Looking for an ice-breaker at the upcoming American College of Cardiology (ACC) scientific session? Try bringing up transcatheter aortic valve replacement (TAVR).
In a preview press conference held March 18, ACC.14 planners discussed conference highlights with a focus on the late-breaking clinical trials. But TAVR dominated the question-answer session as presenters discussed how TAVR might change practice—particularly for cardiac surgeons—and elaborated on its technical and clinical implications.
Two TAVR devices are commercially available in the U.S., but another dozen are in development, said Robert Siegel, MD, ACC.14 co-chair and director of the Cardiac Noninvasive Laboratory at Cedars Sinai Heart Institute in Los Angeles. The FDA approved Edwards Lifesciences’ Sapien valve for inoperable patients with severe aortic stenosis in November 2011 and for high-risk patients in October 2012. Medtronic’s CoreValve device won FDA approval this year for inoperable patients.
“One device may be better than the other for certain patient populations,” he said, making results on efficacy, safety and durability all the more critical.
Today 224 sites perform TAVR procedures, and there are some concerns that with the expansion will come “indication creep.” Cindy Grines, MD, another chair and vice president of academic and clinical affairs at the Detroit Medical Center Cardiovascular Institute, said researchers anticipate operators at sites that didn’t participate in trials may not be as well trained and may be inclined to treat patients outside the trials’ strict protocols.
Prediman K. Shah, MD, ACC.14 co-chair and director of the Oppenheimer Atherosclerosis Research Center and the Atherosclerosis Prevention and Treatment Center at Cedars-Sinai, forewarned cardiac surgeons who perform surgical aortic valve replacement that they should anticipate disruption with TAVR. He described the technology as improving steadily with positive safety and outcome data, making it more difficult to justify standard care.
“Surgeons won’t be out of business,” Shah said, adding that there are many needs beyond aortic stenosis. “In the next several years it will be hard to tell patients [with severe aortic stenosis] that surgery is the best option.”
The presenters, who included ACC President John G. Harold, MD, also of Cedars-Sinai, emphasized that TAVR uses a heart team approach, with cardiac surgeons, interventionalists, imagers and others working collaboratively. The technology has been disseminated in a controlled fashion, and the need for a heart team and upfront investment will limit the number of centers that can offer TAVR.
Demand also may change over time as the backlog eases. “Once they are treated for aortic stenosis, they are treated,” Grines said.
ACC.14 will be held from March 29-31 in Washington, D.C.