Experience With the Wearable Cardioverter-Defibrillator in Patients at High Risk for Sudden Cardiac Death

Wäßnig, Nadine K.; Gunther, Michael F.; Quick, Silvio; Pfluecke, Christian; Rottstädt, Fabian; Szymkiewicz, Steven J; Ringquist, Steven; Strasser, Ruth H.; Speiser, Uwe

doi:10.1161/circulationaha.115.019124

Cited by 110 publications

(107 citation statements)

References 20 publications

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“…These findings contrast with a previously published study that did not show any WCD shock in 254 patients with newly diagnosed NICM . However, the incidence of zero ventricular tachyarrhythmias in this cohort is not supported by the majority of WCD studies in NICM patients and might be partly explained by a shorter WCD wearing time of 71 days (median) . Another recent study on patients with NICM wearing the WCD already reported a relevant risk for ventricular tachyarrhythmias in newly diagnosed HF .…”

Section: Discussioncontrasting

confidence: 99%

Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study

Duncker

König

Hohmann

et al. 2017

Clinical Cardiology

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Background Patients with nonischemic cardiomyopathy (NICM) reportedly have low incidence of appropriate shocks from wearable cardioverter‐defibrillators (WCDs). A recent study questions the benefit from primary preventive implantation of implantable cardioverter‐defibrillators in NICM. We therefore analyzed a subgroup of patients with NICM from the PROLONG study. Hypothesis Patients with newly diagnosed NICM show a risk for ventricular tachyarrhythmia. Methods The PROLONG study included 167 patients with newly diagnosed heart failure and left ventricular ejection fraction (LVEF) ≤35% with a WCD. Patients with NICM were identified and included in this analysis. Results 117 patients presented with NICM. Sixty‐five (55%) were male; mean age was 51 ± 15 years. Mean LVEF at diagnosis was 23% ± 7%. Mean follow‐up was 11 ± 10 months. Mean WCD wear time was 101 ± 82 days; mean wear time per day was 21.4 ± 4.5 hours. Overall, 12 ventricular arrhythmias occurred in 10 (9%) patients (6 DCM, 4 PPCM). Nine appropriate WCD shocks for hemodynamically unstable ventricular tachycardia/fibrillation in 8 (7%) patients were observed. Two patients presented sustained hemodynamically stable ventricular tachycardia for >30 minutes detected by the WCD, but withheld WCD therapy. Conclusions Patients with newly diagnosed NICM and LVEF ≤35% show an elevated risk of ventricular tachycardia/fibrillation during initiation and optimization of heart failure therapy. To prevent sudden cardiac death, WCD should be considered in patients with newly diagnosed NICM with severely reduced LVEF.

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Section: Discussioncontrasting

confidence: 99%

Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study

Duncker

König

Hohmann

et al. 2017

Clinical Cardiology

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“…There are some important distinctions when comparing compliance data in this open‐label randomized trial compared with previously published registry studies 9–12 . In our study, the denominator of the percentage wear‐time is all participants who were randomized to that group, whereas in the registry, these were patients who were prescribed and wore the WCD as part of clinical practice.…”

Section: Discussionmentioning

confidence: 97%

Impact of wearable cardioverter‐defibrillator compliance on outcomes in the VEST trial: As‐treated and per‐protocol analyses

Olgin

Lee

Vittinghoff

et al. 2020

Cardiovasc electrophysiol

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Background: Vest Prevention of Early Sudden Death Trial did not demonstrate a significant reduction in arrhythmic death with the wearable cardioverterdefibrillator (WCD), but compliance with the device may have substantially affected the results. ThePletcher influence of WCD compliance on outcomes has not yet been fully evaluated.Methods: Using linear and pooled logistic models, we performed as-treated analyses omitting person-time in the hospital and adjusted for correlates of WCD compliance.To assess the impact of early stopping of WCD, we performed a per-protocol Kaplan-Meier analysis, censoring after the last day the WCD was worn. Interactions of potential effect modifiers with treatment assignment and WCD compliance on outcomes were investigated. Finally, we used linear models to identify predictors of WCD compliance.Results: A per-protocol analysis demonstrated a significant reduction in total (P < .001) and arrhythmic (P = .001) mortality. Better WCD compliance was independently predicted by cardiac arrest during index myocardial infarction (MI), higher Cr, diabetes, prior heart failure, EF ≤ 25%, Polish enrolling center and number of WCD alarms, while worse compliance was predicted by being divorced, Asian Abbreviations: BMI, body mass index; CABG, coronary artery bypass grafting; EF, ejection fraction; LVEF, left ventricular ejection fraction; MI, myocardial infarction; PCI, percutaneous coronary intervention; VEST, Vest Prevention of Early Sudden Death Trial; WCD, wearable cardioverter-defibrillator. race, higher body mass index, prior percutaneous coronary intervention, or any WCD shock. Neither excluding time in hospital from the as-treated analysis nor adjustment for factors affecting WCD compliance materially changed the results. No variable demonstrated a significant interaction in either the intention-to-treat or as-treated analysis.Conclusion: Robust sensitivity analyses of as-treated and per-protocol analyses suggest that the WCD is protective in compliant patients with ejection fraction less than or equal to 35% during the first 3 months post-MI. K E Y W O R D S defibrillator, heart failure, myocardial infarction, sudden death, ventricular tachycardia, wearable cardioverter-defibrillator

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“…WCD use has been proven safe and effective [16][17][18][19]. Data published in 2015 from the WEARIT-II Registry showed that devices could be safely used.…”

Section: Introductionmentioning

confidence: 99%

The Wearable Cardioverter-Defibrillator: Experience in 153 Patients and a Long-Term Follow-Up

Rosenkaimer

El‐Battrawy

Dreher

et al. 2020

JCM

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Background: The wearable cardioverter-defibrillator (WCD) is available for patients at high risk for sudden cardiac death (SCD) when immediate implantable cardioverter-defibrillator (ICD) implantation is not possible or indicated. Patient selection remains challenging especially in primary prevention. Long-term data on these patients is still lacking. Methods: 153 patients were included in this study. They were prescribed the WCD between April 2012 and March 2019 at the University Medical Center, Mannheim, Germany. The mean follow-up period was 36.2 ± 15.6 months. Outcome data, including all-cause mortality, were analyzed by disease etiology and ICD implantation following WCD use. Results: We analyzed 56 patients with ischemic cardiomyopathy, 70 patients with non-ischemic cardiomyopathy, 16 patients with prior need for ICD/CRT-D (device for cardiac resynchronization therapy with defibrillator) explanation, 8 patients with acute myocarditis and 3 patients with congenital diseases. 58% of the patients did not need ICD/CRT-D implantation after WCD use. 4% of all patients suffered from appropriate WCD shocks. 2 of these patients (33%) experienced appropriate ICD shocks after implantation due to ventricular tachyarrhythmias. Long-term follow-up shows a good overall survival. All-cause mortality was 10%. There was no significant difference between patients with or without subsequent ICD implantation (p = 0.48). Patients with ischemic cardiomyopathy numerically showed a higher long-term mortality than patients with non-ischemic cardiomyopathy (14% vs. 6%, p = 0.13) and received significantly more ICD shocks after implantation (10% of ischemic cardiomyopathy (ICM) patients versus 3% of non-ischemic cardiomyopathy (NICM) patients, p = 0.04). All patients with ventricular tachyarrhythmias during WCD use or after ICD implantation survived the follow-up period. Conclusion: Following WCD use, ICD implantation could be avoided in 58% of patients. Long-term follow-up shows good overall survival. The majority of all patients did not suffer from WCD shocks nor did receive ICD shocks after subsequent implantation. Patient selection regarding predictive conditions on long-term risk of ventricular tachyarrhythmias needs further risk stratification.

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Experience With the Wearable Cardioverter-Defibrillator in Patients at High Risk for Sudden Cardiac Death

Abstract: Supplemental Digital Content is available in the text.

Cited by 110 publications

References 20 publications

Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study

Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study

Impact of wearable cardioverter‐defibrillator compliance on outcomes in the VEST trial: As‐treated and per‐protocol analyses

The Wearable Cardioverter-Defibrillator: Experience in 153 Patients and a Long-Term Follow-Up

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