A further step in process optimization for AF ablation: Safety, feasibility and efficacy of RF point by point PVI with single femoral access and utilisation of a suture mediated closure device

Rolf Weinert (Neumünster)1, T. Patzke (Neumünster)1, R. Asbeck (Neumünster)2, A. M. Holst (Neumünster)1, A. Schuchert (Neumünster)2

1Friedrich-Ebert-Krankenhaus Neumünster GmbH Rhythmologie Neumünster, Deutschland; 2Friedrich-Ebert-Krankenhaus Neumünster GmbH Medizinische Klinik Neumünster, Deutschland

 

Aim: In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity and cut their costs by optimizing process management. Short procedure times and early ambulation therefore play an increasingly important role. Management of vascular access site is a critical part of early ambulation and discharge. We developed a new workflow for point by point radiofrequency pulmonary vein isolation with a single femoral venous access and closure of the venous puncture site with a suture-mediated closure system (Abbott Perclose ProStyle). The main obstacle we had to overcome was to develop a method für a safe transseptal puncture without the aid of a coronary sinus catheter in situ. Therefore, we introduced a virtual CS catheter by means of an image overlay technique originally developed for coronary interventions. The aim of this study is to show the safety, feasibillity and efficacy of this approach.
Methods: Analysis of 50 consecutive patients (mean age 71.3 years) with paroxysmal or persistent AF undergoing pulmonary vein isolation (PVI) with our newly developed workflow. Safety was assessed as rate of major complications within 30 days. Feasibility was assessed as percentage of succesful procedures and percentage of patients deemed suitable for discharge on the day of the procedure. Efficacy was analysed as acute access site closure rate, time to ambulate, and time to patient deemed suitable for discharge. 

Results: Of 50 patients, there were no major complications intraprocedurally or within 30 days after the procedere. All procedures were completed succesfully and 44 patients (88%) were deemed suitable for discharge within six hours after the procedure. 47 (94%) oft the devices were successfully deployed. Immediate (<1 min) haemostasis was reached in 44 (88%) patients, mean time to ambulation was 2.7 hours and mean time to patient deemed suitable for discharge was 4.2 hours.

Conclusion: The use of a single femoral venous access for radiofrequency point by point pulmonary vein isolation together with a suture-mediated cluosure device was proven to be safe, feasible and efficient. 88% of patients were deemed suitable for discharge within six hours after the procedure.

Baseline characteristics
Age [years] 71.3 48-79
Female sex [n] 2244%
Paroxysmal AF [n] 2754%
Persistent AF [n] 2346%
CHA2DS2-Vasc-Score 2.3 0-6


Results
Succesful completion of procedure [n] 50100%
Serious adverse events within 30 days [n] 0 0%
Succesful deployment of suture mediated closure device [n] 47 94%
Hemostasis ≤ 1 min after removal of sheaths [n] 4488%
Mean time to ambulation [h] 2.7 
Mean time to patient deemed suitable for discharge [h] 4.2 
Patients deemed suitable for discharge within six hours after the procedure [n] 4488%
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