Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study

Abstract

Aims: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability.

Methods and results: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%).

Conclusion: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

Trial registration: ClinicalTrials.gov NCT03319160.

Keywords: Education; Implantable cardioverter-defibrillator; Ischaemic cardiomyopathy; Patient compliance; Remote monitoring; Sudden cardiac death; Ventricular arrhythmias; Wearable cardioverter-defibrillator.

Graphical abstract

Figure 1

Flowchart. Among the 1164 enrolled patients, 7 had data not available. Indication for wearable cardioverter-defibrillator was ischaemic cardiomyopathy with left ventricular ejection fraction <30% in 950 patients, post-implantable cardioverter-defibrillator extraction in 119 patients and waiting for heart transplant in 88 patients.

Figure 2

WCD compliance. This figure represents the distribution of average daily wearable cardioverter-defibrillator use, in hours per day. Bars represent separation between quartiles. Quartile 1 corresponds to 22.2 h, meaning that one-quarter of the population is actually wearing the vest <22.2 h. Quartile 3 is 23.8 h, meaning that one-quarter of the population is wearing the vest >23.8 h. The median daily wearable cardioverter-defibrillator wear time was 23.4 h. WCD, wearable cardioverter-defibrillator.

Figure 3

Questionnaire to evaluate WCD therapy acceptability. Five-point Likert agreement response scale assessed patient agreement regarding nine items related to their use of the wearable cardioverter defibrillator (N = 202). The item that patients most agreed with was: ‘I follow life style modification recommendations from my physician’ and the item that users least agreed with was: ‘I sleep significantly better knowing I am protected by the LifeVest’. WCD, wearable cardioverter-defibrillator.