As reported by heartwire, and a savvy reader, Lapeyre here at Cartagena Surgery, the FDA has gone ahead and approved TAVI/ TAVR for patients that are eligible for open surgery.  [We must think alike, as I was drafting this post when I received the reader mail].

Despite the FDA’s previously cited concerns over the excessive stroke rate with the Sapien device (as discussed in the article re-posted below) – the FDA approved the use of this therapy as an alternative to surgery on June 13th.

Now we can sit back and watch as the up selling of this device to the public as news hits the US media and the television advertisements begin.  Soon this device will crowd out surgery as interventionalists cite “patient refused surgery” as the criteria for implantation, no matter what the best interest of the patient really is.  I wonder if they will even disclose the heightened stroke rate when they start implanting this into patients at a much higher rate.  Of the 12 members of the FDA panel, only one member voted against the expansion criteria.

As reported by Shelley Wood in a follow-up Heartwire article , only Dr Valluvan Jeevanandam spoke out against expanding the criteria for use, stating,   “I think this is a very good technology, and it gives us an alternative to AVR surgery, and I’m sure the device will continue to get better,” Jeevanandam, a cardiovascular surgeon, told heartwire after the meeting.

“However, at the current time, compared with standard AVR, this device has a higher stroke rate and a high rate of aortic insufficiency, did not meet the criteria for noninferiority* in males, and has a high incidence of vascular complications.”

These are all issues that need to be very clearly explained to patients as part of the informed-consent process, he stressed. Otherwise, patients who are “enamored at the idea of avoiding a sternotomy” may not fully understand these risks.”  

I fully concur with Dr. Valluvan Jeevanandam except that I might re-phase the term ‘enamored of.’  Actually, I think our so-called peers need to quit coercing patients by intentionally scaring them – in order to bill more procedures out of them.  [Don’t believe it?  Then check out Mark Midei and our overstenting archives.]

I will continue to champion well-established therapies with strong long term data.  I know this will get me labeled as ‘old-fashioned’ (or worse) but as we’ve seen in cardiology – numerous times; easy is not always the best answer..

Yes, conventional surgery hurts – it’s not glamorous, it’s not pretty.  But it’s (statistically) darn safe these days, and most of the surgeons doing it have done it thousands of times.. Even the bioprosthetic valves have a long durability than previously thought – meaning not everyone has to take warfarin..

We shouldn’t exploit people’s fears of surgery to use quasi-experimental procedures, no matter how “cool” they sound..

* I hope readers remember that ‘noninferiority’ is a lesser standard that superior to, or even EQUAL to..

FDA flags strokes, trial conduct, as TAVI maker seeks expanded role for Sapien – from Heartwire.com (Shelley Wood).

Gaithersburg, MD – A higher risk of stroke and differences in how patients randomized to different procedures were actually treated and evaluated within the PARTNER A trial, which compared transcatheter aortic-valve implantation (TAVI) with surgery, are issues the US Food and Drug Administration (FDA) hopes its expert advisors can help clarify in weighing the pros and cons of expanding approval of the Sapien transcatheter valve (Edwards Lifesciences) [1,2]. Those issues and others are detailed in an FDA briefing document, posted online today, that the agency’s Circulatory System Devices Panel will consider in advance of Wednesday’s meeting.

As previously reported by heartwire, the FDA last year reviewed and subsequently approved the Sapien valve and transfemoral delivery system in patients not suited to open-valve replacement, based primarily on the PARTNER B results. Wednesday’s meeting, drawing heavily on the  PARTNER A results, will help the FDA decide whether to expand approval to high-risk patients who are surgery eligible and whether to approve the transapical approach also tested in PARTNER A.

In briefing documents posted online today, the FDA directed its advisors to pay special attention to a number of issues relating to trial conduct as well as patient outcomes.

In particular, the FDA review cites the “doubling” of neurological events seen in the Sapien-treated patients in the first 30 days postprocedure, with a higher stroke rate seen among transapical as compared with the transfemoral group.

The FDA documents also query “attempt-to-treat” decisions, including the higher number of patients randomized to surgery in whom no treatment was attempted; longer delays to treatment in surgical patients; and the higher number of concomitant operations seen in the surgical aortic-valve-replacement group—all factors that could have influenced adverse-event and survival rates in this group.

FDA is also asking its expert panel to weigh in on whether both the transfemoral and transapical approaches should be approved, given the numerically higher mortality in the transapically treated patients as compared with the transfemorally treated patients in the device arm.

General questions the FDA panel will be answering Wednesday include those related to the issues above, as well as to different outcomes seen in men and women, the importance of paravalvular regurgitation seen in patients treated with TAVI, valve durability, the required anticoagulation/antiplatelet regimen, and obtaining true informed consent.

Voting questions center on whether the evidence is sufficient to demonstrate safety and efficacy and whether the benefits of the new device outweigh the risks.

Industry analysts reading the tea leaves in the FDA’s review see the agency’s briefing document as largely promising, with Wells Fargo’s Larry Biegelsen predicting a “tough day, but positive panel outcome” and JP Morgan’s Michael Weinstein stating that the FDA synopsis contained “no major surprises; positive outcome expected.”

In other cardiology news, 

New guidelines recommend the discontinuation of prasugrel a full seven days before surgery to prevent catastrophic bleeding complications. (The cynical side of me expects to see a bigger push by the industry to use prasugrel now that clopidogrel is generic.)  Expect to see a couple more “Ask your doctor” ads..