FDA Expands Sapien TAVI Indication to High-Risk Surgical Patients

Shelley Wood

October 19, 2012

SILVER SPRING, Maryland — The US Food and Drug Administration (FDA) has agreed to expand the approved use of the Sapien transcatheter aortic valve (Edwards Lifesciences) to high-risk aortic-stenosis patients who are also eligible for surgery, but at high risk of serious complications or death [1].

The decision follows a positive opinion in June 2012 from the agency's 12-member circulatory system devices panel, which voted unanimously that the device is effective, 10 to 2 that the device is safe, and 11 to 0 (with one abstention) that the device benefits outweighed any risks. The extended indication is based on the PARTNER A trial results, as reported by heartwire . In that study, one-year mortality was similar between the surgery and TAVR groups at 26.8% and 24.2%, respectively, meeting the predefined margin for noninferiority for transcatheter aortic-valve replacement (TAVR).

The approval includes TAVR via the transfemoral route--already approved for use in nonsurgical patients--as well as a newer transapical delivery system that can be used in patients whose femoral arteries are not suited to being the delivery route for the valve.

"I am delighted that this technology is moving forward," Dr Magnus Ohman (Duke University, Durham, NC) told heartwire . "As with many other new technologies, we have much more to learn, but it is gratifying that the minimally invasive TAVR can now be used in a greater number of patients, who will potentially gain much from this."

Valve replacement using the transfemoral system in inoperable patients was approved in November 2011, as reported by heartwire .

Also commenting on the approval, Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA) told heartwire by email that while the expanded approval will increase the number of people undergoing a transcatheter aortic-valve replacement, "realistically not to the extent that clinicians might initially perceive. . . .  National coverage limitations in the US will keep TAVR closer to on-label indications," he said.

"My estimate is that there will continue to be an increasing number of US sites that initiate a TAVR program this year and next, only to see a slight regression in that number as centers of expertise and referral emerge in more urban areas and smaller centers close down due to low volumes, followed then by another resurgence as technology and practice improve, making TAVR safer, easier, and more accessible. In fact, in Europe, there are a number of centers performing PCI without surgical backup that also perform TAVR with a 'rent a surgeon, rent a bypass pump' strategy."

Kandzari also predicted that the transapical procedure used in PARTNER A "will fade to a very niche product as surgeons gravitate increasingly to direct aortic, some subclavian, and more femoral procedures as catheter/sheath profiles [become smaller]." 

According to an FDA press release, Edwards "will continue to evaluate the device through a national Transcatheter Valve Therapy Registry, which facilitates the continued evaluation of transcatheter devices and procedures."