Usefulness of the wearable cardioverter defibrillator in patients in the early post‐myocardial infarction phase with high risk of sudden cardiac death: A single‐center European experience

Kondo, Yusuke; Linhart, Markus; Andrié, René; Schwab, Joerg O.

doi:10.1016/j.joa.2015.03.007

Cited by 18 publications

(24 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…After title/abstract screening and full-text assessment, 11 studies with nonoverlapping populations and/or endpoints evaluating a cumulative total of 19,882 patients (range: 8-8,453 patients) were included (Table 2). 5,6,[11][12][13][14][15][16][17][18][19] Most studies were retrospective (n = 9; 82%) and multicenter (n = 7; 64%) in nature, with five studies (45%) incorporating data from the manufacturer's registry. Of the studies considered, 56% evaluated patients treated in the US (n = 6), while 36% evaluated patients treated in Germany (n = 4).…”

Section: Resultsmentioning

confidence: 99%

Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis

Nguyen

Weeda

Kohn

et al. 2018

J Innov Cardiac Rhythm Manage

View full text Add to dashboard Cite

Wearable cardioverter-defibrillators (WCDs) protect patients from sudden cardiac death (SCD) by detecting and treating life-threatening ventricular tachycardia/fibrillation (VT/ VF). Recently, two large studies evaluating WCDs were published. However, the results of older and newer studies have yet to be systematically summarized. The objective of the current study was to conduct a meta-analysis assessing the use and effectiveness of WCDs. We searched MEDLINE and Scopus (January 1998-July 2017) as well as the gray literature. We included registry/observational studies that (1) evaluated adult patients using WCDs; (2) provided data on one or more outcomes of interest; and (3) were full-text studies published in English. We calculated pooled incidence and/ or rate [with 95% confidence intervals (CIs)] estimates from nonoverlapping populations using a random-effects meta-analysis model. Statistical heterogeneity was assessed via the I 2 statistic. We identified 11 studies (19,882 patients) with nonoverlapping populations/endpoints; seven of them evaluated WCD use across various indications, while the remaining studies restricted their focus to a single indication. Most of the studies were retrospective (82%) and multicenter (64%) in nature, with 45% using manufacturers' registry data. The median duration of WCD use was three or more months in nine (82%) studies, and daily wear time ranged from a mean/median of 17 hours to 24 hours per day across included studies. Seven (64%) studies reported a mean/median daily wear time of more than 20 hours. This meta-analysis showed that the incidences of all-cause and SCD-related mortality among WCD patients were 1.4% (95% CI: 0.7%-2.4%) and 0.2% (95% CI: 0.1%-0.3%), respectively. VT/VF occurred in 2.6% (95% CI: 1.8%-3.5%) of patients. Across patients, 1.7% (95% CI: 1.4%-2.0%) received appropriate WCD treatment, corresponding to a rate of 9.1 patients/100 person-years (95% CI: 6.2-11.9 patients/100 person-years). Successful VT/VF termination following appropriate treatment occurred in 95.5% of patients (95% CI: 92.0%-98.0%) and the incidence of inappropriate treatment was infrequent (0.9%; 95% CI: 0.5%-1.4%). A moderate-to-high degree of statistical heterogeneity was observed in pooled analyses of mortality, VT/ VF occurrence, and appropriate/inappropriate treatment (I 2 ≥ 41% for all). In conclusion, WCDs appear to be successful in terms of terminating VT/VF in patients with an elevated risk of SCD and are appropriate for use while long-term risk management strategies are being identified.

show abstract

Section: Resultsmentioning

confidence: 99%

Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis

Nguyen

Weeda

Kohn

et al. 2018

J Innov Cardiac Rhythm Manage

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…According to our selection criteria, no randomized controlled trials (RCTs) or non-randomized controlled trials assessing the clinical effectiveness of the WCD were found. For the assessment of safety, one prospective interventional single-arm study, 20 two prospective case series, 21 , 22 and two prospective registry studies 23 , 24 fulfilled our inclusion criteria.…”

Section: Resultsmentioning

confidence: 99%

“…A total of five non-comparative studies were included in the assessment of safety of the WCD: the prospective interventional single-arm study 20 included 289 patients, two prospective case series included a total of 36 patients, 21 , 22 and two prospective registry studies included a total of 2089 patients 23 , 24 ( Table 3 ).…”

Section: Resultsmentioning

confidence: 99%

Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study

Ettinger

Stanak

Szymański

et al. 2017

MDER

View full text Add to dashboard Cite

AimTo summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk.MethodsWe performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment. Primary outcomes for the clinical effectiveness domain were all-cause and disease-specific mortality. Outcomes for the safety domain were adverse events (AEs) and serious adverse events (SAEs). A focus group with cardiac disease patients was conducted to evaluate ethical, organizational, patient, social, and legal aspects of the WCD use.ResultsNo randomized- or non-randomized controlled trials were identified. Non-comparative studies (n=5) reported AEs including skin rash/itching (6%), false alarms (14%), and palpitations/light-headedness/fainting (9%) and discontinuation due to comfort/lifestyle issues (16–22%), and SAEs including inappropriate shocks (0–2%), unsuccessful shocks (0–0.7%), and death (0–0.3%). The focus group results reported that experiencing a sense of security is crucial to patients and that the WCD is not considered an option for weeks or even months due to expected restrictions in living a “normal” life.ConclusionThe WCD appears to be relatively safe for short-to-medium term, but the quality of existing evidence is very low. AEs and SAEs need to be more appropriately reported in order to further evaluate the safety of the device. High-quality comparative evidence and well-described disease groups are required to assess the effectiveness of the WCD and to determine which patient groups may benefit most from the intervention.

show abstract

Usefulness of the wearable cardioverter defibrillator in patients in the early post‐myocardial infarction phase with high risk of sudden cardiac death: A single‐center European experience

Abstract: Early post-MI patients at high risk of sudden cardiac death may benefit from WCD therapy.

Cited by 18 publications

References 16 publications

Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis

Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis

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

Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study

Contact Info

Product

Resources

About