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Comparative Study
. 2025 Aug;18(8):e014771.
doi: 10.1161/CIRCINTERVENTIONS.124.014771. Epub 2025 May 29.

Procedural and Clinical Outcomes According to Ultrasound-Guided Access in TAVI: A Propensity-Matched Comparative Subanalysis From the PULSE Registry

David Grundmann  1 , Tanja Rudolph  2 , Matti Adam  3 , Caroline Kellner  1   4 , Sabine Bleiziffer  2 , Daniel Braun  5 , Alexander R Tamm  6 , Max Meertens  3 , Matthias Renker  7 , Jonas Gmeiner  5 , Alexander Sedaghat  8   9 , David Leistner  10   11   12 , Christian W Hamm  7 , Hendrik Wienemann  3 , Norvydas Zapustas  13 , Benjamin Juri  10   14 , Mostafa Salem  15 , Roman Benetti-Lehmann  2 , Henryk Dreger  16   17   18   19 , Alina Gossling  1   4 , Awesta Nahif  1 , Stefan Blankenberg  1   4   20 , Hermann Reichenspurner  8   20 , Niklas Schofer  1 , Andreas Schaefer  8   9 , Jasmin Popara  15 , Misumasa Sudo  9 , Martin Geyer  6 , Marc Vorpahl  21 , Derk Frank  15   20 , Max Potratz  2 , Won Kim  22 , Moritz Seiffert  1   20   23
Affiliations
Comparative Study

Procedural and Clinical Outcomes According to Ultrasound-Guided Access in TAVI: A Propensity-Matched Comparative Subanalysis From the PULSE Registry

David Grundmann et al. Circ Cardiovasc Interv. 2025 Aug.

Abstract

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 adverse events, particularly in large-bore arterial access. However, large-scale data on this approach are limited, and it has not yet been fully implemented into standard clinical practice. We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided access from a large multicenter TAVI registry.

Methods: The PULSE registry (Plug- or Suture-Based Vascular Closure After TAVI) retrospectively evaluated data of 9295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers (2016-2021). USG and fluoroscopy-guided access were performed in 1992 (21.4%) and 7303 (78.6%) patients, respectively. Propensity score matching (1:1) yielded 895 matched pairs. The primary end point, a composite of minor and major vascular complications or bleeding type II-IV, was assessed according to Valve Academic Research Consortium definitions.

Results: Patients in the USG and fluoroscopy-guided groups (median age, 81.9 [78.3-85.0] years; 47.8% female patients) showed well-balanced baseline characteristics. The overall risk profile was comparable (median EuroSCORE II: 3.2 versus 3.5; SD, 0.007 [-0.086 to 0.099]). The composite primary end point occurred less frequently in the USG group (11.7% versus 16.0%; odds ratio, 0.7; P=0.01), driven by lower rates of procedural bleeding (5.4% versus 9.2%; odds ratio, 0.56; P=0.002) and with lower rates of endovascular treatment (0.7% versus 2.5%; P=0.005).

Conclusions: In patients with transfemoral TAVI, USG access demonstrated lower rates of access-related vascular complications and type II-IV bleeding compared with fluoroscopy-guided access. Implementing USG puncture as the standard of care may improve access-related outcomes after TAVI.

Keywords: fluoroscopy; hemorrhage; morbidity; punctures; registries; retrospective studies; standard of care.

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Conflict of interest statement

Dr Rudolph received speaker and advisory fees from Abbott, Edwards Lifesciences, JenaValve, Boston Scientific, Medtronic, and Amgen. Dr Adam received consultancy or speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic and is a proctor for Abbott, JenaValve, and Medtronic. Dr Braun received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Tamm received consultancy or speaker fees from Edwards Lifesciences, JenaValve, and Medtronic and is a proctor for JenaValve. Dr Bleiziffer received speaker fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Leistner received speaker and advisory fees, and proctoring and travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Renker received proctor fees from Boston Scientific and Medtronic. Dr Dreger received proctoring, speaker, and advisory fees from Abbott and Edwards Lifesciences and research support from Abbott. Dr Reichenspurner received consultancy or speaker fees from Edwards Lifesciences, Abiomed (speakers bureau), and Medtronic (advisory board). Dr Schaefer received speaker fees and travel support from Edwards Lifesciences, Abbott, and Boston Scientific and is a proctor for Abbott, unrelated to the submitted work. Dr Geyer received consultancy or speaker fees from Edwards Lifesciences and is a proctor for JenaValve. Dr Frank received speaker fees from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific, and consulting fees and a research grant from Edwards Lifesciences, all unrelated to the presented work. Dr Kim received personal fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Shockwave Medical. Dr Seiffert received speaker or advisory fees from Abbott Vascular, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers and a research grant from Boston Scientific, all unrelated to the submitted work. The other authors report no conflicts.

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