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Comparative Study
. 2024 Dec 23;17(24):2923-2932.
doi: 10.1016/j.jcin.2024.09.020.

Femoral or Radial Secondary Access in TAVR: A Subanalysis From the Multicenter PULSE Registry

David Grundmann  1 , Won Kim  2 , Caroline Kellner  3 , Matti Adam  4 , Daniel Braun  5 , Alexander R Tamm  6 , Max Meertens  4 , Christian W Hamm  2 , Sabine Bleiziffer  7 , Jonas Gmeiner  5 , Alexander Sedaghat  8 , David Leistner  9 , Matthias Renker  2 , Hendrik Wienemann  4 , Efstratios Charitos  2 , Marie Linnemann  5 , Norvydas Zapustas  10 , Benjamin Juri  11 , Mostafa Salem  12 , Henryk Dreger  13 , Alina Goßling  14 , Awesta Nahif  14 , Lenard Conradi  15 , Niklas Schofer  14 , Andreas Schäfer  16 , Jasmin Popara  12 , Misumasa Sudo  8 , Max Potratz  7 , Martin Geyer  6 , Marc Vorpahl  17 , Derk Frank  18 , Tanja K Rudolph  7 , Moritz Seiffert  19
Affiliations
Free article
Comparative Study

Femoral or Radial Secondary Access in TAVR: A Subanalysis From the Multicenter PULSE Registry

David Grundmann et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Transradial secondary access (TR-SA) may serve as an alternative to the traditional femoral secondary access (TF-SA) for pigtail placement in transcatheter aortic valve replacement (TAVR).

Objectives: The aim of this study was to assess the incidence of secondary access-related vascular complications after TR-SA or TF-SA in TAVR.

Methods: The PULSE (Plug or sUture based vascuLar cloSurE after TAVR) registry retrospectively evaluated data of 10,120 patients who underwent transfemoral TAVR at 10 heart centers from 2016 to 2021. We compared TR-SA and TF-SA groups of 8,851 patients with available data regarding the secondary access location and validated observed data in 1:1 propensity score matching. Outcomes were evaluated according to Valve Academic Research Consortium 3 definitions.

Results: The median age was 82.0 ± 6.9 years, and 49.1% (4,346/8,851) of patients were female. TR-SA was selected in 1,686 patients (19.0%) and TF-SA in 7,165 (81.0%) overall. Vascular complications at the secondary access occurred in 0.3% (5/1,686 [TR-SA]) vs 3.2% (232/7,165 [TF-SA]; P < 0.001) and were considered major in 0.2% (3/1,686 [TR-SA]) vs 1.5% (109/7,165 [TF-SA]) and minor in 0.1% (2/1,686 [TR-SA]) vs 1.7% (123/7,165 [TF-SA]; P < 0.001 for both). Surgical repair was required in 0 TR-SA patients and in 0.9% (66/7,165) of TF-SA patients. Primary access vascular complications were similar (11.6% (196/1,686 [TR-SA]) vs 11.5% (825/7,165 [TF-SA]); P = 0.93); bleeding type III/IV occurred less with TR-SA (2.5% [42/1,686] vs 4.7% [334/7,165] with TF-SA; P < 0.001). After propensity score matching, secondary access-related vascular complication rates remained lower for TR-SA (0.2% [1/512] vs 2.9% [15/512] for TF-SA; P < 0.001).

Conclusions: During transfemoral TAVR, TR-SA was associated with lower rates of access site complications and severe bleeding compared to TF-SA. In fact, secondary access-related complications were 10× higher for TF-SA and frequently required invasive treatments. These findings challenge the fact that most TAVR procedures are still performed with TF-SA.

Keywords: TAVR; access; femoral; radial; secondary.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Kim has received personal fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Shockwave Med. Dr Adam has 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 has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr Tamm has received consultancy or speaker fees from Edwards Lifesciences, JenaValve, and Medtronic; and is a proctor for JenaValve. Dr Bleiziffer has received speaker fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Leistner has received speaker and advisory fees from Abbott. Dr Dreger has received proctoring, speaker, and advisory fees from Abbott and Edwards Lifesciences; and has received research support from Abbott. Dr Conradi has received advisory fees from Abbott, Medtronic, and JenaValve; and has received consulting fees from Edwards Lifesciences, Boston Scientific, MicroPort, PiCardia, MicroInterventions, VenusMedtech, and Smartcanula Sàrl. Dr Schäfer has received speaker fees and/or travel support from Edwards Lifesciences, Abbott, and Boston Scientific unrelated to the submitted work. Dr Geyer has received consultancy or speaker fees from Edwards Lifesciences; and is a proctor for JenaValve. Dr Rudolph has received speaker and advisory fees from Abbott, Edwards Lifesciences, JenaValve, Boston Scientific, Medtronic, and Amgen. Dr Seiffert has received speaker or advisory fees from Abbott Vascular, Abiomed, Amgen, AstraZeneca, Boston Scientific, Bristol Myers Squibb, Daichii-Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers; and has received a research grant from Boston Scientific all unrelated to the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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