Issue link: https://beckershealthcare.uberflip.com/i/948573
18 Executive Briefing Dr. Tillman specifically points to the Cancer Patient Fracture Evaluation (CAFE) trial and the Fracture Reduction Evaluation (FREE) study as two pieces of evidence supporting balloon kyphoplasty. The 2011 CAFE trial compared BKP to NSM for cancer patients suffering from VCFs. 5, 6 Researchers concluded BKP offered a "treatment that rapidly reduces pain and improves function." "In the CAFE trial, the primary endpoint was back functioning, and we found the back function was superior in kyphoplasty at one month," adds Dr. Tillman. The 2009 FREE trial compared Medtronic's Kyphon Balloon Kyphoplasty to NSM for patients with osteoporosis, with a primary outcome of change from baseline to one month in the short-form-36 physical component summary score. The 21-center trial demonstrated BKP's superiority in pain reduction, patient satisfaction and mobility at one month on the SF-36 PCS scale, compared to the NSM group. "In the FREE trial, BKP provided better quality of life that was statistically and clinically significant," says Dr. Tillman, noting SF-36 PCS proved statistically significant through six-month follow-up. A 2011 two-year study built on the findings of the FREE trial; averaged across 24 months, the differences between the two groups proved statistically significant in pain reduction as well as function, disability and quality of life improvement for the BKP group. 7 In addition to FREE and CAFE, Medtronic also participated in a 2013 study on efficacy and safety differences between BKP and NSM over a 24-month period for VCF patients. Researchers found BKP patients experienced more improvements in SF-36 PCS scores at one month and when averaged across 24 months compared to the NSM cohort. 8 A 2014 study focused on a different angle, comparing BKP to vertebroplasty for patients suffering from VCFs stemming from osteoporosis. Researchers discovered BKP and vertebroplasty yielded comparable long-term pain and disability improvement. 9 Of the patients Dr. Buechner treats for VCFs, the vast majority are pleased they don't have to take opioids as part of their treatment. Some of his patients come in with addictive signs to pain medicine, which presents an additional condition Dr. Buechner must address. The FREE trial supports Dr. Buechner's point that BKP can reduce opioid use. At baseline, about 70 percent of the 300 patients were taking a form of opioid pain medication. At the six-month follow-up, 30 percent fewer kyphoplasty patients were taking opioids than NSM patients, which was statistically significaznt. The major highlight here is kyphoplasty delivered "much better pain relief than NSM in combination with using fewer opioids to control that pain," adds Dr. Tillman. In the CAFE trial, analgesic use for pain among kyphoplasty patients trended lower at one-month follow-up compared to NSM patients. Curbing opioid abuse Medtronic is working closely with local clinicians across the region to increase community awareness on benefits of minimally invasive treatment options for VCFs. Along with the National Osteoporosis Foundation, there is an aggressive push for an education outreach program about VCF and treatment options. The program currently reaches 20,000 clinicians and 50,000 consumers. The company offers medical education programs related to VCF as well as offers evidence-based education to nurse practitioners and physician assistants at major meetings. These efforts establish Medtronic as an educational partner in reducing opioid abuse among VCF patients. "We are partnering with local key opinion leaders in driving education on opioid reduction. As a responsible organization, we strongly stand by our commitment to impact communities through our messaging," says Jeff Cambra, general manager of Interventional Pain Therapies – Restorative Therapies Group at Medtronic. Important Safety Information The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious 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 serious adverse events, such as: Cardiac arrest, Cerebrovascular accident, Myocardial infarction, Pulmonary embolism and Cardiac embolism. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product. n References 1 Johnell O and Kanis JA (2006) Osteoporosis Int 17: 1726 2 Singer A, et al. Mayo Clin Proc. 2015; 90: 53-62 3 Guy G Jr, PhD, et al. Vital Signs: Changes in Opioid Prescribing in the United States, 2006–2015. CDC. https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4. htm#contribAff 4 CDC, Opioid Data Analysis. https://www.cdc.gov/drugoverdose/data/analysis.html 5 Berenson J, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35. doi: 10.1016/S1470-2045(11)70008-0. Epub 2011 Feb 16. https://www.ncbi.nlm.nih.gov/pubmed/21333599 6 Wardlaw D, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial The Lancet. 2009 March; PMID: 19246088 DOI: 10.1016/S0140- 6736(09)60010-6. https://www.ncbi.nlm.nih.gov/pubmed/19246088 7 Boonen S, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. Journal of Bone and Mineral Research. 2011 June. DOI: 10.1002/jbmr.364 8 Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine. 2013; 38(12):971-983. 9 Dohm M, Black C, Dacre A, et al. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures (VCFs) due to osteoporosis. AJNR 2014. http://www.ajnr.org/content/35/12/2227.full.pdf+html. PMD020483-1.0 UC201807975 EN Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medi- cal 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 phy- sicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.