As a retrospective analysis of a de-identified database, the research was exempt from IRB review under 45 CFR 46.101(b)(4). All data used to perform this analysis were de-identified and accessed in compliance with the Health Insurance Portability and Accountability Act. This database includes patient demographics, hospital characteristics, complete diagnosis and procedure coding histories, and chargemaster billing records. Both inpatient and hospital-based outpatient visit information was submitted by 98% of providers. This retrospective population-based study used the de-identified Vizient Health Systems database of real-world inpatient and hospital-based outpatient billing records, which include records for insured and uninsured healthcare recipients from over 400 hospitals in 42 states. The results of this study are intended to provide real-world evidence to help medical administrators, physicians, and payers make informed decisions regarding the latest catheter technologies. The objective of the current study was to compare acute procedure-related complications in a large population of real-world AF patients who underwent AF ablation with a contact force sensing THERMOCOOL SMARTTOUCH® Catheter or THERMOCOOL SMARTTOUCH® SF Catheter (ST Biosense Webster, Irvine, CA) or a second-generation Arctic Front Advance™ Cryoablation Catheter (CB2 Medtronic, Minneapolis, MN), representing clinical practices across the USA. 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. Little published evidence exists currently that specifically compares the most recent products. Improvements in outcomes have been reported for both modalities with the introduction of the latest generations of each technology-contact force (CF) sensing RF ablation catheters and second-generation cryoballoon catheters. 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. Both monetary and societal cost associated with AF can be minimized by utilizing the safest and most effective treatments, but technological advances frequently outpace the evidence that is needed for informed decision-making. 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. Increased risk of complication was attributable to low-volume sites and baseline patient characteristics. ConclusionĪcute ablation-related complication rates were low and were not significantly associated with catheter technology. Neither ablation catheter nor AF type was statistically significant after controlling for site volume, patient age, and comorbid conditions (ST vs. 7.3%), as did ablations with ST compared with CB2 within each AF type (PAF 6.0% vs. Ablations for paroxysmal AF (PAF) had a lower complication rate than ablations for persistent AF (PsAF) (6.1% vs. In total, 1473 ablations met all inclusion criteria (407 ST, 1066 CB2). 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. 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 objective of this study was to compare real-world safety outcomes with the latest catheter technologies used for the treatment of atrial fibrillation (AF). Real-world data can help medical administrators, physicians, and payers make evidence-based decisions regarding treatment choices.
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