TRIP

'Heart Team' Key for Medicare TAVI Coverage

MedPageToday, 2012

The registry will capture and report patient demographics, procedure details, and facility and physician information.
The proposed national coverage determination is in response to a formal request from the ACC and STS.
The document is open for public comment until March 3, after which a final determination will be made.
Holmes Jr., MD, president of ACC, said the organization is pleased with the balance CMS struck between ensuring the procedure is performed by "skilled heart care teams in qualified facilities" and "the need to collect data on experience with the device and procedure in the real world."
The valve (Edwards Lifesciences) in November for use in patients with severe aortic stenosis for transfemoral delivery in patients with severe symptomatic aortic valve stenosis.
The FDA based its approval on the pivotal , which compared high-risk patients undergoing TAVI with inoperable patients receiving optimal medical therapy.
However, at 30 days, stroke and major bleeding rates in the TAVI arm (12 and 30, respectively) were significantly higher compared with the control group (three versus two, respectively).
Some differences existed at 30 days including more major vascular complications in the TAVI arm, and more major bleeding and new onset atrial fibrillation in the surgical arm.
Again, there was concern about the higher amount of strokes in the TAVI arm at both 30 days and one year, but only the year-long rate was statistically significant.
In its analysis, CMS noted the high stroke risk in both cohorts, but it also noted the positive aspects related to mortality and symptom release associated with TAVI.
CMS had asked PARTNER investigators for more information regarding randomization but the "study sponsor did not provide additional clarity."