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

Abstract

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

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry

“…This low WCD compliance is responsible that only nine out of 25 patients experiencing sudden death have worn the WCD at the time of death. The importance of wear compliance was stressed in the recently published as-treated analysis of VEST [ 37 ]. In addition, the WEARIT-II-EUROPE registry is hard to compare with VEST because VEST tried to test the WCD as a “therapeutic tool” but not as an approach for protected risk stratification after myocardial infarction.…”

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

“…52 Adherence to wearing the defibrillator was an important issue that conditioned the results of the VEST study, as highlighted by the ontreatment and per-protocol analyses that found a benefit of the wearable defibrillator in the group of patients selected for high compliance to apply the device. 53 Data from the WEARIT-II Registry 54 showed a high rate of VT -3% among patients with ischemic and congenital heart disease and 1% among nonischemic patients -during 3 months of WCD use. In total, there were 120 VT episodes recorded in 41 patients, and 54% of those received appropriate WCD therapy.…”

Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team “vested and active”

“…The investigators reported that 34% of WCD users wore the device for a median of 0 h/day, and 53% wore the device for a median of ≥22 h. Thirty percent of participants stopped wearing the WCD within 1 month of randomization, 43% within 2 months, and 80% before the end of the planned 90-day follow-up period. 8 This follow-up study places further emphasis on the criticality of patient engagement with the WCD, and editorials have called for the likelihood of compliance to figure into shared decision making conversations and benefit estimation. 9 The clinical evidence for the WCD was recently reviewed including 28 studies with 33,242 WCD patients.…”

“…The trial reported particular difficulty with patient adherence to wearing the WCD 7 . More recently, the as‐treated analysis of VEST suggested that the WCD is efficacious in reducing both arrhythmic death ( P = .001) and all‐cause mortality ( P < .001) 8 . These discriminating findings further highlight the importance of shared decision making at the outset and clinical follow‐through by the treatment team to ensure adherence via wearing the WCD.…”

“…7 More recently, the as-treated analysis of VEST suggested that the WCD is efficacious in reducing both arrhythmic death (P = .001) and all-cause mortality (P < .001). 8 These discriminating findings further highlight the importance of shared decision making at the outset and clinical follow-through by the treatment team to ensure adherence via wearing the WCD. For the health care provider, simultaneous consideration of patient fear, adherence, and engagement blended together with professional judgment, clinical trial interpretation, and a patient-centric process that further increases the complexity of the clinical situation.…”