For years, Wichitan Major Murry was a vigorous walker, up to five miles a day.
“Dad was an adamant walker,” said Murry’s son, Ray. “He was adamant about doing this.”
But over the past year, Murry, 86, had slowed down — way down.
Murry’s heart condition had worsened to the point he could barely dress himself, much less maintain his walking routine.
“I was sick,” Murry said. “I couldn’t do anything.”
He wasn’t a candidate for open heart surgery. Doctors said the only treatment available to him was medication. And that was no longer working.
But then came another option: Ascension’s Via Christi Hospital St. Francis had just been selected to participate in a new clinical trial for an experimental heart procedure, a minimally invasive procedure that just might fix his damaged mitral valve.
On July 9, Murry was the first patient in the U.S. to undergo Abbott’s Tendyne transcatheter mitral valve replacement in a procedure lasting a couple of hours.
‘Big hit on the body’
Murry suffered from severe mitral regurgitation, a condition where the heart’s mitral valve doesn’t close tightly, enabling blood to flow backward and causing the patient fatigue, shortness of breath, an irregular heartbeat and possibly even a stroke.
It can be treated with medicine, or in some cases the valve can be repaired.
Absent of those two treatments, the other option is to replace the mitral valve through open heart surgery — “the gold standard” of treatment, said Bassem Chehab, cardiologist and medical director of the Via Christi Structural Heart program at St. Francis.
But that is hard on the human body, involving opening up the chest. It’s especially hard on someone in their late 80s like Murry, who could have faced a longer recovery and a higher risk for complications from the surgery, Chehab said.
“What you (do) is so invasive it can make it much worse” for the patient, he said.
With the Tendyne procedure, doctors insert a catheter in the patient’s femoral artery in the leg and make an inch-wide incision between the patient’s ribs to replace the mitral valve.
“It’s much less invasive so it doesn’t put a big hit on the body like surgery,” Chehab said.
Abbott, an Illinois-based medical device manufacturer and pharmaceutical company, selected St. Francis as one of 80 sites in the U.S., Canada and European Union to participate in the clinical trial it calls SUMMIT. St. Francis is the only Kansas hospital participating in the trial.
Abbott expects to enroll 1,010 patients in the study.
St. Francis was selected for the study after it expressed an interest in participating and was nominated by a local Abbott team, an Abbott spokeswoman said in an e-mail.
“They were evaluated and qualified to participate based on their expertise and experience,” Abbott spokeswoman Mary Kokkinen said.
That expertise, Chehab said, comes from the structural heart program Via Christi established about five years ago, and recruited him from Kansas City to lead.
The program focuses on treating conditions with heart valves, such as the mitral and aortic valves, which has brought new treatments such as transcatheter aortic valve replacement, or TAVR, and Abbott’s MitraClip, which is a minimally invasive procedure to repair mitral valves without open heart surgery.
Patients who are referred to the structural heart program are seen by a team of specialists who together decide on the best course of treatment: medication, a procedure or surgery. In Murry’s case, he was evaluated by Chehab and cardiothoracic surgeon Brett Grizzell.
It’s a team approach based on a Mayo Clinic model, Chehab said. “This has been shown to optimize the outcome, results (for patients) on every level,” he said.
Chehab and Grizzell also worked together to design a procedure room where the structural heart program is housed at St. Francis.
“It’s like a (heart) cath lab and an OR (operating room) put together,” Grizzell said. “They call it a hybrid.”
It’s that hybrid room where Murry received his new mitral valve, and where other patients selected for the Tendyne trial will receive theirs.
‘Like a Band-Aid over a leaky dam’
For Murry, open heart surgery wasn’t an option, but neither was repairing or continuing to treat his damaged mitral valve with medication.
“Medical treatment for this kind of condition is like putting a Band-Aid over a leaky Hoover Dam,” Chehab said. “So you try to manage the symptom or control the symptom, but it’s not going to treat it, and it keeps getting worse and worse until quality of life has no meaning.”
“His main question to me was, ‘Is this going to keep me out of the hospital or not, doc? That’s what I want to know.’”
“Oh, I was in bad shape before,” Murry said. “They gave me a new lease on life.”
Murry added he’s now walking again, for short distances, and “I can get up and dress myself.
“I feel great.”
Chehab said because it’s a clinical trial, patients have to be thoroughly screened and approved before they can be considered for the Tendyne.
“These are research patients,” Chehab said. “They have a lot of criteria that they have to meet to make sure that they qualify for this procedure.
“So, we don’t expect to be doing 200 of these. It’s just like a couple of three cases every month that are hand selected.”
Chehab said the clinical trial of Tendyne is expected to last a couple of years. Patients who receive the Tendyne will be followed for a couple of years after undergoing the procedure. If everything goes well with the trial, he said, the results will be presented at a major medical conference and then it go to the federal Food and Drug Administration for approval.
“So you’re talking five, six, seven years before this becomes commercially available for everyone to use,” Chehab said.
“The beauty of that is we’re able to offer our community these kinds of technologies way ahead of time, without (patients) actually having to go anywhere else.”
This story was originally published September 14, 2018 4:33 PM.