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QOL and EDSS Variations after Percutaneous Transluminal Angioplasty in
170 MS Patients with CCSVI.
M. Magnano
Purpose: In spite of the lack of confirmed data on the real value of transluminal
angioplasty for the treatment of multiple sclerosis (MS) symptoms in patients with
positive chronic cerebrospinal venous insufficiency (CCSVI) after an ultrasound duplex
scan, many patients have received angioplasty treatment in several countries. The
purpose of this study is to evaluate the patient’s perceived improvement of quality of
life (QOL) after angioplasty using the QOL scale and independent objective evaluation
using expanded disability status scale (EDSS).
Materials and Methods: Since October 2010, >380 MS patients with an ultrasound
color duplex scan of CCSVI underwent jugular and azygos percutaneous transluminal
angioplasty in our institution. There were 170 patients of this series evaluated before
the treatment and then after 1 and 3 months. The median age of patients was 34 years
and median EDSS was 4.5 (minimum, 3; maximum, 8 ). An independent physician (not
neurologist, but experienced general practitioner) evaluated the disability scale using the
EDSS scale; and the patients completed a 16-item questionnaire (QOL questionnaire),
which provided a score from 7 (best) to 1 (worst). The questionnaire was collected and
saved anonymously, and in random order.
Results: We calculated the median EDSS value of the 170 patients before the treatment,
after 1 month, and after 3 months; values were 4.5,, and 4, respectively, with bigger
variations on subtypes (severe EDSS demonstrated minor changes). QOL averages
demonstrated a total score of 640 before percutaneous transluminal angioplasty, a score
of 696 after 1 month, and a score of 710 after 3 months; bigger variations on lesser
disability were noted. We are collecting data on 6-month follow-up.
Conclusions: We conclude that MS patients with a diagnosis of CCSVI who are
treated with angioplasty can obtain a slight improvement on disability scale, especially
in EDSS below 7, and somewhat improves the patient’s perceived QOL scale at least
for a 3-month period after the treatment. A longer observation time and a control group
are strongly needed to confirm these data.
Complications and Safety of Jugular and Azygos Angioplasty in CCSVI
Patients with MS.
M. Magnano
Purpose: In spite of the lack of confirmed data on the real value of transluminal
angioplasty for the treatment of MS symptoms in patients reported positive to chronic
cerebrospinal venous insufficiency (CCSVI) with ultrasound duplex scan, many patients
have been so far treated in many countries. Purpose of this study is to evaluate the
safety of procedure.
Materials and Methods: In our institution we have performed 380 jugular
angioplasties since November 2010 on 380 patients, mostly (85%) bilateral. 20% of
patients had also azygos angioplasty in the same session. All patients were MS patients
symptomatic. CSI patients were not included. Age was from 19 years old to 65 years
old. All patients were diagnosed CCSVI using ultrasound color duplex scan using the
so called “Zamboni method” with at least 2 points positive out of 5 on the Venous
Hemodynamic Insufficiency Severity Score scale. In our patient series there was no
known coagulation disease or vasculitis or other known venous abnormalities other than
the CCSVI. We performed in all patients venous access using 8F introducer in 90% of
cases in the left groin. Phlebography of left iliac, iliolumbar, renal, azygos, vertebrale,
and internal jugular vein performed in all patients. Angioplasty was performed using
semi compliant high pressure balloons. All patients were administered low-molecularweight
(LMW) heparin for 3 weeks and included in a follow up program with ultrasound
duplex scan after 1 month and 3 months.
Results: The complications reported were mainly in the access site (25 local hematoma
not needing any further surgery, 1 case severe hematoma with skin ulcer probably due
to long compression, 1 case long thrombosis of common iliac vein in the access side
with pulmonary embolism needing long hospitalization and long anti-coagulating
therapy) and in the jugular district (8 cases subacute thrombosis that were treated
with prolonged LMW heparin for 2 months). We discovered that thrombosis was more
common when using oversized balloons. We never observed venous rupture both in
jugular and azygos district.
Conclusions: We concluded that CCSVI is a safe procedure with a low complication
rate and no mortality rate. We suggest to not oversize balloon diameter, specially on
hypoplastic veins.
I love ISET! And SIR and ISNVD and the symposium that Dr. Sclafani puts on. Anytime when the researchers come together and share what they've been finding.
These patients in Dr. Magnano's study must have been local patients. All 170 patients had follow-up, which is something we've been sorely needing data on.