Abstract
PurposeReal-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).MethodsThe 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.ResultsIn 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).ConclusionAcute 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.
Highlights
The projected total cost of medical and indirect treatment for atrial fibrillation (AF) in 2019 is $35.7 billion according to a 2016 report commissioned by the American Heart Association [1]
The population was restricted to patients for whom AF type was recorded so that the cohorts could be further divided into paroxysmal AF (PAF) and persistent AF (PsAF) subgroups
The CB2 cohort had a lower percentage of PsAF patients than the SF Catheter (ST) cohort (38.3% versus 47.2%), so comparisons between cohorts were stratified by AF type (Table 1)
Summary
The projected total cost of medical and indirect treatment for AF in 2019 is $35.7 billion according to a 2016 report commissioned by the American Heart Association [1]. Both monetary and societal cost associated with AF can be minimized by utilizing the safest and most effective treatments, but. J Interv Card Electrophysiol technological advances frequently outpace the evidence that is needed for informed decision-making. Radiofrequency (RF) and cryoballoon (CB) ablations are well-established treatment modalities for AF ablation, and both are used frequently in paroxysmal (PAF) and persistent (PsAF) populations. Little published evidence exists currently that compares the most recent products. Much of what does exist are single center studies that may not be representative and that lack sufficient power to detect potential differences in complication rates [6,7,8,9,10]
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