University of Oulu

Markus Zabel, Rik Willems, Andrzej Lubinski, Axel Bauer, Josep Brugada, David Conen, Panagiota Flevari, Gerd Hasenfuß, Martin Svetlosak, Heikki V Huikuri, Marek Malik, Nikola Pavlović, Georg Schmidt, Rajevaa Sritharan, Simon Schlögl, Janko Szavits-Nossan, Vassil Traykov, Anton E Tuinenburg, Stefan N Willich, Markus Harden, Tim Friede, Jesper Hastrup Svendsen, Christian Sticherling, Béla Merkely, EU-CERT-ICD Study Investigators, Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study, European Heart Journal, Volume 41, Issue 36, 21 September 2020, Pages 3437–3447, https://doi.org/10.1093/eurheartj/ehaa226

Clinical effectiveness of primary prevention implantable cardioverter-defibrillators : results of the EU-CERT-ICD controlled multicentre cohort study

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Author: Zabel, Markus1,2; Willems, Rik3; Lubinski, Andrzej4;
Organizations: 1Department of Cardiology and Pneumology, Heart Center, University Medical Center Göttingen, Robert-Koch-Strasse 40, 37075 Göttingen, Germany
2DZHK (German Center for Cardiovascular Research), Partner Site Göttingen, Robert-Koch-Str. 42a, 37075 Göttingen, Germany
3Department of Cardiovascular Sciences, University Hospitals of Leuven, Herestraat 49, 3000 Leuven, Belgium
4Department of Cardiology, Medical University of Lodz (MUL) WAM Hospital, ul. Żeromskiego 113, 90-549 Lodz, Poland
5Department of Cardiology, Ludwig-Maximilians-Universität Munich, Klinikum Großhadern, Marchioninistr. 19, 81377 München, Germany
6DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Biedersteiner Str. 29, 80802 München, Germany
7Department of Cardiology, IDIBAPS, Hospital Clinic Barcelona, Carrer de Villaroel, 08036 Barcelona, Spain
8Department of Cardiology, University Hospital Basel, University of Basel, Spitalstr. 21, 4031 Basel, Switzerland
9Department of Medicine, Population Health Research Institute, McMaster University, 237 Barton Street East, Hamilton, ON LBL 2X2, Canada
102 Department of Cardiology, Attikon University Hospital, Rimini 1, Chaidari, 12462 Athens, Greece
11Department of Cardiology and Angiology, Slovak Medical University NUSCH, Pod Krasnou horkou 7185, 83101 Nove Mesto, Bratislava, Slovakia
12Department of Internal Medicine, Medical Research Center, Oulu University Hospital, University of Oulu, PO Box 8000, 90570 Oulu, Finland
13National Heart and Lung Institute, Imperial College, Dovehouse Street, London SW36LY, UK
14Department of Cardiology, KBC Sestre Milosrdnice, Vinogradska Cesta 29, 10000 Zagreb, Croatia
15Med. Klinik und Poliklinik I, Technische Universität München, Klinikum rechts der Isar, Ismaninger Str. 22, 81675 München, Germany
16Department of Cardiology, Magdalena Klinika, Ul. Ljudevita Gaja 9, 49217 Krapinske Toplice, Croatia
17Department of Cardiology, Acibadem City Clinic Tokuda Hospital, bul. "Nikola Y. Vaptsarov" 51Б, 1407 Sofia, Bulgaria
18Department of Cardiology, University Medical Center Utrecht, Heidelberglaan 100, 3584CX Utrecht, Netherlands
19Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Schumannstr. 20/21, 10117 Berlin, Germany
20Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, 37073 Göttingen, Germany
21Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 København, Copenhagen, Denmark
22Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Copenhagen, Denmark
23Heart and Vascular Center, Semmelweis University Heart Center, Gaál József út 9, 1122 Budapest, Hungary
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1.7 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe202101252618
Language: English
Published: Oxford University Press, 2020
Publish Date: 2021-01-25
Description:

Abstract

Aims: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy.

Methods and results: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902).

Conclusion: In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.

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Series: European heart journal
ISSN: 0195-668X
ISSN-E: 1522-9645
ISSN-L: 0195-668X
Volume: 41
Issue: 36
Pages: 3437 - 3447
DOI: 10.1093/eurheartj/ehaa226
OADOI: https://oadoi.org/10.1093/eurheartj/ehaa226
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Subjects:
Funding: This work was supported by the European Community's Seventh Framework Programme FP7/2007-2013 (grant agreement no. HEALTH-F2-2009-602299) for 5 years (starting 1 October 2013).
Copyright information: © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
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