As part of a nationwide clinical trial for patients with complex heart conditions, Abrazo Arizona Heart Hospital is the first in Arizona to perform the first Transcatheter Aortic Valve Replacement (TAVR) procedures on low-risk patients. The procedures are being performed by a team of physicians and other caregivers from the hospital’s Institute for Valvular Diseases who specialize in treating structural heart conditions that interrupt the natural flow of blood through the body.
TAVR is a minimally invasive alternative to open-heart surgery that enables a surgeon to implant a replacement valve through a small incision near the femoral artery in the groin, eliminating the need to crack open a patient’s chest. A patient’s experience with a TAVR procedure may be comparable to a balloon treatment or an angiogram in terms of down time and recovery, and will likely require a shorter (average 3-5 days) hospital stay compared with traditional open-heart surgery, according to the American Heart Association.
Currently, the procedure is available only to high-risk patients with severe aortic stenosis – a narrowing of the aortic valve that obstructs blood flow to the heart and the rest of the body – who have co-occurring conditions or cannot withstand open-heart surgery. Abrazo Arizona Heart Hospital is one of 80 hospitals to participate in the expanded indication trial for the CoreValve Evolut R System, the first and only next-generation recapturable, self-expanding TAVR system commercially available in the United States.
The trial will include 1,200 patients who have a less than 3 percent risk of operative mortality, as determined by a heart team. Low-risk patients will be enrolled with 1:1 randomization to receive the Evolut R System or undergo open-heart surgery.
The trial has a two-year endpoint and allows for a one-year analysis for early FDA submission. Additionally, the trial will include a sub-study of leaflet (heart valve flaps) mobility in 400 patients.
“We are thrilled to join Medtronic in understanding the benefits of TAVR for a greater number of the estimated 1.5 million Americans who suffer from aortic stenosis,” said Dr. Timothy Byrne, physician executive director of cardiac services for Abrazo Community Health Network.
Along with the TAVR study, Abrazo Arizona Heart Hospital is participating in three other clinical studies for treatment of patients with aortic aneurysms and heart failure. The hospital’s stepped-up involvement in research is part of a bigger plan to continue its legacy of excellence in cardiovascular care in Arizona, across the Southwest and throughout the nation.
Earlier this year, the hospital has established six specialty cardiac and vascular institutes, expanded its services and became a training ground for cardiologists nationwide.
“Unlike many other areas of medicine, cardiology continues to progress at a breakneck pace. We are at the forefront of new testing, treatments and technologies that will help patients not only live longer, but also remarkably better,” Dr. Byrne said.
In May, Abrazo led a two-day training session and live case demonstrations of TAVR for heart team members from hospitals across the country. The session was designed to help participants select appropriate patients and understand diagnostic imaging modalities, as well as learn about the design, implantation techniques and best practices in using the CoreValve system.