Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation.
- Zabel M Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Sticherling C Department of Cardiology, University Hospital, Basel, Switzerland.
- Willems R Department of Cardiovascular Sciences, University of Leuven, Belgium.
- Lubinski A Department of Cardiology, Medical University of Lodz (MUL) WAM Hospital, Lodz, Poland.
- Bauer A Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität Munich, Munich, Germany.
- Bergau L Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Braunschweig F Department of Cardiology, Karolinska Institutet, Stockholm, Sweden.
- Brugada J IDIBAPS, Department of Cardiology, Hospital Clinic Barcelona, Barcelona, Spain.
- Brusich S Department of Cardiovascular Disease, KBC Rijeka, Rijeka, Croatia.
- Conen D Department of Cardiology, University Hospital, Basel, Switzerland.
- Cygankiewicz I Department of Electrocardiology, Medical University of Lodz (MUL), Lodz, Poland.
- Flevari P 2nd Department of Cardiology, Attikon University Hospital, Athens, Greece.
- Taborsky M Department of Cardiology, University Hospital, Olomouc, Czech Republic.
- Hansen J Gentofte Hospital, Copenhagen, Denmark.
- Hasenfuß G Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Hatala R Slovak Medical University NUSCH, Bratislava, Slovakia.
- Huikuri HV Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland.
- Iovev S Department of Cardiology, St. Ekaterina University Hospital, Sofia, Bulgaria.
- Kääb S Department of Cardiology, Klinikum Großhadern, Ludwig-Maximilians-Universität Munich, Munich, Germany.
- Kaliska G Department of Cardiology, SUSSCH, Banska Bystrica, Slovakia.
- Kasprzak JD Chair and Department of Cardiology, Bieganski Hospital, Medical University of Lodz (MUL), Lodz, Poland.
- Lüthje L Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Malik M National Heart and Lung Institute, Imperial College, London, UK.
- Novotny T Department of Internal Medicine and Cardiology, University Hospital Brno, Brno, Czech Republic.
- Pavlović N Department of Cardiology, KBC Sestre Milosrdnice, Zagreb, Croatia.
- Schmidt G Med. Klinik und Poliklinik I, Technische Universität München, Klinikum rechts der Isar, Munich, Germany.
- Shalganov T Department of Cardiology, National Heart Hospital, Sofia, Bulgaria.
- Sritharan R Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Schlögl S Department of Cardiology and Pneumology, Heart Center, University Medical Center, Göttingen, Germany.
- Szavits Nossan J Department of Cardiology, Magdalena Klinika, Krapinske Toplice, Croatia.
- Traykov V Department of Cardiology, Acibadem City Clinic Tokuda Hospital, Sofia, Bulgaria.
- Tuinenburg AE Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
- Velchev V Department of Cardiology, St. Anna Hospital, Sofia, Bulgaria.
- Vos MA Department of Medical Physiology, University Medical Center Utrecht, Utrecht, The 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.
- Svendsen JH Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
- Merkely B Department of Cardiology, Semmelweis University Heart Center, Budapest, Hungary.
- 2018-10-10
Published in:
- ESC heart failure. - 2019
Implantable cardioverter defibrillator
Mortality
Risk factors
Sudden cardiac death
Cardiomyopathy, Dilated
Death, Sudden, Cardiac
Defibrillators, Implantable
Electrocardiography
Europe
Follow-Up Studies
Humans
Patient Selection
Primary Prevention
Prospective Studies
Quality of Life
Risk Assessment
Survival Rate
Treatment Outcome
English
AIMS
The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value.
METHODS AND RESULTS
The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years.
CONCLUSIONS
The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.
The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value.
METHODS AND RESULTS
The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years.
CONCLUSIONS
The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1002/ehf2.12367
- PMID 30299600
- Persistent URL
- https://folia.unifr.ch/global/documents/183382
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