NEW ORLEANS – The cost of transcatheter aortic valve replacement among patients with inoperable severe aortic stenosis is in line with other accepted cardiovascular procedures, according to an economic analysis of the PARTNER trial.

Index hospitalization costs for transcatheter aortic valve replacement (TAVR) were $78,540 based on an estimated cost of $30,000 for the investigational Edwards SAPIEN valve. TAVR was, however, associated with a projected gain in survival, resulting in overall lifetime cost effectiveness.

"In this extremely high-risk population, an elderly population, the intervention is adding roughly 2 years of life, and that is the return on investment," principal investigator Dr. Matthew Reynolds said during a press briefing at the annual meeting of the American College of Cardiology. "The cost-effectiveness ratio, when you do the math, works out to just over $50,000 per life-year gained."

Dr. Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, said up-front hospital costs for TAVR will be high because of the need for a hybrid operative/interventional suite, but that as long as the risks and costs are reasonable, patients will opt for the percutaneous approach simply because they don’t want surgery.

During the formal study presentation, invited discussant Dr. Martyn Thomas, director of cardiovascular services at Guy’s and St. Thomas’ Hospitals, London, said clinicians in the United Kingdom were awaiting results of the cost analysis with bated breath to determine if TAVR could get the nod from the National Institute for Health and Clinical Excellence.

"When I plug in our numbers ... I get somewhere around £20,000 [U.S.$32,700] per QALY [quality-adjusted life-year], which for us would be absolutely perfect," Dr. Thomas said.

Anticipation regarding TAVR has been building since efficacy data reported last fall for the same 358 inoperable patients, known as cohort B, demonstrated a 20% survival benefit with TAVR at 1 year, compared with standard medical therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-6070).

The question, however, is whether the novel procedure will be cost effective in an increasingly heated climate of health care cost containment.

In an attempt to tackle the issue, Dr. Reynolds and his colleagues assessed lifetime incremental cost-effectiveness ratios (ICERs) and lifetime incremental costs per QALY using hospital billing data or MEDPAR when bills were unavailable. Costs from the last 6 months for surviving patients were used to project future costs beyond 12 months, while parametric survival models fit to the trial data were used to extrapolate patient-level life expectancy beyond the follow-up period.

The initial $78,540 price tag for TAVR includes $42,806 for procedural costs, $30,756 for nonprocedural expenses, and $4,978 for physician fees, said Dr. Reynolds, director of the Economics and Quality of Life Research Center at the Harvard Clinical Research Institute, Boston. Patients spent an average of 10 days in the hospital, including 4 days in the intensive care unit.

Twelve-month follow-up costs were $23,372 higher for patients treated with standard medical therapy. This was a result of significantly more hospitalizations in the control group than in the TAVR group (2.15 vs. 1.02), mainly due to cardiovascular causes (1.7 vs. 0.50), he said.

The estimated life expectancy was 3.1 years for patients treated with TAVR and 1.2 years for those treated with medical therapy, or a difference of 1.9 years.

The lifetime incremental cost per patient was $79,837, and the lifetime incremental gain in life expectancy was 1.59 years. This translated into an ICER of $50,212 per life-year gained and $61,889 per QALY, he said.

Additional analysis showed that if the price of the device were to drop to $20,000, the ICER would be $43,642 per life-year gained. In Europe, both the SAPIEN valve (Edwards Lifesciences) and the CoreValve (Medtronic) are already on the market.

On the basis of the data, TAVR in this older inoperable cohort falls very close to published cost-effectiveness estimates for implantable defibrillators and atrial fibrillation ablation, and is actually lower than current estimates for hemodialysis or percutaneous coronary intervention for stable coronary artery disease, Dr. Reynolds said.

"For patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVR significantly increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies," he said.

When asked what the budget impact would be of adoption of TAVR, Dr. Reynolds said they have not performed such an analysis, but that an estimated 30% of patients with severe aortic stenosis do not undergo conventional open surgery.

Efficacy data presented at the same session by Dr. Craig Smith on cohort A of the PARTNER trial, revealed that all-cause mortality in 699 high-risk patients with severe aortic stenosis was the same at 1 year, at 24% with TAVR vs. 27% with conventional open surgery, but that the incidence of stroke was increased at 8.3% vs. 4.3%. Cost comparisons of TAVR vs. conventional surgery are not yet available.

Edwards Lifesciences provided grant support for the analysis.

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