Impact of gender on the utilization of cardiac implantable devices and outcome: results from the German DEVICE registry

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are widely used in patients with life-threatening cardiac arrhythmias or systolic heart failure. Real world data regarding gender impact on ICD and CRT implantation and outcome is scarce. Purpose To investigate the impact of gender-specific differences on cardiac devices implantation and outcomes. Methods The German DEVICE registry is a nationwide prospective multicentre database of ICD and CRT devices implantation. A total of 5451 patients were prospectively enrolled in 44 centres between March 2007 and February 2014 and were monitored for a median of 17 months. Results A minority of patients in this registry was female 1050 (19.3%; mean age 64.4 ± 14.6 years; median BMI 27.2) while men represented 80.7% (mean age 65.5 ± 12.4 years; median BMI 26.8). Female patients were less likely to have a LVEF <35% (70.6% vs. 77.7%; p<0.0001) and more likely to have a LVEF >55% (13.3% vs. 6.6%; p<0.0001). Moreover, women were less likely to have coronary artery disease (42.3% vs. 64.7%; p<0.0001), history of myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft (p<0.0001 for all). The rate of CRTs was significantly higher in women than in men (33.4% vs. 28.7%; p=0.0036). In terms of secondary prevention implantations, women were more likely to have history of ventricular fibrillation (VF; 50.7% vs. 37.2%; p<0.0001) but less likely to have history of ventricular tachycardia (VT; 34.5% vs. 47.5%; p<0.0001). The rates of major periprocedural complications and in-hospital complications were higher in women (3.3% vs. 1.7%; p=0.002 and 5.6% vs. 3.7%; p=0.0208). The Kaplan-Meier estimated 1-year all-cause mortality was 5.4% for women and 7.4% for men, while the overall mortality during follow-up was 10% for women and 14% for men (p=0.0004), with no gender differences in terms of death cause. Significantly less women received device shocks (14.2% vs. 17.5%; p=0.0260), while more women needed device revision during follow-up (10.9 % vs. 8.2%; p=0.0246). Similar rates of primary and secondary prevention indication were noted for female and male patients (p=0.9717). There was no difference between the groups regarding the need of postprocedural system revision (p=0.7884), as well as in-hospital death, cardiac death, or sudden cardiac death. The non-fatal complications during follow-up were comparable for men and women. Moreover, similar rates and durations of all cause and cardiac rehospitalizations were found (p=0.1644 and p= 0.1816). Conclusion In this real-life patient cohort only a minority of female patients were enrolled. Female patients were more likely to undergo CRT implantation and had a higher risk for acute major periprocedural complications and in-hospital complications but a lower overall mortality in 1-year follow-up. However, the differences in baseline characteristics should be considered as potential confounders.