The Edwards SAPIEN Transcatheter Heart Valve is approved by the U.S. Food and Drug Administration (FDA) as a therapy for patients with severe symptomatic calcified native aortic valve stenosis who have been determined by a heart team that includes an experienced cardiac surgeon and cardiologist to be inoperable or high risk for open-chest surgery to replace their diseased aortic heart valve. Patients who are candidates for this procedure must not have other conditions that would make them too sick to experience the expected benefit from fixing their aortic stenosis (AS).
This procedure enables the placement of a balloon-expandable heart valve into the body with a tube-based delivery system (catheter). The valve is designed to replace a patient’s diseased native aortic valve without traditional open-chest surgery and while the heart continues to beat – avoiding the need to stop the patient’s heart and connect them to a heart-lung machine which temporarily takes over the function of the heart and the patient’s breathing during surgery (cardiopulmonary bypass).
For both inoperable and high-risk patients, the valve is approved to be delivered with the RetroFlex 3 Delivery System through an artery accessed through an incision in the leg (transfemoral procedure). For high-risk patients who do not have appropriate access through their leg artery, the valve is approved to be delivered with the Ascendra Delivery System via an incision between the ribs and then through the bottom end of the heart called the apex (transapical procedure).
The Edwards SAPIEN valve is the only approved transcatheter aortic valve replacement (TAVR) therapy in the U.S., and select hospitals are now performing the procedure on qualified inoperable and high-risk patients.
Features of the Edwards SAPIEN Transcatheter Heart Valve
The safety and effectiveness of the Edwards SAPIEN valve were evaluated in a randomized, controlled pivotal trial called The PARTNER Trial. The name of the trial signifies the important partnership between cardiac surgeons and interventional cardiologists who were brought together to collaborate on the evaluation, procedure and follow-up treatment of patients using a multi-disciplinary, Heart Team approach.
AA total of 1,057 patients were studied in The PARTNER Trial in two separate groups: Cohort A and Cohort B. Cohort A, or the “high risk” group, included 699 patients who were deemed high risk for surgery but still determined to be candidates for an open-chest procedure to replace their aortic heart valve. Cohort B, or the “inoperable” group, included 358 patients who were deemed not candidates for an open-chest procedure because of factors such as age, history of heart disease, frailty or other health issues.