Comparison of VASCADE MVP XL and Figure of 8 suture for vascular closure of the Faradrive sheath for pulsed field ablation

Background

Hemostasis following atrial fibrillation (AF) ablation is often achieved with figure of 8 suture (F8) and vascular closure devices. The VASCADE MVP XL closure device is indicated for closure of large bore sheaths to a 15Fr outer and 12Fr inner max diameter. Farapulse pulsed field ablation (PFA) is performed through the Faradrive sheath with a 16.8 Fr outer and 13 Fr inner diameter.

Purpose

The purpose of the study is to evaluate the efficacy and safety of VASCADE MVP XL compared with figure of eight stitch (F8) closure of the Faradrive delivery sheath in patients undergoing PFA ablation and same day discharge.

Methods

This was a single center retrospective study, involving 118 patients who underwent Farapulse PFA ablation over a 6 month period and closed with either the VASCADE MVP XL or F8. All patients underwent reversal with protamine prior to sheath removal. The F8 stitch was removed prior to discharge. Outcomes were assessed immediately post procedure and for the duration of observation prior to discharge.

Results

Over a 6-month period, patients were selected retrospectively. A total of 118 patients underwent outpatient PFA for AF. 59 underwent VASCADE MVP XL closure device and 59 underwent FO8 closure. There was no significant difference in Protamine dose between groups. In the VASCADE MVP XL arm(N=59): Success of deployment/closure- 59(100%), bedrest time(avg)-3hours 59(100%), minor bleeding- 0(0%), major bleeding- 0(0%), vascular complication- 0(0%), same day discharge- 59(100%). In the F8 arm(N=59): Success of deployment/closure- 58(98.3%), bedrest time(avg)- 3hours 57(96.6%), 4hours 2(3.4%), minor bleeding- 2(3.4%), major bleeding- 1(1.7%), vascular complication- 1(1.7%), same day discharge- 57(96.6%).

Minor bleeding - bleeding that required additional manual pressure or small hematoma.

Major bleeding - bleeding associated with >2 g/dl drop in hemoglobin, requiring transfusion or large hematoma.

Vascular complication - deep vein thrombosis, arteriovenous fistular, pseudoaneurysm or requiring surgical repair.

Conclusion

In this retrospective single center study, using VASCADE MVP XL for closure of the Faradrive delivery sheath is comparable to figure of eight closure with high deployment success and low risk of bleeding and vascular complication.