Dr. Siskin's Paper - Safety of outpatient CCSVI treatment

[Cece]

a safety of CCSVI publication by Mandato, Siskin et al

Journal of Vascular and Interventional Radiology

Volume 22, Issue 3, Supplement , Page S4, March 2011
.Abstract No. 3:
Safety of outpatient endovascular treatment of the internal jugular and azygos veins for chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis: A retrospective analysis

K. Mandato*, P. Hegener, G. Siskin, M. Englander, S. Garla, A. Herr

Purpose
To evaluate the safety of outpatient endovascular treatment of the internal jugular and azygos veins in MS patients with CCSVI.

Material and Methods
A retrospective analysis of MS patients with CCSVI undergoing endovascular treatment of the internal jugular and/or azygos veins was performed to identify and describe the adverse events occurring within 30 days.

Results
Over 7 months, 247 procedures were performed in 231 patients. The mean patient age was 48.2 years (range: 25.7–70.2 years); 63.7% were female and 36.3% were male. 49.0% (121/247) of the procedures were performed in a hospital and 51.0% (126/247) were performed in the office setting. 92.7% (229/247) were primary procedures while 7.3% (18/247) were secondary due to restenosis. For patients treated primarily, 86.5% (198/229) underwent angioplasty and 11.4% (26/229) underwent stent placement of at least one vessel; the remaining 5 patients were not treated. For patients treated due to restenosis, 50% (9/18 ) underwent angioplasty and 50% (9/18 ) underwent stent placement. After 99.2% (245/247) of the procedures, patients were discharged within 3 hours. A post-procedure, transient headache was reported in 8.5% (21/247); this persisted beyond 30 days in 1 patient. Neck pain was reported in 15.8% of patients (39/247); 53.8% (21/39) of these patients underwent stent placement. 1.7% (4/231) of patients were retreated within 30 days due to symptomatic restenosis. Sustained cardiac arrhythmias were observed in 3 patients during the procedure with 2/3 patients requiring hospital admission. One of these patients, who underwent a complex procedure for in-stent thrombosis, required a prolonged hospitalization due to a stress-induced cardiomyopathy.

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.

http://tinyurl.com/6jbpuqn

It is wonderful to see these publications today!! Congrats to Albany Medical Center and its fine doctors.

[Cece]

I knew this abstract looked familiar, but couldn't think where we'd seen it before. I found it, it was from Dr. Siskin himself in a post the other day:
www.thisisms.com/ftopicp-153118.html#153118

[MS_HOPE]

Thanks very much for this post, Cece, which can be a very helpful paper to bring to the attention of fearful neurologists.

[Cece]

http://www.futuremedicine.com/doi/abs/10.2217/ica.12.35

Interventional Cardiology
August 2012, Vol. 4, No. 4, Pages 473-479 , DOI 10.2217/ica.12.35
(doi:10.2217/ica.12.35)

Review
Complications and safety of jugular and azygous angioplasty in CCSVI patients with multiple sclerosis

Lavanya Varatharajan1, Tristan R A Lane*1, Ankur Thapar1, Ian J Franklin1 & Alun H Davies1

Endovascular procedures for chronic cerebrospinal venous insufficiency are now practiced in several international centers, despite polarization of opinions among clinicians. Complications from these procedures are now presenting to distant centers. This article reviews the reported complications from several of these institutions. The results of this study demonstrate that the reporting of complication data is sparse, prone to bias and lacks long-term follow-up. There is a need for robust interventional registries of chronic cerebrospinal venous insufficiency to operate in conjunction with high-quality randomized controlled trials in order to accurately report the safety and efficacy of endovenous procedures.

Here's a review of different safety studies. They state that the results of this review is that reporting of complication data is "sparse, prone to bias and lacks long-term follow-up." The lack of follow-up has been a concern of mine too. The safety studies generally discuss the safety of the 1 - 2 hour procedure and recovery, not the potential complications such as clotting that can occur weeks later. The authors suggest that there is a need for robust registries, to collect data from people like us who get the procedure done at a clinic outside of academic trials. And of course there is a need for trials.

[marcstck]

The Newfoundland-Labrador year-long review of patients that had undergone CCSVI treatment (which found no discernible improvement) also found that at the 12 month mark 25% of the enrolled patients had venous occlusions resulting from angioplasty/stenting of some kind (clots or scarring). Regardless of what you think of the analysis regarding efficacy, the findings regarding venous occlusions has to be troubling.

I asked a very respected Canadian journalist friend to verify that these were indeed the results found by the study's researchers, and after she contacted the researchers they were confirmed.

[MrSuccess]

just a minute .... that NewFoundland - Labrador study ..... looks at results and problems of NFL & L pwMS have after getting treatment OUTSIDE of their Canadian Healthcare system. This NO DOUBT includes .. MANY .... MEDICAL TOURISM .... treatments.

Something MrSuccess STRONGLY opposses.

My only surprise is the LOW number of poor outcomes reported by those subjected to CCSVI treatment performed by questionable CCSVI treatment centres.

Make no doubt about it Marc ..... MrSuccess' worst fear has come true ... " Tony Sporano's CCSVI treatment centre " ..... is doing a brisk business.

Let's NOT spin news ..... to support your view.

MrSuccess

[Cece]

The newfoundland-labrador is just one study, and not a randomized controlled trial, but still had very concerning results.
It's possible that that high number of occlusions was a result of the earlier procedures and that there has been improvement since then. And I agree that the medical tourism with no continuing care is not good.

I don't like the study results, but we can't ignore them either. http://www.releases.gov.nl.ca/releases/ ... 607n04.htm

[marcstck]

just a minute .... that NewFoundland - Labrador study ..... looks at results and problems of NFL & L pwMS have after getting treatment OUTSIDE of their Canadian Healthcare system. This NO DOUBT includes .. MANY .... MEDICAL TOURISM .... treatments.

Something MrSuccess STRONGLY opposses.

My only surprise is the LOW number of poor outcomes reported by those subjected to CCSVI treatment performed by questionable CCSVI treatment centres.

Make no doubt about it Marc ..... MrSuccess' worst fear has come true ... " Tony Sporano's CCSVI treatment centre " ..... is doing a brisk business.

Let's NOT spin news ..... to support your view.

MrSuccess

And precisely what do you think my "view" is? I don't think my message contained any spin, just stated a fact. I was disinclined to take the efficacy results of the Newfoundland/Labrador study too seriously, aside from the finding of occlusions after 12 months. This is extremely troubling, as, if estimates are correct, over 30,000 people have already received angioplasty for CCSVI, a large percentage of them medical tourists. If the study figures are accurate, many thousands could be walking around with occlusions without knowing it, as I'd guess the majority never had any significant follow-up treatment. To say that this is the result of shoddy technique may or may not be true; even the best CCSVI practitioners seem not to keep track of the long-term outcomes of their patients very well, and we know from Doctor Sclafani's accounts of having to fix the mistakes of other doctors that a figure of 25% isn't beyond believable.

As for my view of CCSVI, it hasn't changed much since the beginning. I believe the discovery of CCSVI is an important one, and that the condition plays some role in not only MS but a host of neurologic diseases. I tend to agree with BNAC and Doctor Zivadinov that CCSVI is more a confounding factor than the cause of these diseases, but certainly the jury is still out in that regard. I do know that many patients have been helped by CCSVI treatment, I also know that many have not. This disparity is puzzling, and certainly much more research is needed before anybody can state anything unequivocably about CCSVI, pro or con. CCSVI treatment certainly isn't the panacea that many hoped it would be at the outset, nor is it the folly or failure that many of its harshest critics would make it out to be.

In the end, we just have to go where the science leads us. There are several interesting studies underway, let's just see where the evidence points…

[MrSuccess]

I'll state my case again ...... it is grossly unfair to portray the gathered results of CCSVI treatment undertaken by pwMS that reside in New Foundland & Labrador ..... as indicative of the effectiveness - GOOD or BAD - of the procedure .....

Here is why.

As we know ...... there is this thing called .... MEDICAL Tourism.

To label CCSVI as effective or a waste of time and money , based on the experiences of pwMS that have travelled the Globe seeking MS treatment , is short sighted.

Professor Zamboni himself ..... went on the record as being concerned his discovery would be abused by opportunists. He wanted Trial's . Not what has evolved.

Marc , if you [ and the number crunchers in NL&L ] want to accept medical tourism results as proof CCSVI works or not ..... be my guest.

The only numbers I'll accept ..... are those produced by respected Trial's.

MrSuccess

[marcstck]

Success-if you read my post, you'll see that I don't accept the Newfoundland/Labrador results on efficacy, precisely for the reasons you cite. I do however accept their findings of occlusions, as those are not open to opinion. An occlusion is an occlusion, there's no debating The existence of a clock or scarring. Yes, some of these problems may have been caused by sub optimal treatment procedures, but the fact is that many patients have, and continue to have, sub optimal treatment.

You seem to have a habit of reading Into a post what you want to read, rather than what is written. By doing so, you do yourself an injustice, because arguments born of such misreading undermine your otherwise fine intellect. Just my two cents, for whatever it's worth (one cent?)…

[MrSuccess]

I think this information needs to be added ......

The Canadian Province of New Foundland & Labrador has a population of about 500,000 people . They have only ONE city of any size. This is called St.John. Due to the low population numbers they do not have enough work to support many medical speciality's. For this very reason , many people from NL&L travel to get medical attention .... often to Toronto Ontario. Travelling abroad for special medical procedures is common place in NL&L . People in Hawaii do the same.

So it's no great leap of faith for pwMS to travel for hard to obtain health care.

We are told that the Government of NL&L are gathering results data of pwMS that have travelled to obtain CCSVI treatment. Is this information gathered from medical tourism hot spots ? Can a guy get a pair of sandals custom made , while in CCSVI recovery ?

All in all .... the so-called CCSVI data .... must be a real dog's breakfast of CCSVI treatment centres. Some performed in hospitals . Others .... well .... I've read the descriptions over the years.

To say their CCSVI data .... is tainted .... is an understatement to say the least. More valuable time wasted ......

MrSuccess