American-led MitralClip System gives new hope to heart problem patients

Heart patient Dan Theuerkauf has a new lease on life thanks to new technology.

TINANA’S Dan Theuerkauf in Queensland Australia happily describes himself as a “miracle man” after becoming the 12th person in Queensland to receive a revolutionary heart operation that saved his life.
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In October, the 56-year-old excavator and trucking business owner was chosen as one of just 150 people in Australia and New Zealand to take part in the multi-million dollar American-led MitralClip System ANZ clinical trial now being conducted at Brisbane’s Prince Charles Hospital in Queensland.

“I had a heart attack in 2004 when I was 48 and they discovered it wasn’t possible to give me a stent to fix my blocked arteries so I got five bypasses done on four arteries instead,” Mr Theuerkauf said yesterday.

Doctors later found the heart attack had caused the mitral valve in his heart to leak, causing shortness of breath.

When the Prince Charles heart specialist phoned to say he might fit the trial of the new clip, it changed Dan’s life.

After days of stringent tests, Dan Theuerkauf finally found himself heading into theatre in Brisbane on October 14.

Four hours later, the three-pronged clip had been pushed up through his groin, a hole bored into his heart cavity and two clips attached to the leaky valve.

The operation was televised and transmitted to the other hospitals.

“I had absolutely no pain afterwards and feel like a new man. What is even more astounding is the op was 100% successful in stopping the leak when the doctors had banked on 90%.”

A metal probe used to insert the clips is now being shared among three major Australian hospitals

Sourced from the local chronicle paper & published by Henry Sapiecha

Further reading below-

Atlanta, GA (updated)Much-anticipated results from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II show that the novel MitraClip (Abbott) device—a percutaneous version of edge-to-edge mitral-valve repair—may lead to fewer early adverse events than traditional valve repair or replacement, with “noninferior” efficacy out to one year.
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The results were presented here during the opening late-breaking clinical-trials session of the American College of Cardiology 2010 Scientific Sessions/i2 Summit. “The MitraClip procedure is an important therapeutic option for selected patients with significant mitral regurgitation, given the demonstrated safety, effectiveness, and clinical benefit,” investigators for the trial conclude.

Speaking with heartwire, lead investigator Dr Ted Feldman (Evanston Hospital, IL) characterized the clip not as something that would supplant surgery but as an additional option for patients deemed suitable for this percutaneous approach. “The cases that are most likely to be successful are the ones where the jet of the mitral regurgitation is central and relatively discrete and when there is a flail leaflet, where the gap between the two leaflets is not too great.”

Dr Ted Feldman
Dr Ted Feldman

During the late-breaking clinical-trials session, Feldman acknowledged that patients in EVEREST II were a highly selected group, but that close attention to appropriate selection is also key for surgical patients.

And in the past, he continued, “many [patients] have been excluded because they are not good candidates for surgery; we have an algorithm now that traditionally only involved medicine, repair, and replacement. And today we have another option.”

The MitraClip device emulates the edge-to-edge repair technique pioneered surgically by Dr Ottavio Alfieri, in which the free edge of the anterior mitral-valve leaflet is joined to the posterior leaflet, creating a point of permanent coaptation and a double orifice. With the MitraClip, the device is threaded via the femoral vein to the right atrium and passed into the left atrium via transseptal puncture. The device is then passed through the mitral valve into the left ventricle. When the clip is deployed, it essentially clothes-pegs the free edge of the anterior mitral-valve leaflet to the posterior leaflet, creating a point of permanent coaptation.

Results from earlier studies established the safety and feasibility of the procedure, but EVEREST II is the first trial to directly compare outcomes with the device against the gold standard, surgery, in a randomized trial.

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