With the onset of a vertebral compression fracture, a patient may experience a downward spiral of morbidity. These risks may include impaired gait, disability, reduced lung function, early satiety, future fracture risk and excess mortality.
During a Medtronic-sponsored webinar, Kevin L. Ong, PhD, PE, principal engineer of Exponent and adjunct member of Drexel University's School of Biomedical Engineering in Philadelphia, and Douglas Beall, MD, chief of radiology services at Clinical Radiology of Oklahoma in Edmond, shared insights into the mortality and morbidity risks for patients with VCFs.1-5
Dr. Ong contributed to the Lau et al., 2008 research, which found patients with VCFs experience an increased mortality risk of 69 percent at five years.6 Various treatment methods, like non-surgical management, vertebroplasty and balloon kyphoplasty, exist for VCF patients.
Curious about the associated morality risks, numerous studies compared these various treatments. In 2009, The New England Journal of Medicine published two papers, which reported similar outcomes for vertebroplasty and control patients. These findings shed speculation on the effectiveness of augmentation.
In response to these papers, Dr. Ong and his colleagues compared non-surgical management, vertebroplasty and balloon kyphoplasty as treatments for VCF patients.
Several recent large studies followed for at least 12 months after vertebral compression fracture (VCF) have concluded that mortality rates following VCFs are significantly higher for patients treated conservatively versus VP or BKP, while other studies have concluded no difference. (For more information, visit www.medtronic.com/bkpmortality)
Comparing VCF treatments
Dr. Ong's team analyzed clinical data from five studies, each with more than 1,000 patients and 12 months of follow-up. Four of the studies revealed balloon kyphoplasty and vertebroplasty offering patients lower mortality risk — up to 43 percent lower risk at five-year follow-up — compared to those patients receiving non-surgical management.
In a subgroup analysis, the fifth study, 2013 McCullough B. et al., discovered no significant differences in mortality risk between augmented patients and non-surgical management patients.
Studies presented have limitation, in particular they (1) are retrospective database analyses and are prone to selection bias; (2) have variables that are not captured in the database that may explain mortality effects; (3) have study designs that cannot demonstrate causality of treatment received with mortality outcomes and (4) may indicate to some extent that BKP (and VP) subjects have better “baseline” health, which may at least partially explain the mortality benefit.
Published in the Journal of Bone and Mineral Research 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-operated management, balloon kyphoplasty or vertebroplasty.
Of the 858,978 patients newly diagnosed with VCFs, 13.9 percent received balloon kyphoplasty and 7.4 percent received vertebroplasty.
"What we found, was that mortality risk at four years was 39 percent for the operated patients compared to 50 percent for the non-operated patients," said Dr. Ong. The researchers also discovered balloon kyphoplasty patients experienced a lower adjusted risk of morality by 23 percent compared to vertebroplasty patients.
Dr. Ong and his team further analyzed the Medicare data, publishing a paper in 2015 in Spine. With a new cohort of more than 1 million patients newly diagnosed with VCFs, the researchers analyzed the morality risk with or without pneumonia diagnosed 90 days before to death. They hoped to learn more about the causes of death with this study.
The study revealed about half of the patients died at four years. Dr. Ong emphasized they also found a "substantial proportion of patients who died with pneumonia diagnosed in the 90 days prior to death."
Overall, Dr. Ong and his colleagues found enhanced outcomes for the operative cohort as well as "relied on morbidities to provide some insights into the potential causes of death for these patients."
The 2013 Chen A. et al. study also supported the findings from the previously mentioned two studies. Utilizing 2006 Medicare data for 68,752 VCF patients, the study found non-operative patients had a survival rate of 42 percent at three years. This compared to a survival rate of about 50 percent for vertebroplasty patients and about 60 percent for balloon kyphoplasty patients. The researchers also noted higher readmission rates for the non-operated group compared to the augmentation group.
The 2014 Lange A. et al. study published in Spine analyzed 441 balloon kyphoplasty patients, 157 vertebroplasty patients and 3,009 non-operated patients. The researchers found the operated patients experienced a 43 percent lower risk of mortality at five years compared to non-operated patients.
In 2013, the National Institute for Health and Care Excellence issued guidelines on vertebroplasty and balloon kyphoplasty, recommending the treatments.
The McCullough study
The 2013 McCullough study utilized a 20 percent sample of Medicare data and encompassed 115,851 control patients and 10,541 augmented patients. These researchers analyzed selection bias by comparing the health status of augmentation patients with control patients.
Commentary on the McCullough study addressed the absence of "separate analyses for vertebroplasty and kyphoplasty procedures," but still concluded the study suggested no beneficial effect of augmentation.
However, this subset analysis excluded the great majority (71 percent) of augmentation patients, because it only included those patients who didn't have augmentation in the first 30 days. Dr. Ong noted, therefore, they focused on only the healthiest augmented patients, whereas the majority of augmented patients may have required emergent care.
Dr. Ong also commented on the flawed interpretation of one-year healthcare utilization, claiming augmented patients used more healthcare resources than the control patients.
"However, their data included use of healthcare resources prior to the actual surgery, and if you look at the use of resources post-augmentation, the rate of healthcare resources is actually lower compared to the control patients," explained Dr. Ong.
Diving into a case study
Dr. Beall introduced a case study involving an 88-year-old female patient with primary osteoporosis and no previous VCFs. Her pain progressed to the point of her hospitalization.
"One thing that we have to keep in mind, is one fracture puts patients at a dramatic increased risk of another," said Dr. Beall. A patient with three or more fractures has a 75 times increased risk of suffering another fracture, according to the JAMA 2001 Lindsay R, et al. study. "So, usually what I tell the family and the patient, is it's not if, it's when."
Additionally, non-surgically managed patients are at a higher risk of pneumonia, deep vein thrombosis, myocardial infarction/cardiac complications and urinary tract infections, according to a 2000 Cauley JA, et al. study.
Non-surgically managed patients also experience longer stays in the hospital, at 7.38 days compared to 3.74 days, based on the Chen A, et al. study. The Chen study also revealed readmission rates of 61.9 percent for non-surgically managed patients, compared to 35.2 percent for balloon kyphoplasty patients.
Dr. Beall performed balloon kyphoplasty on the case study patient at T11, T12 and L1. "An adequate fill is, after ballooning, you get the fill in and around the balloon, so it's very difficult to see the area where you ballooned," explained Dr. Beall.
Following balloon kyphoplasty, the patient reported near complete pain relief the next day. Within two weeks post-procedure, she reported minimal pain and stopped taking pain medications.
"Only about 20 percent of vertebral compression fractures have the chance to undergo vertebral augmentation," said Dr. Beall, referencing the 2016 Cox M., et al. study.
Although bracing is sometimes considered the gold standard, Dr. Beall noted no data exists comparing bracing to vertebral augmentation.
Important risk information:
Balloon Kyphoplasty is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion.
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. It is important to discuss the potential risks, complications and benefits of BKP with a doctor prior to receiving treatment and to rely on the judgment of a physician. Only your doctor can determine whether you are a good candidate for BKP. To learn more about vertical compression fractures, view videos about the procedure or find a practicing BKP specialist, visit Back.com/kyphoplasty.
For more information, visit spine-facts.com.
- 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. PubMed PMID: 21308780. http://www.ncbi.nlm.nih.gov/pubmed/21308780
- Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population. J Bone Joint Surg Am. 2013 Oct 2;95(19):1729-36. doi: 10.2106/JBJS.K.01649. PubMed PMID: 24088964. http://www.ncbi.nlm.nih.gov/pubmed/24088964
- Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine (Phila Pa 1976). 2014 Feb 15;39(4): 318-26. doi: 10.1097/BRS.0000000000000135. PubMed PMID: 24299715. http://www.ncbi.nlm.nih.gov/pubmed/24299715
- Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality 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. http://www.ncbi.nlm.nih.gov/pubmed/26020845
- McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013 Sep 9;173(16):1514-21. doi: 10.1001/jamainternmed.2013.8725. PubMed PMID: 23836009; PubMed Central PMCID: PMC4023124. http://www.ncbi.nlm.nih.gov/pubmed/23836009
- Lau E, Ong K, Kurtz S, et al. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86. doi: 10.2106/JBJS.G.00675. http://www.ncbi.nlm.nih.gov/pubmed/18594096
Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, MD.
Pictured: Dr. Kevin L. Ong and Dr. Douglas Beall
View the webinar slides here.
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