New AF Ablation Tools Offer Promise Of Greater Efficacy, Durability

Article preview from Medtech Insight - August 2013

Novel arrhythmia mapping technologies, once they are clinically proven and validated, could change practice paradigms in the atrial fibrillation ablation space but in the meantime work continues on nearer-term advances that could make AF ablation more effective and durable. Three of the most promising – contact force sensing, endoscopic laser ablation, and atrial fibrosis imaging, from such companies as Endosense, Biosense Webster, CardioFocus, and Marrek – have recently achieved some important milestones in their journeys toward US market approval.

New AF Ablation Tools Offer Promise Of Greater Efficacy, Durability

Article preview from Medtech Insight - August 2013

One adjunctive technology that appears destined to play a major role in AF ablation in the near future is contact force (CF) sensing, designed to help ensure that EPs achieve optimum catheter tip to tissue contact and force during an RF ablation procedure. Too little CF may result in inadequate lesions and poor outcomes, whereas too much can injure the tissues and lead to serious procedure-related complications. Although much of the work on CF sensing has involved pulmonary vein isolation (PVI) procedures, the concept should apply regardless of where the ablation is being performed – whether around the PVs, on the roof of the atrium, or at some rotor or source point. And, it could be particularly useful for less-experienced operators and centers with lower AF patient volumes, helping level the playing field by providing a standardized feedback tool to guide optimum lesion creation.

Over the past several years, the clinical evidence has been piling up in favor of CF measurement, with studies showing that lesions created with CF guidance are more durable and result in better patient outcomes. And, CF could rapidly be adopted as the standard of care once the technology reaches the US market, a milestone that is expected to occur sometime next year.

The field of CF sensing was pioneered by Swiss company Endosense SA, with its TactiCath CF-sensing RF Ablation Catheter, which is CE marked and available in Europe and recently completed a pivotal US trial. As the trailblazer in this space, Endosense performed essentially all of the early heavy lifting, releasing the first abstract on CF sensing back in 2006, and since then, sponsoring a series of well-designed clinical trials that have established the positive impact of adequate CF on ablation lesion quality and procedural success. The company’s work includes the groundbreaking TOCCATA study, completed in 2010, which found that clinical outcomes improve when EPs deliver a CF greater than 20 grams, as well as its EFFICAS I post-market trial, which established a minimum Force Time Integral (FTI; a measure of force and time) of 400 gram-seconds for individual lesions.

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