PURPOSE: To study the frequency by which a significantly elevated international normalized ratio (INR) may be associated with a major bleeding event in mechanical circulatory support device (MCS) patients. METHODS: A retrospective review of mechanical circulatory support device recipients was performed for the years 9/2013-5/2018. The incidence of significant bleeding was determined using the MOMENTUM 3 major adverse event bleeding definition. The incidence of bleeding within 30 days of an INR>4.0 was assessed. RESULTS: Sixty-Four MCS patients (36 Heartware, 18 Heartmate II, 7 Heartmate III, 3 total artificial heart) were reviewed for INR data over the study period. Only ten patients never had any INR values above 4.0. A total of 217 INR measurements were found to be greater than 4.0. There was a total of 56 major bleeding events in 33 patients during the study period. Eleven patients experienced 17 major bleeding events associated with INR>4.0, however 39 bleeds did not register an INR>4.0. The incidence of bleeding and high INR as measured by positive predictive value was 8.3% with a sensitivity of 0.306. The negative predictive value for freedom from bleeding with INR<4.0 was 99.5% with a specificity of 0.968. The average time to bleed after a measured INR>4.0 was 10.3 +/- 10.0 days. Both the bleeding and the non-bleeding groups had an average total number of INR values>4.0 for the study period of 3.9 +/- 3.5. There were 9 gastrointestinal bleeds (GIB), and 6 non GIBs that required transfusion, as well as 2 intracranial hemorrhages (ICH) in the elevated INR group. No bleeds within a month of an INR>4.0 group were fatal, whereas two ICHs in the INR<4.0 group were fatal. CONCLUSION: A single elevated INR>4.0 did not correlate strongly with an incidence of major bleeding in the subsequent 30 days. The amount of time to bleeding events after an elevated INR is also quite variable making the forecasting of potential bleeding difficult. Further study is warranted to improve our understanding of the link between the frequency, amount of time, and individual significance of supratherapeutic INR and bleeding complications.
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine