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TAVR Procedure Extended to Low-Risk Patients

Low-risk patients with severe aortic stenosis are now candidates for transcatheter heart valve replacement. Previously, TAVR was limited to patients at high or moderate risk for open heart surgery.

"The FDA’s approval has brought an influx of low-risk patients,” said Zafir A. Hawa, MD, FACC, FSCAI. “Now, we don’t have to worry about their risk scores, and these patients don’t have to have open heart surgery. We can do what is best for patients, and most go home the next day.”

The surgery is performed with a minimalist approach that does not require general anesthesia, lowers the risk of complications, decreases the average length of stay and improves recovery. Dr. Hawa and James H. Mitchell, MD, FACC, both interventional cardiologists with Meritas Health Cardiology, collaborate with cardiovascular surgeons to perform the procedures at NKCH.

Two TAVR Trials

The FDA’s approval was anticipated, given the results of two trials that looked at patients with severe aortic stenosis and low surgical risk who received TAVR versus surgery. 

Both studies were presented in March 2019 at the American College of Cardiology Scientific Sessions and published in the May 2, 2019, New England Journal of Medicine. Investigators found TAVR outcomes were superior or as good as those after surgical aortic valve replacement.

In the PARTNER 3 trial, 1,000 patients were randomly assigned to undergo TAVR with transfemoral placement of a balloon-expandable valve versus surgery. Researchers found the rate of composite of death, stroke or rehospitalization at one year was significantly lower with TAVR. In the EVOLUT trial, 1,468 patients were randomized to a self-expanding supra-annular bioprosthesis valve compared to surgery. Investigators found the device noninferior to surgery with regard to the composite end point of death or disabling stroke at 24 month. 

Asymptomatic Patients

Because severe aortic stenosis symptoms progress over time, Dr. Hawa said it is imperative physicians not only refer symptomatic but also asymptomatic patients for cardiac intervention.

 “Although TAVR is only approved for symptomatic patients, we can follow those without symptoms until symptoms develop.” Dr. Hawa said. “We know asymptomatic patients can suddenly develop serious symptoms, and their survival sharply declines. By monitoring them, we can watch for symptoms, catch them early and fix the problem.

Zafir A. Hawa, MD, FACC, FSCAI

Zafir A. Hawa, MD, FACC, FSCAI

Dr. Hawa earned his medical degree from the University of Bombay. He completed his internal medicine residency at the University of North Dakota Medical Center, critical care fellowship at the University of Pittsburgh Medical Center, and cardiology research, cardiology and interventional cardiology fellowships at Western Pennsylvania Hospital.