What if my US patient needs a MitraClip today?

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.

Your comments

	What if my US patient needs a MitraClip today?
	# 1 of 6	August 30, 2012 04:48 (EDT)
	Dr. Dave	Dr. Walton-Shirley's summary dismissal of "standard" operative approaches for mitral regurgitation is a mystery to me.  I've operated on many patients with MR over the last 30 years, and the "maiming and death" she refers to have not been so obvious to me.  The safety of elective mitral surgery has been well documented in the STS National Database.  An operative endpoint of 2+ MR is unsatisfactory, and the Alfieri procedure that the MitraClip seeks to emulate is not appropriate for most patients assessed for an operation. If the doctor's experience with surgeons or with operations for MR has been unsatisfactory, then disclosure of the basis for the damning attitude seems a reasonable request.  The short history of the MitraClip is not without failures and catastrophes.  Guess who is asked to address those problems?
	# 2 of 6	August 30, 2012 07:56 (EDT)
	Melissa	Dr. Dave, I think you must have misread the piece. The mitraclip is for patients who have been turned down for surgery. These are patients you would not have taken to the OR.  It's a great option for those patients.  The safety in the STS national database are for those patients who were screened and deemed operative candidates. I have nothing but the utmost respect for my cardiothoracic surgeons and am an avid referrer for those procedures. If you have operated patients who have been deemed inoperable and pulled them through frequently, then my hat's off to you! Melissa
	# 3 of 6	September 17, 2012 10:52 (EDT)
	KatoMDaughter	Three years ago, my then 92-year-old practicing physician mother was dying from severe mitral valve regurgitation. She was absolutely not a canidate for MR surgery. Three different hosptials recommended I take her home and call hospice care. Luckily her cardiologist had heard of a local doctor Saibal Kar MD performing the mitraclip procedure. She was the eldest highest-risk paitient to at Cedars Sinai Medical Center to receive the clip. Happy to report she is doing well, just celebrated her 95th birthday and next month will celebrate the 3rd anniversary of her procedure! As a family member and primary caregiver for my mother I can only say the FDA needs to get off their butts and approve the mitraclip, to save the lives of many patients, like my mother had no other hope!
	# 4 of 6	September 17, 2012 08:29 (EDT)
	Melissa	Kato, I'm so very proud for you and your family. My sentiments exactly.  Look to European equivalent of our FDA . They are the leaders on this one! Melissa
	# 5 of 6	March 3, 2013 12:46 (EST)
	karen denham	Another mitraclip success in Dallas! Long-term family friend was suffering from severe MR & NOT a candidate for MR surgery, being mid-eighties and frail. As an Internet junkie, I happened upon articles discussing the mitraclip studies & was thrilled to find this procedure being performed at Baylor Hospital in Dallas. Our friend was a suitable candidate for mitraclip & has improved significantly thanks to this life-saving procedure! The physicians we worked with AND their support staff were incredibly supportive and we cannot thank them enough! Our friend has passed the 1-year follow-up after mitraclip & just turned 89. This procedure saved her life. Karen Denham, on behalf of Lee Eatenson Author's disclosure (Mar 3, 2013) I have no relevant disclosures to make in connection with this topic.
	# 6 of 6	March 3, 2013 09:41 (EST)
	Melissa Walton-Shirley	Karen great info!!! Thanks so very much and so happy for your friend! It's really a shame that this procedure is readily available in some parts of Europe while here in the US, it's tough to get access! Our FDA should really re-think this one! Author's disclosure (Mar 3, 2013) Have attended many major presentations on this topic and am puzzled why the FDA approves meds that don't lower mortality but improve QoL-but hesitates on devices that so far do the same.

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