Incidence of Bleeding‐Related Complications During Primary Implantation and Replacement of Cardiac Implantable Electronic Devices

BACKGROUND: Use of cardiac implantable electronic devices (CIEDs) is increasing. The incidence of bleeding‐related complications during CIED procedures and the association with subsequent infection risk have been studied in trial settings but not in nonrandomized “real‐world” populations. METHODS AND RESULTS: This retrospective database analysis of US insurance claims from the Truven MarketScan database (2009‐2013) evaluated the incidence of bleeding complications during, or in the 30 days following, a CIED procedure and the association between bleeding and subsequent infection in days 31 to 365 of follow‐up. This study identified 42 606 patients who had a primary or replacement CIED procedure and met all inclusion criteria. Incidence of bleeding ranged from 0.58% to 2.81% by type of pharmaceutical therapy. Incidence of infection during days 31 to 365 of follow‐up was significantly higher among patients with a bleeding complication in the first 30 days versus those without (6.56% vs 1.24%, P<0.001), with results upheld in multivariate analysis (HR=2.97, 95% CI 1.94‐4.54, P<0.001). CONCLUSIONS: This study provides a lower bound of the real‐world incidence of bleeding complications following a CIED procedure within the coding limitations of an insurance claims database. Results confirm the association between bleeding in the pocket and risk of subsequent infection. Further research is needed to precisely identify the costs associated with bleeding in the pocket.