University of Oulu

Markus Zabel, Simon Schlögl, Andrzej Lubinski, Jesper Hastrup Svendsen, Axel Bauer, Elena Arbelo, Sandro Brusich, David Conen, Iwona Cygankiewicz, Michael Dommasch, Panagiota Flevari, Jan Galuszka, Jim Hansen, Gerd Hasenfuß, Robert Hatala, Heikki V. Huikuri, Tuomas Kenttä, Tomasz Kucejko, Helge Haarmann, Markus Harden, Svetoslav Iovev, Stefan Kääb, Gabriela Kaliska, Andreas Katsimardos, Jaroslaw D. Kasprzak, Dariusz Qavoq, Lars Lüthje, Marek Malik, Tomáš Novotný, Nikola Pavlović, Peter Perge, Christian Röver, Georg Schmidt, Tchavdar Shalganov, Rajeeva Sritharan, Martin Svetlosak, Zoltan Sallo, Janko Szavits-Nossan, Vassil Traykov, Bert Vandenberk, Vasil Velchev, Marc A. Vos, Stefan N. Willich, Tim Friede, Rik Willems, Béla Merkely, Christian Sticherling, Present criteria for prophylactic ICD implantation: Insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project, Journal of Electrocardiology, Volume 57, Supplement, 2019, Pages S34-S39, ISSN 0022-0736, https://doi.org/10.1016/j.jelectrocard.2019.09.001

Present criteria for prophylactic ICD implantation : insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project

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Author: Zabel, Markus1,2; Schloegl, Simon1; Lubinski, Andrzej3;
Organizations: 1Univ Med Ctr, Ctr Heart, Dept Cardiol & Pneumol, Gottingen, Germany.
2DZHK German Ctr Cardiovasc Res, Partner Site Gottingen, Gottingen, Germany.
3Med Univ Lodz, WAM Hosp, Dept Cardiol, Lodz, Poland.
4Copenhagen Univ Hosp, Rigshosp, Ctr Heart, Dept Cardiol, Copenhagen, Denmark.
5Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark.
6Ludwig Maximilians Univ Munchen, Klinikum Grosshadern, Dept Cardiol, Munich, Germany.
7Hosp Clin Barcelona, Dept Cardiol, IDIBAPS, Barcelona, Spain.
8KBC Rijeka, Dept Cardiovasc Dis, Rijeka, Croatia.
9Univ Basel, Univ Hosp, Basel, Switzerland.
10McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.
11Med Univ Lodz, CKD Hosp, Dept Cardiol, Lodz, Poland.
12Tech Univ Munich, Med Klin & Poliklin 1, Klinikum Rechts Isar, Munich, Germany.
13Attikon Univ Hosp, Dept Cardiol 2, Athens, Greece.
14Univ Hosp, Dept Cardiol, Olomouc, Czech Republic.
15Palacky Univ, Fac Med & Dent, Olomouc, Czech Republic.
16Gentofte Univ Hosp, Copenhagen, Denmark.
17Slovak Med Univ, Bratislava, Slovakia.
18NUSCH, Bratislava, Slovakia.
19Oulu Univ Hosp, Med Res Ctr, Oulu, Finland.
20Univ Oulu, Oulu, Finland.
21Univ Med Ctr Gottingen, Dept Med Stat, Gottingen, Germany.
22St Ekaterina Univ Hosp, Dept Cardiol, Sofia, Bulgaria.
23SUSSCH, Dept Cardiol, Banska Bystrica, Slovakia.
24Med Univ Lodz, Bieganski Hosp, Chair & Dept Cardiol, Lodz, Poland.
25Imperial Coll, Natl Heart & Lung Inst, London, England.
26Masaryk Univ, Univ Hosp Brno, Dept Internal Med & Cardiol, Brno, Czech Republic.
Format: article
Version: accepted version
Access: open
Online Access: PDF Full Text (PDF, 3.8 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe202002074853
Language: English
Published: Elsevier, 2019
Publish Date: 2020-09-09
Description:

Abstract

Background: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue.

Summary: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12‑lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit.

Conclusion: The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.

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Series: Journal of electrocardiology
ISSN: 0022-0736
ISSN-E: 1532-8430
ISSN-L: 0022-0736
Volume: 57
Issue: Supplement
Pages: S34 - S39
DOI: 10.1016/j.jelectrocard.2019.09.001
OADOI: https://oadoi.org/10.1016/j.jelectrocard.2019.09.001
Type of Publication: A2 Review article in a scientific journal
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Subjects:
Funding: The research leading to the results has received funding from the European Commission Seventh Framework Programme FP7/2007–2013 under grant agreement No. HEALTH-F2-2009-241526, EUTrigTreat, and grant agreement No. HEALTH-F2-2009-602299, EU-CERT-ICD. G.H. and T.F. are principle investigators of the German Center for Cardiovascular Research (DZHK), partner site Göttingen. R.W. is supported as a postdoctoral clinical researcher by the Fund for Scientific Research Flanders (FWO).
Copyright information: © 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/.