This study shows very favorable outcomes for patients who underwent vertebroplasty, and it refutes the flawed NEJM studies previously done.
Scottsdale, AZ (Vocus) September 3, 2010
When insurance companies decide to quit funding procedures, patients suffer greatly. The procedure essentially becomes unavailable to them, as they cannot afford to pay out-of-pocket to fund their own procedure. Many patients will then go without the procedure, which can cause them to suffer long-term, debilitating pain. Since patients will be denied conservative treatment, they will often have no other treatment options than to undergo major surgery.
Compression fractures of the spine are the most common complication of osteoporosis. These painful and debilitating fractures adversely affect quality of life and physical function, and increase mortality rate significantly. Those with vertebral compression fractures have a 23 percent higher mortality rate than those who do not.
Vertebroplasty is a safe, minimally invasive procedure that has been shown to help those with debilitating pain due to spinal compression fractures. The procedure is done with x-ray guidance and medical-grade bone cement is placed through a trocar into the fractured vertebrae. The bone cement hardens and an internal cast is created within the vertebral body that stabilizes a painful fracture.
Unfortunately, these procedures are in danger of no longer receiving funding from insurance companies. Dr. Patrick Hogan is the Vice President of the Arizona Chapter of the American Society of Interventional Pain Physicians and is an advocate for patients. When Dr. Hogan became aware of the possible discontinuation of coverage for vertebroplasty, he submitted a letter that showed the negative impact this would have on patients who suffer from painful compression fractures.
Based on a study that was published by Kallmes and Buchbinder in the New England Journal of Medicine (NEJM) in 2009, vertebroplasty was deemed to lack the clinical data to support it being a funded procedure for Medicare patients. This study caused uproar within the medical community, as it is a procedure that is performed for those in severe pain and doctors have seen long-term, dramatically positive results from the procedure.
Dr. Hogan regularly sees patient’s suffering from severe debilitating pain due to spinal compression fractures in his practice at Arizona Pain Specialists in the Phoenix-area. He also sees these same patients find significant pain relief from vertebroplasty. In regards to the NEJM study he says, “The study was flawed in many ways and was conducted on a biased sample of patients. It also was flawed in terms of patient selection…only 32 percent of the patients were ideal candidates for vertebroplasty.”
Another flaw within the study is that what they were calling a “placebo” was actually another pain relieving procedure. Oddly enough, both groups were recorded as demonstrating clinically significant pain reduction. This only shows that both vertebroplasty and facet injections are effective.
Dr. Hogan adds, “it is a serious error to draw the conclusion that vertebroplasty is not effective based upon the very small sample size contained in these two flawed studies.” Interestingly, the principal investigator in one of the studies, Dr. Kallmes, was quoted in an interview stating that he still performs vertebroplasty on his patients who are in pain. He added that for those patients who present with severe pain and fail conservative care, further treatment with vertebroplasty should be strongly considered.
The conclusion that can be drawn from this is that insurance companies are using an ineffective and poorly constructed study to make a critical decision that could immediately affect thousands of patients who suffer from painful vertebral compression fractures. According to Dr. Hogan, there is a better designed and more recent study called VERTOS II that was published in the journal Lancet in August, 2010. He says, “This study shows very favorable outcomes for patients who underwent vertebroplasty, and it refutes the flawed NEJM studies previously done.”
The VERTOS II study shows that vertebroplasty achieves a higher percent of pain relief than other conservative treatments meant for compression fractures. The report of the study mentions that the biggest advantages to vertebroplasty is that it is safe and extremely effective. In addition, the study also shows pain relief following a vertebroplasty is immediate, lasts a minimum of one year, and is not an extremely costly procedure.
Patients and physicians alike can make sure their voice is heard regarding the possible discontinuation of coverage for vertebroplasty by going to this website.