Data on the use of LivaNova’s implantable neuromodulation technology, Vitaria, for heart failure patients has been shared at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual).
Two posters were published and shared on demand at the meeting, including one reporting improvement in autonomic tone, baroreceptor sensitivity and cardiac electrical stability produced by chronic, continuously cyclic vagus nerve stimulation (VNS) used to deliver autonomic regulation therapy (ART) in patients with chronic, symptomatic heart failure with reduced ejection fraction (HFrEF).
The poster, which was authored by Bruce D Nearing (Harvard Medical School, Boston, USA) and colleagues, concluded that chronic VNS may provide a safe and efficient means to achieve both enduring improvements in mechanical function of the heart in patients with depressed left ventricular ejection fraction, and protection against life-threatening ventricular arrhythmias.
Another poster, authored by Inder Anand (University of Minnesota Medical Center, Minneapolis, USA) demonstrates that potential therapeutic benefits of ART in HFrEF patients are independent of adrenergic receptor blockade.
The LivaNova Vitaria system delivers ART using VNS and is intended for patients who experience symptoms of heart failure despite receiving guideline-directed medical therapy. Vitaria is currently being used to study the effects of ART in a prospective, international, randomised controlled clinical trial, the ANTHEM-HFrEF Pivotal Study.
In a press release published by LivaNova, Marvin Konstam (CardioVascular Center at Tufts Medical Center, Boston, USA) chair of the ANTHEM-HFrEF Pivotal Study steering committee, said: “The work presented here forms part of the rationale for the ANTHEM-HFrEF Pivotal Study. This trial has the potential to demonstrate that ART adds significant symptomatic and clinical outcome benefit to current treatments, thereby improving the health and quality of life of patients with heart failure.”
The Vitaria system received CE mark approval in 2015 and has been granted Expedited Access Pathway as a breakthrough technology by the US Food and Drug Administration (FDA). If approved by the FDA, it could be the first in its class for treating chronic heart failure.
“As we learn more from our ART research, we continue to be excited about its potential as a breakthrough treatment to meaningfully improve the lives of patients with advanced chronic heart failure,” Bryan Olin senior vice president of clinical, quality and regulatory affairs at LivaNova commented in the company press release.