Toward Reducing Disparities in Approval Timelines and Establishing Appropriate Reimbursement Frameworks for Catheter Ablation Systems in Europe, the United States, and Japan

Catheter ablation therapy for patients with tachyarrhythmias, initiated in the 1980s, began with direct current (DC) ablation using external defibrillation systems 1. Over the subsequent three decades, radiofrequency (RF) energy and cryo-thermal ablation became the predominant modalities 2. In the 2020s, pulsed electric field ablation (PFA) was introduced into clinical practice for pulmonary vein isolation in patients with atrial fibrillation (AF) 3. While technological innovation aimed at improving the efficacy and safety of catheter ablation continues to advance, the timing of approval and reimbursement frameworks for new catheter ablation systems varies substantially among major countries. These disparities are influenced by differences in national regulatory requirements, evidence standards for approval, reimbursement processes, and broader economic conditions 4 In the present study by Oguri et al., the authors evaluated differences in approval timelines for catheter ablation systems across three regions: the European Union (EU), the United States, and Japan 5. They reported that the median (range) approval delay in Japan was 23.5 (9.0–73.5) months compared to the EU, 6.0 (−11.3 to 24.5) months compared to the United States, and 25.5 (8.3–42.5) months in the United States compared to the EU. As shown in tab. 1 of the present study, approval delays in Japan became more pronounced with the introduction of new ablation energy sources, such as cryo-thermia and PFA (e.g., Freezor Medtronic, Inc.: 174-month delay vs. the EU; FARAWAVE Boston Scientific, Inc.: 43-month delay vs. the EU) 5. These findings suggest that changes in ablation energy modality are associated with more cautious regulatory evaluation in Japan. The criteria regarding the type, quantity, and rigor of clinical evidence required for regulatory approval differ across countries. In the United States, randomized controlled trial data are considered mostly important, whereas in the EU, conformity assessment supported by clinical evaluation is also taken into account. Over the past three decades of investigation into the efficacy and safety of thermal ablation systems (including RF and cryoablation), no apparent, clinically significant differences attributable to race have been demonstrated. Therefore, once approval has been obtained in the EU, the need to repeat similar domestic clinical trials in Japan appears limited. Instead, careful assessment through postapproval market surveillance, including accurate reporting of complication rates (postmarketing surveillance), may be considered a more appropriate approach. To reduce approval delays in Japan, particularly relative to the EU, conducting simultaneous multinational clinical trials involving EU countries would be desirable. However, achieving this goal is hindered by the inherent difficulties of regulatory harmonization across jurisdictions. As noted by the authors, further facilitation of initiatives such as collaborative consultation programs and the International Medical Device Regulators Forum (IMDRF) will become increasingly important going forward. Although approvals in the EU are often granted earlier than in the United States and Japan, there are cases in which approved systems are not incorporated into routine clinical practice because they fail to obtain reimbursement. For example, intracardiac echocardiography has been shown to improve both the efficacy and safety of ablation procedures and is consistently reimbursed and widely used in the United States and Japan. However, in many EU countries, reimbursement is often limited, and its use is largely restricted to selected centers and specific cases. The extent to which procedures and devices are covered by insurance reimbursement depends heavily on each country's healthcare economic conditions. To ensure the stable and consistent delivery of optimal patient care using new catheter mapping and ablation systems, the maintenance and expansion of reimbursement coverage are critical issues, comparable in importance to the length of regulatory approval timelines. In the early 1990s, DC ablation was abandoned because of a high incidence of complications and limited efficacy 6. Recently, the introduction of lower-energy delivery and pulsed-train applications of DC has led to its re-emergence in contemporary PFA systems 7-9. Clinical studies of AF ablation using PFA systems have demonstrated significant reductions in procedural time. Although noninferiority to RF and cryoablation has been shown with respect to 1-year arrhythmia recurrence rates, the superiority of PFA has not yet been established 3. More recently in Japan, rising costs associated with new PFA systems have made reimbursement for mapping systems—such as high-resolution, high-density three-dimensional mapping catheters—more difficult to obtain, raising concerns about potential negative impacts on the diagnosis and treatment of complex arrhythmias. As noted above, recurrence rates after AF ablation have not shown substantial improvement over at least the past decade. One important reason is the lack of effective catheter mapping technologies that reliably identify the active drivers responsible for the maintenance and re-initiation of AF. When PFA is performed without three-dimensional mapping and/or contact-sensing technologies, operators may be more likely to deliver repeated PFA applications indiscriminately. In particular, PFA delivery in the absence of electrode–myocardial contact fails to create effective ablation lesions 9. It has also been reported to increase the risk of hemolysis-related complications, including acute kidney injury and stroke, with multiple PFA deliveries without electrode contact 10-12. Escalating healthcare costs represent a serious global challenge, and appropriate reimbursement pricing structures should be re-evaluated to ensure the sustainable delivery of state-of-the-art medical care to patients. The development of all-in-one catheter ablation systems incorporating high-resolution, high-density three-dimensional mapping capabilities is highly desirable in the near future. Dr. Hiroshi Nakagawa is a consultant for Johnson & Johnson MedTech, Inc., Abbott, Inc., CardioFocus, Inc., Stereotaxis, Inc., Japan Lifeline, Ltd, Synaptic Medical, Inc., Philips Japan, Ltd, and Fukuda Denshi, Ltd. The remaining authors declare no conflicts of interest.