Little Benefit, Some Harm with Venous Surgery for MS
By John Gever, Senior Editor, MedPage Today
Published: October 12, 2012
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner
LYON, France -- Patients undergoing cranial venoplasty as a multiple sclerosis therapy rarely showed improvement in objective disease measures, although half said they felt better, according to a large Italian study reported here.
Among 462 patients who had endovascular procedures in an attempt to cure or relieve their disease, the vast majority had no change or worsening in disability as measured by EDSS scores, and approximately one-third had relapses and/or new MS-type brain lesions visible on MRI scans, said Angelo Ghezzi, MD, of the University of Milan in Italy.
Fifteen patients in the cohort experienced serious adverse effects following the procedures that could have been treatment-related, including a fatal MI, a nonfatal stroke, and seven cases of jugular thrombosis.
However, 53% of the patients told their neurologists that their symptoms had improved, Ghezzi said at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting.
He said that the latter finding most likely reflected the "high expectations" that patients had from the treatment, which is often billed as "liberation therapy" in Italy and elsewhere. But he also emphasized that patients could have realized genuine improvements in symptoms such as fatigue that are not well measured in the EDSS system.
The findings came from a registry involving 33 MS clinics across Italy, in which neurologists contribute data on their patients who had undergone venoplasty procedures for their MS.
These procedures are based on the controversial theory that a condition called chronic cerebrovascular venous insufficiency (CCSVI) is responsible for MS.
Under this theory, obstructions in large veins draining the skull cause increased vascular pressure within the brain, which in turn causes inflammation that leads to the immune derangements and nervous-system damage characteristic of MS.
It was first advanced by Paolo Zamboni, MD, of the University of Ferrara in Italy, whose 2009 published report galvanized the MS clinical and patient communities. In that report, he claimed that every MS patient he examined met criteria for CCSVI, whereas the condition was not present at all in a control group.
Zamboni, a vascular surgeon, also reported that all patients undergoing venoplasty in his clinic showed substantial improvements in MS symptoms.
But the theory has been widely attacked by other researchers. Numerous attempts by neurologists and radiologists to replicate Zamboni's findings have failed, either because they could not find CCSVI in their patients or because it was commonly present in controls as well as in patients.
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