Cost-utility of VISITAG SURPOINT in catheter ablation of atrial fibrillation.

BACKGROUND: Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. METHODS: We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. RESULTS: CA with VS was associated with lower per patient costs vs CA without VS (Germany: €3295 vs. €3936, Belgium: €3194 vs. €3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: €-52,455/QALY, Belgium: €-50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CONCLUSIONS: CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.

Differences in outcomes among patients with atrial fibrillation undergoing catheter ablation with versus without intracardiac echocardiography.

BACKGROUND: Intracardiac echocardiography (ICE) use can lead to early detection of periprocedural complications and may improve patient outcomes by providing real-time visualization of catheter location and the treatment area during cardiac ablation (CA) for atrial fibrillation (AF). OBJECTIVE: Examine complications and 12-month healthcare use among patients with AF undergoing CA with versus without ICE use during the procedure in a real-world setting. METHODS: The 2015-2020 IBM MarketScan® Database was used to identify non-elderly adults (age 18-64 years) undergoing CA for AF. Patients were classified into ICE/non-ICE groups based on the presence or absence of ICE procedure codes. Patients in each group were matched on study covariates using propensity scores. Peri-procedural complications, 12-month cardiovascular (CV) or AF-related inpatient admission, repeat CA, and cardioversion were compared using a Cox proportional hazard model. RESULTS: 1371 patients were identified in each study cohort (ICE and non-ICE) after propensity matching. Patients who had CA with ICE had a significantly lower rate of complications than those without (2.9% vs. 5.8%; p < .001). The risk of complications was 50% lower with ICE use (hazard ratio [HR] 0.50; 95% confidence interval [CI] 0.34-0.72). For assessment of 12-month healthcare utilization, 1250 patients were identified in each cohort after propensity matching. ICE use was associated with a 36% lower risk of 12-month repeat ablation (HR 0.64; 95% CI 0.49-0.83). No differences in CV- or AF-related inpatient admission and cardioversion were observed. CONCLUSION: Among patients with AF, the use of ICE during an ablation procedure was associated with lower incidence of complications and repeat ablation.

Healthcare utilization and cost in patients with atrial fibrillation and heart failure undergoing catheter ablation.

BACKGROUND: Catheter ablation is an effective treatment for patients with atrial fibrillation (AF) and heart failure (HF). However, little is known about how healthcare utilization and cost change after ablation in this population. We sought to determine healthcare utilization and cost patterns among patients with AF and HF undergoing ablation. METHODS: Using a large United States administrative database, we identified (n = 1568) treated with ablation with a primary and secondary diagnosis of AF and HF, respectively, were evaluated 1-year pre- and postablation for outcomes including inpatient admissions (AF or HF), emergency department (ED) visits, cardioversions, length of stay (LOS), and cost. A secondary analysis was extended to 3-years postablation. RESULTS: Reductions were observed in AF-related admissions (64%), LOS (65%), cardioversions (52%), ED visits (51%, all values, p < .0001), and HF-related admissions (22%, p = .01). There was a 40% reduction in inpatient admission cost ($4165 preablation to $2510 postablation, p < .0001). In a sensitivity analysis excluding repeat-ablation patients, a greater reduction in overall AF management cost was observed compared to the full cohort (-43% vs. -2%). Comparing 1-year pre- to 3-years postablation, both total mean AF-management cost ($850 per-patient per-month 1-year pre- to $546 3-years postablation, p < .0001) and AF-related healthcare utilization was reduced. CONCLUSIONS: Catheter ablation in patients with AF and HF resulted in significant reductions in healthcare utilization and cost through 3-years of follow-up. This reduction was observed regardless of whether repeat ablation was performed, reflecting the positive impact of ablation on longer term cost reduction.

Comparative Safety of Pulsed Field Ablation and Cryoballoon Ablation Technologies for Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: A Critical Literature Review and Indirect Treatment Comparison.

INTRODUCTION: Cryoballoon ablation (CBA) is a standard catheter ablation technology with demonstrated clinical effectiveness for the treatment of paroxysmal atrial fibrillation (PAF); however, it can be associated with major adverse events, including phrenic nerve paralysis. Pulsed field ablation (PFA) is a novel, minimally thermal technology with comparable effectiveness and low safety risk. This study aimed to compare the safety profiles of PFA and CBA through critical analyses of the literature and indirect treatment comparisons. METHODS: Studies were identified by searching the MEDLINE database and the Clinicaltrials.gov registry. Registered clinical trials and/or Food and Drug Administration Investigation Device Exemption (FDA IDE) studies evaluating PFA or CBA in adult patients with drug-refractory PAF between January 2008 and March 2023 were selected. Comparative safety between PFA and CBA was assessed for major and prespecified adverse events. Indirect comparisons were conducted using the proportion of patients experiencing adverse events and confirmed with single-arm meta-analyses and sensitivity analyses. RESULTS: Data were extracted from three PFA publications including a total of 497 patients and six CBA studies including a total of 1113 patients. The analysis revealed that PFA was associated with significantly lower risk of major adverse events {risk difference - 4.3% [95% confidence interval (CI) - 5.8, - 2.8]; risk ratio 0.16 [95% CI 0.07, 0.45]} and prespecified adverse events [risk difference - 2.5% (95% CI - 4.4, - 0.5); risk ratio 0.53 (95% CI 0.31, 0.96)]. Meta-analyses confirmed the lower rate of major adverse events for PFA [0.4% (95% CI 0.0, 1.3)] vs. CBA [5.6% (95% CI 2.6, 8.6)] and prespecified adverse events for PFA [2.7% (95% CI 1.2, 4.1)] vs. CBA [5.8% (95% CI 2.7, 9.0)]. Sensitivity analyses exploring heterogeneity across studies confirmed robustness of the main analyses. CONCLUSION: The findings of this study show that PFA has a more favorable safety profile than CBA, with significantly lower risks of major and prespecified adverse events. These indirect comparisons help contextualize the safety of PFA compared to CBA for the treatment of drug-refractory PAF in the absence of head-to-head studies.

QDOT MICRO™ versus THERMOCOOL® SMARTTOUCH™ and THERMOCOOL SMARTTOUCH® Surround Flow in radiofrequency ablation of paroxysmal atrial fibrillation.

Aim: The objective of this study was to indirectly compare QDOT MICRO™ (QDOT), Thermocool® SmartTouch™ (ST) and Thermocool® SmartTouch® Surround Flow (STSF) to treat paroxysmal atrial fibrillation. Methods: Differences in baseline characteristics between study cohorts were reduced by reweighting patients using inverse probability of treatment weighting. The primary outcome was procedure time. Secondary outcomes were fluoroscopy time, clinical success at 12 months, and rhythm monitoring-adjusted recurrence. Results: QDOT was associated with significantly faster mean procedure and fluoroscopy time, and significant improvement in the rate of recurrence compared with pooled ST/STSF. No difference was observed for clinical success at 12 months. Conclusion: QDOT was associated with greater efficiency, greater effectiveness in rhythm monitoring-adjusted recurrence and similar effectiveness in clinical success at 12 months compared with pooled ST/STSF.

Racial/ethnic and sex differences in safety outcomes and atrial fibrillation/atrial flutter-related acute healthcare utilization after catheter ablation of atrial fibrillation.

Background: Catheter ablation is recommended for the treatment of symptomatic atrial fibrillation (AF) refractory to medical therapy. Objective: The study sought to examine racial/ethnic and sex differences in complications and AF/atrial flutter (AFL)-related acute healthcare utilization following catheter ablation for AF. Methods: We performed a retrospective analysis using data from the Centers for Medicare and Medicaid Services Medicare Standard Analytical Files (October 1, 2014, to September 30, 2019) among patients ≥65 years of age with AF who underwent catheter ablation for rhythm control. The risk of any complication within 30 days and AF/AFL-related acute healthcare utilization within 1 year of ablation by race, ethnicity, and sex were assessed using multivariable Cox regression modeling. Results: We identified 95,394 patients for analysis of postablation complications and 68,408 patients for analysis of AF/AFL-related acute healthcare utilization. Both cohorts were ∼95% White and 52% male. Female patients had a slightly elevated risk of complications compared with male patients (adjusted hazard ratio [aHR] 1.07, 95% confidence interval [CI] 1.03-1.12). Black (aHR 0.78, 95% CI 0.77-1.00) and Asian (aHR 0.67, 95% CI 0.50-0.89) patients had lower utilization compared with White patients. Specifically, Asian men (aHR 0.58, 95% CI 0.38-0.91) had lower utilization compared with White men. Conclusion: Differences in safety and healthcare utilization after catheter ablation for AF were observed by race/ethnicity and sex groups. Underrepresented racial and ethnic groups with AF had a lower risk of AF/AFL-related acute healthcare utilization postablation.

Race and Ethnic and Sex Differences in Rhythm Control Treatment of Incident Atrial Fibrillation.

Background: Atrial fibrillation (AF) is associated with considerable morbidity and mortality. Timely management and treatment is critical in alleviating AF disease burden. Variation in treatment by race and ethnic and sex could lead to inequities in health outcomes. Objective: To identify racial and ethnic and sex differences in rhythm treatment for patients with incident AF. Methods: Using 2010-2019 Optum Clinformatics database, an administrative claims data for commercially insured patients in the United States (US), incident AF patients ≥20 years old who were continuously enrolled 12-months pre- and post-index diagnosis were identified. Rhythm control treatment (ablation, antiarrhythmic drugs [AAD], and cardioversion) for AF were compared by patient race and ethnicity (Asian, Hispanic, Black vs White) and sex (female vs male). Multivariable regression analysis was used to examine the relationship of race and ethnicity and sex with rhythm control AF treatment. Results: A total of 77,932 patients were identified with incident AF. Black and Hispanic female patients had the highest CHA2DS2VASc scores (4.3 ± 1.8) and Elixhauser scores (4.1 ± 2.8 and 4.0 ± 6.7), respectively. Black males were less likely to receive AAD treatment (adjusted odds ratio [aOR] 0.87; 95% confidence interval [CI], 0.79-0.96) or ablation (aOR, 0.72; 95% CI, 0.58-0.90). Compared to White males, all groups had lower likelihood of receiving cardioversion with Asian females having the lowest [aOR, 0.48; 95% CI, (0.37-0.63)]. Conclusion: Black patients were less likely to receive pharmacologic and procedural rhythm control therapies. Further research is needed to understand the drivers of undertreatment among racial and ethnic groups and females with AF.

Atrial fibrillation ablation with advanced radiofrequency catheter versus second-generation cryoballoon catheter.

Aim: To compare cost and readmissions among atrial fibrillation (AF) patients undergoing ablation using the THERMOCOOL SMARTTOUCH™ SF (STSF) radiofrequency catheter versus the Arctic Front Advance™ (AFA) cryoballoon catheter. Patients & methods: The Premier Healthcare Database was used for the study purposes. Propensity score matching was used to match patients in the two groups. Costs and readmissions were assessed. A regression model was used for outcome assessment. Results: After propensity matching, 2767 patients were identified in each of the STSF and AFA cohorts. In the matched cohort, STSF patients had significantly lower supply costs than AFA patients. STSF patients had significantly lower 4-12-month AF-related inpatient readmissions compared with AFA patients (2.58% vs 3.99%; p = 0.0402). Costs of care summing index procedure and readmission costs were also lower for the STSF patients versus AFA patients. Conclusions: Patients who underwent AF ablation using the STSF catheter versus the AFA catheter had lower cost and AF-related readmissions.

Catheter ablation using advanced porous tip contact force-sensing radiofrequency catheter: Impact on health care utilization among patients with persistent atrial fibrillation.

Background: Catheter ablation (CA) is an effective treatment for patients with persistent atrial fibrillation (PsAF); however, little is known about its impact on health care utilization for patients with PsAF. The ThermoCool SmartTouch SF (STSF) catheter (Biosense Webster) incorporates an advanced porous tip and contact force-sensing technology. Objective: The purpose of this study was to determine health care utilization among patients with PsAF who underwent ablation with the STSF catheter. Methods: A retrospective cohort study using the Premier Healthcare Database identified patients with PsAF undergoing CA with the STSF catheter in inpatient and outpatient settings. The proportion of patients experiencing AF-related inpatient admissions, outpatient admissions, emergency department (ED) visits, electrical cardioversion, and a composite outcome in the 12 months pre- vs postablation were compared using the McNemar test. Subanalyses were performed on study outcomes by race/ethnicity. Results: The final sample included 3077 patients (mean age 65.9 years; 31.7% female). Among patients with PsAF undergoing ablation with the STSF catheter, relative reductions in health care utilization in the 12 months post- vs preablation included 55.3% in AF-related inpatient admissions (P <.0001), 38.9% in outpatient admissions (P <.0001), 52.4% in ED visits (P <.0001), and 61.2% in electrical cardioversions (P <.0001). Composite outcome utilization in the 12 months post- vs preablation declined by 40.2% (P <.0001) for the overall cohort, 40.0% for White patients (P <.0001), 52.2% for Black patients (P <.0001), and 50.1% for Asian patients (P = .032). Conclusion: Significant improvements in health care utilization were observed among PsAF patients who underwent ablation using the STSF catheter. Improvements were particularly marked in underrepresented racial and ethnic groups.

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

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.

Real-world outcomes comparison among adults with atrial fibrillation undergoing catheter ablation with a contact force porous tip catheter versus a second-generation cryoballoon catheter: a retrospective analysis of multihospital US database.

OBJECTIVE: To compare real-world clinical and economic outcomes among atrial fibrillation (AF) patients undergoing cardiac ablation with the contact force-sensing porous tip THERMOCOOL SMARTTOUCH SF (STSF) catheter versus the Arctic Front Advance Cryoballoon (AFA-CB) catheter. DESIGN: Retrospective, observational cohort study. SETTING: Premier Healthcare Database (PHD), between 1 September 2016 and 30 June 2018. PARTICIPANTS: Patients with AF (≥18 years) were included if they had an index ablation procedure performed using the STSF catheter or AFA-CB catheter at a US hospital that consistently provided inpatient and outpatient data to PHD in the 12-month preindex period. Using 1:1 propensity score matching, patient groups were matched on study covariates. PRIMARY AND SECONDARY OUTCOME MEASURES: Cost, length of stay (LOS), readmissions, direct current cardioversion (DCCV) and reablation outcomes were compared between matched cohorts of STSF and AFA-CB patients. RESULTS: A total of 3015 patients with AF met the study criteria, of which 1720 had ablation using the STSF catheter and 1295 had ablation using the AFA-CB catheter. In the propensity-matched sample, patients receiving ablation with the STSF catheter had ~17% lower total costs (US$23 096 vs US$27 682, p≤0.0001) and ~27% lower supply costs (US$10 208 vs US$13 816, p≤0.0001) versus patients receiving ablation with the AFA-CB catheter. A significantly lower likelihood of 4-month to 6-month cardiovascular-related readmission (OR 0.460, 95% CI 0.220 to 0.959) was associated with the STSF catheter versus the AFA-CB catheter. No significant differences in LOS, room and board cost, 4-month to 6-month all-cause and AF-related readmissions, DCCV and reablation were observed among technologies. Sensitivity analysis restricting patient sample by provider ablation volume demonstrated similar results. CONCLUSION: Lower index ablation total and supply costs were observed among patients with AF undergoing cardiac catheter ablation using the STSF catheter versus the AFA-CB catheter.

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

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.