Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: the PRO-PVI study

Abstract

Aims The leading reason for delayed discharge after pulmonary vein isolation (PVI) is vascular complications. This study aimed to evaluate feasibility, safety, and efficacy of the Perclose Proglide™ suture-mediated vascular closure in ambulatory PVI, report complications, patient satisfaction, and cost of this approach. Methods and results Patients scheduled for PVI were enrolled prospectively in an observational design. Feasibility was assessed as % discharged the day of procedure. Efficacy was analysed as acute access site closure rate, time to reach haemostasis, time to ambulate, and time to discharge. Safety analysis consisted of vascular complications at 30 days. Cost analysis was reported using direct and indirect cost analysis. A 1:1 propensity matched control cohort was used for comparing time to discharge to usual workflow. Of 50 enrolled patients, 96% were discharged on the same day. 100% of devices were successfully deployed. Immediate (<1 min) haemostasis was reached in 30 patients (62.5%). Mean time to discharge was 5:48 ± 1:03 h (vs. 10:16 ± 1:21 h in the matched cohort, P < 0.0001). Patients reported high level of satisfaction with the post-operative time. No major vascular complication occurred. Cost analysis showed a neutral impact compared to the standard of care. Conclusion The use of the closure device for femoral venous access after PVI led to safe discharge of patients within 6 h from the intervention in 96% of the population. This approach could minimize the overcrowding of healthcare facilities. The gain in post-operative recovery time improved patients’ satisfaction and balanced the economic cost of the device.

Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach ― The Fast and Furious PFA Study ―

“…Ultrasound-guided vascular access reduces the number of vascular access complications, and moreover, use of venous closure devices results in earlier ambulation. 2 Application of thermal energy by cryothermal, laser or radiofrequency (RF) energy is currently the standard approach for lesion formation, but because thermal energy is non-selective there is a risk of collateral damage, including esophageal thermal injury and injury of nervous tissue. [3][4][5] Recently, irreversible electroporation by pulsed field ablation (PFA) has been introduced as a novel source for lesion formation.…”

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study

“…Predefined patient questionnaires assessing comfort/discomfort, pain, and need for pain drugs were performed after the procedure, while 30 days postprocedural, the EQ-5D-5L score was assessed. 12 , 17 , 25 The femoral access site was assessed 30 min after sheath removal, as well as each hour for a minimum of 2 h or until the patient could stand up and walk.…”

“… 11 Furthermore, AF ablation necessitates an intensive periprocedural anticoagulation regime to prevent thromboembolism going along with an increased rate of bleeding and haematoma. 12 , 13 …”

“…Established measures to reduce vascular complications include ultrasound-guided venous puncture, figure-of-eight suture, and manual compression (MC), followed by pressure bandage. 12 , 14 , 15 A short time to ambulation (TTA) and a reduced vascular access complication rate are important prerequisites to successfully implement SDD protocols in real practice. The actual standard of care in achieving haemostasis after venous vascular accesses is MC, with or without a figure-of-eight suture.…”

Venous occlusion after incidental edge-to-edge suturing of a venous valve using suture-mediated closure devices

“… 1 , 2 Recently, feasibility of ambulatory pulmonary vein isolation work flow using the suture-mediated closure (SMC) device was reported. 3 However, reports describing complications associated with venous hemostasis using the SMC device are limited. Herein, we present a case of venous occlusion we encountered that required a surgical repair after incidental edge-to-edge suturing of a venous valve using the SMC device.…”