Cost-effectiveness analysis of TAVR.

Transcather aortic valve replacement (TAVR) has rapidly gained worldwide acceptance for treating very high-risk patients with symptomatic severe aortic stenosis. Two valve systems are currently in common use worldwide and under trial in the United States. The Edwards SAPIEN valve has completed its PARTNER trial and has been approved for use in nonoperative patients. The Medtronic CoreValve is currently completing its US pivotal trial. Both plan studies of intermediate-risk patients. The use of TAVR in Europe has grown rapidly and is now about 23% of the total aortic valve replacements done in which a tissue valve is chosen (generally patients over 60 to 65 years of age). This technology is used in a patient population that was either not receiving any surgical therapy due to extreme risk or was considered very high risk for conventional surgery. The procedure requires a highly trained TAVR team, advanced imaging, and the devices themselves, which are expensive. Medical device trials are generally designed to establish if the device works as planned. For TAVR in today's world of rising health care costs, the additional question of cost effectiveness is important to address. Fortunately, the PARTNER trial addressed this and the CoreValve trial has built this into the trial design as well. This article examines what is currently known about the cost-effectiveness of TAVR.