Friday June 23rd 2017

On the risks of CCSVI treatment: where’s the beef?

As a piece of scientific research, the much-discussed University of Calgary report by eight neurologists published in the September issue of the Canadian Journal of Neurological Sciences is a strange little document indeed. “Complications in MS Patients after CCSVI Procedures Abroad” reviews the cases of five Canadian multiple-sclerosis patients who experienced complications ranging “from moderate to severe” after they traveled for treatment pioneered by Italian vascular specialist Paolo Zamboni—possible stent migration, venous thrombosis, possible cranial nerve injury, abdominal hematoma. These cases, they conclude, “represent the beginning of a wave of complications for which standardized care guidelines do not exist.”

Clearly the folks at the journal want the study to be widely read: they recently began offering it as “Editor’s choice article FREE!” on the journal’s website, allowing readers to sidestep the usual US$120 subscription fee. My colleague Colby Cosh went to town about the study’s findings in a recent blog post that dismissed CCSVI treatment as “trendy” and Zamboni’s science as “junk.” An August 31 Calgary Herald editorial took a different tack, concluding that the spectre of a patient tsunami arising from offshore CCSVI treatment offers “one more reason for the province to conduct full clinical trials. Good science is needed before an informed verdict can be reached.”

Alas, good science is not in abundant supply in this report. Even its basic facts are a little dodgy, beginning with the assertion CCSVI has been “a dominant topic” for 12 months (it’s closer to 24 months). The researchers also shoot down the credibility of Zamboni’s hypothesis claiming “more rigorous studies” have “not found an association between MS and anomalous or pathological venous flow.” That will come as a surprise to the Canadian Institute of Health Research. In June, in a reversal of a year-old decision, it gave CCSVI clinical treatment trials the green light after its CCSVI advisory committee heard a review of research that supports a MS-CCSVI link (the summary will be published in an upcoming Canadian Medical Association Journal). Oddly, two of the researchers behind the University of Calgary report (Drs. Fiona Costello and Michael D. Hill) sit on the CIHR’s CCSVI advisory panel.

The five case histories are cursorily reviewed and lack any follow-up post-emerg, making one wonder why eight neurologists were required for the effort. The five patients observed had differing forms of MS, at various stages of progression and were treated in disparate locations (Eastern Europe, Mexico and India). The Calgary researchers admit they don’t have a clue what treatments or quality of care the patients experienced: “We are unable to comment in detail on the exact procedures or protocols employed by those centres because it is not clear standardized procedures are employed across centres.”

Actually, it’s as clear as crystal that CCSVI practices have not been standardized across centres, either for diagnosis or treatment, a dire situation which explains why research is all over the map, as Dr Robert Fox, an MS specialist at the Cleveland Clinic (and CIHR CCSVI panel member), explains in this video.

A new study from the University of Buffalo that reviewed CCSVI research over the past two years also backs this up: it concludes that because CCSVI diagnosis relies on highly specific “operator-dependent” scanning criteria, results have been wildly inconsistent; it concludes there’s “an urgent need” “to establish reliable, diagnostic gold-standard test(s).”

Unsurprisingly, the U of Calgary study lacks the sort of context that would make it useful: What percentage of total CCSVI post-procedure complications in Calgary did these five cases represent? What percentage of the total number of Alberta residents who’ve traveled abroad for CCSVI do these five patients represent? And how do these outcomes compare with the risks from routine angioplasty and venoplasty performed everyday in Canadian hospitals? Of course, the researchers couldn’t know: nobody has kept track, a situation that should improve with the implementation of CCSVI treatment tracking registries.

It has been guesstimated that anywhere from 12,000 to 15,000 people have received CCSVI treatment worldwide—hundreds, if not thousands, have been Canadian. And they’re not dropping upwards of $20,000 to travel to offshore clinics to be “trendy.” We’re not talking about jetting off for a weekend in Mystique or buying the latest Balenciaga bag. These people are desperately seeking relief from a devastating degenerative disease for which there is no cure, only outrageously expensive “disease-modifying” drugs that come with a host of side effects, including death.

According to anecdotal reports, CCSVI treatment has offered dramatic improvements for many—in mobility, balance, circulation, bladder control, cognitive function and decreased fatigue. Other patients, however, have not experienced such benefits; a few, including one patient in the Calgary study, report their MS symptoms worsened after treatment.

Studies indicate CCSVI treatment—a routine angioplasty—is safe. But all medical intervention involves risk. And in the case of offshore CCSVI treatment, you have to factor in plane travel and clinics of varying quality. Over the two and a half years CCSVI treatment has been available, three related deaths have been reported (two Canadians and one American), all related to blood thinner or anticoagulant use. And at least one patient suffered stent migration so serious that emergency surgery was required.

Stents, used to prevent restenosis of the veins, are commonly used in CCSVI treatment, though they’re not part of the Zamboni protocol and he warns against using them—and of traveling offshore for treatment until conclusive CCSVI clinical trials have been concluded. As Colby points out, stents haven’t been designed for use in veins, which are far less robust than arteries, though researchers are busy working on it now. That isn’t because stents can’t be put in veins (doctors have been doing so for decades), but rather that the venous system has received such stunningly little study there has been limited call for it.

Again, context is useful: George Christakis, a scientist and vascular specialist at Toronto’s Sunnybrook Hospital told advocacy group CCSVI Ontario complications also arise from arterial stents: “You have to realize that there are complications with stents no matter where they are used. People drop dead of heart attacks when their stents in their hearts suddenly block off. You don’t see cardiologists stop doing the procedure.”

Sandy McDonald, a Barrie, Ont. vascular surgeon, who performed six CCSVI procedures in a small, approved trial last year, dismisses the University of Calgary report as “fear-mongering.” But it is significant in that it’s the first time neurologists, traditional MS caregivers, have looked at MS patients who’ve traveled for CCSVI treatment in a peer-reviewed study. Not that neurologists will have to deal with any such complications. That will be up to vascular specialists, the experts in this area.

What struck me about the study—aside from its gaps and its ultimate pointlessness—was the lack of interest in CCSVI patient outcomes. There’s no mention whether these patients experienced any improvements or betterment of their quality of life. Did they feel, despite the complications, it was worth it? Granted, that was beyond the purview of this study, one that chose to focus on burdens to the system not the health of the patient. But isn’t that what really matters?

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