kenneth mandato, md meridith englander, md gary siskin, md interventional radiology

Short-term outcomes after endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple

sclerosis

Kenneth Mandato, MDMeridith Englander, MD

Gary Siskin, MDInterventional RadiologyAlbany Medical Center

Albany, New York

Last Year…Safety of Outpatient Endovascular Treatment for CCSVI in MS

• 231 patients treated • 99% of patients were discharged within 3 hours

of receiving this minimally invasive treatment• CCSVI treatment- minimal risk of significant

complications• We hoped our study would inspire additional

studies to assess both safety and efficacy of treating CCSVI in MS patients

San Francisco 2012…Short-term Outcomes of Endovascular Treatment for CCSVI in MS

• 213 patients treated, 192 responded to a questionnaire assessing quality of life

• Evaluated Physical and Emotional End Points• Findings suggest significant improvements in

quality of life in patients having procedure• This study shows encouraging evidence that

treating CCSVI in MS is effective• Additional research is still needed….

Multiple Sclerosis

• Chronic inflammatory disease characterized by destruction of certain cells in the brain and spinal cord

• Most common explanation is person’s body attacks own cells

• 400,000 patients with MS in United States * Courtesy of

www.usa.siemens.com

*

Multiple Sclerosis

• Few treatment options improve quality of life• Medications have risks and side effects

Chronic Cerebrospinal Venous Insufficiency (CCSVI)

• Departure from current MS concepts• MS patients have blocked veins that drain blood

from brain and spinal cord

Chronic Cerebrospinal Venous Insufficiency (CCSVI)

• Italy, 2009- Dr. Paolo Zamboni published a study of CCSVI with favorable results and safety profile

• Evaluated the Internal Jugular Veins and Azygos Vein and showed that patients with MS have narrowed or otherwise abnormal veins

• Suggested that widening veins with a small balloon (angioplasty) could potentially improve quality of life

Normal Internal Jugular Vein

Normal Azygos Vein

Balloon angioplasty

• Spaghetti size tube• Minimally invasive• Proven successful

track record – Peripheral Arterial

Disease (PAD)– Dialysis veins

Balloon Angioplasty

Materials and Methods

• Retrospective study during 4 month period• Patients received angioplasty of at least one

vessel (3 patients with stent placement)• 192 of 213 patients responded to standard MS

questionnaire (65 men, 127 women; average age 49 years)

• Pre and Three Month Post treatment questionnaires were assessed

Salient features of MS questionnaire

• Physical function• Physical and emotional role limitations• Pain• Emotional well-being• Energy• Health perceptions• Cognitive, social and sexual function• Health distress• Overall quality of life

Salient features of MS questionnaire

• Changes in Quality of Life are measured • Two Subscores are calculated:

– Physical Health– Mental Health

• Composite score change >5 is considered significant

Results

The physical health composite score improved from 43.2 to 52.4 (p<0.05)

The mental health composite score improved from 57.1 to 65.2 (p<0.05)

MS Subtypes

• Primary Progressive (PP)- gradually progressive without remission (30 patients)

• Relapsing Remitting (RR)- unpredictable acute attacks quiescent intervals (96 patients)

• Secondary Progressive (SP)- once RR, now without periods of remission (66 patients)

Results and MS subtype

• Physical health improvement in greater than 75% with RR and PP MS

• Mental health improvement in greater than 70% with RR and PP MS

• Physical and mental health improvements were 59% and 50% respectively with SP MS

Results and Time Since MS Diagnosis

• Greater than 70-78% improvement if treatment performed within 10 years of diagnosis of MS

• 60-66% improvement when treated after 10 years after initial MS diagnosis

Conclusions

Endovascular treatment of CCSVI can produce significant, short-term improvements in the

quality of life of patients with Multiple Sclerosis

Conclusions

While these results are encouraging, they underscore the need for future prospective, double blinded studies to define the role of

endovascular therapy for the treatment of CCSVI and to understand possible implications

regarding patient selection.