Interventional cardiologists with the University of Washington (UW) removed a device from a patient’s mitral valve and then replaced it with a brand new device—all through a catheter, with no open surgery required. It is believed to be the very first procedure of its kind performed anywhere in the world.
The 76-year-old patient, John Steenmeyer, received a MitraClip device in 2021, but it did not resolve the issue. He was referred to UW Medicine in 2022.
James M. McCabe, MD, professor of medicine at UW and director of the cath lab at UW Medical Center, considered multiple treatment options, including implanting an additional MitraClip device.
“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,” McCabe explained in a statement from UW Medicine.
McCabe and his team identified calcium deposits on one side of Steenmeyer’s mitral valve, a clear sign that ‘stacking’ MitraClips was not a viable solution. When the group also confirmed that open surgery was not possible due to the high risk of severe complications, it reached out to Edwards Lifesciences about potentially using a new replacement valve—the SAPIEN M3—that was still being tested in a national clinical trial.
Edwards approved this one-time use of its new device. After waiting six months to receive expanded access approval from the U.S. Food and Drug Administration, McCabe et al. were finally able to go forward.
“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,” McCabe said in the same UW statement. “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.”
The procedure was a success. Steenmeyer was discharged and is now recovering at home.
“I was ready to make out my will, so this came along just at the right time,” he said.
While the new-look Edwards device has been used in patients before, it this is the very first time a MitraClip has been extracted in the same procedure as a full device implantation.
Gabriel Aldea, MD, David Elison, MD, and cardiovascular technologist Bailey Benton all provided assistance during the procedure.
University of Washington cardiologists no strangers to success
In 2022, McCabe and a group of UW colleagues used a new catheter-delivered device, the ŌNŌ retrieval system, to remove a benign tumor from a patient’s heart. It was the first time such a device had ever been used to remove a patient’s heart tumor.
McCabe said that experience helped guide him through this latest historic procedure.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.