Authors' objectives: We aimed to examine the clinical effectiveness of ICD use for primary prevention of SCD. Key Question 1 examined ICD versus no ICD, ICD with ATP versus ICD alone, or ICD with CRT versus ICD alone, and differences among subgroups. Key Question 2 examined early and late adverse events and inappropriate shocks after ICD implantation, and differences among subgroups. Key Question 3 examined eligibility criteria and evaluation methods for patients included in comparative studies and the risk of SCD.

Authors' recommendations: There is a high strength of evidence that ICD therapy for primary prevention of SCD, versus no ICD therapy, shows benefit with regard to all cause mortality and SCD in patients with reduced left ventricular ejection fraction and ischemic or nonischemic cardiomyopathy beyond the immediate post-MI or coronary revascularization periods. Studies failed to show statistically significant differences for all-cause mortality across subgroups. There is insufficient evidence for all-cause mortality for patients who receive CRT-Ds versus ICD alone for primary prevention. There is high strength of evidence that in-hospital adverse events are infrequent (1-3%) and moderate strength of evidence that up to one-fifth of patients receive inappropriate shocks from the ICDs.

Project Status: Completed

Year Published: 2013

URL for published report: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/id91TA.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: Agency for Healthcare Research and Quality

Contact Address: Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA. Tel: +1 301 427 1610; Fax: +1 301 427 1639;

Contact Name: martin.erlichman@ahrq.hhs.gov

Contact Email: martin.erlichman@ahrq.hhs.gov

Copyright: Agency for Healthcare Research and Quality (AHRQ)