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3 6 • S U P P L E M E N T T O O U T PAT I E N T S U R G E R Y M A G A Z I N E • J U N E 2 0 1 8 was lower in the augmented group (5.2 percent) than in the control group (6.7 percent) using traditional covariate adjustments (p<0.001). After propensity score matching, accounting for selection bias, however, the researchers found no significant difference between the augmented (5.6 percent) and control patients (5.2 percent) for one- year morality (p=0.18). 9 5. The 2013 Chen et al. study compared VP, BKP and non-operated management for VCF patients with total follow up of 129,783 person-years. The study involved 68,752 VCF patients broken into the following cohorts: 55.6 percent nonoperative, 11.2 percent VP and 33.2 percent BKP. The study demonstrated kyphoplasty yielded longer three- year patient survival at 59.9 percent compared with VP at 49.7 percent and non-operated treatment at 42.3 percent (p<0.001). 10 6. The 2011 Edidin A. et al. study analyzed Medicare data from 2005 to 2008 to assess the mortality risk for VCF patients receiving non-operated management, BKP or VP with up to four years follow up. Of the 858,978 total patients newly diagnosed with VCFs, 13.9 percent (119,253 patients) received BKP and 7.4 percent (63,693 patients) received VP. Researchers found adjusted survival rates of 60.8 percent in the operated cohort to be higher compared to 50 percent in the non-operated cohort (p<0.001). In comparing the operated subgroups, survival of 57.3 percent for VP patients, was lower than 62.8 percent for BKP patients (p<0.001). 11 Despite much clinical evidence supporting vertebral augmentation, 12,13 some providers strayed away from the procedures. For example, vertebral augmentation volume fell from 24 percent in 2009 to 14 percent in 2014 (p<0.001), according to the 2017 analysis. 6 Payers also harnessed the two 'sham' trials to deny payment for vertebral augmentation. In the U.S., a Medicare contractor published negative coverage, later revising that policy with restrictive requirements. "The 2009 studies caused significant confusion as to the effectiveness of the procedure and what to do with the patient," says Douglas Beall, MD, of Edmond-based Oklahoma Spine Hospital. Josh Hirsch, MD, Boston-based Massachusetts General Hospital's Neuro Interventional Radiology director and the American Society of Spine Radiology's immediate past president, noted, "Trials should inform our decision-making, not make the decision for us. That is the key to patient- centric care." Did the 2009 studies shift VCF treatment patterns? The most recent of the retrospective claims studies on VCFs and mortality risk, the 2017 Ong KL, et al. analysis is titled, "Were VCF Patients at Higher Risk of Mortality Following the 2009 Publication of the Vertebroplasty 'Sham' Trials?" Medtronic funded the analysis and offered minimal input into the study's design, but did not engage in the data collection, management, analysis or interpretation. Kevin Ong, PhD, PE, principal engineer of Exponent and adjunct member of Drexel University's School of Biomedical Engineering in Philadelphia, served as principal researcher for the Exponent-led study. Drs. Beall, Hirsch and others also served as researchers. "[In addition to other factors,] we wanted to examine whether the publication of the 2009 'sham' control studies resulted in lower use of vertebral augmentation. We found that, in the five- year period following 2009, patients had greater mortality risk for VCF patients," says Dr. Ong. Investigators used Medicare data to examine U.S. vertebral augmentation rates between 2010 and 2014 compared to the previous five-year period. The study examined the difference in mortality and morbidity of VCF patients pre- and post-2009 and compared risks between vertebral augmentation and NSM. In addition to the mortality risk findings listed above, the analysis revealed the following key data points: 1. Vertebral augmentation patients accounted for 20 percent of VCF patients in 2005, peaking at 24 percent between 2007 and 2008 before dropping to 14 percent in 2014.