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St. Luke’s Hospital a First for International Study for New Treatment of Chronic Heart Failure

The MedQuarter | October 8th, 2018

Cedar Rapids, IOWA— Doctors at the UnityPoint Health – Cedar Rapids Heart and Vascular Institute recently implanted a medical device aimed at helping patients with chronic heart failure at St. Luke’s Hospital. This implantation of the VITARIA™ System by LivaNova PLC is part of the company’s Autonomic Regulation Therapy (ART) to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction Pivot Study. This implantation is part of an international, multi-center, randomized trial to evaluate the VITARIA System for the treatment of advanced heart failure.

According to the Centers for Disease Control nearly 6 million adults in the United States have heart failure. Heart failure is a condition in which the heart cannot pump enough blood and the heart attempts to compensate for lost pumping power. As a result, the heart may change shape and pump inefficiently. Heart failure is usually a progressive condition that worsens over time. It may be treated by medications, lifestyle modifications and in some cases surgery or medical devices.

ART is investigational and being studied in an international clinical trial called ANTHEM-HFrEF. The trial is currently enrolling patients who are eligible to determine the long-term benefits of ART for heart failure patients. ART applies mild electrical impulses to the vagus nerve with the goal of it helping re-balance the autonomic nervous system and helping the heart beat more efficiently.

The first implant in the ANTHEM-HFrEF study, was performed at St. Luke’s Hospital by Dr. Jared Kray, Physicians’ Clinic of Iowa surgeon on Sept. 6. The patient was David Gee of Cedar Rapids. The 67-year-old Gee was diagnosed with chronic heart failure earlier this year.

“In January I was really fighting something,” recalled Gee. “My recovery was not going well, and I was really tired. I was initially tested for lung issues and they noted something on my EKG. Ultimately, I ended up in the hospital for several days and since then I have been dealing with my diagnosis of chronic heart failure.”

While Vagas nerve stimulation is new for heart failure, the approach has been used with success, for over 20 years in the treatment of epilepsy with over 150,000 implants worldwide. ART has also been tested in the treatment of heart failure in two small human studies that led to the FDA Approval of the ANTHEM- HFrEF trial.

Gee was happy to participate in the clinical study through St. Luke’s. He is very active – exercising several times a day. He’s hopeful the new implant will help his heart function better and allow him to continue to stay active.

“It’s early in the study yet,” said Gee. “I might have noticed a little faster recovery time after I exercise, and I hope that continues to improve over time. Each week I return to UnityPoint Health – St. Luke’s Cardiology for adjustments, where they increase the electrical impulses to my heart. I expect to do that for the next several weeks.”

UnityPoint Health – Cedar Rapids Heart and Vascular Institute was chosen as one of 100 sites to participate in the study. There are currently five individuals enrolled through the Heart and Vascular Institute. The hope is to enroll about 20 individuals locally. St. Luke’s was asked to participate in the study because of previous successes and its heart failure clinic is efficient and well organized according to UnityPoint Health – Cedar Rapids Heart and Vascular Institute physicians.

“Patients with advanced heart failure continue to need additional and complementary therapy options, since drug treatment alone has slowed but not stopped heart failure progression,” said Dr. Ron M. Oren, Heart Failure Cardiologist and Lead Investigator for the Study at the UnityPoint Health – Cedar Rapids Heart and Vascular Institute. “We are pleased to participate in this important study to critically evaluate the safety and efficacy of Autonomic Regulation Therapy delivered by the VITARIA System.”

“The implant procedure is a delicate procedure, which involves surgical implantation of the electrodes around the Vagus nerve in the neck and placement of a generator on the chest wall (much like a pacemaker),” said Dr. Jared Kray, Physicians’ Clinic of Iowa surgeon.  “It has been very well tolerated in our patients so far and the procedure also takes less than one hour to perform.  I am excited to be part of this cooperative effort to hopefully improve the quality of life in patients with heart failure.”

In addition to Drs. Oren and Kray, nurses Amy Schweer and Amy Becker help coordinate the ANTHEM-HFrEF study for UnityPoint Health.

“There haven’t been many new developments in heart failure treatment in recent years,” said Amy Schweer, UnityPoint Health – Cardiology research coordinator. “The addition of this device to our current treatments could be a game-changer in helping patients feel better and be hospitalized less. It’s exciting to be involved in such an important international study.”

For more information about the VITARIA System and the treatment of heart failure with ART, visit ARTforHeartFailure.com or call UnityPoint Health – Cedar Rapids Heart and Vascular Institute at (800) 982-1959 or unitypoint.org/artforheartfailure.

MEDIA CONTACT: Sarah Corizzo, UnityPoint Health – St. Luke’s Hospital, (319) 369-8372 or (319) 560-2385.