The aims of this analysis were to characterize the burden and timing of bleeding events in females versus males on left ventricular assist device (LVAD) support. A single-center retrospective review of 375 patients receiving continuous-flow LVADs was performed. Bleeding events included gastrointestinal, naso-oropharyngeal, gynecologic (GYN), intracranial hemorrhage (ICH), and mediastinal bleeding. Cox hazard ratios (HRs) [95% CI] and incident event rates for females versus males were calculated. Eighty-four females (22%) and 291 males (78%) received an LVAD. There were 189 patients with 406 bleeding events over a median 399 days of support. Two-year freedom from bleeding was 33 ± 6.2% in females and 46 ± 3.7% in males (p = 0.027). Correlates of bleeding included female sex (adjusted HR = 1.6 [1.1–2.2]) and older age (adjusted HR = 1.2 [1.1–1.3] per 10 years). There was no sex-associated difference in 30 day mediastinal bleeding (males 12%; females 16% at 30 days; overall p = 0.35), but incident event rates for overall bleeding and naso-oropharyngeal bleeding were higher in females (p < 0.05) and trends were noted in ICH (eppy: 0.06 male vs. 0.10 female, p = 0.14). Eight females (10%) experienced 12 GYN bleeding events; five required surgical intervention. In summary, females had a 60% higher hazard of bleeding than males with significant morbidity encountered from mucosa (including vaginal) bleeding. Future large device studies should be inclusive of sex-specific outcomes.
From the *Department of Internal Medicine, St. Vincent Medical Group, Indianapolis, Indiana
†Department of Cardiology, St. Vincent Heart Center of Indiana, Indianapolis, Indiana
‡Department of Cardiac Surgery, St. Vincent Heart Center of Indiana, Indianapolis, Indiana.
Submitted for consideration July 2017; accepted for publication in revised form October 2017.
Disclosure: Jennifer A. Cowger received institutional research funds from Abbott and Medtronic, and travel support for research from Abbott. Sina L. Moainie, Christopher T. Salerno, and Ashwin K. Ravichandran were supported by institutional research funds from Abbott and Medtronic.
Correspondence: Zubin Yavar, MD, 2001 W. 86th Street | 3 North, Indianapolis, IN 46260. Email: Zubin.Yavar@ascension.org.