Comments on the authors’ reply to the critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study”

Medical Devices : Evidence and Research, Oct 2018

Comments on the authors’ reply to the critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study” Johannes Sperzel,1 Ingo Staudacher,2 Olaf Goeing,3 Martin Stockburger,4 Thorsten Meyer,5 Ana Sofia Oliveira Gonçalves,6 Hanna Sydow,6 Tonio Schoenfelder,6 Volker Amelung6 1Department of Cardiology, Hospital Kerckhoff Klinik GmbH, Bad Nauheim, Germany; 2Department of Cardiology, Medical University Hospital Heidelberg, Heidelberg, Germany; 3Department of Cardiology, Sana-Hospital Lichtenberg, Berlin, Germany; 4Medical Department I, Havelland Kliniken GmbH, Nauen, Germany; 5Department of Public Health, Universität Bielefeld, Bielefeld, Germany; 6inav – privates Institut für angewandte Versorgungsforschung GmbH, Berlin, GermanySince the authors’ reply to our critical appraisal did not properly address the points we raised, we still see need for further clarification. The wearable cardioverter defibrillator (WCD) is not an adequate substitute for an implantable cardioverter defibrillator (ICD). The authors state that both can be compared immediately post-myocardial infarction (MI). According to the current guidelines, primary prevention of sudden cardiac death with the ICD within 40 days after MI is generally not indicated.1 Therefore, we disagree with the authors’ proposal of conducting such a trial. In this context, the authors mentioned the VEST trial, which compares a WCD population and one receiving medical treatment. There is explicitly no comparison to an ICD population.View the original paper by Sperzel and colleagues.

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Comments on the authors’ reply to the critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study”

Comments on the authors' reply to the critical appraisal concerning ?Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study? Johannes Sperzel 0 Ingo Staudacher 1 0 Department of Cardiology, Hospital Kerckhoff Klinik GmbH , Bad Nauheim , Germany 1 Department of Cardiology, Medical University Hospital Heidelberg , Heidelberg , Germany 2 Department of Cardiology, Sana-Hospital Lichtenberg , Berlin , Germany 3 Medical Department I, Havelland Kliniken GmbH , Nauen , Germany 4 Department of Public Health, Universita?t Bielefeld , Bielefeld , Germany 5 inav - privates Institut fu?r angewandte Versorgungsforschung GmbH , Berlin , Germany PowerdbyTCPDF(ww.tcpdf.org) submit your manuscript | www.dovepress.com Dovepress Since the authors' reply to our critical appraisal did not properly address the points we raised, we still see need for further clarification. The wearable cardioverter defibrillator (WCD) is not an adequate substitute for an implantable cardioverter defibrillator (ICD). The authors state that both can be compared immediately post-myocardial infarction (MI). According to the current guidelines, primary prevention of sudden cardiac death with the ICD within 40 days after MI is generally not indicated.1 Therefore, we disagree with the authors' proposal of conducting such a trial. In this context, the authors mentioned the VEST trial, which compares a WCD population and one receiving medical treatment. There is explicitly no comparison to an ICD population. - open access to scientific and medical research Olaf Goeing 3 Martin Stockburger4 thorsten Meyer 5 Ana Sofia Oliveira Gon?alves6 Hanna Sydow6 Tonio Schoenfelder 6 Volker Amelung6 8 1 0 2 c e D 1 2 n o 5 0 2 . 7 . 8 6 . 1 5 y b / m o c . s s e r p e v o d Sperzel et al large registry studies, which they have excluded. Contrary by Havelland Kliniken GmbH, and Thorsten Meyer is to their study methodology, the EUnetHTA guidelines for employed by Universit?t Bielefeld; none of these authors safety recommend to evaluate a broad range of studies to received financial support for contributing to the writing obtain an exhaustive assessment of adverse reactions with of this letter. Ana Sofia Oliveira Gon?alves, Hanna Sydow, wider generalizability.4 Tonio Schoenfelder, and Volker Amelung are employed by The focus group does not fulfill the criteria of a properly inav ? privates Institut f?r angewandte Versorgungsforscconducted qualitative study. There is a lack of a theoretically hung GmbH [inav ? Institute for Applied Health Services justified sampling strategy that could allow for drawing subResearch GmbH]; these four authors received financial stantial conclusions. In particular, the general idea of saturation support from Zoll GmbH for contributing to the writing of in qualitative research has not been taken into consideration this letter. The authors report no other conflicts of interest by the authors: only one focus group was conducted consistin this communication. ing of only five participants, no women were included, and none of the participants had any experience in using a WCD. However, the benefit of a WCD should be judged by a less selected patient population having experiences in using such a device. Thus, we conclude that the authors? approach does not fulfill the intended purpose of conducting a qualitative study. ./www l.yno interview, which does not constitute a HTA. The authors? This study combined a systematic review with a group conclusions are not supported by their findings, and therefore, should be interpreted with caution. Disclosure Johannes Sperzel is employed by Hospital Kerckhoff Klinik GmbH, Ingo Staudacher is employed by Medical University Hospital Heidelberg, Olaf Goeing is employed by SanaHospital Lichtenberg, Martin Stockburger is employed 119?177. 244?258. Dove Medical Press encourages responsible, free and frank academic debate. The content of the Medical Devices: Evidence and Research ?letters to the editor? section does not necessarily represent the views of Dove Medical Press, its officers, agents, employees, related entities or the Medical Devices: Evidence and Research editors. While all reasonable steps have been taken to confirm the content of each letter, Dove Medical Press accepts no liability in respect of the content of any letter, nor is it responsible for the content and accuracy of any letter to the editor Publish your work in this journal Medical Devices: Evidence and Research is an international, peerreviewed, open access journal that focuses on the evidence, technology, research, and expert opinion supporting the use and application of medical devices in the diagnosis, monitoring, treatment and management of clinical conditions and physiological processes.The identification of novel 1. Ibanez B , James S , Agewall S , et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients (...truncated)


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Johannes Sperzel, Ingo Staudacher, Olaf Goeing, Martin Stockburger, Thorsten Meyer, Ana Sofia Oliveira Gonçalves, Hanna Sydow, Tonio Schoenfelder, Volker Amelung. Comments on the authors’ reply to the critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study”, Medical Devices : Evidence and Research, 2018, pp. 377-378, DOI: 10.2147/MDER.S181474