ENCORE study of Vitaria autonomic regulation therapy device shows benefits in heart failure- Cyberonics

Cyberonics has announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study) using the Vitaria device and Autonomic Regulation Therapy (ART) in heart failure patients. Results show that ART in patients with moderate to severe chronic HF and impaired heart function is well tolerated, safe, improves the heart's ability to pump blood, and reduces the frequency and severity of symptoms associated with chronic HF. Data showed that patients with chronic, reduced ejection fraction HF on stable pharmacological therapy and treated with ART for 12 months via electrical stimulation of the cervical vagus nerve experienced a statistically and clinically significant improvement in heart pump function:

• average left ventricular ejection fraction increased from 33.2% at baseline to 39.5%;
• average left ventricular end-systolic volume decreased 10% from 102 ml to 92 ml, along with reduction in HF symptom burden;
• NYHA class improved in 94% of patients.

Patients also showed improvement in quality of life (assessed by Minnesota Living with HF Questionnaire) and an increase in functional capacity (assessed by six-minute walk distance); and improvement in autonomic regulation of resting heart rate.

During the 6- to 12-month follow-up period, none of the patients experienced serious adverse events related to ART, and the improvements in cardiac function both in terms of ejection fraction and reverse remodeling suggest that ART is ready to be tested in a randomized, control trial. Results from the ENCORE clinical study were presented during the 19th Annual Meeting of the Heart Failure Society of America.