Background:
Large-bore femoral venous access is routinely required for pulsed-field ablation (PFA) of atrial fibrillation and is traditionally managed by manual compression and post-procedural immobilization. A fully resorbable patch-based vascular closure system may provide reliable venous hemostasis following large-bore access.
Objective:
To evaluate the feasibility and safety of a fully resorbable patch-based closure system for large-bore femoral venous access closure after PFA-based pulmonary vein isolation (PVI).
Methods:
We performed a prospective consecutive registry analysis of 50 patients undergoing single-shot PFA-based PVI via a single large-bore femoral venous sheath (16.8F outer diameter) following ultrasound-guided venous puncture. After completion of PVI, venous access was closed using a fully resorbable patch-based closure system followed by a light pressure bandage for 2 hours. Procedural characteristics, anticoagulation parameters (heparin dose and activated clotting time [ACT]), device success, and access-site complications were assessed. Clinical follow-up was performed by telephone 30 days after the procedure.
Results:
Median age was 67.2 years (IQR 48–85), and 22% of patients were female. Atrial fibrillation was paroxysmal in 54% and persistent in 46%. Median procedure time was 31 minutes (IQR 14–82), and median fluoroscopy time was 5.1 minutes (IQR 0.59–16.07). Median heparin dose was 8,500 IU (IQR 6,000–10,000), resulting in a median postprocedural ACT of 300 seconds (IQR 241– > 400). Protamine was administered in 25/47 patients with available data (53.2%) because of ACT values >300 seconds. Device deployment was successful in all patients (50/50, 100%), with immediate hemostasis achieved in all cases. Superficial access-site bleeding related to the skin incision occurred in 6/50 patients (12%) and was not attributed to device failure. No major bleeding events occurred. No vascular access complications, including hematoma, pseudoaneurysm, or arteriovenous fistula, were observed, and no re-interventions were required. Three patients were discharged on the day of the procedure at their own request, whereas all remaining patients underwent overnight observation according to institutional practice. No access-site complications were reported during 30-day follow-up.
Conclusion:
In this prospective consecutive series, closure of large-bore femoral venous access after PFA-based PVI using a fully resorbable patch-based closure system was feasible and achieved immediate hemostasis in all patients. No major vascular access-site complications or re-interventions were observed during index hospitalization or at 30-day follow-up. Prospective comparative studies are warranted to further evaluate the safety and potential clinical benefits of this approach.
