FDA advisors say to Approve Sapien TAVR for high-risk operable patients

[Lynlw]

http://www.theheart.org/article/141...medium=email&utm_source=20120613_breakingNews
Gaithersburg, MD - A panel of expert advisors to the US Food and Drug Administration (FDA) emphatically agrees: approved uses for the Sapien transcatheter valve (Edwards Lifesciences) should include high-risk aortic-stenosis patients who are also eligible for surgery.

In the three-part vote, the panel voted 12:0 that the device was effective, 10:2 that the device is safe, and delivered 11 votes in favor of the statement that its benefits outweighed any risks (one panel member abstained on this question).

Approval of this indication would also usher in the company's transapical delivery system, allowing the device to be deployed in patients whose femoral artery is not suited to transcatheter delivery of the percutaneous valve.

Grounds for expanding the indications for transcatheter aortic-valve replacement (TAVR) with the Sapien device come from the PARTNER A trial, as reported by heartwire. In the study, one-year mortality was similar between the surgery and TAVR groups at 26.8% and 24.2%, respectively, meeting the predefined margin for noninferiority for TAVR.

Throughout the day, the Circulatory System Devices Panel raised concerns over crossover data and how events were assigned to the different treatments, as well as the challenges of interpreting nonrandomized continued-access patients treated after the PARTNER data closed. Panel members also mulled the higher mortality rate among patients treated via the transapical route, as compared to those treated via transfemoral delivery or by conventional open surgical replacement.

Other trial conduct issues also spent some time in the spotlight, including stroke risk; delays to treatment among patients randomized to surgical aortic-valve replacement (AVR); the importance of aortic insufficiency (seen in almost 60% of TAVR patients at one year) to long-term outcomes; and the curious discrepancy between men and women in the trial.

Mid-afternoon, the panel wrestled with issues like risk-scoring, comorbidities, and frailty, trying to put a finger on just what kind of patient could be considered fairly for either treatment approach.

Ultimately the panel agreed that the ability to offer a transcatheter approach to high-risk patients superseded their niggling concerns.... more at link

 

[Roberta]

Thanks for the latest info on TAVR, Lyn. Much appreciated.

 

[Rachel]

Thanks for posting this Lyn!

Rachel

 

[ElectLive]

Thanks Lyn.

There's a very interesting thought from one of the members of the Advisory Panel:

"The panel fell short, I think, of providing answers to some of the gaps in our understanding, particularly issues of gender differences, the link between aortic regurgitation and mortality, the link between atrial fibrillation and aortic regurgitation and stroke, and the potential for reducing vascular complications," he said. "I expected today to be a bit more contentious. . . . If anything, I thought last year's panel meeting, for the cohort B data, actually had a clearer path to approval and that today's meeting would be less predictable. In this case, an alternative exists—surgery—and this trial did not demonstrate superiority. I think that left the door open for more debate than we ended up seeing today." - Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA)

This got me thinking, and while it is a bit off topic, I thought this would be a good opportunity to point out just how thorough the FDA review of these types of things actually is. Oftentimes, the headline grabbing news for the FDA usually involves medicines they are taking back off the market, after unexpectedly high adverse events as a result of supposedly too early approval or improper regard for safety. Certainly there may be cases where this is entirely true. However, when you take the time to review the enormous amounts of data and evidence reviewed and presented to these Advisory Panels, the FDA seems to me at least to be doing a very thorough job. Of course, as the article and quote above alluded to, the Advisory Panels may be deficient at times of not engaging the issues as strongly as they should, but that's another issue entirely.

Anyway, let me get back to your post, relative to this specific Sapien review, I did want to also provide a link to the "case files", so to speak, of the FDA. There are hundreds and hundreds of pages, and no I haven't read them all (YET!), but for anyone who wants the full story, all the drawbacks and limitations of evidence thus far, it is all freely available for review. You know, an FDA stamp of approval is probably enough for a lot of doctors, and perhaps many never even bother reading the evidence. Even if they do, certainly they usually never have the time to properly educate their patients (patient education is actually one of the key point of this specific review, by the way). But anyway, for any high risk patients (15% or higher risk of mortality) or their loved ones that may find their way here, wanting to know more about the Sapien, all the pros and all the cons, the information is out there (June 13th Meeting Materials): http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm300073.htm

Now, as luck would have it, that doctor on the Advisory Panel I quoted is local, so maybe I'll just take up all my future questions directly with him!

 

[normofthenorth]

New note and link at http://www.valvereplacement.org/forums/showthread.php?39005-TAVR-vs-AVR&p=526615#post526615 .