TAVI Cost-Effective Treatment in Surgery-Ineligible Patients

April 03, 2011

April 3, 2011 (New Orleans, Louisiana) — Transcatheter aortic-valve implantation (TAVI) is a cost-effective treatment strategy in surgery-ineligible patients with severe aortic disease, with incremental costs per life-year gained within commonly accepted ranges for other cardiovascular technologies, according to a cost-effectiveness analysis presented here today at the American College of Cardiology (ACC) 2011 Scientific Sessions.

The cost-effectiveness data, from cohort B of the PARTNER trial, a population of patients with severe aortic stenosis ineligible for surgery, showed that TAVI cost approximately $80 000 more than standard medical therapy for inoperable aortic stenosis, the control group of patients, but was associated with increased survival, and this translated into a cost-effectiveness ratio researchers deemed acceptable.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly two years of life, and that is the return on investment," said lead investigator Dr Matthew Reynolds (Harvard Clinical Research Institute, Boston, MA) during a morning press conference. "The cost-effectiveness ratio, when you do the math, works out to just over $50 000 per life-year gained."

Dr Michael Crawford (University of California, San Francisco), who was not affiliated with the PARTNER trial but who spoke with the media during a morning press conference, said that TAVI is associated with a large up-front cost, particularly since a hybrid suite, one that allows surgical and interventional procedures, is needed for the percutaneous valve implantation.

"There is a lot of cost up front now to do this, with the facility, the team, all the imaging techniques that we need to have, so this is only going to be done in major centers that can assemble teams like this, once the device gets approved," said Crawford. "It's hoped that as we gain experience with this technique, this up-front cost will actually go down and the cost-effectiveness will actually get better." He added that it is possible that fewer imaging modalities might be needed, allowing teams to trim some of the costs once they gain more experience over time.

The Cohort B Results From PARTNER

Presented last year at TCT 2010 by co–principal investigator Dr Martin Leon (Columbia University, New York), the results from the PARTNER cohort B comparison showed a relative risk reduction in all-cause mortality of 46% compared with medical therapy (a 20% absolute difference) and a cardiovascular mortality risk reduction of 61% compared with patients receiving the best medical care, including balloon valvuloplasty.

As Long as the Costs Are Reasonable

The new economic analysis took a bit of a back seat to data from PARTNER cohort A, presented by Dr Craig Smith (Columbia University, New York) just before the cost-effectiveness analysis, with investigators showing that the new catheter-based procedure is just as good in surgery-eligible patients for the primary end point of mortality. The enthusiasm of interventionalists was infectious, with Dr David Moliterno (University of Kentucky, Lexington) calling the PARTNER results, both A and B, one of the biggest advances in cardiovascular medicine, possibly in his lifetime. Crawford called the results important simply because patients don't want surgery, and as long as "the risks and costs are reasonable," patients will opt for the interventional approach.

In one of the first attempts to understand whether TAVI represented a reasonable financial option, Reynolds and colleagues performed the analysis to assess the incremental cost-effectiveness ratio, the primary end point, and lifetime incremental costs per quality-adjusted life-year (QALY). The analysis was based on observed survival, quality of life (QoL), healthcare resource use, and hospital billing data. Lifetime analyses were based on projections of survival, quality-adjusted survival, and costs beyond 12 months.

Estimating the cost of the new valve system to be $30 000, the initial costs of TAVI, including care before and after the procedure, was $78 540. During the first year of follow-up, the control group was significantly more likely to be hospitalized, mainly for cardiovascular causes, and this led to costs that were $23 372 higher in the first year for patients treated with medical therapy. With a gain in life expectancy of 1.9 years--3.1 years for patients treated with TAVI and 1.2 years for those treated with medical therapy--this translated into an incremental cost-effectiveness ratio (ICER) of $50 212, or $61 889 per QALY.

During his presentation, Reynolds presented data showing that the cost-effectiveness of TAVI in patients ineligible for surgery compares favorably with other cardiovascular treatments. In terms of QALYs, the cost-effectiveness of TAVI is similar to treatment with dabigatran and radiofrequency catheter ablation for atrial fibrillation. TAVI is cheaper than dialysis, PCI for stable coronary artery disease, and left ventricular assist devices as destination therapy, he said.

Good Stewards of Healthcare Dollars

To heartwire , Moliterno agreed that the cost-effectiveness of TAVI is reasonable compared with these other therapies and that "these numbers fit very well with the number of things we as a society already pay for to extend life." He admitted he had to "swallow hard," considering that the PARTNER cohort A data and the cohort B economic analysis came on the heels of a presidential plenary lecture by Dr James Orbinski (University of Toronto, ON), the former president of the international council of Médecins Sans Frontières (Doctors Without Borders), showing that just a few dollars a day can sustain life in sub-Saharan Africa.

Dr Ralph Brindis (University of California, San Francisco), president of the ACC, told heartwire that cost-effectiveness and clinical-practice guidelines need to be placed within each community and within the financial resources of each healthcare system and that what is medically appropriate in the US is not going to be appropriate in Third World countries.

"You could argue that doing end-of-life care is very expensive and might not be justifiable even in our rich society, based on our need for cost containment and the need to bend the cost curve," said Brindis. "The cohort B cost-effectiveness analysis shows us that even in these inoperable patients, who you might say, 'Gee, is it worth doing this?' it turns out it was, and that to me was, in all honesty, a little surprising. From a public-health perspective, it was very reassuring in terms of being good stewards of our healthcare dollars."

Edwards Lifesciences sponsored the PARTNER trial and supported Harvard Clinical Research Institute with a grant for the analysis.

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