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

Abstract

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.

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

“…We read with great interest the article “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study” by Ettinger et al 1 The authors conclude that wearable cardioverter defibrillators (WCDs) seem to be fairly safe in the short-to-medium term, but the quality of the available evidence is low. They also state that – according to their study inclusion criteria – they were not able to identify studies to assess the clinical effectiveness of the WCD.…”

“…This includes not only randomized controlled studies, but also studies with “weaker” designs should be considered and results should be discussed, taking into consideration their hierarchical importance in terms of internal validity. 2 Ettinger et al 1 decided to exclude retrospective studies, but this type of study design is not only the most often applied to evaluate the WCD’s effects, it is also the one that embodies by far the largest number of patients, such as that of Epstein et al, 3 (N=8,678), Zishiri et al, 4 (N=4,149), and Chung et al, 5 (N=3,569). Simultaneously, the authors included case series involving very few patients (Duncker et al 6 [n=7 of N=12 with WCD] and Kondo et al 7 [N=24]), making it questionable why small one-armed case series are preferred to large retrospective studies with several thousand patients.…”

European Collaboration in Health Technology Assessment (HTA): goals, methods and outcomes with specific focus on medical devices

“…So far, out of twenty EUnetHTA assessments of other technologies, eight applied any kind of patient involvement. The methods used and tested by the authoring teams of the assessments that involved patients are very diverse: focus group meetings for identifying patient-relevant endpoints [21], written feedback by individual patients on the population-indication-comparator-outcomes (PICO) or semi-structured interviews with individual patients, scoping e‑meeting for discussing PICO and collection of patient input using a modification of the HTAi Patient Group Submission template [22].…”

Health Technology Assessment on the use of the Wearable Cardioverter Defibrillator in Patients with Myocardial Infarction and with ICD Explant

“…Overall, we found documents from original researches reporting on efficacy and/or safety and/or compliance of WCD [5,7,8,11,15,17,18,20-22,25,27,30,32,36,38,39,42,47,49,50,52-5 4,57], two original researches were on CEAs using a decision model [37,41], a HTA [23], several literature reviews [6,10,12,13,16,19,26,28,29,33,43,44,48,50,55] a meta-analysis [9], and guidelines [14,35,40], recommendations [34], consensus [45,46,56] a letter to the editor [31] and an editorial [24]. Generally, the main messages reported in these publications are that the WCD shows to be beneficial in patients with appropriate indications.…”