Kamal Sharma1, Rajendra K Premchand2, Sanjay Mittal3, Rufino Monteiro4, Imad Libbus5, Lorenzo A DiCarlo6, Jeffrey L Ardell7, Badri Amurthur5, Bruce H KenKnight5, Inder S Anand8. 1. Sanjivani Super Specialty Hospitals, Ahmedabad, India. 2. Krishna Institute of Medical Sciences, Secunderabad, India. 3. Medanta, The Medicity, Haryana, India. 4. Vintage Hospital, Goa, India. 5. LivaNova PLC, Inc., Houston, TX, United States of America. 6. BioDev LLC, San Francisco, CA, United States of America. 7. University of California at Los Angeles, Los Angeles, CA, United States of America. 8. University of Minnesota, Minneapolis, MN, United States of America. Electronic address: anand001@umn.edu.
Abstract
BACKGROUND: The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months. METHODS: Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months. RESULTS: Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months. CONCLUSIONS: In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.
RCT Entities:
BACKGROUND: The ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months. METHODS: Continuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months. RESULTS: Between 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months. CONCLUSIONS: In a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.
Authors: Joseph Hadaya; Una Buckley; Nil Z Gurel; Christopher A Chan; Mohammed A Swid; Niloy Bhadra; Tina L Vrabec; Jonathan D Hoang; Corey Smith; Kalyanam Shivkumar; Jeffrey L Ardell Journal: Am J Physiol Heart Circ Physiol Date: 2021-12-03 Impact factor: 4.733
Authors: Imad Libbus; Scott R Stubbs; Scott T Mazar; Scott Mindrebo; Bruce H KenKnight; Lorenzo A DiCarlo Journal: J Interv Card Electrophysiol Date: 2021-08-31 Impact factor: 1.759
Authors: Marvin A Konstam; Douglas L Mann; John James E Udelson; Jeffrey L Ardell; Gaetano M De Ferrari; Martin R Cowie; Helmut U Klein; Douglas D Gregory; Joseph M Massaro; Imad Libbus; Lorenzo A DiCarlo; Javed Butler; John D Parker; John R Teerlink Journal: Front Physiol Date: 2022-04-21 Impact factor: 4.755
Authors: Bruce D Nearing; Imad Libbus; Gerrard M Carlson; Badri Amurthur; Bruce H KenKnight; Richard L Verrier Journal: Clin Auton Res Date: 2021-02-16 Impact factor: 4.435
Authors: Imad Libbus; Rajendra K Premchand; Kamal Sharma; Sanjay Mittal; Rufino Monteiro; Badri Amurthur; Bruce H KenKnight; Lorenzo A DiCarlo; Inder S Anand Journal: Front Physiol Date: 2022-03-11 Impact factor: 4.566