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

Clin Cardiol. 2023 Jan;46(1):67-75. doi: 10.1002/clc.23936. Epub 2022 Oct 19.

Abstract

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.

Keywords: TAVR; bleeding complication; protamine-to-heparin ratio; vascular complication.

Publication types

  • Multicenter Study

MeSH terms

  • Aortic Valve / surgery
  • Aortic Valve Stenosis*
  • Hemorrhage / chemically induced
  • Hemorrhage / epidemiology
  • Heparin / adverse effects
  • Humans
  • Myocardial Infarction* / complications
  • Myocardial Infarction* / prevention & control
  • Protamines / adverse effects
  • Risk Factors
  • Stroke* / chemically induced
  • Stroke* / prevention & control
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Treatment Outcome

Substances

  • Heparin
  • Protamines