Health

St. Luke's clinical trial targeting chronic heart failure has seen positive results

Implanted device sends electric pulses to patients with chronic heart failure

UnityPoint Health-St. Luke's Hospital is seen in May 2014 in Cedar Rapids. (The Gazette)
UnityPoint Health-St. Luke’s Hospital is seen in May 2014 in Cedar Rapids. (The Gazette)
/

CEDAR RAPIDS — In late 2018, UnityPoint Health-St. Luke’s in Cedar Rapids became the first in an international clinical trial to test a new device that may offer a therapy for chronic heart failure.

The Cedar Rapids hospital’s 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 device, called the Vitaria System, is surgically implanted into patients.

In September 2018, St. Luke’s surgeons implanted the device into a Cedar Rapids resident diagnosed with chronic heart failure, becoming the first place in the world to implant the device in a patient during the clinical trial.

“It’s groundbreaking. It will fundamentally change the way we approach heart failure therapy and think about heart failure therapy,” Dr. Ron Oren, heart failure cardiologist and the study’s lead investigator at the hospital’s Heart and Vascular Institute, said in 2018.

Oren has since left St. Luke’s for an out-of-state opportunity. A search for his replacement is ongoing.

In the 16 months since the clinical trial began, “everything has been positive,” said Amy Schweer, clinical research coordinator at the Heart and Vascular Institute.

So far, four patients have enrolled in the clinical trial at the institute. Two patients have had the surgical implant.

ARTICLE CONTINUES BELOW ADVERTISEMENT

Dr. Jared Kray, Physicians’ Clinic of Iowa vascular surgeon implants the device and will continue to do so on any future patients.

Institute officials in 2018 said they hoped to enroll about 20 patients during the five-year study.

Schweer said institute officials are continuously looking for qualified candidates but “just haven’t found anyone that is an appropriate candidate” beyond the four patients already enrolled.

“We were lucky that right off the bat we found two that qualified when we first started,” Schweer said. “We haven’t found anyone else recently, but we’re always on the lookout.

“The study would like us to get as many (patients) as possible, but at the same time, patients need to be meeting the criteria. It’s a balancing act.”

Heart failure is a progressive condition — meaning it usually worsens over time — in which the heart muscle can’t pump blood as well as it should.

The condition can be characterized by its effect on the autonomic nervous system, which is responsible for unconsciously directing bodily functions such as breathing, heartbeat and other organ functions.

Treatment for heart failure addresses only part of the imbalance within the nervous system. Researchers testing the Vitaria System hope to change that.

The device automatically stimulates a part of the autonomic nervous system called the vagus nerve, returning its activity to normal levels. Every minute-and-a-half, the device releases about 14 seconds worth of tiny electrical pulses into the nerve.

ARTICLE CONTINUES BELOW ADVERTISEMENT

In theory, those pulses should improve the nervous system’s balance, improving the patient’s condition.

Data analysis still needs to be conducted from the study sites to understand the impact of the experimental therapy. Overall, the St. Luke’s patients who have the device implanted report they are feeling well, Schweer said.

Comments: (319) 368-8536; michaela.ramm@thegazette.com

Give us feedback

We value your trust and work hard to provide fair, accurate coverage. If you have found an error or omission in our reporting, tell us here.

Or if you have a story idea we should look into? Tell us here.

Give us feedback

We value your trust and work hard to provide fair, accurate coverage. If you have found an error or omission in our reporting, tell us here.

Or if you have a story idea we should look into? Tell us here.