Introduction:  PVI is an effective, guideline-based treatment for drug refractory symptomatic AF.  Balloon cryoablation has been shown to be a safe and effective method for PVI.  In the STOP-AF trial, data was produced from practitioners performing PVI with significant experience at high volume centers.  This study evaluates the effectiveness and safety of treating symptomatic, drug refractory AF with PVI via cryoablation after implementation in a regional medical center.

Method:  This represents a retrospective analysis of outcomes after cryoablation treatment for AF in 71 patients over 354.7 +/- 164.4 days.  Reported and recorded episodes of AF were categorized into a representative percent of AF “burden” for each 90 day period.  Primary effectiveness and safety end points paralleled those of the STOP-AF trial.

Results:   Patients undergoing cryoablation had a 91% reduction of AF burden at 6 months following the procedure with an event-free survival rate of 45.5 % at a mean follow up of 12 months.  The mean burden reduction was 3.21% per quarter.  Anti-arrhythmic and anticoagulant medication use was reduced by 14.3% and 26.8% respectively. Significant complications included one report of pulmonary vein stenosis, one report of pseudoaneurysm and 5.5% of patients had transient pericarditis or pericardial effusion following the procedure.

Conclusion:   The results of this study were comparable to those of the high volume multi-center STOP-AF trial. PVI via cryoablation is a safe and effective alternative treatment of drug refractory symptomatic AF in the setting of a regional medical center.

Abbreviations:  Atrial fibrillation (AF), pulmonary vein isolation (PVI)