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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique
Francesco Burzotta, Cristina Aurigemma, Mila Kovacevic, Enrico Romagnoli, Stefano Cangemi, Francecso Bianchini, Marialisa Nesta, Piergiorgio Bruno, Carlo Trani
Francesco Burzotta, Cristina Aurigemma, Enrico Romagnoli, Stefano Cangemi, Francecso Bianchini, Marialisa Nesta, Piergiorgio Bruno, Carlo Trani, Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
Francesco Burzotta, Piergiorgio Bruno, Carlo Trani, Università Cattolica del Sacro Cuore, Rome 00168, Italy
Mila Kovacevic, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
Mila Kovacevic, Institute of Cardiovascular Diseases of Vojvodina, Cardiology Clinic, Sremska Kamenica, Serbia
Author contributions: Burzotta F conceived the study; Burzotta F and Aurigemma C extracted, analyzed, and interpreted the data and drafted and revised the final version of the manuscript; Kovacevic M collected the clinical data and drafted and revised the final version of the manuscript; Trani C, Burzotta F, Aurigemma C, and Romagnoli E performed the procedures; Bruno P, Nesta M, Romagnoli E, Bianchini F, and Cangemi S collected the clinical data and interpreted the data; Trani C helped interpret the data and critically reviewed the manuscript for important intellectual content.
Conflict-of-interest statement: Dr. Burzotta F, Trani C and Aurigemma C received speaker’s fees from Abbott, Medtronic, and Abiomed. Other authors have no conflicts of interest.
Data sharing statement: Data are collected according to our institution center record of the activity of cath laboratory. Clinical data and procedure details were prospectively entered into a TAVI-dedicated section of an electronic database.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Francesco Burzotta, MD, PhD, Academic Research, Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore, L.go A Gemelli 1, Rome 00168, Italy. francesco.burzotta@unicatt.it
Received: October 17, 2021
Peer-review started: October 17, 2021
First decision: January 25, 2022
Revised: February 6, 2022
Accepted: April 24, 2022
Article in press: April 24, 2022
Published online: May 26, 2022
Processing time: 212 Days and 16.7 Hours
ARTICLE HIGHLIGHTS
Research background
The most common technique used for hemostasis in transfemoral transcatheter aortic valve replacement (TF-TAVR) is the use of pre-closure devices. Despite favorable results in terms of successful hemostasis, sometimes it can be followed by device failure and residual bleeding.
Research motivation
Although there are different possibilities to manage residual bleeding after hemostasis device failure, such as bailout additional closure device use, balloon-assisted hemostasis, or surgery, the best management is still unclear.
Research objectives
To describe and report the results of an original technique for managing residual access site bleeding after vascular closure devices failure.
Research methods
The authors developed a novel technique to resolve residual access-site bleeding named “pledget assisted hemostasis”. If residual bleeding was noticed, “pledget assisted hemostasis” with surgical non-absorbable polytetrafluoroethylene 6.5 mm x 4 mm x 1.5 mm pledget was done on the top of double pre-closure device. Proper hemostasis without residual bleeding was confirmed with control angiography.
Research results
A total of 15 consecutive patients (mean age 80.0 ± 7.2 years, 66.7% female) with residual access site bleeding after double pre-closure in TF-TAVR were prospectively included in this pilot study. In the majority of patients 16F sheath was used (n = 12; 80%), 14F sheath was used in 2 patients (6.7%), and 18F in 1 patient (6.7%). Hemostasis with the pledget technique was achieved in all patients (100%) immediately after implantation. Major bleeding defined by Valve Academic Research Consortium-2 definition did not occur. No access site infection was observed in the follow-up period.
Research conclusions
“Pledget assisted hemostasis” after pre-closure vascular device failure might be considered as a possible bailout technique to treat patients with residual access site bleeding. Further studies are needed to compare this approach with other bail-out techniques.
Research perspectives
“Pledget assisted hemostasis” might be considered as a possible bailout technique for vascular closure device failure.
