Scripps Clinic cardiologists on Tuesday became the first in San Diego County to replace a failing aortic heart valve using a minimally invasive procedure rather than open heart surgery in a patient with low surgical mortality risk.
The procedure was part of a new national clinical trial seeking to validate the performance of the transcatheter aortic valve replacement (TAVR) procedure in low-risk patients using the CoreValve Evolut R System. Outside of clinical trials, the system is currently approved by the Food and Drug Administration for use only in patients who are too sick to tolerate conventional open heart surgery.
“We are proud to be part of this important clinical trial, which has the potential to greatly expand the use of a procedure that has been shown to be less invasive, safer and more cost effective compared to open heart surgery in other higher-risk patients,” said Paul Teirstein, M.D., chief of cardiology and director of interventional cardiology at Scripps Clinic, and the primary investigator for the trial’s local site.
“By participating in this study, Scripps is offering a minimally invasive alternative to open heart surgery for patients with aortic stenosis,” he said.
Only study site in San Diego County
Scripps is the only investigation site in San Diego County for the Evolut R System randomized clinical trial, and it is among 80 study sites across the country that are enrolling 1,256 low-risk patients for the study. Participants are being randomized, with half receiving the TAVR procedure and the other half receiving more conventional open heart surgery to replace their faulty valve.
Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets. As the problem worsens the heart must work harder to pump blood throughout the body, potentially leading to heart failure and increased risk of sudden cardiac death.
Risk of developing a more severe form of the disease increases with age. More than one in eight people aged 75 and older have moderate or severe aortic stenosis, according to a 2006 study published by the medical journal The Lancet.
When performing the minimally invasive TAVR procedure, members of a multidisciplinary heart team thread a small, collapsible heart valve through a small incision in the leg or chest and into an artery leading to the heart. Once in position in the heart, the device expands into place and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.
Procedure takes 30 minutes
On Tuesday, Scripps Clinic interventional cardiologist Curtiss Stinis, M.D., and Scripps cardiothoracic surgeon Scot Brewster, M.D., teamed up to perform the TAVR clinical trial procedure on a San Diego patient in a catheterization laboratory in the Scripps Clinic John R. Anderson V Medical Pavilion, located on the campus of Scripps Memorial Hospital La Jolla. The procedure took about 30 minutes, and the patient was expected to be discharged Wednesday morning.
Scripps cardiologists and surgeons have been performing TAVR procedures since 2008 when Drs. Teirstein and Brewster participated in an early clinical trial of a TAVR surgical system on high-risk patients.
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