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Effectiveness, efficacy, and safety of wearable cardioverter-defibrillators in the treatment of sudden cardiac arrest – Results from a health technology assessment

Published online by Cambridge University Press:  30 June 2020

Pamela Aidelsburger Open the ORCID record for Pamela Aidelsburger [Opens in a new window] ,
Janine Seyed-Ghaemi ,
Christian Guinin  and
Andreas Fach
Pamela Aidelsburger*
Affiliation:
CAREM GmbH, Königsdorf, Germany
Janine Seyed-Ghaemi
Affiliation:
CAREM GmbH, Königsdorf, Germany
Christian Guinin
Affiliation:
CAREM GmbH, Königsdorf, Germany
Andreas Fach
Affiliation:
Klinikum Links der Weser, Bremen, Germany
*
Author for correspondence: Dr. med. Pamela Aidelsburger, Dorfstraße 32, 82549 Königsdorf, Deutschland, Tel: 0049-151-58557035, E-mail: p.aidelsburger@carem.de
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Abstract

Objectives

To assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable.

Methods

We performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed.

Results

One randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43–.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37–1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD.

Conclusions

Available evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.

Keywords

Wearable cardioverter defibrillatorExternal defibrillatorSudden cardiac arrestVentricular tachycardiaVentricular fibrillation
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 36 , Issue 4 , August 2020 , pp. 363 - 371
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

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References

Martens, E, Sinner, MF, Siebermair, J, Raufhake, C, Beckmann, BM, Veith, S. Incidence of sudden cardiac death in Germany: Results from an emergency medical service registry in Lower Saxony. Europace. 2014;16:1752–58.CrossRefGoogle ScholarPubMed
Sasson, C, Rogers, MA, Dahl, J, Kellermann, AL. Predictors of survival from out-of-hospital cardiac arrest: A systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010;3:63–81.10.1161/CIRCOUTCOMES.109.889576CrossRefGoogle ScholarPubMed
Nolan, JP, Soar, J, Zideman, DA, Biarent, D, Bossaert, LL, Deakin, C. European resuscitation council guidelines for resuscitation 2010 section 1. Executive summary. Resuscitation. 2010;81:1219–76.CrossRefGoogle ScholarPubMed
Klein, HU, Meltendorf, U, Reek, S, Smid, J, Kuss, S, Cygankiewicz, I, et al. Bridging a temporary high risk of sudden arrhythmic death. Experience with the wearable cardioverter defibrillator (WCD). Pacing Clin Electrophysiol. 2010;33:353–67.CrossRefGoogle Scholar
Piccini, JP, Allen, LA, Kudenchuk, PJ, Page, RL, Patel, MR, Turakhia, MP. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: A science advisory from the American heart association. Circulation. 2016;133:1715–27.CrossRefGoogle ScholarPubMed
Al-Khatib, SM, Stevenson, WG, Ackerman, MJ, Bryant, WJ, Callans, DJ, Curtis, AB, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Circulation. 2018;138:e272–391.Google ScholarPubMed
Olgin, JE, Pletcher, MJ, Vittinghoff, E, Wranicz, J, Malik, R, Morin, DP, et al. Wearable cardioverter-defibrillator after myocardial infarction. N Engl J Med. 2018;379:1205–15.CrossRefGoogle ScholarPubMed
Ludwig Boltzman-Institut. Methodenhandbuch für Health Technology Assessment Version 1.2012. Wien: Gesundheit Österreich GmbH; 2012. Available from: https://hta.lbg.ac.at/uploads/tableTool/UllCmsPage/gallery/Methodenhandbuch.pdfGoogle Scholar
Perleth, M, Busse, R, Gerhardus, A, Gibis, B, Lühmann, D, Zentner, A. Health technology assessment. Berlin: Medizinisch Wissenschaftliche Verlagsgesellschaft; 2014.Google Scholar
Moga, C, Guo, B, Schopflocher, D, Harstall, C. Development of a quality appraisal tool for case series studies using a modified Delphi technique. Edmonton, AB: Institute of Health Economics; 2012.Google Scholar
Zishiri, ET, Williams, S, Cronin, EM, Blackstone, EH, Ellis, SG, Roselli, EE, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013;6:117–28.CrossRefGoogle ScholarPubMed
Barraud, J, Pinon, P, Laine, M, Cautela, J, Orabona, M, Koutbi, L, et al. Ventricular arrhythmia occurrence and compliance in patients treated with the wearable cardioverter defibrillator following percutaneous coronary intervention. Heart Lung Circ. 2018;27:984–88.CrossRefGoogle ScholarPubMed
Barsheshet, A, Kutyifa, V, Vamvouris, T, Moss, AJ, Biton, Y, Chen, L, et al. Study of the wearable cardioverter defibrillator in advanced heart-failure patients (SWIFT). J Cardiovasc Electrophysiol. 2017;28:778–84.CrossRefGoogle Scholar
Bhaskaran, A, Bartlett, M, Kovoor, P, Davis, LM. The wearable cardioverter defibrillator: An early single centre Australian experience. Some pitfalls and caveats for use. Heart Lung Circ. 2016;25:155–59.CrossRefGoogle ScholarPubMed
Daimee, UA, Vermilye, K, Moss, AJ, Goldenberg, I, Klein, HU, McNitt, S, et al. Experience with the wearable cardioverter-defibrillator in older patients: Results from the prospective registry of patients using the wearable cardioverter-defibrillator. Heart Rhythm. 2018;15:1379–86.CrossRefGoogle ScholarPubMed
Erath, JW, Vamos, M, Sirat, AS, Hohnloser, SH. The wearable cardioverter-defibrillator in a real-world clinical setting: Experience in 102 consecutive patients. Clin Res Cardiol. 2017;106:300–06.CrossRefGoogle Scholar
Erath, JW, Vamos, M, Benz, AP, Hohnloser, SH. Usefulness of the WCD in patients with suspected tachymyopathy. Clin Res Cardiol. 2018;107:70–75.CrossRefGoogle ScholarPubMed
Feldman, AM, Klein, H, Tchou, P, Murali, S, Hall, WJ, Mancini, D, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: Results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. 2004;27:4–9.CrossRefGoogle ScholarPubMed
Kao, AC, Krause, SW, Handa, R, Murali, S, Hall, WJ, Mancini, D, et al. Wearable defibrillator use in heart failure (WIF): Results of a prospective registry. BMC Cardiovasc Disord. 2012;12:123.CrossRefGoogle ScholarPubMed
Kondo, Y, Linhart, M, Andrié, RP, Schwab, JO. Usefulness of the wearable cardioverter defibrillator in patients in the early post-myocardial infarction phase with high risk of sudden cardiac death: A single-center European experience. J Arrhythmia. 2015;31:293–95.CrossRefGoogle ScholarPubMed
Kutyifa, V, Moss, AJ, Klein, H, Biton, Y, McNitt, S, MacKecknie, B, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: Data from the prospective registry of patients using the wearable cardioverter defibrillator (WEARIT-II Registry). Circulation. 2015;132:1613–19.CrossRefGoogle Scholar
Kutyifa, V, Vermilye, K, Daimee, UA, McNitt, S, Klein, H, Moss, AJ. Extended use of the wearable cardioverter-defibrillator in patients at risk for sudden cardiac death. Europace. 2018b;20:f225–32.CrossRefGoogle Scholar
Mitrani, RD, McArdle, A, Slane, M, Cogan, J, Myerburg, RJ. Wearable defibrillators in uninsured patients with newly diagnosed cardiomyopathy or recent revascularization in a community medical center. Am Heart J. 2013;165:386–92.CrossRefGoogle ScholarPubMed
Odeneg, T, Ebner, C, Mörtl, D, Keller, H, Dirninger, A, Stix, G, et al. Indications for and outcome in patients with the wearable cardioverter-defibrillator in a nurse-based training programme: Results of the Austrian WCD registry. Eur J Cardiovasc Nurs. 2019;18:75–83.CrossRefGoogle Scholar
Rao, M, Goldenberg, I, Moss, AJ, Klein, H, Huang, DT, Bianco, NR, et al. Wearable defibrillator in congenital structural heart disease and inherited arrhythmias. Am J Cardiol. 2011;108:1632–38.CrossRefGoogle ScholarPubMed
Röger, S, Rosenkaimer, SL, Hohneck, A, Lang, S, El-Battrawy, I, Rudic, B, et al. Therapy optimization in patients with heart failure: The role of the wearable cardioverter-defibrillator in a real-world setting. BMC Cardiovasc Disord. 2018;18:52.10.1186/s12872-018-0790-8CrossRefGoogle ScholarPubMed
Sasaki, S, Shoji, Y, Ishida, Y, Kinjo, T, Tsushima, Y, Seno, M, et al. Potential roles of the wearable cardioverter-defibrillator in acute phase care of patients at high risk of sudden cardiac death: A single-center Japanese experience. J Cardiol. 2017;69:359–63.CrossRefGoogle ScholarPubMed
Beiert, T, Malotki, R, Kraemer, N, Stöckigt, F, Linhart, M, Nickenig, G, et al. A real world wearable cardioverter defibrillator experience—very high appropriate shock rate in ischemic cardiomyopathy patients at a European single-center. J Electrocard. 2017;50:603–09.CrossRefGoogle Scholar
Castro, L, Pecha, S, Linder, M, Vogler, J, Gosau, N, Meyer, C, et al. The wearable cardioverter defibrillator as a bridge to reimplantation in patients with ICD or CRT-D-related infections. J Cardiothorac Surg. 2017;12:99.CrossRefGoogle ScholarPubMed
Christ, M, Grett, M, Breker, IM, Panic, L, Von Auenmüller, KI, Dierschke, W, et al. Patient compliance with wearable cardioverter defibrillators. Kardiologe. 2014;8:161–67.CrossRefGoogle Scholar
Chung, MK, Szymkiewicz, SJ, Shao, M, Zishiri, E, Niebauer, MJ, Lindsay, BD, et al. Aggregate national experience with the wearable cardioverter-defibrillator: Event rates, compliance, and survival. J Am Coll Cardiol. 2010;56:194–203.CrossRefGoogle Scholar
Dillon, KA, Szymkiewicz, SJ, Kaib, TE. Evaluation of the effectiveness of a wearable cardioverter defibrillator detection algorithm. J Electrocard. 2010;43:63–67.CrossRefGoogle ScholarPubMed
Duncker, D, Haghikia, A, König, T, Hohmann, S, Gutleben, K-J, Westenfeld, R, et al. Risk for ventricular fibrillation in peripartum cardiomyopathy with severely reduced left ventricular function-value of the wearable cardioverter/defibrillator. Eur J Heart Fail. 2014;16:1331–36.CrossRefGoogle ScholarPubMed
Duncker, D, König, T, Hohmann, S, Bauersachs, J, Veltmann, C. Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study. Clin Cardiol. 2017a;40:586–90.CrossRefGoogle Scholar
Duncker, D, König, T, Hohmann, S, Bauersachs, J, Veltmann, C. Avoiding untimely implantable cardioverter/defibrillator implantation by intensified heart failure therapy optimization supported by the wearable cardioverter/defibrillator-the PROLONG study. J Am Heart Assoc. 2017b;6:e004512.CrossRefGoogle Scholar
Duncker, D, Westenfeld, R, Konrad, T, Pfeffer, T, de Freitas CA, Correia, Pfister, R, et al. Risk for life-threatening arrhythmia in newly diagnosed peripartum cardiomyopathy with low ejection fraction: A German multi-centre analysis. Clin Res Cardiol. 2017c;106:582–89.CrossRefGoogle Scholar
Ellenbogen, KA, Koneru, JN, Sharma, PS. Benefit of the wearable cardioverter-defibrillator in protecting patients after implantable-cardioverter defibrillator explant: Results from the national registry. JACC Clin Electrophysiol. 2017;3:243–50.CrossRefGoogle ScholarPubMed
Ellenbogen, KA, Wan, C, Shavelle, DM. Outcome of patients with in-hospital ventricular tachycardia and ventricular fibrillation arrest while using a wearable cardioverter defibrillator. Am J Cardiol. 2018;121:205–09.CrossRefGoogle ScholarPubMed
Epstein, AE, Abraham, WT, Bianco, NR, Kern, KB, Mirro, M, Rao, SV, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013;62:2000–007.CrossRefGoogle ScholarPubMed
Everitt, MD, Verma, A, Saarel, EV. The wearable external cardiac defibrillator for cancer patients at risk for sudden cardiac death. Commun Oncol 2011;8:400–03.CrossRefGoogle Scholar
Heimeshoff, J, Merz, C, Ricklefs, M, Kirchhoff, F, Haverich, A, Bara, C, et al. Wearable cardioverter-defibrillators following cardiac surgery—A single-center experience. Thorac Cardiovasc Surg. 2019;67:92–97.Google ScholarPubMed
Kandzari, DE, Perumal, R, Bhatt, DL. Frequency and implications of ischemia prior to ventricular tachyarrhythmia in patients treated with a wearable cardioverter defibrillator following myocardial infarction. Clin Cardiol. 2016;39:399–405.CrossRefGoogle ScholarPubMed
Kaspar, G, Sanam, K, Gholkar, G, Bianco, NR, Szymkiewicz, S, Shah, D. Long-term use of the wearable cardioverter defibrillator in patients with explanted ICD. Int J Cardiol. 2018;272:179–84.CrossRefGoogle ScholarPubMed
Lackermair, K, Schuhmann, CG, Kubieniec, M, Riesinger, LM, Klier, I, Stocker, TJ, et al. Impairment of quality of life among patients with wearable cardioverter defibrillator therapy (LifeVest®): A preliminary study. BioMed Res Int. 2018;2018:6028494.CrossRefGoogle ScholarPubMed
Lamichhane, M, Gardiner, JC, Bianco, NR, Szymkiewicz, SJ, Thakur, RK. National experience with long-term use of the wearable cardioverter defibrillator in patients with cardiomyopathy. J Interv Card Electrophysiol. 2017;48:11–19.CrossRefGoogle ScholarPubMed
Opreanu, M, Wan, C, Singh, V, Salehi, N, Ahmad, J, Szymkiewicz, S, et al. Wearable cardioverter-defibrillator as a bridge to cardiac transplantation: A national database analysis. J Heart Lung Transplant. 2015;34:1305–309.CrossRefGoogle ScholarPubMed
Reek, S, Meltendorf, U, Geller, JC, Wollbrück, A, Grund, S, Klein, HU. The wearable cardioverter defibrillator (WCD) for the prevention of sudden cardiac death—A single center experience. Z Kardiol. 2002;91:1044–52.CrossRefGoogle ScholarPubMed
Salehi, N, Nasiri, M, Bianco, NR, Opreanu, M, Singh, V, Satija, V, et al. The wearable cardioverter defibrillator in nonischemic cardiomyopathy: A US national database analysis. Can J Cardiol. 2016;32:1247.e1–e6.CrossRefGoogle ScholarPubMed
Saltzberg, MT, Szymkiewicz, S, Bianco, NR. Characteristics and outcomes of peripartum versus nonperipartum cardiomyopathy in women using a wearable cardiac defibrillator. J Card Fail. 2012;18:21–27.CrossRefGoogle ScholarPubMed
Skowasch, D, Ringquist, S, Nickenig, G, Andrié, R. Management of sudden cardiac death in cardiac sarcoidosis using the wearable cardioverter defibrillator. PLoS ONE. 2018;13:e0194496.CrossRefGoogle ScholarPubMed
Wäßnig, NK, Günther, M, Quick, S, Pfluecke, C, Rottstädt, F, Szymkiewicz, SJ, et al. Experience With the wearable cardioverter-defibrillator in patients at high risk for sudden cardiac death. Circulation. 2016;134:635–43.CrossRefGoogle ScholarPubMed
Wan, C, Herzog, CA, Zareba, W, Szymkiewicz, SJ. Sudden cardiac arrest in hemodialysis patients with wearable cardioverter defibrillator. Ann Noninvasive Electrocardiol. 2014;19:247–57.CrossRefGoogle ScholarPubMed
Wan, C, Szymkiewicz, SJ, Klein, HU. The impact of body mass index on the wearable cardioverter defibrillator shock efficacy and patient wear time. Am Heart J. 2017;186:111–17.CrossRefGoogle ScholarPubMed
Zylla, MM, Hillmann, HAK, Proctor, Kieser M, Scholz, E, Zitron, E, et al. Use of the wearable cardioverter-defibrillator (WCD) and WCD-based remote rhythm monitoring in a real-life patient cohort. Heart Vessels. 2018;33:1390–402.CrossRefGoogle Scholar
Ettinger, S, Stanak, M, Huic, M, Hacek, RT, Ercevic, D, Grenkovic, R. (2016) Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. Available from: https://www.eunethta.eu/wp-content/uploads/2018/01/Assessment_WCD_final.pdfGoogle Scholar
Ettinger, S, Stanak, M, Szymański, P, Wild, C, Haček, RT, Erčević, D, et al. Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: A health technology assessment and patient focus group study. Med Devices. 2017;14:257–71.CrossRefGoogle Scholar
Nguyen, E, Weeda, E, Kohn, C, D'Souza, Russo BM, Noreika, S, et al. Wearable cardioverter-defibrillators for the prevention of sudden cardiac death: A meta-analysis. J Innov Card Rhythm Manag. 2018;9:1–12.Google ScholarPubMed
Uyei, J, Braithwaite, RS. Effectiveness of wearable defibrillators: Systematic review and quality of evidence. Int J Technol Assess Health Care. 2014;30:194–202.CrossRefGoogle ScholarPubMed
Sperzel, J, Staudacher, I, Goeing, O, Stockburger, M, Meyer, T, Oliveira, AS, et al. Critical appraisal concerning “wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: A health technology assessment and patient focus group study”. Med Devices (Auckl). 2018;11:201–04.Google Scholar
Maceira-Rozas, MC, Puñal Riobóo, J, Varela Lema, L (2018) Chaleco desfibrilador externo LifeVest® para la prevención del paro cardíaco súbito. Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del SNS. Agencia Gallega para la Gestión del Conocimiento en Salud (ACIS), Unidad de Asesoramiento Científico-técnico, Avalia-t 2018. 2018.Google Scholar
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