Report of cardiac electronic device implant complications over a 7-year study period

The global placement of cardiac implantable electronic devices (CIEDs) is on the rise. Complications linked to device implantation present a substantial burden on healthcare systems and patients alike. It is imperative to comprehend the complication rates associated with CIED procedures, enabling informed decision-making and strategic planning for patients, thereby enhancing the overall quality of care.

We sought to determine post CIED implantation complication rates and provide operator specific complication data for quality assurance at our institution.

A comprehensive audit of all procedures completed between April 2016 to March 2023 by 14 high volume operators at a single academic center was completed. Complications and device data were extracted using electronic medical records. Complications evaluated include pneumothorax, infections, hematomas, venous thrombosis, lead perforation, and dislodgement using standardized definitions.

During the 7-year period, a total of 9,467 procedures were completed. Among the cohort, 62% were male, with an average age of 74.6 ± 15.2 years. The procedural breakdown comprised 60% pacemakers, 19% ICDs, 16% CRTs and 3% ILRs. A total of 11,616 leads were implanted (3,644 RA leads and 1,110 LV leads). The overall complication rate was 3.1% (n=316): device pocket infection 0.68%, superficial infection 0.19%, lead dislodgement 0.53%, lead perforation 0.24%, pericardial effusion 0.1%, pneumothorax 0.15%, pocket hematoma 0.83%, DVT 0.36%, and hemothorax 0.02%. Complication rates per operator are shown in Figure-1.

Our findings indicate that the overall complication rates for CIED implants are lower than previously reported rates, and there is no significant difference between operators in overall rates of complication. This observation can be attributed to operator experience, advancements in peri-operative care and guideline-directed post-operative protocols. However, notable variations exist among operators in rates of pocket infection. The ongoing monitoring of CIED complications as a quality indicator remains a crucial benchmark, meriting annual assessments for ongoing evaluation.