New York– A study co-authored by researchers from New York-Presbyterian and Columbia University Medical Center presents a new method to replace the transcatheter aortic heart valve that, compared to open surgery, is highly viable for intermediate risk patients. The study was published this month in the journal The Lancet.
SAPIEN 3, an improvement of the transcatheter aortic valve replacement (TAVR) device, was presented at a conference at the American College of Cardiology (ACC). Lead author of the study Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center, professor of medicine at Columbia University Medical Center, said that SAPIEN 3 is showing important improvements in outcomes for procedures performed.
“There’s strong evidence that SAPIEN 3, compared with earlier versions of TAVR devices, can further reduce the risk of mortality, stroke, and para-valvular regurgitation.”, he said.
According to Dr. Susheel Kodali, director of the Structural Heart and Valve Center at New York-Presbyterian/Columbia, associate professor of medicine at Columbia University Medical Center and co-principle investigator for the study, TAVR is also becoming a safer procedure for patients who need valve replacement or repair.
In an interview, Dr. Vinod Thourani, professor at Emory University School of Medicine and a lead investigator for the study, explains that even when open surgery is very effective not many patients would opt for that.
By using a catheter, TAVR threads the valve in its place through blood vassals. And for now, only patients with a high risk of complications or unlikely to survive surgery will be considered to TAVR.
The study is funded by Edwards Life sciences of Irvine, CA, which happens to be the one that manufactured the aortic valve replacement devices used in the study as well.
Seeking U.S. regulatory approval
According to Chief Executive Michael Mussallem , Edwards is expecting U.S. regulators to review data from Partner II (a previous study presented on Saturday that showed Edwards’ older-model Sapien XT valve showed positive results as surgery in intermediate-risk patients) and the SAPIEN 3 so late this year it can be approved an expanded indication for the Sapien 3 valve.
Mussallem adds that implies a duplication of the eligible patients for the catheter-based approach.
The situation for intermediate-risk patients may change quickly; in consequence, the TAVR market would have an important increase, said J.P. Morgan analyst Michael Weinstein in a note to clients.