Gastrointestinal Bleeding after Continuous Flow Left Ventricular Assist Device Implantation: Analysis of the INTERMACS Registry

Abstract

Continuous flow left ventricular assist devices (CF-LVADs) are associated with increased gastrointestinal bleeding (GIB) when compared with pulsatile devices. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), the national registry of patients with FDA-approved durable devices, was analyzed to characterize GIB in CF-LVAD recipients. Median time from implantation to GIB, frequency of GIB-related rehospitalization, transfusion and death, and risk factors for GIB were determined. Adult patients older than18 years, with primary CF-LVAD implantation between 2006 and 2014, were included. Exclusion criteria were previous or concurrent placement of RVAD or total artificial heart. The primary outcome of interest was incidence of GIB in CF-LVAD recipients. Multivariable Cox proportional hazards model was used to examine associations of GIB with potential risk factors. Of 10,470 patients, 2,717 (26%) experienced GIB, with 1,316 (12.6%) experiencing >1 GIB. Median time to first GIB was 3.1 months (Q1 0.9, Q3 10.2). Rehospitalization occurred in 49.2% of GIB events, with 88.7% requiring transfusion and 0.7% resulting in death. Identified risk factors in multivariable analysis included older age, female sex, ischemic etiology, low pre-operative hemoglobin and elevated creatinine, longer cardiopulmonary bypass time, and lower INR after implantation. The majority of GIB events occur early after CF-LVAD implantation and are primarily associated with older age. Patients in their fifth decade of life have 4.6 times the risk of GIB compared with those in their second decade. Nearly half of patients with GIB experience >1 GIB, and GIB is a significant driver of rehospitalization and transfusion, but rarely results in death.