Comparison of real-world clinical and economic outcomes between the ThermoCool® SF and ThermoCool® catheters in patients undergoing radiofrequency catheter ablation for atrial fibrillation

Larry Chinitz,1 Laura J Goldstein,2 Andrea Barnow,2 Sonia Maccioni,2 Mehmet Daskiran,3 Iftekhar Kalsekar,4 Rahul Khanna4 1NYU Langone Health, New York, NY, USA; 2Johnson & Johnson Medical Devices, Irvine, CA, USA; 3Janssen, Raritan, NJ, USA; 4Johnson & Johnson Medical Device Epidemiology, New Brunswick, NJ, USA Introduction: This study evaluated the real-world clinical and economic outcomes associated with the use of the ThermoCool® Surround Flow (SF) and ThermoCool® catheters in atrial fibrillation (AF) ablation.Methods: Adults with AF who underwent catheter ablation between January 1, 2013, and December 31, 2016, in a hospital outpatient setting were identified from the Premier Healthcare Database. Using a search strategy of hospital-charge descriptors, patients were classified into two mutually exclusive groups: ThermoCool® SF catheter and ThermoCool® catheter. A generalized estimating equation was used to compare index admission cost. Survey logistic regression was used to compare the incidence of inpatient readmission, direct-current cardioversion (DCCV), and repeat ablation. Multivariable analyses were adjusted for hospital clustering and demographic, procedural, hospital, and comorbidity characteristics.Results: There were 1,014 and 463 patients in the ThermoCool® SF and ThermoCool® groups, respectively. The ThermoCool® SF group had significantly lower odds of all-cause (odds ratio [OR] 0.45; 95% CI 0.27–0.76) and cardiovascular-related readmissions (OR 0.45; 95% CI 0.21–0.96), and DCCV (OR 0.61; 95% CI 0.42–0.88) than the ThermoCool® group. In patients susceptible to fluid overload, the ThermoCool® SF group had significantly lower odds of 12-month all-cause (OR 0.42; 95% CI 0.23–0.75), cardiovascular-related (OR 0.31; 95% CI 0.10–0.92), and AF-related readmissions (OR 0.18; 95% CI 0.04–0.80), and DCCV (OR 0.52; 95% CI 0.31–0.87) than the ThermoCool® group.Conclusions: Using the ThermoCool® SF catheter for AF ablation was significantly associated with improved clinical outcomes compared with the ThermoCool® catheter. Keywords: atrial fibrillation, radiofrequency ablation, irrigated-tip catheter, ThermoCool® Surround Flow catheter, ThermoCool® catheter