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DALLAS -- Canadian multiple sclerosis (MS) patients who left the country to undergo a controversial vascular procedure, known as chronic cerebrospinal venous insufficiency (CCSVI), often received poor pre- and postoperative care, but most were still relatively satisfied overall, a researcher reported here.

Among 124 patients in a survey who reported traveling to other countries for cerebrospinal venoplasty -- under a disputed theory that obstructed veins serving the brain cause or exacerbate MS -- nearly 60% indicated that they received no follow-up investigations at the center performing the procedure, and more than 40% had no follow-up care of any kind, according to , of the University of Calgary in Alberta.

Only 6% of respondents said they had not been told of potential adverse effects with the physician who performed the procedure, but some risks -- such as stent migration or kidney damage from contrast dyes used to locate venous obstructions -- were seldom raised, Greenfield reported at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.

However, half of patients rated their overall satisfaction with the procedures as good or better.

Medical Tourism for Venoplasty

The procedure is based on a controversial vascular theory of MS, first proposed 5 years ago by the Italian vascular surgeon Paolo Zamboni, MD. For a variety of reasons, the theory gained immediate traction in segments of the MS patient community unhappy with conventional therapies. However, attempts by neurologists to replicate Zamboni's findings almost uniformly failed and most authorities have declared the theory dead.

Interest in the CCSVI theory was especially strong in Canada, but the health systems there discouraged many physicians from performing venoplasty procedures based on it. As a result, "medical tourism" by Canadian MS patients seeking venoplasty became a recognized phenomenon.

In 2011, researchers in the Alberta province began surveying resident MS patients about their experiences with CCSVI-based treatments. Of 866 who responded, Greenfield and colleagues identified 124 who had traveled outside the country for procedures and answered questions about the types of care they had received and where it was provided.

Curiously, none had gone to Italy – even though Zamboni and his proteges there have established busy venoplasty programs for MS patients. Just under half of the Albertans (55) had gone to the U.S. for treatment; Mexico (26), Costa Rica (14), and Poland (13) were the next most popular destinations. Others included India, Bulgaria, Germany, Jordan, and Scotland.

Patient demographics generally reflected a population with established MS: two-thirds female, mean age about 50, with average disease duration of 12 years. Some 44% had relapsing-remitting disease, and 45% reported having primary or secondary progressive MS.

The remainder weren't sure they had MS at all, responding with "uncertain," "possible MS," and even "not MS" when asked about their diagnoses.

Hardly any chose the treating physician or facility on the basis of a physician's recommendation. Most relied on the Internet or recommendations of friends, relatives, and other patients. Distance and cost were also factors, but less frequently.

From 80% to 90% of patients received only venoplasty without stenting, except those treated in Poland, where stents were placed in more than 40% of patients.

The questionnaire asked patients about numerous aspects of risk communication in discussing the procedure with the clinician who performed the procedure. Large majorities of patients reported being told about risks of thrombosis and restenosis, neck pain, bleeding due to medication, allergy to contrast dyes, and vein damage at the femoral catheter insertion point.

But two patients said they were told explicitly that there were no risks, and five indicated there was no discussion of potential adverse events.

Follow-up care at the treating clinics was mostly lacking, according to the survey results. Only one-third of patients were given prescription anticoagulants and just 24% received aspirin. Other types of post-procedural therapies were even less common.

And studies to confirm that the intervention had achieved its intended goal were even less common. Just 33% of patients reported undergoing an ultrasound scan (the basic type of exam used to diagnose CCSVI in the first place), 17% had an MRI scan, and 11% had any other type of post-procedural evaluation.

Reports from patients who went to the U.S. for treatment generally indicated that practices were in the low to middle range of the global spectrum.

Poland, where there were three clinics patients had used, stood out as having the most extensive record of follow-up care, with about 80% of patients reporting having received something in both post-procedural therapy and evaluation.

Clinics in the U.S., Mexico, and Costa Rica all had similarly low rates of follow-up treatments and evaluations (20% to 30%), with "other" coming in at 75%, according to Greenfield's data. In contrast, levels of overall risk communication varied little by geography.

Costs did vary, and, again, the U.S. was in the low to middle range. Costa Rica (where only one clinic had provided treatment to respondents) was the most expensive, with a reported average of about $14,000. The cheapest was "other" at about $8,000 on average. But costs also had considerable variance, ranging from $5,000 to upwards of $20,000.

Another survey question asked respondents if the procedure outcome was successful and, if so, whether it involved difficulty.

All but two of the 124 patients said it had been successful -- 79% reporting no complications and 19% saying it was "successful with some trouble."

And, rating their overall satisfaction on a scale of 1 (worst) to 10 (best), the median was 7, and three-quarters of respondents rated it 5 or higher.

Greenfield, when asked whether CCSVI-related medical tourism in Canada was still occurring -- in the face of hardening opposition from certified neurologists -- replied that the data suggested that it had abated but the data also had important limitations.

The survey continued through 2013, and she said the vast majority of treatments reported by survey respondents were provided in 2010 and 2011; only a few occurred in later years.

But she noted that survey participation was voluntary and that, precisely because expert opinion has turned against CCSVI, patients who obtained procedures more recently may have been reluctant to share their experiences.

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