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

Abstract

Aim

To 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.

Methods

We 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.

Results

No 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.

Conclusion

The 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.

Keywords:

• sudden cardiac arrest
• ventricular tachycardia
• ventricular fibrillation
• cardioverter defibrillator
• external
• wearable
• patient involvement

Acknowledgments

The authors would like to acknowledge the European Society of Cardiology (ESC). The collaboration with clinical societies, such as the ESC, is highly appreciated to ensure latest professional expertise in the field, to spread, and to disseminate the results. The authors thank Dr. Josef Kautzner for his comments on a draft version of the manuscript. The authors thank Prof. Dr. Diana Delić-Brkljačić and Dr. Olaf Weingart for serving as external experts in the EUnetHTA rapid REA of the WCD. Furthermore, the authors are grateful to Dr. Leonor Varela Lema, Janet Puñal Riobóo, Dr. Sebastian Grümer, and Dr. Stefan Sauerland for the review of the draft EUnetHTA rapid REA report. This work was supported by the European Commission in the framework of the 3rd EU Health Program, which funded the EUnetHTA Joint Action 3 (Grant Agreement No. 724130). Sole responsibility for its contents lies with the author(s), and neither the EUnetHTA nor the European Commission is responsible for any use that may be made of the information contained therein. Since 2006, the EUnetHTA projects aim at sustainably stimulating European collaboration and international information transfer in the field of HTA: in one EU project (EUnetHTA 2006–2008) and 2 Joint Actions (Joint Action 1 2010–2012 and Joint Action 2 2012–2015) involving around 70 HTA organizations from the EU and EFTA countries, processes and tools to reduce redundancies in EU-wide HTA production were developed. In Joint Action 3 (2016–2020), the aim is to support optional collaboration at scientific and technical level between HTA bodies to validate the model for joint work which should be continued after the Joint Action 3.

Disclosure

The authors report no conflicts of interest in this work.