Summary of Findings from CCSVI Treatment in Merida, Mexico

Patients from all over Canada have come to Mérida, Yucatán; México seeking an unconventional treatment for multiple sclerosis (MS). Though the endovascular technique used to treat arteries and veins is nothing new; what is, is its use in venous alterations frequently seen in patients with MS.  Our team has performed “The Liberation Procedure” since June 11, 2010. Until the beginning of May 2011, we have had the opportunity to treat 209 patients. Each and everyone with their own unique history, familial and personal, affected in an array of aspects by MS. So it is obvious to think that results are different for everyone.

Right from the beginning, the venoplasty procedure was done in an ambulatory fashion, spending from 6 to 12 hours in a recovery room before discharge. Previous to the procedure an IV line was inserted and a urinary catheter was placed either before or under sedation/anesthesia, and stayed in place either until discharge or when the patient began to be ambulatory after 5 hours of bedrest. Sedation was used in all but 5 patients.

General anesthesia was used for the following reasons:

• Three patients needed endovenous anesthesia and a laryngeal mask due to agitation.


• One patient required surgical intervention to remove a balloon fragment through a neck incision over the right jugular vein.


• One patient bled from a small branch of the external jugular vein that could not be stopped with compression so, a neck incision was made to suture the bleeding vein on the left side of the neck.

These last two patients account for the only two notable complications in the report and were discharged 48 hours after admittance.

The protocol followed has evolved and changed with time.

Imaging Tools

Magnetic resonance venography (MRV) of vertebral and jugular veins was performed pre and postoperatively in the first cases. Then MRV was substituted for Doppler Ultrasound (DUS) in the postoperative follow-up. Eventually the pre-op MRV was also substituted by DUS in December 2010. These changes were done in accordance to evidence in medical literature. All post-op DUS were performed 24 to 72 hours after the procedure.

Pre-operative  

Routine pre-op blood samples were taken in every patient. A vascular neurologist consultation and application of the Extended Disability Status Scale  (EDSS)  was possible  in 90% of the patients. An intravenous (IV) line was placed in all patients.

Technical aspects of the procedure

Right femoral vein access in the groin was used in 99% of the patients. An 11 Fr. Introducer, a 0.035” guidewire  and a 4 or 5 Fr. Headhunter catheter were used for the venography of  both jugular veins, the azygos vein and selectively on the vertebral veins. Balloon sizes ranged from 6 x 40 mm. to 20 x 40 mm. None of the balloons were inflated to pressures over the burst pressure. High pressure balloons that reach up to 22 atmospheres (ATM) were used routinely starting on the third month of doing the procedure.  From the first procedure through the first 5 months, 3000 to 4000 IU of heparin were given IV immediately following  the insertion of the introducer and a prophylactic single dose of Enoxaparine (40-60 mg.) was given 3 to 5 hours after the IV heparin. Beginning in month 6 of the procedure,  the fixed dose of IV heparin was switched to weight adjusted  dose (70 IU /Kg).   The angioplasty balloon was chosen according to calibrated measurements of the venographic images. The balloons chosen were 40% to 80% oversize the stenosed vein segment but never larger than the non-stenosed or “normal” portion of the same vein.  The balloons were inflated to the established-by-fabricant burst pressure for 1 to 3 minutes and repeated as necessary. More than one balloon size was used in 70% of the patients. A control venography was done in every case before the introducer was removed and hand compression was performed. A gauze pack and elastic tape was left in the puncture site until removal the following day.

Post-op

At discharge from the hospital the patient was recommended to take Clopidogrel 75 mg a day or 81 mg enteric coated Aspirin® if allergic for 6 months. Postoperative DUS was done in all patients beginning month 5 (November, 2010) when MRV was substituted pre-operatively. It was then that small blood clots were being seen on the DUS 12 to 72 hours after the procedure. Accordingly,  the IV heparin dose was modified and selective use of Rivaroxaban 10 mg (Xarelto®) a day was given starting the day the blood clots were evident and continued for 15 to 20 days. Starting January of 2011, Rivaroxaban 10 mg (Xarelto®) was given to every patient daily starting the day of the procedure and continued for 15 to 20 days and then switched to 81 mg enteric coated Aspirin® for 6 months. The evidence of early blood clots seen on the DUS reduced to 0% with these measures. None of the patients showed occlusive thrombus before or after IV heparin adjustment and the use of Rivaroxaban . A flavonoid (diosmine hesperidine 500-100 mg.) supplement was also introduced to the recommendations around the same date. Clopidogrel has been substituted by Aspirin®since no difference in outcomes were noticed.

Results

Of the 209 patients, 70 were men and 139 female.  The male: female ratio was 1:3. Ages ranged from 16 to 75 years with an average of 51 years. 33% of the patients were on MS modifying drugs within 30 days of the procedure date. Sensibility alterations in extremities followed by bladder/bowel disorders, balance affectation and fatigue were the most prevalent symptoms, present in more than 50% of the patients. Patients were confined to a wheelchair in 31% of cases, 25% had no mobility limitations and the remaining 44% needed either crutches, a walker and/or a cane to move. All patients had at least one vein treated and 56% had all 3 (both jugulars and azygos) treated with venoplasty. In one patient, a second venoplasty was done 7 months after his initial treatment due to relapse in symptoms that were partially relieved in the first procedure. The EDSS was obtained in 90% of the patients before and 24 hours after the procedure took place. MS types were distributed in Primary Progressive in 17% of patients, Secondary Progressive in 41%, Relapsing-Remitting in 35% and 7% had Relapsing-Progressive type. Overall complication rates were 3.8% of which 1% (2 patients) was considered major complications. One patient needed surgery for balloon rupture and balloon fragment extraction in the neck and another patient required suture of a small bleeding branch of the external jugular vein. Leakage of contrast media after venoplasty or catheter positioning was seen in almost 3% of the patients. All leaks were self-contained and asymptomatic. No special follow-up was done. Patients were recommended to continue aspirin 81mg therapy for 6 months. Repeat DUS at 6 months or with relapse of previously improved symptoms. Restenosis rate for patients previously treated is 4% per follow-up DUS.

Summary of Findings

Since the origination of our CCSVI treatment program in Merida, Mexico in June, 2010, we have altered our screening protocol to included only pre and post Doppler ultrasound. We are currently using conscious sedation with the aforementioned guidewires and introducers and applicable balloon sizes. Post-op, patients are receiving Aspirin therapy, physiotherapy and flavonoids for 6 months minimum.  In addition, a CCSVI Post-Treatment Survey was administered at 30, 90, and 180 days recording symptoms including:

• fatigue


• headache


• working memory


• hot/cold intolerance


• quality of sleep


• mobility


• sensibility in extremities (numbness, tingling, and electric shock)


• balance/coordination