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Introduction Both radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency. Methods IPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis. Results In the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses. Conclusion Radiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01846-z.

Atrial fibrillation (AF) ablation is most commonly performed using radiofrequency (RF) and cryoballoon (CB) catheters. Ablation Index is a novel lesion-quality marker associated with improved outcomes in RF ablation. Due to lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option. Aim: To conduct a network meta-analysis to evaluate the comparative effectiveness of RF with Ablation Index to other catheter ablation devices in the treatment of AF. Methods: Searches for randomized and nonrandomized prospective comparative studies of ablation catheters were conducted in multiple databases. The outcome of interest was 12-month freedom from atrial arrhythmias after a single ablation procedure. Studies were grouped as high-, low- and unclear-quality based on study design and balanced baseline patient characteristics. Bayesian hierarchical network meta-analysis was conducted and results presented as relative risk ratios with 95% credible intervals (CrIs). Results: 12 studies evaluating five different catheter ablation devices were included. Radiofrequency ablation with Ablation Index was associated with statistically significantly greater probability of 12-month freedom from atrial arrhythmias than Arctic Front (relative risk: 1.77; 95% CrI: 1.21–2.87), Arctic Front Advance™ (1.41; 1.06–2.47), THERMOCOOL™ (1.34; 1.17–1.48) and THERMOCOOL SMARTTOUCH™ (1.09; 1–1.3). Results were robust in multiple sensitivity analyses. Conclusion: Radiofrequency catheter with Ablation Index is superior to currently available options for 12-month freedom from atrial arrhythmias after AF ablation. This study provides decision-makers with robust, pooled, comparative evidence of the latest ablation technologies.

INTRODUCTION: Research evidence has shown that catheter ablation is a safe and superior treatment for atrial fibrillation (AF) compared to medical therapy, but real-world practice has been slow to adopt an early interventional approach. This study aims to determine the cost effectiveness of catheter ablation compared to medical therapy from the perspective of the United Kingdom. METHODS: A patient-level Markov health-state transition model was used to conduct a cost-utility analysis. The population included patients previously treated for AF with medical therapy, including those with heart failure (HF), simulated over a lifetime horizon. Data sources included published literature on utilization and cardiovascular event rates in real world patients, a systematic literature review and meta-analysis of randomized controlled trials for AF recurrence, and publicly available government data/reports on costs. RESULTS: Catheter ablation resulted in a favorable incremental cost-effectiveness ratio (ICER) of £8614 per additional quality adjusted life years (QALY) gained when compared to medical therapy. More patients in the medical therapy group failed rhythm control at any point compared to catheter ablation (72% vs. 24%) and at a faster rate (median time to treatment failure: 3.8 vs. 10 years). Additionally, catheter ablation was estimated to be more cost-effective in patients with AF and HF (ICER = £6438) and remained cost-effective over all tested time horizons (10, 15, and 20 years), with the ICER ranging from £9047-£15 737 per QALY gained. CONCLUSION: Catheter ablation is a cost-effective treatment for atrial fibrillation, compared to medical therapy, from the perspective of the UK National Health Service.

Introduction Ablation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). Methods Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9–15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037–1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. Results Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27–0.95) and matched (0.42, 0.21–0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20–0.85), age and left ventricular ejection fraction (0.37, 0.16–0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13–0.71). Secondary and sensitivity analyses showed similar reductions. Conclusions Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons. Electronic Supplementary Material The online version of this article (10.1007/s12325-019-01173-4) contains supplementary material, which is available to authorized users.

Atrial fibrillation (AF), the most common form of arrhythmia, is fast becoming one of the world’s most significant health issues. It is well established that AF increases the risk of mortality, and is associated with significant morbidity, including an increased risk of stroke. AF also worsens quality of life for patients, which can also be a burden for caregivers. As a result of Europe’s ageing population, the prevalence of AF is expected to rise substantially in the future. With more patients expected to be affected by AF, rates for AF-related strokes, hospitalisations, and doctor visits are also expected to rise, ultimately raising healthcare system costs across Europe. It is estimated that up to 2.6% of total annual healthcare expenditure is associated with AF in European countries. The high cost of AF is largely attributable to hospitalisations and complications such as stroke, i.e., in 2015, stroke was estimated to cost €45 billion a year in the European Union (EU). The purpose of this review is to highlight the current scale and growing burden of this new millennium epidemic in Europe. This review aims to foster a greater awareness and understanding of the magnitude of the clinical, patient, and economic burden of AF. An understanding of the burden of AF is imperative for directing care pathway management and healthcare policies that can help alleviate the burden of AF experienced by patients, caregivers, and healthcare systems in Europe.

Atrial fibrillation (AF), the most common form of arrhythmia, increases the risk of heart failure, stroke, and death. Management of AF focusses on effectively and safely controlling irregular heart rhythm, improving symptoms, and reducing complications. Early treatment of AF is important as it may improve patient life expectancy and quality of life (QoL). Current European guidelines recommend an integrated approach to AF management that involves shared decision making between patients and multidisciplinary teams of healthcare professionals to improve access to care and patient compliance. Treatment options include the use of anticoagulants, cardioversion, rate control therapies, and rhythm control therapies. Over the long term, rhythm control strategies that include antiarrhythmic drugs (AAD) and catheter ablation are the most common methods for controlling AF. The objective of this review is to highlight current European AF care pathway management recommendations and to examine the clinical, economic, and patient impact of different treatment options, including AAD and catheter ablation. While AAD have been shown to improve QoL and are affordable in the short term, treatment is moderately effective, associated with significant side effects, and can be costly long term. Catheter ablation is a highly effective therapy choice that improves patient wellbeing and is associated with a low rate of ablation-related complications. Compared to drug therapy, catheter ablation provides a significant reduction in AF burden, reduces rates of recurrence, provides a greater improvement in QoL, and facilitates long-term cost savings.