Cryoballoon ablation of atrial fibrillation in low and medium volume hospitals – experiences of the German REGIONAL registry
Authors: Michaelsen J , Parade U , Bauerle H , Winter K.-D , Rauschenbach U , Mischke K , Schaefer C , Gutleben K.-J , Rana O.R , Willich T , Schloesser M , Roetzer A , Breithardt O.-A , Middendorf S , Hoffmann R ,   REGIONAL
Published: October 2021

Abstract

Background
Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established and widespread procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at low and medium volume hospitals is unknown.

Aim
To determine safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers.

Methods
This registry study prospectively included 1004 consecutive patients who underwent PVI with CBA for symptomatic paroxysmal (n=563) or persistent AF (n=441) between 01/2019 and 09/2020 at 20 community hospitals (each performing &lt;100 PVI/year). Qualifying criteria for participating hospitals were an experience of performing CBA for at least 1 year and a minimum of 50 CBA performed up to the start of the registry. All CBA procedures were performed according to the individual local standards of each hospital. Procedural data, acute efficacy and complications were determined.

Results
The mean annual number of CBA procedures performed was 59±26/hospital, the mean annual number of PVI performed regardless of the method used was 70±26/center. 8/20 hospitals performed CBA only. There were 22 operators (1,1/center), in 12/20 hospitals CBA was performed by an operator being board certified in invasive electrophysiology. 10/20 hospitals included &lt;60 patients/center (n=381), the centers enrolling &gt;60 patients/hospital included a total of 623 pts (62%). Mean procedure time was 90.1±31.6 min, mean fluoroscopy time was 19.2±11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients. Not achieving the goal of “all veins isolated” in a respective patient was mainly due to early termination of CBA procedure due to phrenic nerve palsy.
Major complications occurred in 1,2% of patients: no in-hospital death (0%), clinical stroke in 2 patients (0.2%), pericardial effusion requiring pericardial drainage in 2 patients (0,2%), vascular complications needing vascular surgery and/or blood transfusion in 2 patients (0,2%), phrenic nerve palsy persisting up to hospital discharge in 6 patients (0,6%). Minor complications occurred in 7,5% of patients: pericardial effusion with no need of intervention in 0,4%, access site complications with no need for therapeutic intervention or prolonged in-hospital stay in 2,1% (mainly superficial hematoma) and phrenic nerve palsy resolving before discharge in 4,2%.
No significant difference in the number of complications could be found when testing for numbers of enrolled patients (&gt; or &lt; than 60/hospital) or regarding the board certification status of the operator.

Conclusions
PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high acute efficacy and low complication rates despite low and moderate annual procedure numbers.

Funding Acknowledgement
Type of funding sources: None.