PARTNER: TAVI Cost Effective Compared With Standard Care

NEW ORLEANS, LA—Now that the first 2 questions have been answered for transthoracic aortic valve replacement (TAVI) compared with standard care—that the catheter-based procedure reduces mortality and improves quality of life—researchers have answered the third important question for the breakthrough technology: The cost of TAVI is well within the acceptable range for cardiovascular therapies.

Researchers led by Matthew R. Reynolds, MD, MSc, of Beth Israel Deaconess Medical Center (Boston, MA), presented late-breaking data from cohort B of the PARTNER (Placement of AoRTic TraNscathetER valve) trial on April 3, 2011, at the annual American College of Cardiology Scientific Session/i2 Summit.

First 2 Analyses: Home Runs

In this arm of PARTNER, 358 patients with severe aortic stenosis who were deemed inoperable were randomized to TAVI (all via the transfemoral route) with the Edwards Sapien aortic valve system (Edwards Lifesciences, Irvine, CA), or standard care. In data presented in September 2010, at the Transcatheter Cardiovascular Therapeutics symposium in Washington, DC, researchers showed that TAVI reduced all-cause mortality and repeat hospitalizations.

In a subanalysis presented in November 2010 at the American Heart Association Scientific Sessions in Chicago, IL, researchers showed that TAVI dramatically improved quality of life, too. Which left the issue of cost effectiveness.

The Money Question

In the cost subanalysis, detailed medical resource utilization data were collected on all study patients, and hospital billing data were collected for both index admissions and follow-up hospitalizations for any cause (n = 234).

Total procedural costs for TAVI, based on factors including procedure duration, valvuloplasty balloons used, closure procedures, and concomitant procedures, was estimated to be $48,000. Combined with physician fees (roughly $5,000) and the cost of the valve system itself (roughly $30,000), the total initial cost of TAVI came to $78,000.

In terms of resource utilization over 12-month follow-up (excluding those used for TAVI admission), the TAVI group had less than one-third as many CV hospitalizations and were in the hospital less than half as long as the standard care group, while rehab days and skilled nursing facility days were similar (table 1).

Table 1. Resource Utilization Over 12-Month Follow-up

These results led to hospitalization costs during this time period that were roughly $26,000 higher in the standard care group. However, this was somewhat ameliorated by rehab costs that were $700 lower and skilled nursing facility care that was about $1,900 lower among standard care patients, leading to an overall $23,000 difference between groups ($29,352 with TAVI vs. $52,724 with standard care; P < 0.001).

Over the 2.5-year observation period of the trial, the investigators found a gain in life expectancy of 0.53 years in the TAVI group. Projected over a 15-year period, this translated to an estimated 1.88-year gain in life expectancy for TAVI patients (3.11 years vs. 1.23 years with standard care). Taking the costs and life-expectancy differences into account, the investigators calculated an incremental cost-effectiveness ratio of $50,200 for each additional year of life gained, or approximately $62,000 per each quality-adjusted life year (QALY) gained.

While the overall costs of TAVI were still higher than standard care, primarily because of the index procedure itself, “for patients with severe aortic stenosis who are unsuitable for surgical [aortic valve replacement, TAVI] significantly increases life expectancy at an incremental cost per life year gained well within accepted values for commonly used cardiovascular technologies,” Dr. Reynolds concluded.

Commenting on the results, Martyn Thomas, MD, of Kings College Hospital (London, United Kingdom), noted that clinicians in the United Kingdom have been waiting for the cost effectiveness data “with baited breath.”

“When I plug in our numbers, and by that I mean the actual cost of the device and the procedure, I get using your figures around ₤20,000, which for us would be absolutely perfect,” he said.

TAVI vs. Other CV Procedures

Responding to a panelist question, Dr. Reynolds put the cost effectiveness of TAVI into perspective with other cardiovascular procedures. “Based on cohort B, we think this intervention in this population falls very close to published cost effectiveness ratios for things like ICDs, which are in the range of $40,000 to $60,000 per QALY or life year gained,” he said. “We think [TAVI] is quite similar to atrial fibrillation ablation, and we think these results are actually better than current estimates for hemodialysis and other things that are commonly done in the United States like, based on the COURAGE trial, PCI vs. medical therapy for stable coronary disease.”

He added that cost comparisons with surgical aortic valve replacement cannot be made, since that analysis has not yet been performed. But he did estimate how many potential TAVI patients could be affected by the new data.

“I’ve heard estimates that 30% of people with severe stenosis in the United States up to now haven’t had surgery,” Dr. Reynolds said. “That might give you an idea [of the current impact on practice.]”

Source:

Reynolds MR. Lifetime cost effectiveness of transcatheter aortic valve implantation compared with standard care among inoperable patients with severe aortic stenosis: Results from the randomized PARTNER trial (Cohort B). Presented at: American College of Cardiology Scientific Session/i2 Summit, April 3, 2011, New Orleans, LA.

Disclosures:

• The trial was funded by Edwards Lifesciences.
• Dr. Reynolds reports consulting/honoraria relationships with Biosense-Webster, Sanofi-Aventis, and St. Jude Medical.
• Dr. Thomas reports no relevant conflicts of interest.

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• PARTNER Analysis: TAVI Substantially Improves QOL vs. Standard Therapy
• PARTNER: All-Cause, CV Mortality Lower in Patients Treated with TAVI vs. Standard Therapy at 1 Year
• Transcatheter Aortic Valve Implantation Improves LV Function Over Surgery