Mitra-Clip

[Marty]

Research says some patients have had "life-transforming" results with MitraClip.
The Chicago Tribune (6/16, Channick) reports that "though it doesn't work for everyone," some patients "have had 'life-transforming' results from the" MitraClip, "said Dr. Ted Feldman...the lead investigator on the clinical trials for the" device, "which he called 'much safer than open-heart surgery.'" Although "the clip is slightly less effective at reducing leakage than surgery, patients recover much faster -- about one week versus six weeks -- and experience one-sixth as many serious complications, said Feldman, who reported findings of the completed study to the American College of Cardiology in March." So far, "hundreds of patients have received the device at 35 sites in the US, including Chicago's Rush University Medical Center, the only other participating Illinois hospital

 

[Luana]

I think that's what Elizabeth Taylor had at Cedars-Sinai in Los Angeles this past winter.

 

[Jkm7]

My cardio and I talked about it and his comment was he hasn't been impressed with what he has seen.

This was two years ago so perhaps there have been improvements?

 

[Marty]

I discussed the clip with Dr. Lefrak a few months ago. He said he would not use it or recommend it.

 

[ElectLive]

This is an old thread but thought I'd add an update since an FDA decision is now pending, probably in the next few months. It already is forecast only for patients at too high risk for open surgery, but even then it seems the controversy continues relative to risk/benefit, even within the FDA. Staff reviewers had recommended against approval, then the later Advisory Panel opinion came out narrowly in favor, as this articles describes: http://www.theheart.org/article/1520603.do.

An excerpt of the same:

"The advisory panel unanimously felt the MitraClip was safe but drew a tie-breaking vote from panel chair Dr Jeffrey Borer (SUNY Downstate Medical Center, New York NY) when it came down to the effectiveness of the device. In voting on efficacy, just four of the nine panel members felt there was a reasonable assurance that the MitraClip was efficacious in patients at high risk for surgery. On the whole, however, most felt that while the studies conducted by the sponsor had, as one panel member put it, "more holes in them than Swiss cheese," they did feel the risk/benefit ratio tipped in favor of the MitraClip.

Stating that he believes the benefits of the device exceed the risks, Dr Marc Katz (Bon Secours Heart and Vascular Institute, Richmond, VA) said the improvements in NYHA functional class in treated patients swayed his vote, as did some of the individual patients who've done well with the device.

"I have a hard time saying to patients, okay, we're going to wait another five years to have this available," said Katz. "In no way do I think this was an elegant study as I did with the PARTNER trial. I think it was really poor in a lot of ways. As I said earlier, I think we're put in a hard position here, but weighing the alternatives, and putting the patients up front here, was a deciding factor." "​

For anyone with interest in reading more about the studies and evidence, you can see the exhaustive FDA materials here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM343684.pdf. Oh, and by the way, it does already have CE Mark approval (2008).

 

[lost_kiwi]

So I’m looking at the COAPT trial –an investigation (“here, hold my beer and watch this!”) to see if the MitraClip is effective for functional MR. I’m 78, like to hike and backpack. Two CABGs make valve replacement questionable.

I was moderate MR until early 2015, but opened the year with paroxysmal Afib, turning into a (never diagnosed ... by five docs) dry cough, turning into cardiogenic shock in june, a v-tach episode in july (thanks, paramedic son who brought me back), followed by a CRT-D… which was installed in “couch-kitchen-crapper” mode. I couldn’t exercise until I diagnosed the problem in September (“change the AT setting to “high””!!!), followed by an adjustment of the A-pacing in December (precipitated by a face-plant on my tread).

Since then things have been back to pre-15 tread levels: ½ marathon in 4 hours, and in an hour on the flat, 4 miles, or at 15% ½ mile ascent. No angina, no a-fib, just pooped.

Which makes me seriously wonder if putting this in jeopardy by clipping is worth it.

Thoughts?