Patients in the Abbott study have now been followed for at least one year. The clip did not extend life, but Dr. David Adams, cardiac surgeon in chief at Mount Sinai Health System and co-principal investigator for the study, said, “We would never see a difference in mortality — one year was not enough time. “
“It’s a big win,” Dr. Kendra Grubb, a cardiac surgeon and director of the Structural Heart Center at Emory University, who was not involved in the study, said. Dr. Grubb, who is on Abbott’s advisory board and a speaker for Edwards, said that although doctors have been able to keep patients alive with medical treatment, “it’s a miserable way to live.”
The clinical trial by Edwards is testing a different method. It replaces the tricuspid valve by inserting a new valve into the heart, pushing the old one out in a way similar to a method called transcatheter aortic valve replacement. The aorta controls the flow of blood out of the heart, and the TAVR method has been used to replace valves in hundreds of thousands of patients.
The development comes after years of inattention to the tricuspid problem. Valve was known for a long time as the forgotten valve. Cardiologists assumed that if they fixed problems on the left side of the heart — such as a leaky mitral or aortic valve — the tricuspid valve would heal itself.
His assumption was wrong.
Patients and cardiologists have long sought an effective treatment for tricuspid leak. The only medical treatment today is with drugs called loop diuretics. They expel excess fluid from the patient’s body, but only temporarily. As diuretic treatment is repeated, patients’ fluid retention becomes worse and worse until the kidneys fail and eventually the tricuspid valve fills with fluids as well.
“Patients are becoming more and more unhappy,” said Dr. Paul Sorza, chair of the Valve Science Center at the Minnesota Heart Institute Foundation and co-principal investigator of the Abbott study.
Some attempt surgery, which is used to repair — not replace — the fragile valve. Most patients have so many other medical problems, often stemming from their tricuspid leak, that open-heart surgery would be too risky. The mortality rate from surgery is 10 percent, which is 10 times higher than the rate for aortic valve replacement.