UnityPoint Health St. Luke’s Heart and Vascular Institute in Cedar Rapids recently became the first in an international clinical trial to test a new device that can offer a therapy for chronic heart failure. One of 100 sites in the multi-national clinical trial called ANTHEM-HFrEF—set up and conducted to determine the benefits for heart failure patients of a new device developed by LivaNova, a UK-based medical device maker. Called Vitaria System, the experimental product is surgically implanted into patients.
Back in late 2018, St. Luke’s surgeons performed the first investigational site to implant the device in a patient during the clinical trial.
A progressively worse condition, heart failure often can lead to the situation where the heart muscle cannot pump blood in a way and with the pressure that it supposed to—this condition can be characterized by its effect on the autonomic nervous system—the responsible mechanism for directing the bodily functions such as breathing. Most treatments deal only with part of the imbalances involved, and the investigators hope to transform this situation with this new study.
Adaptively designed, the multi-center, open-label, randomized controlled clinical trial involved patients with symptomatic heart failure and reduced LVEF. Participants were enrolled and randomized 2:1 to receive Vitaria Systems implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy alone (control arm).
Patients in the therapy arm receive continuous, periodic VNS stimulation after surgery is completed, and will undergo visits for VNS up titration over a period of 3 months. Subjects in the control arm also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm. Data for safety and efficacy assessments will be collected for both study arms at 4 weeks post-randomization, every 3 months for the first 12 months, and every 4 months thereafter.
This device, reports The Gazette, automatically stimulates a part of the autonomic nervous system called the vagus nerve, returning its activity to normal levels. So, for every minute and a half, the device raises about 14 seconds worth of tiny electrical pulses into the nerve.
At the time, Dr. Ron Own, heart failure cardiologist and lead investigator at the hospital’s Heart and Vascular Institute reported back in 2018 that this study was “groundbreaking.” And continued, “It will fundamentally change the way we approach heart failure and think about heart failure therapy.” Dr. Oren has since left the position.
Clinical Research Coordinator Amy Schweer noted that in the 16 months since the study commenced, “Everything has been positive.” She noted, “So far four patients have enrolled in the clinical trial at the institute. Two patients have had the surgical implant.”
LIvaNova, PLC, based in London, UK, is a medical device maker. They develop devices used for cardiac surgery and neuromodulation. They were formed back in 2015 from the $2.7 billion merger between Houston-based Cyberonics, Inc. and Milan, Italy-based Sorin S.p.a. The company trades under the ticker symbol “LIVN” on NASDAQ.
The Clinical Investigational Site
UnityPoint Health St. Luke’s Heart and Vascular Institute is the Cedar Rapids’ area leader in health care—with a full spectrum of advanced cardiovascular services, from prevention and diagnostics through treatment and cardiac rehabilitation. Their Heart & Vascular Institute encompasses the heart care specialists and services of St. Luke’s Hospital, St. Luke’s Cardiology and the cardiovascular surgeons from Physicians’ Clinic of Iowa. A collaborative relationship, it allows them to provide the highest quality of care with fewer complications and better outcomes as well as higher survivor rates, as reported on their website.