Extended Follow-Up Of ANTHEM-HF Patients Shows That Benefits Of Autonomic Regulation Therapy Are Maintained After 12 Months

HOUSTON, Cyberonics, Inc. yesterday announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study).  Results of the study presented by a prominent heart failure (HF) specialist during a major cardiology congress in the United States show that Autonomic Regulation Therapy (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.  More than 10 million people in the United States and Europehave chronic HF, a syndrome characterized by the heart's inability to pump sufficient blood to meet the metabolic demands of the body.

Results from the ENCORE clinical study were presented during a Late Breaking Clinical Trials Session at the 19^th Annual Meeting of the Heart Failure Society of America (HFSA) and 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; 
• reduction in HF symptom burden; NYHA class improved in 94% 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 resting heart rate.  

University of Minnesota Professor of Medicine Inder Anand, M.D., DPhil (Oxon), Chair of the ANTHEM-HF clinical study steering committee and until recently Director of the Heart Failure Program, VA Medical Center,Minneapolis, Minnesota, commented, "Patients with heart failure continue to be at high risk of increased morbidity and mortality.  They need new therapies, such as ART, that work synergistically with evolving forms of drug therapy.  The results from the extension of the ANTHEM-HF study presented during a Late Breaking Clinical Trials Session at HFSA provide important insights into the safety and durability of ART (Autonomic Regulation Therapy).  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 in which a larger cohort of optimally-managed chronic HF patients from the US and the EU would be randomized to a treatment group and a control group to more extensively evaluate safety and efficacy."   

Sponsored by Cyberonics, the ENCORE study was a prospective, multi-center, open-label, extension of the ANTHEM-HF study during which the effects of ART were evaluated in chronic HF 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 (left ventricular ejection fraction less than 40%).  According to investigators, patients enrolled in the study received optimal HF pharmacological therapy prior to and during all phases of study.

Forty-nine patients previously enrolled in the ANTHEM-HF study elected to participate in the ENCORE study and received ART for an additional 6 months (12 months total).  All patients received continuously-cyclic, natural-frequency ART previously described in the publication of ANTHEM-HF results.  Safety was assessed throughout the ENCORE study and outcome measures were assessed after 12 months of ART and compared to baseline values of the ENCORE cohort.

"Chronic heart failure syndrome is a leading cause of death and imposes a significant burden on health care systems throughout the world," commented Rohan Hoare, Chief Operating Officer of Cyberonics.  "We continue to be encouraged by the clinical benefits associated with ART and presented by the investigators.  Based on the ANTHEM-HF and ENCORE study results, we plan to expand the commercial introduction of our VITARIA™ System in Europe and are in planning stages for additional clinical studies."   

More than 20 million people are affected with chronic heart failure throughout the world.  Patients with heart failure experience debilitating symptoms, such as shortness of breath and chronic fatigue.  Heart failure is a progressive syndrome that requires attentive clinical management, including occasional hospitalization. Pharmacological therapy is standard of care; however, morbidity and mortality remain excessive.  

Source: Cyberonics, Inc.