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Extended Use of the Wearable Cardioverter-Defibrillator: Which Patients Are Most Likely to Benefit?

ABSTRACT: Background:Wearable cardioverter-defibrillators (WCD, LifeVest, ZOLL) can protect from sudden cardiac death bridging a vulnerable period until a decision on implantable cardioverter-defibrillator (ICD) implantation can be reached. WCD is commonly used for 3 months or less. It is unknown, which patients use WCD longer and which patients are most likely to benefit from it. Hypothesis:Extended use of WCD is reasonable in selected cases based on underlying heart disease and overall patient risk profile. Methods:We conducted a systematic and comprehensive research of all published clinical studies on PubMed reporting on the use of the WCD. Only original articles reporting on wear times and time to appropriate shocks were included in our analysis. Results:The search resulted in 127 publications. 14 parameters were reported necessary for inclusion in our analysis. Median wear times ranged from 16 to 394 days. The median wear time was especially long for patients suffering from nonischemic cardiomyopathy (NICM) (range: 50-71 days) and specifically peripartum cardiomyopathy (PPCM) (120 days) and for heart transplant candidates. There was a large variation of appropriate shocks according to indication for WCD use. In contrast to NICM in general, the number of appropriate shocks was particularly high in patients with PPCM (0 in 254 patients and 5 in 49 patients, respectively). The median and maximal time periods to the first appropriate shock were longest in patients with PPCM (median time to the first appropriate shock: 68 days). Conclusions:Prolonged use of WCD is not uncommon in available literature. Patients suffering from NICM and specifically PPCM seem most likely to have longer therapy duration with WCD with success. Careful patient selection for prolonged use may decrease the need for ICD implantation in the future; however, prospective data are needed to confirm this hypothesis.

SUBMITTER: Kovacs B

PROVIDER: S-EPMC6304887 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Extended Use of the Wearable Cardioverter-Defibrillator: Which Patients Are Most Likely to Benefit?

Kovacs Boldizsar B Reek Sven S Krasniqi Nazmi N Eriksson Urs U Duru Firat F

Cardiology research and practice 20181129

<h4>Background</h4>Wearable cardioverter-defibrillators (WCD, LifeVest, ZOLL) can protect from sudden cardiac death bridging a vulnerable period until a decision on implantable cardioverter-defibrillator (ICD) implantation can be reached. WCD is commonly used for 3 months or less. It is unknown, which patients use WCD longer and which patients are most likely to benefit from it.<h4>Hypothesis</h4>Extended use of WCD is reasonable in selected cases based on underlying heart disease and overall pa ...[more]

PMID: 30622822

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Project description:BACKGROUND:Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS:We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS:Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS:Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

Project description:AimsThe benefit of prophylactic implantable cardioverter-defibrillator (ICD) is not uniform due to differences in the risk of life-threatening ventricular tachycardia (VT)/ventricular fibrillation (VF) and non-arrhythmic mortality. We aimed to develop an ICD benefit prediction score that integrates the competing risks.Methods and resultsThe study population comprised all 4531 patients enrolled in the MADIT trials. Best-subsets Fine and Gray regression analysis was used to develop prognostic models for VT (≥200 b.p.m.)/VF vs. non-arrhythmic mortality (defined as death without prior sustained VT/VF). Eight predictors of VT/VF (male, age < 75 years, prior non-sustained VT, heart rate > 75 b.p.m., systolic blood pressure < 140 mmHg, ejection fraction ≤ 25%, myocardial infarction, and atrialarrhythmia) and 7 predictors of non-arrhythmic mortality (age ≥ 75 years, diabetes mellitus, body mass index < 23 kg/m2, ejection fraction ≤ 25%, New York Heart Association ≥II, ICD vs. cardiac resynchronization therapy with defibrillator, and atrial arrhythmia) were identified. The two scores were combined to create three MADIT-ICD benefit groups. In the highest benefit group, the 3-year predicted risk of VT/VF was three-fold higher than the risk of non-arrhythmic mortality (20% vs. 7%, P < 0.001). In the intermediate benefit group, the difference in the corresponding predicted risks was attenuated (15% vs. 9%, P < 0.01). In the lowest benefit group, the 3-year predicted risk of VT/VF was similar to the risk of non-arrhythmic mortality (11% vs. 12%, P = 0.41). A personalized ICD benefit score was developed based on the distribution of the two competing risks scores in the study population (https://is.gd/madit). Internal and external validation confirmed model stability.ConclusionsWe propose the novel MADIT-ICD benefit score that predicts the likelihood of prophylactic ICD benefit through personalized assessment of the risk of VT/VF weighed against the risk of non-arrhythmic mortality.

Project description: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. 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. 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. 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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Extended Use of the Wearable Cardioverter-Defibrillator: Which Patients Are Most Likely to Benefit?

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Extended Use of the Wearable Cardioverter-Defibrillator: Which Patients Are Most Likely to Benefit?

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