Women bore brunt of initial NCD for TAVR

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Sapien transcatheter aortic valve.
Source: Edwards Lifesciences

Limiting access to transcatheter aortic valve replacement (TAVR) therapy to inoperable patients suitable for only a transfemoral approach reduced the number of patients who received care, particularly women, in a study that evaluated the effect of the national coverage determination (NCD).  

Following the Centers for Medicare & Medicaid Services’ (CMS) decision in 2012 to cease payment for nontransfemoral TAVR, the University of Miami Hospital experienced a dramatic decrease in the number of TAVR procedures performed in inoperable patients with severe aortic stenosis. Prior to the decision, if femoral vessels were unusable, transapical, transaortic or antigrade transseptal approaches were used.

Of the TAVR patients treated during December 2011 and June 2012, a little more than a third of the patients were treated using the transfemoral approach. A larger proportion of nontransfemoral patients were female, approximately 73 percent. The nontransfemoral group also experienced higher ejection fraction (55.1 percent vs 47.5 percent). Both transfemoral and nontransfemoral TAVR patients experienced a high degree of implant placement success.

Many of their outcomes were similar, although there was a higher rate of death and a slightly lower rate of stroke among nontransfemoral patients.

Following the NCD, the rates of TAVR patients treated dropped. Over the five months preceding, an approximate average of 14 patients a month were being treated with TAVR, going down to a third of that over the following months. Twenty-one cases between July and August of 2012 were determined to be TAVR candidates but were unable to be treated transfemorally. Of those 21, four died before another treatment course could be determined.

While the decision cites earlier studies on nontransfemoral TAVR, Brian P. O’Neill, MD, and colleagues stressed that only 12 percent of elderly, symptomatic patients qualified for the pivotal PARTNER B (The Placement of Aortic Transcatheter Valves) trial. Based on cohort B results, the FDA approved use of the Sapien (Edwards Lifesciences) TAVR valve in inoperable patients with severe aortic stenosis on Nov. 2, 2011. CMS initially agreed to reimburse TAVR only with the transfemoral approach but eased that restriction in September 2013.

“De facto, implementation of the CMS coverage decision denies 9 out of 10 elderly patients the opportunity to decide with their doctors if TAVR would be appropriate for them,” they wrote. “The consequences of this highly restrictive coverage decision are apparent in our experience, as 19% of those patients originally scheduled for TAVR had died at 2 months, which compares to a 14% 30-day mortality in the overall pre-CMS treated cohort.”

O’Neill et al expressed special concern for patients with small, difficult to access vessels, in particular women. The findings were published online July 1 in Catheterization and Cardiovascular Interventions.