythmologyUniversity Hospital St. Josef‐Hospital Bochum, Ruhr University BochumBochumGermany
| | - Norbert Klein
- Department of Cardiology, Angiology and Internal Intensive‐Care MedicineKlinikum St. Georg gGmbH LeipzigLeipzigGermany
| | - Thomas Kuntz
- Department of Cardiology, Angiology and Internal Intensive‐Care MedicineKlinikum St. Georg gGmbH LeipzigLeipzigGermany
| | - Dong‐In Shin
- Department of CardiologyHeart Centre Niederrhein, Helios Clinic KrefeldKrefeldGermany
- Faculty of Health, School of MedicineUniversity Witten/HerdeckeWittenGermany
| | - Hendrik Lapp
- Department of Internal Medicine II, Heart Center BonnUniversity Hospital BonnBonnGermany
| | - Stephanie Rosenkaimer
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive CareUniversity Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg UniversityMannheimGermany
| | - Mohammad Abumayyaleh
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive CareUniversity Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg UniversityMannheimGermany
- German Center for Cardiovascular Research (DZHK)Partner Site Heidelberg‐MannheimMannheimGermany
| | - Nazha Hamdani
- Department of Molecular and Experimental CardiologyInstitut für Forschung und Lehre (IFL), Ruhr University BochumBochumGermany
| | - Ardan Muammer Saguner
- Department of CardiologyUniversity Heart Center, University Hospital ZurichZürichSwitzerland
| | - Jacqueline Kowitz
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive CareUniversity Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg UniversityMannheimGermany
| | - Julia W. Erath
- Department of Cardiology, Frankfurt University HospitalGoethe UniversityFrankfurt am MainGermany
| | - Firat Duru
- Department of CardiologyUniversity Heart Center, University Hospital ZurichZürichSwitzerland
| | - Andreas Mügge
- Department of Cardiology and AngiologyBergmannsheil University Hospital, Ruhr University of BochumBochumGermany
| | - Ibrahim Akin
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive CareUniversity Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg UniversityMannheimGermany
- German Center for Cardiovascular Research (DZHK)Partner Site Heidelberg‐MannheimMannheimGermany
| | - Assem Aweimer
- Department of Cardiology and AngiologyBergmannsheil University Hospital, Ruhr University of BochumBochumGermany
| | - Thomas Beiert
- Department of Internal Medicine II, Heart Center BonnUniversity Hospital BonnBonnGermany
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10
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Cardelli LS, Delbaere Q, Massin F, Granier M, Casella G, Barbato G, Dupasquier V, Macia JC, Leclercq F, Pasquie JL, Roubille F. Wearable Cardioverter Defibrillator Shortens the Lengths of Stay in Patients with Left Ventricular Dysfunction after Myocardial Infarction: A Single-Centre Real-World Experience. J Clin Med 2023; 12:4884. [PMID: 37568286 PMCID: PMC10419391 DOI: 10.3390/jcm12154884] [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: 06/11/2023] [Revised: 06/22/2023] [Accepted: 07/21/2023] [Indexed: 08/13/2023] Open
Abstract
The wearable cardioverter defibrillator (WCD) has been proven to be effective in preventing sudden cardiac death (SCD) in patients soon after acute myocardial infarction (AMI) and left ventricular ejection fraction (LVEF) ≤35%. The aim of this study was to assess whether a WCD may shorten the length of an initial hospital stay (total length, days in the intensive care unit (ICU) and in the acute cardiac care unit (ACCU)) among these patients. This was a single-centre, retrospective observational study of patients referred for the management of SCD risk post-AMI and LVEF ≤35%, in a tertiary care hospital. The clinical characteristics and length of index hospitalization of the group of patients discharged, with or without WCD, were compared. A propensity score analysis was performed, then weighted regression models were conducted. A total of 101 patients in the WCD group and 29 in the control group were enrolled in the analysis. In the weighted regression models, WCD significantly reduced the days spent in ACCU (p < 0.001). WCD patients had significantly fewer days spent in ACCU (5.5 ± 2.6 vs. 8.4 ± 12.8 days, p < 0.001) and shorter hospitalizations (10.2 ± 5.7 vs. 13.4 ± 17.6 days, p = 0.005), compared with the control group. It was concluded that the WCD appears to reduce the total length of hospitalization and lengths of stay in ACCU for patients post-AMI and with left ventricular dysfunction.
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Affiliation(s)
| | - Quentin Delbaere
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - François Massin
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - Mathieu Granier
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - Gianni Casella
- Cardiology Department, Ospedale Maggiore, 40100 Bologna, Italy
| | - Gaetano Barbato
- Cardiology Department, Ospedale Maggiore, 40100 Bologna, Italy
| | - Valentin Dupasquier
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - Jean-Christophe Macia
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - Florence Leclercq
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - Jean-Luc Pasquie
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
| | - François Roubille
- Cardiology Department, Arnaud-De-Villeneuve Hospital, 34090 Montpellier, France (F.R.)
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11
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Fazzini L, Marchetti MF, Perra F, Biddau M, Massazza N, Nissardi V, Agus E, Demelas R, Montisci R. Does Patient Compliance Influence Wearable Cardioverter Defibrillator Effectiveness? A Single-Center Experience. J Clin Med 2023; 12:4743. [PMID: 37510858 PMCID: PMC10381325 DOI: 10.3390/jcm12144743] [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: 06/12/2023] [Revised: 07/11/2023] [Accepted: 07/12/2023] [Indexed: 07/30/2023] Open
Abstract
The study was designed to assess patient adherence to wearable cardioverter defibrillator as an indicator of device effectiveness. The patient training is not widely properly standardized. We enrolled 25 patients with a wearable cardioverter defibrillator to prevent sudden cardiac death between June 2020 and August 2022. Among them, 84% were male with a median age of 63.6 years. The indication was an ischemic (44%) and a non-ischemic (56%) disease. The patients were followed-up until the decision to upgrade to an implantable device was taken. We trained the patients according to our suggested protocol. The median wear time was 90 days, and the median daily wear time was 23.5 h, similar throughout sex, age, and indication groups. In total, 24% of the participants underwent cardioverter defibrillator implantation. Between the device-implanted and non-implanted groups, left ventricular ejection fraction and left ventricular indexed end-diastolic volume were significantly different (EF 35.8 ± 12 vs. 46.4 ± 8.5%, p = 0.028, iEDV 108 ± 52 vs. 70.7 ± 21.1 mL/m2, p = 0.024). We did not find any differences in cardiac magnetic resonance data, even though all patients who underwent device implantation had late gadolinium enhancement spots. Our results support standardized patient training to obtain great patient adherence to the instructions to the wearable device and therefore its effectiveness.
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Affiliation(s)
- Luca Fazzini
- Clinical Cardiology Unit, Department of Medical Sciences and Public Health, University Hospital of Cagliari, Via Carrara 25, 09125 Cagliari, Italy; (M.F.M.); (F.P.); (M.B.); (N.M.); (V.N.); (E.A.); (R.D.); (R.M.)
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12
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Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace 2023; 25:euad062. [PMID: 37021342 PMCID: PMC10227653 DOI: 10.1093/europace/euad062] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2022] [Accepted: 01/31/2023] [Indexed: 04/07/2023] Open
Abstract
AIMS While elevated resting heart rate measured at a single point of time has been associated with cardiovascular outcomes, utility of continuous monitoring of nocturnal heart rate (NHR) has never been evaluated. We hypothesized that dynamic NHR changes may predict, at short term, impending cardiovascular events in patients equipped with a wearable cardioverter-defibrillator (WCD). METHODS AND RESULTS The WEARIT-France prospective cohort study enrolled heart failure patients with WCD between 2014 and 2018. Night-time was defined as midnight to 7 a.m. NHR initial trajectories were classified into four categories based on mean NHR in the first week (High/Low) and NHR evolution over the second week (Up/Down) of WCD use. The primary endpoint was a composite of cardiovascular death and heart failure hospitalization. A total of 1013 [61 (interquartile range, IQR 53-68) years, 16% women, left ventricular ejection fraction 26% (IQR 22-30)] were included. During a median WCD wear duration of 68 (IQR 44-90) days, 58 patients (6%) experienced 69 events. After considering potential confounders, High-Up NHR trajectory was significantly associated with the primary endpoint compared to Low-Down [adjusted hazard ratio (HR) 6.08, 95% confidence interval (CI) 2.56-14.45, P < 0.001]. Additionally, a rise of >5 bpm in weekly average NHR from the preceding week was associated with 2.5 higher composite event risk (HR 2.51, 95% CI 1.22-5.18, P = 0.012) as well as total mortality (HR 11.21, 95% CI 3.55-35.37, P < 0.001) and cardiovascular hospitalization (HR 2.70, 95% CI 1.51-4.82, P < 0.001). CONCLUSION Dynamic monitoring of NHR may allow timely identification of impending cardiovascular events, with the potential for 'pre-emptive' action. REGISTRATION NUMBER Clinical Trials.gov Identifier: NCT03319160.
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Affiliation(s)
- Rodrigue Garcia
- Department of Cardiology, University Hospital of Poitiers, 86021 Poitiers, France
- Centre d'Investigation Clinique CIC1402, CHU Poitiers, 86000, Poitiers, France
| | - Peder Emil Warming
- Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
| | - Kumar Narayanan
- Department of Cardiology, Medicover Hospitals, Hyderabad, Telangana 500081, India
- Université Paris Cité, Inserm, PARCC, F-75015 Paris, France
| | - Pascal Defaye
- Department of Cardiology, University Hospital Grenoble Alpes, Grenoble 38043, France
| | | | - Hugues Blangy
- Department of Cardiology, University Hospital of Nancy, Vandoeuvre-Lès-Nancy 54500, France
| | - Olivier Piot
- Department of Cardiology, Cardiology Center of Nord, Saint Denis 93200, France
| | - Christophe Leclercq
- Department of Cardiology, University Hospital Pontchaillou, Rennes 35000, France
| | - Eloi Marijon
- Department of Cardiology, European Georges Pompidou Hospital, Paris Cedex 15, 75908, France
- Université Paris Cité, Inserm, PARCC, F-75015 Paris, France
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13
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Iliodromitis K, Balogh Z, Triposkiadis F, Deftereos S, Vrachatis D, Bimpong-Buta NY, Schiedat F, Bogossian H. Assessing physical activity with the wearable cardioverter defibrillator in patients with newly diagnosed heart failure. Front Cardiovasc Med 2023; 10:1176710. [PMID: 37252123 PMCID: PMC10213313 DOI: 10.3389/fcvm.2023.1176710] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Accepted: 04/24/2023] [Indexed: 05/31/2023] Open
Abstract
Background The wearable cardioverter defibrillator (WCD), (LifeVest, ZOLL, Pittsburgh, PA, USA) is a medical device designed for the temporary detection and treatment of malignant ventricular tachyarrhythmias. WCD telemonitoring features enable the evaluation of the physical activity (PhA) of the patients. We sought to assess with the WCD the PhA of patients with newly diagnosed heart failure. Methods We collected and analyzed the data of all patients treated with the WCD in our clinic. Patients with newly diagnosed ischemic, or non-ischemic cardiomyopathy and severely reduced ejection fraction, who were treated with the WCD for at least 28 consecutive days and had a compliance of at least 18 h the day were included. Results Seventy-seven patients were eligible for analysis. Thirty-seven patients suffered from ischemic and 40 from non-ischemic heart disease. The average days the WCD was carried was 77.3 ± 44.6 days and the mean wearing time was 22.8 ± 2.1 h. The patients showed significantly increased PhA measured by daily steps between the first two and the last two weeks (Mean steps in the first 2 weeks: 4,952.6 ± 3,052.7 vs. mean steps in the last 2 weeks: 6,119.6 ± 3,776.2, p-value: < 0.001). In the end of the surveillance period an increase of the ejection fraction was observed (LVEF-before: 25.8 ± 6.6% vs. LVEF-after: 37.5 ± 10.6%, p < 0.001). Improvement of the EF did not correlate with the improvement of PhA. Conclusion The WCD provides useful information regarding patient PhA and may be additionally utilized for early heart failure treatment adjustment.
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Affiliation(s)
- Konstantinos Iliodromitis
- Clinic for Cardiology and Electrophysiology, Evangelical Hospital Hagen-Haspe, Hagen, Germany
- School of Medicine, Witten/Herdecke University, Witten, Germany
| | - Zsuzsanna Balogh
- Clinic for Cardiology and Electrophysiology, Evangelical Hospital Hagen-Haspe, Hagen, Germany
| | | | - Spyridon Deftereos
- Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Dimitrios Vrachatis
- Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - Nana-Yaw Bimpong-Buta
- Clinic for Cardiology and Electrophysiology, Evangelical Hospital Hagen-Haspe, Hagen, Germany
- School of Medicine, Witten/Herdecke University, Witten, Germany
| | - Fabian Schiedat
- Clinic for Cardiology, Marienhospital Gelsenkirchen Academic Hospital of the Ruhr University Bochum, Bochum, Germany
| | - Harilaos Bogossian
- Clinic for Cardiology and Electrophysiology, Evangelical Hospital Hagen-Haspe, Hagen, Germany
- School of Medicine, Witten/Herdecke University, Witten, Germany
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14
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Casolo G, Gulizia MM, Aschieri D, Chinaglia A, Corda M, Nassiacos D, Caico SI, Chimenti C, Giaccardi M, Gotti E, Maffé S, Magnano R, Solarino G, Gabrielli D, Oliva F, Colivicchi F. ANMCO position paper: guide to the appropriate use of the wearable cardioverter defibrillator in clinical practice for patients at high transient risk of sudden cardiac death. Eur Heart J Suppl 2023; 25:D294-D311. [PMID: 37213799 PMCID: PMC10194821 DOI: 10.1093/eurheartjsupp/suad101] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/23/2023]
Abstract
Extended risk stratification and optimal management of patients with a permanently increased risk of sudden cardiac death (SCD) are becoming increasingly important. There are several clinical conditions where the risk of arrhythmic death is present albeit only transient. As an example, patients with depressed left ventricular function have a high risk of SCD that may be only transient if there will be a significant recovery of function. It is important to protect the patients while receiving and titrating to the optimal dose the recommended drugs that may lead to an improved left ventricular function. In several other conditions, a transient risk of SCD can be observed even if the left ventricular function is not compromised. Examples are patients with acute myocarditis, during the diagnostic work-up of some arrhythmic conditions or after extraction of infected catheters while eradicating the associated infection. In all these conditions, it is important to offer a protection to these patients. The wearable cardioverter defibrillator (WCD) is of particular importance as a temporary non-invasive technology for both arrhythmia monitoring and therapy in patients with increased risk of SCD. Previous studies have shown the WCD to be an effective and safe therapy for the prevention of SCD caused by ventricular tachycardia/fibrillation. The aim of this ANMCO position paper is to provide a recommendation for clinical utilization of the WCD in Italy, based upon current data and international guidelines. In this document, we will review the WCD functionality, indications, clinical evidence, and guideline recommendations. Finally, a recommendation for the utilization of the WCD in routine clinical practice will be presented, in order to provide physicians with a practical guidance for SCD risk stratification in patients who may benefit from this device.
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Affiliation(s)
- Giancarlo Casolo
- U.O.C. Cardiology, Versilia Hospital, Lido di Camaiore, Lucca 55043
| | - Michele Massimo Gulizia
- U.O.C. Cardiology, Garibaldi-Nesima Hospital, Azienda di Rilievo Nazionale e Alta Specializzazione ‘Garibaldi’, Catania
| | | | | | - Marco Corda
- S.C. Cardiology-UTIC, ARNAS ‘G. Brotzu’, Cagliari
| | - Daniele Nassiacos
- U.O.C Cardiology-UTIC, P.O. Saronno, ASST Valle Olona, Saronno, Varese
| | | | - Cristina Chimenti
- Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Azienda Ospedaliera Universitaria Policlinico Umberto I, Rome
| | - Marzia Giaccardi
- U.O. Cardiology, Santa Maria Annunziata Hospital, Bagno a Ripoli, Florence
| | - Enrico Gotti
- Department of Nephrological, Cardiac and Vascular Diseases, University of Modena and Reggio Emilia, Baggiovara Civil Hospital, Modena
| | - Stefano Maffé
- U.O. Cardiology, SS Trinità Hospital, ASL NO, Borgomanero, Novara
| | | | | | - Domenico Gabrielli
- U.O.C. Cardiology, Department of Cardio-Thoraco-Vascular, Azienda Ospedaliera San Camillo Forlanini, Rome
- Fondazione per il Tuo cuore—Heart Care Foundation, Florence
| | - Fabrizio Oliva
- Cardiology 1-Emodinamics, Cardiothoracovascular Department ‘A. De Gasperis’, ASST Grande Ospedale Metropolitano Niguarda, Milan
| | - Furio Colivicchi
- U.O.C. Clinical and Rehabilitation Cardiology, Presidio Ospedaliero San Filippo Neri—ASL Roma 1, Rome
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15
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Kellnar A, Fichtner S, Sams L, Stremmel C, Estner HL, Lackermair K. Evaluation of a Standardized Training and Adherence Surveillance Programme to Overcome Quality-of-Life Impairments and Enhance Compliance in Patients Treated with Wearable Cardioverter Defibrillator. Patient Prefer Adherence 2023; 17:433-440. [PMID: 36815129 PMCID: PMC9940500 DOI: 10.2147/ppa.s400086] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2022] [Accepted: 01/25/2023] [Indexed: 02/17/2023] Open
Abstract
BACKGROUND Treatment with wearable cardioverter defibrillators (WCD) is a non-invasive, transient therapy option for prevention of sudden cardiac death (SCD) in patients with temporary contraindications for implantation of a permanent cardioverter defibrillator. Due to the constant risk of fatal arrhythmias, compliance is the fundamental requirement for effectiveness of a WCD, but this might be hindered by the poor quality-of-life (QoL) during WCD therapy. In this retrospective single-center study, we examined if a standardized WCD training and adherence surveillance programme could enhance compliance and QoL. METHODS All patients with a prescription for WCD treatment from January 2017 to August 2019 were included and received a standardized WCD training programme. QoL was validated using the modified EQ-5D-3L questionnaire. The findings were compared to a historical, previously published, retrospective cohort from our center (WCD prescription period 03/2012-02/2016), not receiving the additional training programme. Endpoints comprised therapy adherence, arrhythmic episodes, and dimensions of QoL. RESULTS Ninety-two patients underwent WCD treatment in the study cohort for a median of 49 days. Median daily wear time was enhanced in the study cohort (historical cohort vs study cohort 21.9 vs 23.3 hours/per day, p<0.01) and artefact alarms occurred less frequently (67.9% vs 48.9%, p 0.01). Major restrictions in QoL in the study cohort were found in mobility (48%), daily routine (44%), and sleep (49%), but the dimensions pain (36% vs 4%, p<0.01), mental health (43% vs 29%, p 0.03), and restrictions in daily routine (48% vs 30%, p 0.04) improved. CONCLUSION A standardized training and adherence surveillance programme might have beneficial effects on compliance and QoL. As these findings are essential for therapy success, they might potentially lead to a reduction in arrhythmic deaths in upcoming WCD trials.
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Affiliation(s)
- Antonia Kellnar
- Department of Medicine I, University Hospital Munich, Ludwig Maximilian University, Munich, Germany
- Correspondence: Antonia Kellnar, Department of Medicine I, University Hospital Munich, Marchioninistr. 15, Munich, DE-81377, Germany, Tel +49 89 4400 712621, Email
| | - Stephanie Fichtner
- Department of Cardiology, Krankenhaus Landshut-Achdorf, Landshut, Germany
| | - Lauren Sams
- Department of Medicine I, University Hospital Munich, Ludwig Maximilian University, Munich, Germany
| | - Christopher Stremmel
- Department of Medicine I, University Hospital Munich, Ludwig Maximilian University, Munich, Germany
| | - Heidi L Estner
- Department of Medicine I, University Hospital Munich, Ludwig Maximilian University, Munich, Germany
| | - Korbinian Lackermair
- Department of Medicine I, University Hospital Munich, Ludwig Maximilian University, Munich, Germany
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16
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Gleva MJ, Sullivan J, Crawford TC, Walcott G, Birgersdotter-Green U, Branch KR, Doshi RN, Kivilaid K, Brennan K, Rowbotham RK, Gustavson LM, Poole JE. Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies. PLoS One 2023; 18:e0281340. [PMID: 36917566 PMCID: PMC10013906 DOI: 10.1371/journal.pone.0281340] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Accepted: 01/17/2023] [Indexed: 03/16/2023] Open
Abstract
INTRODUCTION The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study. METHODS Animal (swine) studies: #1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate. #2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate. #3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock. Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events. RESULTS Animal Studies #1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p < .001). #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p < .001). #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B. Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients. CONCLUSIONS The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans. TRIAL REGISTRATION Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.
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Affiliation(s)
- Marye J. Gleva
- Division of Cardiology, Department of Medicine, Washington University in Saint Louis School of Medicine in Saint Louis, St. Louis, Missouri, United States of America
- * E-mail:
| | - Joseph Sullivan
- Kestra Medical Technologies, Inc., Redmond, Washington, United States of America
| | - Thomas C. Crawford
- Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor, Michigan, United States of America
| | - Greg Walcott
- Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, United States of America
| | | | - Kelley R. Branch
- Division of Cardiology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America
| | | | | | - Kelly Brennan
- Kestra Medical Technologies, Inc., Redmond, Washington, United States of America
| | - Ron K. Rowbotham
- Kestra Medical Technologies, Inc., Redmond, Washington, United States of America
| | - Laura M. Gustavson
- Kestra Medical Technologies, Inc., Redmond, Washington, United States of America
| | - Jeanne E. Poole
- Division of Cardiology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America
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17
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Abumayyaleh M, Dreher TC, Rosenkaimer S, Röger S, Erath JW, Klein N, Kovacs B, Duru F, Saguner AM, El-Battrawy I, Akin I. Sex differences and adherence of patients treated with wearable cardioverter-defibrillator: insights from an international multicenter register. J Cardiovasc Electrophysiol 2022; 33:2243-2249. [PMID: 35930623 DOI: 10.1111/jce.15648] [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: 01/17/2022] [Revised: 07/13/2022] [Accepted: 07/24/2022] [Indexed: 11/28/2022]
Abstract
AIMS Treatment with the wearable cardioverter defibrillator (WCD) may protect against sudden cardiac death (SCD) as a bridging therapy until a cardioverter-defibrillator may be implanted. We analyzed in a multicenter setting a consecutive patient cohort wearing WCD to explore sex differences. METHODS AND RESULTS We analyzed 708 consecutive patients, 579 (81.8%) from whom were males and 129 (18.2%) females (age, 60.5±14 vs. 61.6±17 years old; p=0.44). While the rate of ischemic cardiomyopathy (ICM) as a cause of prescription of WCD was significantly higher in males as compared to females (42.7% vs. 26.4%; p=0.001), females received it more frequently due to non-ischemic cardiomyopathy (NICM) (55.8% vs. 42.7%); p=0.009). The wear time of WCD was equivalent in both groups (21.1±4.3 hours/days in males vs. 21.5±4.4 hours/days in females; p=0.27; and 62.6±44.3 days in males vs. 56.5±39 days in females; p=0.15). Mortality was comparable in both groups at 2-year-follow-up (6.8% in males vs. 9.7% in females; p=0.55). Appropriate WCD shocks and the incidence of ICD implantations were similar in both groups (2.4% in males vs. 3.9% in females; p=0.07) (35.1% in males vs. 31.8% in females; p=0.37), respectively. In age tertile analysis, compliance was observed more in 73-91 years old group as compared to 14-51 years old group (87.8% vs. 68.3%; p<0.001). CONCLUSION Compliance for wearing WCD was excellent regardless of sex. Furthermore, mortality and the incidence of ICD implantations were comparable in both sexes. Appropriate WCD shocks were similar in both sexes. This article is protected by copyright. All rights reserved.
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Affiliation(s)
- Mohammad Abumayyaleh
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Germany
| | - Tobias C Dreher
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Germany
| | - Stephanie Rosenkaimer
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Germany
| | - Susanne Röger
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Germany
| | - Julia W Erath
- Department of Cardiology/Division of Clinical Electrophysiology, University Hospital Frankfurt, Goethe University, Frankfurt a. M., Germany
| | - Norbert Klein
- Department of Arrhythmias & Invasive Cardiology, St. Georg Hospital, Leipzig, Germany
| | - Boldizsar Kovacs
- Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland
| | - Firat Duru
- Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland
| | - Ardan M Saguner
- Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland
| | - Ibrahim El-Battrawy
- Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany
| | - Ibrahim Akin
- Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Germany
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Blockhaus C, Guelker JE, Feyen L, Bufe A, Seyfarth M, Shin DI. Telemonitoring Potential of Wearable Cardioverter-Defibrillators during the Follow-Up of Patients with Heart Failure. J Cardiovasc Dev Dis 2022; 9:jcdd9060175. [PMID: 35735804 PMCID: PMC9224944 DOI: 10.3390/jcdd9060175] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2022] [Revised: 04/22/2022] [Accepted: 05/31/2022] [Indexed: 11/16/2022] Open
Abstract
Background: Wearable cardioverter-defibrillators (WCDs) are a well-established tool to bridge the recovery time of left ventricular ejection fraction (LVEF) until the implantation of an implantable cardioverter defibrillator (ICD), as recommended by the current guidelines. Besides their function to detect and treat malignant arrhythmias, WCDs may be used as a telemonitoring system. In this study, we sought to illustrate and discuss the telemonitoring potential of WCDs and to analyze physical activity in specific patient cohorts. Methods and Results: We retrospectively included 140 patients with reduced LVEF who were prescribed WCDs in our clinic. We analyzed the patients’ physical activity (n = 105 with a WCD compliance above 21 h/day), body position and resting position. We found a reduced physical activity in women and in patients over the age of 65 compared to younger patients. Furthermore, the patients who were overweight or obese showed significantly reduced physical activity compared to the patients with a normal weight (6365 ± 3572 vs. 4972 ± 2476 vs. 7045 ± 3521, p = 0.02). Conclusion: WCDs may be used as a telemonitoring and intervention tool in patients with reduced LVEF. Specific patient groups may benefit from guidance from their treating physician regarding physical activity.
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Affiliation(s)
- Christian Blockhaus
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (A.B.); (D.-I.S.)
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
- Correspondence:
| | - Jan-Erik Guelker
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
- Department of Cardiology, Petrus Hospital, 42283 Wuppertal, Germany
| | - Ludger Feyen
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
- Department of Diagnostic and Interventional Radiology, Helios Clinic Krefeld, 47805 Krefeld, Germany
- Department of Diagnostic and Interventional Radiology, Helios University Hospital, 42283 Wuppertal, Germany
| | - Alexander Bufe
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (A.B.); (D.-I.S.)
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
| | - Melchior Seyfarth
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
- Department of Cardiology, Helios University Hospital, 42283 Wuppertal, Germany
| | - Dong-In Shin
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (A.B.); (D.-I.S.)
- Faculty of Health, School of Medicine, University Witten/Herdecke, 58448 Witten, Germany; (J.-E.G.); (L.F.); (M.S.)
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Kuehn C, Ruemke S, Rellecke P, Lichtenberg A, Joskowiak D, Hagl C, Hassan M, Leyh RG, Erler S, Garbade J, Eifert S, Grieshaber P, Boening A, Doenst T, Velichkov I, Madej T, Knaut M, Hain A, Burger H. Wearable cardioverter defibrillator multicentre experience in a large cardiac surgery cohort at transient risk of sudden cardiac death. Eur J Cardiothorac Surg 2022; 61:1031-1040. [PMID: 35174386 PMCID: PMC9070494 DOI: 10.1093/ejcts/ezac086] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2021] [Revised: 11/24/2021] [Accepted: 02/08/2022] [Indexed: 11/14/2022] Open
Abstract
OBJECTIVES The wearable cardioverter defibrillator (WCD) is an established, safe, effective solution, protecting patients at risk of sudden cardiac death. We specifically investigated WCD use in cardiac surgery patients since data for this patient group are rare. METHODS Retrospective data analysis in 10 German cardiac surgery centres was performed. Cardiac surgery patients with left ventricular ejection fraction (LVEF) ≤35% or after implantable cardioverter defibrillator (ICD) explantation who received WCD between 2010 and 2020 were assessed using LifeVest Network data. RESULTS A total of 1168 patients with a median age of 66 years [interquartile range (IQR) 57-73] were enrolled; 87% were male. Clinical indications included coronary artery bypass grafting (43%), valve surgery (16%), combined coronary artery bypass graft/valve surgery (15%), ICD explantation (24%) and miscellaneous (2%). The median wear time of WCD was 23.4 h/day (IQR 21.7-23.8). A total of 106 patients (9.1%) exhibited ventricular tachycardia. A total of 93.2% of episodes occurred within the first 3 months. Eighteen patients (1.5%) received 26 adequate shocks. The inadequate shock rate was low (8 patients, 0.7%). LVEF improved from a median of 28% (IQR 22-32%) before WCD prescription to 35% (IQR 28-42%) during follow-up. Excluding ICD explant patients, 37% of patients received an ICD. CONCLUSIONS The risk of sudden cardiac death is substantial within the first 3 months after cardiac surgery. Patients were protected effectively by WCD. Due to significant LVEF improvement, the majority did not require ICD implantation after WCD use. Compliance was high despite sternotomy. This multicentre experience confirms existing data regarding effectiveness, safety and compliance. Therefore, WCD should be considered in cardiac surgery patients with severely reduced LVEF.
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Affiliation(s)
- Christian Kuehn
- Department of Cardiac-,Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany
| | - Stefan Ruemke
- Department of Cardiac-,Thoracic-, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany
| | - Philipp Rellecke
- Department for Cardiac Surgery, Heinrich-Heine-University, Duesseldorf, Germany
| | - Artur Lichtenberg
- Department for Cardiac Surgery, Heinrich-Heine-University, Duesseldorf, Germany
| | - Dominik Joskowiak
- Department of Cardiac Surgery, University Hospital, LMU Munich, Munich, Germany
| | - Christian Hagl
- Department of Cardiac Surgery, University Hospital, LMU Munich, Munich, Germany
| | - Mohamed Hassan
- Department of Cardiovascular Surgery, University Hospital Wuerzburg, Wuerzburg, Germany
| | - Rainer G Leyh
- Department of Cardiovascular Surgery, University Hospital Wuerzburg, Wuerzburg, Germany
| | - Stefan Erler
- Department for Cardiothoracic Surgery, Heart & Vessel Center Bad Bevensen, Bad Bevensen, Germany
| | - Jens Garbade
- Department for Cardiothoracic Surgery, Klinikum Links der Weser, Bremen, Germany
| | - Sandra Eifert
- Department of Cardiac Surgery, University Hospital Leipzig, Heart Center Leipzig, Leipzig, Germany
| | - Philippe Grieshaber
- Department of Adult and Pediatric Cardiovascular Surgery, Giessen University Hospital, Giessen, Germany
| | - Andreas Boening
- Department of Adult and Pediatric Cardiovascular Surgery, Giessen University Hospital, Giessen, Germany
| | - Torsten Doenst
- Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Jena, Germany
| | - Ilia Velichkov
- Department of Cardiothoracic Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Jena, Germany
| | - Tomas Madej
- Department of Cardiac Surgery, Dresden Heart Centre, Carl Gustav Carus University of Dresden, Dresden, Germany
| | - Michael Knaut
- Department of Cardiac Surgery, Dresden Heart Centre, Carl Gustav Carus University of Dresden, Dresden, Germany
| | - Andreas Hain
- Department of Cardiology, Kerckhoff-Clinic Bad Nauheim, Bad Nauheim, Germany
| | - Heiko Burger
- Department of Cardiovascular Surgery, Kerckhoff-Clinic Bad Nauheim, Bad Nauheim, Germany
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20
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Botto GL, Mantovani LG, Cortesi PA, De Ponti R, D'Onofrio A, Biffi M, Capucci A, Casu G, Notarstefano P, Scaglione M, Zanotto G, Boriani G. The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective. Int J Cardiol 2022; 356:12-18. [PMID: 35395289 DOI: 10.1016/j.ijcard.2022.04.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2022] [Revised: 03/16/2022] [Accepted: 04/01/2022] [Indexed: 01/19/2023]
Abstract
AIMS Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. METHODS & RESULTS Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. CONCLUSION WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.
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Affiliation(s)
- Giovanni Luca Botto
- Cardiology - Electrophysiology Division, Department of Medicine, Ospedale di Circolo Rho, Ospedale Salvini Garbagnate M.se, ASST Rhodense, Milan, Italy.
| | - Lorenzo Giovanni Mantovani
- Research Centre on Public Health (CESP), University of Milano-Bicocca, Monza, Italy; Value-Based Healthcare Unit, IRCCS Multimedica, Sesto San Giovanni, Italy
| | - Paolo Angelo Cortesi
- Research Centre on Public Health (CESP), University of Milano-Bicocca, Monza, Italy
| | - Roberto De Ponti
- Department of Heart and Vessels, Ospedale di Circolo-University of Insubria, Varese, Italy
| | - Antonio D'Onofrio
- Cardiology Division - Electrophysiology Department - AORN dei Colli, Ospedale Monaldi, Napoli, Italy
| | - Mauro Biffi
- Cardiology Division - Electrophysiology Department, Policlinico S.Orsola Malpighi, Bologna, Italy
| | - Alessandro Capucci
- Cardiology and Arrhytmology Clinic, Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy
| | - Gavino Casu
- Cardiology and Intensive Care Unit, Ospedale "San Francesco" Nuoro, Italy
| | | | | | | | - Giuseppe Boriani
- Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy
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El-Battrawy I, Kovacs B, Dreher TC, Klein N, Rosenkaimer S, Röger S, Kuschyk J, Saguner AM, Kowitz J, Erath JW, Duru F, Akin I. Real life experience with the wearable cardioverter-defibrillator in an international multicenter Registry. Sci Rep 2022; 12:3203. [PMID: 35217697 PMCID: PMC8881447 DOI: 10.1038/s41598-022-06007-y] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2021] [Accepted: 12/20/2021] [Indexed: 01/10/2023] Open
Abstract
Patients at high risk for sudden cardiac death (SCD) may benefit from wearable cardioverter defibrillators (WCD) by avoiding immediate implantable cardioverter defibrillator (ICD) implantation. Different factors play an important role including patient selection, compliance and optimal drug treatment. We aimed to present real world data from 4 centers from Germany and Switzerland. Between 04/2012 and 03/2019, 708 patients were included in this registry. Patients were followed up over a mean time of 28 ± 35.5 months. Outcome data including gender differences and different etiologies of cardiomyopathy were analyzed. Out of 708 patients (81.8% males, mean age 61.0 ± 14.6), 44.6% of patients had non-ischemic cardiomyopathy, 39.8% ischemic cardiomyopathy, 7.9% myocarditis, 5.4% prior need for ICD explantation and 2.1% channelopathy. The mean wear time of WCD was 21.2 ± 4.3 h per day. In 46% of patients, left ventricular ejection fraction (LVEF) was > 35% during follow-up. The younger the patient was, the higher the LVEF and the lower the wear hours per day were. The total shock rate during follow-up was 2.7%. Whereas an appropriate WCD shock was documented in 16 patients (2.2%), 3 patients received an inappropriate ICD shock (0.5%). During follow-up, implantation of a cardiac implantable electronic device was carried out in 34.5% of patients. When comparing German patients (n = 516) to Swiss patients (n = 192), Swiss patients presented with longer wear days (70.72 ± 49.47 days versus 58.06 ± 40.45 days; p = 0.001) and a higher ICD implantation rate compared to German patients (48.4% versus 29.3%; p = 0.001), although LVEF at follow-up was similar between both groups. Young age is a negative independent predictor for the compliance in this large registry. The most common indication for WCD was non-ischemic cardiomyopathy followed by ischemic cardiomyopathy. The compliance rate was generally high with a decrease of wear hours per day at younger age. Slight differences were found between Swiss and German patients, which might be related to differences in mentality for ICD implantation.
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Affiliation(s)
- Ibrahim El-Battrawy
- grid.5570.70000 0004 0490 981XBergmannsheil University Medical Center, Ruhr University Bochum, Bochum, Germany ,grid.5570.70000 0004 0490 981XDepartment of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Bochum, Germany
| | - Boldizsar Kovacs
- grid.412004.30000 0004 0478 9977Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland
| | - Tobias C. Dreher
- grid.5601.20000 0001 0943 599XUniversity of Mannheim, Mannheim, Germany
| | - Norbert Klein
- grid.470221.20000 0001 0690 7373Department of Cardiology, Angiology and Internal Intensive-Care Medicine, Klinikum St. Georg gGmbH Leipzig, Delitzscher Straße 141, 04129 Leipzig, Germany
| | | | - Susanne Röger
- grid.5601.20000 0001 0943 599XUniversity of Mannheim, Mannheim, Germany
| | - Jürgen Kuschyk
- grid.5601.20000 0001 0943 599XUniversity of Mannheim, Mannheim, Germany
| | - Ardan Muammer Saguner
- grid.412004.30000 0004 0478 9977Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland
| | - Jacqueline Kowitz
- grid.5601.20000 0001 0943 599XUniversity of Mannheim, Mannheim, Germany
| | - Julia W. Erath
- grid.7839.50000 0004 1936 9721Department of Cardiology, Frankfurt University Hospital, Goethe University, Frankfurt am Main, Germany
| | - Firat Duru
- grid.412004.30000 0004 0478 9977Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland
| | - Ibrahim Akin
- grid.5601.20000 0001 0943 599XUniversity of Mannheim, Mannheim, Germany
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22
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Poole JE, Gleva MJ, Birgersdotter-Green U, Branch KRH, Doshi RN, Salam T, Crawford TC, Willcox ME, Sridhar AM, Mikdadi G, Beinart SC, Cha YM, Russo AM, Rowbotham RK, Sullivan J, Gustavson LM, Kivilaid K. A Wearable Cardioverter Defibrillator with a Low False Alarm Rate. J Cardiovasc Electrophysiol 2022; 33:831-842. [PMID: 35174572 PMCID: PMC9305432 DOI: 10.1111/jce.15417] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Revised: 01/10/2022] [Accepted: 01/16/2022] [Indexed: 11/29/2022]
Abstract
BACKGROUND A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to ECG noise and wear discomfort. OBJECTIVE To test a contemporary WCD designed for reduced false shock alarms and improved comfort. METHODS 130 patients with LVEF ≤ 40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms disabled. All WCD episodes and ICD VT/VF episodes were adjudicated. The primary endpoint was the false positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day). RESULTS Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only 3 false positive shock alarm markers were recorded; 1 false positive shock alarm every 1,333 patient-days (0.00075 per patient-day, 95% CI: 0.00015-0.00361; p < 0.001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥ 170 bpm for ≥ 20 seconds) were missed by the WCD during 3,501 patient-days of use. Median wear was 31.0 days (IQR 2.0) and median daily use 23.0 hours (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%). CONCLUSION The ASSURE WCD demonstrated a low false positive shock alarm rate, low patient-reported discomfort, and no serious adverse events. This article is protected by copyright. All rights reserved.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | - Ghiath Mikdadi
- Heart Clinic of Hammond, Hammond, Louisiana, Center for Cardiac and Vascular Research
| | - Sean C Beinart
- Washington Adventist Healthcare White Oak Medical Center, Silver Spring, Maryland
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Marijon E, Garcia R, Narayanan K, Karam N, Jouven X. OUP accepted manuscript. Eur Heart J 2022; 43:1457-1464. [PMID: 35139183 PMCID: PMC9009402 DOI: 10.1093/eurheartj/ehab903] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/08/2021] [Revised: 12/16/2021] [Accepted: 12/21/2021] [Indexed: 11/24/2022] Open
Abstract
More than 40 years after the first implantable cardioverter-defibrillator (ICD) implantation, sudden cardiac death (SCD) still accounts for more than five million deaths worldwide every year. Huge efforts in the field notwithstanding, it is now increasingly evident that the current strategy of long-term prevention based on left ventricular ejection fraction as the key selection criterion is actually of very limited impact, also because the largest absolute numbers of SCD are encountered in the general population not known to be at risk. It has been recently reemphasized that SCD is often not so sudden, with almost half of the victims experiencing typical warning symptoms preceding the event. Importantly, heeded and prompt medical attention can dramatically improve survival. Essentially, such timely action increases the chances of the SCD event being witnessed by emergency medical services and provides the opportunity for early intervention. In addition, newer technologies incorporating digital data acquisition, transfer between interconnected devices, and artificial intelligence, should allow dynamic, real-time monitoring of diverse parameters and therefore better identification of subjects at short-term SCD risk. Along with warning symptoms, these developments allow a new approach of near-term prevention based on the hours and minutes preceding SCD. In the present review, we challenge the current paradigm of mid- and long-term prevention using ICD in patients at the highest risk of SCD, and introduce a complementary concept applicable to the entire population that would aim to pre-empt SCD by timely detection and intervention within the minutes or hours prior to the event.
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Affiliation(s)
- Eloi Marijon
- Corresponding author. Tel: +33 6 62 83 38 48, Fax: +33 1 56 09 30 47,
| | | | - Kumar Narayanan
- Université de Paris, PARCC, INSERM, F-75015 Paris, France
- Paris-Sudden Death Expertise Center (SDEC), Paris, France
- Cardiology Department, Medicover Hospitals, Hyderabad, India
| | - Nicole Karam
- Université de Paris, PARCC, INSERM, F-75015 Paris, France
- Cardiology Department, European Georges Pompidou Hospital, Paris, France
- Paris-Sudden Death Expertise Center (SDEC), Paris, France
| | - Xavier Jouven
- Université de Paris, PARCC, INSERM, F-75015 Paris, France
- Cardiology Department, European Georges Pompidou Hospital, Paris, France
- Paris-Sudden Death Expertise Center (SDEC), Paris, France
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Rohrer U, Manninger M, Zirlik A, Scherr D. Multiparameter Monitoring with a Wearable Cardioverter Defibrillator. SENSORS (BASEL, SWITZERLAND) 2021; 22:22. [PMID: 35009564 PMCID: PMC8747379 DOI: 10.3390/s22010022] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/01/2021] [Revised: 12/14/2021] [Accepted: 12/16/2021] [Indexed: 05/14/2023]
Abstract
A wearable cardioverter-defibrillator (WCD) is a temporary treatment option for patients at high risk for sudden cardiac death (SCD) and for patients who are temporarily not candidates for an implantable cardioverter defibrillator (ICD). In addition, the need for telemedical concepts in the detection and treatment of heart failure (HF) and its arrhythmias is growing. The WCD has evolved from a shock device detecting malignant ventricular arrhythmias (VA) and treating them with shocks to a heart-failure-monitoring device that captures physical activity and cardioacoustic biomarkers as surrogate parameters for HF to help the treating physician surveil and guide the HF therapy of each individual patient. In addition to its important role in preventing SCD, the WCD could become an important tool in heart failure treatment by helping prevent HF events by detecting imminent decompensation via remote monitoring and monitoring therapy success.
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Affiliation(s)
| | | | | | - Daniel Scherr
- Division of Cardiology, Department of Medicine, Medical University of Graz, 8036 Graz, Austria; (U.R.); (M.M.); (A.Z.)
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Abstract
INTRODUCTION Wearable cardioverter-defibrillator (WCD) is a novel tool that may be of interest in situations with atransient risk of sudden cardiac death. It offers a temporary and easy to remove protection against malignant ventricular arrhythmias. In this review, the authors describe evidence in literature and different international guidelines and consensus. AREAS COVERED The authors searched PubMed, Cochrane Central Register of controlled trials, and Google Scholar for relevant studies and comments. EXPERT OPINION If a WCD is indicated, the observance must be as perfect as possible. Thus, patients need proper education in wearing the WCD.The temporary use of a WCD is reasonable in patients with a high risk for SCD, even with a low level of evidence with only one randomized clinical trial (VEST), as its disadvantages are limited to a transitory impairment in quality of life and a low risk of inappropriate shock.Indications are now well accepted: ischemic cardiomyopathy with LVEF below 35% before reassessment, recent onset of NICM or presumed myocarditis with LVEF ≤35% before reassessment, after ICD explant until reimplantation (e.g. infection), and bridge to transplant.Future guidelines on WCD in the prevention of SCD may be warranted to harmonize clinical practice especially in debated indications..
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Affiliation(s)
- Alexandre Bodin
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France
| | - Arnaud Bisson
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France
| | - Laurent Fauchier
- Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, Faculté de Médecine, Université François Rabelais, Tours, France
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Mueller‐Leisse J, Brunn J, Zormpas C, Hohmann S, Hillmann HAK, Eiringhaus J, Bauersachs J, Veltmann C, Duncker D. Extended follow-up after wearable cardioverter-defibrillator period: the PROLONG-II study. ESC Heart Fail 2021; 8:5142-5148. [PMID: 34480414 PMCID: PMC8712878 DOI: 10.1002/ehf2.13586] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2021] [Revised: 07/29/2021] [Accepted: 08/19/2021] [Indexed: 11/05/2022] Open
Abstract
AIM The wearable cardioverter-defibrillator (WCD) is used for temporary protection from sudden cardiac death (SCD) in patients with newly diagnosed heart failure with reduced ejection fraction before considering an implantable cardioverter-defibrillator (ICD). However, the prognostic significance of the WCD remains controversial due to conflicting evidence. The aim of the present study was to evaluate prognosis of patients receiving life-saving WCD shocks. METHODS AND RESULTS All patients receiving a WCD at Hannover Medical School for heart failure with reduced ejection fraction between 2012 and 2017 were included. Data were acquired at baseline, at 3 months and at last available follow-up (FU). Three hundred and fifty-three patients were included (69% male; age 56 ± 15 years; left ventricular ejection fraction 25 ± 8%). FU after the WCD was 2.8 ± 1.5 years with a maximum of 6.8 years. Daily WCD wear time was 22 ± 4 h. Fourteen patients (4%) received appropriate WCD shocks. Two patients (0.6%) died during the WCD period. Thirty patients (9%) died during extended FU. Mean estimated survival after the WCD was similar between patients with and without WCD shocks. Patients without an ICD recommendation after WCD prescription did not experience SCD during FU. CONCLUSIONS Patients with WCD shocks showed a favourable survival. Patients without an ICD recommendation after WCD prescription had no SCD during FU. These findings support the practice of careful risk stratification before considering an ICD and the use of the WCD for temporary protection from SCD.
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Affiliation(s)
- Johanna Mueller‐Leisse
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Johanna Brunn
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Christos Zormpas
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Stephan Hohmann
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Henrike Aenne Katrin Hillmann
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Jörg Eiringhaus
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Johann Bauersachs
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - Christian Veltmann
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
| | - David Duncker
- Hannover Heart Rhythm Center, Department of Cardiology and AngiologyHannover Medical SchoolCarl‐Neuberg‐Str. 1Hannover30625Germany
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Hillmann HAK, Hohmann S, Mueller-Leisse J, Zormpas C, Eiringhaus J, Bauersachs J, Veltmann C, Duncker D. Feasibility and First Results of Heart Failure Monitoring Using the Wearable Cardioverter-Defibrillator in Newly Diagnosed Heart Failure with Reduced Ejection Fraction. SENSORS (BASEL, SWITZERLAND) 2021; 21:7798. [PMID: 34883802 PMCID: PMC8659567 DOI: 10.3390/s21237798] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 10/31/2021] [Revised: 11/20/2021] [Accepted: 11/21/2021] [Indexed: 11/16/2022]
Abstract
The wearable cardioverter-defibrillator (WCD) is used in patients with newly diagnosed heart failure and reduced ejection fraction (HFrEF). In addition to arrhythmic events, the WCD provides near-continuous telemetric heart failure monitoring. The purpose of this study was to evaluate the clinical relevance of additionally recorded parameters, such as heart rate or step count. We included patients with newly diagnosed HFrEF prescribed with a WCD. Via the WCD, step count and heart rate were acquired, and an approximate for heart rate variability (HRV5) was calculated. Multivariate analysis was performed to analyze predictors for an improvement in left ventricular ejection fraction (LVEF). Two hundred and seventy-six patients (31.9% female) were included. Mean LVEF was 25.3 ± 8.5%. Between the first and last seven days of usage, median heart rate fell significantly (p < 0.001), while median step count and HRV5 significantly increased (p < 0.001). In a multivariate analysis, a delta of HRV5 > 23 ms was an independent predictor for LVEF improvement of ≥10% between prescription and 3-month follow-up. Patients with newly diagnosed HFrEF showed significant changes in heart rate, step count, and HRV5 between the beginning and end of WCD prescription time. HRV5 was an independent predictor for LVEF improvement and could serve as an early indicator of treatment response.
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Affiliation(s)
| | | | | | | | | | | | | | - David Duncker
- Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, 30625 Hannover, Germany; (H.A.K.H.); (S.H.); (J.M.-L.); (C.Z.); (J.E.); (J.B.); (C.V.)
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Blockhaus C, List S, Waibler HP, Gülker JE, Klues H, Bufe A, Seyfarth M, Koektuerk B, Shin DI. Wearable Cardioverter-Defibrillator Used as a Telemonitoring System in a Real-Life Heart Failure Unit Setting. J Clin Med 2021; 10:5435. [PMID: 34830724 PMCID: PMC8618886 DOI: 10.3390/jcm10225435] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2021] [Revised: 11/10/2021] [Accepted: 11/18/2021] [Indexed: 01/01/2023] Open
Abstract
BACKGROUND In patients with reduced left ventricular ejection fraction (LVEF) who are at risk of sudden cardiac death, a wearable cardioverter-defibrillator (WCD) is recommended as a bridge to the recovery of LVEF or as a bridge to the implantation of a device. In addition to its function to detect and treat malignant arrhythmia, WCD can be used via an online platform as a telemonitoring system to supervise patients' physical activity, compliance, and heart rate. METHODS We retrospectively analyzed 173 patients with regard to compliance and heart rate after discharge. RESULTS Mean WCD wearing time was 59.75 ± 35.6 days; the daily wearing time was 21.19 ± 4.65 h. We found significant differences concerning the patients' compliance. Men showed less compliance than women, and younger patients showed less compliance than patients who were older. Furthermore, we analyzed the heart rate from discharge until the end of WCD prescription and found a significant decrease from discharge to 4, 8, or 12 weeks. CONCLUSION WCD can be used as a telemonitoring system to help the involved heart failure unit or physicians attend to and adjust the medical therapy. Furthermore, specific patient groups should be educated more intensively with respect to compliance.
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Affiliation(s)
- Christian Blockhaus
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
| | - Stephan List
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
| | - Hans-Peter Waibler
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
| | - Jan-Erik Gülker
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
- Department of Cardiology, Petrus Hospital Wuppertal, 42283 Wuppertal, Germany
| | - Heinrich Klues
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
| | - Alexander Bufe
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
| | - Melchior Seyfarth
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
- Department of Cardiology, Helios University Hospital, 42117Wuppertal, Germany
| | - Buelent Koektuerk
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
| | - Dong-In Shin
- Heart Centre Niederrhein, Department of Cardiology, Helios Clinic Krefeld, 47805 Krefeld, Germany; (S.L.); (H.-P.W.); (H.K.); (A.B.); (B.K.); (D.-I.S.)
- Witten-Herdecke University, 58455 Witten, Germany; (J.-E.G.); (M.S.)
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Real-world experience with the wearable cardioverter defibrillator: clinical effectiveness and wear-time adherence in patients at high risk for sudden cardiac death. Herzschrittmacherther Elektrophysiol 2021; 33:55-62. [PMID: 34694459 DOI: 10.1007/s00399-021-00816-w] [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: 09/16/2021] [Accepted: 09/27/2021] [Indexed: 10/20/2022]
Abstract
BACKGROUND Previous studies established a role for the wearable cardioverter defibrillator (WCD) to effectively and safely bridge temporary risk for sudden cardiac death (SCD) in patients with advanced heart failure. The prognostic relevance of the WCD remains controversial. OBJECTIVES The authors investigated adherence to, as well as the safety and effectiveness of, WCD use in a real-world cohort of patients at high risk for SCD. MATERIAL AND METHODS All consecutive patients (n = 83) receiving a WCD at a German tertiary care hospital between April 2012 and December 2019 were retrospectively included in this analysis. Patient characteristics were collected at the time of the index hospitalization. Using the Zoll® lifeVest® (ZOLL Medical Corporation, Chelmsford, MA, USA) network database, two separate investigators evaluated adherence to the WCD as well as arrhythmic events during WCD wear time. RESULTS During 3680 wearing days (mean WCD wear time, 44 days) with a median daily wear time of 23.1 h, three arrhythmic events of relevance (sustained ventricular tachycardia, VT) occurred, one of which was sufficiently terminated by WCD shock. Another patient died from sudden cardiac death while pausing his WCD. Right bundle branch block correlated significantly with sustained VT occurrence (r = 0.3315; 95% CI -0.1265 to 0.3014; p = 0.0022). In 30 patients (36.1%) a cardioverter/defibrillator was implanted. CONCLUSION In a real-life clinical setting, the use of WCD in patients at high risk for sudden cardiac death is effective and safe and adherence to the device is high. The event rate for VA was lower than in comparable patient cohorts. Adherence remains a crucial issue as one patient in the present series died while not wearing the device.
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Batista E, Moncusi MA, López-Aguilar P, Martínez-Ballesté A, Solanas A. Sensors for Context-Aware Smart Healthcare: A Security Perspective. SENSORS (BASEL, SWITZERLAND) 2021; 21:6886. [PMID: 34696099 PMCID: PMC8537585 DOI: 10.3390/s21206886] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/27/2021] [Revised: 10/12/2021] [Accepted: 10/14/2021] [Indexed: 12/24/2022]
Abstract
The advances in the miniaturisation of electronic devices and the deployment of cheaper and faster data networks have propelled environments augmented with contextual and real-time information, such as smart homes and smart cities. These context-aware environments have opened the door to numerous opportunities for providing added-value, accurate and personalised services to citizens. In particular, smart healthcare, regarded as the natural evolution of electronic health and mobile health, contributes to enhance medical services and people's welfare, while shortening waiting times and decreasing healthcare expenditure. However, the large number, variety and complexity of devices and systems involved in smart health systems involve a number of challenging considerations to be considered, particularly from security and privacy perspectives. To this aim, this article provides a thorough technical review on the deployment of secure smart health services, ranging from the very collection of sensors data (either related to the medical conditions of individuals or to their immediate context), the transmission of these data through wireless communication networks, to the final storage and analysis of such information in the appropriate health information systems. As a result, we provide practitioners with a comprehensive overview of the existing vulnerabilities and solutions in the technical side of smart healthcare.
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Affiliation(s)
- Edgar Batista
- Department of Computer Engineering and Mathematics, Universitat Rovira i Virgili, Av. Països Catalans 26, 43007 Tarragona, Spain; (E.B.); (M.A.M.); (A.M.-B.)
- SIMPPLE S.L., C. Joan Maragall 1A, 43003 Tarragona, Spain
| | - M. Angels Moncusi
- Department of Computer Engineering and Mathematics, Universitat Rovira i Virgili, Av. Països Catalans 26, 43007 Tarragona, Spain; (E.B.); (M.A.M.); (A.M.-B.)
| | - Pablo López-Aguilar
- Anti-Phishing Working Group EU, Av. Diagonal 621–629, 08028 Barcelona, Spain;
| | - Antoni Martínez-Ballesté
- Department of Computer Engineering and Mathematics, Universitat Rovira i Virgili, Av. Països Catalans 26, 43007 Tarragona, Spain; (E.B.); (M.A.M.); (A.M.-B.)
| | - Agusti Solanas
- Department of Computer Engineering and Mathematics, Universitat Rovira i Virgili, Av. Països Catalans 26, 43007 Tarragona, Spain; (E.B.); (M.A.M.); (A.M.-B.)
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Minami Y, Kikuchi N, Shiga T, Suzuki A, Shoda M, Hagiwara N. Incidence and predictors of early and late sudden cardiac death in hospitalized Japanese patients with new-onset systolic heart failure. J Arrhythm 2021; 37:1148-1155. [PMID: 34621413 PMCID: PMC8485812 DOI: 10.1002/joa3.12618] [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: 04/28/2021] [Revised: 07/22/2021] [Accepted: 08/07/2021] [Indexed: 11/11/2022] Open
Abstract
BACKGROUND Patients with heart failure (HF) and low left ventricular ejection fraction (LVEF) are at high risk of sudden cardiac death (SCD). Optimal HF treatment can improve LVEF and reduce the risk of SCD. The aim of this study was to evaluate the incidence and predictors of SCD in Japanese patients with new-onset systolic HF and to investigate factors that affect LVEF improvement. METHODS We retrospectively studied 174 consecutive hospitalized patients with new-onset HF and LVEF ≤35% (median age, 66 years; men, 71%). The primary outcome was a composite of SCD, sustained ventricular arrhythmias, and appropriate implantable cardioverter-defibrillator therapy. RESULTS The cumulative rates of meeting of the primary outcome at 3, 12, and 36 months after discharge were 3.9%, 8.1%, and 10.5%, respectively. Atrial fibrillation was a significant predictor of the primary outcome within 12 months after discharge (odds ratio, 5.87; 95% confidence interval [CI], 1.60-21.57). Among 104 patients who completed follow-up echocardiography within 12 months after discharge, changes in LVEF were inversely associated with SCD (odds ratio/1% increase, 0.78; 95% CI, 0.65-0.93). A QRS duration <130 ms and a B-type natriuretic peptide level <170 pg/mL were predictors of LVEF improvement to >35% (odds ratio, 3.69; 95% CI, 1.15-11.77; odds ratio, 3.19; 95% CI, 1.33-7.69, respectively). CONCLUSIONS Our results showed a high incidence of meeting of the primary outcome within 12 months after discharge in hospitalized patients with new-onset systolic HF. An improved LVEF may reduce the risk of late SCD.
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Affiliation(s)
- Yoshiaki Minami
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
| | - Noriko Kikuchi
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
| | - Tsuyoshi Shiga
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
- Department of Clinical Pharmacology and Therapeutics The Jikei University School of Medicine Tokyo Japan
| | - Atsushi Suzuki
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
| | - Morio Shoda
- Clinical Research Division for Heart Rhythm Management Tokyo Women's Medical University Tokyo Japan
| | - Nobuhisa Hagiwara
- Department of Cardiology Tokyo Women's Medical University Tokyo Japan
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Boriani G, Mantovani LG, Cortesi PA, De Ponti R, D'Onofrio A, Arena G, Curnis A, Forleo G, Guerra F, Porcu M, Sgarito G, Botto GL. Cost-minimization analysis of a wearable cardioverter defibrillator in adult patients undergoing ICD explant procedures: Clinical and economic implications. Clin Cardiol 2021; 44:1497-1505. [PMID: 34427926 PMCID: PMC8571546 DOI: 10.1002/clc.23709] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2021] [Revised: 07/26/2021] [Accepted: 07/30/2021] [Indexed: 12/12/2022] Open
Abstract
Aims Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high‐risk bridging period. Very few economic evaluations on WCD use are currently available. Methods We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in‐hospital stay). For this purpose, a cost‐minimization analysis was conducted, and complemented by a one‐way sensitivity analysis. Results In the base case scenario, the WCD was less expensive compared to standard therapy. The cost‐minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600. Conclusion After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy.
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Affiliation(s)
- Giuseppe Boriani
- Cardiology Division, Department of Biomedical, Metabolic and Neural SciencesUniversity of Modena and Reggio EmiliaPoliclinico di ModenaItaly
| | - Lorenzo Giovanni Mantovani
- Research Centre on Public Health (CESP)University of Milano‐BicoccaMonzaItaly
- Value‐Based Healthcare UnitIRCCS MultimedicaSesto San GiovanniItaly
| | | | - Roberto De Ponti
- Department of Heart and VesselsOspedale di Circolo‐University of InsubriaVareseItaly
| | - Antonio D'Onofrio
- Cardiology Division – Electrophysiology Department – AORN dei Colli – Ospedale MonaldiNapoliItaly
| | - Giuseppe Arena
- Cardiology DepartmentAzienda Usl Toscana Nord OvestMassa CarraraItaly
| | - Antonio Curnis
- Cardiology DepartmentPresidio Ospedaliero di Brescia, ASST Spedali CiviliBresciaItaly
| | - Giovanni Forleo
- Cardiology Department, Electrophysiology and Arrhtymology DivisionOspedale Luigi Sacco ‐ Polo UniversitarioMilanItaly
| | - Federico Guerra
- Cardiology and Arrhytmology ClinicAzienda Ospedaliero Universitaria Ospedali RiunitiAnconaItaly
| | - Maurizio Porcu
- Cardiology DepartmentAzienda Ospedaliera “G. Brotzu”CagliariItaly
| | - Giuseppe Sgarito
- Cardiology Department, Electrophysiology and Arrhtymology DivisionA.R.N.A.S. Ospedali CivicoPalermoItaly
| | - Giovanni Luca Botto
- Cardiology – Electrophysiology Division, Department of MedicineOspedale di Circolo Rho, Ospedale Salvini Garbagnate M.se, ASST RhodenseMilanItaly
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High Incidence of Inappropriate Alarms in Patients with Wearable Cardioverter-Defibrillators: Findings from the Swiss WCD Registry. J Clin Med 2021; 10:jcm10173811. [PMID: 34501258 PMCID: PMC8432131 DOI: 10.3390/jcm10173811] [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: 07/05/2021] [Revised: 08/15/2021] [Accepted: 08/16/2021] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND The wearable cardioverter defibrillator (WCD) uses surface electrodes to detect arrhythmia before initiating a treatment sequence. However, it is also prone to inappropriate detection due to artefacts. OBJECTIVE The aim of this study is to assess the alarm burden in patients and its impact on clinical outcomes. METHODS Patients from the nationwide Swiss WCD Registry were included. Clinical characteristics and data were obtained from the WCDs. Arrhythmia recordings ≥30 s in length were analysed and categorized as VT/VF, atrial fibrillation (AF), supraventricular tachycardia (SVT) or artefact. RESULTS A total of 10653 device alarms were documented in 324 of 456 patients (71.1%) over a mean WCD wear-time of 2.0 ± 1.6 months. Episode duration was 30 s or more in 2996 alarms (28.2%). One hundred and eleven (3.7%) were VT/VF episodes. The remaining recordings were inappropriate detections (2736 (91%) due to artefacts; 117 (3.7%) AF; 48 (1.6%) SVT). Two-hundred and seven patients (45%) had three or more alarms per month. Obesity was significantly associated with three or more alarms per month (p = 0.01, 27.7% vs. 15.9%). High alarm burden was not associated with a lower average daily wear time (20.8 h vs. 20.7 h, p = 0.785) or a decreased implantable cardioverter defibrillator implantation rate after stopping WCD use (48% vs. 47.3%, p = 0.156). CONCLUSIONS In patients using WCDs, alarms emitted by the device and impending inappropriate shocks were frequent and most commonly caused by artefacts. A high alarm burden was associated with obesity but did not lead to a decreased adherence.
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Nogami A, Kurita T, Abe H, Ando K, Ishikawa T, Imai K, Usui A, Okishige K, Kusano K, Kumagai K, Goya M, Kobayashi Y, Shimizu A, Shimizu W, Shoda M, Sumitomo N, Seo Y, Takahashi A, Tada H, Naito S, Nakazato Y, Nishimura T, Nitta T, Niwano S, Hagiwara N, Murakawa Y, Yamane T, Aiba T, Inoue K, Iwasaki Y, Inden Y, Uno K, Ogano M, Kimura M, Sakamoto S, Sasaki S, Satomi K, Shiga T, Suzuki T, Sekiguchi Y, Soejima K, Takagi M, Chinushi M, Nishi N, Noda T, Hachiya H, Mitsuno M, Mitsuhashi T, Miyauchi Y, Miyazaki A, Morimoto T, Yamasaki H, Aizawa Y, Ohe T, Kimura T, Tanemoto K, Tsutsui H, Mitamura H, the JCS/JHRS Joint Working Group. JCS/JHRS 2019 guideline on non-pharmacotherapy of cardiac arrhythmias. J Arrhythm 2021; 37:709-870. [PMID: 34386109 PMCID: PMC8339126 DOI: 10.1002/joa3.12491] [Citation(s) in RCA: 110] [Impact Index Per Article: 27.5] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
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Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquié JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace 2021; 23:73-81. [PMID: 33257972 PMCID: PMC7842091 DOI: 10.1093/europace/euaa268] [Citation(s) in RCA: 38] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Accepted: 08/14/2020] [Indexed: 11/13/2022] Open
Abstract
Aims We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. Methods and results Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37–97) days. Median daily wear time of WCD was 23.4 (22.2–23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95–0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). Conclusion Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.
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Affiliation(s)
- Rodrigue Garcia
- Department of Cardiology, Poitiers University Hospital, 86021 Poitiers, France.,Univ Poitiers, 86000 Poitiers, France
| | - Nicolas Combes
- Department of Cardiology, Pasteur Clinic, 33000 Toulouse, France
| | - Pascal Defaye
- Department of Cardiology, Grenoble University Hospital, 38043 Grenoble, France
| | - Kumar Narayanan
- Department of Cardiology, European Georges Pompidou Hospital, 75015 Paris, France.,University of Paris, PARCC, INSERM, F-75015 Paris, France.,Cardiology Department, Medicover Hospitals, Hyderabad, India
| | | | - Serge Boveda
- Department of Cardiology, Pasteur Clinic, 33000 Toulouse, France
| | - Hugues Blangy
- Department of Cardiology, Nancy University Hospital, 54500 Vandoeuvre-Lès-Nancy, France
| | - Jérôme Bouet
- Department of Cardiology, Hospital Center of Aix, 13080 Aix En Provence, France
| | - Florent Briand
- Department of Cardiology, Besançon University Hospital, 25000 Besançon, France
| | | | - Yves Cottin
- Department of Cardiology, Dijon University Hospital, 28000 Dijon, France
| | - Antoine Da Costa
- Department of Cardiology, Saint-Etienne University Hospital, 42000 Saint-Étienne, France
| | - Bruno Degand
- Department of Cardiology, Poitiers University Hospital, 86021 Poitiers, France
| | - Jean-Claude Deharo
- Department of Cardiology, University Hospital La Timone, 13000 Marseille, France
| | - Romain Eschalier
- Department of Cardiology Clermont-Ferrand University Hospital, 63000 Clermont Ferrand, France
| | - Fabrice Extramiana
- Department of Cardiology, Bichat Hospital - Claude Bernard, 75877 Paris, France
| | - Marc Goralski
- Department of Cardiology, General Hospital of Oréans, 45000 Orléans, France
| | - Benoit Guy-Moyat
- Department of Cardiology, Limoges University Hospital, 87000 Limoges, France
| | - Yves Guyomar
- Department of Cardiology, Hospital Center Saint Philibert, 59160 Lomme, France
| | | | - François Jourda
- Department of Cardiology, General Hospital of Auxerre, 89000 Auxerre, France
| | - Nicolas Lellouche
- Department of Cardiology, University Hospital Henri Mondor, 94000 Creteil, France
| | - Mohanad Mahfoud
- Department of Cardiology, Hospital Center Sud Francilien, 91100 Corbeil Essonnes, France
| | - Vladimir Manenti
- Department of Cardiology, Jacques Cartier Institute, 91300 Massy, France
| | - Jacques Mansourati
- Department of Cardiology, Brest University Hospital, 29200 Brest, France
| | - Angéline Martin
- Department of Cardiology, Fontaine Clinic, 21121 Fontaine-Lès-Dijon, France
| | - Jean-Luc Pasquié
- Department of Cardiology, Montpellier University Hospital, 34000 Montpellier, France
| | - Philippe Ritter
- Department of Cardiology, Bordeaux University Hospital, 33600 Pessac, France
| | - Anne Rollin
- Department of Cardiology, Toulouse University Hospital, 31000 Toulouse, France
| | - Thierry Tibi
- Department of Cardiology, General Hospital of Cannes, 06150 Cannes, France
| | - Arab Yalioua
- Department of Cardiology, General Hospital of Angoulême, 16000 Angoulême, France
| | - Daniel Gras
- Department of Cardiology, Hopital privé du Confluent, 44000 Nantes, France
| | - Nicolas Sadoul
- Department of Cardiology, Nancy University Hospital, 54500 Vandoeuvre-Lès-Nancy, France
| | - Olivier Piot
- Department of Cardiology, Cardiology Center of Nord, 93200 Saint Denis, France
| | | | - Eloi Marijon
- Department of Cardiology, European Georges Pompidou Hospital, 75015 Paris, France.,University of Paris, PARCC, INSERM, F-75015 Paris, France
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Nogami A, Kurita T, Abe H, Ando K, Ishikawa T, Imai K, Usui A, Okishige K, Kusano K, Kumagai K, Goya M, Kobayashi Y, Shimizu A, Shimizu W, Shoda M, Sumitomo N, Seo Y, Takahashi A, Tada H, Naito S, Nakazato Y, Nishimura T, Nitta T, Niwano S, Hagiwara N, Murakawa Y, Yamane T, Aiba T, Inoue K, Iwasaki Y, Inden Y, Uno K, Ogano M, Kimura M, Sakamoto SI, Sasaki S, Satomi K, Shiga T, Suzuki T, Sekiguchi Y, Soejima K, Takagi M, Chinushi M, Nishi N, Noda T, Hachiya H, Mitsuno M, Mitsuhashi T, Miyauchi Y, Miyazaki A, Morimoto T, Yamasaki H, Aizawa Y, Ohe T, Kimura T, Tanemoto K, Tsutsui H, Mitamura H. JCS/JHRS 2019 Guideline on Non-Pharmacotherapy of Cardiac Arrhythmias. Circ J 2021; 85:1104-1244. [PMID: 34078838 DOI: 10.1253/circj.cj-20-0637] [Citation(s) in RCA: 90] [Impact Index Per Article: 22.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Affiliation(s)
- Akihiko Nogami
- Department of Cardiology, Faculty of Medicine, University of Tsukuba
| | | | - Haruhiko Abe
- Department of Heart Rhythm Management, University of Occupational and Environmental Health, Japan
| | - Kenji Ando
- Department of Cardiology, Kokura Memorial Hospital
| | - Toshiyuki Ishikawa
- Department of Medical Science and Cardiorenal Medicine, Yokohama City University
| | - Katsuhiko Imai
- Department of Cardiovascular Surgery, Kure Medical Center and Chugoku Cancer Center
| | - Akihiko Usui
- Department of Cardiac Surgery, Nagoya University Graduate School of Medicine
| | - Kaoru Okishige
- Department of Cardiology, Yokohama City Minato Red Cross Hospital
| | - Kengo Kusano
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
| | | | - Masahiko Goya
- Department of Cardiovascular Medicine, Tokyo Medical and Dental University
| | | | | | - Wataru Shimizu
- Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School
| | - Morio Shoda
- Department of Cardiology, Tokyo Women's Medical University
| | - Naokata Sumitomo
- Department of Pediatric Cardiology, Saitama Medical University International Medical Center
| | - Yoshihiro Seo
- Department of Cardiology, Faculty of Medicine, University of Tsukuba
| | | | - Hiroshi Tada
- Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui
| | | | - Yuji Nakazato
- Department of Cardiovascular Medicine, Juntendo University Urayasu Hospital
| | - Takashi Nishimura
- Department of Cardiac Surgery, Tokyo Metropolitan Geriatric Hospital
| | - Takashi Nitta
- Department of Cardiovascular Surgery, Nippon Medical School
| | - Shinichi Niwano
- Department of Cardiovascular Medicine, Kitasato University School of Medicine
| | | | - Yuji Murakawa
- Fourth Department of Internal Medicine, Teikyo University Hospital Mizonokuchi
| | - Teiichi Yamane
- Department of Cardiology, Jikei University School of Medicine
| | - Takeshi Aiba
- Division of Arrhythmia, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
| | - Koichi Inoue
- Division of Arrhythmia, Cardiovascular Center, Sakurabashi Watanabe Hospital
| | - Yuki Iwasaki
- Department of Cardiovascular Medicine, Graduate School of Medicine, Nippon Medical School
| | - Yasuya Inden
- Department of Cardiology, Nagoya University Graduate School of Medicine
| | - Kikuya Uno
- Arrhythmia Center, Chiba Nishi General Hospital
| | - Michio Ogano
- Department of Cardiovascular Medicine, Shizuoka Medical Center
| | - Masaomi Kimura
- Advanced Management of Cardiac Arrhythmias, Hirosaki University Graduate School of Medicine
| | | | - Shingo Sasaki
- Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine
| | | | - Tsuyoshi Shiga
- Department of Cardiology, Tokyo Women's Medical University
| | - Tsugutoshi Suzuki
- Departments of Pediatric Electrophysiology, Osaka City General Hospital
| | - Yukio Sekiguchi
- Department of Cardiology, Faculty of Medicine, University of Tsukuba
| | - Kyoko Soejima
- Arrhythmia Center, Second Department of Internal Medicine, Kyorin University Hospital
| | - Masahiko Takagi
- Division of Cardiac Arrhythmia, Department of Internal Medicine II, Kansai Medical University
| | - Masaomi Chinushi
- School of Health Sciences, Faculty of Medicine, Niigata University
| | - Nobuhiro Nishi
- Department of Cardiovascular Therapeutics, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
| | - Takashi Noda
- Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
| | - Hitoshi Hachiya
- Department of Cardiovascular Medicine, Tsuchiura Kyodo General Hospital
| | | | | | - Yasushi Miyauchi
- Department of Cardiovascular Medicine, Nippon Medical School Chiba-Hokusoh Hospital
| | - Aya Miyazaki
- Department of Pediatric Cardiology, Congenital Heart Disease Center, Tenri Hospital
| | - Tomoshige Morimoto
- Department of Thoracic and Cardiovascular Surgery, Osaka Medical College
| | - Hiro Yamasaki
- Department of Cardiology, Faculty of Medicine, University of Tsukuba
| | | | | | - Takeshi Kimura
- Department of Cardiology, Graduate School of Medicine and Faculty of Medicine, Kyoto University
| | - Kazuo Tanemoto
- Department of Cardiovascular Surgery, Kawasaki Medical School
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Blaschke F, Lacour P, Dang PL, Parwani AS, Hohendanner F, Walter T, Klingel K, Kühl U, Heinzel FR, Sherif M, Boldt LH, Pieske B, Tschöpe C. Wearable cardioverter-defibrillator: friend or foe in suspected myocarditis? ESC Heart Fail 2021; 8:2591-2596. [PMID: 33932118 PMCID: PMC8318471 DOI: 10.1002/ehf2.13340] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2020] [Revised: 12/22/2020] [Accepted: 03/29/2021] [Indexed: 12/26/2022] Open
Abstract
Aim Wearable cardioverter defibrillator (WCD, LifeVest, and Zoll) therapy has become a useful tool to bridge a temporarily increased risk for sudden cardiac death. However, despite extensive use, there is a lack of evidence whether patients with myocarditis and impaired LVEF may benefit from treatment with a WCD. Methods and results We conducted a single‐centre retrospective observational study analysing patients with a WCD prescribed between September 2015 and April 2020 at our institution. In total, 135 patients were provided with a WCD, amongst these 76 patients (mean age 48.9 ± 13.7 years; 84.2% male) for clinically suspected myocarditis. Based on the results of the endomyocardial biopsy and, where available cardiac magnetic resonance imaging, 39 patients (51.3%) were diagnosed with myocarditis and impaired LVEF and 37 patients (48.7%) with dilated cardiomyopathy (DCM) without evidence of cardiac inflammation. The main immunohistopathological myocarditis subtype was lymphocytic myocarditis in 36 (92.3%) patients, and four patients (10.3%) of this group had an acute myocarditis. Three patients had cardiac sarcoidosis (7.7%). Ventricular tachycardia occurred in seven myocarditis (in total 41 VTs; 85.4% non‐sustained) and one DCM patients (in total one non‐sustained ventricular tachycardia). Calculated necessary WCD wearing time until ventricular tachycardia occurrence is 86.41 days in myocarditis compared with 6.46 years in DCM patients. Conclusions Our data suggest that myocarditis patients may benefit from WCD therapy. However, as our study is not powered for outcome, further randomized studies powered for the outcome morbidity and mortality are necessary.
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Affiliation(s)
- Florian Blaschke
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Philipp Lacour
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Phi Long Dang
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany
| | - Abdul Shokor Parwani
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Felix Hohendanner
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,Berlin Institute of Health (BIH), Berlin, Germany
| | - Thula Walter
- Department of Radiology, Charité - University Medicine Berlin, Berlin, Germany
| | - Karin Klingel
- Department of Cardiopathology, Institute for Pathology and Neuropathology, University Hospital Tuebingen, Tuebingen, Germany
| | - Uwe Kühl
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany
| | - Frank R Heinzel
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Mohammad Sherif
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Leif-Hendrik Boldt
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany
| | - Burkert Pieske
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,Department of Internal Medicine and Cardiology, German Heart Center Berlin, Berlin, Germany.,Berlin Institute of Health (BIH), Berlin, Germany
| | - Carsten Tschöpe
- Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany.,BCRT - Berlin Institute of Health Center for Regenerative Therapies and Department of Cardiology (Virchow Klinikum), Charité - Universitätsmedizin Berlin and German Centre for Cardiovascular Research (DZHK) - Partner Site, Berlin, Germany.,DZHK (German Centre for Cardiovascular Research) - Partner Site, Berlin, Germany.,Berlin Institute of Health (BIH), Berlin, Germany
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38
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Sudden Cardiac Death in Patients with Heart Disease and Preserved Systolic Function: Current Options for Risk Stratification. J Clin Med 2021; 10:jcm10091823. [PMID: 33922111 PMCID: PMC8122448 DOI: 10.3390/jcm10091823] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2021] [Revised: 04/17/2021] [Accepted: 04/20/2021] [Indexed: 12/26/2022] Open
Abstract
Sudden cardiac death (SCD) is the leading cause of cardiovascular mortality in patients with coronary artery disease without severe systolic dysfunction and in heart failure with preserved ejection fraction. From a global health perspective, while risk may be lower, the absolute number of SCDs in patients with left ventricle ejection fraction >35% is higher than in those with severely reduced left ventricle ejection fraction (defined as ≤35%). Despite these observations and the high amount of available data, to date there are no clear recommendations to reduce the sudden cardiac death burden in the population with mid-range or preserved left ventricle ejection fraction. Ongoing improvements in risk stratification based on electrophysiological and imaging techniques point towards a more precise identification of patients who would benefit from ICD implantation, which is still an unmet need in this subset of patients. The aim of this review is to provide a state-of-the-art approach in sudden cardiac death risk stratification of patients with mid-range and preserved left ventricular ejection fraction and one of the following etiologies: ischemic cardiomyopathy, heart failure, atrial fibrillation or myocarditis.
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Tscholl V, Wielander D, Kelch F, Stroux A, Attanasio P, Tschöpe C, Landmesser U, Roser M, Huemer M, Heidecker B, Nagel P. Benefit of a wearable cardioverter defibrillator for detection and therapy of arrhythmias in patients with myocarditis. ESC Heart Fail 2021; 8:2428-2437. [PMID: 33887109 PMCID: PMC8318510 DOI: 10.1002/ehf2.13353] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2020] [Revised: 01/04/2021] [Accepted: 03/29/2021] [Indexed: 12/20/2022] Open
Abstract
Aims Myocarditis may lead to malignant arrhythmias and sudden cardiac death. As of today, there are no reliable predictors to identify individuals at risk for these catastrophic events. The aim of this study was to evaluate if a wearable cardioverter defibrillator (WCD) may detect and treat such arrhythmias adequately in the peracute setting of myocarditis. Methods and results In this observational, retrospective, single centre study, we reviewed patients presenting to the Charité Hospital from 2009 to 2017, who were provided with a WCD for the diagnosis of myocarditis with reduced ejection fraction (<50%) and/or arrhythmias. Amongst 259 patients receiving a WCD, 59 patients (23%) were diagnosed with myocarditis by histology. The mean age was 46 ± 14 years, and 11 patients were women (19%). The mean WCD wearing time was 86 ± 63 days, and the mean daily use was 20 ± 5 h. During that time, two patients (3%) had episodes of sustained ventricular tachycardia (VT; four total) corresponding to a rate of 28 sustained VT episodes per 100 patient‐years. Consequently, one of these patients underwent rhythm stabilization through intravenous amiodarone, while the other patient received an implantable cardioverter defibrillator. Two patients (3.4%) were found to have non‐sustained VT. Conclusions Using a WCD after acute myocarditis led to the detection of sustained VT in 2/59 patients (3%). While a WCD may prevent sudden cardiac death after myocarditis, our data suggest that WCD may have impact on clinical management through monitoring and arrhythmia detection.
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Affiliation(s)
- Verena Tscholl
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Dennis Wielander
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Felicitas Kelch
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Andrea Stroux
- Institute for Biometry and Clinical Epidemiology and Berlin Institute of Health (BIH), Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Philipp Attanasio
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Carsten Tschöpe
- Berlin Institute of Health at Charite (BIH)- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Charité - University Medicine Berlin, Campus Virchow Clinic, Augustenburgerplatz 1, 13353, Berlin, Germany.,Department of Internal Medicine and Cardiology, Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Augustenburgerplatz 1, 13353, Berlin, Germany.,DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany
| | - Ulf Landmesser
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.,Berlin Institute of Health at Charite (BIH)- Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Charité - University Medicine Berlin, Campus Virchow Clinic, Augustenburgerplatz 1, 13353, Berlin, Germany.,DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany
| | - Mattias Roser
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Martin Huemer
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Bettina Heidecker
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
| | - Patrick Nagel
- Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany
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40
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Clementy N, Bensaid R, Bouteau J, Fedida J, Kiavue Y, Socie P, Ackermann R, Goralski M, Fauchier L, Bernard A, Angoulvant D, Babuty D. The IC-D score for predicting prophylactic cardioverter-defibrillator implantation following acute myocardial infarction. PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2021; 44:973-979. [PMID: 33846979 DOI: 10.1111/pace.14244] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/24/2021] [Revised: 03/29/2021] [Accepted: 04/04/2021] [Indexed: 11/29/2022]
Abstract
BACKGROUND A reduced left ventricular ejection fraction (LVEF) ≤35% ≥6 weeks following an acute myocardial infarction (MI) may indicate prophylactic implantation of a cardioverter-defibrillator (ICD). We sought to find predictors of absence of significant left ventricular (LV) remodeling post-MI. METHODS All consecutive patients hospitalized for acute MI with an LVEF ≤35% at discharge in our institution from 2010 were retrospectively included. Patients were assigned to two groups according to the persistence of an LVEF ≤35% (ICD+) or a recovery >35% (ICD-). Logistic regression was performed to build a predictive score, which was then externally validated. RESULTS Among a total of 1533 consecutive MI patients, 150 met inclusion criteria, 53 (35%) in the ICD+ group and 97 in the ICD group. After multivariable analyses, an LVEF ≤25% at discharge (adjusted OR 6.23 [2.47 to 17.0], p < .0001) and a CPK peak at the MI acute phase >4600 UI/L (adjusted OR 9.99 [4.27 to 25.3], p < .0001) both independently predicted non-recovery at 6 weeks. The IC-D (Increased Cpk-LV Dysfunction) score predicted persistent LVEF ≤35% with areas under curve of 0.83 and 0.73, in the study population and in a multicenter validation cohort of 150 patients, respectively (p < .0001). CONCLUSIONS The association of a severely reduced LVEF and a major release of myocardial necrosis biomarkers at the acute phase of MI predict unfavorable remodeling, and prophylactic ICD implantation.
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Affiliation(s)
- Nicolas Clementy
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Reda Bensaid
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Jérémie Bouteau
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Joël Fedida
- Cardiology Department, Bicêtre Hospital, Kremlin-Bicêtre, France
| | - Yoann Kiavue
- Cardiology Department, Georges Pompidou European Hospital, Paris, France
| | - Pierre Socie
- Cardiology Department, Chartres Louis Pasteur Hospital, Le Coudray, France
| | - Romain Ackermann
- Cardiology Department, Orleans La Source Hospital, Orleans, France
| | - Marc Goralski
- Cardiology Department, Orleans La Source Hospital, Orleans, France
| | - Laurent Fauchier
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Anne Bernard
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Denis Angoulvant
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
| | - Dominique Babuty
- Cardiology Department, Trousseau Hospital, University of Tours, Tours, France
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Cooper M, Berent T, Auer J, Berent R. Recommendations for driving after implantable cardioverter defibrillator implantation and the use of a wearable cardioverter defibrillator. Wien Klin Wochenschr 2020; 132:770-781. [DOI: 10.1007/s00508-020-01675-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2019] [Accepted: 05/04/2020] [Indexed: 11/29/2022]
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Ashraf S, Ilyas S, Siddiqui F, Ando T, Shokr M, Panaich S, Briasoulis A, Afonso L, Khan M. Keeping up to date: a current review of wearable cardioverter defibrillator use. Acta Cardiol 2020; 75:695-704. [PMID: 31687917 DOI: 10.1080/00015385.2019.1682337] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
Abstract
The introduction of wearable cardioverter defibrillators (WCD) provides a novel means of protection in select patients at high risk for sudden cardiac death. The WCD can safely record and terminate life-threatening arrhythmias. In this review, we explore the data behind indications for WCD use and discuss its limitations. We searched PubMed, Google Scholar and Cochrane Central Register of controlled trials for relevant studies. The VEST trial, the first randomised controlled trial on WCD use, did not show statistical significance in utility of the WCD in post-myocardial infarction patients with low ejection fraction. While the use of WCD in this select patient population showed no benefit, the findings of the trial merit closer inspection. Various other indications of WCD use still exist and others require exploration. Select subsets of patients who stand to benefit for other indications include severely decreased left ventricular function post-revascularization with high arrhythmic burden, severe non-ischaemic cardiomyopathy, patients awaiting heart transplant and patients who have had their implantable cardioverter device temporarily removed. The role of the WCD is also being explored in children, peripartum cardiomyopathy, haemodialysis patients, and in syncope secondary to high-risk arrhythmias.
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Affiliation(s)
- Said Ashraf
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Suleman Ilyas
- Department of Medicine, The Warren Alpert Medical School of Brown University, Providence, RI, USA
| | - Fayez Siddiqui
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Tomo Ando
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Mohamed Shokr
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Sidakpal Panaich
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Alexandros Briasoulis
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Luis Afonso
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
| | - Mazhar Khan
- Division of Cardiology, Detroit Medical Center/Wayne State University, Detroit, MI, USA
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The impact of wearable cardioverter-defibrillator use on long-term decision for implantation of a cardioverter-defibrillator in a semirural acute care hospital. J Interv Card Electrophysiol 2020; 62:401-407. [PMID: 33200285 PMCID: PMC8536590 DOI: 10.1007/s10840-020-00898-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2020] [Accepted: 10/12/2020] [Indexed: 12/26/2022]
Abstract
Purpose Large-scale multi-center studies have reported on efficacy of the wearable cardioverter-defibrillator (WCD). However, outcomes focused on WCD patients treated at community-based acute care centers are lacking. Methods Patients with cardiomyopathy were included when left ventricular ejection fraction (LVEF) at baseline was ≤ 35%. There were 120 patients meeting the criteria who also had LVEF measured at baseline and after 90 days of WCD use. Results After 90 days of WCD use, there were 44 (37%) patients in whom LVEF improved to > 35%. Comparison of patients, by whether LVEF improved or not, indicated that median days of WCD wear and hours of daily use were similar as well as characteristics, such as gender, age, and starting LVEF; and diagnoses leading to WCD prescription were similar between groups as were symptom-based prescription of medications. At the end of WCD use, improved LVEF > 35% correlated with fewer implantable cardioverter-defibrillator (ICD) implants. There were 4 (3%) episodes of new atrial fibrillation detected during WCD use. The WCD appropriately delivered a shock to 3 (2.5%) patients with VT/VF being terminated by the first shock. All shocked patients survived for at least 24 h post-shock. Conclusions During WCD use, ischemic and non-ischemic cardiomyopathy patients manifest improved LVEF by 90 days. Long-term care decisions, such as implantation of an ICD, were influenced by LVEF improvement and occurrence of spontaneous VT/VF. The WCD protected patients from sudden cardiac death (SCD) until patient response to guideline-directed medical therapy could be determined.
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45
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Aidelsburger P, Seyed-Ghaemi J, Guinin C, Fach A. Effectiveness, efficacy, and safety of wearable cardioverter-defibrillators in the treatment of sudden cardiac arrest - Results from a health technology assessment. Int J Technol Assess Health Care 2020; 36:1-9. [PMID: 32600490 DOI: 10.1017/s0266462320000379] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
OBJECTIVES To assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable. METHODS We performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed. RESULTS One randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43-.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37-1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD. CONCLUSIONS Available evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.
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Veltmann C, Winter S, Duncker D, Jungbauer CG, Wäßnig NK, Geller JC, Erath JW, Goeing O, Perings C, Ulbrich M, Roser M, Husser D, Gansera LS, Soezener K, Malur FM, Block M, Fetsch T, Kutyifa V, Klein HU. Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry. Clin Res Cardiol 2020; 110:102-113. [PMID: 32377784 PMCID: PMC7806570 DOI: 10.1007/s00392-020-01657-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/16/2019] [Accepted: 04/25/2020] [Indexed: 12/22/2022]
Abstract
Background The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death. Methods and results 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown. Conclusions Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation. Graphic abstract ![]()
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Affiliation(s)
- Christian Veltmann
- Rhythmology and Electrophysiology, Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
| | | | - David Duncker
- Rhythmology and Electrophysiology, Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany
| | | | | | - J Christoph Geller
- Arrhythmia Section, Division of Cardiology, Zentralklinik Bad Berka, Bad Berka, Germany.,Otto-Von-Guericke University School of Medicine, Magdeburg, Germany
| | - Julia W Erath
- Abteilung für Klinische Elektrophysiologie, Medizinische Klinik III, Universitätsklinikum Frankfurt, Frankfurt, Germany
| | | | | | | | - Mattias Roser
- Klinikum Benjamin Franklin, Charité Berlin, Berlin, Germany
| | - Daniela Husser
- Klinik für Kardiologie, Herzzentrum Leipzig, Leipzig, Germany
| | - Laura S Gansera
- Klinik für Kardiologie, Klinikum Augsburg, Augsburg, Germany
| | | | | | - Michael Block
- Klinik für Kardiologie, Klinikum Augustinum München, Munich, Germany
| | - Thomas Fetsch
- CRI-Clinical Research Institute München, Munich, Germany
| | - Valentina Kutyifa
- Medical Center, Clinical Cardiovascular Research Center, University of Rochester, Rochester, NY, USA
| | - Helmut U Klein
- Medical Center, Clinical Cardiovascular Research Center, University of Rochester, Rochester, NY, USA
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Olgin JE, Lee BK, Vittinghoff E, Morin DP, Zweibel S, Rashba E, Chung EH, Borggrefe M, Hulley S, Lin F, Hue TF, Pletcher MJ. Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses. J Cardiovasc Electrophysiol 2020; 31:1009-1018. [PMID: 32083365 PMCID: PMC9374026 DOI: 10.1111/jce.14404] [Citation(s) in RCA: 63] [Impact Index Per Article: 12.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2019] [Revised: 01/21/2020] [Accepted: 02/01/2020] [Indexed: 08/13/2023]
Abstract
BACKGROUND Vest Prevention of Early Sudden Death Trial did not demonstrate a significant reduction in arrhythmic death with the wearable cardioverter-defibrillator (WCD), but compliance with the device may have substantially affected the results. ThePletcher influence of WCD compliance on outcomes has not yet been fully evaluated. METHODS Using linear and pooled logistic models, we performed as-treated analyses omitting person-time in the hospital and adjusted for correlates of WCD compliance. To assess the impact of early stopping of WCD, we performed a per-protocol Kaplan-Meier analysis, censoring after the last day the WCD was worn. Interactions of potential effect modifiers with treatment assignment and WCD compliance on outcomes were investigated. Finally, we used linear models to identify predictors of WCD compliance. RESULTS A per-protocol analysis demonstrated a significant reduction in total (P < .001) and arrhythmic (P = .001) mortality. Better WCD compliance was independently predicted by cardiac arrest during index myocardial infarction (MI), higher Cr, diabetes, prior heart failure, EF ≤ 25%, Polish enrolling center and number of WCD alarms, while worse compliance was predicted by being divorced, Asian race, higher body mass index, prior percutaneous coronary intervention, or any WCD shock. Neither excluding time in hospital from the as-treated analysis nor adjustment for factors affecting WCD compliance materially changed the results. No variable demonstrated a significant interaction in either the intention-to-treat or as-treated analysis. CONCLUSION Robust sensitivity analyses of as-treated and per-protocol analyses suggest that the WCD is protective in compliant patients with ejection fraction less than or equal to 35% during the first 3 months post-MI.
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Affiliation(s)
- Jeffrey E Olgin
- Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco, San Francisco, California
| | - Byron K Lee
- Division of Cardiology and the Cardiovascular Research Institute, University of California San Francisco, San Francisco, California
| | - Eric Vittinghoff
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California
| | - Daniel P Morin
- Ochsner Medical Center and Ochsner Clinical School, School of Medicine, University of Queensland, Brisbane, Australia
| | - Steven Zweibel
- Hartford Healthcare, Vascular Institute and University of Connecticut School of Medicine, Hartford, Connecticut
| | | | - Eugene H Chung
- Department of Internal Medicine, Michigan Medicine University of Michigan, Ann Arbor, Michigan
| | - Martin Borggrefe
- First Department of Medicine-Cardiology, University Medical Center Mannheim, Mannheim, Germany
- DZHK (German Center for Cardiovascular Re-search), Berlin, Germany
| | - Stephen Hulley
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California
| | - Feng Lin
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California
| | - Trisha F Hue
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California
| | - Mark J Pletcher
- Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California
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Jagadish PS, Aziz M, Chinta V, Khouzam RN. Misunderstood or Mistrusted? The Under-Utilization of the Wearable Cardioverter Defibrillator in Clinical Practice. Curr Probl Cardiol 2020; 45:100395. [PMID: 30340770 DOI: 10.1016/j.cpcardiol.2018.09.002] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2018] [Accepted: 09/10/2018] [Indexed: 11/29/2022]
Abstract
Annually in the United States, sudden cardiac death (including out-of-hospital cardiac arrests) is responsible for over 300,000 deaths, comprising 40%-50% of total mortality rates from cardiovascular disease. Among the highest-risk patients are those with ischemic and nonischemic cardiomyopathy who have a reduced left ventricular ejection fraction (≤ 35%-40%). However, not everyone is a candidate for an implantable cardioverter defibrillator. In 2002, the wearable cardioverter defibrillator (WCD) gained Food and Drug Administration approval for its efficacy in the prevention of sudden cardiac arrest or death in certain at-risk populations and has been making its way into national guidelines with Class IIa to IIb strength of evidence. Despite the prevalence of sudden cardiac death and the demonstrated efficacy of the WCD, this technology remains under-prescribed. This study seeks to explicate the potential causes for under-utilization of WCDs and offer means of overcoming barriers to its use. Among these reasons include confusion about the guidelines and when to prescribe, who can prescribe the device, and debate about whether the WCD is efficacious based on recent studies. Other social barriers to prescription include cost and adherence to therapy by the patient. This study sets the stage for further research on the improvement of education about the device and opens discourse about its prescription in clinical practice.
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49
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Rosenkaimer SL, El-Battrawy I, Dreher TC, Gerhards S, Röger S, Kuschyk J, Borggrefe M, Akin I. The Wearable Cardioverter-Defibrillator: Experience in 153 Patients and a Long-Term Follow-Up. J Clin Med 2020; 9:E893. [PMID: 32214048 PMCID: PMC7141506 DOI: 10.3390/jcm9030893] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2020] [Revised: 03/09/2020] [Accepted: 03/19/2020] [Indexed: 01/07/2023] Open
Abstract
Background: The wearable cardioverter-defibrillator (WCD) is available for patients at high risk for sudden cardiac death (SCD) when immediate implantable cardioverter-defibrillator (ICD) implantation is not possible or indicated. Patient selection remains challenging especially in primary prevention. Long-term data on these patients is still lacking. METHODS 153 patients were included in this study. They were prescribed the WCD between April 2012 and March 2019 at the University Medical Center, Mannheim, Germany. The mean follow-up period was 36.2 ± 15.6 months. Outcome data, including all-cause mortality, were analyzed by disease etiology and ICD implantation following WCD use. RESULTS We analyzed 56 patients with ischemic cardiomyopathy, 70 patients with non-ischemic cardiomyopathy, 16 patients with prior need for ICD/CRT-D (device for cardiac resynchronization therapy with defibrillator) explanation, 8 patients with acute myocarditis and 3 patients with congenital diseases. 58% of the patients did not need ICD/CRT-D implantation after WCD use. 4% of all patients suffered from appropriate WCD shocks. 2 of these patients (33%) experienced appropriate ICD shocks after implantation due to ventricular tachyarrhythmias. Long-term follow-up shows a good overall survival. All-cause mortality was 10%. There was no significant difference between patients with or without subsequent ICD implantation (p = 0.48). Patients with ischemic cardiomyopathy numerically showed a higher long-term mortality than patients with non-ischemic cardiomyopathy (14% vs. 6%, p = 0.13) and received significantly more ICD shocks after implantation (10% of ischemic cardiomyopathy (ICM) patients versus 3% of non-ischemic cardiomyopathy (NICM) patients, p = 0.04). All patients with ventricular tachyarrhythmias during WCD use or after ICD implantation survived the follow-up period. CONCLUSION Following WCD use, ICD implantation could be avoided in 58% of patients. Long-term follow-up shows good overall survival. The majority of all patients did not suffer from WCD shocks nor did receive ICD shocks after subsequent implantation. Patient selection regarding predictive conditions on long-term risk of ventricular tachyarrhythmias needs further risk stratification.
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Affiliation(s)
- Stephanie L. Rosenkaimer
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
| | - Ibrahim El-Battrawy
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
- DZHK (German Center for Cardiovascular Research), Partner Site, Heidelberg-Mannheim, 68167 Mannheim, Germany
| | - Tobias C. Dreher
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
- DZHK (German Center for Cardiovascular Research), Partner Site, Heidelberg-Mannheim, 68167 Mannheim, Germany
| | - Stefan Gerhards
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
| | - Susanne Röger
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
| | - Jürgen Kuschyk
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
| | - Martin Borggrefe
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
- DZHK (German Center for Cardiovascular Research), Partner Site, Heidelberg-Mannheim, 68167 Mannheim, Germany
| | - Ibrahim Akin
- First Department of Medicine, Medical Faculty Mannheim, University Heidelberg, 68167 Mannheim, Germany; (S.L.R.); (T.C.D.); (S.G.); (S.R.); (J.K.); (M.B.); (I.A.)
- DZHK (German Center for Cardiovascular Research), Partner Site, Heidelberg-Mannheim, 68167 Mannheim, Germany
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Ritzka D, Petzold C, Wäßnig N, Schmalbach B, Petrowski K. Investigation of the factorial structure and psychometrics of the German version of the Florida Shock Anxiety Scale. PSYCHOL HEALTH MED 2020; 25:344-353. [DOI: 10.1080/13548506.2019.1612077] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
Affiliation(s)
- Desiree Ritzka
- Department of Psychology and Psychotherapy, University Witten/Herdecke, Witten, Germany
- Medical Psychology and Medical Sociology, Clinic and Policlinic for Psychosomatic Medicine and Psychotherapy, University Medicine Mainz, Mainz, Germany
| | - Christian Petzold
- Medical Clinic and Cardiology, Heart Center Dresden, University Hospital Carl Gustav Carus Dresden, Technical University Dresden, Dresden, Germany
| | - Nadine Wäßnig
- Medical Clinic and Cardiology, Heart Center Dresden, University Hospital Carl Gustav Carus Dresden, Technical University Dresden, Dresden, Germany
| | - Bjarne Schmalbach
- Medical Psychology and Medical Sociology, Clinic and Policlinic for Psychosomatic Medicine and Psychotherapy, University Medicine Mainz, Mainz, Germany
- Department of Psychology, University of Münster, Münster, Germany
| | - Katja Petrowski
- Medical Psychology and Medical Sociology, Clinic and Policlinic for Psychosomatic Medicine and Psychotherapy, University Medicine Mainz, Mainz, Germany
- Department of Psychotherapy and Psychosomatic Medicine, University Hospital Carl Gustav Carus Dresden, Technical University Dresden, Dresden, Germany
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