Nonsurgical heart valve procedure spurs cost concerns

Results from the latest trial comparing nonsurgical implantation of a prosthetic transcatheter aortic valve replacement, or TAVR, with traditional surgical aortic valve replacement have raised the possibility that the new method could be used for a broader range of patients.

But shifting to wider TAVR device use could hurt hospitals financially because of their high cost.

At the American College of Cardiology's annual scientific session in Washington, medical devicemaker Medtronic reported results from the high-risk patient group included in the U.S. Pivotal trial of its CoreValve TAVR device. Session co-chair Dr. Prediman Shah, director of the Atherosclerosis Prevention and Treatment Center at Los Angeles' Cedars-Sinai Medical Center, said in a March 18 telebriefing that TAVR would someday replace surgery as the preferred method for aortic valve replacement.

“It's going to be very hard to tell a patient, if they need an aortic valve, that surgery is their best option,” he said in a March 19 report in Cardiology News.

Some experts say the latest results could promote expanded TAVR use among high-risk patients for whom surgery is an option. But others say the price of TAVR devices may deter providers if they can achieve the same or better results through surgery for that patient subgroup.

TAVR devices typically cost about $32,000, compared with surgical valves that average between $4,000 and $7,000, said Dr. Lars Svensson, director of quality and process improvement in the Cleveland Clinic's department of thoracic and cardiovascular surgery.

Some hospitals in high-cost areas such as New York can receive Medicare reimbursement for performing TAVR procedures as high as $92,000. But in other areas such as Cleveland, reimbursement for TAVR is lower, making it a losing proposition. “For institutions in the middle of the country, they typically get paid less than it costs to do the procedure,” Svensson said. “It varies, but most of the (TAVR) programs are just breaking even.”

Valve replacement is recommended for severe cases of aortic stenosis, a narrowing of the heart's aortic valve that affects more than 1 million Americans, most of them elderly. About 290,000 patients are eligible for TAVR, according to a 2013 study in the Journal of the American College of Cardiology, with 27,000 more becoming eligible for the procedure each year.

The TAVR technique, which the Food and Drug Administration first approved in 2011 for use in patients not eligible for surgery, involves inserting a prosthetic valve with a catheter threaded through an artery in the groin or rib cage. The method typically requires a shorter recovery time than open-heart surgery. In 2012, it was approved for use in high-risk surgery patients.

Medtronic's CoreValve became the second prosthesis approved for use in the U.S. in January. The first, the SAPIEN transcatheter heart valve, created by Edward Lifesciences Corp., was approved in 2011.

The reported results were promising in CoreValve trials treating patients who faced “extreme risk” in undergoing surgery. The rate of all-cause mortality or major stroke after one year was 25%, below the trial goal of 43%. Rates of developing a major stroke were 2.4% after 30 days and 4.1% after one year, which led to FDA approval.

But TAVR did not fare as well as the surgical option when compared with stroke risk. In a review of more than 7,000 procedures published in a 2013 study in the Journal of American Medical Association, TAVR patients developed stroke at more than double the rate of those who had open-heart surgery.

For many patients deemed too sick or frail for open-heart surgery, however, the introduction of TAVR offers new hope. “TAVR is tremendous,” said Dr. Torrey Simons, a fellow at Stanford University's health services research and development program.

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