PMID- 25187002 OWN - NLM STAT- MEDLINE DCOM- 20150825 LR - 20220331 IS - 1532-8414 (Electronic) IS - 1071-9164 (Linking) VI - 20 IP - 11 DP - 2014 Nov TI - Autonomic regulation therapy via left or right cervical vagus nerve stimulation in patients with chronic heart failure: results of the ANTHEM-HF trial. PG - 808-16 LID - S1071-9164(14)01189-0 [pii] LID - 10.1016/j.cardfail.2014.08.009 [doi] AB - OBJECTIVE: ANTHEM-HF evaluated a novel autonomic regulation therapy (ART) via either left or right vagus nerve stimulation (VNS) in patients with heart failure (HF) and reduced ejection fraction (HFrEF). METHODS AND RESULTS: Sixty subjects (New York Heart Association [NYHA] functional class II-III, left ventricular ejection fraction (LVEF) /= 50 mm to < 80 mm) receiving optimal pharmacologic therapy were randomized at 10 sites. VNS systems were randomly implanted on the left (n = 31) or right (n = 29) side. All patients were successfully implanted and 59 were titrated over 10 weeks to a well tolerated stimulation intensity. One patient died 3 days after an embolic stroke that occurred during implantation. Common device-related adverse events after VNS titration were transient mild dysphonia, cough, and oropharyngeal pain, which were similar for left- and right-side VNS. After 6 months of ART, the adjusted left-right differences in LVEF, left ventricular end-systolic volume (LVESV), and left ventricular end-systolic diameter (LVESD) were 0.2% (95% CI -4.4 to 4.7), 3.7 mL (95% CI -7.0 to 14.4), and 1.3 mm (95% CI -0.9 to 3.6), respectively. In the combined population, absolute LVEF improved by 4.5% (95% CI 2.4-6.6), LVESV improved by -4.1 mL (95% CI -9.0 to 0.8), and LVESD improved by -1.7 mm (95% CI -2.8 to -0.7). Heart rate variability improved by 17 ms (95% CI 6.5-28) with minimal left-right difference. Six-minute walk distance improved an average of 56 m (95% CI 37-75); however, improvement was greater for right-side ART (77 m [95% CI 49-105]). NYHA functional class improved in 77% of patients (baseline to 6 months). CONCLUSIONS: Chronic open-loop ART via left- or right-side VNS is feasible and well tolerated in HFrEF patients. Safety and efficacy measures are encouraging and warrant further study. CI - Published by Elsevier Inc. FAU - Premchand, Rajendra K AU - Premchand RK AD - Department of Cardiology, Krishna Institute of Medical Sciences, Secunderabad, India. FAU - Sharma, Kamal AU - Sharma K AD - Department of Cardiology, Sanjivani Super Specialty Hospitals, Ahmedabad, India. FAU - Mittal, Sanjay AU - Mittal S AD - Department of Cardiology, Medanta, Medicity, Haryana, India. FAU - Monteiro, Rufino AU - Monteiro R AD - Department of Cardiology, Vintage Hospital, Goa, India. FAU - Dixit, Satyajit AU - Dixit S AD - Department of Cardiology, Sanjivani Super Specialty Hospitals, Ahmedabad, India. FAU - Libbus, Imad AU - Libbus I AD - Emerging Therapies, Cyberonics, Houston, Texas. FAU - DiCarlo, Lorenzo A AU - DiCarlo LA AD - Biodev, San Francisco, California. FAU - Ardell, Jeffrey L AU - Ardell JL AD - Department of Medicine, University of California, Los Angeles, California. FAU - Rector, Thomas S AU - Rector TS AD - Department of Medicine University of Minnesota, Minneapolis, Minnesota. FAU - Amurthur, Badri AU - Amurthur B AD - Emerging Therapies, Cyberonics, Houston, Texas. FAU - KenKnight, Bruce H AU - KenKnight BH AD - Emerging Therapies, Cyberonics, Houston, Texas. FAU - Anand, Inder S AU - Anand IS AD - Department of Medicine University of Minnesota, Minneapolis, Minnesota. Electronic address: anand001@umn.edu. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20140901 PL - United States TA - J Card Fail JT - Journal of cardiac failure JID - 9442138 SB - IM MH - Aged MH - Autonomic Nervous System/*physiopathology MH - Feasibility Studies MH - Female MH - Follow-Up Studies MH - Heart Failure/physiopathology/*therapy MH - Humans MH - Male MH - Middle Aged MH - Retrospective Studies MH - Stroke Volume/physiology MH - Time Factors MH - Treatment Outcome MH - Vagus Nerve Stimulation/*methods MH - Ventricular Function, Left/*physiology MH - *Ventricular Remodeling OTO - NOTNLM OT - Heart failure OT - autonomic regulation therapy OT - nonpharmacologic therapy OT - vagus nerve stimulation EDAT- 2014/09/05 06:00 MHDA- 2015/08/26 06:00 CRDT- 2014/09/05 06:00 PHST- 2014/07/16 00:00 [received] PHST- 2014/08/18 00:00 [revised] PHST- 2014/08/18 00:00 [accepted] PHST- 2014/09/05 06:00 [entrez] PHST- 2014/09/05 06:00 [pubmed] PHST- 2015/08/26 06:00 [medline] AID - S1071-9164(14)01189-0 [pii] AID - 10.1016/j.cardfail.2014.08.009 [doi] PST - ppublish SO - J Card Fail. 2014 Nov;20(11):808-16. doi: 10.1016/j.cardfail.2014.08.009. Epub 2014 Sep 1.