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

Abstract

Background The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death. Methods and results 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription ( p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown. Conclusions Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation. Graphic abstract

Feasibility and First Results of Heart Failure Monitoring Using the Wearable Cardioverter–Defibrillator in Newly Diagnosed Heart Failure with Reduced Ejection Fraction

“…Patients with newly diagnosed HFrEF without meeting ICD implantation criteria were included in this analysis, representing a well-established indication for WCD prescription [ 16 , 17 , 23 ]. Patient characteristics in this study were comparable to previous studies regarding the use of the WCD [ 17 , 24 , 25 , 26 ]. Heart rate and heart rate variability are especially important parameters for heart failure therapy optimization and long-term management of heart failure [ 19 ].…”

Wearable Cardioverter-Defibrillator Used as a Telemonitoring System in a Real-Life Heart Failure Unit Setting

“…Most studies show a daily WCD wearing time of more than 20 h per day, except the VEST trial, where this time was significantly below 20 h per day and where most deaths occurred in patients who did not wear the WCD. Compared with the data of investigators from other WCD-registers (WEARIT-France, median wear time 23.4 h per day [9]; WEARIT-II, median wear time 22.5 h per day [10]; WEARIT-II-EUROPE, mean wear time 20.3 ± 4.6 h per day [11]), this seems to be a standard value for the overall wearing compliance. In their study, Goldenberg et al found sex differences showing women having a higher burden of atrial and ventricular arrhythmias [24].…”

“…Furthermore, WCD is recommended as a bridge to implantation in patients with existing ICD indications who cannot receive the device or where an existing device has to be extracted due to temporary disorders, such as local or systemic infections [5][6][7][8]. Many studies suggest that using a WCD significantly reduces all-cause mortality in patients at high risk of SCD [9][10][11][12]. However, in a randomized VEST trial including more than 2000 patients, the use of a WCD showed a reduction in SCD but without statistical significance [13].…”

“…However, in a randomized VEST trial including more than 2000 patients, the use of a WCD showed a reduction in SCD but without statistical significance [13]. Furthermore, the device has been proven to detect non-life-threatening cardiac arrhythmias, such as non-sustained ventricular tachycardia (nsVT) or atrial fibrillation (AF) [11]. For the appropriate detection of arrhythmias, it is essential that patients wear the WCD all day and every day, with minimal interruptions.…”

Extended follow‐up after wearable cardioverter‐defibrillator period: the PROLONG‐II study

“…While several observational trials and one randomized controlled trial have addressed short‐term survival of patients wearing the WCD, there are limited data on long‐term survival. The longest previously available FU from the large observational studies was 1 year in the WEARIT‐II 12 and WEARIT‐II‐Europe 13 registries.…”