For Inoperable Patients, TAVR Carries Benefits but Raises Lifetime Costs

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Patients with severe and symptomatic but inoperable aortic stenosis stand to gain better quality of life and survival from transcatheter aortic valve replacement (TAVR) compared with medical therapy. However, the treatment is less cost-effective, according to a new analysis published online July 9, 2013, ahead of print in Circulation: Cardiovascular Quality Outcomes.

Cyrena T. Simons, MD, PhD, of Stanford University (Palo Alto, CA), and colleagues estimated the lifetime costs and benefits of transfemoral TAVR vs. medical management alone (without balloon aortic valvuloplasty) in a hypothetical cohort of patients with severe symptomatic aortic stenosis using a decision analytic Markov model. The model assumed patients were ineligible for surgery and was calibrated to the PARTNER (Placement of Aortic Transcatheter Valves) trial.

Complications Including Stroke Higher with TAVR

Compared with medical management, TAVR increased life expectancy as well as quality-adjusted life years (QALYs); most of the post-TAVR total life years (61%) were spent with class I/II level symptoms. While TAVR reduced subsequent hospitalizations, complications were increased, particularly stroke. Furthermore, TAVR raised lifetime medical costs (table 1).

Table 1. Lifetime Health and Economic Outcomesa

 

Medical Management

TAVR

TAVR. vs. Medical Management

Life Years

2.08

2.93

0.86
(95% CI 0.05-1.83)

QALYs

1.19

1.93

0.73
(95% CI 0.09-1.60)

Average Number of Hospital Admissions

4.12

2.27

1.40
(95% CI 4.31-0.04)

Risk of Major Stroke

0.01

0.11

0.09
(95% CI 0.01-0.29)

Risk of Major Vascular Complication

0.16

0.16
(95% CI 0.09-0.25)

Risk of Major Bleed

0.02

0.21

0.18
(95% CI 0.06-0.33)

Costs

$83,600

$169,100

$85,600
(95% CI $37,700-$140,900)

a Mean values.

The mean incremental cost-effectiveness ratio (ICER) of TAVR compared with medical management was $99,900 (95% CI $38,200-$486,400) per life year gained and $116,500 (95% CI $46,300-$551,900) per QALY gained.

While varying most model parameters including complication rates within clinically reasonable ranges did not strongly alter model results, the results were quite sensitive to annual health care costs unrelated to aortic stenosis. When nonaortic stenosis-related baseline annual health care expenditures were less than $18,000, ICER was lowered to less than $100,000 per QALY.

Added Lifespan with TAVR Comes at a Price

According to Matthew R. Reynolds, MD, and David J. Cohen, MD, MSc, both of Harvard Clinical Research Institute (Boston, MA), the current paper reaches “a somewhat more pessimistic view” of TAVR’s cost-effectiveness than other analyses generated from the same PARTNER data.

Using a higher figure in their model for annual costs after TAVR contributed to that view, Drs. Reynolds and Cohen suggest in an accompanying editorial. But in agreement with Simons et al, they say that the findings point more toward patients, rather than the TAVR technology, as the driver of costs.

In the real world, TAVR patients would be expected to have longer lifespans than those managed medical, they explain. As a result, high chronic medical care costs accumulate over a longer time in the TAVR group, especially among sicker patients, guaranteeing that survival is the more expensive outcome for some patients. That makes TAVR a better value in patients who are excluded from surgery because of technical considerations rather than because of severe, complex comorbidity.

Drs. Reynolds and Cohen conclude, “There is no question that TAVR improves both quality of life and survival in this population, and that it increases costs.” Based on PARTNER trial experience, their estimate for a “true” cost-effectiveness ratio for TAVR is between $50,000 and $100,000 per QALY gained in the United States.

“The health benefits of TAVR for these patients are thus obtained at neither exceptionally good nor exceptionally poor value,” they add.

Cost-effectiveness a Moving Target

Peter C. Block, MD, of Emory University School of Medicine (Atlanta, GA), told TCTMD in a telephone interview that these sorts of analyses “always look back at patients who have already gone by.”

While the Sapien valve (Edwards Lifesciences, Irvine, CA) used in PARTNER remains for now the only one commercially available in the United States, he said, it is no longer considered the “state of the art,” and the next-generation device expected to be approved before long will be smaller, more user friendly, and less likely to incur bleeding complications.

“The fact remains, however, that with TAVR essentially we are prolonging cardiac life but not prolonging ‘comorbid’ life. The bottom line is not the cost of the valve, but the cost of the comorbidities,” Dr. Block said.

“Because we know that we lose money for the hospital when we choose TAVR, we are becoming more careful about selecting patients who have very severe chronic lung disease or end stage renal failure,” he said.

Dr. Block noted further, however, that data are emerging suggesting that the lung and renal issues are trumped in some patients by the improvements afforded by a new valve—through increasing cardiac output and reducing symptoms. “The problem is that we can’t prospectively pinpoint who those patients are,” he said, adding that doing so would require a better decision tree, which by necessity would be “terribly complicated and difficult to utilize for individual patients.”

The take home message from the current study, Dr. Block noted, is that cost will not strongly impact patient selection. “We grapple with that every day, anyhow. It will become a public health issue for the United States when the health care system dictates that we can no longer try to extend life as far as possible using newer technologies like TAVR, as is occurring in some European systems where dialysis for renal failure is disallowed over a certain age.”

 


Sources:
1. Simons CT, Cipriano LE, Shah RU, et al. Transcatheter aortic valve replacement in nonsurgical candidates with severe symptomatic aortic stenosis: A cost-effectiveness analysis. Circ Cardiovasc Qual Outcomes. 2013;Epub ahead of print.

2. Reynolds MR, Cohen DJ. The cost-effectiveness of transcatheter aortic valve replacement for nonsurgical candidates: Revisionist history of the final word [editorial]? Circ Cardiovasc Qual Outcomes. 2013;Epub ahead of print.

 

 

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For Inoperable Patients, TAVR Carries Benefits but Raises Lifetime Costs

Patients with severe and symptomatic but inoperable aortic stenosis stand to gain better quality of life and survival from transcatheter aortic valve replacement (TAVR) compared with medical therapy. However, the treatment is less cost effective, according to a new analysis
Disclosures
  • Drs. Simons and Block report no relevant conflicts of interest.
  • Dr. Reynolds reports receiving research support from Edwards Lifesciences and Medtronic and consulting for Medtronic.
  • Dr. Cohen reports receiving research grant support from Boston Scientific, Edwards Lifesciences, and Medtronic and consulting for Medtronic.

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