When Carol Jackson visited Hursh Naik, MD, for an annual checkup in January 2019, the doctor detected leakage in the 87-year-old’s tricuspid value — which helps regulate blood flow.
Over a year later, a non-invasive heart procedure is allowing Mr. Jackson to get his life back in order. And medical professionals are trying to make the procedure a better alternative to open heart surgery.
Mr. Jackson is one of the first persons in the southwestern United States to undergo the TRILUMINATE Pivotal trial to treat a common cardiac condition that affects 1 in 30 Americans over 65, according to Dignity Health.
The trial is the first in the nation to evaluate a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation, a condition in which the tricuspid heart valve does not close properly, allowing blood to flow backward into the heart and forcing the heart to work harder.
When severe cases are left untreated, tricuspid regurgitation can lead to heart failure.
Dignity Health St. Joseph Hospital and Medical Center is one of the first hospitals in the U.S. to conduct the trial and procedure.
Dr. Naik, a cardiologist who is leading the clinical trial at St. Joseph’s, says the new procedure may have revolutionary impact on cardiology.
“We’ve been interested in the tricuspid valve for a little while just because it’s considered the forgotten valve,” Dr. Naik said. “There was no definitive treatment for it. If someone had a leaky valve, the only treatment was open heart surgery, which based on the data doesn’t really help long-term outcomes. Or more commonly, we treated it with a water pill, just to relieve all the fluid that accumulates when you have a leaky valve.”
Back when Mr. Jackson’s annual checkup showed his tricuspid valve was leaking, he didn’t notice any serious physical effects on his body. But months later, he would have shortness of breath while carrying laundry at his home in Westbrook Village, or stopping a quarter of a mile on his walks. He also had liver congestion.
“It was affecting my breathing quite a bit,” Mr. Jackson said.
Mr. Jackson had experienced periodic heart problems dating to 2004 when his heart went out of rhythm as he exercised on a treadmill. In 2016, Mr. Jackson had a mitral valve clip installed.
But when Dr. Naik detected leakage in the Peoria man’s tricuspid value, the doctor informed Mr. Jackson of the upcoming TRILUMINATE trials and that the procedure would benefit him. Mr. Jackson and his family also thought it best to go through with the trial, or else having to resort to open heart surgery — which they saw as a last resort.
Before the procedure was created, patients typically had open-heart surgery which requires a much more complex recovery period. Officials say the traditional open-heart procedure is technically challenging and involves patching the leak to eliminate backflow.
The other option was to use a water pill, which would only relieve the buildup of liquid around the heart. But that didn’t resolve the mechanical issue of the leaky valve.
Mr. Jackson’s big day came in October 2019.
The procedure involves using the Abbott TriClip repair system in a minimally invasive manner without needing to stop the heart temporarily. Doctors use a catheter to deliver an implantable clip into the heart via an incision in the upper leg.
Once the catheter is put into place on the tricuspid valve, the catheter is removed. The clip then becomes a permanent implant in the heart, allowing the valve to close tightly and restore normal blood flow through the heart.
“I feel great. I feel as good as I did before,” Mr. Jackson said about the procedure. “My walking is not quite as far as it had been, but it’s getting close.”
And he already has a goal to reach.
“There’s a loop there that’s about 2.2 miles. My goal is to be back up to walking that entire loop,” Mr. Jackson said about his neighborhood near 91st Avenue and Union Hills Drive. “And I’ll be there within a month or two. I’ll be there again.”
Dignity Health St. Joseph’s Hospital and Medical Center is part of a national study — the TRILUMINATE Pivotal trial — testing the minimally invasive non-surgical procedure. The trial is ongoing, and those interested in participating can visit www.bit.ly/triluminatestudy or call 602-842-7352.
If proven successful, officials said the procedure could replace invasive heart surgery and become the new standard of care for leaky tricuspid valves.
“We’ve found that the procedure also has other benefits, including improving the heart’s function,” Dr. Naik said. “It potentially can make a weak heart stronger.”
The trial, sponsored by Abbott, is expected to enroll about 700 patients by 2022.