Evolution of Forces on the Development and Adoption of AF Therapies

Despite two decades of research and development, there are currently only three technologies that are FDA approved for catheter-based pulmonary vein isolation (PVI) ablation to treat paroxysmal atrial fibrillation (PAF): focal irrigated radiofrequency ablation (RFA), cryoballoon ablation (CBA), and laser balloon ablation (LBA). There are other technologies under development that are based on alternative energy sources such as radiation, electroporation, and ultrasound, as well as other balloon-based catheters and linear catheters that rely on radiofrequency and cryoenergy. However, what will it take for these new technologies to be successfully adopted into practice?

The answer to what factors are important to the adoption of new AF ablation tools is evolving (Figure 1). In the late 1990s, the discovery that the PVs were a common source of triggers in patients with paroxysmal AF was groundbreaking, and generated great interest in ablation of focal triggers in patients with very frequent bursts of AF. The attention at that time was given to the electrophysiology and mechanisms, and conventional ablation catheters were being used. As the number of AF ablation procedures expanded, there was more focus on procedural safety and efficacy. 

Over the last two decades, the number of AF ablation procedures has exploded as efficacy has been established, better tools have been developed, and more patients with persistent AF and those with structural heart disease are being treated with ablation. It is predicted that AF ablation procedures will continue to grow exponentially, with some predicting that within the next few years, the annual worldwide AF ablation volume will approach one million cases. The growth in AF ablation will be driven by an expansion of indications, an increase in the prevalence of obesity, and progressive aging of the population. 

This growth in AF ablation will have tradeoffs. On one hand, growth has the potential to help a much larger number of patients who could benefit. On the other hand, AF ablation will be subjected to much more scrutiny. As with other procedures that have become common, such as cataract surgery and hip replacement, AF ablation is starting to hit the radar of many groups, including hospital supply chain managers, insurance companies, and the federal government. Patients are also becoming increasingly aware of the procedure. It is now common for patients with refractory AF to have a friend or family member who has had an AF ablation procedure. These factors will start causing new pressures on the field to demonstrate value, cost effectiveness, and a reduction in mortality. If growth occurs as anticipated, it will also add pressure to increase the number of physicians who can safely perform the procedure. Any new AF ablation therapy under development will be faced with obstacles that the predicate devices did not necessarily encounter.

As newer AF ablation tools are being developed, it is important that there is recognition of the new pressures on the field to address safety, costs, added value, and outcomes, so that AF ablation continues to receive the support that it needs from our peers, patients, and payors.