Gastrointestinal Bleeding, International Normalized Ratio, and Subsequent Risk of Recurrent Thromboembolic Events among Left Ventricular Assist Device Patients

• Published in: The Journal of heart and lung transplantation Vol. 40; no. 4; pp. S179 - S180
• Main Authors: Sherazi, S., Goldenberg, I., McNitt, S., Polonsky, B., Gosev, I., Vidula, H., Alexis, J.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.04.2021
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2021.01.526

Patients have an increased risk of gastrointestinal bleeding (GIB) and thromboembolic events (TE) after left ventricular assist device (LVAD) implantation. We hypothesized that GIB in LVAD recipients leads to low international normalized ratio (INR) values that may predispose to increased risk of TE. This study included 410 patients in the University of Rochester Medical Center LVAD Database who were implanted between 2008 and 2020 (mean age 56 ± 13 years, 80% male, 84% white). Longitudinal data on INR was categorized as therapeutic (2-3), sub-therapeutic (<2) and supra-therapeutic (>3). A TE event was defined as device malfunction, confirmed or suspected pump thrombosis, ischemic stroke, transient ischemic attack, venous thromboembolism, or arterial non-CNS thromboembolism. The primary outcome was recurrent TE. The Anderson-Gill recurrent regression analysis was used to obtain hazard ratios and confidence intervals. During median follow-up of 2.07 years 83 (20%) patients had TE. After multivariate adjustment, GIB was associated with a 28% increased likelihood for subsequent sub-therapeutic INR values (<0.0001). Multivariate recurrent event analysis showed that the presence of sub-therapeutic INR values during follow-up was associated with a significant 93% increased risk for subsequent recurrent TE (HR 1.93; 95% CI 1.19-3.14; p < 0.008). The association between sub-therapeutic INR and increased risk of TE was evident among both HMII and HM3 patients (p-value for interaction = 0.692) Our findings suggest that the occurrence of GIB following LVAD implantation may predispose to increased risk of recurrent TE through sub-therapeutic INR values. INR < 2 is a powerful predictor of TE in both HMII and HM3 patients.