Study of the wearable cardioverter defibrillator in advanced heart‐failure patients (SWIFT)

Abstract

Introduction The wearable cardioverter defibrillator (WCD) may allow stabilization until reassessment for an implantable cardioverter defibrillator (ICD) among high‐risk heart failure (HF) patients. However, there are limited data on the WCD benefit in the acute decompensated HF setting. Methods and results The Study of the Wearable Cardioverter Defibrillator in Advanced Heart Failure Patients (SWIFT) was a prospective clinical trial carried out at two medical centers. Patients hospitalized with advanced HF symptoms and reduced left ventricular ejection function (LVEF) were enrolled and prescribed a WCD prior to discharge for a total of 3 months. Outcome measures included arrhythmic events, WCD discharge, and death. Study patients (n = 75, mean age 51 ± 14 years, 31% women) had a mean LVEF of 21.5 ± 10.4%. Non‐ischemic cardiomyopathy was present in 66% of patients. The median WCD wearing time was 59 (interquartile range 17–97) days, and 80% of patients wore the device >50% of daily hours. WCD interrogations showed a total of 8 arrhythmic events in 5 patients, including 3 nonsustained or self‐terminating ventricular tachycardia (VT) events, and one polymorphic VT successfully terminated by the WCD. None of the patients died while wearing the device and no inappropriate device therapies occurred. Upon termination of treatment with the WCD, 21 patients (28%) received an ICD. At 3 years, the cumulative death rate was 20% in the ischemic and 21% in non‐ischemic cardiomyopathy patients. Conclusion A management strategy incorporating the WCD can be safely used to bridge the decision regarding the need for ICD implantation in high‐risk patients with advanced HF.

Impairment of Quality of Life among Patients with Wearable Cardioverter Defibrillator Therapy (LifeVest®): A Preliminary Study

“…As we know from other studies on WCD therapy [ 3 – 5 , 17 , 18 ], the overall incidence rate of shock therapy is low; therefore the number needed to treat to save one patient from SCD by WCD therapy will be quite high and it is an expensive therapy (in Germany the monthly cost amounts to roughly 2650 euros). In addition, WCD therapy remarkably diminishes QoL in our collective.…”

Effectiveness, efficacy, and safety of wearable cardioverter-defibrillators in the treatment of sudden cardiac arrest – Results from a health technology assessment

“…After addition of two citations identified by hand search, forty-six primary studies, two systematic reviews, and one HTA were included for final analysis (see Figure 1). The forty-six primary studies included one RCT 7, one nrCT (11), sixteen non-comparative prospective trials (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27), and twenty-eight non-comparative retrospective trials (4;28-54). The RCT showed a low and the nrCT a high risk of bias.…”

The Wearable Cardioverter-Defibrillator

“…No patient in the study received inappropriate therapy delivery. At the end of the study, 28% of patients went on to permanent device implantation, and the cumulative mortality rate at 3 years in this population was 21% for patients with nonischemic cardiomyopathy compared to 21% for those with ischemic cardiomyopathy [19].…”

“…No inappropriate therapies were delivered, and no patients died in the course of the study. When the study concluded, 28% were implanted with an ICD [19].…”