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Observational Study
. 2021 Jan;110(1):102-113.
doi: 10.1007/s00392-020-01657-2. Epub 2020 May 6.

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry

Christian Veltmann  1 , Stefan Winter  2 , David Duncker  3 , Carsten G Jungbauer  4 , Nadine K Wäßnig  5 , J Christoph Geller  6   7 , Julia W Erath  8 , Olaf Goeing  9 , Christian Perings  10 , Michael Ulbrich  11 , Mattias Roser  12 , Daniela Husser  13 , Laura S Gansera  14 , Korkut Soezener  15 , Frank Michael Malur  16 , Michael Block  17 , Thomas Fetsch  18 , Valentina Kutyifa  19 , Helmut U Klein  19
Affiliations
Observational Study

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry

Christian Veltmann et al. Clin Res Cardiol. 2021 Jan.

Erratum in

Abstract

Background: The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death.

Methods and results: 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown.

Conclusions: Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.

Keywords: Heart failure; Implantable cardioverter-defibrillator; Sudden cardiac death; Wearable cardioverter-defibrillator.

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Conflict of interest statement

D. Duncker received lecture honorary, travel support, and/or a fellowship grant from Biotronik, Boehringer Ingelheim, Boston Scientific, Medtronic, Sorin/LivaNova, St. Jude Medical/Abbott, Zoll. J. W. Erath reports receiving travel support and lecture fees from ZOLL Medical and Servier and is a fellow of the Boston Scientific heart rhythm fellowship program, J. C. Geller is a consultant for St. Jude Medical, Biosense Webster, Boston Scientific, Medtronic, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo and Pfizer, and has received speaker fees from St. Jude Medical, Boston Scientific, Medtronic, Biotronik, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Novartis, Pfizer, Sanofi Aventis and Zoll. O. Göing received lecture honoraria from Zoll. H.U. Klein received research grants, travel support and lecture honoraria from ZOLL-Lifecor Medical Corp. (Pittsburgh, PA, USA); consulting fees and lecture honoraria from Boston Scientific. V. Kutyifa received research grants and consulting fees from ZOLL-Lifecor Medical Corp (Pittsburgh, PA, USA and Boston-scientific, F. M, Malur received lecture fees and travel support from ZOLL CMS-Germany and consulting fees and travel support from Boehringer-Ingelheim Germany, C. Veltmann received received lecture honoraria, travel support, consulting fees and research grant from Biotronik, BMS, Boehringer Ingelheim, Boston Scientific, CVRx, Daiichi Sankyo, Medtronic, St. Jude Medical/Abbott, Zoll. N. K. Wäßnig received lecture honoraria from Bayer Vital GmbH, Novartis and ZOLL-CMS, Germany, S. Winter received lecture fees from ZOLL-CMS Germany, Medtronic and Biotronik. M. Roser received grants from CRI during the conduct of the study; grants and personal fees from Biotronik, personal fees from Boston Scientific, personal fees from St. Jude Medical/Abbott, personal fees from ZOLL CMS, personal fees from Bayer Healthcare, personal fees and non-financial support from Berlin Chemie, personal fees from Boehringer Ingelheim, personal fees from Medtronic, outside the submitted work. M. Block received lecture honorary and travel support from ZOLL. C. Perings received lecture honorary from ZOLL. The remaining authors did not declare any potential conflict of interests.

Figures

Fig. 1
Fig. 1
Flow chart of the WEARIT-II-EUROPE registry
Fig. 2
Fig. 2
Cumulative survival according to LVEF development during WCD prescription
Fig. 3
Fig. 3
Mode of death according to ICD status
Fig. 4
Fig. 4
Cumulative survival according to ICD implantation following WCD prescription
Fig. 5
Fig. 5
Distribution of LVEF at baseline (a) and at the end of Phase 1 (b) after initiation and optimization of guideline-directed heart failure medication during WCD prescription
See this image and copyright information in PMC

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