ICD risk stratification studies - EU-CERT-ICD and the European perspective.
In patients with ischemic or non-ischemic cardiomyopathy and impaired left ventricular ejection fraction, treatment with implantable cardioverter-defibrillator (ICD) has been shown to improve survival and guidelines recommend their use for primary prevention of sudden cardiac death. Experts disagree regarding the validity of decade-old trial results as the basis for this recommendation, therefore, reconsideration of prophylactic ICD treatment is needed.



In order to update the evidence on prophylactic ICD treatment, several prospective studies are underway in Europe. The prospective EU-CERT-ICD cohort study (NCT 02064192) is enrolling 2500 patients and compares patients undergoing first ICD implantation with controls with an earlier clinical decision to go without ICD implantation strictly unrelated to the study. The DANISH ICD study (NCT 00542945) has randomized 1000 patients with dilated cardiomyopathy and an LVEF ≤35% (1:1 ICD implantation vs. control). The prospective DO-IT multicenter registry will include 1500 ICD patients in multiple Dutch high-volume implanting centers. Due to the widespread use of ICD therapy, new randomized trials seem not straightforward to envisage in many countries.



The above described ICD studies will provide additional evidence regarding the effectiveness of primary prophylactic ICDs in Europe and may have an impact on ICD treatment guidelines. They could also help to design randomized trials in low risk patients.
Department of Cardiology and Pneumology, Division of Clinical Electrophysiology, University Medical Center Göttingen, Germany; Department of Internal Medicine II, Division of Cardiology, University Hospital Regensburg, Germany.
Joachim
J
Seegers
Department of Cardiology and Pneumology, Division of Clinical Electrophysiology, University Medical Center Göttingen, Germany.
Leonard
L
Bergau
Department of Cardiology and Pneumology, Division of Clinical Electrophysiology, University Medical Center Göttingen, Germany.
Tobias
T
Tichelbäcker
National Heart and Lung Institute, Imperial College, London, United Kingdom.
Marek
M
Malik
Department of Cardiology and Pneumology, Division of Clinical Electrophysiology, University Medical Center Göttingen, Germany. Electronic address: markus.zabel@googlemail.com.
Markus
M
Zabel
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015984:Causality; D015897:Comorbidity; D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D005060:Europe / Q000453:epidemiology; D005062:European Union / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine; D005260:Female; D006333:Heart Failure / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods; D012680:Sensitivity and Specificity; D016019:Survival Analysis; D016896:Treatment Outcome
Cardioverter defibrillator, implantable; Mortality; Risk factors; Sudden cardiac death