Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.
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I n 2009, The New England Journal of Medicine published two studies, the INVEST and Australian trials, that cast doubt on the benefits of vertebral augmentation. 1,2 The analyses found no significant differences in pain relief between vertebroplasty and a sham intervention. These studies fueled confusion among providers, leaving many in the industry unsure of the potential benefits associated with vertebral augmentation. Patients with a VCF have a five-fold increased risk of suffering a subsequent vertebral fracture compared with their pre-morbid condition or age matched controls. 3,4 Each additional VCF increases a patient's mortality risk. 5 Several recent large clinical studies followed for at least 12 months after vertebral compression fracture (VCF) have concluded that mortality rates following VCFs are significantly higher for patients treated conservatively versus VP or BKP, while other studies have concluded no difference. For more information, visit www.medtronic.com/ bkpmortality. Since 2009, six retrospective claims studies have been published, where researchers focused on mortality risk of balloon kyphoplasty and vertebroplasty compared to that of non-surgical management. 1. The 2017 Ong et al. analysis investigated if VCF patients were at a higher risk of mortality in the years following the publication of the 2009 trials. The study included more than 2 million patients, broken down as follows: 261,756 BKP patients, 117,232 VP patients and 1,698,956 NSM patients. 6 Overall, the propensity-adjusted 10-year mortality risk for the VCF population was 85.1 percent; procedure comparisons at 10-year follow up showed: • 24 percent higher mortality risk for NSM versus BKP, p<0.001 • 8 percent higher mortality risk for NSM versus VP, p<0.001 • 13 percent lower mortality risk for BKP versus VP, p<0.001 2. The Edidin et al. 2015 study examined a total of 1,038,956 VCF patients with up to four years follow up. Of the patients, 141,343 patients underwent BKP and 75,364 underwent VP. The non-operated patients had a 55 percent higher propensity- adjusted mortality risk (p<0.001) than the BKP patients and a 25 percent higher mortality risk (p<0.001) than the VP patients. Researchers found the non-operated patients experienced significantly higher adjusted risks of pneumonia, myocardial infarction/cardiac complications, deep vein thrombosis and urinary tract infection than the BKP patients experienced. Also, the non-operated group had lower adjusted risks of subsequent augmentation/fusion, subsequent augmentation and pulmonary/respiratory complications. 7 3. The 2014 Lange et al. study analyzed 3,607 patients with osteoporotic VCFs, of which 598 underwent BKP or VP with a five-year follow up. Using propensity score matching, researchers found patients in the operated group were 43 percent less likely to die compared to the non- operated cohort (p<0.001). Further, those patients receiving BKP had a 66.7 percent 60-month adjusted survival rate compared to the 58.7 percent survival rate for VP (p=0.68). 8 4. In 2013, McCullough et al. studied one-year mortality risk among 10,541 augmented patients and 115,851 NSM patients. The study, utilizing a 20 percent sample of Medicare data, found mortality The Evidence-Based Medicine Behind Vertebral Augmentation: Changing the Discussion Post-2009 Sponsored by SPECIAL ADVERTISING SUPPLEMENT J U N E 2 0 1 8 • O U T PAT I E N TS U R G E R Y. N E T • 3 5