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

Clin Res Cardiol (2024). DOI 10.1007/s00392-024-02406-5
D. 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

Background

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. 

 

Methods

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. 

 

Results

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. 

 

Conclusion

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.