K. Mandato

Safety of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency: A Report of 240 Patients with Multiple Sclerosis

PURPOSE To evaluate the safety of outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). MATERIALS AND METHODS A retrospective analysis was performed to assess complications occurring within 30 days of endovascular treatment of CCSVI. The study population comprised 240 patients; 257 procedures were performed over 8 months. The indication for treatment in all patients was symptomatic MS. Of the procedures, 49.0% (126 of 257) were performed in a hospital, and 51.0% (131 of 257) were performed in the office. Primary procedures accounted for 93.0% (239 of 257) of procedures, and repeat interventions accounted for 7% (18 of 257). For patients treated primarily, 87% (208 of 239) had angioplasty, and 11% (26 of 239) had stent placement; 5 patients were not treated. Of patients with restenosis, 50% (9 of 18) had angioplasty, and 50% (9 of 18) had stent placement. RESULTS After the procedure, all but three patients were discharged within 3 hours. Headache after the procedure was reported in 8.2% (21 of 257) of patients; headache persisted > 30 days in 1 patient. Neck pain was reported in 15.6% (40 of 257); 52.5% (21 of 40) of these patients underwent stent placement. Three patients experienced venous thrombosis requiring retreatment within 30 days. Sustained intraprocedural arrhythmias were observed in three patients, and two required hospital admission. One of these patients, who was being retreated for stent thrombosis, was hospitalized because of a stress-induced cardiomyopathy. CONCLUSIONS Endovascular treatment of CCSVI is a safe procedure; there is a 1.6% risk of major complications. Cardiac monitoring is essential to detect intraprocedural arrhythmias. Ultrasonography after the procedure is recommended to confirm venous patency and to identify patients experiencing acute venous thrombosis.

Recommendations for Multimodal Noninvasive and Invasive Screening for Detection of Extracranial Venous Abnormalities Indicative of Chronic Cerebrospinal Venous Insufficiency: A Position Statement of the International Society for Neurovascular Disease

Under the auspices of the International Society for Neurovascular Disease (ISNVD), four expert panel committees were created from the ISNVD membership between 2011 and 2012 to determine and standardize noninvasive and invasive imaging protocols for detection of extracranial venous abnormalities indicative of chronic cerebrospinal venous insufficiency (CCSVI). The committees created working groups on color Doppler ultrasound (US), magnetic resonance (MR) imaging, catheter venography (CV), and intravascular US. Each group organized a workshop focused on its assigned imaging modality. Non-ISNVD members from other societies were invited to contribute to the various workshops. More than 60 neurology, radiology, vascular surgery, and interventional radiology experts participated in these workshops and contributed to the development of standardized noninvasive and invasive imaging protocols for the detection of extracranial venous abnormalities indicative of CCSVI. This ISNVD position statement presents the MR imaging and intravascular US protocols for the first time and describes refined color Doppler US and CV protocols. It also emphasizes the need for the use of for noninvasive and invasive multimodal imaging to diagnose adequately and monitor extracranial venous abnormalities indicative of CCSVI for open-label or double-blinded, randomized, controlled studies.

Results of Iliac Artery Stent Placement in Patients Younger than 50 Years of Age

PURPOSE To determine long-term outcome in patients 50 years of age or younger treated with iliac artery stent placement. MATERIALS AND METHODS The records of 412 patients who underwent iliac artery stent placement during a 62-month study period were reviewed retrospectively. Forty-two patients younger than age 50 (mean age = 45 y) at the time of stent placement were included in the study population. Presenting symptoms included claudication (47%), rest pain (17%), ulceration/tissue loss (31%), and blue toe syndrome (5%). Anatomic, hemodynamic, and clinical success rates of the stent placement procedure were assessed. Stent patency rates were calculated by life-table methods. RESULTS Fifty-nine iliac lesions were treated with stents; 62% of patients underwent treatment of a single lesion whereas 38% had multiple lesions treated. Thirty-one percent were treated after a failed angioplasty procedure and 69% were treated with stent placement primarily. After stent placement, 34 patients (82%) experienced symptomatic relief, although eight of these patients (19%) underwent a planned ipsilateral infrainguinal bypass procedure during the same hospitalization. During follow-up, five patients (12%) required a bypass procedure as a result of stent failure and two patients (5%) required below-knee amputation. Seven patients (17%) required endovascular stent revision, with none requiring additional surgery. At 1, 2, and 3 years, the primary patency rates were 86%, 72%, and 65%, and the secondary patency rates were 90%, 88%, and 88%, respectively. CONCLUSIONS Iliac stent placement successfully addresses the presenting symptoms of young patients with peripheral vascular disease and results in patency rates that are similar to those reported in a more general population. With appropriate postprocedural surveillance, restenosis can be addressed in many patients with use of endovascular techniques, limiting the need for surgical revision.

Review of Venous Anatomy for Venographic Interpretation in Chronic Cerebrospinal Venous Insufficiency

Chronic cerebrospinal venous insufficiency (CCSVI) represents a recently described condition that may potentially contribute to the symptoms experienced by patients with multiple sclerosis. The evaluation of a prospective patient for CCSVI often involves an invasive evaluation with venography of the internal jugular and azygos veins. The purpose of this article is to review the normal anatomy of the internal jugular, vertebral, and azygos veins, as an understanding of these veins is necessary for appropriate interpretation of the venograms obtained to evaluate patients for CCSVI.

Internet-Based Social Networking and Its Role in the Evolution of Chronic Cerebrospinal Venous Insufficiency

The Internet is being seen as a growing resource for health-related information for a large number of patients. It is undeniable that its widespread presence has led to the growth of awareness that chronic cerebrospinal venous insufficiency (CCSVI) as an entity that may contribute to the symptoms experienced by patients with multiple sclerosis (MS). Social networking and file-sharing Web sites have brought patients with MS together from all over the world and have facilitated the distribution of personal experiences and information derived from medical research as it relates to CCSVI. As a result, there has been an accelerated growth in the number of patients seeking treatment for this syndrome in light of the possibility that it may improve their present condition. This article will review this phenomenon, the Internet-based resources available to MS patients seeking information about CCSVI, and the responsibilities of physicians as they participate in these online discussions.

Catheter Venography and Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency

Multiple sclerosis (MS) is a disorder characterized by damage to the myelin sheath insulation of nerve cells of the brain and spinal cord affecting nerve impulses which can lead to numerous physical and cognitive disabilities. The disease, which affects over 500,000 people in the United States alone, is widely believed to be an autoimmune condition potentially triggered by an antecedant event such as a viral infection, environmental factors, a genetic defect or a combination of each. Chronic cerebrospinal venous insufficiency (CCSVI) is a condition characterized by abnormal venous drainage from the central nervous system that has been theorized to have a possible role in the pathogenesis and symptomatology of MS (1). A significant amount of attention has been given to this theory as a possible explanation for the etiology of symptoms related to MS patients suffering from this disease. The work of Dr. Zamboni, et al, who reported that treating the venous stenoses causing CCSVI with angioplasty resulting in significant improvement in the symptoms and quality of life of patients with MS (2) has led to further interest in this theory and potential treatment. The article presented describes endovascular techniques employed to diagnose and treat patients with MS and CCSVI.

The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research

The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.