Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Propensity-matched comparison of plug- and suture-based vascular closure after TAVI in the PULSE registry
D. Grundmann1, W.-K. Kim2, C. Kellner1, M. Adam3, D. Braun4, A. R. Tamm5, M. Meertens6, C. W. Hamm7, S. Bleiziffer8, J. Gmeiner4, A. Sedaghat9, D. Leistner10, M. Renker2, H. S. Wienemann3, E. Charitos2, M. Linnemann4, T. Lerchner11, B. Juri12, M. Salem13, R. Benetti-Lehmann14, H. Dreger15, A. Gossling1, A. Nahif1, L. Conradi16, N. Schofer17, A. Schäfer16, J. Popara13, M. Sudo9, S. Scholtz18, R. S. von Bardeleben19, M. M. Vorpahl11, D. Frank20, T. K. Rudolph14, M. Seiffert1
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 2Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 3Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 4Medizinische Klinik und Poliklinik I, LMU Klinikum der Universität München, München; 5Kardiologie 1, Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 6Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 7Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 8Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 9Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 10Med. Klinik III - Kardiologie, Angiologie, Universitätsklinikum Frankfurt, Frankfurt am Main; 11Medizinische Klinik 3 - Kardiologie, Helios Klinikum Wuppertal - Herzzentrum, Wuppertal; 12CC 11: Med. Klinik für Kardiologie, Charité - Universitätsmedizin Berlin, Berlin; 13Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Kiel; 14Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 15CC11: Med. Klinik m. S. Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin; 16Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 17Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 18Klinik für Kardiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 19Zentrum für Kardiologie im Herz- und Gefäßzentrum, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 20Med. Klinik III / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Kiel;

Background

Vascular access site and bleeding complications remain of concern in transfemoral transcatheter aortic valve implantation (TAVI). A relevant share is related to insufficient vascular closure at the large-bore access site. Plug- and suture-based vascular closure strategies have been evaluated before, but results remain inconsistent. We assessed vascular access and bleeding complications in a large multicenter real-world registry to compare both approaches.

 

Methods

The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 10,120 consecutive patients who underwent transfemoral TAVI at 10 German heart centers from 2016 to 2021. A propensity score was used to match 962 patients who received plug-based (P-VCD; Manta, Teleflex) with 1,942 patients who received suture-based (S-VCD; Perclose Proglide, Abbott Vascular) vascular closure in a 1:2 fashion. Vascular anatomy was assessed from contrast-enhanced multidetector computed tomography. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions and compared between P-VCD and S-VCD groups. 

 

Results 

Mean age was 81.9±6.4 years, 45.9% of patients were female and the median of EuroSCORE II was 3.30% overall. Comorbidities and clinical variables were well-balanced in matched P-VCD and S-VCD patients. The incidence of vascular complications was higher in P-VCD vs. S-VCD (17.3.% vs. 13.8%, p=0.017). Large-bore access related complications occurred in 15.1% vs. 10.0% (p=0.001), respectively, and were considered major in 3.3% vs. 4.0% (p=0.409) or minor in 11.8% vs. 5.9% (p=0.001). Bleeding accounted for most of these complications (68.5% for both groups) and was treated with prolonged balloon inflation (41.1% vs. 22.9%, p=0.001), covered stent implantation (31.8% vs. 11.2%, p=0.001) and surgical repair (4.7% vs. 14.9%, p=0.007). In 0.3% vs. 3.4% (p=0.001) vascular complications were linked to the secondary access. Time to vascular closure was shorter in P-VCD vs. S-VCD (8.0 vs. 11.0 min, p<0.001). Type 3/4 bleeding was more frequent in S-VCD patients (2.0% vs. 3.8%, p=0.010); the remaining VARC-3 outcomes did not differ significantly between both groups. 

 

Conclusion

In this large propensity-matched comparison of patients treated with transfemoral TAVI, P-VCD was associated with higher rates of vascular access site complications compared to S-VCD, primarily driven by minor vascular complications at the large-bore access site. Both VCD strategies required a different skillset for complication management. In addition, secondary access related complications led to a relevant number of vascular and bleeding complications. These aspects should be considered when selecting access and closure options for TAVI procedures.
https://dgk.org/kongress_programme/jt2023/aV1261.html