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MHVI Launches National Clinical Study of TAVR’s Use in Low Risk Patients

A new, less invasive option for patients with aortic stenosis may become more widely available, thanks to a new study at MedStar Heart & Vascular Institute (MHVI) at MedStar Washington Hospital Center.

MHVI is the first in the nation to launch a clinical trial evaluating the use of TAVR (transcatheter aortic valve replacement), to replace narrowed heart valves in patients who are considered at low risk for death from surgery. The Food and Drug Administration granted an Investigational Device Exemption, which allows MHVI to use TAVR in a research setting, and to enroll these patients into the study.

Paul Corso, MD, sitting, and Ron Waksman, MD, are evaluating the use of TAVR in patients considered low risk for death from surgery.

“Right now, the procedure is only FDA-approved for patients considered inoperable or too frail to have an open-heart procedure,” notes Paul Corso, MD, chair of cardiac surgery at MHVI. “But TAVR has a faster recovery time and maybe it would be a good option even for those who can tolerate surgery.”

He cautions, “Though the total recovery is faster with TAVR, the prosthesis is more expensive. Also, the surgical mortality and complication rate has decreased to below one percent in good centers. The long-term survival of the prosthesis will need to be competitive with the surgical prosthesis. Traditional surgical prostheses last from ten to 30 years.”

For decades, traditional open-heart surgery to replace the valve has been the gold standard for treating patients with severe aortic stenosis. With TAVR, physicians insert a valve through a catheter threaded into the heart through a small incision in the groin or chest wall.

“We appreciate the FDA’s trust in our ability to conduct this important investigation and its safety and efficacy in the low-risk population,” says Ron Waksman, MD, lead investigator of the study and director of Cardiovascular Research and Advanced Education at MHVI. “We have some of the most experienced TAVR cardiologists and surgeons in the country and know these studies open new possibilities for this technology and for patients.”

The study is expected to enroll up to 200 patients in at least four centers across the U.S.

“We’re using several different types of TAVR technology,” says Dr. Corso. “We are trained in all of them, and we need to actively study them before patients make decisions about major surgery.”

Results from this trial will be released this year, says Dr. Waksman. “It is expected, based on the results, that the FDA will approve TAVR for intermediate risk,” he says. “If it shows equivalent outcomes to surgery, we can offer a much less invasive option to the majority of patients.”

For more information on TAVR, or to request an
appointment with a specialist, call 202-877-3627.

MedStar Union Memorial Hospital Participates in Low-Risk TAVR Trial

With outcomes that have consistently exceeded national benchmarks for TAVR, MedStar Heart & Vascular Institute at MedStar Union Memorial Hospital is one of a select few hospitals in the Baltimore metropolitan region chosen to participate in an industry-sponsored low-risk TAVR trial. This trial is being conducted at 80 centers around the world. There is no upper or lower age limit to participate and this trial randomizes low risk patients in a 1:1 fashion to either traditional cardiac surgery or TAVR.

To refer a patient for TAVR or if you may have a patient who is eligible for the trial, please contact Judith Raqueno, TAVR coordinator at 443-278-9170, ext. 1.