Kyphoplasty and vertebroplasty for vertebral compression fracture
My doctor told me there’s no evidence for Kyphoplasty!
You ask yourself, why would your pain doctor, or the interventional radiologist suggest it and then your primary doctor argue against it? Especially if you were 8.6 times more likely to die if you DIDN’T have the procedure?
The past few years have witnessed the publication of poorly conducted science published in high-level journals. It’s not your internist’s or your family doctor’s fault. He or she is trying to stay current with the tsunami of incoming literature. Surfing the top is all we can do sometimes when understanding other specialties. Recently, both procedures were widely accepted with numbers of vertebral fractures treated reaching 150,000 per annum in 2009 prior to the publication of two randomized control trials comparing vertebroplasty with sham treatment published in the New England Journal of Medicine in August of 2009 (3,4,5).
The publication of these trials generated a substantial controversy as the results seemed to fly in the face of clinical experience and consequently, numerous societies and physician groups issued statements commenting on the studies’ conclusions. With such debasement, it’s surprising to evaluate the under-presented and somewhat alarmingly supportive literature.
Since that time there has been a flood of information discussing vertebral augmentation (VA), a term that includes Vertebroplasty (VP) and Balloon Kyphoplasty (BKP). This information provides valuable insight into the treatment of patients with osteoporotic vertebral compression fractures. It is worth evaluating this information especially as it relates to current “recommendations” that are often followed blindly by medical and administrative groups unfamiliar with the either the VA procedures or the high-level, and unpresented-by-the-recomendations, body of evidence surrounding VA. The repercussions for patients denied treatment may be profound.
Some facts to ponder:
A meta-analysis of all of the level I and Level II data shows that surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later (8). The longer the fracture had been present, the greater the need for post procedure analgesia. What can be determined from this information is that painful VCF’s are well treated regardless of age and that the sooner they are treated, the less the requirement will be for post op pain medication.
If all of the best Level I data that follows patient for more than 6 months is analyzed, the benefit is consistent and persistent for the treated patients up to two years (9, 10, 11). The long term benefits are more difficult to accurately characterize because these patients are not typically followed for more than two years but based on current information, if the patient doesn’t have an additional fracture or other spine injury, their pain relief should be durable.
Two short-term placebo-controlled (sham procedure) trials of vertebroplasty in patients with osteoporotic compression fractures have not shown a significant benefit in reducing pain (12, 13). These articles are vertebroplasty articles only but the authors extrapolate their recommendation toBKP as well despite the fact that it is a different procedure.
There are 1587 vertebral augmentation articles in the English language. The most recent meta-analysis published in 2012 is the first meta-analysis of only Level I and Level II data and evaluated 27 studies including eight randomized studies. The authors concluded after analyzing this body of literature in great detail that both VP and BKP provide significant pain relief and 50% reduced rate of additional fracture over nonsurgical management. They also concluded that BKP has better anatomy restoration, and may be more beneficial than VP for improving quality of life and disability.
A recommendation against a procedure that has very strong support by a large body of high quality literature is not a logical recommendation but to extrapolate that recommendation to a procedure that has even greater support in the literature is completely inexplicable. [PM1]
A meta-analysis published in 2012 was the first to include all available prospective evidence, including six RCT’s. This meta-anlysis concluded that compared with nonsurgical management (NSM), Vertebroplasty was more effective in relieving pain and in improving the QOL for patients with VCFs.
Recommendations should be based on all of the available high quality data not just two, small selected studies.
Out of 27 articles identified by Papanastassiou, et al in their 2012 summary of all Level I and Level II data on VA, 18 of the studies involved BKP. All of these studies by definition included over 20 patients and the BKP articles included the FREE trial with 300 patients and a trial comparing BKP and VP with 100 patients (10, 19). The conclusion of Papanastassiou regarding BKP was that it decreased pain to a greater degree than VP (5.07 vs 4.55 points on the VAS) and resulted in significantly better improvement in quality of life than both VP and NSM. This meta-analysis was taken from 1587 articles on vertebral augmentation, more articles than in any other concentration of spinal medicine. If the authors’ contention that the trials are limited for BKP then it would follow that there is no other area of spine that had anything but limited information. There is more than adequate information upon which to base a decision that BKP is effective.
Vertebroplasty and kyphoplasty are not without risk. Short-term complications occur predominantly due to extravasation of the cement and may include increased pain and damage from heat or pressure to the spinal cord or nerve roots , and rarely cement embolization . Extravasation has been reported in 11 to 73 percent of vertebroplasty procedures , and less commonly with kyphoplasty.
However, local tissue damage has been reported only anecdotally (20). This has remained true over time and exothermic damage to neural elements and other structures is either very rare or nonexistent. A recent randomized control trial of 256 patients examined the differences between traditional polymethylmethacrylate (bone cement) and Cortoss, an injectable, Combeite glass ceramic tri-resin polymer with little to no exothermic reaction. The study showed no difference in complication rates, no evidence of adverse exothermic events with bone cement and no difference between cements in the reduction of the patients’ pain levels (11).
Detractorsd, also characterize cement embolization and extravasation as adverse effects. A better description reveals embolization and extravasation as extremely common with embolization occurring in 5-23% of all patients and extravasation up to 73% as stated above (21-24). Important however, is that the vast majority of embolisms and extravasation are neither symptomatic or adverse. A review of all of the Level I and II data shows that most studies either did not report or failed to encounter any serious adverse events (SAEs). Overall, the literature suggests that both procedures had safe SAE profiles with occasional case reports of symptomatic cement extravasation in the VP arm (24-32).
The risk of performing VA should be balanced with the risk of withholding the procedure as these patients are typically debilitated, suffer a mortality rate of 8.6 times age matched controls, and have a 40% greater mortality than those with native spines after 8 years (33, 34). In the first longitudinal, population-based comparison of mortality risk between surgical and nonsurgical groups, a Medicare dataset from 2005 to 2008 containing 858,978 patients with vertebral compression fractures was analyzed (35). This included 119,253 patients treated with BKP, 63,693 patients treated with VP and the remainder treated with NSM. The findings at the 4 year follow-up showed the VA treatment group was 37% less likely to die than the NSM group and that the adjusted life expectancy was 85% greater for the VA group. The adjusted life expectancy for the BKP was greater for that of VP and was increased 115% compared to the NSM group. Overall the median life expectancy was increased between 2.2 and 7.3 years across all treated groups as compared with nonsurgical management. A retrospective review of the treatment of refractory osteoporotic vertebral compression fractures by Gerling, et al where treatment with VA was compared with NSM in a hospital setting found a significant survival advantage (p<0.001) for patients treated with VA over those patients treated with NSM, regardless of co-morbidities, age or the number of fractures diagnosed at the start-date (36). [PM2]
If all of the Level I and II data on VA is analyzed, rather than focusing on particular studies, the adjacent level fracture rate for those patients treated with VA is 11% compared with 22% for those patients treated with NSM (8). The rate of adjacent level fractures in untreated patients is 20% (37). Not only does there appear to be no increased risk of adjacent level fractures, there is very strong supporting evidence that treatment with VA reduces the rate of adjacent level fractures by half.
There have been more scientific contributions to the English literature on vertebral augmentation than for any other topic in spine medicine. Augmentation detractors often present a partial or incomplete summary of the evidence possibly out of ignorance, but it appears that policy makers issue statements that seems best suited to sway readers, as opposed to inform readers with a clear summary of high-level evidence. If the highest quality portion of vertebral augmentation literature is analyzed, the only relevant conclusion is that augmentation provides significantly better outcomes than nonsurgical management by a variety of measures. Clearly the evidence is strong for decreasing pain if augmentation is performed in the first seven weeks. This analysis also shows significantly fewer additional fractures for those patients treated with vertebral augmentation rather than those treated with nonsurgical management. Additionally, those patients treated with Kyphoplasty had a significantly better improvement in their quality of life than those treated with Vertebroplasty.
Most of the high-level contributions to the literature have been added relatively recently, but many of the current analyses and recommendations are based on older literature. Especially concerning, is the possibility of population-based medical decision making, which ignores profoundly important population-based mortality evidence as well as scientific rigueur, for what seems to the non-scientist to be a complete, unbiased and contemporary distillate. The data that shows significantly higher mortality in those patients treated with nonsurgical management as compared with those patients treated with vertebral augmentation emphasizes the importance of offering the treatment most likely to benefit the patient. If all of these factors are taken into consideration it appears that the denial of this treatment likely promotes pain and suffering while greatly increasing the risk of mortality associated with osteoporotic vertebral compression fractures.
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