When Choosing a CCSVI Provider, Quality of Care is Key - facebook prikbord

Calculating the real cost of CCSVI intervention

The internet is awash with accounts of the sad story of Mahir Mostic, a 35-year-old Canadian MS patient who traveled to Costa Rica for treatment for CCSVI. After his initial treatment, MS symptoms worsened and Mr. Mostic returned to Clinica Biblica in San Jose Costa Rica where he died on October 19th.

The CCSVI "Liberation" treatment was coined by Italian interventional cardiologist Dr. Paulo Zamboni, who theorized that MS is a vascular disease caused by blocked or twisted veins in the chest and neck. Put simply, the treatment is an angiolasty performed in the jugular and/or azygous veins to increase blood flow from the brain.

An Ontario vascular surgeon consulting with the doctor who performed Mr. Mostic's procedure has stated that although she believes int he potential of the treatment, the procedure Mostic underwent was very different from protocol recommended by Zamboni, with the venoplasty performed one day, and a stent inserted on the following afternoon. When Mostic returned to Canada his symptoms worsened, and an ultrasound revealed that his stent was blocked with a blood clot; Mostic died shortly after a clot-busting drug was injected into the stent.

A similar case was reported by the New York Times detailing the cases of a woman, aged 50, treated with stents at Stanford University; she died of a brain hmorrhage after returning home, as well as another MS patient who who needed heart surgery after the stent placed in the neck vein came loose and was swept into the heart. After these cases, Stanford stopped performing the CCSVI intervention.

Interventional radiologist Dr. Simon acknowledges that CCSVI intervention is considered an experimental procedure, however, notes that IRs do not have to ask hospitals for permission to perform it, because the procedure in its details is similar to other procedures that interventional radiologists do every day. It is not uncommon for IRs to take a device approved for one purpose and use it for another, a practice called “off-label” use which the U.S. Food and Drug Administration allows. In the story Dr. Simon is quoted as saying "interventional radiology is an “off-label specialty” that depends on innovation and adaptability.

Certainly not all cases of stent use have resulted in fatalities. In March 2009, MS patient Neelima Raval was treated for CCSVI by Dr. Simon and reported feeling immediate improvement in function: her fatigue went away, she walked and climbed stairs more easily, and the
color in her face improved. But a month later she was having trouble walking, and a venogram showed restenosis. She had a total of four invasive procedures in just three months, and Dr. Simon implanted stents in her two jugular veins. So far there has been no recurrence of restenosis, and Ms. Raval continues to improve.

But IR is not the only interested specialty; neurologists and MS Society officials have given been vocal about their skepticism over the possibility that obstruction of venous
drainage in the neck and/or chest caused blood to back up and leak toxic iron from damaged thin-walled veins deep in the brain, killing nerve cells. Some haave even called CCSVI a hoax”

Dr. Zamboni himself has said that the procedure should not yet be done outside of studies. He said in an interview that he was conducting research only and had turned down thousands of requests from people wanting to go to his clinic at the University of Ferrara. But patients say they cannot afford to wait for research results, fearing they will wind up in wheelchairs before the studies can be launched, much less completed. A lifelong course of drugs with limited benefits and harsh side effects has been the only answer for MS patients, and for many, the venoplasty treatment seems no riskier than these drugs.

The caution asgainst oversimplifying the efficacy and, more important, the risks associated with treatment for CCSVI is warranted. Unlike the better known anatomy of arteries associated with the central nervous system,the venous system is much less understood. The knowns of angioplasty in the arteries are a guideline, not a guarantee, of the safety and efficacy of the same treatment in the veins.

As well, MS itself is not fully understood; it is a disease with a history of misdiagnosis, with the National Institutes of Health reporting as many as 10-15% of MS patients are misdiagnosed, skewing clinical study results. In response to this problem, the NIH developed the “Natural History of MS” to create a standard clinical

definition of MS.

Then too, though we'd prefer it not to be the case, there is opportunism in medicine as anywhere else. As an MS patient noted in a Facebook CCSVI in Multiple Sclerosis entry, "There is always someone trying to make a buck off sick people."

What's an MS Patient To Do?
Every patient must make a cost-benefit analysis when considering any medical treatment - this is unavoidable.

In assessing the price of treatment, one of the most important considerations patients weigh in the cost/benefit

analysis is whether to have the treatment as an in-patient or out-patient. Though out-patient treatment might save the patient a few thousand dollars, that benefit of hospitalization should not be lightly dismissed. Hospitalization for CCSVI treatment at state-of-the-art hospital system such as Hospital Angeles means access to on-site catheterization labs, 24×7 nursing, emergency, and ICU care, as well as specialists in emergency surgery, neurology, and cardiology – key for MS patients who are not ambulatory or experiencing severely impaired function.

Another important consideration is the depth of experience of the medical team. It can be easy to oversimplify the risks of angioplasty, which are well know. However, while the risks of the angioplasty procedure are well-understood, there are more unknowns than knowns regarding the venoplasty treatment for CCSVI and its aftermath.

"We are not interested in being pioneers!" emphasizes Dr. Jorge Luna, Stanford-trained interventional cardiologist at Hospital Angeles, recently spoke at a free webinar offered to patients investigating CCSVI treatment. It is essential for patients to work with a multi-disciplinary team because multiple points of view are needed with a problem that is not well-understood. Multiple points of view will always yield more information, and a more robust understanding of any complications that might arise as a result of the procedure."

Not sure about the experience of your medical team? Ask! Lower priced, late entrants to the treatment arena are often lower priced and late entrants for a reason - lack of experience, as demonstrated by the hasty phone calls reported by one treating physician at Hospital Angeles, asking for instructions by phone on the Zamboni procedure. While lack of experience in and of itself does not mean danger to the patient, it is clearly a significant consideration in the cost/benefit analysis of a treatment that has demonstrable risks, as seen with Mr. Mostic last month.

The Hospital Angeles CCSVI treatment team follows the Zamboni protocol and is led by Dr. Jorge Luna and Dr. Daniel Morales, a neurosurgeon trained in the relatively new subspecialty of interventional neurology, a team of interventional radiologists with long-term MS patient experience, as well as a rehabilitation therapist.

In sum: Working with a smaller less state-of-the-art facility with less experienced/credentialed team can save the patient a few thousand dollars, however this benefit must be carefullyweighed against the risk factors presented by the fact that “normal venous anatomy” is not definitely known, therefore CCSVI diagnostic testing and treatment protocols (such as the appropriate use of stents), requires particular experience as well as expertise.

In sum: CCSVI is most safely performed as an in-patient

treatment at a well-regulated hospital, with patients remaining under medical supervision for up to 5 days after treatment. The treating medical team ideally should be on-staff at the hospital, ensuring they have met a number of institutional and governmental credentialing checks regarding training, continuing education and professional standing in the medical community. In addition the medical team should be comprised of specialists across the subspecialties of interventional radiology and

interventional cardiology, as well as neurology or, ideally, interventional neurology (a new subspecialty of neurosurgery, responding to the need of vascular interventions being done in the neck and above, as is the case with treatment for CCSVI.). Patients treated for CCSVI should be followed as part of a Patient Registry for publication of study findings, as is the case with Angeles.