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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

. 2019 Nov-Dec ; 57S () : S34-S39. [epub] 20190904

Language English Country United States Media print-electronic

Document type Journal Article, Research Support, Non-U.S. Gov't, Review

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.

2nd Dept of Cardiology Attikon University Hospital Athens Greece

Chair and Dept of Cardiology Bieganski Hospital Medical University of Lodz Lodz Poland

Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Dept of Cardiology Acibadem City Clinic Tokuda Hospital Sofia Bulgaria

Dept of Cardiology and Pneumology Heart Center University Medical Center Göttingen Germany

Dept of Cardiology and Pneumology Heart Center University Medical Center Göttingen Germany; DZHK partner site Göttingen Göttingen Germany

Dept of Cardiology KBC Sestre Milosrdnice Zagreb Croatia

Dept of Cardiology Klinikum Großhadern Ludwig Maximilians Universität Munich Germany

Dept of Cardiology Magdalena Klinika Krapinske Toplice Croatia

Dept of Cardiology Medical University of Lodz CKD Hospital Lodz Poland

Dept of Cardiology Medical University of Lodz WAM Hospital Lodz Poland

Dept of Cardiology National Heart Hospital Sofia Bulgaria

Dept of Cardiology St Anna Hospital Sofia Bulgaria

Dept of Cardiology St Ekaterina University Hospital Sofia Bulgaria

Dept of Cardiology SUSSCH Banska Bystrica Slovakia

Dept of Cardiology The Heart Centre Rigshospitalet Copenhagen University Hospital Copenhagen Denmark; Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Dept of Cardiology University Hospital Olomouc Czech Republic; Faculty of Medicine and Dentistry Palacký University Olomouc Czech Republic

Dept of Cardiovascular Disease KBC Rijeka Rijeka Croatia

Dept of Internal Medicine and Cardiology University Hospital Brno Masaryk University Brno Czech Republic

Dept of Medical Physiology University Medical Center Utrecht Netherlands

Dept of Medical Statistics University Medical Center Göttingen Göttingen Germany

DZHK partner site Göttingen Göttingen Germany; Dept of Medical Statistics University Medical Center Göttingen Göttingen Germany

Gentofte Hospital Copenhagen Denmark

Heart and Vascular Center Semmelweis University Budapest Hungary

IDIBAPS Dept of Cardiology Hospital Clinic Barcelona Spain

Institute for Social Medicine Epidemiology and Health Economics Charité Universitätsmedizin Berlin Berlin Germany

Med Klinik und Poliklinik 1 Technische Universität München Klinikum rechts der Isar Munich Germany

Medical Research Center Oulu University Hospital Finland; University of Oulu Finland

National Heart and Lung Institute Imperial College London United Kingdom

Slovak Medical University Bratislava Slovakia; NUSCH Bratislava Slovakia

University Hospital University of Basel Switzerland

University Hospital University of Basel Switzerland; Population Health Research Institute McMaster University Hamilton Ontario Canada

University Hospitals of Leuven Leuven Belgium

References provided by Crossref.org

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