Sistema ETD

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Tesi etd-06192017-102412

Tipo di tesi
Tesi di specializzazione (5 anni)
Percutaneous angioplasty of internal jugular and azygous veins in patients with chronic cerebrospinal venous insufficiency and multiple sclerosis: preliminary results for a randomized controlled trial
Corso di studi
relatore Prof. Caramella, Davide
correlatore Dott. Napoli, Vinicio
Parole chiave
  • internal jugular vein
  • multiple sclerosis
  • chronic cerebrospinal venous insufficiency
  • percutaneous angioplasty
Data inizio appello
Riassunto analitico
Purpose: The aims of this study are to assess the hemodynamic efficacy and safety of PTA in patients with CCSVI and MS, comparing the pressure values measurements obtained by venous catheterization (CV) in the three IJV segments (J1-J2-J3) and azygos vein before and after PTA, to the neurophysiopathological clinical parameters of multiple sclerosis.
Study design and methods: This is a Phase II multicentric pilot clinical, prospective, blinded randomized trial assessing the efficacy and safety of PTA. From December 2011 to November 2017, 55 patients with relapsing remitting MS (RR0=30), secondary progressive MS (SP1= 15) or primary progressive MS (PP2= 10), positive at color-doppler sonography (CDS) for at least two Zamboni criteria for CCSVI and a neurologist-confirmed diagnosis of MS, have been enrolled. After providing their informed consent they were admitted to our department and underwent diagnostic phlebography and endovascular treatment for CCSVI. Primary endpoints are (1) a quantitative evaluation of postoperative gradient pressure in the three IJV segments (J1-J2-J3) and azygos vein, (2) comparing them to the neurophysiopathological clinical parameters between two groups (group A Sperimental, n=31; group B Control, n=35) and different stages of MS (RR0=30) (SP1= 15) (PP2= 10). Procedural success and complications within 30 days have been included as secondary endpoints.
Results: Post-PTA angiographic control showed stenosis resolutions in all the patients. Postoperative gradient pressure measurements decreased in the three IJV segments (J1-J2-J3) and azygos vein with no statistical significance (p value: >0,05). No stents were ever implanted in the IJV. The feasibility rate was as high as 96,3% (2, 3,6% no catheterizable; 5, 9,1% Orthodromic access for performing PTA only on left jugular vein). Overall major and minor complication rates at 30 days were 0,05% and 0,02%, respectively. Clinical analysis not showed significantly improvement (or worsening) associated with the intervention between groups ( A, sperimental / B, control, p value >0,05), and different stages of MS (RR 0=30 p value >0,05) (SP1= 15, p value >0,05) (PP2= 10, p value >0,05).
Conclusion: Study’s aim is to assess the efficacy of PTA on CCSVI and MS patients’ functional disability. Endovascular treatment of the IJV is proven to be a safe procedure (major complication <0,05%) with no significant improvement of IJV flow haemodynamic parameters and clinical improvement in patients with CCSVI and MS. The study undoubtedly provided standardization of diagnostic protocols (ECDs) and angiographic (PTA), useful in possible future multicentric, blinded, randomized clinical trials.