News | Structural Heart | May 16, 2023

Prowess, Persistence Yield First-anywhere Heart Procedure

Cardiologists detached and removed a patient's failed mitral-valve clip device, then implanted a new biologic valve — all via catheter

Photo courtesy of James McCabe

Photo courtesy of James McCabe


March 16, 2023 — Cardiologists at the UW Medicine Heart Institute recently performed a first-in-the-world procedure, detaching and retrieving a clip device from a patient’s mitral valve and placing a replacement biologic valve — all through a catheter. Previously this sequence of tasks had been performed only via open surgery.

The patient, John Steenmeyer, 76, of Bellingham, Wash., was discharged this week from the University of Washington Medical Center in Seattle. His new mitral valve is functioning well, said Dr. James McCabe, who led the catheterization procedure on April 27.

For years, Steenmeyer’s energy had declined as a poor seal between the two leaflets of his mitral valve had allowed blood to leak backward into the left atrium. Such “regurgitation” is a common heart-valve problem that, in mild cases, someone can live with for years, but in severe cases requires medical intervention. 

“It affected my life quite a bit,” Steenmeyer said of his failing valve. “It got to the point that I couldn’t do anything with the cadets,” he said, referencing his role as Whatcom County's commanding officer of the Sea Cadets, a U.S. Navy-sponsored youth development program.

In 2021, his Bellingham cardiologists determined he could wait no longer, but also that surgery was too risky. Steenmeyer underwent a catheter-based procedure to implant a MitraClip, a clothespin-like device that pulled his mitral valve’s two flapping leaflets together to improve their seal. Alas, soon after, his doctors realized that the clip was not sufficiently reducing the leak.

In August 2022, he was referred to UW Medicine. “I was ready to make out my will,” Steenmeyer said, “so this came along just at the right time.”

McCabe said he routinely fields calls from regional cardiologists asking, “‘Hey, we don’t know what to do for this patient. Can you help?’ So we start with a pretty open playbook.”

His first thought was that, as with other patients in this circumstance, Steenmeyer might benefit from an additional MitraClip.

“You can stack them but also you have to be thinking: How small are you making the valve openings? There’s an inflection point at which you can make the valve too small, and then you’re trading leak for stenosis [over-narrowing] and other problems.”

Ultimately, calcium deposits on one side of Steenmeyer’s mitral valve made the decision for McCabe: Since they would continue to expand, and shrink the valve’s circumference, no additional MitraClips could be placed. The subsequent confirmation that Steenmeyer was not surgery-viable seemed to exhaust his options.

McCabe approached Edwards Lifesciences, a company that makes replacement valves. One of its new devices, a catheter-placed mitral valve, is currently being tested in a national clinical trial.  McCabe is UW Medicine’s principal investigator in that trial.

He asked Edwards: If there was a way to remove Steenmeyer’s MitraClip without surgery, could he be considered for the test device? The answer was a qualified yes; Steenmeyer couldn’t be included in the trial, but could get the test valve if the U.S. Food and Drug Administration would authorize a Compassionate Use exemption.

Getting the approvals took six months. “During that time, we made a plan that leveraged our experience from last year,” McCabe said, describing another first-anywhere catheter procedure in which electrocautery was used to cut a benign tumor away from a patient’s inner heart wall and remove it in a small basket.

He described Steenmeyer’s procedure: “We cut the back leaflet, and while we’re holding onto the clip, we cut the front leaflet and then drew it back into this basket. We had to pull it from the left atrium across the wall between the two atria, where we’d made a hole, into a large sheath in his interior vena cava, then we removed it.

“We’re just trying to emulate surgery for people who can’t have surgery,” said McCabe. “We’re glad Mr. Steenmeyer is doing well.”

Neither Edwards Lifesciences nor Medtronic, another manufacturer of a transcatheter mitral valve in clinical trial, was aware of a previous procedure involving their device and a catheter-based MitraClip extraction, McCabe confirmed. 

McCabe was assisted in the procedure by Drs. Gabriel Aldea and David Elison and cardiovascular technologist Bailey Benton of the UW Medicine Heart Institute.

For more information: www.uwmedicine.org

 


Related Content

News | Structural Heart

April 9, 2024 — UC Davis Health cardiology team members are among the first in the country to treat patients with ...

Home April 09, 2024
Home
News | Structural Heart

March 25, 2024 — In a groundbreaking medical advancement, three esteemed cardiologists from CLS Health, Dr. Bahaeddin ...

Home March 25, 2024
Home
News | Structural Heart

March 12, 2024 — Medtronic plc, a global leader in healthcare technology, today announced two late-breaking data ...

Home March 12, 2024
Home
News | Structural Heart

February 20, 2024 — As New Jersey’s leading provider of high-quality cardiac procedures and diagnostic testing and an ...

Home February 20, 2024
Home
News | Structural Heart

February 15, 2024 — Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee ...

Home February 15, 2024
Home
News | Structural Heart

February 9, 2024 — Physicians in the Smidt Heart Institute at Cedars-Sinai have achieved two significant firsts ...

Home February 09, 2024
Home
News | Structural Heart

January 4, 2024 — Laguna Tech USA, a privately-held medical technology company dedicated to innovations in structural ...

Home January 04, 2024
Home
News | Structural Heart

December 12, 2023 — Think of them as the Energizer Bunnies of the heart, tiny natural batteries that keep this vital ...

Home December 12, 2023
Home
News | Structural Heart

October 31, 2023 — Edwards Lifesciences Corporation announced one-year results from CLASP IID, the first randomized ...

Home October 31, 2023
Home
News | Structural Heart

October 26, 2023 — Abbott announced data from late-breaking presentations showing the impact of its minimally invasive ...

Home October 26, 2023
Home
Subscribe Now