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

Kévin Roulot; Marion Kibler; Antonin Trimaille; Adrien Carmona; Amandine Granier; Philoktimon Plastaras; Jérôme Rischner; Stéphane Gréciano; Pierre Leddet; F. De Poli; Mohamad Kanso; Ulun Crimizade; Kim L. Boyer; Hoàng Văn Minh; Michel Kindo; Laurence Jesel; Olivier Morel; Patrick Ohlmann

doi:10.3390/jcm14197113

Figures

Why the study?

Femoral artery vascular closure during TAVI remains prone to complications, and the efficacy and safety of a single ProGlide strategy compared to the traditional two-device technique required evaluation.

Does a single-ProGlide vascular closure strategy reduce in-hospital vascular and bleeding complications compared to the traditional double-ProGlide strategy in patients with aortic stenosis undergoing transfemoral TAVI?

Structured PICO

Does a single-ProGlide vascular closure strategy reduce in-hospital vascular and bleeding complications compared to the traditional double-ProGlide strategy in patients with aortic stenosis undergoing transfemoral TAVI?

P

Population

1,303 consecutive, unselected patients with aortic stenosis undergoing transfemoral transcatheter aortic valve implantation (TAVI), mean age 81.7 years, 47% female, at a single center in France (University Hospitals of Strasbourg) between January 2020 and December 2023.

I

Intervention

Single Perclose ProGlide suture-based vascular closure device strategy (1P) deployed at the 12 o'clock position for pre-closing femoral arterial access (n=733, 56.3%). Additional devices were implanted at the 12 o'clock orientation if initial deployment was insufficient. Both groups received ultrasound-guided femoral puncture, heparin 100 IU/kg (ACT >250 s), protamine 1 mg per 100 IU of heparin after closure, and 3-5 minutes of manual compression.

C

Comparator

Traditional double Perclose ProGlide suture-based vascular closure device strategy (2P) positioned at 10 o'clock and 2 o'clock orientations for pre-closing femoral arterial access (n=570, 43.7%). Additional devices were implanted at 12 o'clock if insufficient. Both groups received ultrasound-guided femoral puncture, heparin 100 IU/kg (ACT >250 s), protamine 1 mg per 100 IU of heparin after closure, and 3-5 minutes of manual compression.

O

Outcome

Composite of all vascular and bleeding complications, as defined by the Valve Academic Research Consortium-3 (VARC-3) classification system, occurring during hospitalization.composite

In patients undergoing transfemoral TAVI, a single-ProGlide pre-closure strategy provides comparable overall vascular and bleeding safety to the traditional double-ProGlide technique while significantly reducing closure device failure rates and overall device utilization.

Limitations

Retrospective, single-center, observational design susceptible to confounding factors
Selection bias as the 1P and 2P approaches were carried out by different operators at their discretion, and operator-specific information was not captured
Temporal confounding and learning curve differential, as 2P was used in earlier years while 1P was introduced at registry initiation
Anatomical characteristics of the vascular access points (femoral artery diameter, calcifications, tortuosity) may have impacted outcomes
Database did not capture detailed, separate information on whole blood or red blood cell transfusion requirements

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Implication

Single-ProGlide was associated with fewer device failures and similar complications in TAVI; hypothesis-generating and requires RCT confirmation before practice change.

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.

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Cite This Study

Roulot et al. (2025) studied this question.

synapsesocial.com/papers/69db57230d8d6ef495a3d517 https://doi.org/10.3390/jcm14197113

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

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Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Figures

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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