In early June 2012, the South Carolina Heart Valve Center (HVC) at MUSC was approved by Edwards Lifesciences, the manufacturer of the Edwards SAPIEN and the smaller Edwards SAPIEN XT transcatheter heart valves, as one of only 50 sites nationwide for the PARTNER 2 trial (NCT01314313) of transcatheter aortic valve replacement (TAVR) using SAPIEN XT in intermediate-risk patients.
This trial is an extension of the original PARTNER trial (NCT00530894), which compared TAVR using the Edwards SAPIEN valve versus surgical aortic replacement in patients at high surgical risk (cohort A) and TAVR versus medical management in patients who were not candidates for surgical aortic replacement (cohort B). Data from cohort B of the original PARTNER trial led to FDA approval in November 2011 for its use in patients who are not candidates for aortic valve replacement.
On June 13, 2012, on the basis of data from cohort A, the FDA’s Circulatory Systems Devices Panel recommended approval of TAVR for use in high-risk surgical patients. The FDA has 100 days to decide whether it will follow the panel’s recommendation.
PARTNER 2 (NCT01314313) will compare the safety and effectiveness of the smaller SAPIEN XT transcatheter heart valve versus surgical valve replacement in patients with severe symptomatic aortic stenosis who are at intermediate surgical risk.
The HVC has been performing TAVR for inoperable patients since shortly after its approval by the FDA for that indication. It plans to enroll its first intermediate-risk patients in September of this year. If, as expected, the FDA accepts the recommendation of the Circulatory Systems Devices Panel, TAVR using the Edwards SAPIEN device will also be approved for high-risk surgical patients by September, and the HVC will immediately begin offering the procedure in this population.
For a referral to the TAVR program, contact MEDULINE at 1-800-922-5250 or 843-792-2200 and ask to be connected to John S. Ikonomidis, M.D., PhD, Director of Cardiovascular Surgery at MUSC's HVC; Daniel H. Steinberg, M.D., the primary interventional cardiologist at the HVC involved in the TAVR program; or Suzanne Richardson, RN, the TAVR program coordinator.