The everyday practice of medicine involves constant judgmental decisions by physicians in the conscious institution of procedures, tests and observations recognized as effective in treating the patient. Medical treatment in any form is accompanied by risk. Determination of the best treatment option involves weighing the potential benefits of the treatment against potential complications. Emotions are inevitably going to influence deliberations of risk versus benefit. When death is included as a possibility, emotion can overwhelm rational thought.
Treatment of CCSVI is a new medical reality. It has been broadly available for less than 4 years. Much of the available information on the procedure, and the relative associated risks has been shared via social media and the Internet. While sharing of information is empowering for the CCSVI community in general, much of the time actual scientific data is missing or misinterpreted.
In fact, the safety data regarding risk is readily available in medical literature for those that choose to research the topic more thoroughly before making an informed decision. The pooled risk of major complication based on the published data following treatment of CCSVI is 1.6%. http://www.jevtonline.org/doi/abs/10.1583/11-3440.1?journalCode=enth, and http://phleb.rsmjournals.com/content/25/6/286.abstract?sid=11dbf18b-3b66-4b42-8608-9b0672cfe4b5, and also http://www.jvir.org/article/S1051-0443(11)01302-9/abstract .
Treatment of CCSVI, perhaps in part because of its novelty has been associated with controversy. Critics of CCSVI tend to focus on the small number of deaths associated with the procedure, fueling an emotionally charged state. Patient deaths should inspire critical evaluation and this can only happen when emotions are held in check.
There have been three deaths reported following treatment of CCSVI. Several points should be considered when evaluating these events. All three deaths were bleeding complications that took place after the procedure. Each one of these is tragic in its own right. However, to understand them as they relate to the care of CCSVI they must be evaluated relative to the number of procedure performed. In other words the denominator must be known. The current estimate is that CCSVI has been treated with over 30,000 procedures worldwide. From this basis the mortality rate of CCSVI treatment is 0.01%. This number must also be evaluated in the context of acceptable risk based on current medical standards. For example a recent risk assessment of surgical mortality rates in the journal Lancet found the chances of death following surgery was much higher than expected at 3.6%. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961148-9/fulltext.
New treatments making the transition from ‘research based’ to ‘community based’ care inevitably experience an increase in complications. Twenty years ago laparoscopic surgery made a rapid transition from research to community care. The transition was associated with complications including patient deaths. Despite protective body statements of risk http://link.springer.com/article/10.1007%2FBF02498856?LI=true and fact that there was a lack of solid scientific data to support its broad implementation laparoscopic surgery became standard therapy. Unlike removing a gallbladder where an accepted surgical option existed CCSVI/Dysautonomia has no scientifically proven treatment. Patients demanded a less-invasive option for surgery so the health care system adapted to provide this option as safely as possible.
Experience with a treatment typically results in an improved safety profile and a trend towards decreased complication. All three deaths following CCSVI treatment took place during the first 2 years of its initial broad adoption within the medical community. Treatment has evolved and safety has no doubt improved. This is supported by fact that it has been almost 2 years since a patient has died following treatment of CCSVI.
If the general practice of medicine and surgery is to progress, there must be a certain amount of innovation carried on; but such innovation must be done with the knowledge and consent of the patient or those responsible for the patient. Analogous to CCSVI treatment is the off-label use of prescription drugs which also presents a tension between innovative medical care and regulatory and patient concerns about safety and efficacy. Off-label use of prescription drugs is recognized as an acceptable, and in some cases important, aspect of medical care. Neurologists may use medications in off-label manner in care of a patient with multiple sclerosis. Prescribing off-label gives physicians the freedom to innovate in the face of otherwise untreatable conditions, and allows physicians to take advantage of the most current medical knowledge just as the pursuit of innovative treatments for CCSVI.
Assessment of risk is an important aspect of any healthcare decision. However, critical evaluation of a treatment like CCSVI cannot take place when emotions play too big a part in the conversation. Acknowledging the powerful feelings generated by patient deaths is important for all of us. For practitioners it’s an opportunity to take thoughtful pause and evaluate our progress as well as our past failures, while viewing these events in the context of overall risk.
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