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Sabine Ettinger,1 Michal Stanak,1 Piotr Szymański,2 Claudia Wild,1 Romana Tandara Haček,3 Darija Erčević,3 Renata Grenković,3 Gregor Goetz,1 Mirjana Huić3 1Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; 2Institute of Cardiology, Warsaw, Poland; 3Department for Development, Research, and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaAlthough we clearly outlined our answers in our previous letter,1 we are pleased to clarify further any remaining open issues. There might be diverse views with regard to comparators of the wearable cardioverter defibrillator (WCD). We would like to refer the readers to our previous answer,1 where we explained our rationale for choosing the implantable cardioverter defibrillator as one of the comparators. It was selected based on broad indications stated in the CE mark and after discussions with clinicians. Furthermore, in this case, a change of the comparator, ie, the implantable cardioverter defibrillator, would not have led to a different result or conclusion.View the original paper by Ettinger and colleagues.Two previous letters have been published Sperzel et al Sperzel et al

Sabine Ettinger,1 Michal Stanak,1 Piotr Szymański,2 Claudia Wild,1 Romana Tandara Haček,3 Darija Erčević,3 Renata Grenković,3 Mirjana Huić3 1Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; 2Institute of Cardiology, Warsaw, Poland; 3Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia 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