(137) - Pre-MCS Prothrombin and Factor V Leiden Gene Mutation Testing May Lead to More Bleeding

Abstract

Due to recent concerns over pump thrombosis and the potential for other embolic events, some centers routinely evaluate for hypercoagulable states such as Factor V Leiden and Prothrombin 20210 gene mutations to assess for thrombotic/embolic risk. The purpose of this analysis is to determine if pre-operative evaluation of Factor V Leiden and Prothrombin 20210 gene mutations impacts post-operative outcomes. A detailed, retrospective cohort analysis was completed involving all patients undergoing durable mechanical circulatory support implantation at St. Vincent Hospital between 2009 - 2014. Testing for Factor V Leiden and Prothrombin gene mutations was available for 156 patients. Patients with heterozygous gene mutations had INR goals of 2.5-3.5, and all others a goal of 2.0-3.0. The cohort was divided into hypercoagulable (HC, heterozygous for either gene mutation) and non-hypercoagulable (NoHC) groups. Kaplan-Meier estimates of survival were calculated and compared with log rank testing. Rates (per patient year, PPY) of gastrointestinal (GI) bleeding, embolic stroke, hemorrhagic stroke, and device exchange were calculated. Mean ± standard deviation patient age was 55.8 ± 13.6 years, and 73.7% were male. Thirteen (8.3%) of 156 patients were identified as having either Factor V (n=8) or Prothrombin (n=5) gene mutations. Mean duration of support was 338 ± 297 days. Survival at 1 year in HC vs. NoHC was 67% and 63%, respectively (p=0.43). Rates of infections (0.24 PPY HC vs. 0.10 PPY NoHC), GI bleeds (0.24 PPY vs. 0.07 PPY), and hemorrhagic stroke (0.16 PPY vss 0.03 PPY) were higher in those with a HC mutation than those without. No embolic events or device exchanges were seen in those with a mutation. In this small cohort, patients with Factor V Leiden or Prothrombin gene mutations did not have more thrombotic events than those without gene mutations. Rather, GI bleeding and hemorrhagic stroke rates were higher in gene positive patients. Future study is needed to determine if higher bleeding events are causal or secondary to higher intensity anticoagulation strategies. Additionally, sending gene mutation testing may only serve to add to the already costly pre-operative evaluation.