David Grundmann; Won Kim; Caroline Kellner; Matti Adam; Daniel Braun; Alexander Tamm; Max Meertens; Christian Hamm; Sabine Bleiziffer; Jonas Gmeiner; Alexander Sedaghat; David Leistner; Matthias Renker; Hendrik Wienemann; Efstratios Charitos; Marie Linnemann; Tobias Lerchner; Benjamin Juri; Mostafa Salem; Roman Benetti-Lehmann; Henryk Dreger; Alina Goßling; Awesta Nahif; Lenard Conradi; Niklas Schofer; Andreas Schäfer; Jasmin Popara; Misumasa Sudo; Smita Scholtz; Ralph von Bardeleben; Marc Vorpahl; Derk Frank; Tanja Rudolph; Moritz Seiffert

doi:10.4244/EIJ-D-24-00120

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

Your reference journal for coronary, valvular and structural interventions

Original Research

DOI: 10.4244/EIJ-D-24-00120

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

David Grundmann¹, MD, MHBA; Won Kim², MD; Caroline Kellner¹^,³, MSc; Matti Adam⁴, MD; Daniel Braun⁵, MD; Alexander R. Tamm⁶, MD; Max Meertens⁴, MD; Christian W. Hamm², MD; Sabine Bleiziffer⁷, MD; Jonas Gmeiner⁵, MD; Alexander Sedaghat⁸, MD; David Leistner⁹^,¹⁰, MD; Matthias Renker², MD; Hendrik Wienemann⁴, MD; Efstratios Charitos², MD, PhD; Marie Linnemann⁵, MD; Tobias Lerchner¹¹, BSc; Benjamin Juri⁹^,¹², MD; Mostafa Salem¹³, MD; Roman Benetti-Lehmann⁷, MD; Henryk Dreger¹⁴^,¹⁵, MD; Alina Goßling¹, MSc; Awesta Nahif¹, MD; Lenard Conradi¹⁶, MD; Niklas Schofer¹, MD; Andreas Schäfer¹⁶, MD, MHBA; Jasmin Popara¹³, MD; Misumasa Sudo⁸, MD, PhD; Smita Scholtz⁷, MD; Ralph Stephan von Bardeleben⁶, MD; Marc Vorpahl¹¹, MD; Derk Frank¹³^,¹⁷, MD; Tanja K. Rudolph⁷, MD; Moritz Seiffert¹^,³^,¹⁷^,¹⁸, MD

1. Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 2. Abteilung Kardiologie/Kardiochirurgie, Kerckhoff-Klinik GmbH, Herz und Thorax Zentrum, Bad Nauheim, Germany; 3. Center for Population Health Innovation (POINT), University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 4. University Hospital Cologne – Heart Center, Klinik III für Innere Medizin - Kardiologie, Pneumologie und internistische Intensivmedizin, Cologne, Germany; 5. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; 6. Zentrum für Kardiologie - Kardiologie I, Universitätsmedizin Mainz, Mainz, Germany; 7. Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany; 8. Med. Klinik II - Kardiologie, Universitätsklinikum Bonn, Bonn, Germany; 9. Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), Medizinische Klinik für Kardiologie, Berlin, Germany; 10. Med. Klinik III - Kardiologie, Universitätsklinikum Frankfurt, Frankfurt, Germany; 11. Helios Universitätsklinikum Wuppertal - Herzzentrum Universität Witten/Herdecke, Wuppertal, Germany; 12. Department of Cardiology, University Hospital Zurich, Zurich, Switzerland; 13. Klinik für Innere Medizin III, Schwerpunkte Kardiologie, Angiologie und Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Kiel, Germany; 14. Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow-Klinikum, Berlin, Germany; 15. DZHK (German Centre for Cardiovascular Research), partner site Berlin, Berlin, Germany; 16. Department of Cardiovascular Surgery, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 17. German Centre for Cardiovascular Research (DZHK), partner site Hamburg/Lübeck/Kiel, Hamburg/Lübeck/Kiel, Germany; 18. BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany

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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