Low-dose 3-factor prothrombin complex concentrate for warfarin reversal prior to heart transplant.

BACKGROUND: Anticoagulation with warfarin is common in patients presenting for heart transplant. Prior to surgery, anticoagulation reversal is necessary to avoid significant intraoperative and perioperative bleeding complications. Commonly, warfarin reversal is achieved with vitamin K and fresh frozen plasma (FFP); however, these therapies have significant limitations. An alternative to FFP for reversal exists with prothrombin complex concentrate (PCC). A warfarin reversal protocol prior to heart transplant was implemented using low-dose PCC at our institution. OBJECTIVE: To assess blood product use, effectiveness, and safety post-low-dose PCC administration in patients needing warfarin reversal prior to heart transplant compared with historical controls. METHODS: This was a single-center, retrospective cohort study. The PCC cohort included patients undergoing heart transplant presenting with an international normalized ratio ≥1.5 on warfarin therapy and who received at least 1 dose of PCC. Blood product use was measured from postoperative day 0 to 2. RESULTS: The PCC and historical control cohorts included 16 and 50 patients, respectively. There was a significant reduction in the use of FFP (4 vs 8 units, P = 0.0239) in the PCC cohort compared with the historical control cohort. No differences were identified in the use of other blood products as well as other secondary efficacy or safety end points. CONCLUSIONS: Use of PCC, per the reversal protocol, prior to heart transplant reduced FFP use and showed a non-statistically significant trend toward reductions in the use of other blood products in the intraoperative and perioperative setting, with no difference identified in thrombotic or embolic complications compared with historical controls.

Validity of criteria used to evaluate fingerstick devices that assess international normalized ratio.

BACKGROUND: Investigators commonly rely on unvalidated, mainly arithmetic criteria to predict if point-of-care fingerstick devices that assess International Normalized Ratio (INR) lead to the same warfarin dosing decisions as a standard measure. METHODS: Criteria that predict warfarin dosing agreement between 2 INR measurements were evaluated using clinicians' actual dosing decisions as the standard. Bayesian hierarchical modeling was used to rank the criteria by the proportion of correct dosing predictions and the magnitude of difference between actual and predicted dosing agreement. RESULTS: The prediction criteria misclassified dosing agreement for between 19% and 38% of paired INR values (x: 27%). The magnitude of misclassification varied inconsistently throughout the INR scale. CONCLUSION: The unvalidated criteria used to predict warfarin dosing agreement between 2 INR measurements are associated with large error. Warfarin dosing decisions should be measured directly in such assessments.

Comparison of Anticoagulation Strategies After Left Ventricular Assist Device Implantation.

Appropriate early anticoagulation after left ventricular assist device (LVAD) implantation has not been established with practices ranging from no anticoagulation to early heparinization. The goal of this study was to evaluate the efficacy and morbidity of three strategies before initiating oral anticoagulation therapy. This was a noninterventional, retrospective, matched historical control cohort study. The primary and secondary endpoints were thrombotic complications (TCs) and bleeding up to 30 days post-LVAD implantation. There was a significant difference in the overall rate of TCs between strategies (p = 0.017). The incidence of TCs was significantly lower in the heparin group versus no bridging (4.9 vs. 27.0%, p = 0.008) on univariate analysis. On multivariate analysis, heparin was independently associated with a lower odds of TCs (odds ratio [OR], 0.10; 95% confidence interval [CI], 0.01-0.85). No differences were observed in bleeding between groups (p = 0.127) on univariate analysis; however, heparin was independently associated with increased odds of bleeding compared with no bridging on multivariate analysis (OR, 2.93; 95% CI, 1.15-7.43). Compared with no bridging, bivalirudin did not significantly differ in TC or bleeding events. Heparin seems to be the most effective regimen to use post-LVAD implantation but may increase the patient's risk for bleeding.