Background: The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Meshonly) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Meshonly for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used.
Methods and results: We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3-85.2], 67.0% were female, the STS score was 4.2% [2.8-6.5]. The use of the Meshonly was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Meshonly group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Meshonly was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02-0.48]; p = 0.004).
Conclusions: Transfemoral implantation of the ACURATE neo device using the Meshonly was associated with a lower rate of major access-related complications when compared to the standard of care.
Keywords: ACURATE; Introducer sheath; TAVI; TAVR; Transfemoral access; Vascular complication.
Copyright © 2019 Elsevier B.V. All rights reserved.