Review of Vertebral Augmentation: An Updated Meta-analysis of the Effectiveness.

BACKGROUND: To update vertebral augmentation literature by comparing outcomes between vertebroplasty (VP), balloon kyphoplasty (BKP), vertebral augmentation with implant (VAI), and nonsurgical management (NSM) for treating vertebral compression fractures (VCFs). METHODS: A PubMed literature search was conducted with keywords kyphoplasty, vertebroplasty, vertebral body stent, and vertebral augmentation AND implant for English-language articles from February 1, 2011, to November 22, 2016. Among the results, 25 met the inclusion criteria for the meta-analysis. Inclusion criteria were prospective comparative studies for mid-/lower-thoracic and lumbar VCFs enrolling at least 20 patients. Exclusion criteria included studies that were single arm, systematic reviews and meta-analyses, traumatic nonosteoporotic or cancer-related fractures, lack of clinical outcomes, or non-Level I and non-Level II studies. Standardized mean difference between baseline and end point for each outcome was calculated, and treatment groups were pooled using random effects meta-analysis. RESULTS: Visual analog scale pain reduction for BKP and VP was -4.05 and -3.88, respectively. VP was better than but not significantly different from NSM (-2.66), yet BKP showed significant improvement from both NSM and VAI (-2.77). The Oswestry Disability Index reduction for BKP showed a significant improvement over VAI (P < .001). There was no significant difference in changes between BKP and VP for anterior (P = .226) and posterior (P = .293) vertebral height restoration. There was no significant difference in subsequent fractures following BKP (32.7%; 95% confidence interval [CI]: 8.8%-56.6%) or VP (28.3%; 95% CI: 7.0%-49.7%) compared with NSM (15.9%; 95% CI: 5.2%-26.6%). CONCLUSIONS/LEVEL OF EVIDENCE: Based on Level I and II studies, BKP had significantly better and VP tended to have better pain reduction compared with NSM. BKP tended to have better height restoration than VP. Additionally, BKP had significant improvements in pain reduction and disability score as compared with VAI. CLINICAL RELEVANCE: This meta-analysis serves to further define and support the safety and efficacy of vertebral augmentation.

Baseline and postfusion opioid burden for patients with low back pain.

OBJECTIVES: To evaluate opioid usage patterns for patients with low back pain (LBP) with and without spinal fusion surgery (fusion patients and nonfusion patients, respectively), including long-term prescriptions post fusion. STUDY DESIGN: Claims data of outpatient pharmaceutical prescriptions from privately insured patients. METHODS: The 3-year utilization, cost, and morphine milligram equivalents (MME) of opioid prescriptions were evaluated for patients with LBP with and without lumbar fusion. For fusion patients, opioid prescriptions before and after fusion, as well as prescription use 3, 6, and 12 months following fusion surgery, were analyzed. RESULTS: Thirty-one percent of patients with LBP had opioid prescriptions within the first 6 months of initial diagnosis, which increased to 42.1% within 3 years. More than twice as many fusion patients as nonfusion patients filled opioid prescriptions (87.2% vs 41.5%; P <.001). Fusion patients had 62% and 48% more days with opioid dosages of at least 50 and at least 90 MME/day, respectively, than nonfusion patients (≥50 MME/day, 84 days vs 52 days; ≥90 MME/day, 50 days vs 34 days; both P <.001). Opioid burden was greater for fusion patients following surgery. Fusion patients continued to have 2 months' supply with at least 50 MME/day and 1 month's supply with at least 90 MME/day at least 12 months following surgery. CONCLUSIONS: The opioid burden in the LBP population is high and is further elevated in those who subsequently undergo fusion surgery. Long-term opioid prescriptions persisted in 27% of fusion patients 12 months post surgery. Efforts to identify efficacious alternative therapies to treat LBP may reduce the societal burden of chronic opioid use.

Computational simulations of flow dynamics and blood damage through a bileaflet mechanical heart valve scaled to pediatric size and flow.

Despite pressing needs, there are currently no FDA approved prosthetic valves available for use in the pediatric population. This study is performed for predictive assessment of blood damage in bileaflet mechanical heart valves (BMHVs) with pediatric sizing and flow conditions. A model of an adult-sized 23 mm St. Jude Medical (SJM) Regent(™) valve is selected for use in simulations, which is scaled in size for a 5-year old child and 6-month old infant. A previously validated lattice-Boltzmann method (LBM) is used to simulate pulsatile flow with thousands of suspended platelets for cases of adult, child, and infant BMHV flows. Adult BMHV flows demonstrate more disorganized small-scale flow features, but pediatric flows are associated with higher fluid shear stresses. Platelet damage in the pediatric cases is higher than in adult flow, highlighting thrombus complication dangers of pediatric BMHV flows. This does not necessarily suggest clinically important differences in thromboembolic potential. Highly damaged platelets in pediatric flows are primarily found far downstream of the valve, as there is less flow recirculation in pediatric flows. In addition, damage levels are well below expected thresholds for platelet activation. The extent of differences here documented between the pediatric and adult cases is of concern, demanding particular attention when pediatric valves are designed and manufactured. However, the differences between the pediatric and adult cases are not such that development of pediatric sized valves is untenable. This study may push for eventual approval of prosthetic valves resized for the pediatric population. Further studies will be necessary to determine the validity and potential thrombotic and clinical implications of these findings.

Effect of hinge gap width of a St. Jude medical bileaflet mechanical heart valve on blood damage potential--an in vitro micro particle image velocimetry study.

The hinge regions of the bileaflet mechanical heart valve (BMHV) can cause blood element damage due to nonphysiological shear stress levels and regions of flow stasis. Recently, a micro particle image velocimetry (µPIV) system was developed to study whole flow fields within BMHV hinge regions with enhanced spatial resolution under steady leakage flow conditions. However, global velocity maps under pulsatile conditions are still necessary to fully understand the blood damage potential of these valves. The current study hypothesized that the hinge gap width will affect flow fields in the hinge region. Accordingly, the blood damage potential of three St. Jude Medical (SJM) BMHVs with different hinge gap widths was investigated under pulsatile flow conditions, using a µPIV system. The results demonstrated that the hinge gap width had a significant influence during the leakage flow phase in terms of washout and shear stress characteristics. During the leakage flow, the largest hinge gap generated the highest Reynolds shear stress (RSS) magnitudes (~1000 N/m²) among the three valves at the ventricular side of the hinge. At this location, all three valves indicated viscous shear stresses (VSS) greater than 30 N/m². The smallest hinge gap exhibited the lowest level of shear stress values, but had the poorest washout flow characteristics among the three valves, demonstrating propensity for flow stasis and associated activated platelet accumulation potential. The results from this study indicate that the hinge is a critical component of the BMHV design, which needs to be optimized to find the appropriate balance between reduction in fluid shear stresses and enhanced washout during leakage flow, to ensure minimal thrombotic complications.

A numerical investigation of blood damage in the hinge area of aortic bileaflet mechanical heart valves during the leakage phase.

Previous experimental and numerical blood studies have shown that high shear stress levels, long exposure times to these shear stresses, and flow recirculation promote thromboembolism. Artificial heart valves, in particular bileaflet mechanical heart valves (BMHVs), are prone to developing thromboembolic complications. These complications often form at the hinge regions of BMHVs and the associated geometry has been shown to affect the local flow dynamics and the associated thrombus formation. However, to date no study has focused on simulating the motion of realistically modeled blood elements within the hinge region to numerically estimate the hinge-related blood damage. Consequently, this study aims at (a) simulating the motion of realistically modeled platelets during the leakage (mid-diastole) phase in different BMHV hinge designs placed in the aortic position and (b) quantitatively comparing the blood damage associated with different designs. Three designs are investigated to assess the effects of hinge geometry and dimensions: a 23 mm St. Jude Medical Regent™ valve hinge with two different gap distances between the leaflet ear and hinge recess; and a 23 mm CarboMedics (CM) aortic valve hinge. The recently developed lattice-Boltzmann method with external boundary force method is used to simulate the hinge flow and capture the dynamics and surface shear stresses of individual platelets. A blood damage index (BDI) value is then estimated based on a linear shear stress-exposure time BDI model. The velocity boundary conditions are obtained from previous 3D large-scale simulations of the hinge flow fields. The trajectories of the blood elements in the hinge region are found to be qualitatively similar for all three hinges, but the shear stresses experienced by individual platelets are higher for the CM hinge design, leading to a higher BDI. The results of this study are also shown to be in good agreement with previous studies, thus validating the numerical method for future research in BMHV flows. This study provides a general numerical tool to optimize the hinge design based on both hemodynamic and thromboembolic performance.

Numerical investigation of the effects of channel geometry on platelet activation and blood damage.

Thromboembolic complications in Bileaflet mechanical heart valves (BMHVs) are believed to be due to the combination of high shear stresses and large recirculation regions. Relating blood damage to design geometry is therefore essential to ultimately optimize the design of BMHVs. The aim of this research is to quantitatively study the effect of 3D channel geometry on shear-induced platelet activation and aggregation, and to choose an appropriate blood damage index (BDI) model for future numerical simulations. The simulations in this study use a recently developed lattice-Boltzmann with external boundary force (LBM-EBF) method [Wu, J., and C. K. Aidun. Int. J. Numer. Method Fluids 62(7):765-783, 2010; Wu, J., and C. K. Aidun. Int. J. Multiphase flow 36:202-209, 2010]. The channel geometries and flow conditions are re-constructed from recent experiments by Fallon [The Development of a Novel in vitro Flow System to Evaluate Platelet Activation and Procoagulant Potential Induced by Bileaflet Mechanical Heart Valve Leakage Jets in School of Chemical and Biomolecular Engineering. Atlanta: Georgia Institute of Technology] and Fallon et al. [Ann. Biomed. Eng. 36(1):1]. The fluid flow is computed on a fixed regular 'lattice' using the LBM, and each platelet is mapped onto a Lagrangian frame moving continuously throughout the fluid domain. The two-way fluid-solid interactions are determined by the EBF method by enforcing a no-slip condition on the platelet surface. The motion and orientation of the platelet are obtained from Newtonian dynamics equations. The numerical results show that sharp corners or sudden shape transitions will increase blood damage. Fallon's experimental results were used as a basis for choosing the appropriate BDI model for use in future computational simulations of flow through BMHVs.