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Hummel J, Houmsse M, Tomassoni G, Nair D, Romero J, Hargrove J, Mathews K, Thakkar AB, Ullery S, Eapen ZJ, Kumar UN, Mehran R, Butler J. A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. J Am Coll Cardiol 2024; 84:525-536. [PMID: 39084827 DOI: 10.1016/j.jacc.2024.04.063] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2024] [Accepted: 04/19/2024] [Indexed: 08/02/2024]
Abstract
BACKGROUND For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA. OBJECTIVES This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD. METHODS The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d. RESULTS A total of 305 patients (mean age: 57.9 years; 30.2% female, 27.9% non-White) were enrolled, of which 290 had available device data. The clinically significant cutaneous adverse device effect rate was 2.30% (upper 1-sided 98% CI: 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d. CONCLUSIONS The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495).
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Affiliation(s)
- John Hummel
- The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | - Mahmoud Houmsse
- The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
| | | | - Devi Nair
- St Bernard's Heart and Vascular Center, Jonesboro, Arkansas, USA
| | - Jorge Romero
- Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Joe Hargrove
- Cardiology and Medicine Clinic, Little Rock, Arkansas, USA
| | - Kiran Mathews
- Element Science, Inc, San Francisco, California, USA
| | - Anjali B Thakkar
- Division of Cardiology, Department of Medicine, University of California-San Francisco, San Francisco, California, USA
| | | | - Zubin J Eapen
- Element Science, Inc, San Francisco, California, USA
| | - Uday N Kumar
- Element Science, Inc, San Francisco, California, USA
| | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Javed Butler
- Baylor Scott and White Research Institute, Dallas, Texas, USA; Department of Medicine, University of Mississippi, Jackson, Mississippi, USA.
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Nasir M, Dejene K, Bedru M, Ahmed M, Markos S. Predictors of complications and mortality among patients undergoing pacemaker implantation in resource-limited settings: a 10-year retrospective follow-up study. BMC Cardiovasc Disord 2024; 24:400. [PMID: 39090565 PMCID: PMC11293136 DOI: 10.1186/s12872-024-04068-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/10/2024] [Accepted: 07/22/2024] [Indexed: 08/04/2024] Open
Abstract
INTRODUCTION Pacemakers (PMs) are used to treat patients with severe bradycardia symptoms. They do, however, pose several complications. Even with these risks, there are only a few studies assessing PM implantation outcomes in resource-limited settings like Ethiopia and other sub-Saharan countries in general. Therefore, this study aims to assess the mid-term outcome of PM implantation in patients who have undergone PM implantation in the Cardiac Center of Ethiopia by identifying the rate and predictors of complications and death. METHODOLOGY This retrospective study was conducted at the Cardiac Center of Ethiopia from October 2023 to January 2024 on patients who had PM implantation from September 2012 to August 2023 to assess the midterm outcome of the patients. Complication rate and all-cause mortality rate were the outcomes of our study. Multivariable logistic regression was used to identify factors associated with complications and death. To analyze survival times, a Kaplan-Meier analysis was performed. RESULTS This retrospective follow-up study included 182 patients who underwent PM implantation between September 2012 and August 2023 and were at least 18 years old. The patients' median follow-up duration was 72 months (Interquartile range (IQR): 36-96 months). At the end of the study, 26.4% of patients experienced complications. The three most frequent complications were lead dislodgement, which affected 6.6% of patients, PM-induced tachycardia, which affected 5.5% of patients, and early battery depletion, which affected 5.5% of patients. Older age (Adjusted Odds Ratio (AOR) 1.1, 95% CI 1.04-1.1, p value < 0.001), being female (AOR 4.5, 95%CI 2-9.9, p value < 0.001), having dual chamber PM (AOR 2.95, 95%CI 1.14-7.6, p value = 0.006) were predictors of complications. Thirty-one (17%) patients died during the follow-up period. The survival rates of our patients at 3, 5, and 10 years were 94.4%, 92.1%, and 65.5% respectively with a median survival time of 11 years. Patients with a higher Charlson comorbidity index before PM implantation (AOR 1.2, 95% CI 1.1-1.8, p = 0.04), presence of complications (AOR 3.5, 95% CI 1.2-10.6, p < 0.03), and New York Heart Association (NYHA) class III or IV (AOR 3.3, 95% CI 1.05-10.1, p = 0.04) were associated with mortality. CONCLUSION Many complications were experienced by patients who had PMs implanted, and several factors affected their prognosis. Thus, it is essential to identify predictors of both complications and mortality to prioritize and address the manageable factors associated with both mortality and complications.
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Affiliation(s)
- Mohammed Nasir
- Pediatrics and Child Health Department, Hawassa University, Hawassa, Ethiopia.
| | | | | | - Muluken Ahmed
- Pediatrics and Child Health Department, Arba Minch University, Arba Minch, Ethiopia
| | - Sura Markos
- Internal Medicine Department, Division of Cardiology, Hawassa University, Hawassa, Ethiopia
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Sombun S, Ongthiemsak C. In vitro study of the accuracy and efficiency of wireless intraoral scanners at various battery levels. J Dent 2023; 138:104686. [PMID: 37666467 DOI: 10.1016/j.jdent.2023.104686] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2022] [Revised: 08/21/2023] [Accepted: 09/01/2023] [Indexed: 09/06/2023] Open
Abstract
OBJECTIVES To determine the trueness and precision of 2 wireless intraoral scanners (IOSs) under various battery levels, and assess scanning efficiency. METHODS A maxillary cast with 4 metal spheres attached was fabricated. Two wireless IOSs (TRIOS 3 and TRIOS 4) were evaluated under 3 battery levels (1-30%, 31-60%, and 61-100%; n = 30). Six horizontal distances and 1 vertical distance were measured between 4 spherical centers and 1 generated plane. The distance deviations were determined with a coordinate-measuring machine data set. Kruskal-Wallis and Levene tests were used to analyze trueness and precision. Scan time and the number of three-dimensional (3D) images captured were analyzed by using a 2-way analysis of variance. RESULTS In terms of trueness and precision, no significant differences were found at various battery levels over the majority of the measured distances. TRIOS 4 demonstrated better trueness than TRIOS 3 for cross-arch scan. The 61-100% battery level resulted in the shortest scan time and the least number of 3D images captured (p < 0.001). Scan time and number of 3D images captured were strongly correlated for TRIOS 3 (r = 0.66) and TRIOS 4 (r = 0.89). CONCLUSIONS Changes in battery level had no impact on the trueness and precision of TRIOS 3 and TRIOS 4. High battery level IOSs resulted in faster scans and fewer 3D images captured with less storage space. TRIOS 4 scanned faster, captured fewer images, and demonstrated better trueness than TRIOS 3. CLINICAL SIGNIFICANCE Although all battery levels of wireless IOSs provide comparable trueness and precision, a wireless IOS with a high battery level is more time efficient than one with a low battery level in complete-arch scan.
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Affiliation(s)
- Santisuk Sombun
- Department of Prosthetic Dentistry, Faculty of Dentistry, Prince of Songkla University, 15 Kanjanavanich road, Hat Yai District, Songkhla, Thailand
| | - Chakree Ongthiemsak
- Department of Prosthetic Dentistry, Faculty of Dentistry, Prince of Songkla University, 15 Kanjanavanich road, Hat Yai District, Songkhla, Thailand.
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Wang S, Cui Q, Abiri P, Roustaei M, Zhu E, Li YR, Wang K, Duarte S, Yang L, Ebrahimi R, Bersohn M, Chen J, Hsiai TK. A self-assembled implantable microtubular pacemaker for wireless cardiac electrotherapy. SCIENCE ADVANCES 2023; 9:eadj0540. [PMID: 37851816 PMCID: PMC10584332 DOI: 10.1126/sciadv.adj0540] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/04/2023] [Accepted: 09/15/2023] [Indexed: 10/20/2023]
Abstract
The current cardiac pacemakers are battery dependent, and the pacing leads are prone to introduce valve damage and infection, plus a complete pacemaker retrieval is needed for battery replacement. Despite the reported wireless bioelectronics to pace the epicardium, open-chest surgery (thoracotomy) is required to implant the device, and the procedure is invasive, requiring prolonged wound healing and health care burden. We hereby demonstrate a fully biocompatible wireless microelectronics with a self-assembled design that can be rolled into a lightweight microtubular pacemaker for intravascular implantation and pacing. The radio frequency was used to transfer energy to the microtubular pacemaker for electrical stimulation. We show that this pacemaker provides effective pacing to restore cardiac contraction from a nonbeating heart and have the capacity to perform overdrive pacing to augment blood circulation in an anesthetized pig model. Thus, this microtubular pacemaker paves the way for the minimally invasive implantation of leadless and battery-free microelectronics.
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Affiliation(s)
- Shaolei Wang
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Qingyu Cui
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Parinaz Abiri
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Mehrdad Roustaei
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Enbo Zhu
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
- Department of Microbiology, Immunology and Molecular Genetics, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Yan-Ruide Li
- Department of Microbiology, Immunology and Molecular Genetics, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Kaidong Wang
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
- Department of Medicine, Great Los Angeles VA Healthcare System, Los Angeles, CA 90073, USA
| | - Sandra Duarte
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Lili Yang
- Department of Microbiology, Immunology and Molecular Genetics, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Ramin Ebrahimi
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Department of Medicine, Great Los Angeles VA Healthcare System, Los Angeles, CA 90073, USA
| | - Malcolm Bersohn
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Department of Medicine, Great Los Angeles VA Healthcare System, Los Angeles, CA 90073, USA
| | - Jun Chen
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
| | - Tzung K. Hsiai
- Department of Bioengineering, University of California Los Angeles, Los Angeles, CA 90095, USA
- Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
- Department of Medicine, Great Los Angeles VA Healthcare System, Los Angeles, CA 90073, USA
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Crozier I, Haqqani H, Kotschet E, Wiggenhorn C, Lande J, Thompson A, Cheng A, Bhatia V, O’Donnell D. Three-year chronic follow-up from the pilot study of a substernal extravascular implantable cardioverter-defibrillator. Europace 2023; 25:euad301. [PMID: 37847230 PMCID: PMC10580370 DOI: 10.1093/europace/euad301] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2023] [Accepted: 09/30/2023] [Indexed: 10/18/2023] Open
Affiliation(s)
- Ian Crozier
- Department of Cardiology, Christchurch Hospital, 2 Riccarton Avenue, PO Bag 4710, Christchurch 8140, New Zealand
| | - Haris Haqqani
- Department of Cardiology, The Prince Charles Hospital, Brisbane, Australia
| | - Emily Kotschet
- Department of Caridac Rhythm Services, Monash Medical Centre, Melbourne, Australia
| | | | - Jeff Lande
- Department of Cardiac Rhythm Managment, Medtronic Inc., Mounds View, MN, USA
| | - Amy Thompson
- Department of Cardiac Rhythm Managment, Medtronic Inc., Mounds View, MN, USA
| | - Alan Cheng
- Department of Cardiac Rhythm Managment, Medtronic Inc., Mounds View, MN, USA
| | - Varun Bhatia
- Department of Cardiac Rhythm Managment, Medtronic Inc., Mounds View, MN, USA
| | - David O’Donnell
- Department of Cardiology, The Austin Hospital, Melbourne, Australia
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Lisowski D, Lutyj P, Abazari A, Weick S, Traub J, Polat B, Flentje M, Kraft J. Impact of Radiotherapy on Malfunctions and Battery Life of Cardiac Implantable Electronic Devices in Cancer Patients. Cancers (Basel) 2023; 15:4830. [PMID: 37835524 PMCID: PMC10571836 DOI: 10.3390/cancers15194830] [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: 09/02/2023] [Revised: 09/29/2023] [Accepted: 09/29/2023] [Indexed: 10/15/2023] Open
Abstract
PURPOSE This study analyses a large number of cancer patients with CIEDs for device malfunction and premature battery depletion by device interrogation after each radiotherapy fraction and compares different guidelines in regard to patient safety. METHODS From 2007 to 2022, a cohort of 255 patients was analyzed for CIED malfunctions via immediate device interrogation after every RT fraction. RESULTS Out of 324 series of radiotherapy treatments, with a total number of 5742 CIED interrogations, nine device malfunctions (2.8%) occurred. Switching into back-up/safety mode and software errors occurred four times each. Once, automatic read-out could not be performed. The median prescribed cumulative dose at planning target volume (PTV) associated with CIED malfunction was 45.0 Gy (IQR 36.0-64.0 Gy), with a median dose per fraction of 2.31 Gy (IQR 2.0-3.0 Gy). The median maximum dose at the CIED at time of malfunction was 0.3 Gy (IQR 0.0-1.3 Gy). No correlation between CIED malfunction and maximum photon energy (p = 0.07), maximum dose at the CIED (p = 0.59) nor treatment localization (p = 0.41) could be detected. After excluding the nine malfunctions, premature battery depletion was only observed three times (1.2%). Depending on the national guidelines, 1-9 CIED malfunctions in this study would have been detected on the day of occurrence and in none of the cases would patient safety have been compromised. CONCLUSION Radiation-induced malfunctions of CIEDs and premature battery depletion are rare. If recommendations of national safety guidelines are followed, only a portion of the malfunctions would be detected directly after occurrence. Nevertheless, patient safety would not be compromised.
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Affiliation(s)
- Dominik Lisowski
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Paul Lutyj
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Arya Abazari
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Stefan Weick
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Jan Traub
- Department of Internal Medicine I, Division of Cardiology, University Hospital Würzburg, 97080 Würzburg, Germany
| | - Bülent Polat
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Michael Flentje
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
| | - Johannes Kraft
- Department of Radiation Oncology, University Hospital Würzburg, 97080 Würzburg, Germany (J.K.)
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Chen W, Gong Y, Xia L, Zhang Y, Lu H, Bhatia V, Thompson A, Cao J, Yang J, Yao W, Qiu Z. Characterization of the substernal space with computed tomography imaging in patients with and without median sternotomy: Assessing a novel implant location for extravascular defibrillation lead placement. Pacing Clin Electrophysiol 2023; 46:1066-1072. [PMID: 37504377 DOI: 10.1111/pace.14797] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2023] [Revised: 07/03/2023] [Accepted: 07/16/2023] [Indexed: 07/29/2023]
Abstract
BACKGROUND Implantable cardioverter-defibrillators (ICDs) provide clinically significant therapy for the prevention of sudden cardiac death. This study aimed to characterize the substernal space using computed tomography (CT) in patients with and without prior midline sternotomy to investigate the feasibility of substernal ICD lead implantation in post-sternotomy patients. METHODS High-quality electrocardiogram-gated CT images from 100 patients (71% male, average body mass index 23.5 ± 2.9) were retrospectively collected, including 50 patients with prior midline sternotomy (S-group) and 50 patients with no prior sternotomy (NS-group). Distances were measured from the retrosternal surface to the epicardial surface of the heart and segmented into four regions from the xiphoid tip and superiorly along the sternum. RESULTS Results generally showed a measurable but narrower average sternum-to-heart distance in the prior sternotomy group compared to the non-sternotomy group in all four regions (p < .05). In the S-group, the sternum-to-heart distances across all regions ranged from 0 to 32.0 mm, while in the NS-group, the distances ranged from 0 to 39.9 mm. CONCLUSION Small but measurable separations between the heart and sternum were observed in patients with prior sternotomy, particularly near the xiphoid region, indicating the potential viability of extravascular substernal ICD lead implantation in post-sternotomy patients.
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Affiliation(s)
- Wanlan Chen
- Department of Cardiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Department of Cardiology, The First People's Hospital of Foshan, Foshan, Guangdong, China
| | - Yongjun Gong
- Department of Radiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Limin Xia
- Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
| | - Yu Zhang
- Department of Cardiology, Huadong Hospital, Fudan University, Shanghai, China
| | - Hongyang Lu
- Cardiac Rhythm Management Research, Medtronic (Shanghai) Ltd., Shanghai, China
| | - Varun Bhatia
- Cardiac Rhythm Management Research, Medtronic, Inc., Mounds View, Minnesota, USA
| | - Amy Thompson
- Cardiac Rhythm Management Research, Medtronic, Inc., Mounds View, Minnesota, USA
| | - Jian Cao
- Cardiac Rhythm Management Research, Medtronic, Inc., Mounds View, Minnesota, USA
| | - Jun Yang
- Department of Radiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Weiwu Yao
- Department of Radiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Zhaohui Qiu
- Department of Cardiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Arcinas LA, Sheldon RS. Complications related to pacemakers and other cardiac implantable electronic devices: essentials for internists and emergency physicians. Intern Emerg Med 2023; 18:851-862. [PMID: 36892799 DOI: 10.1007/s11739-023-03227-6] [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: 12/10/2022] [Accepted: 02/11/2023] [Indexed: 03/10/2023]
Abstract
With the aging population, improving technology, and expanding indications for diagnosing and treating arrhythmias and heart failure, many patients are receiving cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators. Consequently, patients with CIEDs are frequently encountered in the emergency department and in the wards. It is imperative that emergency physicians and internists have a strong foundation on CIEDs and their potential complications. This review aims to help physicians develop a framework in approaching CIEDs and to recognize and manage clinical scenarios that may arise from CIED complications.
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Affiliation(s)
- Liane A Arcinas
- Section of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada.
| | - Robert S Sheldon
- Section of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 3280 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada
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Kondaveeti GA, Bhatia VA, Lahm RP, Harris ML, Gaewsky JP, Gayzik FS, Greenhalgh JF, Hamilton CA, Stacey RB, Weaver AA. Quantifying Cardiothoracic Variation with Posture and Respiration to Inform Cardiac Device Design. Cardiovasc Eng Technol 2023; 14:13-24. [PMID: 35618869 PMCID: PMC9699900 DOI: 10.1007/s13239-022-00631-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2021] [Accepted: 05/06/2022] [Indexed: 11/28/2022]
Abstract
PURPOSE With extravascular implantable cardioverter defibrillator leads placed beneath the sternum, it is important to quantify heart motion relative to the rib cage with postural changes and respiration. METHODS MRI scans from five males and five females were collected in upright and supine postures at end inspiration [n = 10 each]. Left and right decubitus [n = 8 each] and prone [n = 5] MRIs at end inspiration and supine MRIs at end expiration [n = 5] were collected on a subset. Four cardiothoracic measurements, six cardiac measurements, and six cardiac landmarks were collected to measure changes across different postures and stages of respiration. RESULTS The relative location of the LV apex to the nearest intercostal space was significantly different between the supine and decubitus postures (average ± SD difference: - 15.7 ± 11.4 mm; p < 0.05). The heart centroid to xipho-sternal junction distance was 9.7 ± 7.9 mm greater in the supine posture when compared to the upright posture (p < 0.05). Cardiac landmark motion in the lateral direction was largest due to postural movement (range 23-50 mm) from the left decubitus to the right decubitus posture, and less influenced by respiration (5-17 mm). Caudal-cranial displacement was generally larger due to upright posture (13-23 mm caudal) and inspiration (7-20 mm cranial). CONCLUSIONS This study demonstrates that the location of the heart with respect to the rib cage varies with posture and respiration. The gravitational effects of postural shifts on the heart position are roughly 2-3 times larger than the effects of normal respiration.
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Affiliation(s)
- Geeth A Kondaveeti
- Department of Biomedical Engineering, Wake Forest School of Medicine, 575 N. Patterson Ave. Suite 530, Winston-Salem, NC, 27101, USA
| | - Varun A Bhatia
- Cardiac Rhythm Management, Medtronic Inc., 8200 Coral Sea Street NE, Mounds View, MN, 55112, USA
| | - Ryan P Lahm
- Cardiac Rhythm Management, Medtronic Inc., 8200 Coral Sea Street NE, Mounds View, MN, 55112, USA
| | - Megan L Harris
- Cardiac Rhythm Management, Medtronic Inc., 8200 Coral Sea Street NE, Mounds View, MN, 55112, USA
| | - James P Gaewsky
- Department of Biomedical Engineering, Wake Forest School of Medicine, 575 N. Patterson Ave. Suite 530, Winston-Salem, NC, 27101, USA
- Elemance LLC, 3540 Clemmons Rd #127, Clemmons, NC, 27012, USA
| | - F Scott Gayzik
- Department of Biomedical Engineering, Wake Forest School of Medicine, 575 N. Patterson Ave. Suite 530, Winston-Salem, NC, 27101, USA
| | | | - Craig A Hamilton
- Department of Biomedical Engineering, Wake Forest School of Medicine, 575 N. Patterson Ave. Suite 530, Winston-Salem, NC, 27101, USA
| | - R Brandon Stacey
- Department of Cardiology, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA
| | - Ashley A Weaver
- Department of Biomedical Engineering, Wake Forest School of Medicine, 575 N. Patterson Ave. Suite 530, Winston-Salem, NC, 27101, USA.
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Römers H, van Dijk V, Boersma L. Evolution of extravascular implantable cardioverter-defibrillator therapy for ventricular arrhythmias. Heart Rhythm O2 2022; 4:59-64. [PMID: 36713037 PMCID: PMC9877388 DOI: 10.1016/j.hroo.2022.09.021] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Abstract
Implantable cardioverter-defibrillators have become an established therapy for the prevention of sudden cardiac death due to life-threatening ventricular arrhythmias in the last decades. In all those years, the use of transvenous leads has proven to be the most vulnerable part of the system. The development of the completely subcutaneous implantable cardioverter-defibrillator opened a new era of device therapy outside of the vascular system. The next step, enabling extravascular devices with the option of antitachycardia pacing, is just around the corner. This may become an important option for all patients without a bradycardia pacing indication that are in need for antitachycardia pacing because of monomorphic ventricular tachycardia.
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Affiliation(s)
- Hans Römers
- Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands
- Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
- Address reprint requests and correspondence: Dr Hans Römers, Cardiology, St Antonius Hospital, University of Amsterdam, Koekoekslaan 1, Nieuwe-gein, Utrecht 3435CM, the Netherlands.
| | - Vincent van Dijk
- Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands
| | - Lucas Boersma
- Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands
- Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
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11
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Pacemaker Malfunction–Review of Permanent Pacemakers and Malfunctions Encountered in the Emergency Department. Emerg Med Clin North Am 2022; 40:679-691. [DOI: 10.1016/j.emc.2022.06.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
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12
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Bernardes-Souza B, Tiecher RD, Do DH, Saint-Martin P, Sathyavagiswaran L, Ukpo OC, Rogers CB, Boyle NG. Forensic cardiac device analysis at the Los Angeles County Department of the Coroner: A 20-year experience. J Forensic Sci 2022; 67:1924-1931. [PMID: 35883263 DOI: 10.1111/1556-4029.15107] [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: 06/15/2022] [Revised: 07/09/2022] [Accepted: 07/12/2022] [Indexed: 11/28/2022]
Abstract
Cardiac implantable electronic devices (CIEDs) store information continuously; however, the log of these devices is rarely analyzed in forensic practice. We retrospectively reviewed all cases referred for CIED interrogation by the Los Angeles County Department of Medical Examiner-Coroner between 2001 and 2020. According to the Department's practice, CIED interrogation may be requested for decedents in which details or cause of death are not clear from autopsy and clinical history. The CIED analysis was considered informative for the coroner's investigation either if it detected an arrhythmia or malfunction likely related to decedent's terminal event or if it was essential to determine time of death or identity of decedent. A total of 57 CIEDs were evaluated during the 20-year period. In almost half of cases (26/57: 45.6%), device analysis was informative for coroner's investigation. Arrhythmias likely related to terminal event were commonly detected (21/57: 36.8%). Device malfunction was identified as the likely cause of death in almost 10% of decedents (5/57: 8.8%), including three cases of battery depletion (3/57: 5.3%), one case of misclassification of ventricular tachycardia as supraventricular tachycardia with failure to deliver therapy (1/57: 1.7%), and one case of lead failure due to a broken pacing wire (1/57: 1.7%). Not infrequently, CIED interrogation was essential for determination of time of death (9/57: 15.8%), and there was one case (1/57: 1.7%) in which interrogation was essential for identifying the decedent. Our study shows that postmortem CIED interrogation can provide unique information regarding mechanism and time of death, and decedent's identity.
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Affiliation(s)
- Breno Bernardes-Souza
- UCLA Cardiac Arrhythmia Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
| | - Ricardo D Tiecher
- UCLA Cardiac Arrhythmia Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
| | - Duc H Do
- UCLA Cardiac Arrhythmia Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
| | | | | | - Odey C Ukpo
- Los Angeles County Department of Medical Examiner-Coroner, Los Angeles, California, USA
| | - Christopher B Rogers
- Los Angeles County Department of Medical Examiner-Coroner, Los Angeles, California, USA
| | - Noel G Boyle
- UCLA Cardiac Arrhythmia Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
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13
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Caldara M, Belgiovine C, Secchi E, Rusconi R. Environmental, Microbiological, and Immunological Features of Bacterial Biofilms Associated with Implanted Medical Devices. Clin Microbiol Rev 2022; 35:e0022120. [PMID: 35044203 PMCID: PMC8768833 DOI: 10.1128/cmr.00221-20] [Citation(s) in RCA: 55] [Impact Index Per Article: 18.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/21/2023] Open
Abstract
The spread of biofilms on medical implants represents one of the principal triggers of persistent and chronic infections in clinical settings, and it has been the subject of many studies in the past few years, with most of them focused on prosthetic joint infections. We review here recent works on biofilm formation and microbial colonization on a large variety of indwelling devices, ranging from heart valves and pacemakers to urological and breast implants and from biliary stents and endoscopic tubes to contact lenses and neurosurgical implants. We focus on bacterial abundance and distribution across different devices and body sites and on the role of environmental features, such as the presence of fluid flow and properties of the implant surface, as well as on the interplay between bacterial colonization and the response of the human immune system.
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Affiliation(s)
- Marina Caldara
- Interdepartmental Center on Safety, Technologies, and Agri-food Innovation (SITEIA.PARMA), University of Parma, Parma, Italy
| | - Cristina Belgiovine
- IRCCS Humanitas Research Hospital, Rozzano–Milan, Italy
- Scuola di Specializzazione in Microbiologia e Virologia, Università degli Studi di Pavia, Pavia, Italy
| | - Eleonora Secchi
- Institute of Environmental Engineering, ETH Zürich, Zürich, Switzerland
| | - Roberto Rusconi
- IRCCS Humanitas Research Hospital, Rozzano–Milan, Italy
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele–Milan, Italy
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14
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Wang L, Li B, Hu B, Shen G, Zheng Y, Zheng Y. Failure mode effect and criticality analysis of ultrasound device by classification tracking. BMC Health Serv Res 2022; 22:429. [PMID: 35361206 PMCID: PMC8973517 DOI: 10.1186/s12913-022-07843-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2021] [Accepted: 03/25/2022] [Indexed: 11/12/2022] Open
Abstract
Background Medical ultrasound device has been more and more widely used in the hospital and Its safety risk is significantly increased when failures occur. However, there is a lack of quantitative risk assessments of different types of failure modes for medical ultrasound device. This study utilizes a failure mode, effect and criticality analysis (FMECA) approach for quantitative risk evaluation of different failure modes for ultrasound devices. Methods The 4216 medical ultrasound device failure records at various hospitals were investigated. A failure mode and effect analysis method was developed for the quantitative evaluation of the risks of different failure modes. Visual correlation analysis was conducted for all categories to identify the causes of various failure modes. Based on the severity, occurrence and detectability of the failure causes determined, the risk priority number (RPN) for each failure mode was back-calculated through the obtained tracking diagram. Results The failure modes of unclear images, unable to power on and dark shadows on an image had the highest RPNs. One failure mode could be caused by various factors, and the failure location was not necessarily related to the cause of the failure. Conclusions This quantitative approach more accurately evaluated the risks of different failure modes, and the results of the corresponding analysis of failure modes and causes could support the rapid determination of the causes of failures in clinical practice.
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Affiliation(s)
- Longchen Wang
- Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China
| | - Bin Li
- Department of Biomedical Engineering, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
| | - Bing Hu
- Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China
| | - Guofeng Shen
- School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, 200030, China
| | - Yunxin Zheng
- Department of Biomedical Engineering, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
| | - Yuanyi Zheng
- Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
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15
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Thompson AE, Marshall M, Lentz L, Mazzetti H. Three-Year Extraction Experience of a Novel Substernal Extravascular Defibrillation Lead in Sheep. Pacing Clin Electrophysiol 2022; 45:314-322. [PMID: 35048393 PMCID: PMC9302635 DOI: 10.1111/pace.14451] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2021] [Revised: 12/09/2021] [Accepted: 01/02/2022] [Indexed: 11/28/2022]
Abstract
Background The extravascular implantable cardioverter‐defibrillator (EV ICD) with lead implantation in the substernal space may provide an alternative to transvenous and subcutaneous systems. This is the first‐reported chronic extraction experience for EV ICD leads. The aim of the study is to evaluate the chronic encapsulation and extractability of EV ICD leads. Methods Two EV ICD leads and one transvenous lead were implanted in each of 24 mature sheep. A subset of animals was evaluated yearly for histology and lead extractability. Extractions were performed using simple traction or extraction tools. Histology evaluated the encapsulating tissue. Results At 1 year, extraction was performed successfully for two of five EV ICD leads with traction alone using ≤3.1 kg‐force (kgf) and the remainder extracted successfully with extraction tools; no transvenous leads were removed with traction alone. At 2 years, no EV ICD or transvenous leads were extracted with traction alone, while at 3 years, one of eight EV ICD leads and two of four transvenous leads were extracted with traction (0.8 and ≤2.3 kgf, respectively). There was one observation of hemopericardium resulting in tamponade with EV ICD extraction but without injury to cardiovascular structures and related to the unique implant tract. Among transvenous leads, inversion of the ventricle with loss of cardiac output resulted in abandonment of traction for two animals. Conclusions Chronic extraction of EV ICD leads from the substernal space was successfully performed using traction and simple tools through 3 years in sheep with one observation of hemopericardium that did not originate from cardiovascular injury.
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16
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van Dijk VF, Boersma LVA. Non-transvenous ICD therapy: current status and beyond. Herz 2021; 46:520-525. [PMID: 34751802 DOI: 10.1007/s00059-021-05077-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/07/2021] [Indexed: 11/28/2022]
Abstract
Subcutaneous implantable cardioverter/defibrillators (S-ICDs) have been developed to offer ICD treatment to patients without venous access to the heart and to overcome complications associated with transvenous leads, particularly lead fracture/insulation defects and endocarditis. Several studies and registries have demonstrated the feasibility and safety of S‑ICD in different groups of patients. Further developments in S‑ICD technology involve the combination with devices that can provide anti-bradycardia and anti-tachycardia pacing if needed. The extravascular ICD (EV-ICD) is a new system that similarly offers ICD therapy without a transvenous lead but uses a substernal instead of a subcutaneous lead to facilitate detection of ventricular fibrillation and to provide anti-tachycardia and also temporary anti-bradycardia pacing. The first animal but also clinical data on EV-ICDs have been published. This review discusses the current state, potential advantages and limitations, and future research of both S‑ICD and EV-ICD.
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Affiliation(s)
- Vincent F van Dijk
- Department of Cardiology, St Antonius Hospital, Koekoekslaan 1, 3435, CM Nieuwegein, The Netherlands
| | - Lucas V A Boersma
- Department of Cardiology, St Antonius Hospital, Koekoekslaan 1, 3435, CM Nieuwegein, The Netherlands. .,Heart Centre, Department of Clinical and Experimental Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
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17
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Haanschoten D, Elvan A. The DAPA Trial in the Context of Previous Prophylactic ICD Landmark Trials. Arrhythm Electrophysiol Rev 2021; 10:154-158. [PMID: 34777819 PMCID: PMC8576491 DOI: 10.15420/aer.2021.23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2021] [Accepted: 07/28/2021] [Indexed: 12/04/2022] Open
Abstract
In patients with ischaemic cardiomyopathy and severely reduced left ventricular ejection fraction (LVEF), an arrhythmogenic milieu is created by a complex interplay between myocardial scarring (assessed by cardiac MRI) and multiple other factors (ventricular ectopy, ischaemia and autonomic imbalance), favouring the occurrence of arrhythmic sudden cardiac death (SCD). Currently, a dynamic and robust model of dichotomised SCD risk assessment after primary percutaneous coronary intervention (PCI) is lacking, underlining the urgent need for further refinement of the widely accepted and guidelines-based criteria (ischaemic cardiomyopathy, LVEF ≤35%) for primary prevention. This review addresses the potential additional value of the recently published Defibrillator After Primary Angioplasty (DAPA) trial results. The DAPA trial conveys important messages and provides novel perspectives regarding left ventricular function post-primary PCI as an (early) risk marker for SCD and the impact of prophylactic ICD implantation on survival in this cohort. In the context of other previous primary prevention trials, DAPA was the first trial including only ST-elevation MI patients all treated with acute PCI.
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Affiliation(s)
| | - Arif Elvan
- Heart Centre, Department of Cardiology, Isala Hospital, Zwolle, the Netherlands
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18
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Narducci M, Scacciavillani R, Pinnacchio G, Bencardino G, Perna F, Comerci G, Campisi M, Ceccarelli I, Pavone C, Spera F, Bisignani A, Crea F, Pelargonio G. The potential impact of acute coronary syndromes on automatic sensing system in Subcutaneous-ICDs. IJC HEART & VASCULATURE 2021; 35:100841. [PMID: 34345651 PMCID: PMC8319739 DOI: 10.1016/j.ijcha.2021.100841] [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: 06/13/2021] [Revised: 07/02/2021] [Accepted: 07/05/2021] [Indexed: 11/26/2022]
Abstract
BACKGROUND The Subcutaneous-ICD (S-ICD) is emerging as a suitable option for most ICD candidates, however some open issues regarding the sensing algorithm still remain. OBJECTIVES We aimed to examine the performance of the S-ICD sensing algorithm in patients hospitalized for ST elevation myocardial infarction (STEMI), non ST elevation acute coronary syndrome (NSTE-ACS) or chronic coronary syndrome (CCS), before and after revascularization. METHODS We performed a S-ICD automated screening on 75 patients, 21 hospitalized for STEMI, 23 for NSTE-ACS and 31 for CCS, before and after percutaneous revascularization, regardless their eligibility to ICD implantation. RESULTS Patients did not differ in clinical, electrocardiographic and echocardiographic parameters. Rates of screening pass were significantly lower in STEMI patients compared to NSTE-ACS and CCS (5% vs 56.7% vs 81% respectively, p < .0001). The viability of the primary vector was lower in STEMI patients compared to NSTE-ACS and CCS (33% vs 56% vs 71%, p .027 respectively). After revascularization, there were no more significant differences between groups. Pairing subjects at baseline and after revascularization, STEMI subjects percentages of screening success were respectively 5% and 81% (p < .001) and the rates of primary vector viability were 33% and 81% (p .002). STEMI was the only independent predictor of screening failure at multivariate logistic regression analysis (odds ratio 10.68 confidence interval 2.77-41.38, p = .001). CONCLUSION The performance of the S-ICD and possible malfunction detections in the context of an acute ischemic event deserve further evaluation. Adequate patient selection and the development of dynamic device programming are warranted.
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Affiliation(s)
- M.L. Narducci
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - R. Scacciavillani
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - G. Pinnacchio
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - G. Bencardino
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - F. Perna
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - G. Comerci
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - M. Campisi
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - I. Ceccarelli
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - C. Pavone
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - F. Spera
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - A. Bisignani
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
| | - F. Crea
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
- Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy
| | - G. Pelargonio
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo Agostino Gemelli, 8, Roma, Italy
- Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy
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19
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Crozier I, O'Donnell D, Boersma L, Murgatroyd F, Manlucu J, Knight BP, Birgersdotter-Green UM, Leclercq C, Thompson A, Sawchuk R, Willey S, Wiggenhorn C, Friedman P. The extravascular implantable cardioverter-defibrillator: The pivotal study plan. J Cardiovasc Electrophysiol 2021; 32:2371-2378. [PMID: 34322918 PMCID: PMC9290824 DOI: 10.1111/jce.15190] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2021] [Revised: 05/23/2021] [Accepted: 06/08/2021] [Indexed: 11/29/2022]
Abstract
Background Transvenous implantable cardioverter defibrillators (TV ICD) provide life‐saving therapy for millions of patients worldwide. However, they are susceptible to several potential short‐ and long‐ term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD system's novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs. Study Design The EV ICD pivotal study is a prospective, multicenter, single‐arm, nonrandomized, premarket clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for implantation of an ICD. Implanted subjects will be followed up to approximately 3.5 years, depending on when the patient is enrolled. Objective The clinical trial is designed to demonstrate safety and effectiveness of the EV ICD system in human use. The safety endpoint is freedom from major complications, while the efficacy endpoint is defibrillation success. Both endpoints will be assessed against prespecified criteria. Additionally, this study will evaluate antitachycardia pacing performance, electrical performance, extracardiac pacing sensation, asystole pacing, appropriate and inappropriate shocks, as well as a summary of adverse events. Conclusion The EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.
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Affiliation(s)
- Ian Crozier
- Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand
| | - David O'Donnell
- Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia
| | - Lucas Boersma
- Department of Cardiology, St. Antonius Hospital Nieuwegein and Amsterdam UMC, Amsterdam, Netherlands
| | | | - Jaimie Manlucu
- Division of Cardiology, London Health Sciences Centre, London, Ontario, Canada
| | - Bradley P Knight
- Division of Cardiology, Northwestern University, Chicago, Illinois, USA
| | | | - Christophe Leclercq
- Department of Cardiology, CHU de Rennes-Hôpital Pontchaillou France, Rennes, France
| | - Amy Thompson
- Department of Cardiac Rhythm, Medtronic plc, Mounds View, Minnesota, USA
| | - Robert Sawchuk
- Department of Cardiac Rhythm, Medtronic plc, Mounds View, Minnesota, USA
| | - Sarah Willey
- Department of Cardiac Rhythm, Medtronic plc, Mounds View, Minnesota, USA
| | | | - Paul Friedman
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA
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20
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Gebran A, Refaat MM. Long-term evaluation of a novel extravascular implantable cardioverter defibrillator. J Cardiovasc Electrophysiol 2021; 32:2379-2380. [PMID: 34314084 DOI: 10.1111/jce.15184] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/21/2021] [Accepted: 07/25/2021] [Indexed: 11/26/2022]
Affiliation(s)
- Anthony Gebran
- Division of Trauma Emergency Surgery and Surgical Critical Care, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Marwan M Refaat
- Division of Cardiology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
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21
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Wong GR, Ang M, Jayarajan J, Walker F, Lambiase PD. Pregnancy in patients with implantable cardiac defibrillators. Herzschrittmacherther Elektrophysiol 2021; 32:214-220. [PMID: 33970332 DOI: 10.1007/s00399-021-00750-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2021] [Accepted: 03/15/2021] [Indexed: 02/05/2023]
Abstract
The number of patients of reproductive age with inherited and congenital heart disease receiving implantable cardiac defibrillators (ICD) is steadily increasing. Safely and effectively coordinating pregnancy in this high-risk cohort is important to optimise maternal-foetal outcomes. As members of the multidisciplinary team caring for pregnant patients with indications for ICD, cardiologists and electrophysiologists should be aware of the considerations and nuances involved in managing these patients. This article reviews the pathophysiology of arrhythmias, ICD implantation considerations, novel minimal fluoroscopy techniques and subcutaneous ICD. In addition, antenatal and device management during pregnancy and delivery are discussed.
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Affiliation(s)
- Geoffrey R Wong
- Department of Electrophysiology, St Bartholomews Hospital NHS Trust & Institute of Cardiovascular Science UCL, London, UK
| | - Megan Ang
- Department of Obstetric Imaging, Mercy Hospital for Women, Melbourne, Australia
| | - Jasveer Jayarajan
- Department of Obstetric Imaging, Mercy Hospital for Women, Melbourne, Australia
| | - Fiona Walker
- Department of Grown-Up Congenital Heart Disease, St Bartholomews Hospital, London, UK
| | - Pier D Lambiase
- Department of Electrophysiology, St Bartholomews Hospital NHS Trust & Institute of Cardiovascular Science UCL, London, UK.
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22
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23
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da Silva RM, de Souza Maciel A. Conduction Disorders: The Value of Surface ECG. Curr Cardiol Rev 2021; 17:173-181. [PMID: 32392118 PMCID: PMC8226204 DOI: 10.2174/1573403x16666200511090151] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2020] [Revised: 04/03/2020] [Accepted: 04/09/2020] [Indexed: 02/08/2023] Open
Abstract
PURPOSE OF REVIEW The purpose of the current mini-review is to describe the importance of surface ECG for the diagnosis of conduction disorder. METHODS The MEDLINE/PubMed database was used, with the keywords "ECG" and "conduction disorders"; over the past 10 years. Other documents were included because of their relevance. MAIN FINDINGS Data on the anatomy and function of the cardiac electrical system have been described. Conduction disorders including sinus node dysfunction, atrioventricular blocks, intraventricular conduction disorders are exposed as to their epidemiology, etiology, presentation, anatomical site of impaired conduction of the electrical stimulus. The importance of ECG in patients with a cardiac implantable electronic device was also discussed, in addition to future perspectives. CONCLUSION Surface ECG allows the diagnosis of atrioventricular and intraventricular conduction disorder and its anatomical block site most of the time, without the need for invasive tests such as electrophysiological study. Dysfunctions of cardiac implantable electronic devices can be diagnosed by ECG, as well as the prediction of response to cardiac resynchronization therapy.
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Affiliation(s)
- Rose M.F.L. da Silva
- Department of Internal Medicine, Faculty of Medicine, University of Minas Gerais, Hospital das Clínicas, Federal, Belo Horizonte/Minas Gerais, Brazil
| | - Alessandra de Souza Maciel
- Department of Internal Medicine, Faculty of Medicine, University of Minas Gerais, Hospital das Clínicas, Federal, Belo Horizonte/Minas Gerais, Brazil
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24
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First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol 2020; 6:1525-1536. [DOI: 10.1016/j.jacep.2020.05.029] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2020] [Revised: 05/15/2020] [Accepted: 05/21/2020] [Indexed: 01/10/2023]
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25
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van Dijk VF, Boersma LVA. The subcutaneous implantable cardioverter defibrillator in 2019 and beyond. Trends Cardiovasc Med 2020; 30:378-384. [DOI: 10.1016/j.tcm.2019.09.006] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2019] [Revised: 09/24/2019] [Accepted: 09/25/2019] [Indexed: 11/16/2022]
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26
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Kella DK, Isath A, Yasin O, Padmanabhan D, Webster T, Mulpuru S, Cha Y, Friedman PA. Fibroplasty (venoplasty) to facilitate transvenous lead placement: A single‐center experience. J Cardiovasc Electrophysiol 2020; 31:2425-2430. [DOI: 10.1111/jce.14655] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2020] [Revised: 05/31/2020] [Accepted: 06/29/2020] [Indexed: 11/30/2022]
Affiliation(s)
- Danesh K. Kella
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | - Ameesh Isath
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | - Omar Yasin
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | | | - Tracy Webster
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | - Siva Mulpuru
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | - Yong‐Mei Cha
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
| | - Paul A. Friedman
- Division of Cardiovascular Diseases Mayo Clinic Rochester Minnesota USA
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27
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Sabbagh E, Abdelfattah T, Karim MM, Farah A, Grubb B, Karim S. Causes of Failure to Capture in Pacemakers and Implantable Cardioverter-defibrillators. J Innov Card Rhythm Manag 2020; 11:4013-4017. [PMID: 32368374 PMCID: PMC7192127 DOI: 10.19102/icrm.2020.110207] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2019] [Accepted: 08/13/2019] [Indexed: 11/22/2022] Open
Abstract
The number of patients with implantable electronic cardiac devices is continuously increasing. As more pacemakers and implantable cardioverter-defibrillators (ICDs) are being placed, a basic understanding of some troubleshooting for devices is becoming essential. Loss of capture can be an emergent presentation for an unstable patient and can be encountered intermittently in hospitalized patients. There are many causes for a loss of capture, with the timing of the implant having a high correlation with certain causes over others. The most common acute cause just after the insertion procedure is lead dislodgement or malposition. In comparison, an increase in the required threshold promoting a loss of capture can happen after months to years of insertion of the pacemaker or ICD. This change can be due to a cardiomyopathy, fibrosis medications, metabolic imbalance, lead fracture, or an exit block. Loss of capture can also occur from external electrical stimuli and inappropriate pacemaker or ICD settings. Further, there are also potential noncardiac causes, such as medications, electrolyte imbalance, and acidemia. A knowledge of these factors is essential for health care providers, given the morbidity and mortality that can potentially be associated with device-related issues, especially in patients who are dependent on the included pacing function.
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Affiliation(s)
- Ebrahim Sabbagh
- Division of Electrophysiology, Department of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USA
| | - Thaer Abdelfattah
- Division of Electrophysiology, Department of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USA
| | - Mohammad M Karim
- Deparment of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA
| | - Amjad Farah
- Division of Electrophysiology, Department of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USA
| | - Blair Grubb
- Division of Electrophysiology, Department of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USA
| | - Saima Karim
- Division of Electrophysiology, Department of Cardiovascular Medicine, University of Toledo Medical Center, Toledo, OH, USA.,Department of Cardiology, Metrohealth Medical Center, Cleveland, OH, USA
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Yue T, Chen B, Wu L, Xu J, Pu J. Prognostic Value of Late Gadolinium Enhancement in Predicting Life‐Threatening Arrhythmias in Heart Failure Patients With Implantable Cardioverter‐Defibrillators: A Systematic Review and Meta‐Analysis. J Magn Reson Imaging 2019; 51:1422-1439. [DOI: 10.1002/jmri.26982] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2019] [Revised: 10/16/2019] [Accepted: 10/16/2019] [Indexed: 01/01/2023] Open
Affiliation(s)
- Ting Yue
- Department of Radiology, Ren Ji HospitalShanghai Jiao Tong University School of Medicine Shanghai China
| | - Bing‐Hua Chen
- Department of Radiology, Ren Ji HospitalShanghai Jiao Tong University School of Medicine Shanghai China
| | - Lian‐Ming Wu
- Department of Radiology, Ren Ji HospitalShanghai Jiao Tong University School of Medicine Shanghai China
| | - Jian‐Rong Xu
- Department of Radiology, Ren Ji HospitalShanghai Jiao Tong University School of Medicine Shanghai China
| | - Jun Pu
- Department of Cardiology, Ren Ji HospitalShanghai Jiao Tong University School of Medicine Shanghai China
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29
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Govindarajulu U, Bedi S, Kluger A, Resnic F. Survival analysis of hierarchical learning curves in assessment of cardiac device and procedural safety. Stat Med 2018; 37:4185-4199. [PMID: 30062850 DOI: 10.1002/sim.7906] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2017] [Accepted: 06/14/2018] [Indexed: 11/07/2022]
Abstract
Many Americans rely on cardiac surgical procedures and devices such as pacemakers and thrombolytic catheters to treat or manage their cardiovascular diseases. However, the failure of these cardiac devices and procedures could have grave consequences. One reason cardiac devices tended to fail was due to physician error; there is a learning effect for the physician or operator to come up to speed in skillfully implanting devices and conducting procedures. In order to better understand these learning effects, we had previously modeled the resulting learning curve effects in simulations a hierarchical setting with physicians clustered within institutions using our unique methodology (see the work of Govindarajulu et al 2017). Previously, we had employed these in hierarchical linear modeling and also in generalized estimating equations. In this setting, we have demonstrated how to apply similar methodology but revised in a survival analytic framework or time-to-event analyses. Through simulations and real dataset applications, we found that, out of the three shapes modeled to fit the learning curve, the logarithmic shape tended to have the best fit, similar to previous work (see the work of Govindarajulu et al 2017). However, as seen before, modeling the learning rate can be dataset specific and one shape may be better than another. We learned that modeling the learning rate could also be applied in the survival analysis setting through this new methodology. The goal of this paper is to model cardiac device and procedure learning curve effects in a time-to-event setting so that this knowledge may allow for the improvement of both short and long-term patient survival.
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Affiliation(s)
- Usha Govindarajulu
- Department of Epidemiology and Biostatistics, SUNY Downstate School of Public Health, Brooklyn, New York
| | - Sandeep Bedi
- Department of Epidemiology and Biostatistics, SUNY Downstate School of Public Health, Brooklyn, New York
| | - Aaron Kluger
- Department of Epidemiology and Biostatistics, SUNY Downstate School of Public Health, Brooklyn, New York
| | - Frederic Resnic
- Department of Cardiology, Lahey Clinic, Burlington, Massachusetts
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30
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Tjong FV, Knops RE, Udo EO, Brouwer TF, Dukkipati SR, Koruth JS, Petru J, Sediva L, van Hemel NM, Neuzil P, Reddy VY. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis. Heart Rhythm 2018; 15:1387-1393. [DOI: 10.1016/j.hrthm.2018.04.027] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2018] [Indexed: 11/28/2022]
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31
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Bouslama MA, Ferhi F, Hacheni F, Ons K, Abdeljelil K, Jazia KB, Khairi H. Pregnancy and delivery in woman with implantable cardioverter-defibrillator: what we should know. Pan Afr Med J 2018; 30:236. [PMID: 30574255 PMCID: PMC6295306 DOI: 10.11604/pamj.2018.30.236.9995] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2016] [Accepted: 12/06/2017] [Indexed: 11/18/2022] Open
Abstract
We report the observation of a 25-year-old pregnant patient of 39 weeks of amenorrhea proposed for elective cesarean section. This patient suffers from hypertrophic cardiomyopathy since the age of 12. She has an implantable cardioverter defibrillator (ICD). The peculiarities of the ICD in the parturient and the perioperative management of the patient are being reported in this paper.
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Affiliation(s)
| | - Fehmi Ferhi
- Anesthesia Department, CHU Farhat Hached, Sousse, Tunisia
| | - Faten Hacheni
- Obstsetric Department, Farhat Hached Hospital, Sousse, Tunisia
| | - Kaabia Ons
- Obstsetric Department, Farhat Hached Hospital, Sousse, Tunisia
| | | | | | - Hedi Khairi
- Obstsetric Department, Farhat Hached Hospital, Sousse, Tunisia
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32
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Perioperative management of cardiac rhythm assist devices in ambulatory surgery and nonoperating room anesthesia. Curr Opin Anaesthesiol 2018; 30:676-681. [PMID: 28957879 DOI: 10.1097/aco.0000000000000532] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
PURPOSE OF REVIEW Patients with cardiac implantable electronic devices (CIEDs) frequently undergo various surgical procedures and in the past perioperative management involved only placing magnet over the device. New programming features, development of implantable cardiac defibrillator (ICD), cardiac resynchronization therapy, and increasing complexity of the operating room equipment have led to new sources of electromagnetic interference (EMI). A comprehensive understanding of the CIED is necessary to provide a timely and optimal care to the patients. RECENT FINDINGS Technological advancements and direct implantation of the transvenous implantable cardiac defibrillators into the heart have led to less clear lines between the pacemakers and the ICD. Subcutaneous ICD as well as the leadless transcatheter deployed intracardiac pacemaker development has complicated the issue further. SUMMARY Rapidly developing technologies and increasing number of patients with these devices coming for noncardiac surgeries necessitate continuous education of the anesthesia team regarding perioperative management of such devices.
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Desveaux L, Gagliardi AR. Comparing the application of two theoretical frameworks to describe determinants of adverse medical device event reporting: secondary analysis of qualitative interview data. BMC Health Serv Res 2018; 18:402. [PMID: 29866152 PMCID: PMC5987566 DOI: 10.1186/s12913-018-3251-2] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2017] [Accepted: 05/29/2018] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Post-market surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Few studies have examined factors that influence whether and how physicians report AMDEs, an essential step in the development of behaviour change interventions. This study was a secondary analysis comparing application of the Theoretical Domains Framework (TDF) and the Tailored Implementation for Chronic Diseases (TICD) framework to identify potential behaviour change interventions that correspond to determinants of AMDE reporting. METHODS A previous study involving qualitative interviews with Canadian physicians that implant medical devices identified themes reflecting AMDE reporting determinants. In this secondary analysis, themes that emerged from the primary analysis were independently mapped to the TDF and TICD. Determinants and corresponding intervention options arising from both frameworks (and both mappers) were compared. RESULTS Both theoretical frameworks were useful for identifying interventions corresponding to behavioural determinants of AMDE reporting. Information or education strategies that provide evidence about AMDEs, and audit and feedback of AMDE data were identified as interventions to target the theme of physician beliefs; improving information systems, and reminder cues, prompts and awards were identified as interventions to address determinants arising from the organization or systems themes; and modifying financial/non-financial incentives and sharing data on outcomes associated with AMDEs were identified as interventions to target device market themes. Numerous operational challenges were encountered in the application of both frameworks including a lack of clarity about how directly relevant to themes the domains/determinants should be, how many domains/determinants to select, if and how to resolve discrepancies across multiple mappers, and how to choose interventions from among the large number associated with selected domains/determinants. CONCLUSIONS Given discrepancies in mapping themes to determinants/domains and the resulting interventions offered by the two frameworks, uncertainty remains about how to choose interventions that best match behavioural determinants in a given context. Further research is needed to provide more nuanced guidance on the application of TDF and TICD for a broader audience, which is likely to increase the utility and uptake of these frameworks in practice.
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34
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Wang HT, Chen YL, Wu CJ. Acute Inferior Wall ST Segment Elevation Myocardial Infarction Caused Atrial Lead Dysfunction Reversed by Primary Percutaneous Coronary Intervention. Int Heart J 2018; 59:618-621. [PMID: 29628473 DOI: 10.1536/ihj.17-270] [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] [Indexed: 11/18/2022]
Abstract
The mechanism of atrial lead dysfunction varies in patients receiving pacemaker implantation and this needs to be investigated, especially when the causes are reversible. We report and discuss a 76-year-old female who had atrial lead dysfunction caused by acute myocardial infarction and who was recovered after primary percutaneous coronary intervention. The sequential electrocardiographic changes were demonstrated and the possible mechanisms were discussed.
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Affiliation(s)
- Hui-Ting Wang
- Department of Emergency, Kaohsiung Chang Gung Memorial Hospital.,Chang Gung University College of Medicine
| | - Yung-Lung Chen
- Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital.,Chang Gung University College of Medicine
| | - Chiung-Jen Wu
- Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital.,Chang Gung University College of Medicine
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35
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Riva G, Alessandro O, Spoto R, Ferrari A, Garibaldi C, Cattani F, Luraschi R, Rondi E, Colombo N, Giovenzana FLF, Cipolla CM, Winnicki M, Persiani M, Castelluccia F, Fiore MS, Orecchia R, Jereczek-Fossa BA. Radiotherapy in patients with cardiac implantable electronic devices: clinical and dosimetric aspects. Med Oncol 2018; 35:73. [DOI: 10.1007/s12032-018-1126-3] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2018] [Accepted: 04/04/2018] [Indexed: 10/17/2022]
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Gagliardi AR, Ducey A, Lehoux P, Turgeon T, Kolbunik J, Ross S, Trbovich P, Easty A, Bell C, Urbach DR. Multiple constraints compromise decision-making about implantable medical devices for individual patients: qualitative interviews with physicians. BMC Med Inform Decis Mak 2017; 17:178. [PMID: 29273040 PMCID: PMC5741896 DOI: 10.1186/s12911-017-0577-3] [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: 04/11/2017] [Accepted: 12/13/2017] [Indexed: 11/16/2022] Open
Abstract
Background Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. Methods A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. Results Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. Conclusions This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients. Electronic supplementary material The online version of this article (10.1186/s12911-017-0577-3) contains supplementary material, which is available to authorized users.
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Affiliation(s)
| | | | | | | | | | - Sue Ross
- University of Alberta, Edmonton, Canada
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37
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Gagliardi AR, Lehoux P, Ducey A, Easty A, Ross S, Bell CM, Trbovich P, Takata J, Urbach DR. Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians. Int J Qual Health Care 2017; 29:276-282. [PMID: 28453827 PMCID: PMC5412024 DOI: 10.1093/intqhc/mzx013] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2016] [Accepted: 01/20/2017] [Indexed: 01/03/2023] Open
Abstract
Objective Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. Design Qualitative interviews using a basic descriptive approach. Setting Canada. Participants Practicing cardiovascular and orthopaedic physicians. Main outcome measures Level, processes and determinants of PE in medical device discussions and decisions. Results Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. Conclusions This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.
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Affiliation(s)
- Anna R Gagliardi
- Toronto General Hospital Research Institute, University Health Network, 200 Elizabeth Street, Toronto, M5G2C4, Canada
| | - Pascale Lehoux
- Department of Public Health Administration, University of Montreal, C.P. 6128, succ. Centre-ville Montréal, H3C 3J7, Canada
| | - Ariel Ducey
- Department of Sociology, University of Calgary, Social Sciences Building, Room 956618 Campus Place N.W., 2500 University Drive NW, Calgary, T2N2N4, Canada
| | - Anthony Easty
- Institute of Biomaterial & Biomedical Engineering, University of Toronto
| | - Sue Ross
- Women & Children's Health Research Institute, University of Alberta, 11405 87 Avenue NW, Edmonton, T6G1C9, Canada
| | - Chaim M Bell
- Department of General Internal Medicine, Mount Sinai Hospital, 600 University Avenue, Toronto, M5G1X5, Canada
| | - Patricia Trbovich
- Toronto General Hospital Research Institute, University Health Network, 200 Elizabeth Street, Toronto, M5G2C4, Canada
| | - Julie Takata
- Toronto General Hospital Research Institute, University Health Network, 200 Elizabeth Street, Toronto, M5G2C4, Canada
| | - David R Urbach
- Toronto General Hospital Research Institute, University Health Network, 200 Elizabeth Street, Toronto, M5G2C4, Canada
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38
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The Price of Imperfection. JACC Clin Electrophysiol 2017; 3:1306-1307. [DOI: 10.1016/j.jacep.2017.09.181] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2017] [Accepted: 09/27/2017] [Indexed: 11/16/2022]
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Syncope: Primary Care Office Evaluation and Workup. PHYSICIAN ASSISTANT CLINICS 2017. [DOI: 10.1016/j.cpha.2017.06.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
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Jacheć W, Tomasik A, Polewczyk A, Kutarski A. Impact of ICD lead on the system durability, predictors of long-term survival following ICD system extraction. PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2017; 40:1139-1146. [PMID: 28846144 DOI: 10.1111/pace.13173] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/07/2017] [Revised: 07/07/2017] [Accepted: 07/30/2017] [Indexed: 11/30/2022]
Abstract
BACKGROUND Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems are considered as having higher risk of complication and shorter durability but reasons of this multifactorial phenomenon remain unclear. We aimed to analyze this problem in population of patients with ICD leads referred for lead extraction (TLE). METHODS We have compared TLE indications, procedural results, and defined the long-term outcomes of TLE in patients with ICD/CRT-D devices (n = 482, ICD (+)) with lead extractions in patients with standard pacemakers (n = 1,402, ICD (-)). Demographic, clinical characteristics, and procedural outcomes were ascertained from single, primary operator registry. Long-term survival data were provided by the National Health Fund. RESULTS The ICD (+) subgroup had a significantly higher incidence rate of either infective or noninfective indications for TLE. The clinical success rate of extraction was 99.2% in ICD (+) versus 97.4% in ICD (-) (P = 0.05) at a complication rate of 1.04% versus 2.14% (NS), respectively. In the median follow-up of 3.39 years, 142 patients from the ICD (+) subgroup and 303 from the ICD (-) subgroup died. The highest mortality rate of 41.1% was observed in the ICD (+) subgroup with infective indications. Infection, renal failure, diabetes, and age were the multivariate factors associated with increased mortality in the ICD (+) subgroup. CONCLUSION ICD leads remain more vulnerable, with respect to mechanical failure and their propensity to infection, in comparison to pacing leads. Their TLE is very effective at least complication rate, when performed by a highly skilled and experienced operator. However, long-term mortality after their TLE is high and is affected mostly by infections or patient-related factors.
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Affiliation(s)
- Wojciech Jacheć
- 2nd Department of Cardiology, Medical Faculty with Dentistry Division in Zabrze, Silesian Medical University, Katowice, Poland
| | - Andrzej Tomasik
- 2nd Department of Cardiology, Medical Faculty with Dentistry Division in Zabrze, Silesian Medical University, Katowice, Poland
| | - Anna Polewczyk
- 2nd Clinical Cardiology Department, Świętokrzyskie Cardiology Center, Kielce, Poland.,Department of Health Sciences, The Jan Kochanowski University, Kielce, Poland
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Abstract
OBJECTIVES Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. METHODS We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). RESULTS During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. CONCLUSIONS Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.
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2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm 2017; 14:e503-e551. [PMID: 28919379 DOI: 10.1016/j.hrthm.2017.09.001] [Citation(s) in RCA: 818] [Impact Index Per Article: 102.3] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2017] [Indexed: 02/06/2023]
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43
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de Vries LM, Leening MJG, Dijk WA, Hooijschuur CAM, Stricker BHC, van Hemel NM. Trends in service time of pacemakers in the Netherlands: a long-term nationwide follow-up study. Neth Heart J 2017; 25:581-591. [PMID: 28770398 PMCID: PMC5612868 DOI: 10.1007/s12471-017-1024-x] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2016] [Accepted: 07/12/2017] [Indexed: 12/18/2022] Open
Abstract
AIMS After decades of experience and strongly improved technology, service time of pacemaker generators is expected to increase. To test this hypothesis, we conducted a retrospective review of a large cohort of patients with a pacemaker. METHODS We reviewed data collected between 1984 and 2006 in the first national Dutch pacemaker registry. This registry covered 96% of all generators implanted. We analysed the time of and reason for explantation of pacemaker generators. A 7-year follow-up interval after first implantation and following replacements was used to analyse changes over time. RESULTS During 22 years of data collection, nearly 97,000 first pacemaker generators were implanted. A total of 27,937 (22.4%) generators were explanted within a mean of 6.3 (standard deviation 3.3) years. Reasons for approximately 60% of these explantations were 'end of life' of the pacemaker generator or elective system change. Complications or failures such as infections and recalls accounted for approximately 20% of the explantations. For the remaining 20%, the reasons for explantation had not been registered. CONCLUSION Despite progress in technology, a substantial proportion of pacemaker generators is explanted before its expected service time, with one in five generators being replaced due to technical failures, infections or other complications. Furthermore, the time interval between pacemaker implantation and explantation due to normal 'end of life' (battery EOL) decreased. Infections continue to rank highly as a cause for pacing system replacement, despite all current preventive measures.
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Affiliation(s)
- L M de Vries
- Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands
| | - M J G Leening
- Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands
- Department of Cardiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA
| | - W A Dijk
- Thorax Center, University Medical Center Groningen, Groningen, The Netherlands
| | - C A M Hooijschuur
- Thorax Center, University Medical Center Groningen, Groningen, The Netherlands
| | - B H C Stricker
- Department of Epidemiology, Erasmus MC - University Medical Center Rotterdam, Rotterdam, The Netherlands.
| | - N M van Hemel
- Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands
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Gagliardi AR, Ducey A, Lehoux P, Turgeon T, Ross S, Trbovich P, Easty A, Bell C, Urbach D. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices. BMJ Qual Saf 2017; 27:190-198. [PMID: 28768712 PMCID: PMC5867432 DOI: 10.1136/bmjqs-2017-006481] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/21/2017] [Indexed: 12/18/2022]
Abstract
BACKGROUND Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. METHODS Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. RESULTS Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. CONCLUSIONS There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.
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Affiliation(s)
- Anna R Gagliardi
- Toronto General Hospital Research Institute, University Health Network, Toronto, Canada
| | - Ariel Ducey
- Department of Sociology, University of Calgary, Calgary, Canada
| | - Pascale Lehoux
- Département d'administration de la santé, Université de Montréal, Montreal, Canada
| | - Thomas Turgeon
- Concordia Hip and Knee Institute, Concordia Hospital, Winnipeg, Canada
| | - Sue Ross
- Women & Children's Health Research Institute, University of Alberta, Edmonton, Canada
| | - Patricia Trbovich
- Institute for Health Policy, Management & Evaluation, University of Toronto, Toronto, Canada
| | - Anthony Easty
- Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, Canada
| | - Chaim Bell
- Division of General Internal Medicine, Sinai Health System, Toronto, Canada
| | - David Urbach
- Toronto General Hospital Research Institute, University Health Network, Toronto, Canada
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Chan JY, Lelakowski J, Murgatroyd FD, Boersma LV, Cao J, Nikolski V, Wouters G, Hall MC. Novel Extravascular Defibrillation Configuration With a Coil in the Substernal Space. JACC Clin Electrophysiol 2017; 3:905-910. [DOI: 10.1016/j.jacep.2016.12.026] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2016] [Revised: 12/05/2016] [Accepted: 12/22/2016] [Indexed: 11/26/2022]
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Zippel C, Bohnet-Joschko S. Post market surveillance in the german medical device sector – current state and future perspectives. Health Policy 2017; 121:880-886. [DOI: 10.1016/j.healthpol.2017.06.005] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2016] [Revised: 06/15/2017] [Accepted: 06/19/2017] [Indexed: 10/19/2022]
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Manolis AS, Maounis T, Koulouris S, Vassilikos V. "Real life" longevity of implantable cardioverter-defibrillator devices. Clin Cardiol 2017; 40:759-764. [PMID: 28543134 DOI: 10.1002/clc.22729] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2017] [Revised: 04/11/2017] [Accepted: 04/24/2017] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND Manufacturers of implantable cardioverter-defibrillators (ICDs) promise a 5- to 9-year projected longevity; however, real-life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. HYPOTHESIS Real-life longevity of ICDs may differ from that stated by the manufacturers. METHODS The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single- (n = 292) or dual-chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). RESULTS Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single-chamber devices and shortest for CRT devices. Latest-generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. CONCLUSIONS ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical therapy.
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Affiliation(s)
- Antonis S Manolis
- Third Department of Cardiology, Athens University School of Medicine, Greece
| | | | | | - Vassilios Vassilikos
- Third Department of Cardiology, Hippokratio Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece
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Abstract
Advances in the field of defibrillation have brought to practice different types of devices that include the transvenous implantable cardioverter-defibrillator (ICD) with or without cardiac resynchronization therapy, the subcutaneous ICD (S-ICD), and the wearable cardioverter-defibrillator. To ensure optimal use of these devices and to achieve best patient outcomes, clinicians need to understand how these devices work, learn the characteristics of patients who qualify them for one type of device versus another, and recognize the remaining gaps in knowledge surrounding these devices. The transvenous ICD has been shown in several randomized clinical trials to improve the survival of patients resuscitated from near-fatal ventricular fibrillation and those with sustained ventricular tachycardia with syncope or systolic heart failure as a result of ischemic or nonischemic cardiomyopathy despite receiving guideline-directed medical therapy. Important gaps in knowledge regarding the transvenous ICD involve the role of the ICD in patient subgroups not included, or not well represented, in clinical trials and the need to refine the selection criteria for the ICD in patients who are indicated for it. S-ICDs were recently introduced into the clinical arena as another option for many patients who have an approved indication for a transvenous ICD. The main advantage of the S-ICD is a lower risk of infection and lead-related complications; however, the S-ICD does not offer bradycardia or antitachycardia pacing. The S-ICD may be ideal for patients with limited vascular access, high infection risk, or some congenital heart diseases. However, more data are needed regarding the efficacy and effectiveness of the S-ICD in comparison to transvenous ICDs, the extent of defibrillation testing required, and the use of the S-ICD with other novel technologies, including leadless pacemakers. Cardiac resynchronization therapy-defibrillators are indicated in patients with a left ventricular ejection fraction ≤35%, QRS width ≥130 ms, and New York Heart Association class II, III, or ambulatory IV symptoms despite treatment with guideline-directed medical therapy. Multiple randomized controlled trials have shown that the cardiac resynchronization therapy-defibrillator improves survival, quality of life, and several echocardiographic measures. One main challenge related to cardiac resynchronization therapy-defibrillators is the 30% nonresponse rate. Many initiatives are underway to address this challenge including improved cardiac resynchronization therapy and imaging technologies and enhanced selection of patients and device programming.
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Affiliation(s)
- Sana M Al-Khatib
- From the Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.M.A.); Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.F.); and Division of Cardiology, Virginia Commonwealth University School of Medicine, Richmond, VA (K.A.E.).
| | - Paul Friedman
- From the Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.M.A.); Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.F.); and Division of Cardiology, Virginia Commonwealth University School of Medicine, Richmond, VA (K.A.E.)
| | - Kenneth A Ellenbogen
- From the Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.M.A.); Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.F.); and Division of Cardiology, Virginia Commonwealth University School of Medicine, Richmond, VA (K.A.E.)
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Hayashi Y, Takagi M, Kakihara J, Tatsumi H, Atsushi D, Yoshiyama M. A case of unexpected early battery depletion caused by lithium cluster formation in implantable cardioverter-defibrillator. J Cardiol Cases 2017; 15:184-186. [PMID: 30279775 DOI: 10.1016/j.jccase.2017.02.007] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/24/2016] [Revised: 01/13/2017] [Accepted: 02/02/2017] [Indexed: 11/15/2022] Open
Abstract
Device failure from unexpected battery depletion is uncommon but can be life-threatening. Lithium cluster formation at the cathode is a novel mechanism of sudden implantable cardioverter-defibrillator (ICD) battery depletion that was first reported in 2014. We report a rare case of a 78-year-old woman with an ICD battery failure due to lithium cluster formation. Although she had never received ICD therapy, the battery voltage had dropped from 2.9 V to 2.54 V (end of life) unexpectedly for only 2 days. The prevalence of this rare phenomenon was reported to be 0.004% in 2014. However, it had gone up to 0.21% in October 2016. Both device manufacturers and clinicians should be aware of this phenomenon, and remote monitoring systems and vibratory patient notifier alerts should be considered for early detection and early treatment. <Learning objective: Lithium cluster formation is a novel mechanism of premature ICD battery depletion that was first reported in 2014. Although the prevalence of this rare phenomenon was first reported as 0.004% in 2014, according to the data of St. Jude Medical, it had gone up to 0.21% in October 2016. We should be aware of this rare but important phenomenon and use remote monitoring systems and vibratory patient notifier alerts for early detection and treatment.>.
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Affiliation(s)
- Yusuke Hayashi
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Masahiko Takagi
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Jun Kakihara
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Hiroaki Tatsumi
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Doi Atsushi
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
| | - Minoru Yoshiyama
- Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan
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Mesquita J, Cavaco D, Ferreira A, Lopes N, Santos PG, Carvalho MS, Haas A, Costa F, Carmo P, Morgado F, Adragão P, Mendes M. Effectiveness of subcutaneous implantable cardioverter-defibrillators and determinants of inappropriate shock delivery. Int J Cardiol 2017; 232:176-180. [DOI: 10.1016/j.ijcard.2017.01.034] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/15/2016] [Revised: 01/02/2017] [Accepted: 01/04/2017] [Indexed: 01/14/2023]
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