Device complications in adult congenital heart disease

BACKGROUND Pacemakers and implantable cardioverter-defibrillators (ICDs) are increasingly implanted in adults with congenital heart disease (CHD), but little is known about implant-related complications and mortality. OBJECTIVE The purpose of this study was to compare pacemaker and ICD implantation complication rates between adults with and those without CHD using a comprehensive, statewide database. METHODS We used the Healthcare Cost and Utilization Project database to identify initial transvenous pacemaker and ICD implantations and implant-related complications in California hospitals from January 1, 2005, to December 31, 2011. We calculated relative risks of implant-related complications by comparing those with and those without CHD using Poisson regression with robust standard errors, adjusting for age and medical comorbidities. RESULTS We identified 105,852 patients undergoing pacemaker implantation, 1465 with noncomplex CHD and 66 with complex CHD. CHD was not associated with increased risk of pacemaker implant-related complications: adjusted risk ratio (aRR) 0.92, 95% confidence interval (CI) 0.74-1.14, P = .45. We identified 32,948 patients undergoing ICD implantation, 815 with noncomplex CHD and 87 with complex CHD. Patients with CHD had increased risk of ICD implant-related complications: aRR 1.36, 95% CI 1.05-1.76, P = .02. Patients with complex CHD had greater increased risk of ICD implant-related complications: aRR 2.14, 95% CI 1.16-3.95, P = .02. In patients receiving devices, CHD was associated with a trend toward lower 30-day in-hospital mortality after pacemaker (P = .07) and ICD (P = .19) implantation. CONCLUSION Among adult patients undergoing device implantation in California, CHD was associated with increased risk of ICD implant-related complications, but not pacemaker implant-related complications or higher 30-day in-hospital mortality.