Heartfelt with Dr Melissa Walton-ShirleyView all posts »
What if my US patient needs a MitraClip today?Aug 27, 2012 08:48 EDT
It's aggravating when a much-needed therapy is not available in the US when it is readily available in another country. I had a discussion on the topic of why that's the case today with a colleague. It is like trying to explain air or God or love. It just is. It likely has to do with our FD A's penchant for randomized controlled trials when it comes to devices. If only the MitraClip were a pill, perhaps with the same luck as the 75-mg dose of dabigatran, who doesn't know if it likes a large adequately controlled randomized controlled trial or not, because the 75-mg dose has never met one. We'd be farther ahead of the game, I assure you if the MitraClip's hemodynamic data were weighted as heavily as the pharmacokinetic data of a 75-mg pill of dabi.
I had the same conversation with a patient recently who has "wide-open" MR, who for now is minimally symptomatic but will at some point experience the inevitable dam breach of flash pulmonary edema or one of the more subtle presentations of dyspnea on exertion, paroxysmal nocturnal dyspnea, or orthopnea.Dr Wolfgang Schillinger of the University Medical Center of Gottingen-Heart Center Germany discussed the presentation " Effect of MitraClip therapy on mitral regurgitation" today at the ESC 2012 meeting. These data from the ACCESS-EU phase 1 series demonstrated that in a cohort of mostly 3+ to 4+ mitral-regurgitation patients, 79% were free from MR grade above 2+ at one year. 82% were alive at one year, and 94% had successfully avoided the surgery that in all likelihood would have maimed or killed them.
There are so many lovely things about the MitraClip device. It doesn't require an arterial access, so almost all the vascular complications that can occur with its cousin the TAVR are a nonissue. After a total of around three hours of general anesthesia time, one-hour real procedure time, a femoral stick and a transseptal puncture later—voilà! Their MR jet shrinks! The patient spends one night in the ICU and then five or so more days in a German hospital. The out-of-pocket cost (not a realistic concern for European patients), were a patient to actually have to pay it—say, if they flew to Germany from some "other country"—would include a €21 000 price tag for just the device itself, and another €7000 euro for the stay. Add round-trip airfare for two, and the entire trip, providing everything went perfectly, would roughly cost €34 000, or around $42 585 US, room and board for the companion not included.
Unfortunately, not everyone with severe MR is a candidate for the device. It will not work in a highly calcified valve with significant deformity, but it could save so many with functional or secondary MR when the risk of surgery for them far outweighs the benefit. "There is also the possibility it may not work," said Dr Schillinger, who is careful to add this information to his preprocedural risk/benefit conversations. "80% get good results; 70% get better symptoms; 30% still have some symptoms; and there is a 3.4% mortality rate in the year following the procedure," but, he added, "Most of the mortality risk is not related to the procedure but a consequence of their comorbidities. What we do know is that it's very safe."
I want that "safety" and efficacy for my patients who are suffering or who are about to start their long winding road of in-and-out hospital stays, medication titration, and sleepless nights. Spending hours upright in a chair waiting for the sun to rise seems senseless, when just across the pond, others with the same pathology are lying flat, breathing easily, and living a better life. Perhaps presentations like this will push open the door more widely toward US MitraClip approval or crack it just a bit.
We can only hope.