Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study
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Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study. / Amat-Santos, Ignacio J; Santos-Martínez, Sandra; Conradi, Lenard; Taramasso, Maurizio; Poli, Arnaldo; Romaguera, Rafael; Pan, Manuel; Bagur, Rodrigo; Del Valle, Raquel; Nombela-Franco, Luis; Bhadra, Oliver D; Aparisi, Álvaro; Redondo, Alfredo; Gutiérrez, Hipólito; Gómez, Itziar; Roman, J Alberto San.
In: CATHETER CARDIO INTE, Vol. 98, No. 2, 01.08.2021, p. E291-E298.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study
AU - Amat-Santos, Ignacio J
AU - Santos-Martínez, Sandra
AU - Conradi, Lenard
AU - Taramasso, Maurizio
AU - Poli, Arnaldo
AU - Romaguera, Rafael
AU - Pan, Manuel
AU - Bagur, Rodrigo
AU - Del Valle, Raquel
AU - Nombela-Franco, Luis
AU - Bhadra, Oliver D
AU - Aparisi, Álvaro
AU - Redondo, Alfredo
AU - Gutiérrez, Hipólito
AU - Gómez, Itziar
AU - Roman, J Alberto San
N1 - © 2020 Wiley Periodicals LLC.
PY - 2021/8/1
Y1 - 2021/8/1
N2 - 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.
AB - 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.
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Female
KW - Heart Valve Prosthesis
KW - Humans
KW - Male
KW - Prosthesis Design
KW - Retrospective Studies
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
U2 - 10.1002/ccd.29423
DO - 10.1002/ccd.29423
M3 - SCORING: Journal article
C2 - 33315296
VL - 98
SP - E291-E298
JO - CATHETER CARDIO INTE
JF - CATHETER CARDIO INTE
SN - 1522-1946
IS - 2
ER -