Volta Medical has announced that peer-reviewed results from the company’s Ev-AIFib proof of concept study with its VX1 decision support software has been published in the Journal of Cardiovascular Electrophysiology (JCE).
The artificial intelligence (AI) software is designed to assist operators in the real-time identification of specific abnormal electrograms (EGM) during atrial fibrillation (AF) procedures.
The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician EGM analysis and assists operators in the real-time identification of specific abnormal EGMs, known as dispersed EGMs, during ablation procedures in a persistent AF population.
Results demonstrated that VX1 allowed for the building of standardized “Volta VX1 maps”, used as a reference for operators to conduct EGM-guided ablation. The standardisation of the detection of abnormal EGMs facilitated a robust patient-to-patient and centre-to-centre uniformity in EGM-based ablation.
No major differences between operator’s visual analysis and VX1 EGM maps were recorded, and there were no statistically significant differences between outcomes across the eight study centres and 17 operators. Furthermore, after a one-year follow-up, patients demonstrated a high freedom from AF and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively. Also, notably there was acute AF termination of 88% for subjects in all centres.
“Catheter ablation is well-established as an important treatment for AF and is by far the most common cardiac ablation procedure performed worldwide. Due to the complexity of persistent AF, however, there is no uniform standard of care resulting in heterogenous approaches that yield mixed and often disappointing results associated with high recurrence rates,” said Jean-Paul Albenque (Clinique Pasteur, Toulouse, France), co-author of the study. “Strategies using EGM assessment to guide ablation visually, rely heavily on the individual experience of the treating electrophysiologist to identify relevant areas making outcomes highly operator-dependent.”
Based on these results, Volta Medical has initiated the TAILORED-AF trial, a randomised controlled clinical trial to evaluate VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach. The aim of the study is to confirm the clinical significance of Volta Medical’s technology and lay the ground for establishing VX1 as a new standard of care for persistent AF ablation.
“The results of the Ev-AIFib trial show that Volta’s AI enhanced VX1 software is finally able to provide reliability and reproducibility in an EGM based approach – the holy grail of EGM based ablation approaches. The technology has shown a high potential to assist in treating the complex persistent AF patients,” said Isabel Deisenhofer (German Heart Centre Munich, Munich, Germany) principal investigator of the international, multicentre TAILORED-AF trial. “In my experience, VX1 has been an extremely helpful tool, and I look forward to further explore and confirm the technology’s potential in the ongoing TAILORED-AF trial.”
