Patients suffer vertebral compression fractures when their bones become too fragile. VCF complications may include impaired gait, disability, reduced lung function, early satiety, future fracture risk and mortality. The National Osteoporosis Foundation reports a vertebral fracture occurs every 22 seconds globally, and about two-thirds of VCFs are initially asymptomatic and under-diagnosed.1
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Older women, especially, are at great risk of developing VCFs. A 2015, 12-year study published in Mayo Clinic Proceedings compared hospitalizations for osteoporotic fractures in women 55 years and older to hospitalizations for other conditions. The study discovered 4.9 million hospitalizations for osteoporotic fractures in women, more than the hospitalizations for myocardial infarction, stroke or breast cancer.2
Patients with VCFs have a variety of treatment options, including non-surgical management (NSM), balloon kyphoplasty (BKP) and vertebroplasty. NSM often involves bracing patients and prescribing opioids for pain management.
NSM in the elderly population poses a particularly challenging healing environment, "because if you give them enough time, they will form fibrosis in the fracture, but if their bone quality is that bad, they have no innate ability to heal themselves," says Brett Schlifka, DO, a neurosurgeon in Wellington, Fla. "I never brace anybody because [it can be] such a worthless endeavor." And adding narcotics into the mix presents a "recipe for disaster" for the elderly, as the medication will make them "loopy" and at risk of losing their balance, says Dr. Schlifka.
Drug reliance can be a problem
Opioids play a major role in NSM of VCFs, so many providers seek alternative treatment methods to combat the opioid epidemic sweeping the nation. In 2015, the amount of opioids prescribed tripled the amount prescribed in 1999, according to the CDC.3
The CDC reported 22,000-plus deaths related to prescription opioids in the United States in 2015, translating to about 62 deaths daily.4 Consuming opioids for extended periods of time or in greater doses will increase risk of addiction, overdose or death.
This nationwide epidemic is especially active in rural areas. Radiologist David Buechner, MD, of Memphis Radiological in Germantown, Tenn., notes the opioid epidemic is very present in his practice, and opioid-addicted patients have a higher morbidity rate, which leads to an excess of hospital admissions. Tennessee lawmakers are now taking action, pioneering a legislative commission in January 2018 dedicated to opioid issues.
"Just having strict legislation to try to reduce the amount of prescriptions is only part of the answer," Dr. Buechner argues. "The problem is so complex; we have to offer alternative forms of therapy to patients." And it is imperative these alternative treatment options catch the condition early. The addictive potential of opioids poses a critical reason for the importance of early detection of VCFs.
Dr. Schlifka agrees: "There are many benefits to treating early. We need a quick procedure with low morbidity and low risk that yields a high benefit of getting people out of the hospital, mobilized and off their narcotics quicker."
That's where procedure-based pain management techniques, such as balloon kyphoplasty, come in.
How balloon kyphoplasty stacks up against non-surgical management
Balloon kyphoplasty is an augmentation procedure designed to stabilize the spine.
Balloon kyphoplasty is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer or benign lesion. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung, or lymphoma. Benign lesions include hemangioma and giant cell tumor.
Surgeons mechanically treat a fracture by inserting and inflating a balloon to create an open cavity inside the bone for injecting bone cement. Surgeons insert a controlled amount of Kyphon bone cement into the cavity, which creates an internal cast to stabilize the fracture.
"In my practice, the reason we want to do more balloon kyphoplasty is because evidence shows [patients] have much better pain relief short- and long-term and rewduce the amount of opioid use," explains Dr. Buechner. "Pain is the number one reason people seek medical care, so we need a viable procedurebased option to treat pain."
Medtronic's BKP offering is Kyphon Balloon Kyphoplasty, a minimally invasive procedure designed to repair spinal fractures. More than 15,000 physicians have undergone balloon kyphoplasty training worldwide and treated more than 1 million fractures with the procedure.
Medtronic has conducted five multicenter trials on VCFs in patients with osteoporosis and cancer, and has the largest randomized controlled trial on BKP versus NSM.
"We have certainly observed pain relief profiles across these studies, finding statistically and clinically significant pain reductions from baseline observed early from week one that persisted through 12 months or 24 months," says John Tillman, PhD, clinical director at Medtronic.
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 significant. 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.
References
1Johnell O and Kanis JA (2006) Osteoporosis Int 17: 1726
2Singer A, et al. Mayo Clin Proc. 2015; 90: 53-62
3Guy 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
4CDC, Opioid Data Analysis. https://www.cdc.gov/drugoverdose/data/analysis.html
5Berenson 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
6Wardlaw 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
7Boonen 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
8Van 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.
9Dohm 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.
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