Population-Level Gender Differences in Acute Complications of Cardiac Implantable Electronic Devices: Implications for Patient Safety

Abstract

Background: To date, limited population-level data has examined the impact of gender on the acute complications of Cardiac Implantable Electronic Devices (CIED). Objective: We sought to determine the infuence of gender on acute complications of CIED implantation in Australia and New Zealand. Methods: All patients aged ≥18 years from 2010-2015 who were a resident of an Australian state or territory, or New Zealand, undergoing their frst PPM or ICD generator implant were studied. Data from both countries are collected using a standardised set of variables that includes patient demographic characteristics, primary and secondary diagnoses, procedures performed, and the patient status at discharge. Diagnoses and procedures were coded as per the International Classifcation of Diseases 10th Edition, and the Australian Classifcation of Health Interventions The primary endpoint was the incidence of CIED-related complications in-hospital or within 90-days of discharge The independent effect of gender was evaluated using multiple logistic regression. Results: A total of 81,650 frst time PPM (n=65,711) and ICD (n=15,593) implants was included, with 39% of devices implanted in females. Overall, 8.5% of females (F), and 8.0% of males(M) experienced an acute complication in the frst 90 days post-implant (P=0.008) The unadjusted risk of complications was higher for females than males for both PPM (F 8.1% vs M 7.5% P=0.006) and ICDs (F 8.5% vs M 8.0%, P<0.001). Differences between females and males remained signifcant after covariate adjustment (OR 1.10, 95%CI: 1.04-1.15, P<0.001) with this difference more pronounced for ICDs (OR 1.27, 95%CI 1.12-1.43, P<0.001) compared with PPM (OR 1.07, 95%CI 1.01-1.13 P=0.027). Differences in CIED complication rates were primarily driven by differences in rates of in-hospital re-operation (F 3.3% vs M 2.6%, P<0.001). Conclusion: In real-world population-level data in Australia and New Zealand, females are at higher risk of acute CIED complications. Health system level patient safety strategies may be required to address the disproportionate impact of CIED complications on female patients.