Abrazo Arizona Heart Hospital is celebrating a milestone with patients who have complex heart conditions.
Amid a 10-year clinical trial, the U.S. Food and Drug Administration has approved the use of Transcatheter Aortic Valve Replacement (TAVR) in patients who are at low surgical risk of major complications or death.
TAVR is a minimally invasive alternative to open-heart surgery that enables a medical team 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 downtime and recovery, and could result in a shorter (average two-day) hospital stay compared with traditional open-heart surgery, according to the American Heart Association.
Abrazo Arizona Heart Hospital is participating in a worldwide clinical study of a next-generation recapturable, self-expanding TAVR system.
The procedure was previously available to extremely high-, high- and intermediate-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 could withstand open-heart surgery.
“What this means is 40 percent more patients will have an easier path to treatment, giving them the benefit of quality and life,” said Dr. Timothy Byrne, executive director of Cardiac Services at Abrazo Arizona Heart Hospital and a principal investigator in the trial.
The clinical trial began in 2016 and included approximately 1,200 patients with a less than 3 percent risk of operative mortality, as determined by a heart team. Low-risk patients were enrolled with 1:1 randomization to receive the minimally invasive valve replacement or undergo open-heart surgery. Patients are followed over 10 years after their TAVR procedures.
Globally, results of the trial have been outstanding, according to researchers, with the TAVR valve performing as well as, or better, than surgical aortic valve replacement (SAVR) in all patients.
“The same is true in Arizona,” Byrne said. “The procedure is proving to be safer, with fewer complications, a shorter hospital stay and a quicker recovery.”
Along with the TAVR study, clinicians in Abrazo Arizona Heart Hospital’s six specialty cardiac and vascular institutes are playing an integral role in other heart and cardiovascular clinical trials. Among them is an investigational study called the APOLLO pivotal trial to replace the heart’s mitral valve using a new Transcatheter Mitral Valve Replacement therapy called the Intrepid TMVR system.
Byrne called these developments game-changing for patients. “New technologies and minimally invasive procedures are not only enabling us to deliver quality care, but they are also helping patients live longer and better,” he said.
For more information, visit AbrazoHealth.com.