Safety and Efficacy of Single Femoral Vein Puncture Technique for Double Access in Patent Foramen Ovale Closure Under ICE Guidance-A Single Center Experience of the "Two-In-One Technique"

Abstract

Background: In selected patient populations, percutaneous closure of patent foramen ovale has been shown to be beneficial in preventing cerebral ischaemic events. In most cases, this procedure requires echocardiographic guidance, which may be transesophageal, transthoracic or intracardiac. Intracardiac echocardiography (ICE) has the advantage of not requiring general anaesthesia but usually requires a second vascular access.

Aims: The aim of this study was to evaluate the safety and efficacy of the single femoral vein puncture technique for double veinous access compared to conventional bilateral double puncture during patent foramen ovale (PFO) closure under intracardiac echocardiography (ICE) guidance.

Methods: A retrospective study including all patients who underwent PFO closure under ICE guidance between January 2018 and April 2024 in University Hospital of Dijon, comparing the single puncture technique, defined as a single vascular hole for two sheaths, with those who underwent bilateral puncture. We collected baseline patient characteristics as well as intra- and post-procedural data, especially significant vascular complications (bleeding, false aneurysm, deep vein thrombosis, arteriovenous fistula) and procedural success (defined as successful placement of the prosthesis, meeting stability criteria, without embolization). In addition, patients were asked to rate the comfort of the procedure on a scale of 0 to 10 after the procedure.

Results: We analyzed 179 consecutive patients, of whom 126 received a femoral vein approach using the two-in-one technique and 53 received a bilateral femoral vein puncture. PFO closure was successful in all cases regardless of group. No tamponade, device migration, or death was observed during hospitalization. Vascular complication rate was comparable (3 (1.6%) vs. 2 (3.8%); p = 0.582). In addition, the single puncture technique was associated with an increased comfort score compared with the bilateral puncture technique (9.20 ± 1.55 vs. 8.44 ± 1.93; p = 0.044), shorter procedure time (40 min [32; 50] vs. 60 min [48; 70]; p < 0.001), hospital stay duration (0.82 ± 1.02 days vs. 2.04 ± 0.83 days; p < 0.001) and fluoroscopy time (5.71 min [4.28; 8.33] vs. 9.57 min [7.42; 13.11]; p < 0.001).

Conclusion: The single femoral vein puncture technique for double femoral vein access is safe and effective for PFO closure under ICE guidance. It is also associated with increased patient comfort and reduced fluoroscopy time, although large multicenter studies are needed to confirm these results.

Keywords: ICE; PFO closure; intracardiac echocardiography; local anesthesia; vascular access.

Figure 1

Main steps of the two‐in‐one technique applied to ICE‐guided PFO closure. (A) Single femoral venous puncture. (B) Preclosure with suture‐based vessel closure device (Perclose ProStyle System (Abbott Vascular Inc., United States)). (C) Double 0.035" wiring of the introducer sheath. (D) Insertion of the two introducers. (E) ICE‐guided device positioning. [Color figure can be viewed at wileyonlinelibrary.com]