1Universitätsklinikum Schleswig-Holstein Klinik für Rhythmologie Lübeck, Deutschland; 2IRCCS Cardiologico Monzino Department of Cardiology Milano, Italien; 3Medical School / Regiomed GmbH Coburg, Deutschland; 4Universitätsklinikum Münster Klinik für Kardiologie II - Rhythmologie Münster, Deutschland; 5LANS Cardio Hamburg Kardiologie Hamburg, Deutschland; 6Asklepios Klinik St. Georg Kardiologie & internistische Intensivmedizin Hamburg, Deutschland; 7Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; 8Universitätsklinikum Mannheim I. Medizinische Klinik Mannheim, Deutschland; 9Evangelisches Krankenhaus Düsseldorf Klinik für Kardiologie Düsseldorf, Deutschland; 10IHF GmbH Ludwigshafen am Rhein, Deutschland; 11IHF GmbH Statistik Ludwigshafen am Rhein, Deutschland; 12Stiftung Institut für Herzinfarktforschung Ludwigshafen am Rhein, Deutschland
Purpose: To determine the impact of gender on the ICD implantation and outcome.
Methods: The German DEVICE registry is a prospective, nationwide database of ICD and CRT devices implantation and revisions. Between March 2007 and February 2014, 3794 patients undergoing a single or dual chamber ICD implantation and revisions were prospectively included in 44 centres and monitored for a median of 17 months. Herein we conducted the gender-based analysis of the ICD recipients.
Results: A total of 688 (18.1%) women (mean age 62.5 ± 16.0, median BMI 26.7) and 3106 men (mean age 64.6 ± 12.9, median BMI 26.8) were included in this registry. Significantly less women had coronary artery disease (p<0.001), while more women had hypertrophic cardiomyopathy (p=0.024) and primary electrical heart disease (p<0.001), mainly because of a higher incidence of long QT syndrome and arrhythmogenic right ventricular cardiomyopathy in this population. There was a trend towards a higher rate dual chamber ICDs in the female population (31.7% vs. 28.1%; p=0.061). Women were less likely to undergo ambulatory interventions (6.4% vs. 9.0%; p=0.026) and had a trend towards higher rate of ICD implantation for secondary prevention (52.3% vs. 48.7%; p=0.086). Females were more likely to have a history of ventricular fibrillation (51.7% vs. 39.4%; p<0.001) and resuscitation (54.7% vs. 46.3%; p=0.006), but less likely to have a history of ventricular tachycardia (33.1% vs. 45.2%; p<0.001). The overall rate of in-hospital complications (5.3% vs. 2.7%; p=0.005) as well as the rate of major periprocedural complications (3.1% vs. 1.3%; p=0.002) was significantly higher in the female population. The higher complication rate was mainly driven by a higher incidence of pneumothorax (1.0% vs. 0.1%; p=0.004) and haemothorax (0.4% vs. 0.0%; p=0.02). The Kaplan-Meier estimated 1-year all-cause mortality was 5.2% for women and 7.1% for men (p=0.073), while the estimated incidence of all-cause mortality or device shocks was significantly lower in the female population (15.1% vs. 19.0%; p=0.02). Women were more likely to undergo resuscitation during follow-up (FU; 1.3% vs. 0.3%; p<0.001) and showed a higher fear of receiving device shocks. The in-hospital minor complications, device revision and mortality were similar between genders. There was no difference in terms of ICD-shocks, syncope, VT-storm and ablation rates during FU. The all- cause, device-related, and other cardiovascular rehospitalisation rates as well as the incidence of non-arrhythmic, non-lethal adverse events during FU were similar between the genders.
Conclusions: In this real-life patient cohort only a minority of patients was females. Female patients had a higher risk of major periprocedural complications and in-hospital complications and a trend towards a lower all-cause mortality during FU.