TAVR Effective in High-Risk Patients at ‘Acceptable’ Cost

Relative to surgery, transcatheter aortic valve replacement (TAVR) results in meaningful clinical benefit in high-risk patients with incremental costs that are considered acceptable from the perspective of the U.S. health care system, according to late-breaking clinical trial results presented at TCT 2014. 

Matthew R. Reynolds, MD, MSc, of the Harvard Clinical Research Institute, Boston, and colleagues examined the cost-effectiveness of TAVR with CoreValve (Medtronic; n=390) relative to surgical aortic valve replacement (SAVR; n=357) in the high-risk arm of the CoreValve US Pivotal Trial. The groups were well matched at baseline with an average age of 83 years.

The main trial results showed that TAVR resulted in a lower mortality rate at 1 year, and for the purposes of the cost-effectiveness analysis, the researchers assumed that there was no additional survival benefit beyond 1 year. The cost of the CoreValve device was set at $32,000.

Compared with SAVR, TAVR reduced length of hospital stay (8.1 days vs. 12.5 days; P<.001) and resulted in less need for rehabilitation services at discharge (23.1% vs. 43.7%; P<.001). A higher percentage of TAVR patients were discharged directly home (64.6% vs. 38.4%; P<.001).

Although initial hospitals costs — which accounted for the device, procedural and non-procedural costs, and physician fees — were higher in the TAVR group ($69,592 vs. $58,332; P<.001), the costs of follow-up in the first year were not different between the groups. However, the projected lifetime costs were $13,680 higher with TAVR, largely due to the higher index admission costs.

Quality of life per EQ-50 utilities was better for TAVR vs. SAVR at 1 month, but not at 6 or 12 months. Projected life expectancy was slightly higher with TAVR (5.43 vs. 5.12 years), and the estimated gain in quality-adjusted life years (QALYs) using lifetime projections was 0.20 in the TAVR group. The incremental cost-effectiveness ratio (ICER) amounted to $67,059 per QALY gained with TAVR vs. SAVR, which is “perfectly acceptable from the U.S. perspective today,” Reynolds said, noting that the threshold is generally set at $50,000.

Cost-effectiveness was better among patients eligible for iliofemoral access (83% of the study population), in whom the ICER was $55,534 per QALY gained. The ICER for patients not eligible for iliofemoral access was $118,247 per QALY gained, although Reynolds noted that the estimates are less certain because of the small sample size.

A sensitivity analysis showed that reducing initial hospitalization costs — which is anticipated in the coming years, according to Reynolds — will further improve cost-effectiveness. Lowering costs by just $2,000 to $4,000 would bring the ratios below $50,000 per QALY gained. “It doesn’t take a lot of cost savings just from reducing complications or length of stay to get this into a very high-value range,” he added.

Cost-effectiveness in daily practice

Panelist Zoltan G. Turi, MD, of Robert Wood Johnson University Hospital, New Brunswick, N.J., commented that cost-effectiveness analyses have an impact on the day-to-day practice of TAVR. “There’s a lot of pressure from hospital administrators to try to bring the costs of this procedure under control. There’s also a lot of pressure to do more of these procedures because there is a need out there,” he said.

He noted that many TAVR procedures in the United States are performed in hybrid operating rooms, and “when this moves to cardiac cath labs, as it is in other parts of the world, I think the costs will come down substantially.” Ultimately, he said, “society and individual hospitals have to pay for this procedure [because] it’s hard to imagine 5 years from now that TAVR is not going to be the routine procedure of choice for most patients with isolated aortic stenosis.”

 Disclosures:

• Both the main trial and the cost analysis were supported by Medtronic.

• Reynolds reports receiving grant/research support from Edwards Lifesciences and Medtronic and consulting fees/honoraria from Medtronic.     

• Turi reports no relevant conflicts of interest.