ICD risk stratification studies - EU-CERT-ICD and the European perspective
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Joachim Seegers1, Leonard Bergau2, Tobias Tichelbäcker2
1Department 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.
Insights
Implantable cardioverter-defibrillators (ICDs) are recommended for preventing sudden cardiac death in heart failure patients. New European studies are evaluating the effectiveness of prophylactic ICD treatment to update current guidelines and inform future research.
Area of Science:
- Cardiology
- Electrophysiology
- Preventive Medicine
Background:
- Implantable cardioverter-defibrillators (ICDs) are recommended for primary prevention of sudden cardiac death in patients with cardiomyopathy and reduced ejection fraction.
- Current guidelines rely on decade-old trial data, prompting debate and the need for updated evidence.
Purpose of the Study:
- To re-evaluate the effectiveness of prophylactic ICD treatment in contemporary patient populations.
- To provide updated evidence for ICD implantation guidelines in Europe.
Main Methods:
- The EU-CERT-ICD cohort study is enrolling 2500 patients comparing ICD implantation with no ICD.
- The DANISH ICD study is a randomized trial of 1000 patients with dilated cardiomyopathy.
- The DO-IT multicenter registry will include 1500 ICD patients.
Main Results:
- Ongoing European studies (EU-CERT-ICD, DANISH-ICD, DO-IT) are gathering new evidence on prophylactic ICD effectiveness.
- These studies involve thousands of patients across various European centers.
Conclusions:
- The ongoing studies are expected to provide crucial evidence on the efficacy of primary prophylactic ICDs.
- Findings may influence European ICD treatment guidelines and inform the design of future randomized trials, particularly in lower-risk populations.
Background And Rationale:
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.
Eu-Cert-Icd, Danish-Icd And Do-It:
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.
Conclusion:
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.
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