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

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 a...

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Autores principales:	Ettinger S, Stanak M, Szymański P, Wild C, Tandara Haček R, Erčević D, Grenković R, Huić M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	sudden cardiac arrest ventricular tachycardia ventricular fibrillation (cardioverter-) defibrillator (external wearable) patient involvement Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/0f879163cb404dda8349892c1bf5e2b1
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spelling	oai:doaj.org-article:0f879163cb404dda8349892c1bf5e2b12021-12-02T07:34:19ZWearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study1179-1470https://doaj.org/article/0f879163cb404dda8349892c1bf5e2b12017-11-01T00:00:00Zhttps://www.dovepress.com/wearable-cardioverter-defibrillators-for-the-prevention-of-sudden-card-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Sabine 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 involvementEttinger SStanak MSzymański PWild CTandara Haček RErčević DGrenković RHuić MDove Medical Pressarticlesudden cardiac arrestventricular tachycardiaventricular fibrillation(cardioverter-) defibrillator (externalwearable)patient involvementMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 10, Pp 257-271 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	sudden cardiac arrest ventricular tachycardia ventricular fibrillation (cardioverter-) defibrillator (external wearable) patient involvement Medical technology R855-855.5
spellingShingle	sudden cardiac arrest ventricular tachycardia ventricular fibrillation (cardioverter-) defibrillator (external wearable) patient involvement Medical technology R855-855.5 Ettinger S Stanak M Szymański P Wild C Tandara Haček R Erčević D Grenković R Huić M Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
description	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
format	article
author	Ettinger S Stanak M Szymański P Wild C Tandara Haček R Erčević D Grenković R Huić M
author_facet	Ettinger S Stanak M Szymański P Wild C Tandara Haček R Erčević D Grenković R Huić M
author_sort	Ettinger S
title	Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
title_short	Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
title_full	Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
title_fullStr	Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
title_full_unstemmed	Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
title_sort	wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/0f879163cb404dda8349892c1bf5e2b1
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Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study

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