Femoral Closure with Single ProGlide® in Transcatheter Aortic Valve Implantation: A Registry-Based Study

Abstract

Background: Vascular closure of the femoral artery during transcatheter aortic valve implantation (TAVI) remains a critical step prone to complications, despite advancements in introducer technology. The traditional technique involves using two ProGlide^® suture closure devices (2P), but alternative approaches, such as employing a single ProGlide^® device (1P), have emerged. Aims: We sought to evaluate the efficacy and safety of the 1P strategy compared to the standard 2P closure technique during transfemoral TAVI procedures. Methods: A registry-based study was conducted at the University Hospitals of Strasbourg, France, from January 2020 to December 2023. Consecutive patients who underwent TAVI via the transfemoral approach were deemed eligible. Results: The study cohort consisted of 1303 patients, with a mean age of 81.7 years and 47% female. The 1P strategy was used in 733 cases (56.3%), while the 2P technique was employed in 570 patients (43.7%). Hemostasis was achieved in the catheterization laboratory without additional devices in 30.4% of the single-ProGlide^® pre-closing cases. Vascular complication rates were similar in both groups, at 11.3% for the 1P technique and 11.4% for the 2P technique (p = 0.964). However, vascular closure device failure was significantly less frequent in the 1P group (1.6%) compared to the 2P group (5.3%). Conclusions: The 1P strategy for pre-closing during TAVI is as effective and safe as the conventional 2P approach. The 1P method offers potential advantages in terms of simplicity and cost-effectiveness.

Keywords: femoral procedures; registry; transcatheter aortic valve implantation; vascular access; vascular closure device.

Figure 1

Distribution of vascular closure devices used per patient by pre-closing strategy for arterial access closure. Upper panel: distribution of vascular closure devices (VCD) used in the single-ProGlide^® (1P) and double-ProGlide^® (2P) strategies. The categories 1VCD, 2VCD, 3VCD, and >3VCD represent the percentage of patients requiring one, two, three, or more than three VCDs to achieve effective vascular closure, while “Failure” indicates the percentage of patients experiencing closure failure. Lower panel: percentage of patients achieving complete hemostasis with one VCD, one or two VCDs, or one, two, or three VCDs in both the 1P and 2P strategy groups.

Figure 2

Treatment approaches for vascular and bleeding complications, showing the number of patients requiring various interventions including medical treatment, balloon angioplasty for hemostasis, uncovered stent implantation, covered stent implantation, vascular surgery, or other therapeutic approaches.

Figure 3

Upper panel: number of patients experiencing vascular closure failure in the single-ProGlide^® (1P) and double-ProGlide^® (2P) strategy groups, detailing complications treated by vascular surgery, balloon inflation, covered stent implantation, or uncovered stent placement. Lower panel: percentage of patients with device failure in the entire cohort and stratified by 1P and 2P strategy groups. The rate of failure of vascular closure devices was 3.2% among the 1303 patients treated via a percutaneous transfemoral approach for transcatheter aortic valve implantation. The failure rates were 1.6% with the single ProGlide^® strategy (1P) and 5.3% with the double ProGlide^® approach (2P) (p < 0.001).

Figure 4

Description of the patient cohort showing the distribution of patients in the single-ProGlide^® and double-ProGlide^® strategy groups, the number and percentage of bleeding and vascular complications, vascular closure device (VCD) failure rates, and the number of vascular closure devices required per 100 patients treated.