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Multicenter Study
. 2021 Aug 1;98(2):E291-E298.
doi: 10.1002/ccd.29423. Epub 2020 Dec 14.

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study

Ignacio J Amat-Santos  1 , Sandra Santos-Martínez  1 , Lenard Conradi  2 , Maurizio Taramasso  3 , Arnaldo Poli  4 , Rafael Romaguera  5 , Manuel Pan  6 , Rodrigo Bagur  7 , Raquel Del Valle  8 , Luis Nombela-Franco  9 , Oliver D Bhadra  2 , Álvaro Aparisi  1 , Alfredo Redondo  1 , Hipólito Gutiérrez  1 , Itziar Gómez  1 , J Alberto San Roman  1
Affiliations
Multicenter Study

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study

Ignacio J Amat-Santos et al. Catheter Cardiovasc Interv. .

Abstract

Background: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes.

Methods and results: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge.

Conclusions: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality.

Keywords: ACURATE neo; TAVI; TAVR; trans-subclavian; transaxillary.

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References

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