Key result
Contact force sensing radiofrequency ablation resulted in similar acute complication rates compared to second-generation cryoballoon ablation for atrial fibrillation (6.1% vs 6.8%; adjusted OR 0.86, p=0.5544).
Why the study?
Real-world data can guide evidence-based decisions, prompting a comparison of real-world safety outcomes with newer catheter technologies for atrial fibrillation ablation.
Does contact force sensing radiofrequency ablation compared to cryoballoon ablation reduce acute complications in patients undergoing atrial fibrillation ablation?
Cohort (n=1,473)
Yes
Does contact force sensing radiofrequency ablation compared to cryoballoon ablation reduce acute complications in patients undergoing atrial fibrillation ablation?
Odds Ratio: 0.86 (95% CI 0.53–1.41)
Absolute Event Rate: 6.1% vs 6.8%
p-value: p=0.5544
Acute ablation-related complication rates are low and comparable between contact force radiofrequency and cryoballoon technologies, with risk primarily driven by low-volume sites and patient characteristics.
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.
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Natale et al. (2020) conducted a cohort in Atrial fibrillation (n=1,473). Contact force sensing radiofrequency ablation (ST) vs. Second-generation cryoballoon ablation (CB2) was evaluated on Composite of acute ablation-related complications (OR 0.86, 95% CI 0.53-1.41, p=0.5544). Contact force sensing radiofrequency ablation resulted in similar acute complication rates compared to second-generation cryoballoon ablation for atrial fibrillation (6.1% vs 6.8%; adjusted OR 0.86, p=0.5544).
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