Extended use of the wearable cardioverter-defibrillator in patients at risk for sudden cardiac death

Kutyifa, Valentina; Vermilye, Katherine; Daimee, Usama A.; McNitt, Scott; Klein, Helmut U.; Moss, Arthur J.

doi:10.1093/europace/euy091

Cited by 16 publications

(9 citation statements)

References 20 publications

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“…Patients with LVEF <30% early after myocardial infarction are a difficult group for decision-making, due to possible transient nature of risk for SCD and also because very late ventricular arrhythmia occurence. 18 A significant proportion (almost half in our study) of these patients were not implanted with an ICD after optimization of pharmacological therapies, due to their recovery of LVEF. The WCD offers an opportunity for a bridge to recovery or to ICD implantation.…”

Section: Discussionmentioning

confidence: 81%

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

et al. 2020

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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.

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Section: Discussionmentioning

confidence: 81%

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

et al. 2020

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“…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.…”

Section: Resultsmentioning

confidence: 99%

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

Aidelsburger¹,

Seyed-Ghaemi²,

Guinin³

et al. 2020

Int J Technol Assess Health Care

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Objectives To assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable. Methods We performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed. Results One randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43–.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37–1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD. Conclusions Available evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.

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“…The proportion of one third of patients who may end up with a prophylactic ICD is consistent with the literature. 9 Our score is of simple use. LVEF at the acute phase of MI can accurately predict contractile function recovery.…”

Section: Discussionmentioning

confidence: 99%

The IC‐D score for predicting prophylactic cardioverter‐defibrillator implantation following acute myocardial infarction

Clémenty

Bensaid

Bouteau

et al. 2021

Pacing Clinical Electrophis

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Background A reduced left ventricular ejection fraction (LVEF) ≤35% ≥6 weeks following an acute myocardial infarction (MI) may indicate prophylactic implantation of a cardioverter‐defibrillator (ICD). We sought to find predictors of absence of significant left ventricular (LV) remodeling post‐MI. Methods All consecutive patients hospitalized for acute MI with an LVEF ≤35% at discharge in our institution from 2010 were retrospectively included. Patients were assigned to two groups according to the persistence of an LVEF ≤35% (ICD+) or a recovery >35% (ICD‐). Logistic regression was performed to build a predictive score, which was then externally validated. Results Among a total of 1533 consecutive MI patients, 150 met inclusion criteria, 53 (35%) in the ICD+ group and 97 in the ICD group. After multivariable analyses, an LVEF ≤25% at discharge (adjusted OR 6.23 [2.47 to 17.0], p < .0001) and a CPK peak at the MI acute phase >4600 UI/L (adjusted OR 9.99 [4.27 to 25.3], p < .0001) both independently predicted non‐recovery at 6 weeks. The IC‐D (Increased Cpk—LV Dysfunction) score predicted persistent LVEF ≤35% with areas under curve of 0.83 and 0.73, in the study population and in a multicenter validation cohort of 150 patients, respectively (p < .0001). Conclusions The association of a severely reduced LVEF and a major release of myocardial necrosis biomarkers at the acute phase of MI predict unfavorable remodeling, and prophylactic ICD implantation.

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Extended use of the wearable cardioverter-defibrillator in patients at risk for sudden cardiac death

Cited by 16 publications

References 20 publications

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

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

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

The IC‐D score for predicting prophylactic cardioverter‐defibrillator implantation following acute myocardial infarction

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