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December 14, 2020
Boston Scientific’s Acurate Neo System Studied for Transaxillary TAVR
December 14, 2020—The multicenter TRANSAX study evaluated transcatheter aortic valve replacement (TAVR) with the Acurate Neo aortic valve (Boston Scientific Corporation) via a transaxillary (TAx) approach, which is an off‐label procedure. The study’s aim was to gather information on Acurate Neo patients implanted via the TAx approach and report major outcomes.
Ignacio J. Amat‐Santos MD, et al published findings from the TRANSAX study online ahead of print in Catheterization and Cardiovascular Interventions.
KEY FINDINGS
- Risk scores were higher when right axillary artery and surgical cut‐down were selected.
- There were no severe complications (valve embolization, coronary obstruction, annulus rupture, and procedural mortality).
- Cardiac tamponade occurred in two patients (2.7%), with one requiring conversion to open surgery (1.3%).
- Bail‐out stenting was required in seven (9.3%) patients.
- Surgical vascular repair was required in three (4%) patients.
- New permanent pacemaker was required in 8%.
- Procedural success (96%), in‐hospital mortality (2.7%), and 1‐year mortality (8%) were comparable in all settings.
- One patient (1.3%) experienced a cerebrovascular event and one patient (1.3%) presented moderate aortic regurgitation before discharge.
The TRANSAX investigators retrospectively gathered 75 patients (79 ± 10 years; 32% women) from nine centers in Europe and North America who were treated with the Acurate Neo valve through the TAx approach up to May 2019. Most patients were treated through the left axillary artery (72%) and under conscious sedation (95.2%). Follow-up was prespecified at 1 year and was obtained for all patients.
Overall, the investigators concluded that TAx TAVR procedures with the Acurate Neo valve resulted in high success rates and low in‐hospital and 1‐year mortality.
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