Dataset Information

Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.

ABSTRACT:

Background

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, and it increases the risk of stroke, heart failure, and other cardiac complications. Catheter ablation is well-established as a treatment for paroxysmal AF, and the recent PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF) clinical trial resulted in the catheter gaining approval for the treatment of persistent AF in the United States.

Objectives

To construct an economic simulation model, based on the results of the PRECEPT trial, to monetize the impact of radiofrequency catheter ablation (RFCA) compared with medical therapy (MT).

Methods

Cost-offset and break-even analyses were performed to assess the economic impact of RFCA vs MT for adult persistent AF patients. Three perspectives were considered: commercial payers, Medicare, and self-insured employers. A cohort-level decision tree model was developed and validated in TreeAge Pro 2019. Sensitivity analyses were performed to determine the robustness of findings.

Results

For all 3 types of payer, RFCA had a higher initial cost compared with MT. However, reductions in health care utilization after ablation, driven by decreased cardiovascular hospitalizations, led to an annual cost offset of between $5037 and $8402 after the first year. Projecting this forward resulted in an estimated cost break-even after 5.9, 4.2, and 5.1 years for commercial payers, Medicare, and self-insured employers, respectively.

Conclusion

In addition to providing clinical benefits, RFCA may be a valuable economic investment for U.S. payers, substantially reducing utilization after the first year.

SUBMITTER: Osorio J

PROVIDER: S-EPMC9795304 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.

Osorio Jose J Mansour Moussa M Melby Daniel D Imhoff Ryan J RJ Hunter Tina D TD Maccioni Sonia S Wei Tom T Natale Andrea A

Heart rhythm O2 20220920 6Part A

<h4>Background</h4>Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, and it increases the risk of stroke, heart failure, and other cardiac complications. Catheter ablation is well-established as a treatment for paroxysmal AF, and the recent PRECEPT (Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF) clinical trial resulted in the catheter gaining approval for the treatment of persistent AF ...[more]

PMID: 36589917

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Project description:ImportanceThe ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions.ObjectiveTo use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication.Design, setting, and participantsThis retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data.ExposuresUse of the CF-I6 or CF-I56 catheter.Main outcomes and measuresThe primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs.ResultsOverall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P < .001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%).Conclusions and relevanceIn this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices.

Dataset Information

Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.

Background

Objectives

Methods

Results

Conclusion

Publications

Economic Evaluation of Contact Force Catheter Ablation for Persistent Atrial Fibrillation in the United States.

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