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

Abstract

Aim The wearable cardioverter‐defibrillator (WCD) is used for temporary protection from sudden cardiac death (SCD) in patients with newly diagnosed heart failure with reduced ejection fraction before considering an implantable cardioverter‐defibrillator (ICD). However, the prognostic significance of the WCD remains controversial due to conflicting evidence. The aim of the present study was to evaluate prognosis of patients receiving life‐saving WCD shocks. Methods and results All patients receiving a WCD at Hannover Medical School for heart failure with reduced ejection fraction between 2012 and 2017 were included. Data were acquired at baseline, at 3 months and at last available follow‐up (FU). Three hundred and fifty‐three patients were included (69% male; age 56 ± 15 years; left ventricular ejection fraction 25 ± 8%). FU after the WCD was 2.8 ± 1.5 years with a maximum of 6.8 years. Daily WCD wear time was 22 ± 4 h. Fourteen patients (4%) received appropriate WCD shocks. Two patients (0.6%) died during the WCD period. Thirty patients (9%) died during extended FU. Mean estimated survival after the WCD was similar between patients with and without WCD shocks. Patients without an ICD recommendation after WCD prescription did not experience SCD during FU. Conclusions Patients with WCD shocks showed a favourable survival. Patients without an ICD recommendation after WCD prescription had no SCD during FU. These findings support the practice of careful risk stratification before considering an ICD and the use of the WCD for temporary protection from SCD.

Delayed Improvement of Left Ventricular Function in Newly Diagnosed Heart Failure Depends on Etiology—A PROLONG-II Substudy

“…We and others have previously argued that a prolonged time should be taken for therapy optimization and risk stratification before deciding on ICD implantation [13][14][15]. The PROLONG and PROLONG-II study have suggested that ICD implantations can be avoided in some patients with newly diagnosed HFrEF by this practice without increasing the risk of sudden cardiac death [13,23]. The present analysis was conducted to evaluate which patients benefit from an extended waiting period.…”

“…The PROLONG-II study was an observational single-center study evaluating the prognosis of patients with HFrEF after WCD prescription. Detailed trial design has been described elsewhere [23]. In brief, patients receiving a WCD (LifeVest, Zoll, Pittsburgh, PA, USA) for newly diagnosed HFrEF at Hannover Medical School between 2012 and 2017 were included.…”

“…In the PROLONG-II study, it was shown that overall survival after the WCD was favorable, including in patients after a WCD shock. These results argued against a mere mortality shift from sudden to non-sudden deaths by the WCD [23]. The aim of the present analysis was to evaluate the potential for LVEF improvement, and the incidence of early and late life-threatening arrhythmias and mid-term mortality in different entities of HFrEF.…”

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

“…The PROLONG-II study enrolled patients who received a WCD (LifeVest, ZOLL, Pittsburgh, PA, USA) at Hannover Medical School [ 18 ]. The aim of the present study was to provide extended follow-up after WCD prescription.…”

Multiparameter Monitoring with a Wearable Cardioverter Defibrillator

“…The TRENDS data were captured and available also in clinical patients outside of clinical trials, while the visibility within the online network needs to be activated for each patient and each physician separately and is not routinely used for follow-ups. Recently, a retrospective analysis of TRENDS data patients from the PROLONG II trial [ 52 ] proposed a clinical application of the TRENDS data: 267 patients (31.9% female, mean LVEF 25.3 ± 8.5%) with a newly diagnosed CMP were observed over the time of WCD prescription (111.8 ± 74.5 days). The first and last seven days of usage were compared and showed significant changes in heart rate, step count, and five-minute heart rate variability approximate (HRV5), which is a surrogate for beat-to-beat heart rate variability and was calculated from the data available from the online network.…”