EFFICACY AND SAFETY OF PROTAMINE IN REDUCING BLEEDING AND VASCULAR COMPLICATIONS AFTER TAVR: A META-ANALYSIS

Document Type

Conference Proceeding

Publication Date

4-1-2025

Publication Title

J Am Coll Cardiol

Keywords

heparin, protamine, acute kidney failure, bleeding, complication, conference abstract, heart infarction, hospitalization, human, major bleeding, male, meta analysis, minor bleeding, mortality, mortality risk, pacemaker implantation, postoperative hemorrhage, special situation for pharmacovigilance, systematic review, therapy, thromboembolism, transcatheter aortic valve implantation, vascularization

Abstract

Background: Transcatheter aortic valve replacement (TAVR) often causes postoperative bleeding and vascular complications due to intraoperative heparin. Protamine sulfate reverses heparin but its routine clinical use in TAVR remains debated. This meta-analysis aims to evaluate protamineʼs efficacy and safety in reducing bleeding and vascular complications compared to standard practices Methods PubMed, Embase, Cochrane and clinicaltrials.gov were searched. Primary outcomes were 30-day mortality, major bleeding, lifethreatening bleeding, and vascular complications. Secondary outcomes were minor bleeding, myocardial infarction, stroke, acute kidney injury, and hospital stay. Odds ratios (OR) and mean differences (MD) were calculated through a random-effects model using RevMan 5.4 Results 6 studies with a total of 4,123 patients were included in the quantitative synthesis. Protamine reduced minor (OR=0.63, p=0.01), major (OR=0.46, p<0.001), and life-threatening bleeding (OR=0.35, p<0.001), minor (OR=0.82, p=0.03) and major vascular complications (OR=0.45, p<0.001), and shortened hospital stay (MD=-1.95 days, p=0.02). Protamine did not significantly affect 30-day mortality, risk of pacemaker implantation, myocardial infarction, stroke, acute kidney injury, or postoperative transfusion requirement Conclusion Protamine reduces bleeding and vascular complications in TAVR without raising mortality or thromboembolic risks. More trials are needed to support routine use [Formula presented]

Volume

85

Issue

12

First Page

1071

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