Instability of the Vertebrae Remains following Balloon Kyphoplasty.
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SUBMITTER: Tarukado K
PROVIDER: S-EPMC4078138 | biostudies-other | 2014 Jun
REPOSITORIES: biostudies-other
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Project description:This retrospective analysis of insurance claims evaluated real-world trends in prescription fills among patients treated with balloon kyphoplasty (N = 6,656) or vertebroplasty (N = 2,189) following diagnosis of vertebral compression fracture. Among those with evidence of opioid use, nearly half of patients discontinued or reduced prescription fills relative to pre-operative levels.IntroductionVertebral compression fractures (VCF) are associated with debilitating pain, spinal misalignment, increased mortality, and increased healthcare-resource utilization in elderly patients. This study evaluated the effect of balloon kyphoplasty (BKP) or vertebroplasty (VP) on post-procedure opioid prescription fills and payer costs in patients with VCF.MethodsThis was a retrospective analysis of a large, nationally representative insurance-claims database. Clinical characteristics, opioid prescription patterns, and payer costs for subjects who underwent either BKP or VP to treat VCF were evaluated beginning 6 months prior to surgery through 7-month follow-up that included a 30-day, postoperative medication washout. Patient demographics, changes in opioid utilization, and payer costs were analyzed.ResultsA total of 8,845 patients met eligibility criteria (75.3% BKP and 24.7% VP) with a mean of age 77 and 74% female. Among the 75% of patients who used opioids, 48.7% of patients discontinued opioid medication and 8.4% reduced prescription fills versus preoperative baseline. Patients who reduced or discontinued prescriptions exhibited a decrease in all-cause payer costs relative to pre-intervention levels, which was a significantly greater change relative to patients with no change, increase, or new start of opioids.ConclusionsInterventional treatment for VCF was associated with decreased or discontinued opioid prescription fills and reduced payer costs in follow-up in a significant proportion of the study population. Reduction of opioid-based harms may represent a previously unrecognized benefit of vertebral augmentation for VCF, especially in this elderly and medically fragile population.
| S-EPMC8930950 | biostudies-literature
Project description:Study Design A biomechanical and radiographic study using vertebral analogues. Objectives Kyphoplasty and vertebroplasty are widely used techniques to alleviate pain in fractures secondary to osteoporosis. However, cement leakage toward vital structures like the spinal cord can be a major source of morbidity and even mortality. We define safe cement injection as the volume of the cement injected into a vertebra before the cement leakage occurs. Our objective is to compare the amount of cement that can be safely injected into an osteoporotic vertebra with simulated compression fracture using either vertebroplasty or balloon kyphoplasty techniques. Methods Forty artificial vertebral analogues made of polyurethane with osteoporotic cancellous matrix representing the L3 vertebrae were used for this study and were divided into four groups of 10 vertebrae each. The four groups tested were: low-viscosity cement injected using vertebroplasty, high-viscosity cement injected using vertebroplasty, low-viscosity cement injected using balloon kyphoplasty, and high-viscosity cement injected using balloon kyphoplasty. The procedures were performed under fluoroscopic guidance. The injection was stopped when the cement started protruding from the created vascular channel in the osteoporotic vertebral fracture model. The main outcome measured was the volume of the cement injected safely into a vertebra before leakage through the posterior vascular channel. Results The highest volume of the cement injected was in the vertebroplasty group using high-viscosity cement, which was almost twice the injected volume in the other three groups. One-way analysis of variance comparing the four groups showed a statistically significant difference (p < 0.005). Conclusions High-viscosity cement injected using vertebroplasty delivers more cement volume before cement leakage and fills the vertebral body more uniformly when compared with balloon kyphoplasty in osteoporotic vertebrae with compression fractures.
| S-EPMC4516756 | biostudies-other
Project description:Background and purposeBalloon kyphoplasty is a minimally invasive surgical approach for treating vertebral compression fractures, including osteoporotic vertebral compression fractures. The purpose of this study was to determine the effect of balloon inflation and postural reduction on balloon kyphoplasty for the deformity correction of vertebral compression fractures and to explore the correlative factors affecting the deformity correction.Materials and methodsA retrospective study of 72 patients (75 levels) who had undergone balloon kyphoplasty was conducted. Imaging data and clinical features were collected and analyzed. Independent-samples t test analysis was used to find the possible factors affecting deformity correction.ResultsPostural correction in the overextending position significantly increased anterior middle vertebral height, kyphotic angle, and Cobb angle (each P < .05). There was no significant difference in anterior, middle vertebral height, kyphotic angle, and Cobb angle between postural reduction and balloon dilation (each P > .05). The improvement on the Visual Analog Scale was notable (P < .05). Among a variety of factors, the fracture type (wedge type and biconcave type) affected both the height restoration (P = .003) and kyphotic angle reduction (P = .007). The bone cement injected volume was related to height restoration (P = .011) and kyphotic angle reduction (P = .018).ConclusionsBalloon inflation was useless for deformity correction. The deformity correction was attributed to postural reduction with cement strengthening. The most significant factors affecting deformity correction were the fracture type and bone cement injected volume.
| S-EPMC7966489 | biostudies-literature
Project description:The cost-effectiveness of surgical versus conservative medical management of vertebral compression fractures in the US was analyzed in the context of inpatient versus outpatient treatment. Surgical intervention (balloon kyphoplasty and vertebroplasty) was found to be cost-effective relative to conservative medical management at a US willingness-to-pay threshold.IntroductionTo date, only one published study has evaluated the cost-effectiveness (C/E) of balloon kyphoplasty (BKP) or vertebroplasty (VP) in US Medicare patients with osteoporotic vertebral compression fractures. This study further evaluates the C/E of surgical treatment vs. conservative medical management (CMM), expanding on prior modeling by accounting for quality-adjusted life-years gained.MethodsA Markov microsimulation model of 1000 patients was constructed. Cost data were based on an analysis of Medicare claims payments, with propensity-score matching performed for BKP and VP vs. controls (CMM). Mortality inputs were based on US life tables, modified to account for age at initial fracture, presence of subsequent fracture(s), and relative risk of mortality by treatment. Separate incremental cost-effectiveness ratios (ICERs) were calculated for BKP and VP in inpatient and outpatient surgical treatment locations to account for individual clinical profiles presenting to each.ResultsThe discounted ICER for inpatient BKP vs. CMM was $43,455 per QALY gained; for outpatient BKP vs. CMM, $10,922; for inpatient VP vs. CMM, $39,774; and for outpatient VP vs. CMM, $12,293. Probabilistic sensitivity analysis confirmed that both BKP and VP would be considered C/E vs. CMM at a US willingness-to-pay (WTP) threshold of $50,000/QALY in 80% and 100% of 500 model simulations, respectively. The most sensitive parameters included quality of life estimates and hazard ratios for mortality.ConclusionWhile VP and BKP are more expensive treatment options than CMM in the short term, model results suggest interventional treatment is cost-effective, among patients eligible for surgery, at a US WTP threshold. This conclusion supports those from economic analyses conducted in EU-member countries.
| S-EPMC7661420 | biostudies-literature
Project description:BACKGROUND: Spinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and correct vertebral deformities. We performed a meta-analysis to determine the efficacy and safety of BKP for spinal fractures in cancer patients. METHODS: We searched several electronic databases up to September 2008 and the reference lists of relevant publications for studies reporting on BKP in patients with spinal fractures secondary to osteolytic metastasis and multiple myeloma. Outcomes sought included pain relief, functional capacity, quality of life, vertebral height, kyphotic angle and adverse events. Studies were assessed for methodological bias, and estimates of effect were calculated using a random-effects model. Potential reasons for heterogeneity were explored. RESULTS: The literature search revealed seven relevant studies published from 2003 to 2008, none of which were randomized trials. Analysis of those studies indicated that BKP resulted in less pain and better functional outcomes, and that these effects were maintained up to 2 years post-procedure. While BKP also improved early vertebral height loss and spinal deformity, these effects were not long-term. No serious procedure-related complications were described. Clinically asymptomatic cement leakage occurred in 6% of all treated levels, and new vertebral fractures in 10% of patients. While there is a lack of studies comparing BKP to other interventions, some data suggested that BKP provided similar pain relief as vertebroplasty and a lower cement leakage rate. CONCLUSION: It appears that there is level III evidence showing BKP is a well-tolerated, relatively safe and effective technique that provides early pain relief and improved functional outcomes in patients with painful neoplastic spinal fractures. BKP also provided long-term benefits in terms of pain and disability. However, the methodological quality of the original studies prevents definitive conclusions being drawn. Further investigation into the use of BKP for spinal fractures in cancer patients is warranted.
| S-EPMC2746801 | biostudies-other
Project description:BackgroundBecause of aging of population, osteoporotic vertebral compression fracture (OVCF) appears an increasing incidence rate. Conservative therapy (CT) and balloon kyphoplasty (BKP) have been used to treat OVCFs. However, an increase in new vertebral compression fractures at nontreated levels following BKP is of concern. It is still not clear whether new fractures were a result of BKP and the purpose of this meta-analysis was to evaluate the new fractures risk after BKP compared with CT.MethodsAn exhaustive literature search of PubMed, EMBASE, and the Cochrane Library was conducted to identify randomized controlled trials and prospective nonrandomized controlled study that compared BKP with CT for patients suffering OVCF. A random-effect model was used. Results were reported as standardized mean difference or risk ratio with 95% confidence interval.ResultsTwelve studies were included and there was no significant difference in total new fractures (P = .33) and adjacent fractures (P = .83) between 2 treatments. Subgroup analyses did not demonstrate significant differences in follow-up period, mean age, anti-osteoporosis therapy, and the proportion of women.ConclusionOur systematic review revealed that an increased risk of fracture of vertebral bodies was not associated with BKP compared with CT.
| S-EPMC6200511 | biostudies-literature
Project description:This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.
| S-EPMC2200787 | biostudies-literature
Project description:We retrospectively evaluated single-level compression fractures (T12-L3) scheduled for a short-segment POS (posterior-only stabilization) using polyaxial screws. Patients averaged 55.7 years (range, 19-65). Patients received either POS or, concomitantly, BK (balloon kyphoplasty) of the fractured vertebrae as well. Primary endpoint was the radiological outcome at the last radiographic follow-up prior to implant removal. POS together with BK of the fractured vertebrae resulted in a significant improvement of the local kyphosis angle and vertebral body compression rates immediately post-OP. During the further course of FU, a considerable loss of correction was observed post-OP in both groups. (Local KA: pre-OP/ post-OP/ FU: 12.6±4.8/ 3.35±4.8/ 11.6±6.0; anterior vertebral body compression%: pre-OP/post-OP/ FU: 71.94±12.3/ 94.78±19.95/ 78.17±14.74). VAS was significantly improved from 7.2±1.3 pre-OP to 2.7±1.3 (P<0.001) at FU. We found a significant restoration of the vertebral body height by BK. Nevertheless, follow-up revealed a noticeable loss of reduction. Given the fact that BK used together with polyaxial screws did not maintain intra-operative reduction, our data do not support this additional maneuver when used together with bi-segmental polyaxial pedicle screw fixation.
| S-EPMC7233542 | biostudies-literature
Project description:When a dielectric elastomer (DE) balloon is subjected to electromechanical loading, instability may happen. In recent experiments, it has been shown that the instability configuration of a DE balloon under electromechanical loading can be very different from that only subjected to mechanical load. It has also been observed in the experiments that the electromechanical instability phenomena of a DE balloon can be highly time-dependent. In this article, we adopt a nonlinear viscoelastic model for the DE membrane to investigate the time-dependent electromechanical instability of a DE balloon. Using the model, we show that under a constant electromechanical loading, a DE balloon may gradually evolve from a convex shape to a non-convex shape with bulging out in the centre, and compressive hoop stress can also gradually develop the balloon, resulting in wrinkles as observed in the experiments. We have further shown that the snap-through instability phenomenon of the DE balloon also greatly depends on the ramping rate of the applied voltage.
| S-EPMC6784404 | biostudies-literature
Project description:PurposeBalloon kyphoplasty is currently widely used for the treatment of vertebral compression fractures (VCFs). Procedure safety is directly linked to precise radiological imaging generated by various X-ray systems (C-arm, O-arm, angiography table, etc.). This minimally invasive spinal surgery is, by definition, associated with significant radiation exposure for both patient and surgeon. Real dose exposure received by the surgeon is usually difficult to precisely record. In our center, all Balloon Kyphoplasty Procedures (BKP) are now performed using an O-arm image guidance system to control cement augmentation in VCF. Our preliminary experience described reduced dose exposure compared to C-arm guided procedures. We present here an additional way to considerably reduce the amount of radiation received by the surgeon during BKP using a new injection system.MethodsWe prospectively evaluated O-arm guided BKP in 20 consecutive patients alternatively allocated to either classic O-arm BKP with direct bone filler injection or BKP using a new Cement Delivery System (CDS). Eye, wrist, finger and leg measurements were taken bilaterally and compared between the two groups.ResultsThe radiation dose received by the surgeon's finger, wrist and leg was reduced by greater than 80% when using the CDS. It allows the surgeon to work way below the most severe annual limit of dose exposure, which may not be the case when using a classical bone filler direct injection mechanism.ConclusionWe believe that when using this new intraoperative injection system, the surgeon's overall anatomic exposure is significantly reduced without compromising the critical procedure steps.
| S-EPMC3731504 | biostudies-literature