Adverse events after endovascular treatment of chronic cerebro-spinal venous insufficiency (CCSVI) in patients with multiple sclerosis

Abstract

Although it is debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients undergo endovascular treatment (ET) of CCSVI. A study is ongoing in Italy to evaluate the clinical outcome of ET. Severe adverse events (AEs) occurred in 15/462 subjects at a variable interval after ET: jugular thrombosis in seven patients, tetraventricular hydrocephalus, stroke, paroxysmal atrial fibrillation, status epilepticus, aspiration pneumonia, hypertension with tachicardia, or bleeding of bedsore in the remaining seven cases. One patient died because of myocardial infarction 10 weeks after ET. The risk of severe AEs related to ET for CCSVI must be carefully considered.

Keywords

CCSVI multiple sclerosis endovascular treatment

Get full access to this article

View all access options for this article.

References

Zamboni

Galeotti

Menegatti

. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg 2009; 50: 1348–1358.

Ludyga

Kazibudzki

Simka

. Endovascular treatment for chronic cerebrospinal venous insufficiency: Is the procedure safe? Phlebology 2010; 25: 286–295.

Kostecki

Zaniewski

Ziaja

. An endovascular treatment of chronic cerebro-spinal venous insufficiency in multiple sclerosis patients — 6 month follow-up results. Neuro Endocrinol Lett 2011; 32: 557–562.

Petrov

Grozdinski

Kaninski

. Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Endovasc Ther 2011; 18: 314–323.

Mandato

Hegener

Siskin

. Safety of endovascular treatment of chronic cerebrospinal venous insufficiency: A report of 240 patients with multiple sclerosis. J Vasc Interv Radiol 2012; 23: 55–59.

Zamboni

Galeotti

Weinstock-Guttman

. Venous angioplasty in patients with multiple sclerosis: Results of a pilot study. Eur J Vasc Endovasc Surg 2012; 43: 116–122.

Salvi

Bartolomei

Buccellato

. Venous angioplasty in multiple sclerosis: Neurological outcome at two years in a cohort of relapsing–remitting patients. Funct Neurol 2012, 27: 55–59.

United States Food and Drug Administration. Medical devices, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm#.T6vm8Mc8cjc.email (2012, 8 September).

Ghezzi

Annovazzi

Cocco

. Endovascular treatment of CCSVI in patients with multiple sclerosis: Clinical outcome of 462 cases. Neurol Sciences (in press).

10.

United States Food and Drug Administration. Safety, http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm (accessed 24 Nov 2012).

11.

European Medicines Agency. ICH Topic E 2 A Clinical safety data management: Definitions and standards for expedited reporting, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002749.pdf (1995, accessed 24 November 2012).