New Heart Valve Implant Clears Way for Patient in Need of Liver Transplant and Hip Replacement

DETROIT (June 6, 2023) - Janice Couch, 62, a retired pre-school teacher from Grand Rapids, Michigan, is finally physically ready to receive two procedures that stand to change her life, thanks to Henry Ford Health interventional cardiologists who paved the way by implanting a new aortic valve device for the first time in the health system's history.

That novel aortic valve, known as the JenaValve Trilogy Heart Valve System™, was made available through a clinical trial approved by the Food & Drug Administration (FDA). On May 11, 2023, at Henry Ford Hospital, Couch underwent the procedure that implanted the investigational device in her heart, with the hope it would treat her severe aortic insufficiency-a condition that's been prohibiting her from receiving other necessary medical procedures.

Couch has battled chronic liver damage, known as cirrhosis, for 16 years. With cirrhosis, patients may experience fatigue, weakness, and weight loss-and in the most advanced cases, may require a liver transplant. Couch may have inherited the liver condition from her mother, a former nurse who died from complications due to cirrhosis at 44.

"Because of my cirrhosis, I have a low immune system and I get infections frequently," said Couch, who contracted septic arthritis in her left hip three and a half years ago. Surgery was done to help clean out the infection and all the remaining cartilage in her hip had to be removed. As a result, her hip joint is bone-on-bone and has rapidly worsened.

For years she thought her liver disease and deteriorating hip condition were the reasons for the lack of energy and mobility, which have severely limited her quality of life. But as it turned out, leaky heart valves were also contributing greatly to her slowing down.

The journey that brought her to Henry Ford Health started with her search for a possible liver transplant or living liver donation to address the cirrhosis.

"Janice's cirrhosis led to her to our team due to her cardiac issues and the barrier they presented to being treated for liver disease," said Tiberio Frisoli, M.D., who along with Brian O'Neill, M.D., and Dee Dee Wang, M.D., engineered and performed a life-changing procedure using the new device ― the JenaValve Trilogy Heart Valve System™.

The Henry Ford Health Structural Heart team and JenaValve team pose for a group photo following successful implant procedure on May 11, 2023 at Henry Ford Hospital in Detroit.

Couch's gastroenterologist referred her to one of the Henry Ford Health specialists who make monthly visits to her physician's Grand Rapids office to have her evaluated for a possible liver transplant. Shannon Todd, P.A., a liver disease specialist, connected Couch with interventional cardiologist and medical director of the Henry Ford Health Center for Structural Heart Disease, William O'Neill, M.D.who entrusted her case to his partner, Dr. Frisoli, to assess if her heart was healthy enough for a possible liver transplant down the road, and for a much-needed hip replacement in the short term.

Henry Ford physicians discovered Couch had both mitral and aortic heart valve issues, which needed to be corrected before she could be cleared for a liver transplant and hip replacement.

Her heart valve had lesions known as vegetations that created a condition called endocarditis, an infection that occurs along the edges of the heart valves.

Normally, the mitral and aortic valve problems would be treated at the same time with open heart surgery, but her cirrhosis made her too high risk for such a surgery. That is where the Structural Heart Disease team, one that specializes in minimally invasive, or transcatheter, heart procedures came in. While there are FDA-approved transcatheter interventions for mitral regurgitation, there are none for aortic valve regurgitation. Henry Ford's Center for Structural Heart Disease had access to the JenaValve investigational device as one of only a few sites in the United States enrolling in the ALIGN trial for high-risk patients like Couch.

Before she could qualify for the new aortic valve, Dr. Frisoli had to repair Couch's leaky mitral valve in November of 2022. The minimally invasive, non-surgical procedure was done by implanting a mitral valve clip. The miniature clip was attached to the abnormal part of the valve, closing it tightly, while allowing the rest of the valve to open and close normally. The clip helps prevent or minimize the amount of regurgitation of blood through the mitral valve.

Next, Dr. Frisoli and the Henry Ford Health Structural Heart team engineered a way for Couch to receive the novel JenaValve she so badly needed.

"Janice's leaky mitral valve would have excluded her from receiving the new aortic valve. So, we had to work backwards," said Dr. Frisoli. "We reduced her mitral regurgitation from severe to mild, which opened the door to implant the new aortic valve technology."

Once the mitral valve intervention was successfully done in November, Couch was screened and enrolled in the trial for the novel valve, and finally received the new valve in May.

She had the new valve procedure in the morning and by the afternoon, she felt better than she had in a long time.

"All of a sudden, I had energy. I think I talked that entire afternoon," recalled Couch. "I was like 'Oh, this is what I've been missing.' I didn't realize my lack of energy was due to my heart valve issues. The whole time I thought it was because of my hip and liver conditions. It was my heart all along, and the Henry Ford Health team saved my life, totally."

"She is an amazing success story," said Dr. Frisoli, "This is someone who could have easily spiraled downward and become too sick for any cardiac intervention."

Couch's aortic valve pressure had been very low prior to the procedure. Her diastolic blood pressure (i.e. the "lower number") ran between 20-40 mm Hg (millimeters of mercury) before the procedure; immediately after the novel valve implant her pressure levels rose to 70 -90 mmHg.

"When I look at her echocardiogram now, she has no aortic valve leak or mitral valve leak," said Dr. Frisoli. He further explained the reason this is important is because, if left untreated, aortic valve insufficiency can cause the pumping chamber of the heart to become larger and weaker over time. This can lead to refractory congestive heart failure.

The heart valves that once were barriers to receiving additional therapies are now bridges to the life-improving procedures for hip replacement and liver transplant or partial live donor liver donation that Couch so desperately seeks.

Next up for Couch is getting that new hip. Her procedure is scheduled on her birthday, July 13, with Trevor North, M.D., a Henry Ford Health orthopedic surgeon and joint replacement specialist.

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MEDIA CONTACT: Sal Giacona/[email protected]/ 313-421-9108

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