Chronic cerebrospinal venous insufficiency controversy

Chronic cerebrospinal venous insufficiency
Veins of the neck. V.jugularis interna is proposed to be stenosed or have a malformed valve in CCSVI cases.
SpecialtyCardiology Edit this on Wikidata

Chronic cerebrospinal venous insufficiency (CCSVI or CCVI) is a term invented by Italian researcher Paolo Zamboni in 2008 to describe compromised flow of blood in the veins draining the central nervous system.[1][2] Zamboni hypothesized that it might play a role in the cause or development of multiple sclerosis (MS).[3][4] Zamboni also devised a surgical procedure which the media nicknamed a liberation procedure or liberation therapy, involving venoplasty or stenting of certain veins.[5] Zamboni's ideas about CCSVI are very controversial, with significantly more detractors than supporters, and any treatments based on his ideas are considered experimental.[6][7]

There is no scientific evidence that CCSVI is related to MS, and there is no good evidence that the surgery helps MS patients. Zamboni's first published research was neither blinded nor did it have a comparison group.[5] Zamboni also did not disclose his financial ties to Esaote, the manufacturer of the ultrasound specifically used in CCSVI diagnosis.[8] The "liberation procedure" has been criticized for possibly resulting in serious complications and deaths, while its purported benefits have not been proven.[5][7] In 2012, the United States Food and Drug Administration states that it is not clear if CCSVI exists as a clinical entity and that these treatments may cause more harm.[9] In 2017 they emphasized that this use of balloon angioplasty is not an approved use.[10] In a 2017 study Zamboni et al. stated "Venous PTA cannot be recommended for patients with relapsing-remitting multiple sclerosis."[11] In 2018 a study in Neurology concluded "Our data do not support the continued use of venoplasty of extracranial jugular and/or azygous venous narrowing to improve patient-reported outcomes, chronic MS symptoms, or the disease course of MS."[12]

Research on CCSVI was fast-tracked, but researchers have been unable to find a connection between CCSVI and MS.[13] This has raised serious objections to the hypothesis of CCSVI originating multiple sclerosis.[14] Additional research investigating the CCSVI hypothesis is underway.[15] A 2013 study found that CCSVI is equally rare in people with and without MS, while narrowing of the cervical veins is equally common.[16][17]

  1. ^ Cite error: The named reference pmid19060024 was invoked but never defined (see the help page).
  2. ^ Al-Omari MH, Rousan LA (April 2010). "Internal jugular vein morphology and hemodynamics in patients with multiple sclerosis". International Angiology. 29 (2): 115–20. PMID 20351667.
  3. ^ Khan O, Filippi M, Freedman MS, Barkhof F, Dore-Duffy P, Lassmann H, et al. (March 2010). "Chronic cerebrospinal venous insufficiency and multiple sclerosis". Annals of Neurology. 67 (3): 286–90. CiteSeerX 10.1.1.606.8269. doi:10.1002/ana.22001. PMID 20373339. S2CID 16580847. A chronic state of impaired venous drainage from the central nervous system, termed chronic cerebrospinal venous insufficiency (CCSVI), is claimed to be a pathologic phenomenon exclusively seen in multiple sclerosis (MS).
  4. ^ Lee AB, Laredo J, Neville R (April 2010). "Embryological background of truncular venous malformation in the extracranial venous pathways as the cause of chronic cerebro spinal venous insufficiency". International Angiology. 29 (2): 95–108. PMID 20351665. A similar condition involving the head and neck venous system may cause chronic cerebro-spinal venous insufficiency (CCSVI) and may be involved in the development or exacerbation of multiple sclerosis.
  5. ^ a b c Cite error: The named reference pmid20398855 was invoked but never defined (see the help page).
  6. ^ Ferral, Hector; Lorenz, Jonathan M. (13 April 2018). Radcases Interventional Radiology. Thieme Medical Publishers. ISBN 978-1-62623-283-9.
  7. ^ a b Cite error: The named reference pmid20186848 was invoked but never defined (see the help page).
  8. ^ Stone K (March 2012). "Medical device conflict of interest in the CCSVI debate". Annals of Neurology. 71 (3): A6-8. doi:10.1002/ana.23560. PMID 22451214. S2CID 205343879.
  9. ^ FDA (May 2012). "FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients". Food and Drug Administration. Retrieved 6 November 2013.
  10. ^ "Safety Alerts for Human Medical Products — Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication — FDA concern over experimental procedures". www.fda.gov. Retrieved 9 March 2017.
  11. ^ Zamboni P, Tesio L, Galimberti S, Massacesi L, Salvi F, D'Alessandro R, et al. (January 2018). "Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis: A Randomized Clinical Trial". JAMA Neurology. 75 (1): 35–43. doi:10.1001/jamaneurol.2017.3825. PMC 5833494. PMID 29150995.
  12. ^ Traboulsee AL, Machan L, Girard JM, Raymond J, Vosoughi R, Hardy BW, et al. (October 2018). "Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled phase II trial". Neurology. 91 (18): e1660–e1668. doi:10.1212/WNL.0000000000006423. PMC 6207414. PMID 30266886.
  13. ^ Cite error: The named reference pmid21161309 was invoked but never defined (see the help page).
  14. ^ Cite error: The named reference Dorne was invoked but never defined (see the help page).
  15. ^ Jagannath VA, Pucci E, Asokan GV, Robak EW (May 2019). "Percutaneous transluminal angioplasty for treatment of chronic cerebrospinal venous insufficiency (CCSVI) in people with multiple sclerosis". The Cochrane Database of Systematic Reviews. 5 (7): CD009903. doi:10.1002/14651858.CD009903.pub3. PMC 6543952. PMID 31150100.
  16. ^ Traboulsee AL, Knox KB, Machan L, Zhao Y, Yee I, Rauscher A, et al. (January 2014). "Prevalence of extracranial venous narrowing on catheter venography in people with multiple sclerosis, their siblings, and unrelated healthy controls: a blinded, case-control study". Lancet. 383 (9912): 138–45. doi:10.1016/S0140-6736(13)61747-X. PMID 24119384. S2CID 25925875.
  17. ^ Paul F, Wattjes MP (January 2014). "Chronic cerebrospinal venous insufficiency in multiple sclerosis: the final curtain". Lancet. 383 (9912): 106–8. doi:10.1016/S0140-6736(13)61912-1. PMID 24119383. S2CID 205970625. Archived from the original on 29 October 2019. Retrieved 29 October 2019.

© MMXXIII Rich X Search. We shall prevail. All rights reserved. Rich X Search