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

Karol Zbroński; Kajetan Grodecki; Roksana Gozdowska; Szymon Jędrzejczyk; Ewa Ostrowska; Julia Wysińska; Bartosz Rymuza; Piotr Scisło; Radosław Wilimski; Janusz Kochman; Krzysztof J. Filipiak; Grzegorz Opolski; Zenon Huczek

doi:10.5114/aic.2020.99266

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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abstract:

Original paper

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

Karol Zbroński

¹

,

Kajetan Grodecki

¹

,

Roksana Gozdowska

¹

,

Szymon Jędrzejczyk

¹

,

Ewa Ostrowska

¹

,

Julia Wysińska

¹

,

Bartosz Rymuza

¹

,

Piotr Scisło

¹

,

Radosław Wilimski

²

,

Janusz Kochman

¹

,

Krzysztof J. Filipiak

¹

,

Grzegorz Opolski

¹

,

Zenon Huczek

¹

First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
Department of Cardiac Surgery, Medical University of Warsaw, Warsaw, Poland

Adv Interv Cardiol 2020; 16, 3 (61): 306–314

DOI: https://doi.org/10.5114/aic.2020.99266

Online publish date: 2020/10/02

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AMA

Zbroński K, Grodecki K, Gozdowska R, et al. Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(3):306-314. doi:10.5114/aic.2020.99266.

APA

Zbroński, K., Grodecki, K., Gozdowska, R., Jędrzejczyk, S., Ostrowska, E.,  & Wysińska, J. et al. (2020). Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(3), 306-314. https://doi.org/10.5114/aic.2020.99266

Chicago

Zbroński, Karol, Kajetan Grodecki, Roksana Gozdowska, Szymon Jędrzejczyk, Ewa Ostrowska, Julia Wysińska,  and Bartosz Rymuza et al. 2020. "Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 16 (3): 306-314. doi:10.5114/aic.2020.99266.

Harvard

Zbroński, K., Grodecki, K., Gozdowska, R., Jędrzejczyk, S., Ostrowska, E., Wysińska, J., Rymuza, B., Scisło, P., Wilimski, R., Kochman, J., Filipiak, K., Opolski, G.,  and Huczek, Z. (2020). Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(3), pp.306-314. https://doi.org/10.5114/aic.2020.99266

MLA

Zbroński, Karol et al. "Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 16, no. 3, 2020, pp. 306-314. doi:10.5114/aic.2020.99266.

Vancouver

Zbroński K, Grodecki K, Gozdowska R, Jędrzejczyk S, Ostrowska E, Wysińska J et al. Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(3):306-314. doi:10.5114/aic.2020.99266.

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.

keywords:

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

Karol Zbroński 1 , Kajetan Grodecki 1 , Roksana Gozdowska 1 , Szymon Jędrzejczyk 1 , Ewa Ostrowska 1 , Julia Wysińska 1 , Bartosz Rymuza 1 , Piotr Scisło 1 , Radosław Wilimski 2 , Janusz Kochman 1 , Krzysztof J. Filipiak 1 , Grzegorz Opolski 1 , Zenon Huczek 1

protamine sulfate, bleeding complications, transcatheter aortic valve implantation