A couple of days ago we reported that Boston Scientific had missed its primary efficacy endpoint in its study into use of Vagus Nerve Stimulation in Heart Failure patients. Cyberonics, Inc. has since announced results from the ANTHEM-HF clinical study, presented during the European Society of Cardiology congress. Unlike the Boston Study, this one shows so-called Autonomic Regulation Therapy (ART) in patients with moderate to severe chronic heart failure and impaired heart function improves the heart’s ability to pump blood, and reduces symptoms associated with chronic heart failure.
Cyberonics, Inc. developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses an implanted medical device that delivers electrical stimulation to the vagus nerve. As a heart failure treatment, the principle is that Autonomic Regulation Therapy increases parasympathetic activity and thereby counteracts the sympathetic hyperactivation that is known to commonly ensue as a compensatory response to heart damage resulting from myocardial infarction or chronic hypertension.
Cyberonics’ ANTHEM-HF study was a prospective, multi-center, open-label, clinical study of patients with New York Heart Association (NYHA) Class II and III heart failure, QRS complex interval less than 150 milliseconds, and reduced heart pumping function (ejection fraction less than 40%). According to investigators, patients enrolled in the study received optimal heart failure pharmacological therapy prior to and during the study.
Sixty patients at 10 clinical centers across India underwent implantation of a Cyberonics VNS Therapy® System randomized to either the right or left vagus nerve to assess the safety and efficacy of ART. Following titration (gradual adjustment of stimulation parameters), all patients received continuously-cyclic, low-intensity, natural-frequency ART. Safety was assessed throughout the study and outcome measures were assessed after three months and six months and compared to baseline values.
Results from the study were presented during a Hot Line Session at the European Society of Cardiology Congress and showed that heart failure (HF) patients on stable pharmacological therapy and treated with ART via vagus nerve stimulation experienced a clinically significant:
- improvement in heart pump function; average left ventricular ejection fraction increased from 32% at baseline to 37% after 6 months of ART;
- reduction in heart failure symptom burden; NYHA class improved in 77% of patients;
- improvement in quality of life (assessed by Minnesota Living with HF Questionnaire);
- increase in functional capacity (assessed by Six-minute walk distance); and
- improvement in autonomic regulation of heart rate.
University of Minnesota Professor Inder Anand, M.D., DPhil (Oxon), Chair of the ANTHEM-HF clinical study steering committee and Director of the Heart Failure Program, VA Medical Center, Minneapolis, Minnesota, commented, “Despite decades of research targeting the pathophysiology of chronic heart failure and development of pharmacological treatments that impart significant benefits, heart failure remains a leading cause of disability and death. We are encouraged by the significant beneficial effects of Autonomic Regulation Therapy in heart failure patients with reduced ejection fraction represented by the ANTHEM-HF study cohort. Presentation of the results and simultaneous publication in the Journal of Cardiac Failure provide important details that should permit selection of many patients that may benefit from this therapy, which appears to work synergistically with drugs commonly prescribed in connection with published guidelines.”
“Heart failure remains a difficult and challenging syndrome throughout the world, despite optimal medical management,” commented Dan Moore, President and Chief Executive Officer of Cyberonics. “We are pleased that patients with chronic heart failure participating in the ANTHEM-HF study experienced meaningful improvements and benefited from our proven VNS technology platform that has been prescribed and implanted more than 100,000 times for the treatment of drug-resistant epilepsy over the past 20 years. Based on the ANTHEM-HF study results, we remain committed to completing the development and commercial introduction of our new VITARIA™ System for ART.”
Source: Cyberonics, Inc. PR Newswire