My letter to NICE written on 16-Apr-12......................MarkW
Prof. Carole M. Longson – Director, Centre for Health Technology Evaluation.
Prof. Bruce Campbell – Chairman, Interventional Procedures Advisory Committee.
IPG420 - Percutaneous venoplasty for chronic cerebrospinal venous insufﬁciency in multiple sclerosis
Comments from - Mark A. Walker
Charity Address - Chair, Oxfordshire MS Therapy Centre, 37E Milton Park, Abingdon OX14 4RT
I welcome IPG420, a significant improvement in the Institute’s final guidance, when compared with the draft document. Many people with Multiple Sclerosis (pwMS) who made submissions to NICE will also welcome IPG420, as it permits us to obtain percutaneous venoplasty in the UK.
I am particularly relieved that NICE has removed any reference to sham trial for CCSVI. I am aware that NICE received comments from pwMS, similar to mine made on 20th Sept 2011: - Trials comparing venoplasty against sham is a research dream. Real life patient experiences, including my own, report that balloon venoplasty (inflation of the balloon) is felt during treatment. In some cases pain is reported and local pain killers (eg Fentanyl via catheter) are used. Heavy sedation of patients in order to facilitate a sham trial would place trial subjects under increased risk, due to the sedative drug. I doubt that heavy sedation of patients would be accepted by any UK ethics committee and it is certainly not in the best interests of the trial subjects (people with Multiple Sclerosis).
My objective remains to ensure that pwMS can access the procedure using current guidance and based on leading practise. In order that NICE is aware of errors or ommisions in your published guidance, I detail these below. Also, I await the letter indicated by Prof Longson’s paragraph:
Comments on IPG420:
My current comments use the paragraph points of IPG420. I document these at the current time so that there can be no doubt to my current view on NICE’s document IPG420.
In section 1, IPG420 states that further research is encouraged ‘in the form of robust controlled clinical trials’:
1.1 Current evidence on the efficacy of percutaneous venoplasty for chronic cerebrospinal venous insufficiency (CCSVI) for multiple sclerosis (MS) is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research.
1.2 NICE encourages further research on percutaneous venoplasty for CCSVI for MS, in the form of robust controlled clinical trials. Studies should clearly define selection criteria and patient characteristics. They should also clearly define technical success which may include measurement of pressure gradients across treated vein segments before and after venoplasty. Outcomes should include clinical and quality of life measures.
I applaud that the NICE guidance (IPG420) and comments by Prof Campbell have focused on the technical success of surgical procedures, rather the data generated from placebo controlled double blind drug trials usually used by the pharmaceutical industry. Additionally, the phrase ‘quality of life measures’ used by NICE should reassure pwMS that our real life experiences will not be dismissed as ‘placebo’ following a CCSVI procedure. NICE’s phrase should permit pwMS to decide the appropriate level of benefit for themselves. Slowing progression of MS may not be ‘substantial’ in the eyes of MS Neurologists but was the primary reason I sought the procedure in June 2010 and it is a goal of most pwMS, living with this life-long disease.
IPG420 should result in the increase of ‘patient financed open trials in private medicine’ in the UK. It is clear from the NICE IPG420 that this type of trial is sanctioned. Patient’s ‘real life’ experiences thankfully challenged the logic of blinded trials. It is relief that patients’ voices were acted upon in this case, and a challenge to NICE, on equality grounds, was avoided.
PwMS still struggle to finance open label procedures of percutaneous venoplasty for CCSVI in the UK. Unfortunately, many travel abroad for treatment, instead. I hope that IPG420 means that other centres in the UK offer percutaneous venoplasty during 2012. I expect that initial studies will be open trials in private medicine but hope that the National Health Service will also consider trials very soon.
In section 2.2.1, IPG420 has been amended but inaccurately. Unfortunately the renal and iliac veins are outside the definition of ‘head, neck and chest’ used in IPG420. Treating the renal veins has been reported at the SIR 2012 conference, as well as numerous reports on the internet. I am concerned that IPG420 includes such an error as it could misguide interventionalists who may use this technique. I am unclear why NICE used the term ‘trunk’ in its first document, but says the term is inappropriate now?
IPG420 contains three sections which have become out of date already, when presentations at recent conferences (ISNVD/CIRSE/SIR) are considered.
These sections would need regular updating if IPG420 seeks to remain current and a source of leading practice:
2.5 Other comments
Prof Longson’s letter of 270312 said:
Although NICE amended section 2.3.5 (above), it is apparent to those of us who have studied Multiple Sclerosis and CCSVI syndrome for many years that the ‘Specialist Advisors’ in the main lacked detailed knowledge of CCSVI syndrome. Maybe, a panel selection error was made by NICE, when many Neurologists were included as Specialist Advisors for an interventional procedure.
I am focussed on achieving the best solution for pwMS. My study of MS and CCSVI leads me to agree with NICE that “the aim of percutaneous venoplasty is to relieve MS symptoms by improving cerebrospinal venous drainage”. I remain certain that MS is a multi-factorial disease and the approach of safely treating symptoms is the only logical one to adopt, currently.
Insert - Letter of Oct 2011 gave details on steps for percutaneous venoplasty
I am not aware of published documents that give future practitioners of percutaneous venoplasty any basic instructions, which I assembled but only just understand. The importance of the best methods and tools is emerging at conferences, example ref A. Such developments are vital to pwMS who seek percutaneous venoplasty, so that the safest procedure is offered in the UK .
I remain available to discus any points of IPG420 with NICE personnel, in order to assist NICE in providing fair and accurate guidance to pwMS.
Society of Interventional Radiology 2012
Sun, 3/25: 11:26 AM - 11:34 AM
Abstract No: 47
Authors: S. J. Sclafani1, 2, K. Zhang2
Institutions: 1. American Access Care, Brooklyn, NY, United States. 2. Radiology, SUNY Downstate Medical Center, Brooklyn, NY, United States.
Professor Salvatore Sclafani, MD, FSIR - View Disclosure
American Access Care
The nature of Internal Jugular Vein (IJV) obstructions associated with chronic cerebrospinal venous insufficiency (CCSVI) is not well established, but it appears to be different from those stenoses caused by thrombotic recanalization, scarring, tumor encasement and access intimal hyperplasia. We sought to determine the balloon sizes and pressures that were necessary to attain complete distension of IJV obstructions in CCSVI.
The records of all patients undergoing endovascular treatment of the IJV for CCSVI were reviewed. Angioplasty was based upon venographic findings such as stenosis >50%, stasis, reflux, collaterals or upon intravascular ultrasound (IVUS) findings, such as cross sectional area stenoses (CSA)>50%, immobile valves, septa, membranes,or webs. Balloon sizing was initially calculated by visual estimation, but converted to IVUS measurement of CSA. Inflation endpoints were elimination of balloon waist without recoil or exceeding rated burst pressure. Balloon size and maximum pressure were recorded. Complications were reviewed.
93% of 150 treated patients underwent angioplasty of 239 IJVs. 82% received bilateral IJV angioplasty. Balloons used were slightly larger in diameter on the right (avg. 15.8mm, range 10-20mm) than on the left (avg 14.4mm range 8-20 mm). Endpoint pressure requirements averaged 12.7 Atmospheres (range 4-25 atm) on the right side and 13.2 atm (range 6-23 atm) on the left side. There were three balloon ruptures, two occurred during removal from the sheath.There were three dissections, two perforations and ten thromboses (6.3% of treated veins). All but one dissection and one thrombosis occurred prior to using IVUS CSA for balloon selection. Complication rate of 16% using visual estimation was reduced to 1.3% using IVUS CSA measurements.
High pressures are required to completely dilate the lesions of CCSVI. IVUS reduces risk of vein injury.
Mark Walker - Oxfordshire, England. Retired Pharmacist. 12 years of study around MS.
Mark's CCSVI Report 7-Mar-11: