Cardiologists Make History, Removing Device & Implanting New Valve in First Heart Procedure of Its Kind

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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.

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