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Transaxillary transcatheter ACURATE neo aortic valve implantation – The TRANSAX multicenter study
Author(s) -
AmatSantos Ignacio J.,
SantosMartínez Sandra,
Conradi Lenard,
Taramasso Maurizio,
Poli Arnaldo,
Romaguera Rafael,
Pan Manuel,
Bagur Rodrigo,
Valle Raquel,
NombelaFranco Luis,
Bhadra Oliver D.,
Aparisi Álvaro,
Redondo Alfredo,
Gutiérrez Hipólito,
Gómez Itziar,
Roman J. Alberto San
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29423
Subject(s) - medicine , surgery , axillary artery , valve replacement , cardiac tamponade , cardiology , stenosis
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.