As TAVR marches forward

The Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C., offered some reassuring findings on transcatheter aortic valve replacement (TAVR) this week, but that doesn’t mean it is a green light for expanded indications.

Two late-breaking clinical trial presentations—one that assessed data on inoperable patients in Edwards Lifesciences’ PARTNER study and the other high-risk patients in the Medtronic’s CoreValve study—answered critical questions about the use of the technology. The PARTNER presentation by Samir R. Kapadia, MD, director of the Cleveland Clinic’s Sones Catheterization Laboratory, demonstrated that TAVR added more than two years to the life of patients implanted with the Sapien device.

Beyond mortality, the survivors were functional and remained out of the hospital, meaning the extra years gained were worthwhile and not as costly. These factors fit into the equation for cost effectiveness, which influences payers’ decisions to reimburse the procedure.

Kapadia also mentioned that the valve showed good durability. Long-term durability may be less of an issue for inoperable patients, who generally are in the 80s, but it will gain importance as younger and healthier patients with a longer life expectancy undergo TAVR.

The conference also included two analyses of CoreValve data. Matthew R. Reynolds, MD, MSc, director of Economics and Quality of Life Research at the Harvard Clinical Research Institute in Boston, used data from the U.S. CoreValve High Risk trial in a cost-effectiveness analysis.

“The costs weren’t equal; there was an incremental cost with TAVR but in light of the benefits, the cost effectiveness lands in the vicinity of high value,” Reynolds told Cardiovascular Business.

The trial had shown that the CoreValve device was superior to open-heart surgery. The two-year results presented at TCT add weight to the argument that TAVR offers value to payers. Reynolds cautioned that as the risk bar lowers, these analyses will need to continue to show effectiveness within acceptable costs.

A presentation by his colleague Suzanne Baron, MD, MSc, of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., underscored that opportunities exist for lowering the cost of TAVR. Her analysis focused on periprocedural complications in CoreValve’s extreme risk cohort. The study identified the most costly complications as well as the most frequent complications.

They found that 71 percent of patients had at least one complication and that the total attributable cost of complications was $10,745.

Good long-term outcomes, durability, value and opportunities to lower cost, which bumps up value even more. All of this is positive. These trends will need to be sustained, though, before payers will support TAVR in lower risk populations.

Candace Stuart

Editor, Cardiovascular Business