Real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation.

PURPOSE: Real-world data can help medical administrators, physicians, and payers make evidence-based decisions regarding treatment choices. The objective of this study was to compare real-world safety outcomes with the latest catheter technologies used for the treatment of atrial fibrillation (AF).

METHODS

The Vizient Health Systems database, a large US hospital database, was used to compare acute complications in AF ablation with the contact force sensing THERMOCOOL SMARTTOUCH® Catheter or the THERMOCOOL SMARTTOUCH® SF Catheter (ST) versus the second-generation Arctic Front Advance™ Cryoablation Catheter (CB2) between September 2015 and June 2017. The primary outcome was a composite safety endpoint of acute ablation-related complications defined via ICD-10 diagnosis and procedure codes, including tamponade and other pericardial events, respiratory complications, stroke, cerebral or pre-cerebral occlusion/stenosis without infarction, vascular access complications, hemorrhage, phrenic nerve injury, myocardial infarction, and pulmonary embolism.

RESULTS

In total, 1473 ablations met all inclusion criteria (407 ST, 1066 CB2). Ablations for paroxysmal AF (PAF) had a lower complication rate than ablations for persistent AF (PsAF) (6.1% vs. 7.3%), as did ablations with ST compared with CB2 within each AF type (PAF 6.0% vs. 6.1%, PsAF 6.3% vs. 7.8%). Neither ablation catheter nor AF type was statistically significant after controlling for site volume, patient age, and comorbid conditions (ST vs. CB2: OR 0.86, p = 0.5544; PsAF vs. PAF: OR 1.08, p = 0.7376).

CONCLUSION

Acute ablation-related complication rates were low and were not significantly associated with catheter technology. Increased risk of complication was attributable to low-volume sites and baseline patient characteristics.