Association between timing of kyphoplasty and opioid prescribing risk after vertebral fracture.

OBJECTIVE: Approximately 550,000 Americans experience vertebral fracture annually, and most receive opioids to treat the resulting pain. Kyphoplasty of the fractured vertebra is a procedural alternative that may mitigate risks of even short-term opioid use. While reports of kyphoplasty's impact on pain scores are mixed, no large-scale data exist regarding opioid prescribing before and after the procedure. This study was conducted to determine whether timing of kyphoplasty following vertebral fracture is associated with duration or intensity of opioid prescribing. METHODS: This retrospective cohort study used 2001-2014 insurance claims data from a single, large private insurer in the US across multiple care settings. Patients were adults with vertebral fractures who were prescribed opioids and underwent balloon-assisted kyphoplasty within 4 months of fracture. Opioid overdose risk was stratified by prescribed average daily morphine milligram equivalents using CDC guidelines. Filled prescriptions and risk categories were evaluated at baseline and 90 days following kyphoplasty. RESULTS: Inclusion criteria were met by 7119 patients (median age 77 years, 71.7% female). Among included patients, 3505 (49.2%) were opioid naïve before fracture. Of these patients, 31.1% had new persistent opioid prescribing beyond 90 days after kyphoplasty, and multivariable logistic regression identified kyphoplasty after 8 weeks as a predictor (OR 1.34, 95% CI 1.02-1.76). For patients previously receiving opioids, kyphoplasty > 4 weeks after fracture was associated with persistently elevated prescribing risk (OR 1.84, 95% CI 1.23-2.74). CONCLUSIONS: New persistent opioid prescribing occurred in nearly one-third of patients undergoing kyphoplasty after vertebral fracture, although early treatment was associated with a reduction in this risk. For patients not naïve to opioids before fracture diagnosis, early kyphoplasty was associated with less persistent elevation of opioid overdose risk. Subsequent trials must compare opioid use by vertebral fracture patients treated via operative (kyphoplasty) and nonoperative (ongoing opioid) strategies before concluding that kyphoplasty lacks value, and early referral for kyphoplasty may be appropriate to avoid missing a window of efficacy.

The risk factors of vertebral refracture after kyphoplasty in patients with osteoporotic vertebral compression fractures: a study protocol for a prospective cohort study.

BACKGROUND: Percutaneous kyphoplasty (PKP) is the first-line treatment for osteoporotic vertebral compression fractures (OVCFs) that can immediately relieve pain and allow the quick recovery of lost mobility. However, some studies reported that after PKP, the incidence of vertebral refracture, particularly adjacent vertebral fracture (AVF), was high. Our previous meta-analysis suggested that the risks for vertebral refracture and AVF did not increase after percutaneous vertebral augmentation in OVCF patients. Despite the negative results of our meta-analysis, there is still significant evidence regarding the relationship between kyphoplasty and AVF, so a new prospective cohort study is warranted. In addition, in our previous retrospective study, we found that advanced age, female sex and low oestradiol (E2) concentrations might be related to the occurrence of postoperative vertebral refracture after PKP. To sufficiently evaluate the probable factors involved in the occurrence of postoperative vertebral refracture, we designed this prospective study. METHODS: This is a prospective cohort study of patients admitted for PKP to treat painful OVCFs. The baseline data, including demographic information, lifestyle, bone metabolic status, sex hormone and sex hormone-binding globulin (SHBG) levels, and clinical characteristics will be collected at the time of enrolment. Surgical features of PKP will be recorded on the operation day. Lifestyle, bone metabolic status, sex hormone levels, and SHBG levels will be assessed during the follow-up period at 1 m, 3 m, 12 m, and 24 m postoperatively. Patients suffering from acutely aggravated back pain will be referred to an orthopaedist, and refractured vertebrae will be confirmed by magnetic resonance imaging and computed tomography. The primary outcome will be the incidence of vertebral refracture. Multivariate analyses will be carried out to evaluate the variables that are independently correlated with vertebral refracture. DISCUSSION: To evaluate the risk of postoperative refracture preoperatively and to identify the surgical points related to postoperative refracture, this study will explore the risk factors related to vertebral refracture after PKP. The results may provide new information about defining OVCF patients suitable for PKP treatment. TRIAL REGISTRATION: ChiCTR-ROC-17011562 . Registered on July 4th, 2017.

Current status of percutaneous vertebroplasty and percutaneous kyphoplasty--a review.

Percutaneous vertebroplasty (PV) and kyphoplasty (PK) are the 2vertebral augmentation procedures that have emerged as minimally invasive surgical options to treat painful vertebral compression fractures (VCF) during the last 2 decades. VCF may either be osteoporotic or tumor-associated. Two hundred million women are affected by osteoporosis globally. Vertebral fracture may result in acute pain around the fracture site, loss of vertebral height due to vertebral collapse, spinal instability, and kyphotic deformity. The main goal of the PV and PK procedures is to give immediate pain relief to patients and restore the vertebral height lost due to fracture. In percutaneous vertebroplasty, bone cement is injected through a minimal incision into the fractured site. Kyphoplasty involves insertion of a balloon into the fractured site, followed by inflation-deflation to create a cavity into which the filler material is injected, and the balloon is taken out prior to cement injection. This literature review presents a qualitative overview on the current status of vertebral augmentation procedures,especially PV and PK, and compares the efficacy and safety of these 2 procedures. The review consists of a brief history of the development of these 2 techniques, a discussion on the current research on the bone cement, clinical outcome of the 2 procedures, and it also sheds light on ongoing and future research to maximize the efficacy and safety of vertebral augmentation procedures.

[Kyphoplasty update : What are the limits - what is possible?]. / Kyphoplastie Update : Wo liegen die Grenzen - was geht?

Kyphoplasty is an established procedure for the treatment of osteoporotic vertebral compression fractures. Developments in instrumentation and techniques have facilitated its use also for other localizations. In the hands of experienced practitioners smaller working cannulas and balloons have made successful treatment of high thoracic and cervical fractures and metastases possible. Balloon kyphoplasty performed for sacral insufficiency fractures in older patients plagued by chronic pain leads to marked pain reduction as well as faster weight-bearing. There are also early research results regarding the repair of tibial head defects and reinforcement with resorbable cement. These new procedures, which are currently applied by only a few surgeons, will be introduced and described in a case-specific manner.

Independent Living 1 Year After Balloon Kyphoplasty for Osteoporotic Vertebral Compression Fracture.

BACKGROUND: The prevalence of osteoporotic vertebral compression fracture (OVCF) is increasing. The indications for and efficacy of balloon kyphoplasty (BKP) are controversial. We sought to identify predictors of outcome after BKP in patients with OVCF. METHODS: Between January 2001 and December 2019, 152 patients underwent BKP for painful OVCFs at our institution. This study included 115 patients who were followed for >12 months, and their data were retrospectively analyzed. With regard to the degree of independent living 1 year after BKP, patients were divided into a good outcome group (composed of patients who could independently go indoors) and a poor outcome group. We analyzed factors associated with outcome and subsequent OVCF. RESULTS: Mean age of patients was 77.9 years, 58.2% were female, 81% had a good outcome, and 19% had a poor outcome. Univariable analysis revealed significant differences in age, bone mineral density, preoperative vertebral body decompression rate, body mass index (BMI), preoperative Japanese Orthopaedic Association score, preoperative modified Rankin Scale score, and subsequent OVCF. Multivariable logistic analysis showed that low BMI (odds ratio 1.415, 95% confidence interval 1.06-1.87, P = 0.046) and subsequent OVCF (odds ratio 0.13, 95% confidence interval 0.02-0.69, P = 0.044) were independent risk factors. The incidence of subsequent OVCF was also lower among patients with higher BMI (odds ratio 0.83, 95% confidence interval 0.72-0.95, P = 0.001). CONCLUSIONS: BMI and subsequent OVCF are the most influential predictors of independent living 1 year after BKP for OVCF.

Vertebroplasty and kyphoplasty in the USA from 2004 to 2017: national inpatient trends, regional variations, associated diagnoses, and outcomes.

BACKGROUND: To explore the national inpatient trends, regional variations, associated diagnoses, and outcomes of vertebral augmentation (vertebroplasty and kyphoplasty) in the USA from 2004 to 2017. METHODS: Data from the National Inpatient Sample were used to study hospitalization records for percutaneous vertebroplasty and kyphoplasty. Longitudinal projections of trends and outcomes, including mortality, post-procedural complications, length of stay, disposition, and total hospital charges were analyzed. RESULTS: Following a period of decreased utilization from 2008 to 2012, hospitalizations for vertebroplasty and kyphoplasty plateaued after 2013. Total hospital charges and overall financial burden of hospitalizations for vertebroplasty and kyphoplasty increased to a peak of $1.9 billion (range $1.7-$2.2 billion) in 2017. Overall, 8% of procedures were performed in patients with a history of malignancy. In multivariable modeling, lung cancer (adjusted OR (aOR) 2.6 (range 1.4-5.1)) and prostate cancer (aOR 3.4 (range 1.2-9.4)) were associated with a higher risk of mortality. The New England region had the lowest frequency of routine disposition (14.1±1.1%) and the lowest average hospital charges ($47 885±$1351). In contrast, 34.0±0.8% had routine disposition in the West Central South region, and average hospital charges were as high as $99 836±$2259 in the Pacific region. The Mountain region had the lowest number of procedures (5365±272) and the highest mortality rate (1.2±0.3%). CONCLUSION: National inpatient trends of vertebroplasty and kyphoplasty utilization remained stable after a period of decline from 2008 to 2012, while the financial burden of hospitalizations increased. Despite recent improvements in outcomes, significant regional variations persisted across the USA.

Cost-Benefit Analysis of Routine Bone Biopsy During Augmentation of Osteoporotic Vertebral Compression Fractures.

STUDY DESIGN: Multi-center prospective study. OBJECTIVE: To analyze the cost of routine biopsy during augmentation of osteoporotic vertebral compression fractures (VCF) and the affect it has on further treatment. SUMMARY OF BACKGROUND DATA: Vertebroplasty (VP) and Balloon Kyphoplasty (BKP) are accepted treatments for VCF. Bone biopsy is routinely performed during every VCF surgery in many centers around the world to exclude an incidental finding of malignancy as the cause of the pathological VCF. The incidence been reported as 0.7% to 7.3%, however the published cohorts are small and do not discuss cost-benefit aspects. METHODS: From 2008 to 2016 we performed 122 vertebral biopsies routinely on 116 patients in three hospitals. Twenty-three patients had history of malignancy (26 biopsies) and four were suspected of having malignancy based on imaging findings. The remaining 86 patients (99 biopsies) were presumed osteoporotic VCF. RESULTS: Out of 99 biopsies in the VCF cohort group only one yielded an unsuspected malignancy (1.16%), positive for multiple myeloma (MM). The ability of clinical assessment and imaging alone to diagnose malignancy was found to be 91.7% sensitive and 84.2% specific in our cohort. CONCLUSION: Routine bone biopsy during vertebral augmentation procedure is a safe option for evaluating the cause of the VCF but has significant cost to the health system. The cost of one diagnosed case of unsuspected malignancy was $31,000 in our study. The most common pathology was MM, which has not been proven to benefit from early diagnosis. When comparing clinical diagnosis with imaging, a previous history of malignancy was found in only 40.7% of VCF patients, while imaging was 100% accurate in predicting presence of malignancy on biopsy. This study reassures spine surgeons in their ability to diagnose malignant VCFs and does not support the significant cost of routine bone biopsies. LEVEL OF EVIDENCE: 3.

Medicare Utilization and Reimbursement for Vertebroplasty and Kyphoplasty: A National Analysis From 2012-2017.

STUDY DESIGN: Retrospective cohort study OBJECTIVE.: This study seeks to identify recent trends in utilization and reimbursements of these procedures between 2012and 2017, a period which experienced a change in national guideline recommendations for these procedures. SUMMARY OF BACKGROUND DATA: Minimally invasive vertebral augmentation procedures, including vertebroplasty and kyphoplasty, have been typically reserved for fractures associated with refractory pain, deformity, or progressive neurological symptoms. However, controversy exists regarding the safety and effectiveness of these procedures, in particular vertebroplasty. METHODS: Annual Medicare claims and payments to surgeons were aggregated at the county level to assess regional trends. Descriptive statistics and multivariate regression models were used to evaluate trends in procedure volume, utilization rates, and reimbursement rates, and to examine associations between county-specific variables and outcome variables. RESULTS: A total of 24,316 vertebroplasties and 138,778 kyphoplasties were performed in the Medicare population between 2012 and 2017. Annual vertebroplasty volume fell by 48.0% from 5744 procedures in 2012 to 2987 in 2017, with a compound annual growth rate (CAGR) of -12.3%. Annual kyphoplasty volume also declined by 12.7% (CAGR -2.7%), from 24,986 in 2012 to 21,681 in 2017. Surgeon reimbursements for vertebral augmentation procedures increased by a weighted average of 93.7% (inflation-adjusted increase of 78.2%) between 2012 and 2017, which was primarily driven by a dramatic 113.3% (inflation-adjusted increase of 96.2%) increase in mean reimbursements for kyphoplasty procedures from an average of $895 to $1764, between 2012 and 2017, respectively. CONCLUSION: This large national Medicare database study found that vertebroplasty and kyphoplasty procedure volume and utilization of both procedures have declined significantly. Although average reimbursements to surgeons for vertebroplasties have significantly declined, payments for kyphoplasty procedures have risen significantly. Although vertebroplasty volume has significantly decreased, it is still being performed and being reimbursed for, in spite of its controversial role in its treatment of vertebral fractures. LEVEL OF EVIDENCE: 3.

Percutaneous Vertebral Augmentation for Vertebral Compression Fractures: National Trends in the Medicare Population (2005-2015).

STUDY DESIGN: Retrospective analysis of Medicare data OBJECTIVE.: To analyze trends of vertebral augmentation in the elderly Medicare population in the context of evolving evidence and varied medical society opinions. SUMMARY OF BACKGROUND DATA: Percutaneous vertebral augmentation offers a minimally invasive therapy for vertebral compression fractures. Numerous trials have been published on this topic with mixed results. The impact of these studies and societal recommendations on physician practice patterns is not well understood. METHODS: The Centers for Medicare and Medicaid Services annual Medicare Physician Supplier Procedure Summary database was examined for kyphoplasty and vertebroplasty procedures from 2005 through 2015. Top provider specialties were determined based on annual procedural volume, and grouped into the three broad categories of radiology, surgery, and anesthesia/pain medicine. Data entries were independently analyzed by provider type, site of service, submitted charges, and reimbursement rates for interventions during the study period. RESULTS: Between 2005 and 2015 total annual claims for vertebral augmentation procedures in the Medicare population increased from 108.11% (37,133-77,276) peaking in 2008 and declining by 15.56% in 2009. Radiology is the largest provider of vertebral augmentation by specialty with declining market shares from 71% in 2005 to 43% in 2015. The frequency of vertebroplasty declined by 61.7% (35,409-13,478) from 2005 to 2015 with reduction in Medicare reimbursement. Annual volume of kyphoplasty grew by 18.3% (48,725-57,646) with significant increase in reimbursement for office-based procedures ($728.50/yr, P < 0.001, R = 0.69). CONCLUSION: The annual volume of vertebral augmentation declined in 2009 following two negative trials on vertebroplasty. Although these publications had a persistent negative impact on practice of vertebroplasty, the overall frequency of vertebral augmentation in the Medicare population has not changed significantly between 2005 and 2015. Instead, there has been a significant shift in provider practice patterns in favor of kyphoplasty in increasingly outpatient and office-based settings. LEVEL OF EVIDENCE: 3.

Percutaneous kyphoplasty: Risk Factors for Recollapse of Cemented Vertebrae.

INTRODUCTION: Percutaneous kyphoplasty can offer pain relief and restoration of vertebral height immediately after the procedure; however, little is known about how many vertebrae recollapse during follow-up or why recollapse occurs. In the present study, we define recollapse of a treated vertebra, assess how common it is following percutaneous kyphoplasty, and investigate risk factors for the condition. METHODS: In total, 203 consecutive patients who underwent percutaneous kyphoplasty were reviewed after an average 12.7 months to assess what proportion of cement-augmented vertebrae had recollapsed. Potential risk factors for recollapse included age, gender, body weight, body height, body mass index, treated level, duration of symptoms, follow-up duration, preoperative T-scores, surgical approach, the intravertebral cleft, contact of polymethyl methacrylate (PMMA) with endplates, cement volume, cement leakage, and midline vertebral body height. Stepwise multivariate linear regression was conducted to predict recollapse as quantified by midline vertebral height loss. RESULTS: Overall, 38.9% of the augmented vertebrae recollapsed. In the recollapse group, the average midline vertebral height ratio and kyphotic angles statistically significantly changed during follow-up (P < 0.05). Pain scores decreased immediately after percutaneous kyphoplasty and generally remained low at follow-up. Significant predictors of midline vertebral height loss at follow-up included presence of an intravertebral cleft, postoperative vertebral height, and non-PMMA-endplate-contact. Together, these factors accounted for 28% of the variability in midline height loss. CONCLUSIONS: Benefits of percutaneous kyphoplasty are partly offset by subsequent recollapse. Recollapse is greater if there is an intravertebral cleft, non-PMMA-endplate-contact and an increase in the post vertebral height.

Timing of Prophylactic Anticoagulation and Its Effect on Thromboembolic Events After Surgery for Metastatic Tumors of the Spine.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To investigate the effect of timing of initiation of prophylactic anticoagulation (AC) on the incidence of venous thromboembolism (VTE) after surgery for metastatic tumors of the spine. SUMMARY OF BACKGROUND DATA: VTE is a known complication in patients undergoing surgery for metastatic spine disease. However, there is limited data on the use of prophylactic AC in this population and its impact on the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the risk of epidural hematoma. METHODS: A retrospective review of our institutional neurosurgical spine database for the years 2012 through 2018 was performed. Patients who underwent surgery for metastatic tumors were identified. The development of VTE within 30 days was examined, as well as the occurrence of epidural hematoma. The incidence of VTE was compared between patients receiving "early" (within postoperative days 1-3) and "delayed" prophylactic AC (on or after postoperative day 4). RESULTS: Sixty-five consecutive patients were identified (mean age 57, 62% male). The overall rate of VTE was 16.9%-all of whom had DVTs with a 3.1% rate of nonfatal PE (two patients also developed PE). From the overall cohort, 36 of 65 (56%) received prophylactic AC in addition to mechanical prophylaxis-22 in the early group (61.1%) and 14 in the delayed group (38.9%). The risk of VTE was 9.1% in the early group and 35.7% in the delayed group (26.6% absolute risk reduction; P = 0.049); there was one case of epidural hematoma (1.5%). On multivariate analysis, delayed prophylactic AC was found to significantly increase the odds of VTE development (OR 6.43; 95% CI, 1.01-41.2; P = 0.049). CONCLUSION: The findings of this study suggest that administration of prophylactic AC between days 1 and 3 after surgery for metastatic tumors of the spine may significantly reduce the risk of postoperative thromboembolic events. LEVEL OF EVIDENCE: 4.

30-day adverse outcomes, re-admissions and mortality following vertebroplasty/kyphoplasty.

OBJECTIVES: Despite vertebral fractures being a common occurrence in elderly osteoporotic individuals, literature remains scant with regards to 30-day outcomes following vertebral augmentation for these injuries. We studied a national database of elderly osteoporotic patients who underwent vertebroplasty and kyphoplasty. PATIENTS AND METHODS: The 2012-2014 ACS-NSQIP database was queried using CPT codes for vertebroplasty (22520, 22521 and 22522) and kyphoplasty (22523, 22524 and 22525). Patients undergoing concurrent spinal fusion and/or laminectomies/laminotomies/laminoplasties were removed from the study. Patients with missing data were also excluded from the study. RESULTS: Following inclusion/exclusion criteria, a total of 2433 patients were included in the study out of which 242(9.9%) underwent vertebroplasty and 2191(90.1%) underwent kyphoplasty. Following adjusted analysis, having a dependent functional health status pre-operatively (OR 1.78; p = 0.010), pre-operative sepsis/SIRS (OR 2.52; p = 0.009), history of COPD (OR 1.62; p = 0.025), disseminated cancer (OR 1.94; p = 0.028), pre-operative wound infection (OR 3.47; p = 0.003) and inpatient admission status (OR 3.22; p < 0.001) were independent predictors of having any complication within 30-days of the procedure. Significant independent risk factors for 30-day mortality were functional health status prior to surgery (OR 2.92; p = 0.002), pre-operative dialysis use (OR 11.74; p = 0.003), Disseminated cancer (OR 7.09; p < 0.001), chronic steroid use (OR 3.59; p < 0.001), and inpatient admission status (OR 4.95; p < 0.001). CONCLUSION: Vertebroplasty/Kyphoplasty is associated with significant adverse outcomes. Providers can utilize these data to better pre-operatively filter high-risk patients and tailor an appropriate peri-operative medical optimization program to enhance care to lower the risk of complications, readmissions and mortality from this procedure.

Percutaneous Kyphoplasty: Is Bilateral Approach Necessary?

STUDY DESIGN: A multicenter retrospective study of patients who underwent unilateral and bilateral balloon kyphoplasty. OBJECTIVE: The aim of this study was to compare the radiographic and clinical results of unilateral and bilateral balloon kyphoplasty to treat osteoporotic vertebral compression fractures. SUMMARY OF BACKGROUND DATA: Percutaneous kyphoplasty has long been used as a successful method in the treatment of osteoporotic vertebral compression fractures. Although the bilateral approach is considered to be the mainstay application of percutaneous kyphoplasty, the unilateral approach has also been shown to be sufficient and even more effective in some cases. METHODS: A total of 87 patients who underwent percutaneous kyphoplasty due to osteoporotic vertebral compression fractures between 2009 and 2016 were retrospectively evaluated and divided into two groups as patients who underwent unilateral or bilateral percutaneous kyphoplasty. Unilateral percutaneous kyphoplasty was performed in 36 and bilateral percutaneous kyphoplasty in 51 patients. The groups were compared in terms of clinical outcomes, radiological findings, and complications. Clinical outcomes were evaluated using Visual Analogue Scale and Oswestry Disability Index and the radiological findings were evaluated by comparing the preoperative and postoperative day 1 and year 1 values of anterior, middle, and posterior vertebral heights and kyphosis angle. RESULTS: Clinical improvement occurred in both groups but no significant difference was observed. In radiological workup, no significant difference was found between the groups in terms of improvements in vertebral heights and kyphosis angle. Operative time and the amount of cement used for the surgery were significantly lower in the patients that underwent unilateral kyphoplasty. CONCLUSION: Unilateral percutaneous kyphoplasty is as effective as bilateral percutaneous kyphoplasty both radiologically and clinically. Operative time and the amount of cement used for the surgery are significantly lower in unilateral kyphoplasty, which may play a role in decreasing complication rates. LEVEL OF EVIDENCE: 3.

Discharge to Inpatient Care Facility After Vertebroplasty/Kyphoplasty: Incidence, Risk Factors, and Postdischarge Outcomes.

INTRODUCTION: Vertebral compression fractures are a common clinical occurrence in elderly individuals with osteoporosis. No current evidence exists on risk factors and clinical impact of discharge to inpatient (IP) care facility after vertebral augmentation procedures. MATERIALS AND METHODS: The 2012-2014 American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) database files were queried using Current Procedural Terminology codes for vertebroplasty (22520, 22521, and 22522) and kyphoplasty (22523, 22524, and 22525). Discharge to IP care facility included skilled-care facilities and IP rehabilitation units. A total of 2361 patients were included in the final cohort. RESULTS: Of 2361 patients, 1962 (83.1%) were discharged home and 399 (16.9%) were discharged to an IP care facility. Multivariate analysis identified age ≥65 years (P < 0.001), dependent preoperative functional health status (P < 0.001), hypertension (P = 0.001), preoperative transfusion (P = 0.043), IP admission status (P < 0.001), thoracolumbar procedure versus thoracic-only procedure (P = 0.012), and length of stay >1 day (P < 0.001) to be significant predictors for a discharge to an IP care facility. In addition, discharge to an IP care facility was associated with a significant greater risk of 30-day mortality (P = 0.001). No significant associations were found with between IP-care discharge destination and any 30-day complication, 30-day readmission, and 30-day reoperation. CONCLUSIONS: Discharge to IP care facilities after vertebroplasty/kyphoplasty is associated with a 3.6 times greater odds of mortality as compared with home discharge. Providers can use the risk profile data to better allow preoperative stratification of patients to ensure that discharge location is appropriate to a patient's need to minimize the risk of adverse outcomes.

Risk Factors for Cement Leakage After Vertebroplasty or Kyphoplasty: A Meta-Analysis of Published Evidence.

BACKGROUND: Cement leakage is the most common complication of vertebroplasty and kyphoplasty. So far, the reported risk factors remain conflicting because of limited data and lack of uniform measurement and evaluation. Here, we performed a systematic review and meta-analysis of potential risk factors for cement leakage after vertebroplasty or kyphoplasty. METHODS: Relevant literature was retrieved using PubMed, EMBASE, Cochrane Controlled Trial Register, and MEDLINE with no language restriction, supplemented by a hand search of the reference lists of selected articles. A fixed-effects model was used if homogeneity existed among included studies; otherwise, a random-effects model was used. The results were presented with weighted mean difference for continuous outcomes and odds ratio (OR) for dichotomous outcomes with a 95% confidence interval (CI). RESULTS: Twenty-two studies consisting of 2872 patients with 4187 vertebrae were included in the meta-analysis. The incidences of cement leakage for percutaneous vertebroplasty and percutaneous balloon kyphoplasty were 54.7% and 18.4%, respectively. The significant risk factors for new vertebral compression fractures were intravertebral cleft (OR, 1.40; 95% CI, 1.09-1.78; P < 0.01), cortical disruption (OR, 5.56; 95% CI, 1.84-16.81; P < 0.01), cement viscosity (OR, 3.32; 95% CI, 1.36-8.07; P < 0.01) and injected cement volume (weighted mean difference, 0.59; 95% CI, 0.02-1.17; P < 0.05). Age, sex and fracture type, operation level, and surgical approach were not significant risk factors. CONCLUSIONS: The results of this meta-analysis suggest that patients with intravertebral cleft, cortical disruption, low cement viscosity, and high volume of injected cement may be at high risk for cement leakage after vertebroplasty or kyphoplasty. Rigorous patient selection and individual therapeutic strategy irrespective of age, sex and fracture type, operation level, and surgical approach may reduce the occurrence of cement leakage. Given the inherent limitation of the meta-analysis, more large sample-sized randomized controlled trials are needed to further validate the present findings.

Trends in Inpatient Vertebroplasty and Kyphoplasty Volume in the United States, 2005-2011: Assessing the Impact of Randomized Controlled Trials.

STUDY DESIGN: Retrospective analysis of the Nationwide Inpatient Sample, 2005-2011. OBJECTIVE: To identify trends in procedural volume and rates in the time period surrounding publication of randomized controlled trials (RCTs) that examined the utility of vertebroplasty and kyphoplasty. SUMMARY OF BACKGROUND DATA: Vertebroplasty and kyphoplasty are frequently performed for vertebral compression fractures. Several RCTs have been published with conflicting outcomes regarding pain and quality of life compared with nonsurgical management and sham procedures. Four RCTs with discordant results were published in 2009. MATERIALS AND METHODS: The Nationwide Inpatient Sample provided longitudinal, retrospective data on United States' inpatients between 2005 and 2011. Inclusion was determined by a principal or secondary International Classification of Diseases, Ninth Revision, Clinical Modification code of 81.65 (percutaneous vertebroplasty) or 81.66 (percutaneous vertebral augmentation; "kyphoplasty"). No diagnoses were excluded. Years were stratified as "pre" (2005-2008) and "post" (2010-2011) in relation to the 4 RCTs published in 2009. Patient, hospital, and admission characteristics were compared using Pearson χ test. RESULTS: The estimated annual inpatient procedures performed decreased from 54,833 to 39,832 in the pre and post periods, respectively. The procedural rate for fractures decreased from 20.1% to 14.7% (P<0.0001). Patient and hospital demographics did not change considerably between the time periods. In the post period, weekend admissions increased (34.2% vs. 12.4%, P<0.0001), elective admissions decreased (21.4% vs. 40.0%, P<0.0001), routine discharge decreased (33.0% vs. 52.1%, P<0.0001), and encounters with ≥3 Elixhauser comorbidities increased (54.5% vs. 39.1%, P<0.0001). CONCLUSIONS: The absolute rate of inpatient vertebroplasty and kyphoplasty procedures for fractures decreased 5% in the period (2010-2011) following the publication of 4 RCTs in 2009. The proportion of elective admissions and routine discharges decreased, possibly indicating a population with greater disease severity. Although our analysis cannot demonstrate a cause-and-effect relationship, the decreased inpatient volume and procedural rates surrounding the publication of sentinel negative RCTs is clearly observed.

Vertebroplasty and kyphoplasty: national outcomes and trends in utilization from 2005 through 2010.

BACKGROUND CONTEXT: Vertebral compression fractures secondary to low bone mass are responsible for almost 130,000 inpatient admissions and 133,500 emergency department visits annually, totaling over $5 billion of direct inpatient costs. Although most vertebral compression fractures heal within a few months with conservative therapy, a significant portion fail to improve with conservative treatment and require long-term care, conservative treatment, or both. Fractures that fail conservative therapy are treated with vertebral augmentation procedures (VAPs) such as vertebroplasty (VP) and kyphoplasty (KP). Two large randomized clinical trials published in 2009 questioned the efficacy of VP in treatment of VAPs. PURPOSE: This study aimed to investigate trends in utilization of VP and KP between 2005 and 2010 to capture the impact of the 2009 literature on utilization of VAPs. The study also compares patient characteristics and perioperative outcomes between VP and KP to further delineate the risks of each procedure. STUDY DESIGN: Retrospective analysis of national utilization rates, clinical outcomes, patient demographics, and patient comorbidities using a large national inpatient database. PATIENT SAMPLE: A total of 63,459 inpatient admissions from 46 states and more than 1,000 different hospitals were included in the analysis. OUTCOME MEASURES: Length of stay (LOS), total direct cost, mortality, postoperative complications. METHODS: Data were obtained from the National Inpatient Sample database for the period between 2005 and 2010. National Inpatient Sample is the largest publicly available all payer inpatient database in the United States. Patients undergoing VP and KP were identified via corresponding the International Classification of Diseases, 9th Revision procedure codes. National utilization trends were estimated using weights supplied as part of the National Inpatient Sample dataset. Information on patient comorbidities and demographics was collected. A series of univariate and multivarariate analyses were used to identify statistically significant differences in patient characteristics, clinical outcomes, as well as cost and LOS between patients undergoing VP versus KP. RESULTS: A total of 307,050 inpatient VAPs were performed in the United States between 2005 and 2010. Of those procedures, 225,259 were KP and 81,790 were VP. Kyphoplasty utilization showed an increasing trend between 2005 and 2007, increasing from 27 to 33 procedures per 100,000 capita older than 40 years. During the same time period, VP utilization remained constant at approximately nine procedures per 100,000 capita older than 40 years. After 2007, utilization of both VP and KP decreased. The most precipitous decrease in VAP utilization occurred in 2009. Patients undergoing VP were on average older (76.7 vs. 77.8, p<.0001), more frequently women (74.48% vs. 73.15%, p=.00083), and black (1.77% vs. 1.55%, p=.004059). Patients undergoing VP had on average more comorbidities then those undergoing KP. Patients undergoing VP had a higher rate of postoperative anemia secondary to acute bleeding and higher rate of venous thromboembolic events. Those undergoing KP had a greater rate of cardiac complications; however, this difference was not statistically significant when taking into account patient age and comorbidity burden. Vertebroplasty was associated with higher mortality (0.93% vs. 0.60%, p<.001), longer LOS (6.78 vs. 5.05 days, p<.0001), and lower total cost ($42,154 vs. $46,101, p<.0001). CONCLUSIONS: Overall, KP was associated with lower complication rates, shorter LOS, and a higher total direct cost compared with VP. Utilization rates showed a significant decrease since 2009 in both VP and KP, suggesting that both procedures were impacted by the two randomized controlled trials published in 2009 that suggested poor efficacy of VP.

Morbidity, mortality, and readmission after vertebral augmentation: analysis of 850 patients from the American College of Surgeons National Surgical Quality Improvement Program database.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To identify risk factors for poor short-term outcomes after vertebral augmentation procedures. SUMMARY OF BACKGROUND DATA: Vertebral compression fractures are the most common fractures of osteoporosis and are frequently treated with vertebroplasty or kyphoplasty. There is a shortage of information about risk factors for short-term, general health outcomes after vertebral augmentation in the literature. METHODS: Patients older than 65 years who underwent vertebroplasty or kyphoplasty in 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Patient characteristics were tested for association with 30-day adverse events, mortality, and readmission using bivariate and multivariate analyses. RESULTS: A total of 850 patients met inclusion criteria. The average age was 78.9±11.7 years (mean±standard deviation) and females made up 70.8% of the cohort. Of these patients, 9.5% had any adverse event (AAE), and 6.6% had a serious adverse event (SAE). Death occurred in 1.5% of patients, and 10.8% were readmitted within the first 30 postoperative days.On multivariate analysis, AAE and SAE were both significantly associated with American Society of Anesthesiologists class 4 (AAE: odds ratio [OR]=2.7, P=0.013; SAE: OR=2.5, P=0.040) and inpatient status before procedure (AAE: OR=2.7, P<0.001, SAE: OR=2.4, P=0.003). Increased postoperative mortality rate was associated with American Society of Anesthesiologists class 4 (OR=6.4, P=0.024) and the use of nongeneral anesthesia (OR=4.0, P=0.022). Readmission was associated with history of pulmonary disease (OR=2.0, P=0.005) and inpatient status before procedure (OR=1.9, P=0.005). CONCLUSION: Adverse general health outcomes were relatively common, and the factors identified in the earlier text associated with patient outcomes after vertebral augmentation may be useful for preoperative discussions and counseling. LEVEL OF EVIDENCE: 3.