plethysmography neck collars (Zamboni)

[Cece]

Dr. Beggs presented on plethysmography at the 2013 ISNVD http://isnvd2013.euromedicpoland.com/us ... tracts.pdf

INTERPRETATION OF CERVICAL PLETHYSMOGRAPHY DATA WITH RESPECT TO THE
DIAGNOSIS OF CHRONIC CEREBROSPINAL VENOUS INSUFFICIENCY

Clive Beggs, PhD, Simon Shepherd, PhD, Erica Menegatti, PhD, Paolo Conforti, MD, Mirko Tessari, RVT and Paolo Zamboni, MD

1Medical Biophysics Laboratory, University of Bradford, Richmond Road, West Yorkshire, Bradford, UK
2Vascular Diseases Centre, University of Ferrara, Ferrara, Italy

ABSTRACT:
Introduction
There is considerable debate regarding the applicability of magnetic resonance imaging and echo color Doppler (ECD) scan techniques for assessing cerebral venous return [1]. This has generated much scientific controversy regarding the diagnosis of chronic cerebrospinal venous insufficiency (CCSVI) [2, 3], which is characterized by restricted venous outflow from the brain. It is however possible to assess cerebral venous return in relation to the change in a subject’s position by means of a novel cervical plethysmography method, which utilizes a passive straingauge collar [4]. While the new cervical plethysmography technique has great potential as a low cost diagnostic tool for CCSVI, much remains unknown about the haemodynamics associated with this procedure. The aim of this study was therefore to gain a deeper understanding of the observed haemodynamics associated with this new diagnostic tool.

Materials & Methods
In a single-center, cross-sectional, blinded case-control study, 40 healthy controls and 44 CCSVI patients underwent cervical plethysmography. All participants were previously scanned using ECD sonography and separated into two subsets, a control group and a CCSVI group. The plethysmography procedure involved placing a strain-gauge collar around the subjects’ necks and tipping them from the upright (90°) to supine position (0°) in a chair. Once stabilized, they were returned to the upright position, allowing blood to drain from the neck. Measured outcomes included venous volume (VV), filling time (FT), filling gradient (FG) required to achieve 90% of VV, residual volume (RV), emptying time (ET), and emptying gradient (EG) required to achieve 90% of emptying volume (EV), where EV=VV-RV. A novel mathematical model was developed to calculate the hydraulic resistance of the extracranial venous system for each subject in the study [5].

Results
The rate at which venous blood discharged in the vertical position (EG) was significantly faster in the controls (2.73 mL/second ± 1.63) compared with the patients with CCSVI (1.73 mL/second ± 0.94; P = 0.001). In addition, respectively, in controls and in patients with CCSVI, the following parameters were highly significantly different: FT 5.81 ± 1.99 seconds vs 4.45 ± 2.16 seconds (P = 0.003); FG 0.92 ± 0.45 mL/second vs 1.50 ± 0.85 mL/second (P < 0.001); RV 0.54 ± 1.31 mL vs 1.37 ± 1.34 mL (P = 0.005); ET 1.84 ± 0.54 seconds vs 2.66 ± 0.95 seconds (P < 0.001). The mean hydraulic resistance of the extracranial venous system was 10.28 (SD 5.14) mmHg.s/mL in the healthy controls and 16.81 (SD 9.22) in the CCSVI patients (p<0.001).

Conclusion
Cerebral venous return haemodynamics of the patients with CCSVI were markedly different from those of the controls, with the hydraulic resistance of the CCSVI patients being on average 63.5% greater in the CCSVI patients. As such, this appears to corroborate Monti et al [6], who found reduced cerebral venous outflow in the upright position to be strongly associated (p<0.0001) with MS. Given that CCSVI has been shown by many researchers to be associated with MS [7-9], this suggests the presence of abnormal cerebral venous drainage hydrodynamics in many patients with MS [6]. Furthermore, the results suggest that cervical plethysmography has great potential as an inexpensive screening device and as a postoperative monitoring tool.

[NZer1]

YES!
This is wait I have been waiting to hear!
My dream or Goal is to buy one of the Chairs and test equipment and go on the Road around NZ and test PwMS and other de-generative diseases and achieve a ground swell of 'reaction' to the results and accelerate the treatment possibility in NZ!!!!!!!!!

Happy Day, ;)
Nigel

[PointsNorth]

Nigel,

You'll first have to get yer PNC Operator's license!

Points

[NZer1]

Thanks PN

I heard through the grape vine that they made it idiot proof, so I'm in!

;)
Nigel

[MarkW]

Has anyone seen a price for a chair and neck collar??? If we had 3 in GB (say Bradford, Glasgow, Oxford) we could cover the most of the MS population within a 3 hour drive. I am serious, if they are idiot proof I think we could find premises to do the test.
MarkW

[Anonymoose]

I'm getting a visual. Please invite a film crew to follow you and make a documentary.

[Cece]

Wouldn't there be liability? The UK might be less litigious than the US.
The test involves having people lie down and then be jerked to an upright position. That would have to be done safely. There is the positioning of the collar itself around the neck which could be done too tightly. A medical professional would need to be involved.

I don't know the price or if a plethysmography machine is something that is already in existence at hospitals or clinics. If we get more research supporting it, or even if we don't, I could see it coming into use at the CCSVI clinics. For marketing, it would be something to set a clinic apart from other clinics.

I would be very curious to see where I would fall on the spectrum between CCSVI and normal for plethysmography results.

[NZer1]

I have a personal goal, and I want to procure, somehow, one of Dr Zamboni's machines and travel our country (NZ) with it to create a ground swell of 'people' of many de-generative diseases and others that will move the Vascular Knowledge ahead.

Numbers of people with ill health and some technical data will move mountains!

;)
Nigel

[thisisalex]

I am really curious about the availablity and price of this machine. Do we know something about it? Is there a plan to sell a few machine to every country? I definitely would by one for the hungarian doctors....

[ErikaSlovakia]

I am really curious about the availablity and price of this machine. Do we know something about it? Is there a plan to sell a few machine to every country? I definitely would by one for the hungarian doctors....

Hi Alex!
Yes, at least one would be necessary for Slovakia as well.
Erika

[MarkW]

Wouldn't there be liability? The UK might be less litigious than the US.
The test involves having people lie down and then be jerked to an upright position. That would have to be done safely. There is the positioning of the collar itself around the neck which could be done too tightly. A medical professional would need to be involved.
I don't know the price or if a plethysmography machine is something that is already in existence at hospitals or clinics. If we get more research supporting it, or even if we don't, I could see it coming into use at the CCSVI clinics. For marketing, it would be something to set a clinic apart from other clinics.
I would be very curious to see where I would fall on the spectrum between CCSVI and normal for plethysmography results.

Hello Cece,
I was thinking of EHC in Glasgow, Dr Beggs in Bradford and OMSTC near Oxford (www.omstc.org). At OMSTC we offer therapies from medical professionals already. I do not see any problem with insurance as the procedure is non invasive. I do not understand why you used the term 'jerked'. I read the phrase 'once stabilized' in the abstract. I see a gentle tipping from vertical to horizontal and back again. A few readings would be taken in each position, so they could be averaged and checked for variation. Do you have any info on the type of 'medical professional' to do this test ?? If this screening test could be proven to be reliable and was available without too much travel (eg 3 centres in GB) I think there would be real demand from pwMS in Great Britain. I see this as a cheap screening test (like having a blood pressure test and a body mass index in a pharmacy). If you fall into the CCSVI group you need to find an expert in de-stenosis to get the problem sorted out which is expensive if you are self paying. The neck collar test would be a check up say every 3 or 6 months after the de-stenosis procedure.
So my big questions are: how much is a neck collar ?? Is the tipping chair special ?? I am not sure who knows.
Kind regards,
MarkW

[1eye]

I like Nigel's idea. He should have a documentary film made showing peoples' reactions as the person with 'MS' and their healthy friends, co-workers, and care-givers are tested.

Those discovered by this test to be positive for CCSVI can then either have a DUS, a Haacke venogram, or go straight into venography with or without other optional venoplasty components depending on the doctor's recommendation.

Maybe such a documentary should start by interviewing key people like Dr. Beggs.

This is very good to read about

[Cece]

I am as excited about plethysmography as the day I first heard about the concept as applied to CCSVI.
Dr. Zamboni's presentation at ISNVD 2014 was on the topic of plethysmography.
To quote from the CCSVI Alliance facebook page:

People with MS have double the time of clearance of blood from the brain back to the heart compared to normals--because venous outlets are restricted. His group is close to bringing this means of measurement to other research labs, hopefully by summer 2014.

Double the clearance time!
Bring plethysmography to other research labs!
Even in 2014, years after this began, we still need to establish CCSVI as real and as abnormal and as worthy of treatment. Plethysmography may be the tool to do this. Yay.

[NZer1]

I still want to get one of these and travel the country and test as many PwMS as are willing and publish the results!
;)
Nigel

[Cece]

http://www.isnvdconference.org/program/ ... -book.html

12 FEBRUARY 7 – 9, 2014 | ISNVD 2014

Identifying CCSVI with Cervical Plethysmography. TELEPASS Study and Kosmomed Project Presentation

Paolo Zamboni, M.D., Simon Shepherd, Clive Beggs, Francesco Speziale, Robert Zivadinov, Pierfrancesco Veroux, Stefano Bastianello, Michael D. Dake, Fabrizio Salvi, Mariano Bizzarri.

Background: A significant heterogeneity of prevalence studies on chronic cerebrospinal venous insufficiency (CCSVI) by the means of Doppler ultrasound (DUS) generates a significant scientific controversy.

Recently, it has been also developed a cervical plethysmography (CP) in order to objectively measure the cerebral venous return. Given that the cervical plethysmography technique produces clear quantifiable results this suggests that the new technique has great potential as an inexpensive diagnostic tool. Kosmomed is a telemedicine project supported by the European Space Agency, which approved the Telepass study acronym of Telemedicine Plethysmography Cerebral Venous Return Assessment. This study is ongoing and represents an opportunity for experimenting a CCSVI screening program.

Objectives: To investigate sensitivity and specificity of CP performed by a technician and interpreted in remote fashion. Results of cervical plethysmography will be compared in patients and controls to the results of a multi modal protocol recently proposed (Premise trial).

Methods: Thirty (30) healthy controls matched for age and gender with 70 MS patients, and 50 patients affected by other neurological diseases (OND). They will be blindly screened by the means of CP. Subsequently, subjects of all 3 groups will be blindly evaluated with multimodal protocol including: DUS, MRV, Catheter venography (CV) and IVUS. All image modalities will be analyzed in a blinded manner by more than one viewer, upon which consensus will be reached. The sensitivity and specificity will be calculated using contingency tables denoting the presence or absence of vein-specific abnormality findings between all imaging modalities used individually as the gold standard.

How to improve diagnostic accuracy: Currently, CP sensitivity and specificity are both around 70%. We aim to improve this very considerably using SVM machine-learning techniques. In simple terms, an SVM seeks to translate the low dimensional vector space where the data resides (called the input space) to a higher dimensional vector space (called the feature space) in order to make clustering (and hence classification) easier and more powerful. At all stages of the project, the diagnostic results will be validated by the “gold standard” multimodality techniques.

This will permit to know the diagnostic accuracy of CP in telemedicine modality as a CCSVI screening device and to obtain final validation of CP as screening system.

I very much like the multimodal protocol. Patients will be screened first with plethysmography, and then Doppler ultrasound, MRV, catheter venography and IVUS.

I don't think it's good, though, that plethysmography sensitivity and specificity are both at 70%. That's lower than I would have expected. In a clinical setting, you don't want to screen out people as not having CCSVI when they actually do have CCSVI. And in a research setting also, it is important for it to be a highly effective diagnosis tool. SVM machine-learning techniques might improve this but even the "in simple terms" explanation is rather complex for me.

By comparing the plethysmography results to the multimodal results, it does give me confidence in the results.