Contact: Amanda Jekowsy, ajekowsk@acc.org, 202-731-3069

CATHETER-BASED SYSTEM REPLACES HEART VALVES IN HIGH-RISK SENIORS AT COMPETITIVE PRICE
New Technique Lengthens Life, Reduces Hospital Admission for Oldest and Sickest Patients

New Orleans, LA − A novel system to replace heart valves without open-heart surgery substantially extended life expectancy and reduced hospital admissions for elderly frail patients at an overall cost within the price range for common cardiovascular procedures now covered by the U.S. health care system, according to research from the PARTNER Trial presented today at the American College of Cardiology’s 60th Annual Scientific Session. ACC.11 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further advances in cardiovascular medicine.

Cohort B of the PARTNER Trial evaluated the effectiveness and cost-effectiveness of an experimental treatment called transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis – narrowing of the valve between the heart and the body’s largest artery – in patients too ill for conventional valve-replacement surgery. Without valve replacement, prognosis is poor once symptoms appear. The new valve replacement system significantly lowered death and hospital readmission rates in high-risk patients, as reported previously. This is the first presentation of cost-effectiveness data for the technique.

“This was an unusually old and sick patient population for a clinical trial,” said Matthew R. Reynolds, M.D., director of economics and quality of life research at Harvard Clinical Research Institute and a cardiologist for the VA Boston Healthcare System. “The mean age was 83, there was a very high prevalence of coronary artery disease and previous bypass surgery and about one-quarter had advanced lung disease. Despite this, the patients treated with TAVR did remarkably well.”

Twenty-one sites participated in the trial. Half of the patients were randomly assigned to TAVR (originally published as transcatheter aortic valve implantation). The other half received standard non-surgical care, including medications and stretching the valve with a balloon catheter. With 179 patients in each group, the two trial arms were well-balanced in numbers as well as patient characteristics.
Cost-effectiveness results for the first 12 months were based on detailed medical resource utilization data for all patients, and hospital billing data were collected for a subset of the patients. Long-term survival, quality-adjusted survival and costs were projected from the observed 12-month data to estimate the cost-effectiveness of TAVR over the full expected lifespan of the patients. A previous report from this trial indicated substantial improvements in quality of life after TAVR compared with standard care.

The initial cost for TAVR, along with care before and after the procedure (including both hospital and physician fees), was approximately $78,000, with the commercial cost for the new valve system estimated at about $30,000. The standard care group was three times more likely to be hospitalized for cardiovascular reasons than the TAVR group during the first year of follow-up. As a result, follow-up costs during the first 12 months were roughly $23,000 higher for the standard care group, partially offsetting the initial costs of the TAVR approach.

The investigators projected a gain in life expectancy of approximately 1.9 years for the TAVR group over standard care (3.1 years vs. 1.2 years) at an incremental cost-effectiveness ratio of about $50,200 for each additional year of life gained, or approximately $62,000 per each quality-adjusted life year gained.

“For patients with severe aortic stenosis who are unsuitable for surgical valve replacement, TAVR significantly increases life expectancy at an incremental cost per life of year gained that is well within accepted values for commonly used cardiovascular technologies,” Reynolds said. “Our perspective is that the costs of this intervention, even in this elderly and extremely high-risk population, are justified by the very significant benefits, and that the ratio of costs to benefits stacks up well compared with other therapies the U.S. health care system pays for today.”

The trial was funded by Edwards Lifesciences, Inc., which supported Harvard Clinical Research Institute with a research grant for this analysis.

Dr. Reynolds will be available to the media on Sunday, April 3, at 10:15 a.m. CDT, in Room 338/339.
Dr. Reynolds will present the study, “Lifetime Cost Effectiveness of Transcatheter Aortic Valve Replacement Compared with Standard Care Among Inoperable Patients with Severe Aortic Stenosis: results from the Randomized PARTNER Trial (Cohort B),” on Sunday, April 3, at 8:00 a.m. CDT, in the Joint Main Tent: La Nouvelle.

The American College of Cardiology (www.cardiosource.org) represents the majority of board certified cardiovascular care professionals through education, research, promotion, development and application of standards and guidelines – and to influence health care policy. ACC.11 is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
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