TAMPA — Facing the painful, debilitating physical and mental symptoms of multiple sclerosis, more and more patients are turning to a treatment that isn't government-approved for MS, and is still being studied by scientists.
Eager patients have traveled thousands of miles and paid thousands of dollars for the treatment, which a few doctors in the Tampa Bay area offer.
Some say it's helping them more than MS medications.
Balloon angioplasty is used to open clogged vessels in heart patients. But when the procedure — called a venoplasty when it is used in veins — clears veins in the neck thought to be restricting blood flow to the brain, some MS patients' symptoms subside.
Some doctors are so impressed they are sending patients to an interventional radiologist willing to perform the procedure "off label,'' which is permitted under Food and Drug Administration rules.
Others aren't so sure.
"We need objective, clinical data that people are better, not just them saying they are better," said Dr. Bruce Zwiebel, director of vascular and interventional radiology at Tampa General Hospital.
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Known as venoplasty for chronic cerebrospinal venous insufficiency (CCSVI), the procedure was named by Italian vascular surgeon Paulo Zamboni, whose wife has MS, an autoimmune disease that affects the brain and spinal cord. Inflammation damages the nerves, causing impulses to be stopped or slowed. The cause is unknown; there is no cure.
Zamboni theorized blood flow to and from the head might be impaired, possibly by iron deposits clustered around the jugular veins. Almost all the patients he tested with Doppler ultrasound had veins in the neck that were narrowed, twisted or blocked. In 2009 he published results of a study after trying the balloon procedure on a small group, including his wife, and finding that most had fewer MS attacks and improved quality of life.
Word of Zamboni's success spread rapidly. Patients reported abandoning their wheelchairs, being able to think more clearly and being able to see better.
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Most physicians want to wait for more research, but patients like Barbara Garcia, 48, say they have no time to wait.
Right after her first treatment in July, he saw results.
"Two hours later she got up and took some steps. It was like a miracle," he said. "I was having a hard time believing it myself."
Arslan has treated 85 MS patients. "Concrete evidence is not strong, but the anecdotal evidence is good — patients walking without walkers, patients who were legally blind and regained some vision," he said.
"I have no question that this procedure alleviates a certain number of patients' symptoms.''
However, "it's not a cure.''
Garcia has had the procedure twice — it's common for blockages to reoccur. She went from needing a wheelchair all the time to walking around the house unassisted. She's now able to care for her two young granddaughters.
"As long as I can walk, and I use a cane when I feel shaky, that's what I'm happy with," she said. "I never expected to be 100 percent. As long as I can get around my home, I'm happy."
Nicki Watts, 55, of Sarasota was treated in August by Arslan. She reports greater energy and strength, and is less reliant on her walker. Michelle Sciuto, 54, also of Sarasota, was treated in December. The mental fog so common with MS lifted, but she didn't regain physical strength.
Still, she said, "I'm not disappointed with the results. I didn't have any expectations.''
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"We looked at doing it so people wouldn't have to travel the world to get it,'' he said. "We are one of the least expensive centers in the country, and we are offering it with a standard of care that is very high," says Niedzwiecki, who charges $7,500 (he has heard of patients paying up to $30,000). To date, 40 patients have been treated at Advanced Imaging, most of them from Canada.
"I tell patients not to expect a Lazarus moment, and they say to me, 'If I can go from needing full assistance to get up out of a chair to being able to get up on my own, that's all I care about,' " he said.
Neurologist Mark Cascione, medical director of the South Tampa Multiple Sclerosis Center, was skeptical of CCSVI, but does not discourage patients.
"I am now more on the fence about it," he said. "Is it intriguing? Absolutely. But whether this procedure slows down their MS or addresses the cause of MS, we don't know."
Irene Maher can be reached at firstname.lastname@example.org.