Dataset Information

The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study.

ABSTRACT:

Purpose

Balloon 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.

Methods

We 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.

Results

The 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.

Conclusion

We believe that when using this new intraoperative injection system, the surgeon's overall anatomic exposure is significantly reduced without compromising the critical procedure steps.

SUBMITTER: Schils F

PROVIDER: S-EPMC3731504 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Publications

The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study.

Schils Frédéric F Schoojans Werner W Struelens Lara L

European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 20130209 8

<h4>Purpose</h4>Balloon 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, ...[more]

PMID: 23397218

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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.

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.

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.

Project description:STUDY DESIGN: Comparative effectiveness review. STUDY RATIONALE: The spine is among the most common location for bony metastases. In many cases these metastases cause fractures leading to increased morbidity. Percutaneous cement augmentation techniques have been developed over the past decades for the treatment of these fractures; however, there are little data comparing these interventions. CLINICAL QUESTION: Do comparative studies of vertebral cement augmentation for fractures caused by spinal tumors provide evidence of improved patient outcomes? METHODS: A systematic search and review of the literature was undertaken to identify studies published through June 8, 2011. Two individuals independently reviewed articles based on inclusion and exclusion criteria which were set a priori. Each article was evaluated using a predefined quality-rating system and an overall strength of evidence determined. RESULTS: The literature consists primarily of case series. Only two studies comparing vertebroplasty with kyphoplasty were found. Pain scores in both treatment groups were significantly decreased relative to preoperative scores and appear to have been sustained at follow-up times to 1 year. It is unclear whether one treatment provided superior pain relief than the other. Both studies reported decreased analgesic use after both treatments but neither study compared use between treatment groups. Balloon rupture occurred in one kyphoplasty patient in one study and extravasation of polymethylmethacrylate (PMMA) cement into the anterior perivertebral soft tissue was seen in another patient in the vertebroplasty group and no patients in the kyphoplasty group in the other study. No other intraoperative or postoperative complications occurred. CONCLUSIONS: There is only limited evidence from comparative studies (two small retrospective cohort studies) regarding the benefits of vertebroplasty versus kyphoplasty in patients with spinal fractures caused by tumors. Both appear to be effective in reducing pain with relatively few complications. Whether one method provides superior results over the other cannot be determined from the available evidence. Study limitations preclude making definitive conclusions. The overall strength of evidenced is very low.

Dataset Information

The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study.

Purpose

Methods

Results

Conclusion

Publications

The surgeon's real dose exposure during balloon kyphoplasty procedure and evaluation of the cement delivery system: a prospective study.

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