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.
- Zabel M Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany; DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany. Electronic address: markus.zabel@med.uni-goettingen.de.
- Schlögl S Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Lubinski A Dept. of Cardiology, Medical University of Lodz (MUL) WAM Hospital, Lodz, Poland.
- Svendsen JH Dept. of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
- Bauer A Dept. of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität Munich, Germany.
- Arbelo E IDIBAPS, Dept. of Cardiology, Hospital Clinic Barcelona, Spain.
- Brusich S Dept. of Cardiovascular Disease, KBC Rijeka, Rijeka, Croatia.
- Conen D University Hospital, University of Basel, Switzerland; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
- Cygankiewicz I Dept. of Cardiology, Medical University of Lodz (MUL) CKD Hospital, Lodz, Poland.
- Dommasch M Med. Klinik und Poliklinik I, Technische Universität München, Klinikum rechts der Isar, Munich, Germany.
- Flevari P 2nd Dept. of Cardiology, Attikon University Hospital, Athens, Greece.
- Galuszka J Dept. of Cardiology, University Hospital, Olomouc, Czech Republic; Faculty of Medicine and Dentistry, Palacký University, Olomouc, Czech Republic.
- Hansen J Gentofte Hospital, Copenhagen, Denmark.
- Hasenfuß G Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany; DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany.
- Hatala R Slovak Medical University, Bratislava, Slovakia; NUSCH, Bratislava, Slovakia.
- Huikuri HV Medical Research Center, Oulu University Hospital, Finland; University of Oulu, Finland.
- Kenttä T Medical Research Center, Oulu University Hospital, Finland; University of Oulu, Finland.
- Kucejko T Dept. of Cardiology, Medical University of Lodz (MUL) WAM Hospital, Lodz, Poland.
- Haarmann H Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Harden M Dept. of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
- Iovev S Dept. of Cardiology, St. Ekaterina University Hospital, Sofia, Bulgaria.
- Kääb S Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
- Kaliska G Dept. of Cardiology, SUSSCH, Banska Bystrica, Slovakia.
- Katsimardos A 2nd Dept. of Cardiology, Attikon University Hospital, Athens, Greece.
- Kasprzak JD Chair and Dept. of Cardiology, Bieganski Hospital, Medical University of Lodz (MUL), Lodz, Poland.
- Qavoq D Chair and Dept. of Cardiology, Bieganski Hospital, Medical University of Lodz (MUL), Lodz, Poland.
- Lüthje L Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Malik M National Heart and Lung Institute, Imperial College, London, United Kingdom.
- Novotný T Dept. of Internal Medicine and Cardiology, University Hospital Brno, Masaryk University, Brno, Czech Republic.
- Pavlović N Dept. of Cardiology, KBC Sestre Milosrdnice, Zagreb, Croatia.
- Perge P Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
- Röver C Dept. of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
- Schmidt G Med. Klinik und Poliklinik I, Technische Universität München, Klinikum rechts der Isar, Munich, Germany.
- Shalganov T Dept. of Cardiology, National Heart Hospital, Sofia, Bulgaria.
- Sritharan R Dept. of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Svetlosak M Slovak Medical University, Bratislava, Slovakia; NUSCH, Bratislava, Slovakia.
- Sallo Z Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
- Szavits-Nossan J Dept. of Cardiology, Magdalena Klinika, Krapinske Toplice, Croatia.
- Traykov V Dept. of Cardiology, Acibadem City Clinic Tokuda Hospital, Sofia, Bulgaria.
- Vandenberk B University Hospitals of Leuven, Leuven, Belgium.
- Velchev V Dept. of Cardiology, St. Anna Hospital, Sofia, Bulgaria.
- Vos MA Dept. of Medical Physiology, University Medical Center Utrecht, Netherlands.
- Willich SN Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
- Friede T DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany; Dept. of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
- Willems R University Hospitals of Leuven, Leuven, Belgium.
- Merkely B Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
- Sticherling C University Hospital, University of Basel, Switzerland.
- 2019-09-19
Published in:
- Journal of electrocardiology. - 2019
English
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.
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.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/j.jelectrocard.2019.09.001
- PMID 31526572
- Persistent URL
- https://sonar.ch/global/documents/53889
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