Safety and efficacy of the unilateral, suture-based, dry-closure technique in percutaneous trans-axillary aortic valve implantation.

Abstract

Background: Transaxillary transcatheter aortic valve implantation (TAx-TAVI) is the most used alternative access when severe iliofemoral disease renders transfemoral access infeasible. Compared to surgical transaxillary access, a true percutaneous approach using vascular closure devices (VCD) has advantages but can be challenging. Herein, we describe the impact of the "unilateral, suture-mediated, dry-closure technique" on vascular safety and efficacy in patients undergoing true percutaneous TAx-TAVI.

Methods: A total of 77 patients undergoing percutaneous TAx-TAVI were categorized into a cohort before (C1, n = 40) and after (C2, n = 37) implementation of the suture-based dry-closure technique using an upstream occlusion balloon. In C1, arteriotomy closure mainly consisted of plug-based VCD. The primary (safety) endpoint was occurrence of major or minor access-site related vascular complications in accordance with Valve Academic Research Consortium 3 criteria. Technical success rates (at exit from procedure room) were used to assess procedural efficacy.

Results: The mean age of the study population was 79 ± 7 years and 49 % were male. From C1 to C2, the Society of Thoracic Surgeons Predicted Risk of Mortality reduced numerically (from 4.1 to 3.6 %, p = 0.060). Procedures became more streamlined with use of local anesthesia in 100 % (83 % in C2) and the left axillary artery in 76 % (68 % in C2). The primary (safety) endpoint occurred in 34 % of the patients, but reduced from 45 % in C1 to 16 % in C2 (p = 0.011). Concurrently, there was a reduction in VCD failure (45 vs 14 % [incomplete arteriotomy closure in all 5 cases], p = 0.003), bleeding complications (45 vs 14 %, p = 0.003) and bailout vascular surgery/stenting (40 % vs. 16 %, p = 0.021). Technical success was 80 % in C1 and 87 % in C2 (p = 0.45) and median length of hospital stay reduced from 5 (25th-75th percentile: 2-7) to 3 days (25th-75th percentile: 2-5, p = 0.080).

Conclusions: The unilateral, suture-based dry-closure technique facilitates safe and effective access management in high-risk patients selected for percutaneous TAx-TAVI procedures.