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Published online: 2021-07-20
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Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

Karol Zbroński, Kajetan Grodecki, Roksana Gozdowska, Ewa Ostrowska, Julia Wysińska, Bartosz Rymuza, Piotr Scisło, Radosław Wilimski, Janusz Kochman, Krzysztof J Filipiak, Grzegorz Opolski, Zenon Huczek
DOI: 10.33963/KP.a2021.0070
·
Pubmed: 34292562

open access

Online first
Original article
Published online: 2021-07-20

Abstract

Background: Bleeding complications after transcatheter aortic valve implantation (TAVI) negatively affect the post-procedural prognosis. Routine use of protamine sulfate (PS) to reverse unfractionated heparin after TAVI was never assessed in a randomized controlled trial.
Aims: The aim of this study was to assess the impact of PS on bleeding complications after TAVI.
Methods: Between December 2016 and July 2020 311 patients qualified to TAVI in one academic center were screened. Patients that met the inclusion criteria were randomized to either PS or normal saline administration at the moment of optimal valve deployment. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was a composite of life-threatening and major bleeding according to Valve Academic Research Consortium within 48 hours after the procedure.
Results: Overall, 100 patients (48 males, median age 82 years) met the inclusion criteria and were included in the study. Forty-seven subjects (47%) were randomized to PS. The primary endpoint occurred in the 29% of the study population. Despite a numerically lower rates of PE in patients randomized to PS, a statistical significance was not reached (21% in the PS group and 36% in the placebo group; odds ratio [OR], 0.48; 95% confidence intervals [CI] 0.2–1.2; P = 0.11). There were no significant differences in secondary endpoints.
Conclusions: Routine protamine sulfate administration did not significantly decrease the rate of major and life-threatening bleeding complications after TAVI. Larger studies are required to assess the impact of routine PS use.

Abstract

Background: Bleeding complications after transcatheter aortic valve implantation (TAVI) negatively affect the post-procedural prognosis. Routine use of protamine sulfate (PS) to reverse unfractionated heparin after TAVI was never assessed in a randomized controlled trial.
Aims: The aim of this study was to assess the impact of PS on bleeding complications after TAVI.
Methods: Between December 2016 and July 2020 311 patients qualified to TAVI in one academic center were screened. Patients that met the inclusion criteria were randomized to either PS or normal saline administration at the moment of optimal valve deployment. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was a composite of life-threatening and major bleeding according to Valve Academic Research Consortium within 48 hours after the procedure.
Results: Overall, 100 patients (48 males, median age 82 years) met the inclusion criteria and were included in the study. Forty-seven subjects (47%) were randomized to PS. The primary endpoint occurred in the 29% of the study population. Despite a numerically lower rates of PE in patients randomized to PS, a statistical significance was not reached (21% in the PS group and 36% in the placebo group; odds ratio [OR], 0.48; 95% confidence intervals [CI] 0.2–1.2; P = 0.11). There were no significant differences in secondary endpoints.
Conclusions: Routine protamine sulfate administration did not significantly decrease the rate of major and life-threatening bleeding complications after TAVI. Larger studies are required to assess the impact of routine PS use.

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Keywords

aortic, implantation, protamine, sulfate, transcatheter, valve

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About this article
Title

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

Journal

Kardiologia Polska (Polish Heart Journal)

Issue

Online first

Article type

Original article

Published online

2021-07-20

DOI

10.33963/KP.a2021.0070

Pubmed

34292562

Keywords

aortic
implantation
protamine
sulfate
transcatheter
valve

Authors

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

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