A minimally invasive procedure to replace the aortic heart valve is better in terms of decreasing risk of complications compared to open surgery, an observational trial found. The patients who received the heart valve implant Sapien 3 had fewer strokes and a lower mortality rate one year after the procedure.
Transcatheter aortic valve replacement (TAVR) with the Sapien 3 can be an alternative to open heart surgery in patients at intermediate risk for complications, according to the study that was presented at the American College of Cardiology (ACC) meeting in Chicago on April 3. The study, which involved more than 1,000 patients suffering from severe and symptomatic aortic stenosis, showed that the procedure could be used in patients that are not eligible for, or who may not survive, open heart surgery.
Lesser Risk Of Complications
The observational trial found that 4.6 percent of patients who received the Sapien 3 implant had a stroke and 7.4 percent succumbed to complications within a year after the procedure. Of those who underwent surgery, however, 8.2 percent suffered from stroke and 13 percent died.
The Sapien 3 data were compared with the outcomes in a related trial, Partner II, which involved more than 940 patients who underwent open heart surgery. In the Partner II study, Sapien XT - a previous model of the valve - was shown to be as effective as surgery in patients at intermediate risk for complications.
"Results from the Partner II Trial presented at ACC should establish the Sapien 3 valve as the new benchmark for the treatment of intermediate-risk patients with severe, symptomatic aortic stenosis," said Dr. Vinod Thourani of the Emory University School of Medicine and one of the study's lead authors.
Seeking Regulatory Approval
In 2015, the U.S. Food and Drug Administration (FDA) approved the Sapien 3 valve for treating patients with severe, symptomatic aortic stenosis at high risk of complications, but has not approved the implant for people at intermediate risk.
It is hoped that the Sapien 3 study, which was also published in The Lancet, would help in earning the go-ahead from the FDA. If approved, the Sapien 3 valve, which is developed by Edwards Lifesciences, may finally be used to treat patients at intermediate risk for complications.
"The only option up until now has been open surgery, which is very effective, but many patients would not opt for that," said Edwards Lifesciences CEO Michael Mussallem.
Edwards Lifesciences is a company that leads in patient-focused innovations for structural heart problems and critical care monitoring.
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