CCSVI November


MSResearch#; #CCSVI Trials maybe doomed to fail

Kazibudzki M, Latacz P, Ludyga T, Simka M. Efficacy and safety of cutting balloons for the treatment of obstructive lesions in the internal jugular veins. J Cardiovasc Surg (Torino). 2013 Oct 24. [Epub ahead of print]

Aim: In this technical note we present the results of endovascular treatment for chronic cerebrospinal venous insufficiency with the use of cutting balloons, with focus on feasibility and safety of these endovascular devices. 
Methods: We used cutting balloons during 70 procedures in 65 multiple sclerosis patients presenting with strictures of the internal jugular veins, primarily at the level of jugular valves. These devices were used only in selected cases, following unsuccessful standard balloon angioplasty, and on condition that commercially available devices could be applied (currently they are maximally 8 mm in diameter). 

Results: In all cases the perioperative course was uneventful, with no serious adverse events. Immediate technical success rate was 94.3%. In four cases (5.7%) cutting-balloon angioplasty alone was unsuccessful and stents were implanted. Primary, assisted primary and secondary patency rates after 6 months were: 94%, 98.5%, and 98.5%, respectively. Follow-up has revealed that out of the remaining 66 angioplasties four procedures failed (failure rate: 6.1%): in two patients stents were implanted, in one patient successful redo cutting-balloon angioplasty was performed, while in another case the treated segment of jugular vein totally occluded and was not feasible to reopen endovascularly. 
Conclusion: Cutting balloons can be safely used for the management of stenosed internal jugular veins. These devices can replace stents in the majority of cases, especially if standard balloon angioplasty is insufficient to restore proper outflow. However, the use of cutting balloons in this particular venous territory is limited by the fact that currently only small diameter devices are available.

A cutting balloon- It has a special balloon tip with small blades, that are activated when the balloon is inflated. Our advice is only to do this as part of a controlled trial until the process is of proven benefit.

Diaconu CI, Fox RJ, Grattan A, Rae-Grant A, Lu M, Gornik HL, Kim ES. Hydration status substantially affects chronic cerebrospinal venous insufficiency assessments. Neurol Clin Pract. 2013;3:386-391.

We sought to determine the effect of hydration on the criteria for chronic cerebrospinal venous insufficiency (CCSVI), a proposed hypothesis for the aetiology of multiple sclerosis (MS). Sixteen subjects (11 MS and 5 controls) were asked to fast overnight. The following morning, 2 CCSVI ultrasound examinations were performed: 1 in the mildly dehydrated state, and another 30-45 minutes after rehydrating with 1.5 L of Gatorade. Seven subjects fulfilled CCSVI criteria in the dehydrated state. Of these, 5 (71%) no longer fulfilled CCSVI criteria after rehydration. One additional subject met CCSVI criteria only after rehydration. Hydration status has a substantial effect on CCSVI criteria, suggesting that the sonographic findings of CCSVI may represent a physiologic rather than pathologic state.

Oops maybe having a drink of water or not can affect whether you have CCSVI or not.  So nt surprising that some people question the existence of this

BACKGROUND: Normally, chronic cerebrospinal venous insufficiency (CCSVI) has been studied using echo-colour Doppler (ECD). Subjects are examined in the supine and sitting positions, in accordance with a static protocol without rotation of the head. A dynamic approach, to assess venous sizes with different degrees of head rotation, has only been performed to improve jugular venous catheterisation. These echographic studies have suggested that head rotation to the contralateral side increases the cross-sectional area (CSA) of the internal jugular veins (IJVs) in supine subjects. Our goal was to evaluate the behaviour of CSA of the IJVs during supine head rotation in multiple sclerosis (MS) patients with CCSVI, compared to healthy controls (HCs).
METHODS: The IJVs of 313 MS patients with CCSVI (male 43.7%, male/female 137/176; mean age 45 years old, range 19–77 years) and 298 HCs, matched by gender (male 43.6%, male/female 130/168) and age (mean age 46 years old, range 20–79 years), were compared using ECD. Their CSAs were evaluated with the subjects seated in a tiltable chair, first in the supine position at the level of the cricoid cartilage, with the head in a neutral position, and then after contralateral rotation to 90[degree sign] from midline.
RESULTS: Significant differences between the jugular CSAs before and after head rotation were observed only in the MS patients for the IJVs with wall collapse (F[6,1215] = 6414.57, p < 0.001), showing on longitudinal scans a typical “hourglass” aspect that we defined as “miopragic”. No significant difference was found in the distribution of these miopragic veins with regard to MS duration. There was a strong association between the CCSVI scores and the complexity of jugular morphological types (Chi2 [9, N = 313] = 75.183, p < 0.001). Wall miopragia was mainly observed in MS patients with SP (59.3%) and PP (70.0%) clinical forms, compared to RR (48.3%) forms (p = 0.015).
CONCLUSION: A dynamic ECD approach allowed us to detect IJVs with a significant increase in their CSAs during head rotation, but only in MS subjects. This feature, most likely the expression of congenital wall miopragia, could be secondary to dysregulation of collagen synthesis, but further histochemical studies will be needed to confirm this hypothesis.

Barkhof F, Wattjes MP. Multiple sclerosis: CCSVI deconstructed and discarded. Nat Rev Neurol. 2013 Nov 12. doi: 10.1038/nrneurol.2013.228. [Epub ahead of print]

Neurologists have had enough of this where are others may take a different tack see below

Alexander MD, McTaggart RA, Choudhri OA, Marcellus ML, Do HM. Percutaneous sclerotherapy with ethanolamine oleate for venous malformations of the head and neck. J Neurointerv Surg. 2013 Nov 14. doi: 10.1136/neurintsurg-2013-010924. [Epub ahead of print]

INTRODUCTIONVenous malformations frequently occur in the head and neck, and they can require treatment for a variety of reasons. Amongmultiple therapeutic approaches employed, percutaneous sclerotherapy has become one of the most commonly used treatments, with numerous sclerosants successfully utilized. Ethanolamine oleate has approval from the Food and Drug Administration for sclerosis of esophageal varices, and is used by some practitioners for the treatment of venous malformations. This study reports single center results of percutaneous sclerotherapy with ethanolamine oleate to treat venous malformations of the head and neck.
MATERIALS AND METHODS: Prospectively maintained procedural records were retrospectively reviewed to identify all patients with venous malformations who underwent percutaneous sclerotherapy. The Mulliken and Glowacki classification was used to diagnose venous malformations. Medical records and images were reviewed to record demographic information, lesion characteristics, treatment sessions, and clinical and imaging response. Quantitative volumetric analysis was conducted to augment commonly used poorly reproducible subjective outcome measures. Response was assessed after each session and completion of all percutaneous treatment. A χ2 analysis was performed to evaluate the effects of the above described characteristics on outcomes.
RESULTS: 52 interventions were performed for lesions in 26 patients. No complications occurred following any procedures. Response to individual sessions was categorized as excellent following two (3.8%) sessions, good following 45 (86.5%), and fair following four (7.7%) session. No sessions resulted in poor responses. Final results were excellent in two patients (7.7%), good in 22 (84.6%), and fair in two (7.7%). Average lesion volume reduction was 39% following each session, and 61% after treatment completion. Periorbital lesions were significantly less likely than lesions located elsewhere to have good or excellent outcomes. No other lesion or demographic features affected outcomes.
CONCLUSIONS: Percutaneous sclerotherapy with ethanolamine oleate appears to be safe and effective for the treatment of venous malformations and should be considered when treating these complex lesions. The efficacy of this agent appears to match or exceed that of other sclerosants used for such treatment, and further investigation in prospective controlled research is warranted

Further studies are warrant then let the people do them 

Sternberg Z, Grewal P, Cen S, Debarge-Igoe F, Yu J, Arata M.
Blood pressure normalization post-jugular venous balloon angioplasty. Phlebology. 2013 Nov . [Epub ahead of print]

OBJECTIVE: This study is the first in a series investigating the relationship between autonomic nervous system (controls involuntary body activities) dysfunction and chronic cerebrospinal venous insufficiency in multiple sclerosis patients. We screened patients for the combined presence of the narrowing of the internal jugular veins and symptoms of autonomic nervous system dysfunction (fatigue, cognitive dysfunction, sleeping disorders, headache, thermal intolerance, bowel/bladder dysfunction) and determined systolic and diastolic blood pressure responses to balloon angioplasty.

METHODS: The criteria for eligibility for balloon angioplasty intervention included ≥50% narrowing in one or both internal jugular veins, as determined by the magnetic resonance venography, and ≥3 clinical symptoms of autonomic nervous system dysfunction. Blood pressure was measured at baseline and post-balloon angioplasty.
RESULTS: Among patients who were screened, 91% were identified as having internal jugular veins narrowing (with obstructing lesions) combined with the presence of three or more symptoms of autonomic nervous system dysfunction. Balloon angioplasty reduced the average systolic and diastolic blood pressure. However, blood pressure categorization showed a biphasic response to balloon angioplasty. The procedure increased blood pressure in multiple sclerosis patients who presented with baseline blood pressure within lower limits of normal ranges (systolic ≤105 mmHg, diastolic ≤70 mmHg) but decreased blood pressure in patients with baseline blood pressure above normal ranges (systolic ≥130 mmHg, diastolic ≥ 80 mmHg). In addition, gender differences in baseline blood pressure subcategories were observed.
DISCUSSION: The coexistence of internal jugular veins narrowing and symptoms of autonomic nervous system dysfunction suggests that the two phenomena may be related. Balloon angioplasty corrects blood pressure deviation in multiple sclerosis patients undergoing internal jugular vein dilation. Further studies should investigate the association between blood pressure deviation and internal jugular veins narrowing, and whether blood pressure normalization affects Patient’s clinical outcomes.

What we want to know is, Is this treatment good for symptom control?

Tromba L, Blasi S, Vestri A, Kiltzanidi D, Tartaglia F, Redler A.Prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: a blinded sonographic evaluation.Phlebology. 2013 Nov . [Epub ahead of print]

OBJECTIVES: To verify the prevalence of chronic cerebrospinal venous insufficiency in patients affected by different clinical forms of multiple sclerosis and in healthy subjects using the Zamboni ultrasound protocol combined with M-mode ultrasound examination.

MATERIALS AND METHODS: We enrolled 112 patients with multiple sclerosis and 67 healthy subjects from 20 to 67 years of age. All the patients underwent Duplex and color-Doppler sonography of the neck vessels, transcranial colour duplex sonography, M-mode study of the valve system and of venous abnormalities. Subjects were positive for chronic cerebrospinal venous insufficiency when at least two of five hemodynamic criteria of the Zamboni protocol were fulfilled. Chronic cerebrospinal venous insufficiency condition was further analyzed by a multivariate analysis including age, sex, disease duration, subtypes of multiple sclerosis and expanded disability status scale score as independent variables.
RESULTS: No healthy subjects was positive for chronic cerebrospinal venous insufficiency, while in the sample of patients affected by multiple sclerosis the diagnosis was made in 59.8% of cases (p < 0.0001). The first criterion was the most frequent in patients affected by multiple sclerosisand chronic cerebrospinal venous insufficiency (respectively 54.4% and 76.1%, p < 0.001). The second, third and fourth criteria were never present in healthy subjects but were detected in patients with multiple sclerosis. The positivity of the second criterion was associated with diagnosis of chronic cerebrospinal venous insufficiency in 100% of cases. The third criterion had a prevalence of 52.2% in the subgroup of chronic cerebrospinal venous insufficiency patients. It was positive in 36 multiple sclerosis patients and was associated with chronic cerebrospinal venous insufficiency diagnosis in all cases except one.The multivariate analysis showed that age, disease duration, sex, subtypes of multiple sclerosis and expanded disability status scale score were not considered predictors of this haemodynamic condition.
CONCLUSION: Chronic cerebrospinal venous insufficiency is a haemodynamic condition strongly associated with multiple sclerosis and is not found in normal controls. The addition of M-mode ultrasound to the diagnostic protocol allows improved observation of venous valve abnormalities.

The plot twists yet again some people agree with Zamboni  with a 100% v 0% in healthy controls, so now we look at other peoples experiences

Leone MA, Raymkulova O, Lucenti A, Stecco A, Bolamperti L, Coppo L, Liboni W, Rivadossi G, Zaccala G, Maggio M, Melis F, Giaccone C, Carriero A, Lochner P. A reliability study of colour-Doppler sonography for the diagnosis of chronic cerebrospinal venous insufficiency shows low inter-rater agreement. BMJ Open. 2013 Nov 15;3(11):e003508. doi: 10.1136/bmjopen-2013-003508.

OBJECTIVE: Chronic cerebrospinal venous insufficiency (CCSVI) has been extremely variable, associated with multiple sclerosis in colour-Doppler sonographic studies. We aimed to evaluate inter-rater agreement in a colour-Doppler sonography venous examination.
PARTICIPANTS: 38 patients with multiple sclerosis and 55 age-matched (±5 years) controls.
INTERVENTION: Sonography was carried out in accordance with Zamboni’s five criteria by eight sonographers with different expertise, blinded to the status of cases and controls. Each participant was evaluated by two operators.
RESULTS: The agreement was no higher than chance for criterion 2-reflux in the deep cerebral veins and criterion 4-flow not Doppler detectable in one or both the internal jugular veins (IJVs) or vertebral veins (VVs; -0.09). It was substantially low for criterion 1-reflux in the IJVs and/or VVs (0.29), criterion 3-IJV stenosis or malformations (0.23) and criterion 5-absence of IJV diameter increase when passing from the sitting to the supine position (0.22). The κ value for CCSVI as a whole was 0.20 (95% confidence limit -0.01 to 0.42). Intraclass correlation coefficients for the measure of cross-sectional area ranged from 0.05 to 0.25. Inter-rater agreement was low for CCSVI experts (κ=0.24; -0.11 to 0.59) and non-experts (0.20; -0.33 to 0.73); neurologists (0.21; -0.06 to 0.47) and non-neurologists (0.18; -0.20 to 0.56); cases (0.19; -0.14 to 0.52) and controls (0.21; -0.08 to 0.49). Zamboni-trained neurosonographers ascertained CCSVI more frequently than the non-trained neurosonographers.
CONCLUSIONS: Agreement was unsatisfactory for the diagnosis of CCSVI as a whole, for each of its five criteria and according to the different subgroups. Standardisation of the method is urgently needed prior to its further application in studies of patients with multiple sclerosis or other neurological diseases.

There is not agreement between individuals, so the specificity of the test is very low. This is failing the smack you in the eye test i.e if you cant obviously see the difference is it really there. However the post below is even more damming

Van den Berg PJ, Visser LH The Fluctuating Natural Course of CCSVI in MS Patients and Controls, a Prospective Follow-Up. PLoS One. 2013 Nov ;8(11):e78166.

OBJECTIVES: A new treatable venous disorder, chronic cerebrospinal venous insufficiency (CCSVI), has been proposed in patients with multiple sclerosis. The natural course of CCSVI has not been examined yet. This is crucial given the fact that surgical procedures are increasingly offered to MS patients to treat venous stenosis.

METHODS: To document the natural course of venous haemodynamics we performed extra- and transcranial echo colour Doppler (ECD) in 52 multiple sclerosis patients and 28 healthy controls (HC) and re-examined this group after a median period of 16 weeks. The reexamination was done being blinded to the initial findings and the patients did not undergo any intervention.
RESULTS: The ECD examination at baseline showed CCSVI in 5 (9.6%) of the 52 multiple sclerosis patients and 0 HC (P = 0.26). At follow-up the diagnosis CCSVI could not be reconfirmed in 3 out of 5 patients at follow-up, while 2 new CCSVI-positive multiple sclerosis patients were detected.
CONCLUSIONS: ECD examination shows a fluctuating natural course of the extracranial venous haemodynamics, which makes determination of CCSVI by ECD examination unreliable.

Oh Dear this suggests that clinical trials will be meaningless because if CCSVI is here one minute and gone the next then how can you do proper studies….you can’t.

Ciciarello F, Mandolesi S, Galeandro AI, Marceca A, Rossi M, Fedele F, Gesualdo M, Cortese F, Zito A, Federico F, Livrea P, Trojano M, Scicchitano P, Ciccone MM. Age-Related Vascular Differences Among Patients Suffering from Multiple Sclerosis. Curr Neurovasc Res. 2013 Nov 24. [Epub ahead of print]

The aim of our study was to analyze morphological and functional aspects of cerebral veins by mean of eco-color-Doppler in young (i.e., ≤30 years old) and older (i.e., >30 years old) patients suffering from multiple sclerosis. 552 multiple sclerosis patients were evaluated by mean of a dedicated Echo-Color-Doppler support (MyLab Vinco echo-color Doppler System, Esaote), in both supine and sitting positions. 458 (83%) showed alterations in their morphological and functional structures of cerebral veins and were divided in two different groups: 1) ≤30 (110 patients) and 2) >30 years old (348 patients). Young patients showed a statistically significant higher number of both haemodinamically (44% vs 35%, p<0.01) and non-haemodinamically (51% vs 45%, p<0.05) significant stenosis in the internal jugular veins. A lower percentage of young patients showed blocked outflow in the cervical veins (50% vs 65%, p<0.01) as compared to older. Patients >30 years old outlined a significant higher disability degree (Expanded Disability Status Scale score: 5 vs 3, p<0.01) as well as higher disease duration (12 vs 5 months, p<0.01) than younger. No differences could be outlined about multiple sclerosis clinical form of the disease. Young and adult groups are different kind of patients, the former showing much more cerebral veins stenosis and blocked flow in internal jugular veins and vertebral veins than the latter. Duration of disease could explain such differences: the higher the diseases duration, the higher the degree of vascular alterations and, therefore, the disability degree. This could be due to the complex venous hemodynamic impairments induced by the alterations in vascular walls: the blocked or difficult blood flow through stenosis could increase the hydrostatic pressure in the skull and this could induce cerebral cells damages that could lead to the genesis of more advanced morphological abnormalities. Furthermore, the vessels’ alterations could impair venous endothelial functions which could turn in a possible alteration of the controls of cerebral vein return which could worsen the cerebral vascular outflow. 

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