Transcatheter Aortic Valve Replacement is a procedure for patients who won't survive an open heart surgery or at risk of complications. The procedure is seeking U.S. regulatory approval for Edwards Lifesciences Corporation.
A study by Sapien 3 shows those patients who undergo TAVR had lessened mortality rate and strokes after one year than those who undergo open heart surgery. The procedure is presented at the American College of Cardiology in Chicago, according to Reuters.
A professor and a lead investigator of the study named Dr. Vinod Thourani said in an interview: "It seems likely that TAVR will become the new benchmark for the treatment of severe aortic stenosis in intermediate-risk patients." TAVR includes using catheter by threading the valve through the blood vessels.
According to Sapien 3, the study discovered 4.6 percents of patients who received Edward's valve has a stroke and 7.4 percent died within a year during procedure. For patients who took surgery, 13 percent died and 8.2 percent suffered a stroke.
The outcome of the surgery had less leakage than TAVR procedure. A few people in both procedures experienced complications, only 1.5 percent.
Michael Musssallem said in an interview that the Edward Lifesciences Corporation that information from both studies shall be analyzed by U.S. regulators to approve the expanded proposal indication for Sapien 3. "The only option up until now has been open surgery, which is very effective, but many patients would not opt for that," he said.
According to Bloomberg, Roxana Mehran, director of Interventional Cardiovascular Research at Mount Sinai Hospital in New York said that the totality of evidence of the two trials is "very positive for the transcatheter approach."
"This has huge implications that the tide is turning toward transcatheter valve replacement as the possible new gold standard," she said. "The caveat is that we don't have very long-term data yet on these valves."
