Abstract 4367784: Use of Protamine to Mitigate Bleeding Risk Following Transcatheter Aortic Valve Implantation; A Systematic Review and Meta-analysis.

Background: Bleeding is a major concerns during transcatheter aortic valve implantation (TAVI). Protamine is routinely used to reverse unfractionated heparin, but its overall safety profile remains debated. Methods: A meta-analysis of available studies comparing protamine to placebo during TAVI was conducted using electronic databases; PubMed and Embase. Primary outcomes assessed included blood transfusion requirements, acute kidney injury (AKI), and any bleeding. Odds ratios (OR) with 95% confidence intervals (CI) were calculated using a random-effects model. A p value <0.05 was considered as statistical significant. Results: A total of 5 studies were included with patients receiving Protamine; 1778 and Placebo; 1222. Protamine significantly reduced the need for blood transfusion (OR 0.70; 95% CI 0.55–0.88; p < 0.005), Life threatening bleed (OR 0.33; 95%CI 0.12-0.87, p=0.03), Major bleeding (OR 0.54; 95%CI: 0.31-0.92, p=0.02) and major vascular complications (OR 0.44; 95%CI: 0.28-0.67, p<0.005). However, other outcomes were comparable for MI (OR 0.47; 95%CI: 0.08-2.9, p=0.42), minor vascular complication (OR: 0.76; 95%CI: 0.51-1.15, p=0.19), stroke (OR: 0.82; 95%CI: 0.43-1.59, p=0.56), AKI (OR: 0.81; 95%CI: 0.61, 1.07, p=0.14) and mortality (OR: 1.12; 95%CI: 0.68-1.85, p=0.65) Conclusion: Protamine significantly reduces need for blood transfusion, life threatening bleed, major bleeding and major vascular complications for patients undergoing TAVI. These findings suggest that protamine may be an effective intervention for reducing bleeding complications post-TAVI. However, large trials are required to validate these findings.