Volta Medical, a pioneering health tech company developing artificial intelligence (AI) software solutions to assist electrophysiologists to treat cardiac arrhythmias, today announced that the Journal of Cardiovascular Electrophysiology (JCE) has published peer-reviewed results from the Company’s successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution to assist operators in the real-time identification of specific abnormal electrograms (EGM) during atrial fibrillation (AF) procedures. The article titled “Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation” is available at https://onlinelibrary.wiley.com/doi/abs/10.1111/jce.15657.
The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram (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 standardization of the detection of abnormal EGMs facilitated a robust patient-to-patient and center-to-center 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 8 study centers and 17 operators. Furthermore, after a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation 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 centers.
“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, MD, Cardiac Electrophysiologist at the Clinique Pasteur, Toulouse, France, and 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.”
With VX1, Volta has developed the first commercially available companion AI decision support software to assist operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial abnormal EGMs during atrial fibrillation or atrial tachycardia. The cutting-edge software solution uses machine learning including deep learning algorithms to detect abnormal signals and thus highlights potential regions of interest during AF ablation procedures. The system works in real time and identifies specific abnormal EGMs, known as dispersed EGMs.
Théophile Mohr Durdez, CEO and Co-Founder of Volta Medical, added: “The publication of these peer-reviewed trial results provides further validation of our approach to leverage AI with cutting-edge software solutions and assist operators during cardiac ablation procedures. Over 1000 procedures have so far been supported in the EU and US by VX1 and based on clinician’s feedback and clinical results, we are confident that this approach will ultimately contribute to make ablation outcomes significantly more reliable.”
Based on these encouraging results, Volta Medical has initiated the TAILORED-AF trial, the first randomized 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 Prof. Dr. Isabel Deisenhofer, MD, head of electrophysiology at German Heart Centre Munich, and principial investigator of the international, multicenter TAILORED-AF trial. She continues: “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.”
About Ev-AIFib Trial
The EV-AIFib trial, a prospective, multicenter, non-randomized, study was designed to determine the feasibility and relevance of constructing standardized dispersion maps, so called 'Volta VX1 maps’, to be used as a reference to operators conducting EGM-guided ablation of patients in persistent atrial fibrillation (AF), as well as the use of the VX1 technology for center-to-center standardization of dispersion mapping. In the trial physicians were provided with VX1 adjudications in real time and used their discretion to ablate where it was the most clinically relevant.
Carried out in 8 different centers with 17 participating operators, the study compared the acute and long-term outcomes of 85 patients after ablation in regions exhibiting dispersion between a primary and satellite centers. At the primary center, operators were the most experienced at dispersion-based ablation, while satellite centers corresponded to hospitals where physicians had little experience at performing dispersion-based ablation. The results were also compared to a control group in which dispersion-guided ablation was performed visually by trained operators.
About Atrial Fibrillation (AF)
AF can be considered an “electrical storm” in the atria in which all synchronized activities have disappeared, and the necessary coordination of the contraction stops. This can lead to a number of symptoms including palpitations, shortness of breath and in some patients, heart failure.
AF affects approximately 33 million patients worldwide – a figure expected to double by 2030 driven by an aging population.1 Evidence suggests a higher prevalence of AF in patients with hypertension, heart failure, coronary heart disease, obesity and diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AF before, during or after the initial event. AF is also a major risk factor for stroke, increasing the likelihood of stroke by four to five times, as stagnant blood in the atrium during AF may lead to the formation of a clot, which can migrate to the brain. In addition, AF-induced strokes are associated with more severe damage.
Common treatment for AF includes medication that regulates or slows the heart rate.2 For patients who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care.2 Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heartbeat.1 However, the efficacy of this approach depends to a large degree on the experience and intuition of the ablating physician.
About the Volta VX1 AI decision support software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and mapping technologies currently used in operating rooms or electrophysiology labs. VX1 is a medical device which is FDA cleared and has a CE mark. The FDA label reads “The VX1 assists operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial EGMs exhibiting specific abnormal EGM, known as dispersion, during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial EGMs exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.”
About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a health tech company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures. Volta’s overarching goal is to drastically improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data with the highest standards of data protection. Its first product, VX1, a digital AI companion device and algorithm assists cardiologists for the real-time identification of specific abnormal EGMs, known as dispersed EGMs.