Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Femoral or Radial Secondary Access in TAVI: A Sub-Analysis from the Multicenter 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, N. Zapustas11, B. Juri12, M. Salem13, H. Dreger14, A. Goßling1, A. Nahif1, L. Conradi15, N. Schofer16, A. Schäfer15, J. Popara13, M. Sudo9, M. Potratz17, R. S. von Bardeleben18, M. M. Vorpahl11, D. Frank19, T. K. Rudolph20, 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; 14CC11: Med. Klinik m. S. Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin; 15Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 16Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 17Klinik für Kardiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 18Zentrum für Kardiologie im Herz- und Gefäßzentrum, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 19Med. Klinik III / Kardiologie, Angiologie, Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Kiel; 20Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen;

Background

Radial access is the primary choice for percutaneous coronary interventions due to lower rates of access-related complications. Similarly, radial access (TR-SA) may serve as an alternative to the traditional femoral secondary access (TF-SA) for pigtail placement in transcatheter aortic valve implantation (TAVI). Due to the paucity of large-scale data on the impact of secondary access strategies on clinical outcomes, we compared both approaches during TAVI in a large multicenter registry. 

 

Methods

The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 8.792 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. Secondary access was selected at the operator’s discretion and both groups (TF-SA and TR-SA) were compared. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions.

 

Results

Mean age was 82.0±6.9 years and 49.0% of patients were female. The overall risk profile was higher in TF-SA vs. TR-SA (mean EuroSCORE II: 3.5 [2.2, 5.8] vs. 2.8 [1.8, 4.8], p<0.001). TF-SA was selected in 7,109 patients (80.9%) and TR-SA in 1,683 (19.1%) overall. Mean sheath size for secondary access was 6 French (6.0,6.0). Overall access site complication rates did not differ in TF-SA vs. TR-SA (15.4% vs. 14.2%, p=0.24), however major complications were observed more often in TF-SA (6.5% vs. 4.5%, p=0.003). While similar vascular complication rates occurred related to the large-bore TAVI access (11.4% vs. 11.5%, p=0.94), 3.2% vs. 0.3%, (p=0.001) were linked to the TF vs. TR secondary access alone (major: 47%, minor: 53%). Surgical repair and endovascular stent implantation were required in 28.4% and 3.6% of these secondary access vascular complications in TF-SA and none in TR-SA. Type 3 or 4 bleeding was more frequent in TF-SA patients (4.7 vs. 2.4%, p=0.001). Stroke (2.3 vs. 2.4%, p=1.0) and acute kidney injury stage IV (0.6 vs. 0.4%, p=0.39) were similar in both groups.

 

Conclusion

In patients treated with transfemoral TAVI, a radial secondary access was associated with lower rates of major access site complications and severe bleeding compared to a (bi-)femoral strategy. In fact, vascular complications related to the secondary access alone were 10-times higher in patients with a femoral secondary access and were followed by invasive treatments in a relevant number of patients. These findings challenge the fact that most TAVI procedures are still performed with a femoral secondary access.
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