But Dr. Miller also offered a note of caution: “This is a study involving idiopathic or valvular cardiomyopathy, not ischemic cardiomyopathy. I don't want the audience going home and trying it for the ischemic mitral regurgitation patients. That's a totally different kettle of fish.”
Elsewhere at the meeting, however, Dr. Bolling, a coinvestigator in the Acorn trial, said he thinks the CSD ought to be able to induce favorable reverse LV remodeling in patients with ischemic, as well as in those with dilated, cardiomyopathy.
“Now that we really understand that this [functional mitral regurgitation] is a ventricular disease, I think we should change our mantra for these patients. It should be: 'Find mitral regurgitation in patients with cardiomyopathy, fix mitral regurgitation, but more importantly, fix the left ventricle.' … I think any treatment directed at the ventricle itself is going to be better than mitral valve surgery alone,” said Dr. Bolling, professor of surgery at the University of Michigan, Ann Arbor.
Having personally implanted the CSD, however, he's not convinced it's the answer. “The Acorn procedure is somewhat technically difficult and unfamiliar to the surgeon,” he said, adding that he sees the CSD as having only “limited potential” as an LV remodeling device.
Dr. Bolling holds a financial interest in the GeoForm MV repair ring, a silicone and titanium device he coinvented and has licensed to Edwards Lifesciences Corp. The GeoForm has already received Food and Drug Administration approval for MV repair. At the thoracic surgeons' meeting, he presented initial prospective data in 10 patients—half with ischemic and half with dilated cardiomyopathy—indicating a 26- or 28-mm GeoForm ring not only improved mitral regurgitation but also reversed LV remodeling.
The ring's unique three-dimensional shape encourages alignment of heart muscle in a way that promotes remodeling, he explained, adding that larger multicenter studies are underway.