Procedural and clinical outcomes according to ultrasound-guided access in TAVI: A propensity-matched comparative sub-analysis from the PULSE registry

David Grundmann (Hamburg)1, T. K. Rudolph (Bad Oeynhausen)2, M. Adam (Köln)3, C. Kellner (Hamburg)1, S. Bleiziffer (Bad Oeynhausen)4, D. Braun (Dießen)5, A. R. Tamm (Mainz)6, M. Meertens (Mainz)7, C. W. Hamm (Gießen)8, J. Gmeiner (München)9, A. Sedaghat (Bonn)10, D. Leistner (Frankfurt am Main)11, M. Renker (Bad Nauheim)12, H. S. Wienemann (Köln)3, N. Zapustas (Wuppertal)13, B. Juri (Berlin)14, M. Salem (Kiel)15, R. Benetti Lehmann (Detmold)16, A. Goßling (Hamburg)1, A. Nahif (Hamburg)1, S. Blankenberg (Hamburg)1, H. Reichenspurner (Hamburg)17, L. Conradi (Hamburg)17, N. Schofer (Hamburg)18, A. Schäfer (Hamburg)17, J. Popara (Kiel)19, M. sudo (Bonn)10, M. Geyer (Mainz)6, M. M. Vorpahl (Wuppertal)20, D. Frank (Kiel)15, S. Scholtz (Bad Oeynhausen)21, W.-K. Kim (Bad Nauheim)12, M. Seiffert (Hamburg)1

1Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; 2Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 3Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 4Herz- und Diabeteszentrum NRW Klinik für Thorax- und Kardiovaskularchirurgie Bad Oeynhausen, Deutschland; 5Kardiologie Ammer-Lech Drs. D. Braun/ M. Orban Dießen, Deutschland; 6Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; 7Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie Mainz, Deutschland; 8Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; 9LMU Klinikum der Universität München Kardiologie München, Deutschland; 10Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; 11Universitätsklinikum Frankfurt Med. Klinik III - Kardiologie, Angiologie Frankfurt am Main, Deutschland; 12Kerckhoff Klinik GmbH Abteilung für Kardiologie Bad Nauheim, Deutschland; 13Helios Universitätsklinikum Wuppertal - Herzzentrum Universität Witten/Herdecke Wuppertal, Deutschland; 14Charité - Universitätsmedizin Berlin CC 11: Med. Klinik für Kardiologie Berlin, Deutschland; 15Universitätsklinikum Schleswig-Holstein Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin Kiel, Deutschland; 16Klinikum Lippe Detmold Klinik für Kardiologie, Angiologie, Intensivmedizin Detmold, Deutschland; 17Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, Deutschland; 18Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland; 19Universitätsklinikum Schleswig-Holstein Kiel, Deutschland; 20Helios Universitätsklinikum Wuppertal - Herzzentrum Medizinische Klinik 3 - Kardiologie Wuppertal, Deutschland; 21Herz- und Diabeteszentrum NRW Klinik für Kardiologie Bad Oeynhausen, Deutschland



Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. 



The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. 



Median age was 81.9 [interquartile range 78.3, 85.0] years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (median EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p<0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p<0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (2.7% vs. 2.0%, p=0.31) were similar in both groups. 



In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

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