James McGuckin Comments
This is Marie writing this note.
I recently had the opportunity to speak at a conference for CCSVI Seattle along with several physicians and a registered vascular technician. I am an RN and author of CCSVI as the Cause of Multiple Sclerosis, which is why I was invited. One of the presenting physicians was James McGuckin MD, owner of Vascular Access Centers, where they started treating CCSVI at six clinics nationwide in 2010. I wanted to share with you some interesting advancements in vascular treatment that he is investigating.
In addition to taking the traditional approach to treating CCSVI with balloons and stents, Dr. McGuckin has been researching the use of radio frequency (RF) ablation for opening occluded stents. (In this instance, “ablation” refers to destroying problem tissue.) This is an important contribution to the medical “toolkit,” because occluded stents have traditionally been very difficult to repair. The difficulty is largely due to the fact that the IR needs at least one small, unblocked space within the stent for the catheter tip to enter. From that entry point, they can begin breaking down the blockage. However, in totally occluded stents, an entry point doesn’t exist and that is why so many doctors throughout the years have given up on saving such vessels.
Dr. McGuckin has been working on perfecting and refining the technique of using RF ablation to break through the fibrous blockage in fully occluded stents. RF ablation is an FDA approved approach that physicians use to destroy problem tissue (like tumors) which has been available for some years now. Using it to open occluded stents is off label use with great promise. This approach may help those of us with a totally occluded stent, such as the one I have in my left jugular.
After his presentation, patients on Facebook’s CCSVI Seattle page asked very probing and pointed questions about CCSVI treatment offered by Dr. McGuckin and Vascular Access Centers (VAC). Dr. McGuckin kindly took time to answer these questions and his responses are reproduced here (with permission) for our group as follows:
Greetings, CCSVI Seattle! I thought I would take this opportunity to join in to bring some clarity to questions surrounding my treatment of CCSVI. I am not a Facebook regular, but I felt the gravity of importance to provide responses to your questions.
First & foremost, I am a practicing Interventional Radiologist, board certified, with a certificate of added qualification in Vascular Interventional Radiology & a medical license in the state of Washington. I practice full-time, except when doing research internationally.
I have multiple interests in medicine, including limb salvage, treating patients' chronic venous obstructions, resolving blood clots & blockages in blood vessels, & treating patients with MS & CCSVI. I had the wonderful opportunity to speak last Fri night in front of a highly CCSVI-savvy audience & unlike all other physicians presenting that evening, I personally do the interventional treatment of CCSVI patients on a daily basis. I have over 20 state licenses & this has given me the opportunity to treat patients around the country. This has also provided me the venue in which to train scores of physicians around the country throughout my career.
I spend every professional day working in the vascular system & I have dedicated my career to vascular medicine - both arterial & venous disorders. I provide the extra layer of coverage around the country for cases which are referred in regionally that represent the most challenge.
My partners & I are excited to be able to bring the Zamboni protocol to patients throughout the United States. The Zamboni protocol involves evaluating all the venous territories, including the valvular structures & treating all stenoses regardless of origin.
I have seen no patients to date that have had negative venographic studies and this is consistent with the retrospective analysis by Dr. Hubbard. Prospectively, our results thus far are approaching 80% with regard to patients who experience improvement. However, long-term follow up is required.
I have been treating venous disorders throughout my career & restenosis w/in the venous system is a well-known phenomena that is unpredictable & presently not preventable. However, it can be treated if symptoms recur.
I think the most important element of follow up post-procedure is the clinical status of the patient & return of symptoms, as well as the information required by the Hubbard Registry. I do not believe that pre-treatment Doppler ultrasound should be required- not b/c of its ability to diagnose jugular reflux, but rather b/c a negative study can falsely discourage a patient to undergo venography, where central vein, azygous, & pelvic venous stenoses or obstructions can be evaluated, unlike in a Doppler study.
With regards to MRV, I have seen false positives & false negatives repeatedly, & these studies are quite costly. In patients who have had prior stents, artifact can occur, further decreasing the value of the study. Simple diagnostic venography, although an invasive study, provides the gold standard of information of the structure abnormalities, while affording the sizing & opportunity to treat a causitive stenosis in one setting, in a minimally-invasive, outpatient format, & through a bandaid-sized incision.
I do believe, however, that these procedures are best performed under conscious sedation to provide patient comfort. Presently, we offer the Liberation Procedure at multiple sites in the US, including Seattle/Tukwila.. I will post a subsequent message in a little while to answer some of the specific questions I see on here.
(ed comment: Dr. McGuckin continues on in direct response to questions)
In response to Randal's questions:
1) How aggressively do you treat stenosis? Are the veins/valves simply stretched, or are they 'disrupted'? Angioplasty causes a controlled tear in the lining & the wall of the blood vessel, leading to plastic deformation & therefore disruption of the stricture/web/stenosis/valvular irregularity, resulting in an increase in diameter of the vein. Increased diameter leads to increased flow, which leads to decreased venous pressure. We disrupt all narrowings via angioplasty.
2) How do you choose balloon size/pressure? Balloon size is chosen to match the patients anatomy. You would be surprised how different people are on the inside. Some big men have very small vessels, & some tiny women have the opposite. So, the venogram gives the correlative picture upon which the balloon size is chosen. It's very important to treat these narrowings with high pressure angioplasty b/c some of these lesions are extremely resistant. Our goal is to use the largest balloons that the anatomy will tolerate @ the highest rated burst pressure of the balloon, with prolonged inflation.
3) What is the prevalence of problems with valves in the patients that you treat? Do you routinely do valvuloplasties? Most patients have valvular disorders causing stenoses. All these stenoses get valvuloplasty
4) What is your philosophy/experience with stents? At what point would you insert a stent? Stents are an incredibly important tool in minimally invasive medicine b/c they enable holding open a vessel that re-narrows after a successful angioplasty. I recommend stents, however, only @ times of failed angioplasty, dissection/rupture of the vessel, when recanalizing an occluded vessel, or intra-stent stenosis which also has failed angioplasty. I think it has received a lot of bad press b/c of mishaps, but I can assure you that it is generally very safe, & when appropriately sized & delivered, an invaluable tool. It would be a mistake to restrict its usage in the proper setting.
5 ) Will you treat a patient for whom there is little apparent stenosis? Yes. I have seen amazingly thin webs & synechiae in the azygous, iliac, & jugular systems that would be easily missed by a non-invasive study.
6) If a clot forms, is this usually an emergency situation? Is there a doctor at the VAC Center in Tukwila at all times who can deal with it? Or can this be treated by most vascular/coronary doctors. How much time would a patient have to get treatment? Is it like a blood clot leading to the brain (not away from it)? All VAC physicians are prepared to perform CCSVI procedures & it's potential complications, including the potential need for stenting or thrombolysis. Clots rarely form in endovascular procedures, but when they do, the clot can be removed, broken up, or dissolved in rapid fashion. If a clot were to occur, it would be in a vein leading away from the brain & the other veins draining the brain would compensate. While this is an important condition to resolve, it is not typically life-threatening.
7) How often does severe restenosis occur? Could this be an emergency situations in some cases? Is there at doctor at the VAC Center at any time to deal with this? My analogy for stenosis is as if a bridge on your commuter path were being narrowed inch by inch, day by day. Commuters would learn of the impending slow-down & would learn to take alternate routes as the commute worsened. The body does the same thing when stenoses occur & these alternate routes are called collaterals. When we treat the underlying stenoses successfully, typically these collaterals will regress. Restenosis in venous therapy is common, but fortunately treatable
<p>.</p><p>8) What kind of follow-up do you have? Do you check for restenosis? How often? I think the best indicator of the patients' vascular health is the monitoring of their own symptoms. If the symptoms present @ the time of Liberation recur over a prolonged period, it is likely that restenosis has occurred. We are aiming to adhere to the Hubbard Registry protocol & also request that our patients fill out a MS QOL form @ 1, 3, 6, & 12 months post-procedure.</p>
9) What kind of blood thinner do you use? Is any kind of follow-up needed for this? Would it be a good idea to get a blood test to see the ability of the blood to coagulate (can't remember the right term here). I don't use any anti-coagulant during the procedure & I only use Plavix post-procedure for patients that receive stents, as stents are foreign bodies & require a few weeks time to get covered by a fresh lining, called endothelialization. Typically, I'll have them stay on the medicine for a month, but I would prefer it indefinitely.
10) Generally, what have the results been for VAC. What is the rate of restenosis? Our positive results are approaching 80%, but we inform the patients about the "rule of thirds" - 1/3 of patients see dramatic improvement, 1/3 of patients see some transient improvement, & 1/3 of patients see little to no improvement at all. Restenosis is a process that typically occurs @ 6 months to 12 months post-procedure, so I do not have an accurate assessment thus far. I can say, in patients that I have treated that have been seen elsewhere, that restenosis is typically w/in existing stents or stenoses are being discovered that were never treated.
11) In the case of restenosis, is there a reduced charge for treatment? charges vary based on treatment
12) Who are the other IR's who perform angioplasties in Dr. McGuckin's absence? Would he be available in an emergency situation? How quickly? Other IR physicians @ VAC include Dr. Robert Worthington-Kirsch, Dr. Mario Moya, Dr. Jorge Salazar, Dr. David Singh, Dr. John Rundback, & Dr. Daniel Simon. Treatment of CCSVI is an elective procedure & scheduled @ a time that works mutually for the physician & patient. This is an outpatient procedure & patients typically travel the following day. To date, we have not seen any complications post-procedure
Additional questions from Bradin:
Some very simple things I'd like to know:
1) how many patients has he treated to date? Total - everywhere - not just Seattle. over 75
2) who in the CCSVI field has he worked with/studied with. I want names please - not places. I am a leader in Vascular medicine & have been practicing for over 15 years & I have trained scores of physicians.
3) what is his policy on stents? See Randal's questions
4) what is his policy on ballooning - how aggressive does he get - what size balloons does he use? See Randal's questions
5) what other techniques is he using - i.e. cutting balloons, using blood flow in the azygos to diagnose stenosis, etc. When high-pressure angioplasty fails (which is very uncommon), we use a cutting balloon technique to achieve maximum dilation & resolve the underlying pathology.
6) is he part of Dr. Hubbards registry? If not - why not? Our patients are bringing the data to the registry presently, as we actively pursue membership to the registry. We are also in the process of pursing our own IRB-sanctioned prospective CCSVI study.
7) has he found any MS patients who DIDN'T have CCSVI? No
8) what veins is he actually testing/treating Iliac, IVC, Renals, SVC, Brachiocephalic, Azygous, Jugulars
9) I'd like to hear an overview and his impressions of CCSVI, how he relates it to MS, what's his impression of this discovery. Budd-Chiari is a similar disease process effecting the liver & causing fibrosis from iron deposition. The treatment here is promoting venous drainage from the liver. The treatment of opening the venous drainage of the brain in CCSVI patients makes sense from this perspective. While I think MS has multiple etiologies, the vascular component can be treated successfully.
10) and whatever else he thinks is important. I think that patients need to understand that the procedural risk is very low & treatment typically takes less than an hour, however, the benefits can be amazing. If I had MS, I would seek out the Liberation procedure.
11) many people were concerned about the lack of pre-treatment testing and post treatment followup care. Again, this is not a big concern for me - but perhaps some information on his thoughts/reasons around this would be helpful. I know he did discuss this a bit at the meeting but again - I wasn't there and it's not on the website. Please see previous posts.
Thank you sincerely for your interest.
Gang, in the middle of cases, but I want to keep up on your questions. I received a
question about whether an MS diagnosis is required for CCSVI treatment, if they have MS-like symptoms. I have treated a patient with MS-like symptoms before that could not have an MRI b/c of a previous existing medical device implantation. The patient had the Zamboni criteria based on Doppler studies & underwent venography where valvular stenoses were notes and treated for CCSVI. As you know, the formal diagnosis of MS requires attacks and a positive MRI or a positive CSF oligoclonal IgG band in the CSF.
Additionally, another question was posed regarding venous stenoses cephalad (towards the head) from the IJV valves. I agree with Dr. Arata that the most significant stenoses at the jugular level are at the valve planes. The most prominent restenoses I have seen, whether intra-stent or not, are at these higher jugular levels below the skull base or in the mid cervical region, & therefore, we should show hesitancy before we treat these regions unless they are the primary lesion. Our primary goal should be valvular disruption in this region.
This concludes the comments Dr. McGuckin made in answer to questions posed by patients on the CCSVI Seattle facebook page. Putting them in a note here keeps them archived for later review.
I should say in full disclosure that I am seeing Dr. McGuckin myself for possible RF ablation of my occluded stent. Though in the above remarks Dr. McGuckin stated that in his opinion doppler studies are not critical, in my case it was a doppler study that proved that my “wide open stent on the right” does not carry all the blood away from my brain and leave me reflux free, as other practitioners had believed.
Zamboni-style dopplers done by Eric Feigenbutz at Arizona Doppler Specialists proved that I still have reflux and sent me to consult Dr. McGuckin to get his opinion on whether he could open my occluded stent using his technique.
I think the research in this field will yield incredible results as the years go forward—here we have a doctor researching the use of RF ablation for stent clearing—adding that to all the other work being done we have a system wide explosion of new findings coming our way. It is really amazing.
Marie Rhodes RN