Becker's Spine Review

January_February Issue of Beckers Spine Review

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23 Executive Briefing: 2. VCF patients' propensity-adjusted mortality risk was 4 percent greater between 2010 and 2014, compared to VCF patients' risk in the 2005 to 2009 time period (p<0.001). 3. At one year, cardiac complications and pneumonia were associated with at least 10 percent greater morbidity risk for NSM pa- tients compared to BKP patients. Dr. Ong and his team did not see a higher prevalence of baseline co-morbidities in NSM patients com- pared to augmentation patients. 4. The length of stay for NSM patients clocked in at 0.2 days shorter than the BKP patients. However, about twice as many BKP patients were discharged home. 6 The following limitations apply to the 2017 study and are generally applicable to the oth- er retrospective claims analyses: • Retrospective database analyses may be prone to selection bias 6-11 • Confounding by other unmeasured selec- tion bias or variables not considered in the analysis is possible 6-11 • Causality of treatment received with mortali- ty outcomes cannot be demonstrated 6-11 nor can causality of the sham trial publications to increased mortality found in the 5-year peri- od following 6 • Cause of death not available in database 6-11 • Was not possible to evaluate all possible co- morbidities 8,10 • Outcomes such as pain and quality of life were not available 6-11 Dr. Hirsch agrees with the conclusion: "We found that there has been an increase in the mortality rate of all VCF patients in the second group [2010 to 2014] compared to the first group [2005 to 2009]." Impact on payers, referrers and providers The 2017 analysis' findings align with the ma- jority of the five above studies on mortality and VCF patients published after the 2009 'sham' studies. "[The study] will certainly help strengthen our overall data collectively and protect our posi- tive coverage policies that are in place," says Jeff Cambra, general manager of Medtronic. "This will likely be valuable data, especially for treating and referring physicians." Dr. Hirsch believes this study will provoke a discussion among referring clinicians about the best evidence-based treatment for their patients. "These procedures really do provide mean- ingful benefits to patients," he says. "I man- age many patients with conservative therapy; there's a role for that. What I object to is when patients call their doctors and the doctor says there is nothing to do [for treatment]." About Balloon Kyphoplasty - Indication and Risk Statement Kyphon™ Balloon Kyphoplasty is a minimally invasive procedure for the treatment of patho- logical fractures of the vertebral body due to osteoporosis, cancer or benign lesion. The complication rate with Kyphon Balloon Kyph- oplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including seri- ous complications, and through rare, some of which may be fatal. Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other seri- ous adverse events, such as: Cardiac arrest , Cerebrovascular accident, Myocardial infarc- tion, Pulmonary embolism and Cardiac embo- lism. For complete information regarding in- dications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product. Conclusion Medtronic is laser-focused on enhancing treat- ments for patients with VCFs and partners with the National Osteoporosis Foundation and National Bone Health Alliance. The nation- al education outreach partnerships are de- signed to raise awareness about spine fracture risk and BKP as a treatment alternative among 70,000-plus clinicians and consumers at soci- ety meetings and via social media channels. "We are committed to driving innovation, building upon our strong portfolio of clinical data, and educating consumers and clinicians on ways to prevent, diagnose and treat pa- tients with vertebral compression fractures," says Mr. Cambra. Since surgeons performed the first Medtronic Kyphon® Balloon Kyphoplasty procedures in 1998, it has been used to treat more than 1 million fractures. Drs. Ong, Beall and Hirsch are hopeful the new analyses will shed light on the implica- tions of VCF treatment patterns and add to the conversation. "These findings give a real insight in the impli- cations of the shifting in treatment patterns," concludes Dr. Ong. "I think our study will add to the debate about whether VCF patients should be treated with augmentation." n References 1 Kallmes D, et. al, A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. The New England Journal of Medicine. 2009 Aug. DOI: 10.1056/NEJMoa0900563. 2 Buchbinder R, et. al, A Randomized Trial of Vertebroplas- ty for Painful Osteoporotic Vertebral Fractures. The New England Journal of Medicine. 2009 Aug. DOI: 10.1056/ NEJMoa0900429. 3 Lindsay R, et al., Risk of new vertebral fracture in the year following a fracture. JAMA. 2001; 285(3):320-33 4 Ross P, et al., Pre-Existing Fractures and Bone Mass Pre- dict Vertebral Fracture Incidence in Women. Ann Intern Med. 1991; 114(11):919-923. 5 Kado DM, et al. (1999) Arch Intern Med 159:1215 6 Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials? Osteopo- rosis International 2017 Oct 24. doi: 10.1007/s00198- 017-4281-z. PubMed PMID: 29063215. 7 Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mor- tality after Vertebral Fractures: Comparison of Vertebral Augmentation and Non-Operative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097. PubMed PMID: 26020845. 8 Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percu- taneous vertebroplasty using German claims data. Spine (Phila Pa 1976). 2014 Feb 15;39(4): 318-26. doi: 10.1097/ BRS.0000000000000135. PubMed PMID: 24299715. 9 McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal aug- mentation vs conservative therapy. JAMA Intern Med. 2013 Sep 9;173(16):1514-21. doi: 10.1001/jamaint- ernmed.2013.8725. PubMed PMID: 23836009; PubMed Central PMCID: PMC4023124. 10 Chen A, et. al, Impact of Nonoperative Treatment, Ver- tebroplasty, and Kyphoplasty on Survival and Morbidity After Vertebral Compression Fracture in the Medicare Population. J Bone & Joint Surgery, 2013. 11 Edidin AA, Ong KL, Lau E, Kurtz SM. Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res. 2011 Jul;26(7):1617-26. doi: 10.1002/jbmr.353. 12 Wardlaw D, et al., Efficacy and safety of balloon kyph- oplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. The Lancet. 2009 Feb. DOI: 10.1016/S0140- 6736(09)60010-6. 13 Klazen CA, et al. Clinical course of pain in acute oste- oporotic vertebral compression fractures. Journal of Vascular and Interventional Radiology. 2010 Sept. DOI: 10.1016/j.jvir.2010.05.018. PMD020431-1.0 UC201806890 EN Kyphon ™ Balloon Kyphoplasty incorporates tech- nology developed by Gary K. Michelson, M.D. Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hos- pitals and patients in approximately 160 countries. The company is focused on col- laborating with stakeholders around the world to take healthcare Further, Together.

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