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.

The South Carolina Heart Valve Center (HVC) at MUSC is the first center in South Carolina and among the first in the nation to perform transcatheter aortic-valve replacement (TAVR), a cutting-edge procedure for implanting a heart valve that does not require open heart surgery. Although surgical aortic valve replacement (AVR) remains the gold standard for treatment of severe aortic stenosis, TAVR makes treatment available to patients in whom surgery is contraindicated because of advanced age, frailty, or poor lung function (among other reasons) who would otherwise have gone untreated. According to John S. Ikonomidis, M.D., PhD, Director of Cardiothoracic Surgery at MUSC, “It’s difficult, if you look across the medical community, to find a single procedure that modifies mortality in the way this procedure has in medically managed patients.”

Both TAVR and aortic valve replacement are treatments for severe aortic stenosis, or the obstruction of blood flow across the aortic valve because of calcific plaque. An estimated 2% to 9% of the elderly have aortic stenosis. Although aortic stenosis can gradually develop over years without symptoms, once symptomatic it takes a high toll in terms of mortality, higher even than a variety of cancers, including lung cancer. Patients with severe aortic stenosis have a survival of only 50% at 2 years and 20% at 5 years if the condition is left untreated.

Until TAVR, those deemed unsuitable for surgical AVR had to face such grim statistics knowing that no treatments outside of medical management were open to them. It is estimated that 43% to 74% of patients with severe aortic stenosis never undergo surgery, either by choice or because it is contraindicated. Preliminary data from the PARTNER trial (on which FDA approval was based; NCT00530894) showed a 20% to 25% reduction in mortality at 2 years with TAVR versus medical management alone.¹ Patients also report an improved quality of life after successful TAVR.

Instead of implanting a replacement heart valve during open heart surgery, TAVR involves collapsing a bovine heart valve mounted onto a stainless steel stent (the Edwards SAPIEN® valve, Edwards Life Sciences, Irving, CA [pictured here]) tightly over a balloon, inserting it via a catheter into the ileofemoral artery and advancing it to the aortic valve. The procedure is performed twice: on the first pass, the balloon is expanded to open up the stenosis and on the second pass the Edward SAPIEN valve is deployed.

The interdisciplinary HVC at MUSC was specifically created to leverage these new types of valve technologies that dramatically alter a patient’s treatment options. The multidisciplinary capabilities of the Heart Valve Center, including its depth of expertise both in interventional cardiology and cardiac surgery as well as cardiac imaging and anesthesia, were key to its being approved by Edwards, the manufacturer of the Edwards SAPIEN® heart valve, to implant the device. These devices can only be implanted once both an interventional cardiologist and a cardiac surgeon have assessed the patient (in part by preprocedural imaging) and have agreed that he or she has a greater than 50% chance of dying or experiencing long-term complications from surgical aortic valve repair.

Possible complications of TAVR include stroke (some plaque may be dislodged as the valve is advanced through the vessel) and vascular damage, both of which can be life-threatening. Careful patient screening (ie, to ensure that the patient’s vessels are of sufficient size to allow the device to be implanted via a catheter) should help to minimize those risks.     

TAVR is most appropriate in patients with severe aortic stenosis who are not suitable candidates for surgery and who would stand to gain considerable quality of life as a result of the procedure. It offers a treatment option, increased survival, and increased quality of life to a large pool of patients who would otherwise go untreated. For a referral to the TAVR program, contact MEDULINE at 1-800-922-5250 or 843-792-2200 and ask to be connected to 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.

¹  Leon MB, Smith Cr, Mack M, et al; for the PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607.