MONTREAL — Canadian Press Last updated on Monday, Apr. 06, 2009 11:28PM EDT
Four months ago, 11-year-old Maryjane Yale would struggle for breath.
Try as she might to keep up to her friends, Maryjane just couldn't because a severe case of Kawasaki disease had ravaged her coronary arteries. One was completely blocked and open-heart surgery seemed the only option.
Today, after undergoing an experimental procedure that essentially jackhammered a hole through the clogged artery in her heart, Maryjane's friends probably struggle to keep up with her.
“I'm less out of breath when I jump on the trampoline and when I do sports,” the bright-eyed little girl told reporters Thursday.
The team of doctors who performed the procedure on Maryjane last June say she was the first child in the world to have it.
Kawasaki disease affects children exclusively and, in about 20 per cent of cases, causes inflammation in the arteries that leads to scarring and blockages.
Dr. Nagib Dahdah, a cardiologist at Ste-Justine Hospital, said Maryjane's case was severe and that “she was really very sick.”
The only conventional treatment was double bypass surgery — an invasive and risky procedure with a long road to recovery.
But Dr. Dahdah had read about clinical trials for the CROSSER, essentially a miniature medical jackhammer that drills a hole through the clog and allows doctors to use conventional methods to do the rest.
The machine has not yet been approved for use anywhere in the world but Dr. Dahdah and his colleagues contacted the manufacturer, U.S.-based FlowCardia, and then persuaded Health Canada to give them special permission to use the machine.
The procedure took a couple of hours, including a “few intense minutes” for excavation of the blockage,” Dr. Dahdah said.
The thin catheter was inserted into the artery in her groin and slowly guided up into her heart.
Vibrating at an extremely high frequency, it drilled through the blockage and doctors were able to insert a conventional balloon catheter to open the artery fully before shoring up the artery walls with a traditional stent.
“The next morning, she was at home, very happy, very content,” Dr. Dahdah said. “There were no cuts, nothing to bother her.”
There are an average of 13 cases of Kawasaki disease annually per 100,000 children under age five. Ste-Justine hospital has up to 1,300 patients with Kawasaki in its database alone.
Less than 15 per cent of them have severe coronary disease like Maryjane, but doctors believe there are three or four patients right now who could be good candidates for the procedure.
“It certainly was a success for Maryjane and I think it's going to be a success for a lot more patients, but we don't know how many,” said Dr. Reda Ibrahim, a cardiologist at the Montreal Heart Institute who took part.
FlowCardia expects to submit clinical trial results to the U.S. Food and Drug Administration this week.
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