Optimal protamine‐to‐heparin dosing ratio for the prevention of bleeding complications in patients undergoing TAVR—A multicenter experience

• Published in: Clinical Cardiology Vol. 46; no. 1; pp. 67 - 75
• Main Authors: Al‐Kassou, Baravan, Veulemans, Verena, Shamekhi, Jasmin, Maier, Oliver, Piayda, Kerstin, Zeus, Tobias, Aksoy, Adem, Zietzer, Andreas, Meertens, Max, Mauri, Victor, Weber, Marcel, Sinning, Jan‐Malte, Grube, Eberhard, Adam, Matti, Bakhtiary, Farhad, Zimmer, Sebastian, Baldus, Stephan, Kelm, Malte, Nickenig, Georg, Sedaghat, Alexander
• Format: Journal Article
• Language: English
• Published: United States Wiley 01.01.2023; John Wiley & Sons, Inc; John Wiley and Sons Inc
• Subjects: Analysis; Angioplasty; Anticoagulants; Aortic stenosis; Aortic Valve; Aortic Valve - surgery; Aortic Valve Stenosis; bleeding complication; Cardiovascular disease; Clinical Investigations; Clinical outcomes; ddc:no; Disease prevention; Health aspects; Heart; Heart attack; Hemorrhage; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Heparin; Heparin - adverse effects; Humans; Kidneys; Medical imaging; Medical research; Medicine, Experimental; Mortality; Myocardial Infarction; Myocardial Infarction - complications; Myocardial Infarction - prevention & control; Patients; Prevention; Protamines; Protamines - adverse effects; protamine‐to‐heparin ratio; Regression analysis; Risk Factors; Stroke; Stroke - chemically induced; Stroke - prevention & control; Surgeons; Surgery; TAVR; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Replacement - adverse effects; Treatment Outcome; vascular complication; Vein & artery diseases; vascular complication; bleeding complication; protamine-to-heparin ratio; TAVR
• ISSN: 0160-9289; 1932-8737; 1932-8737
• DOI: 10.1002/clc.23936

Background Despite major advances, transcatheter aortic valve replacement (TAVR) is still associated with procedure‐specific complications. Although previous studies reported lower bleeding rates in patients receiving protamine for heparin reversal, the optimal protamine‐to‐heparin dosing ratio is unknown. Hypothesis The aim of this study was a comparison of two different heparin antagonization regimens for the prevention of bleeding complications after TAVR. Methods The study included 1446 patients undergoing TAVR, of whom 623 received partial and 823 full heparin antagonization. The primary endpoint was a composite of 30‐day mortality, life‐threatening, and major bleeding. Safety endpoints included stroke and myocardial infarction at 30 days. Results Full antagonization of heparin resulted in lower rates of the primary endpoint as compared to partial heparin reversal (5.6% vs. 10.4%, p < .01), which was mainly driven by lower rates of life‐threatening (0.5% vs. 1.6%, p = .05) and major bleeding (3.2% vs. 7.5%, p < .01). Moreover, the incidence of major vascular complications was significantly lower in patients with full heparin reversal (3.5% vs. 7.5%, p < .01). The need for red‐blood‐cell transfusion was lower in patients receiving full as compared to partial heparin antagonization (10.4% vs. 15.9%, p < .01). No differences were observed in the incidence of stroke and myocardial infarction between patients with full and partial heparin reversal (2.2% vs. 2.6%, p = .73 and 0.2% vs. 0.4%, p = .64, respectively). Conclusions Full heparin antagonization resulted in significantly lower rates of life‐threatening and major bleeding after TAVR as compared to partial heparin reversal. The occurrence of stroke and myocardial infarction was low and comparable between both groups. Optimal protamine‐to‐heparin dosing ratio for the prevention of bleeding complications after TAVR. Full antagonization of heparin was associated with a reduction of life‐threatening bleeding by 69% and major bleedings by 57%, compared to patients with partial heparin reversal. Whereas partial antagonization of heparin was associated with a relative increase of the post‐interventional drop in hemoglobin by 13% and red blood cell transfusion by 53%, as compared to full heparin antagonization. life‐threat., life‐threatening; RBC, red blood cell; TAVR, transcatheter aortic valve replacement.