• Isuru Ranasinghe, Craig S Parzynski, James V Freeman, Rachel P Dreyer, Joseph S Ross, Joseph G Akar, Harlan M Krumholz, and Jeptha P Curtis.
• Ann. Intern. Med. 2016 Jul 5; 165 (1): 20-29.

BackgroundLong-term nonfatal outcomes after implantable cardioverter-defibrillator (ICD) placement are poorly defined.ObjectiveTo determine the long-term risk for ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications, and to assess associated patient and device characteristics.DesignObservational cohort study of ICD implantations from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims data.Setting1437 U.S. hospitals.Patients114 484 patients aged 65 years or older (mean, 74.8 years [SD, 6.2]; 72.4% male) receiving an ICD for the first time from 2006 to 2010 (single-chamber, 19.8%; dual-chamber, 41.3%; cardiac resynchronization therapy with a defibrillator [CRT-D], 38.9%).MeasurementsRate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications.ResultsDuring a median follow-up of 2.7 years (interquartile range, 1.8 to 3.9 years), 40 072 patients died, representing 12.6 (95% CI, 12.5 to 12.7) deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 (CI, 6.0 to 6.2) ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 (CI, 3.8 to 4.0) reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation (65 to 69 vs. >85 years) (hazard ratio [HR], 1.55 [CI, 1.43 to 1.69]), receipt of a CRT-D device (HR, 1.38 [CI, 1.31 to 1.45]) versus a single-chamber device, female sex (HR, 1.16 [CI, 1.12 to 1.21]), and black race (HR, 1.14 [CI, 1.05 to 1.23]) were associated with the greatest increased risks for ICD-related complications.LimitationThe analysis was limited to Medicare fee-for-service patients aged 65 years or older.ConclusionPatients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation.Primary Funding SourceAmerican College of Cardiology Foundation's National Cardiovascular Data Registry.

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