Complications in MS Patients after CCSVI Procedures Abroad

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Complications in MS Patients after CCSVI Procedures Abroad

Postby eric593 » Tue Aug 23, 2011 12:58 pm

This is why it's good to ask questions of complications experienced by your potential IR's patients. Or a reason to wait for better research.

http://www.ncbi.nlm.nih.gov/pubmed/21856578


Complications in MS Patients after CCSVI Procedures Abroad

(Calgary, AB).Burton JM, Alikhani K, Goyal M, Costello F, White C, Patry D, Bell R, Hill MD.

Source

Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.

Abstract

Background:
The "chronic cerebrospinal venous insufficiency" or "CCSVI" hypothesis, namely that multiple sclerosis (MS) is caused by abnormalities in the azygous and internal jugular veins with subsequent alterations in venous hemodynamics in the central nervous system, has been a dominant topic in MS care in Canada over the past year. Although there is no methodologically rigorous evidence to support this hypothesis presently, a considerable number of MS patients have undergone endovascular CCSVI procedures. Such procedures include angioplasty or stent placement in jugular and azygous veins. The safety and efficacy of these procedures is unknown, but not without risk.

Methods:
Chart and patient review of five patients with confirmed MS followed in Calgary were undertaken after patients came to medical attention by referral or admission secondary to complications believed to be associated with CCSVI procedures.

Results:
Complications upon investigation and review included internal jugular vein stent thrombosis, cerebral sinovenous thrombosis, stent migration, cranial nerve injury and injury associated with venous catheterization.

Conclusions:
As the debate about CCSVI and its relationship to MS continues, the complications and risks associated with venous stenting and angioplasty in jugular and azygous veins are becoming clearer. As increasing numbers of MS patients are seeking such procedures, these five cases represent the beginning of a wave of complications for which standardized care guidelines do not exist.

Our experience and that of our colleagues will be used to develop guidelines and strategies to monitor and manage these patients as their numbers increase.

PMID: 21856578 [PubMed - in process]
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Postby Lyon » Tue Aug 23, 2011 1:32 pm

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Last edited by Lyon on Sun Nov 20, 2011 3:52 pm, edited 2 times in total.
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Postby Cece » Tue Aug 23, 2011 1:34 pm

Complications upon investigation and review included internal jugular vein stent thrombosis, cerebral sinovenous thrombosis, stent migration, cranial nerve injury and injury associated with venous catheterization.

Yikes.
Internal jugular vein stent thrombosis has been discussed here, that's a known risk and a reason for the IRs to only use stents when absolutely necessary and to carefully monitor afterwards (which is hard with travelling patients) and to prescribe anticoagulation.

Cerebral sinovenous thrombosis is concerning because this was a thrombosis that entered the dural sinuses which are north of the jugulars, directly under the brain.

Stent migration? I can only remember two other reports of stent migration. The first is unforgettably an early patient's experience, in which it migrated to the heart and required open heart surgery. The second was a mention in which the stent had migrated out of position but remaining in the vein; it may have been disrupting the flow in the innominate vein slightly. This was last fall and by memory so not precise.

Cranial nerve injury...it would be good to know more. The only similar case would be the spinal accessory nerve damage in some early patients, when too big of stents were used.

Injury associated with venous catheterization. This could be scarring or intimal hyperplasia? Not sure.

This is not a random selection of patients who had been treated, it was patients coming forward with complications, and it is a small sample of five patients. We have no information on where they were treated as the procedure is not standardized and certain techniques may lead to a greater complications rate.

We have a few safety studies:
http://tinyurl.com/6jbpuqn
Conclusion
Endovascular treatment of CCSVI in MS patients is a safe procedure when performed on an outpatient basis. Cardiac monitoring is essential to permit detection and rapid treatment of patients with procedure-induced arrhythmias. Post-procedure ultrasound is recommended to detect venous thrombosis. In addition, consideration should be given to performing complex re-interventions in a hospital given the complication risk in this sub-population of patients.

This was from a study of 231 patients.

www.ncbi.nlm.nih.gov/pubmed/21679067
J Endovasc Ther. 2011 Jun;18(3):314-23.
Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis.
Petrov I, Grozdinski L, Kaninski G, Iliev N, Iloska M, Radev A.
SourceCardiology Department, Tokuda Hospital Sofia, Bulgaria. petrovivo@hotmail.com

Abstract
PURPOSE: To evaluate the safety of endovascular treatment of chronic cerebrovascular insufficiency (CCSVI) in patients with multiple sclerosis (MS).

METHODS: In a 1-year period, 461 MS patients (261 women; mean age 45.4 years, range 21-79) with CCSVI underwent endovascular treatment of 1012 venous lesions during 495 procedures [34 (6.9%) reinterventions]. While balloon angioplasty was preferred, 98 stents were implanted in 76 patients for lesion recoil, restenosis, or suboptimal dilation. The procedures were analyzed for incidences of major adverse events (death, major bleeding, or clinical deterioration of MS), access site complications, procedure-related complications, and procedural safety-related variables (fluoroscopy and contrast times). The complication rates were compared to published data for similar endovascular methods.

RESULTS: There were no deaths, major bleeding events, or clinical deterioration of MS. Access site complications included limited groin hematoma (5, 1.0%); there were no arteriovenous fistulas or puncture site infections. Systemic complications included only rare cardiac arrhythmias (6, 1.2%). Procedure-related complications included vein rupture (2, 0.4%), vein dissection (15, 3.0%), acute in-stent/in-segment thrombosis (8, 1.6%), and acute recoil (1, 0.2%); there was no stent migration or fracture or distal embolization. Mean fluoroscopy time was 22.7 minutes, and mean contrast volume was 136.3 mL.

CONCLUSION: Endovascular therapy appears to be a safe and reliable method for treating CCSVI. Innovations such as purpose-specific materials and devices are needed, as are case-controlled and randomized data to establish efficacy in ameliorating MS symptoms.

This was a study of 461 patients but I do not think there was follow-up, so it is only pertinent to the immediate safety of the procedure.
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Postby eric593 » Tue Aug 23, 2011 2:01 pm

Thanks for that additional info, Lyon. I think Dr. Siskin's cautions about avoiding repeat procedures where possible is very important. And with this information, it is important for people to investigate the complication rate of the IR's before ever considering the treatment, or weigh carefully the risks of the more uncommon treatment methods that are being used that don't have a lot of IR expertise in them at all let alone to treat CCSVI.

The problem is that even the IR's may not be aware of complications if their patients don't inform them after the fact. I imagine the rate is likely even higher than we believe given that many people don't go for any follow up, so may not even know that complications from the procedure have occurred, they just assume it didn't work or attribute problems to MS activity.
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Postby Cece » Tue Aug 23, 2011 2:13 pm

With any surgical procedure, there will be patients who have complications, but the benefit outweighs the risk. A problem with CCSVI treatment is that the benefit is not precisely known (and there may be different degrees of benefit in different patient groups, such as RR or PP or lyme disease patients with CCSVI).

Angioplasty has been in use for 25 years.

Large scale research is needed.

Lyon, thanks for that blurb, I don't think there is public access to that commentary. It does raise concerns.
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Postby Lyon » Tue Aug 23, 2011 2:40 pm

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Last edited by Lyon on Sun Nov 20, 2011 3:51 pm, edited 1 time in total.
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Postby scorpion » Tue Aug 23, 2011 4:40 pm

I am reading a book about the history of cancer and I am struck by what I see as some of the similarities with CCSVI /angioplasty. A gentleman by the name of Halsted believed that it might be possible to "cure" breast cancer by cutting away pieces of the chest in order to remove the cancer from a person's body. As time went by Halsted decided that since many of the (mostly women) were not being cured, that it must be because he was not removing enough of the chest cavity so he began cutting deeper and deeper into the chest eventually even removing a shoulder and breastbone. Eventually it seems he came to understand that his radical surgery did not cure cancer but he convinced himself his surgery relieved the symptoms of cancer. The author states it much more eloquently then i ever could so:


Halsted, Brunschwig, and Pack persisted with their mammoth operations because they genuinely believed that they could relieve the dreaded symptoms of cancer. But they lacked formal proof, and as they went further up the isolated promontories of their own beliefs, proof became irrelevant and trials impossible to run. The more fervently surgeons believed in the inherent good of their operations, the more untenable it became to put these to a formal scientific trial. Radical surgery thus drew the blinds of circular logic around itself for nearly a century.
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Postby Cece » Tue Aug 23, 2011 4:52 pm

My mother had breast cancer. She was treated with a double masectomy, which involved cutting away pieces of the chest.
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Postby scorpion » Tue Aug 23, 2011 5:38 pm

Cece wrote:My mother had breast cancer. She was treated with a double masectomy, which involved cutting away pieces of the chest.


Not my point. Due to their unwavering belief in what they were doing, even though in most cases such radical surgery was not necessary, their surgery became more about "faith" then science. At some point, scientific trials, logic, and any chance of finding the truth were thrown out the window because it seems ego(being right) came to mean more then finding out if what they were doing truly benefited the people they performed surgery on.
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Postby eric593 » Tue Aug 23, 2011 6:04 pm

scorpion wrote:
Cece wrote:My mother had breast cancer. She was treated with a double masectomy, which involved cutting away pieces of the chest.


Not my point. Due to their unwavering belief in what they were doing, even though in most cases such radical surgery was not necessary, their surgery became more about "faith" then science. At some point, scientific trials, logic, and any chance of finding the truth were thrown out the window because it seems ego(being right) came to mean more then finding out if what they were doing truly benefited the people they performed surgery on. Remember the Hippocratic oath?


Scorpion, in the CCSVI hypothesis and treatment development, this is further confounded by the profit factor of treating physicians. The demand for greater, more enduring benefits is high, and doctors claiming to use unique but untested treatment methods can gain greater market share by advertising these "special" techniques without reporting results or complications. Advertising and marketing have become part and parcel of CCSVI now which causes more uncertainty as to effective treatment approaches and risks associated.

So not only do we have doctors unwavering , blind belief like in the cancer example, but also desire to attract a good share of the patient base for financial reason using a variety of means to promote their services. We certainly see doctors advertising and boasting of their "special" approach here as well as the availability of appointments.

All of this makes for an even muddier view of risks versus benefits, particularly when data is not obtained from clinical trials where variables are controlled, but from profiting doctors. Certainly doctors have a vested interest in what they report and trying to gain better satisfaction through aggressive means in order to secure a greater market share. This may be not so much in the patient's best interests outside research trials but instead more about attracting more paying customers at the risk of patient health.
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Postby Cece » Tue Aug 23, 2011 7:44 pm

At some point, scientific trials, logic, and any chance of finding the truth were thrown out the window because it seems ego(being right) came to mean more then finding out if what they were doing truly benefited the people they performed surgery on.

It is the age of evidence based medicine. There is CCSVI research underway. We won't know until we know. But more research will be in within months and years, not decades and centuries.

There will always be those who go first, just as there will always be those who go last. This is a personality type. Who here is a risk taker? Because CCSVI treatment is not without its risks.

Life with a neurodegenerative disease has its own risks.
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