Dr. Morgan Lorio surveys the landscape of vertebral augmentation to find contentious studies and offers suggestions to educate the public and other practitioners.
Morgan P. Lorio, MD, FACS
Chair, ISASS Coding & Reimbursement Task Force
The AAOS Clinical Practice Guidelines on the Treatment of Symptomatic Osteoporotic Compression Fractures, adopted in September 2010, were developed by a multidisciplinary volunteer work group and based on an algorithm that used level of evidence to rigorously qualify data.
Two studies (2009) – by Buchbinder and Kallmes – were identified by AAOS to be Level I and were apparently determined to be a sufficient litmus test to diminish the importance of the mountain of Level II-IV evidence that suggested value to these procedures.
A SpineLine Panel Review (2010) appropriately recommended exploration of “the seeming disconnect between the conclusions of these two [Level I] PRCT’s and previous experience and data.” A recent (2012) meta-analysis by Paul Anderson, et al., downgraded the 2009 studies by Kallmes and Buchbinder to Level II based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the Cochrane Risk of Bias Table, and Levels of Evidence for Primary Research (as adopted by NASS) due to selection bias and to unsound inclusion criteria.
In 2011, Edidin et al., suggested a higher survival rate in the patient group receiving vertebral body augmentation (VBA) versus the group receiving non-surgical management (NSM). A meta-analysis by Papanastassious et al., “Comparing effects of kyphoplasty, vertebroplasty, and nonsurgical management…,” (2012) analyzed all the existing Level I and Level II data on VBA compared with NSM and concluded that there was a statistically significant reduction in pain and subsequent fractures with VBA over NSM. They also concluded that balloon kyphoplasty (BKP) is favored over vertebroplasty (VP) for disability improvement and quality of life improvement. The aforementioned meta-analysis by Anderson et al. concludes that VP offers greater pain relief, functional improvement, and quality of life than does NSM and states that there is “strong evidence” in favor of VP in the treatment of Vertebral Compression Fractures (VCFs).
Given the abundance of high quality information, we can confidently advocate that there is strong support for intervention for VBA for patients with VCFs. Defining when (timing) and for whom (patient subgroup) VBA works best represents an ISASS policy challenge. Most clinical recommendations center around those patients who fail NSM (or are in intractable pain) whereas the preliminary recommendations of the April 2013 NICE (National Institute of Health and Clinical Excellence) Committee are for VBA in patients who have severe pain after VCF – within six weeks – despite optimal pain treatment. IASP, ISASS’s sister organization focused on advocacy, must stand for our spine patients while rebuking the myriad lay press releases with false sham VP categorizations and incorrect classification of the foremost publication on BKP (the FREE trial that was classified as Level II rather than Level I). To that end ISASS must ensure that a fair and accurate reflection of these procedures is presented on such websites as UpToDate.com, the Hayes Report, and Wikipedia.com. These sites are used by private insurance carriers, lay persons, and our patients as supposedly trusted sources of information.
Additionally, we at ISASS must work towards an ISASS Position Statement on VBA to address the egregious bias currently present at UpToDate.com, the Hayes Report, Wikipedia.com. This will entail 1) an update of the clinical literature and procedural benefits on the existing VP page on those sites; and 2) the development of a unique page for BKP on those sites – supported by ISASS’s foremost experts.
When discussing the VP and BKP body of pertinent evidence we must additionally include the CAFE trial, the meta-analysis of VP by Ming-Min She, and other meta-analyses by Boonen, Klazen, and Ferrokhi. Media amplified “bad news” lingers regardless of how flawed the information may be. We (ISASS) must diligently work towards accurate and transparent reporting on procedural assessment.
My thanks to Douglas Beall, MD for bringing this to our attention along with his ideas for modification and active input.
Conflict of Interest Statement: Dr. Lorio is a co-Principal Investigator for the Alphatec Osseofix trial.