Complications upon investigation and review included internal jugular vein stent thrombosis, cerebral sinovenous thrombosis, stent migration, cranial nerve injury and injury associated with venous catheterization.
Internal jugular vein stent thrombosis has been discussed here, that's a known risk and a reason for the IRs to only use stents when absolutely necessary and to carefully monitor afterwards (which is hard with travelling patients) and to prescribe anticoagulation.
Cerebral sinovenous thrombosis is concerning because this was a thrombosis that entered the dural sinuses which are north of the jugulars, directly under the brain.
Stent migration? I can only remember two other reports of stent migration. The first is unforgettably an early patient's experience, in which it migrated to the heart and required open heart surgery. The second was a mention in which the stent had migrated out of position but remaining in the vein; it may have been disrupting the flow in the innominate vein slightly. This was last fall and by memory so not precise.
Cranial nerve injury...it would be good to know more. The only similar case would be the spinal accessory nerve damage in some early patients, when too big of stents were used.
Injury associated with venous catheterization. This could be scarring or intimal hyperplasia? Not sure.
This is not a random selection of patients who had been treated, it was patients coming forward with complications, and it is a small sample of five patients. We have no information on where they were treated as the procedure is not standardized and certain techniques may lead to a greater complications rate.
We have a few safety studies:http://tinyurl.com/6jbpuqn
Endovascular treatment of CCSVI in MS patients is a safe procedure when performed on an outpatient basis. Cardiac monitoring is essential to permit detection and rapid treatment of patients with procedure-induced arrhythmias. Post-procedure ultrasound is recommended to detect venous thrombosis. In addition, consideration should be given to performing complex re-interventions in a hospital given the complication risk in this sub-population of patients.
This was from a study of 231 patients.www.ncbi.nlm.nih.gov/pubmed/21679067
J Endovasc Ther. 2011 Jun;18(3):314-23.
Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis.
Petrov I, Grozdinski L, Kaninski G, Iliev N, Iloska M, Radev A.
SourceCardiology Department, Tokuda Hospital Sofia, Bulgaria. email@example.com
PURPOSE: To evaluate the safety of endovascular treatment of chronic cerebrovascular insufficiency (CCSVI) in patients with multiple sclerosis (MS).
METHODS: In a 1-year period, 461 MS patients (261 women; mean age 45.4 years, range 21-79) with CCSVI underwent endovascular treatment of 1012 venous lesions during 495 procedures [34 (6.9%) reinterventions]. While balloon angioplasty was preferred, 98 stents were implanted in 76 patients for lesion recoil, restenosis, or suboptimal dilation. The procedures were analyzed for incidences of major adverse events (death, major bleeding, or clinical deterioration of MS), access site complications, procedure-related complications, and procedural safety-related variables (fluoroscopy and contrast times). The complication rates were compared to published data for similar endovascular methods.
RESULTS: There were no deaths, major bleeding events, or clinical deterioration of MS. Access site complications included limited groin hematoma (5, 1.0%); there were no arteriovenous fistulas or puncture site infections. Systemic complications included only rare cardiac arrhythmias (6, 1.2%). Procedure-related complications included vein rupture (2, 0.4%), vein dissection (15, 3.0%), acute in-stent/in-segment thrombosis (8, 1.6%), and acute recoil (1, 0.2%); there was no stent migration or fracture or distal embolization. Mean fluoroscopy time was 22.7 minutes, and mean contrast volume was 136.3 mL.
CONCLUSION: Endovascular therapy appears to be a safe and reliable method for treating CCSVI. Innovations such as purpose-specific materials and devices are needed, as are case-controlled and randomized data to establish efficacy in ameliorating MS symptoms.
This was a study of 461 patients but I do not think there was follow-up, so it is only pertinent to the immediate safety of the procedure.