SALUS Clinical Trial Restores Valve Function of 93 Year Old Woman

For immediate release: April 22, 2015


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Fran Smith, a sprite 93-year old from Lutherville, Maryland, was the first patient at the University of Maryland Medical Center (UMMC) to benefit from the implantation of the Direct Flow transcatheter aortic valve as part of the SALUS clinical trial. The implantation of this investigational valve is the latest milestone for interventional cardiologists and cardiac surgeons from the University of Maryland School of Medicine who constantly evaluate new valve options for patients with aortic and mitral valve diseases.Fran Smith SALUS trial

She was evaluated by the multidisciplinary team of doctors and deemed “extreme risk,” a categorization that is essential for qualifying for the clinical trial. To be eligible for the SALUS clinical trial, patients must have severe, symptomatic, calcific aortic stenosis. Two surgeons at UM must also determine that the patient is unable to withstand traditional valve replacement surgery.

“Ms. Smith’s advanced age, frail state and weak heart made her a candidate for the SALUS trial because this valve does not require rapid pacing during implantation, which is often required for patients undergoing TAVR,” said Bartley Griffith, MD, the Thomas E. and Alice Marie Hales Distinguished Professor of Transplant Surgery at the University of Maryland School of Medicine.

As with all transcatheter aortic valve treatments at the University of Maryland, Smith’s procedure was led by a cardiac surgeon and interventional cardiologist, working together in the hybrid operating room. The new valve was fed up through a catheter placed in her groin and replaced the hardened aortic valve in her heart.

Physicians at the University of Maryland Heart Center are excited about the promise of this new investigational valve. “The new valve represents the next generation of aortic valves that conform to the patient’s anatomy,” added Griffith, who is also a co-principal investigator of the trial.

The valve’s double-ring, polymer-based frame is made of nylon and polyester. Initially inflated with saline to conform to the patient’s anatomy, the saline is exchanged with a hardening polymer, creating a tight seal to the native aortic annulus. The polymer hardens the valve frame within 90 minutes. Once hardened, the Direct Flow valve is permanently affixed in place. 

The Heart Center is renowned for treating hundreds of patients with valve disease each year and contributing to the development of new valves. Participation in national clinical trials means UM doctors get special access to the latest valves that might help our patients. 

“The University of Maryland’s reputation as an early adopter of new techniques and valves gives us a voice with partners who are researching the design and efficacy of new therapies for complex patients,” said Anuj Gupta, MD, assistant professor of medicine at the University of Maryland School of Medicine and co-principal investigator of the SALUS trial. “Our team feels comfortable trying new things because of our rich experience treating a range of complex patients,” added Gupta, who is also director of the cardiac catheterization lab at the University of Maryland Medical Center.

Valve technology and implantation practices continue to improve and help those who might otherwise have no options for treatment, like Smith.  But for now, she has resumed a busy social life and is considering when next to enjoy her favorite pastime – cruising.