CEDAR RAPIDS — A Cedar Rapids hospital’s Heart and Vascular Institute has successfully performed the first surgical implant in an international clinical trial to test a new therapy for chronic heart failure.
It’s a therapy that, if it pans out the way researchers hope, will be “a game-changer for heart failure therapy,” said Amy Schweer, clinical research coordinator at the institute.
UnityPoint Health-Cedar Rapids Heart and Vascular Institute is one of 100 sites — 50 in the United States and 50 in other countries — to participate in ANTHEM-HFrEF, a clinical trial to determine the benefits for heart failure patients of a new device developed by England-based medical manufacturer LivaNova.
The surgery to implant the device, called the Vitaria System, in a patient was performed at UnityPoint Health-St. Luke’s Hospital on Sept. 6 — making it the first site in the world to implant the device in a patient during the clinical trial.
The device was placed by Physicians’ Clinic of Iowa Surgeon Dr. Jared Kray in the chest and neck of David Gee, a 67-year-old Cedar Rapids resident who was diagnosed with chronic heart failure earlier this year.
Dr. Ron Oren, heart failure cardiologist and lead investigator for the study at UnityPoint Health-Cedar Rapids Heart and Vascular Institute, also described the study as “a game changer” for long-term patient outcomes.
Heart failure is a progressive condition in which the heart muscle can’t pump blood as well as it should, and usually worsens over time.
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For Gee, that resulted in fatigue and an overall poor feeling. But treatment options were nearly non-existent, he said, meaning his long-term prognosis wasn’t good.
So when Oren, his doctor, offered him the opportunity to be part of the clinical trial, Gee said he was glad to volunteer for “anything that might help.”
“I just felt lucky I was in the right place at the right time when the doctor decided to ask me if I wanted to be in the study,” Gee said.
Heart failure can be characterized by its effect on the autonomic nervous system — the part of the nervous system responsible for unconsciously directing bodily functions such as breathing, heartbeat and other organ functions.
Oren said treatment currently available for heart failure only addresses part of the imbalance within the nervous system.
However, the Vitaria System could change that.
The device automatically stimulates a part of the autonomic nervous system called the Vagas nerve, returning its activity to normal levels. For every minute and a half, the device releases about 14 seconds worth of tiny electrical pulses into the nerve, Oren said.
This, in turn, is theorized to result in improved balance for the nervous system and a better condition for the patient.
“Its groundbreaking,” Oren said. “It will fundamentally change the way we approach heart failure therapy and think about heart failure therapy and therefore interesting.”
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The Heart and Vascular Institute will enroll about 20 patients locally into the study, but only half will be selected randomly to have the Vitaria System implanted.
Oren said four individuals have enrolled so far, two of whom already have had the device implanted, including Gee. It’s too soon to see any results in the two patients yet, he added.
“We hope to begin seeing the benefits over the course of the next few months,” Oren said.
The Cedar Rapids provider’s dive into the ANTHEM-HFrEF clinical trial is part of an ongoing effort of Oren’s since he joined UnityPoint Health-Cedar Rapids a year and a half ago to develop a clinical research program at the institute.
“The Heart and Vascular Institute’s goal is to be a cardiovascular center of excellence,” Schweer said. “Expanding the research portion is really part of that.”
Oren said the heart failure therapy is the only major clinical trial the organization has taken on at this time, but officials are considering others for the near future.
According to the Centers for Disease Control and Prevention, about 5.7 million adults in the United States have suffered from heart failure. In addition, heart failure costs the nation an estimated $30.7 billion each year in health care services, medications and missed days of work.
But health officials say heart failure is becoming more common nationwide. According to the American Heart Association’s latest heart disease report, the number of individuals living with heart failure is projected to rise 46 percent by 2030.
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