Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications

INTRODUCTION: Bleeding complications after transcatheter aortic valve implantation (TAVI) are an important issue and negatively affect survival. The rate and impact of protamine sulfate (PS) administration on bleeding complications after TAVI remain unclear. AIM: To assess the impact of PS on bleeding complications after TAVI. MATERIAL AND METHODS: Between March 2010 and November 2016 two hundred fifty-eight patients qualified for TAVI in one academic center were screened. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was major bleeding according to the Valve Academic Research Consortium up to 48 h after the procedure. RESULTS: Overall, 186 patients (96 females, mean age: 80 years) met the inclusion criteria. Thirty-nine (21%) subjects received PS. PE occurred in 24.7% of the study population. There were no significant differences in terms of the PE rate between the groups (25.6% in the PS group and 24.7% in the remaining cohort, p = 0.9, odds ratio (OR) = 1.05, confidence interval (CI): 0.47–2.4, p = 0.9). Multivariate analysis identified female gender (OR = 2.2, CI: 1.08–4.4, p = 0.03) as an independent predictor of PE occurrence. Similarly, female gender (OR = 2, CI: 1.06–3.84, p = 0.03) as well as general anesthesia (GA, OR = 2.23, CI: 1.13–4.63, p = 0.02) and dose of unfractionated heparin per kilogram (UFH/kg, OR = 1.02, CI: 1–1.03 per 1 IU increment, p = 0.02) predicted the occurrence of a composite of major and minor bleeding. CONCLUSIONS: In this analysis, PS administration did not decrease the PE rate. Female gender predicted PE occurrence. Randomized, placebo-controlled trials are required to accurately assess the impact of PS.