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PARIS -- Transcatheter aortic valve implantation (TAVI) using Medtronic's CoreValve is cost-effective compared with medical therapy for patients with severe aortic stenosis, researchers found.

Using data from a real-world registry of patients who received CoreValve, and from the medical management arm of the PARTNER trial (which evaluated the Edwards Sapien valve), an analysis showed that the cost per quality-adjusted life year (QALY) gained with CoreValve was £11,265 ($17,129) for all patients, according to Stephen Brecker, MD, of St. George's Hospital in London.

That figure rose to £13,778 ($20,951) per QALY gained among the highest-risk patients with a logistic EuroSCORE of at least 20%, but still came in below the generally accepted cost-effectiveness threshold of £20,000 to £30,000 ($30,411 to $45,617), he reported at the EuroPCR meeting here.

"We know that TAVI is effective clinically; that's been proven in clinical trials," Brecker said in an interview. "What this does is show that it is worthwhile in terms of health economic data as well."

He added that he thinks the findings are relevant to the U.S., where CoreValve has not been approved for use, despite differences in the healthcare systems between the U.S. and the U.K.

"Although in the U.K. we're somewhat skeptical of our National Health Service, much of the health economic benchmarking that is applied to decide upon whether an intervention should be delivered within a healthcare system ... is used by other countries, including the U.S.," he said.

The current study was based on patient-level data on costs and effectiveness from the ADVANCE study, a real-world registry of patients who underwent TAVI with CoreValve at one of 44 centers in 12 countries in Europe, Asia, and South America.

Short-term costs took into account the procedure itself, both intensive and non-intensive care, post-hospital rehabilitation, and any care and monitoring that occurred at home. Longer-term costs with a time horizon of 10 years largely focused on expenses related to care at home and the need for a second procedure.

For the model, the researchers made the following assumptions based on the ADVANCE study:

• 5 days minimum in the hospital
• 29.2% of patients requiring a pacemaker
• 0% of patients receiving balloon valvuloplasty
• 0.8% of patients ultimately needing surgical valve replacement
• 24.9% of patients using postoperative rehabilitation

Costs were calculated from the perspective of the U.K. healthcare system. The total cost for the TAVI procedure -- including the device, the time in the procedure room, and stays in the intensive care unit and hospital -- was set at £23,048 ($35,046).

Then, using 12-month mortality data from ADVANCE and 3-year data from PARTNER B that were extrapolated out to 10 years, the researchers estimated lifetime costs -- £32,462 ($49,360) for TAVI and £2,343 ($3,563) for medical management.

The TAVI group, however, had the advantage in total life-years gained (4.22 versus 1.56) and QALYs gained (3.57 versus 0.9).

Modifying various inputs in the model changed the estimates of the costs per QALY gained with TAVI, but all came in below the accepted threshold for cost-effectiveness, Brecker said.

Even in the subgroup of patients in the highest-risk subset (a logistic EuroSCORE of 20% or higher), introducing an assumption that all would be dead within 10 years still yielded an estimate under the threshold -- £22,735 ($34,570).

Brecker noted that the cost-effectiveness of the Edwards Sapien valve has been studied using data from the PARTNER trial, and that the findings are mirrored in the current study.

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