Volta Medical has announced the publication in Nature Medicine of the TAILORED-AF clinical trial, which demonstrated that an artificial intelligence (AI)-guided procedure for persistent atrial fibrillation (AF) in combination with conventional pulmonary vein isolation (PVI) treatment resulted in better outcomes than PVI alone. More specifically, the study showed superiority in the percentage of patients that achieved freedom from AF with or without anti-arrhythmic drugs at 12 months after a tailored cardiac ablation guided by AI in combination with PVI when compared to PVI alone, as stated in a company press release.
“Atrial fibrillation, when left untreated, doubles the risk of heart-related deaths and is associated with a five-fold increased risk for stroke,” said Seth Goldbarg (NewYork-Presbyterian Queens Hospital, Flushing, USA). “However, advancements in AI are transforming this landscape. This trial featuring AI-guided assessment of AF represents a true milestone for improvement of outcomes for this underserved and difficult-to-treat patient community.”
The TAILORED-AF clinical trial is the first large-scale transatlantic randomised controlled trial (RCT) of ablation, in a persistent AF population, to show the benefit of going beyond conventional PVI-only extra-pulmonary vein procedures. Volta claims that previous studies looking at ablation strategies for persistent AF patients have not demonstrated superior efficacy to PVI alone.
The Volta AF-Xplorer technology—a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as spatiotemporal dispersed EGMs—was used in the TAILORED-AF trial.
In the clinical trial, adults with symptomatic persistent or long-standing persistent AF who were candidates for a first-time ablation were enrolled in Europe and the USA. A total of 187 patients underwent a tailored cardiac ablation guided by Volta’s AI technology in addition to PVI (tailored cohort), while 183 patients received the conventional treatment of PVI only (anatomical cohort), and all were followed up for 12 months. A total of 51 electrophysiologists at 26 centres in five countries participated.
The trial met its primary endpoint by demonstrating superior results in patients assigned to the tailored cohort compared to the anatomical cohort, Volta notes, also highlighting the following details:
- Some 88% of patients in the tailored cohort experienced freedom from AF 12 months after one procedure with or without anti-arrhythmic drugs compared to 70% in the anatomical cohort (p<0.0001)
- In the tailored cohort, patients experienced a higher rate of freedom from any arrhythmia after 1.2 procedures than in the anatomical cohort (79% vs 71%, respectively; p<0.01) and, according to Volta, recurrences in the tailored cohort were regarded as a “simplification” of AF—which are generally easier to ablate and can be seen as a step towards stable sinus rhythm
- The trial also examined several prespecified secondary endpoints and a prespecified subgroup analysis of patients with sustained persistent AF lasting six months or longer prior to enrolment, and, in these patients—who represent a more advanced AF disease progression—those in the tailored cohort experienced a significantly higher rate of freedom from any arrhythmia after one single procedure than in the anatomical cohort (62% vs 48%; p=0.04)
- The safety endpoint did not differ between the groups, although the procedure and ablation times were twice as long in the tailored arm, which Volta notes is consistent with the treatment time for other ‘PVI+’ methods
“Previously, there has not been a replicable, effective treatment strategy for patients with persistent atrial fibrillation,” said Théophile Mohr-Durdez, chief executive officer (CEO) and co-founder of Volta. “Volta’s AI solution finally offers a solution for this large and underserved patient population. The TAILORED-AF trial highlights AI’s ability to help physicians treat cardiovascular disease and improve patient outcomes. In fact, this is the first large-scale international RCT in interventional cardiology demonstrating superior efficacy through the use of AI.”
