Issue link: https://beckershealthcare.uberflip.com/i/829284
23 Executive Briefing rience, understanding what we can do well, what we can do better and defining the population," Dr. Hirsch explains. "This VAPOUR trial demonstrates the dangers of forming such strong opinions in vul- nerable populations based on a total of about 200 patients, 100 of which went into therapy." Limitations of this study included the single center predominance; the high volumes of cement inject- ed; and the reality that many patients endure pain for longer than six weeks. Dr. Hirsch, who wrote the invited comment, noted that conservative therapy was not risk free; further height loss in the sham group led to meaningful complications. 8 Clinical evidence A heated debate about whether augmentation offers a mortality benefit has captured the indus- try for years, resulting in a variety of trials. Several recent large clinical studies followed patients for at least 12 months after VCF. Four studies revealed balloon kyphoplasty and ver- tebroplasty offered patients lower mortality risk compared to those patients receiving non-sur- gical management. For more information, visit www.medtronic.com/bkmortality. 1. Published in Journal of Bone and Mineral Re- search in 2011, the Edidin A. et al., study utilized Medicare data from 2005 to 2008 to assess the mortality risk for VCF patients receiving non-op- erated management, balloon kyphoplasty or vertebroplasty. Of the 858,978 patients newly diagnosed with VCFs, 13.9 percent received bal- loon kyphoplasty and 7.4 percent received ver- tebroplasty. Researchers found adjusted survival rates of 57.3 percent for vertebroplasty patients; 62.8 percent for kyphoplasty patients; and 50 percent for non-operated patients. 9 2. Baltimore-based Johns Hopkins research- ers compared vertebroplasty, kyphoplasty and non-operated management for VCF patients in the Chen et al., a 2013 study published in The Jour- nal of Bone & Joint Surgery. The study, involving 72,693 VCF patients, demonstrated kyphoplasty yielded longer patient survival compared to verte- broplasty and non-operated treatment. 10 3. The 2014 Lange et al., study published in Spine, involved 3,607 patients with osteoporotic verte- bral compression fractures. Of those patients, 598 underwent operations. Over the five-year period, the operated group was 43 percent less likely to die compared to the non-operated cohort. Fur- ther, those patients receiving balloon kyphoplasty had a 66.7 percent 60-month adjusted survival rate compared to the 58.7 percent survival rate for those receiving vertebroplasty. 11 4. The 2015 Edidin A. et al., Spine-published study encompassed 141,343 balloon kypho- plasty patients and 75,364 vertebroplasty pa- tients. Researchers found a 55 percent higher adjusted mortality risk for the non-operated patients than the balloon kyphoplasty patients and a 25 percent higher mortality risk than the vertebroplasty patients. 12 "The mortality benefit always made intuitive sense when one compares the fundamental tenets of conservative therapy which include limitation of activities, back brace and narcotic medication to early mobilization," says Dr. Hirsch of the study. "While claims-based data should always be in- terpreted with caution, Chen's analysis raises im- portant questions for patients who may have been denied the opportunity to consult with a specialist regarding the role augmentation might offer in their case. Put differently, what the medical com- munity lacked, I felt, was a dialogue that would have allowed for a data-driven determination on a person-by-person level." One study, however, discovered no significant differences in mortality risk between augmented patients and non-surgical management patients. The 2013 McCullough B. et al., published in JAMA Internal Medicine, involved 15,851 control patients and 10,541 augmented patients. The study utilized a 20 percent sample of Medicare data. 13 Medtronic has been active in the augmentation scene for decades, with surgeons first perform- ing its Kyphon® Balloon Kyphoplasty in 1998. Surgeons have leveraged Medtronic's balloon kyphoplasty to treat more than 1 million frac- tures; more than 15,000 physicians have under- gone balloon kyphoplasty training worldwide. "Balloon kyphoplasty is one of the few treatment solutions in clinical studies to give patients pain re- lief and quality of life," Mr. Cambra says. To prove the technique's effectiveness, the 21-center Fracture Reduction Evaluation study compared Medtronic's Kyphon® Balloon Kyphoplasty with non-surgical treatment for acute VCF. Researchers found balloon kyphop- lasty relieved back pain, enhanced patient satis- faction and improved mobility and quality of life to a greater effect than non-surgical care. "Medtronic continues to invest in clinical and outcomes research for our balloon kyphoplasty, to offer evidence of health benefits and treat- ments of VCF," Mr. Cambra adds. The compa- ny is currently collecting balloon kyphoplasty 12-month outcome data as well as daily living quality of life and safety measures. Stopping the crisis Every May, NOF raises awareness about preven- tion, diagnosis and treatment during National Osteoporosis Month. The foundation strongly supports the American Society of Bone and Mineral Research Call to Ac- tion to enhance screening, diagnosis and treat- ment of high-risk individuals. Further, the bone health industry is striving to prevent fractures as well as work with patients on informed deci- sion-making for osteoporosis treatments. In February 2017, NOF collaborated with more than 300 patient advocacy and health organi- zations to draft a letter to Congress concerning non-interference in Medicare Part D negotia- tions, urging patient access to all osteoporosis treatment medications. Medtronic is actively contributing to the NOF's cause, offering a continuing education oppor- tunity highlighting cases and mortality data for clinicians to apply in their practices. Medtronic reaches more than 20,000 clinicians through its digital marketing campaign, enlightening them about the risks of leaving VCFs untreated. Through its collaboration with NOF, Medtronic contributes to the foundation's series of educa- tional materials, such as Bone Basics. Medtronic is currently bundling the series into a digital and print publication for clinicians to share with pa- tients, touching on topics such as VCF risk factors, moving safely and spine fractures. Healthcare providers may also access NOF's pro- fessional learning center as well as attend its annual clinical conference for more information about osteoporosis and fractures. Medtronic also sponsors or supports a variety of educational and awareness efforts: • Referral education activities • Dedicated interventional sales reps • Peer-to-peer educational balloon training programs • Clinical update symposiums • Patient education • Direct mailers • Assistance to local education programs • Community outreach References 1 Johnell O and Kanis JA (2006) Osteoporosis Int 17: 1726 2 Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A Tosteson A. Incidence and Economic Burden of Osteoporosis-Related Fractures in the United States, 2005-2025. J Bone Miner Res 2007. 22(3): 465-475. 3 Lindsay R, et al., Risk of new vertebral fracture in the year follow- ing a fracture. JAMA. 2001; 285(3):320-33 4 Ross P, et al., Pre-Existing Fractures and Bone Mass Predict 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 Singer A, et al. Mayo Clin Proc. 2015; 90: 53-62 7 Clark W, et al., Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, ran- domised, double-blind, placebo-controlled trial. The Lancet. 8 file:///C:/Users/ASC6/Downloads/Resurrection%20of%20evi- dence%20for%20vertebroplasty%20(1).pdf 9 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. 10 Chen A, et. al, Impact of Nonoperative Treatment, Vertebro- plasty, and Kyphoplasty on Survival and Morbidity After Verte- bral Compression Fracture in the Medicare Population. J Bone & Joint Surgery, 2013. 11 Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous verte- broplasty using German claims data. Spine (Phila Pa 1976). 2014 Feb 15;39(4): 318-26. doi: 10.1097/BRS.0000000000000135. PubMed PMID: 24299715. 12 Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality after Ver- tebral Fractures: Comparison of Vertebral Augmentation and Non-Op- erative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097. PubMed PMID: 26020845. 13 McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conserva- tive therapy. JAMA Intern Med. 2013 Sep 9;173(16):151421. doi: 10.1001/jamainternmed.2013.8725. PubMed PMID: 23836009; PubMed Central PMCID: PMC4023124. BKP is a minimally invasive procedure for the treatment of patholog- ical fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. Keep in mind that results of this procedure may vary, and all treatment and outcome results are specific to the individual patient. Results may vary. A prescription is required. The complication rate for balloon kyphoplasty has been demonstrated to be low. There are risks associated with the procedure, including serious complications, and though rare, some of which may be fatal. These include, but are not limited to heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs, heart, or brain). Other complications include infection and leakage of bone cement into the muscle and tissue. Cement leakage into the blood vessels may result in damage to the blood vessels, lungs, heart, and/or brain. Cement leakage into the area surrounding the spinal cord may result in nerve injury that can, in rare instances, cause paralysis. Please consult your physician for a complete list of indications, contraindications, benefits, and risks. Only you and your physician can determine whether this procedure is right for you. Learn more about osteoporosis, visit www.nof.org. Learn more about spine fracture at spine-facts.com. Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD. 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, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.