The substantial number of U.S. patients who have undergone TAVR despite relatively low STS PROM scores, a pattern first seen in baseline data from the entire group of 7,710 patients with in-hospital data in the registry reported last November, also stuck out in the subgroup of 5,980 patients with 1-year data in the new report. Some experts at the meeting commented on the low PROM scores, a phenomenon that last year’s JAMA report dubbed "risk creep," as well as on the rapid uptake of TAVR in routine U.S. practice, with some 8,000 patients undergoing the procedure at about 230 U.S. sites during the first 21 months it was available.
"I’m amazed that we brought 200 centers online [performing TAVR] in just 20 months," commented Dr. David L. Brown, an interventional cardiologist and professor of medicine at Stony Brook (N.Y.) University.
"It’s very striking how quickly the technology was adopted in the United States; 5,980 patients is an enormous number compared with the numbers in the randomized trials," commented Dr. Cindy L. Grines, an interventional cardiologist and vice president at Detroit Medical Center.
"There was incredible, pent-up interest" in TAVR, Dr. Holmes explained.
Dr. Brown characterized the low STS PROM scores of many of the TAVR patients in the registry as "real-world risk creep." Dr. Grines provided a rationale for why patients with relatively low STS PROM scores may undergo TAVR. "There is something to be said for the eyeball estimate of how sick a patient is, and no registry can collect all that information," she said.
"It’s frailty that often gets a patient to TAVR, and frailty is hard to quantify. Frailty can exist even when the STS score is not high," commented Dr. James B. Hermiller, an interventional cardiologist at St. Vincent Heart Center in Indianapolis.
The registry does not receive commercial support. Dr. Holmes had no relevant disclosures. Dr. Kandzari has been a consultant to or received honoraria from Micell Technologies, Biotronik, and other companies. Dr. Brown had no disclosures. Dr. Grines has been a consultant to or received honoraria from Bristol-Meyers Squibb, Merck, and other companies. Dr. Hermiller has been a consultant to or received honoraria from St. Jude, Abbott Vascular, Boston Scientific, and Medtronic.
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