Rhode Island Hospital is now the first site in New England to partner with Providence-based Volta Medical and use their VX1 artificial intelligence (AI) software to treat persistent atrial fibrillation (AFib), and to participate in Volta’s international study of the VX1 device.
Volta’s VX1 is a specialized software solution that can only function with cutting-edge cardiac mapping and recording systems, and a highly specialized staff to run them. Rhode Island Hospital is currently the only advanced arrhythmia center in the Rhode Island capable of supporting VX1. The VX1 software is the first AI-based interventional cardiac electrophysiology tool to receive approval from the Food and Drug Administration (FDA).
“Rhode Island Hospital is a world-class research institution and a leader in the application of new technologies. I look forward to the results of this important work and its impact on the patients and communities we serve,” said Saul N. Weingart, MD, president, Rhode Island Hospital and Hasbro Children’s Hospital.
“It’s always exciting when we can both participate and be leaders in translational research. Applying what we learn to ensure the highest standard of care for patients is the purpose of continuous exploration and examination,” said Lifespan Vice President for Research and Chief Research Officer Michael Henderson.
Atrial Fibrillation is a heart condition characterized by an irregular heartbeat that can lead to more serious health issues such as heart failure and stroke. AFib is commonly treated with medication that regulates or slows the heart rate. For patients who cannot tolerate or are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care.
“Patients with atrial fibrillation broadly fall into two groups depending on the duration of the rhythm, and an ablation has very different success rates in those groups,” said Daniel Philbin, MD a cardiac electrophysiologist and Director of the Arrhythmia Service at the Lifespan Cardiovascular Institute. “Patients with paroxysmal atrial fibrillation that comes and goes on its own have a very high success rate. Patients with persistent atrial fibrillation have a much lower likelihood of success, and the odds go down the longer the rhythm has been present. That’s the group we’re targeting.”
During AFib ablation, an electrophysiologist inserts a catheter through the blood vessels into the heart to burn tissue that is causing abnormal electrical signals, creating scarring that restores a normal heartbeat. VOLTA VXI is designed to provide more accurate AFib ablation by using a highly specialized software that analyzes the patient's electrograms in real-time so that physicians better decide where to burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways that cause AFib.
“The Volta software algorithm has been trained on a massive database derived from patients with persistent atrial fibrillation who have had a successful ablation. Using artificial intelligence and deep machine learning, the algorithm helps the operator target patient specific sites during the ablation procedure that are like those that have succeeded in other patients,” said Dr. Philbin.
The Tailored-AF study will target patients with persistent atrial fibrillation due to their lower likelihood of successful outcomes and whose odds may be further diminished the longer the irregular heartbeat has been present. “The Tailored AF clinical trial is designed to compare this individualized approach using the Volta solution to the standard ablation approach for persistent AF, hypothesizing that the tailored approach should be superior,” said Dr. Philbin.
The Tailored-AF trial will take about two years to complete and is an international, multi-center, randomized, double-blind trial.