Table 2.
Complications reported after endovascular treatments (‘Liberation procedure’) for chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis (MS).
| Study | Country | Patients treated with ‘Liberation procedure’ (n) | Complications |
|---|---|---|---|
| Zamboni et al. [2009c] | Italy | 65 | No major complication reported |
| Mild post-procedural headache with spontaneous resolution (n = 6) | |||
| Minor hemorrhages (hematomas) at the vascular access sites (exact number not reported) | |||
| Samson [2010] | USA | > 35 | Fatal brainstem hemorrhage in a patient treated with coumadin following insertion of two self-regulating stents in the right IJV (n = 1) |
| Migration of stent placed in IJV to the right ventricle. Open heart surgery was performed to remove the device (n = 1) | |||
| Ludyga et al. [2010] | Poland | 331 | Stent thrombosis (n = 2) |
| Surgical removal of angiographic balloon (n = 1) | |||
| Local bleeding from groin (n = 4) | |||
| Two cases with femoral artery pseudoaneurysm treated with thrombin injection (n = 2) | |||
| Gastrointestinal bleeding requiring hospitalization following clopidogrel treatment after stent placement (n = 1) | |||
| Transient atrial fibrillation during the procedure requiring pharmacological treatment (n = 2) | |||
| Migration of stent placed in IJV (n = 4). Second stent placement required to secure the first one (n = 4) | |||
| Thapar et al. [2011] (Supplemental Reference s-4) | UK | Not reported. Endovascular procedure performed outside UK | IJV thrombosis following venoplasty (n = 1). Open thrombectomy performed for symptom relief |
| Burton et al. [2011] (Supplemental Reference s-5) | Canada | Not reported. Endovascular procedures performed outside Canada in Eastern Europe (n = 2), India (n = 1), Mexico (n = 1) and USA (n = 1) | IJV thrombosis following stent placement (n = 1) |
| Cranial nerve palsies (hypoglossal and accessory nerves) caused by bilateral oversized stent placement in IJV (n = 1) | |||
| Migration of stent from azygos to renal vein causing syncope (n = 1) | |||
| Surgical dissection of femoral vein during balloon withdrawal causing large extraperitoneal hematoma within the space of Retzius causing bladder compression (n = 1) | |||
| IJV thrombosis following stent placement complicated by thrombosis of ipsilateral transverse and sigmoid sinuses (n = 1). Anticoagulation was required to treat iatrogenic cerebral venous sinus thrombosis | |||
| Hubbard et al. [2012] | USA | 259 | Deep vein thrombosis at the venous access site (n = 1) |
| Doležal et al. [2012] (Supplemental Reference s-6) | Slovakia | Not reported. Endovascular procedure performed in Poland | Dislocation of right IJV stent to ipsilateral brachiocephalic vein and thrombosis of left IJV stent requiring anticoagulation (n = 1) |
| Zamboni et al. [2012b] | Italy/USA | 8 | Vaso-vagal syncope reported 3 h after procedure (n = 1) |
IJV, internal jugular vein.