Experimental heart valve operation helps Meyer enjoy 75th

By Lois Mittino Gray

“This was a gift I fell into and what a great birthday gift it was! Being accepted into this experimental trial was a lifesaver for me,” enthused New Harmony resident Ken Meyer. “I had my procedure done on Friday afternoon, October 10, spent the night in the hospital, and got discharged Saturday afternoon just in time to celebrate my 75th birthday on Sunday. What a big difference from the risk of open heart surgery. I didn’t even have to take any pain medications afterwards. ”

Ken celebrated his Diamond Jubilee birthday after having a JenaValve put into his heart to repair his aortic valve’s regurgitation (backflow of blood). JenaValve is a technology innovation redefining what it means to treat patients with severe aortic regurgitation. It is a next-generation device technically defined as a “well-proven porcine (pig) root valve mounted on a low-profile nitinol stent.” For older patients with aortic regurgitation, this takes the place of open heart surgery. Feeler guided positioning and clip fixation allows for anatomically correct implantation of the device right over and the old aortic valve where it “clips” right into it.

The JenaValve procedure, a Trilogy TAVR system, is a new treatment option done in three hospitals in the United States. The company is completing its pivotal ALIGN-AR experimental trial to support a Premarket Approval submission to the FDA, which is expected to be applied for in late 2025. Ken was accepted into the ALIGN-AR trial as a high risk, older person who does not have the anchoring and stability of calcification around the valve to attach the replacement to in his heart. Patients with aortic stenosis have been able to get new valves in a procedure like this if they have the calcium buildup. For Ken, a JenaValve would be put right into the old aortic valve without needing the stability of calcium. “I guess my flaps were loose and flopping all over,” he commented. “Blood was backwashing.”

Meyer had the procedure done in a two hour operation at Barnes-Jewish Hospital in St. Louis in October. The Barnes team did their first one in 2024 and many successful ones since. They have a record of no morbidities (deaths) and success in over 500 implantations. The multidisciplinary Structural Intervention Group, including Cardiovascular Division faculty members Drs. Zajarias, Sintek, Lasala, and Quader, along with colleagues in Cardiothoracic Surgery are the team.

“Dr. Zajarias did the procedure, but there were lots of others in the room watching it. There were all kinds of tests and monitors and probes on during the surgery. They put in a catheter through my wrist and the anesthesiologist monitored my blood pressure every second. One was in my femoral artery. There was a camera in my throat to see the little curve at the top of my heart to put it in the right place over the old valve,” he described.

“This was a big deal. If I was 15 and in good health, I might have opted for the open heart surgery since that valve replacement would last longer, about 10-15 years. Age is not a factor in having the Jena installed. A 90 year old woman had it done and she is just fine. She has a new lease on life now,” Ken reflected.

The remarkable thing is that Ken had this experimental valve procedure done in October after having a 14 hour major brain surgery done in April to remove a tumor. That was done at Barnes, too. Neurologists and cardiologists were consulted and conferred with to determine which he needed to do first. It was agreed the brain surgery would take priority. He is recovering from that successful operation.

Ken’s heart history begins when he had his mitral valve repaired 11 years ago with an actual open heart surgery. He was doing fine with that and retired in 2023 from proprietorship of Lifestyle Tours, a company he founded. On January 9, 2024, it was time for his annual physical and his cardiologist noted he’d no echocardiogram in four years. “Let’s find out how you are doing…,” she said. The aortic valve was clogged and needed repair, having backflow of blood.

“Coincidentally, in December 2024 before this discovery in the physical, I ran into an old high school buddy who said, ‘Here’s the guy I use for my heart and gave me a card with a name. On January 30, 2025, I met another old friend who handed me a card and said, ‘Here’s the doctor my brother uses and it had the same name!’ I took it as an omen,” Ken said.

“So I was meeting with Dr. Quader two weeks later on February 18. She suspected I might be eligible for the trial study and submitted my name.” A nurse did a follow up, that same day, and he was accepted as a ‘human guinea pig’ into the trial.

By March 6, 2025, there was a whirlwind of activity. Ken was having double vision and hearing loss from the brain tumor. Which should he do first? He was referred to the valve team doing the trial at Barnes. They suggested he do the brain first and his cardiologist in Evansville agreed. “All the pieces began to fit together. I knew it was not optimal to have two major surgeries in the same year. If I could be in this valve trial, I would accept it to avoid risky open heart surgery.”

“They told me I could get out of the trial anytime I want. They gave me a huge manual all about the procedure that was 16 pages long. About 15 and a half of those pages was what could happen if things went wrong. Death seemed the easy way out,” he joked.

Ken is telling his story because he would like people to know about this procedure if it becomes FTC approved. The Trilogy TAVI treatment system is currently approved for investigational use in the U.S. and has obtained CE Mark approval in Europe. The Federal Trade Commission (FTC) is attempting to block the acquisition of JenaValve by Edwards Lifesciences due to concerns about monopolizing the TAVR-AR market. GlobalData estimates the current US TAVR (transcatheter aortic valve replacement) market to be worth $3.2 billion dollars.

.Ken and his wife, Peggy, have plenty of good words for the Barnes Hospital facility and staff in midtown St. Louis. “Barnes has a wonderful new sixteen story heart hospital that just opened. If I waited a few more weeks for my work, I would have been there. It is two and a half miles long and has a Doubletree Inn in it. “They were very personal and good to us. I would just call security and they drove me over to the hotel at night,” Peggy noted and Ken agreed.

Two of the couple’s three children live in St. Louis, Kathy and John, so they will get to see them and grandchildren on trips back to the doctor. Medicare paid for the surgery and his supplemental insurance did the rest. Any other costs were covered by the trial.

As for now, Ken comments that “I think it will take me awhile to get past this. I feel fine, but not necessarily a whole lot better.” No pain medicines were required after surgery. He needs to get an echocardiogram in November and then again six months later. He will be required to get one every year for the next five years. He’s a fighter with his dukes up in the ring.