Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Plug- or suture-based vascular closure after TAVI: Results from a large multicenter registry
D. Grundmann1, W.-K. Kim2, D. Braun3, A. R. Tamm4, S. Bleiziffer5, C. W. Hamm6, J. Gmeiner3, D. Frank7, M. Renker2, D. Leistner8, S. Blankenberg9, M. Linnemann3, M. Meertens10, T. Lerchner11, H. Reichenspurner12, J. Popara13, B. Juri8, A. Goßling1, L. Conradi12, D. Westermann14, N. Schofer14, S. Scholtz15, R. S. von Bardeleben16, M. Adam17, M. M. Vorpahl11, T. K. Rudolph18, M. Seiffert19
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; 3Medizinische Klinik und Poliklinik I, LMU Klinikum der Universität München, München; 4Kardiologie 1, Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 5Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 6Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 7Klinik für Innere Medizin III, Kardiologie, Angiologie und Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Kiel; 8CC 11: Med. Klinik für Kardiologie, Charité - Universitätsmedizin Berlin, Berlin; 9Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Hamburg; 10Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 11Medizinische Klinik 3 - Kardiologie, Helios Klinikum Wuppertal - Herzzentrum, Wuppertal; 12Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 13Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Kiel; 14Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 15Klinik für Kardiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 16Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 17Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 18Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 19Klinik und Poliklinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg;

Background

Transfemoral transcatheter aortic valve implantation (TAVI) requires large-bore access with the subsequent risk of access site complications. Vascular complications and bleeding events are associated with impaired outcomes. Plug- or suture-based vascular closure is frequently performed but data comparing both approaches remain inconsistent. We assessed access and bleeding complications in a large multicenter registry to evaluate both strategies.

 

Methods

We retrospectively evaluated data of 6,049 patients who underwent transfemoral TAVI at 9 German heart centers from 2016 to 2021. Vascular closure was performed with a plug-based (P-VCD; Manta, Teleflex) or suture-based (S-VCD; Perclose Proglide, Abbott Vascular) device in 1,198 (19.8%) and 4,851 (80.2%) patients according to the operators’ preference. 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 S-VCD and P-VCD groups.

 

Results

Mean age was 80.7±6.8 years and 48.7% of patients were female (mean logistic EuroSCORE II: 4.8±6.4%), overall. Peripheral artery disease was more prevalent in P-VCD vs. S-VCD (16.3 vs. 13.1%, p=0.01) patients. Minimal lumen diameters of the common femoral arteries (7.6±3.4 vs. 7.3±1.5 mm), sheath sizes (14.6±1.3 vs. 14.7±1.2 French, both p=ns) and the fraction of balloon-expandable devices (39.6 vs. 41.3%, p=0.31) were similar. Overall access site complication rates did not differ between both devices (13.0 vs. 12.3%, p=0.52). P-VCD was associated with fewer major complications (2.5 vs. 5.3%, p<0.01) but more minor complications (10.5 vs. 7.0%, p<0.01). Type 3/4 bleeding was more frequent in S-VCD patients (4.3% vs. 2.7%, p<0.01), no significant difference was observed in type 2 bleeding (4.4% vs. 5.7%, p=0.07). All-cause 30-day mortality was similar at 2.2% and 2.1% (p=0.82).

 

Conclusion

In patients treated with transfemoral TAVI, a plug-based vascular closure device was associated with lower rates of severe bleeding or major access site complications compared to a suture-based strategy, however minor access site complications were more frequent after plug-based closure. Future analyses should aim to identify which patients benefit most from either of the two approaches.
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