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Comparative Study
. 2025 Mar 3;21(5):e272-e281.
doi: 10.4244/EIJ-D-24-00120.

A propensity-matched comparison of plug- versus suture-based vascular closure after TAVI

David Grundmann  1 , Won Kim  2 , Caroline Kellner  1   3 , Matti Adam  4 , Daniel Braun  5 , Alexander R Tamm  6 , Max Meertens  4 , Christian W Hamm  2 , Sabine Bleiziffer  7 , Jonas Gmeiner  5 , Alexander Sedaghat  8 , David Leistner  9   10 , Matthias Renker  2 , Hendrik Wienemann  4 , Efstratios Charitos  2 , Marie Linnemann  5 , Tobias Lerchner  11 , Benjamin Juri  9   12 , Mostafa Salem  13 , Roman Benetti-Lehmann  7 , Henryk Dreger  14   15 , Alina Goßling  1 , Awesta Nahif  1 , Lenard Conradi  16 , Niklas Schofer  1 , Andreas Schäfer  16 , Jasmin Popara  13 , Misumasa Sudo  8 , Smita Scholtz  7 , Ralph Stephan von Bardeleben  6 , Marc Vorpahl  11 , Derk Frank  13   17 , Tanja K Rudolph  7 , Moritz Seiffert  1   3   17   18
Affiliations
Comparative Study

A propensity-matched comparison of plug- versus suture-based vascular closure after TAVI

David Grundmann et al. EuroIntervention. .

Abstract

Background: Vascular access site complications are associated with increased morbidity and mortality after transcatheter aortic valve implantation (TAVI). Current results comparing strategies with plug- (P-VCD; MANTA) and suture-based vascular closure devices (S-VCD; Perclose ProGlide) remain inconsistent.

Aims: It was our aim to assess the incidence of access-related vascular complications after P-VCD or S-VCD strategies after transfemoral TAVI.

Methods: The Plug or sUture based vascuLar cloSurE after TAVI (PULSE) registry retrospectively evaluated 10,120 consecutive patients who had undergone transfemoral TAVI at 10 centres from 2016 to 2021. A propensity score was used to match 900 P-VCD patients with 1,800 S-VCD patients in a 1:2 fashion. The primary outcome measures were major and minor access-related vascular complications at the primary access site, adjudicated according to Valve Academic Research Consortium 3 definitions.

Results: The median age was 81.8 years, 46.4% of patients were female, and the median European System for Cardiac Operative Risk Evaluation II was 3.50%. In matched P-VCD and S-VCD groups, large-bore access-related complications occurred in 14.9% vs 10.3% (p<0.001; major: 3.6% vs 4.6%; p=0.218; minor: 11.3% vs 5.8%; p<0.001) of patients. Bleeding accounted for most of these complications (9.6% vs 7.2%; p=0.028) and was treated with endovascular balloon inflation (5.4% vs 2.6%; p<0.001), stent implantation (4.7% vs 0.7%; p<0.001) or surgical repair (0.7% vs 1.7%; p=0.03).

Conclusions: P-VCD were associated with higher rates of primary access-related vascular complications, driven by minor complications, compared to S-VCD. Endovascular treatment was more common after P-VCD failure.

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Conflict of interest statement

W. Kim received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Shockwave Medical. M. Adam received consultancy or speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and is a proctor for Abbott, JenaValve, and Medtronic. D. Braun received speaker fees from Abbott and Edwards Lifesciences. D. Leistner received speaker and advisory fees from Abbott. H. Dreger received proctoring, speaker and advisory fees from Abbott and Edwards Lifesciences; as well as research support from Abbott. L. Conradi received advisory fees from Abbott, Medtronic, and JenaValve; as well as consulting fees from Edwards Lifesciences, Boston Scientific, MicroPort, Pi-Cardia, and MicroInterventions. A Schäfer received speaker fees and/or travel support from Edwards Lifesciences, Abbott, and Boston Scientific - unrelated to the submitted work. S. Scholtz received speaker fees from Edwards Lifesciences - unrelated to the submitted work. R.S. von Bardeleben received consulting fees from Abbott. T.K. Rudolph received speaker and advisory fees from Abbott, Edwards Lifesciences, JenaValve, Boston Scientific, Medtronic, and Amgen. M. Seiffert received speaker or advisory fees from Abbott, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol-Myers Squibb, Daichii Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers; and a research grant from Boston Scientific - all unrelated to the submitted work. The other authors have no conflicts of interest to declare.

References

    1. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis, De Paulis, Delgado V, Freemantle N, Haugaa KH, Jeppsson A, Jüni P, Pierard L, Prendergast BD, Sádaba JR, Tribouilloy C, Wojakowski W. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. EuroIntervention. 2022;17:e1126–96. - PMC - PubMed
    1. Hayashida K, Lefèvre T, Chevalier B, Hovasse T, Romano M, Garot P, Mylotte D, Uribe J, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Morice MC. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4:851–8. - PubMed
    1. van Gils, Daemen J, Walters G, Sorzano T, Grintz T, Nardone S, Lenzen M, De Jaegere, Roubin G, Van Mieghem. MANTA, a novel plug-based vascular closure device for large bore arteriotomies: technical report. EuroIntervention. 2016;12:896–900. - PubMed
    1. Toggweiler S, Leipsic J, Binder RK, Freeman M, Barbanti M, Heijmen RH, Wood DA, Webb JG. Management of vascular access in transcatheter aortic valve replacement: part 1: basic anatomy, imaging, sheaths, wires, and access routes. JACC Cardiovasc Interv. 2013;6:643–53. - PubMed
    1. Wood DA, Krajcer Z, Sathananthan J, Strickman N, Metzger C, Fearon W, Aziz M, Satler LF, Waksman R, Eng M, Kapadia S, Greenbaum A, Szerlip M, Heimansohn D, Sampson A, Coady P, Rodriguez R, Krishnaswamy A, Lee JT, Ben-Dor I, Moainie S, Kodali S, Chhatriwalla AK, Yadav P, O’Neill B, Kozak M, Bacharach JM, Feldman T, Guerrero M, Nanjundappa A, Bersin R, Zhang M, Potluri S, Barker C, Bernardo N, Lumsden A, Barleben A, Campbell J, Cohen DJ, Dake M, Brown D, Maor N, Nardone S, Lauck S, O’Neill WW, Webb JG SAFE MANTA Study Investigators. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device. Circ Cardiovasc Interv. 2019;12:e007258. - PubMed

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