The CoreValve Evolut R System has been cleared by European regulators for treating intermediate-risk patients, making it the first transcatheter aortic valve replacement (TAVR, also known as TAVI) device to win an expanded indication for this population.
“The highly-anticipated intermediate risk indication marks an important milestone for the industry as we look to safely expand TAVI access to younger and less sick patient populations,” said Eberhard Grube, MD, of University Hospital in Bonn, Germany, in the announcement from devicemaker Medtronic. Grube was a principal investigator of the device’s post-market trial.
The self-expanding, recapturable device is still only FDA-approved for high-risk patients in the U.S. — but that may change soon, according to Jon R. Resar, MD, of Johns Hopkins Hospital in Baltimore.
Resar told MedPage Today in a telephone interview that he “fully anticipates” approval of an expanded indication for TAVR on this side of the Atlantic — starting with the Edwards Sapien 3 device in the fall. “With respect to U.S. trials, Medtronic is a little behind the Edwards dataset,” he said.
Over in Europe, the regulatory approval is “a big step forward because there are a lot of patients at intermediate risk. It’s going to increase the volume of patients being treated,” he added.
“The evolution of TAVR indications is not unexpected,” Donald E. Cutlip, MD, of Beth Israel Deaconess Medical Center in Boston told MedPage Today. “Approval of TAVR for intermediate risk patients expands the population likely to benefit from TAVR and is overall a good decision.”
Even so, “the available data suggest it should be used thoughtfully and continue to involve a multidisciplinary decision that weighs all of the risks and benefits. The access options, risks of vascular complication, and features of the aortic annulus that might increase risk for aortic insufficiency should all be considered in the decision and are more relevant among intermediate- than higher-risk patients, for whom the benefit over surgery is clear.”
“Thus far, long-term valve dysfunction has not been strongly considered,” Cutlip also commented. Citing a recent report on degeneration of TAVR implants, he said: “For intermediate-risk patients, this should be considered as another part of the decision making, especially for younger patients, but does not detract from the importance of having TAVR available as an option for this large and important group of patients.”
“These data must be interpreted in light of the advanced age and other high-risk features of the patients in these early studies, subsequent improvements in valve design, as well as whether the degradation data are substantially different than what might be expected from bioprosthetic surgical valves in similar patients,” Cutlip said.
Resar agreed that the data on device dysfunction were “hypothesis-generating.”
“In low-risk patients and younger intermediate-risk patients, we need to continue learning about TAVR durability,” he said.
Resar disclosed serving on the steering committee for Medtronic’s ongoing low-risk TAVR study and being principal investigator for PORTICO, a St. Jude Medical trial.
Cutlip reported receiving research support from Medtronic and Boston Scientific.