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Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion
Takahashi, Shinji; Buser, Zorica; Cohen, Jeremiah R; Roe, Allison; Myhre, Sue L; Meisel, Hans-Joerg; Brodke, Darrel S; Yoon, S Tim; Park, Jong-Beom; Wang, Jeffrey C; Youssef, Jim A
STUDY DESIGN/METHODS:A retrospective cohort study. OBJECTIVE:To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). SUMMARY OF BACKGROUND DATA/BACKGROUND:Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the "off-label" use of rhBMP2 in upper and lower posterior cervical fusion approaches. MATERIALS AND METHODS/METHODS:Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. RESULTS:Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). CONCLUSIONS:Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. LEVEL OF EVIDENCE/METHODS:Level III.
PMID: 27632774
ISSN: 2380-0194
CID: 5185802
Trends, Costs, and Complications of Anterior Cervical Discectomy and Fusion With and Without Bone Morphogenetic Protein in the United States Medicare Population
Lord, Elizabeth L; Cohen, Jeremiah R; Buser, Zorica; Meisel, Hans-Joerg; Brodke, Darrel S; Yoon, S Tim; Youssef, Jim A; Wang, Jeffrey C; Park, Jong-Beom
STUDY DESIGN/METHODS:Retrospective database review. OBJECTIVES/OBJECTIVE:After the Food and Drug Administration approved bone morphogenetic protein-2 (BMP) in 2002, BMP was used off-label in the cervical spine to increase bone growth and bony fusion. Since then, concerns have been raised regarding complication rates and safety. This study was conducted to examine the use of BMP in anterior cervical discectomy and fusion (ACDF) in the Medicare population and to determine risk of complications and associated costs within 90 days of surgery. METHODS:Patients who underwent ACDF were identified using Current Procedural Terminology (CPT) and International Classification of Diseases, Ninth Revision Procedure codes (ICD9-P). Complications were identified using ICD9 diagnostic codes. Charges were calculated as amount billed, and reimbursements were calculated as amounts paid by Medicare. Data for these analyses came from a nationwide claims database. RESULTS:A total of 215 047 patients were identified who had ACDF from 2005 to 2011. For the majority of the procedures (89.0%), BMP was not used. BMP use rose from 11.84% in 2005 to a peak of 16.73% in 2007 before decreasing to 12.01% in 2011. BMP was used 16% more in women than men. BMP use was the highest in the West (13.6%) followed by Midwest (11.8%), South (10.6%), and Northeast (7.5%). There was a higher overall complication rate in the BMP group (2.1%) compared with the non-BMP group (1.9%) (odds ratio [OR] = 1.11, 95% CI = 1.01-1.22). The BMP group also had a higher rate of wound complications (0.98% vs 0.76%, OR = 1.29, 95% CI = 1.12-1.48). In this study population, there was no difference in dysphagia/hoarseness, neurologic, medical, or other complications. During the 90-day perioperative period, BMP surgeries were charged at 17.6% higher than non-BMP surgeries. CONCLUSIONS:The use of BMP in ACDF in the Medicare population has decreased since a peak in 2007. The rate of wound and overall complications for BMP use with ACDF was higher than without. Our results regarding dysphagia/hoarseness did not show a statistically meaningful difference, which is in contrast with many other studies. Charges associated with BMP use were higher during the 90-day perioperative period.
PMCID:5624371
PMID: 28989837
ISSN: 2192-5682
CID: 5186072
Trends Analysis of rhBMP Utilization in Single-Level Posterior Lumbar Interbody Fusion in the United States
Lao, Lifeng; Cohen, Jeremiah R; Buser, Zorica; Brodke, Darrel S; Youssef, Jim A; Park, Jong-Beom; Yoon, S Tim; Wang, Jeffrey C; Meisel, Hans-Joerg
STUDY DESIGN/METHODS:Retrospective study. OBJECTIVES/OBJECTIVE:Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely used in spinal fusion surgery, but there is little information on rhBMP-2 utilization in single-level posterior lumbar interbody fusion (PLIF). The purpose of our study was to evaluate the trends and demographics of rhBMP-2 utilization in single-level PLIF. METHODS:Patients who underwent single-level PLIF from 2005 to 2011 were identified by searching ICD-9 diagnosis and procedure codes in the PearlDiver Patient Records Database, a national database of orthopedic insurance records. The year of procedure, age, gender, and region of the United States were recorded for each patient. Results were reported for each variable as the incidence of procedures identified per 100 000 patients searched in the database. RESULTS:< .01) compared to single-level PLIF with rhBMP-2 (0.21 cases per 100 000 patients). The average rate of single-level PLIF with rhBMP-2 utilization was the highest in West (30.1%), followed by Midwest (26.9%), South (20.5%), and Northeast (17.8%). The highest incidence of single-level PLIF with rhBMP-2 was observed in the age group <65 years (0.3 per 100 000 patients). CONCLUSIONS:To our knowledge, this is the first study to report on the demographics associated with rhBMP-2 use in single-level PLIF. There was a 3-fold increase in the rate of PLIF without rhBMP-2 compared to PLIF with rhBMP-2, with both procedures being mainly done in patients less than 65 years of age.
PMCID:5624372
PMID: 28989840
ISSN: 2192-5682
CID: 5186082
Trends analysis of surgical procedures for cervical degenerative disc disease and myelopathy in patients with tobacco use disorder
Grisdela, Phillip; Buser, Zorica; D'Oro, Anthony; Paholpak, Permsak; Liu, John C; Wang, Jeffrey C
PURPOSE:This study defined the incidence and trends of surgeries performed for patients with cervical disc degeneration with and without tobacco use disorder (TUD). METHODS:This study utilized the Humana Inc. database between 2007 and 2013 to identify patients with cervical disc degeneration with or without myelopathy. International Classification of Diseases, ninth revision (ICD-9) and Current Procedural Terminology (CPT) codes determined the initial diagnosis of disc degeneration, myelopathy status and TUD, whether patients received surgery, and TUD status at surgery. RESULTS:The prevalence of disc degeneration with myelopathy increased by 32.8% between 2007 and 2013, while disc disease with myelopathy and TUD increased by 91.6%. For patients without myelopathy, the prevalence of disc degeneration alone increased by 65.4%, and disc degeneration with myelopathy increased by 148.7%. Of myelopathy patients, 1717 (6.4%) had TUD and 1024 (59.6%) received surgery, compared to 6508 patients without TUD (26.1%). For patients without myelopathy, 11,337 (3.5%) had TUD and 787 (6.9%) underwent surgery, compared to 9716 patients (3%) without TUD. Of surgical patients, 781 (76.3%) with myelopathy and TUD still had a TUD diagnosis at surgery, and 542 (68.9%) of patients without myelopathy still had a TUD diagnosis at surgery. CONCLUSIONS:The prevalence of degenerative disc disease and TUD has increased more than disc disease alone. Patients with TUD were more likely to get surgery, and to have surgeries earlier than patients without TUD. Patients with TUD at the time of the diagnosis of their disc degeneration likely still had a TUD diagnosis at the time of surgery.
PMID: 28488093
ISSN: 1432-0932
CID: 5185962
Kinematic evaluation of cervical sagittal balance and thoracic inlet alignment in degenerative cervical spondylolisthesis using kinematic magnetic resonance imaging
Paholpak, Permsak; Nazareth, Alexander; Hsieh, Patrick C; Buser, Zorica; Wang, Jeffrey C
BACKGROUND CONTEXT:T1 slope is a novel thoracic parameter used to assess cervical spine sagittal balance. Thoracic index (TI) parameters including T1 slope and cervical sagittal alignment parameters may play an important role in degenerative cervical spondylolisthesis (DCS). Current literature regarding the relationship between TI and cervical sagittal alignment parameters in patients with DCS is limited. PURPOSE:(1) To evaluate the T1 slope, cervical sagittal alignment, and thoracic inlet parameter in patients with DCS using kinematic magnetic resonance imaging (kMRI), and (2) to find a correlation between the T1 slope, TI, and other cervical sagittal parameters in patients with DCS. DESIGN/SETTING:Retrospective kMRI study, Level III. PATIENT SAMPLE:Fifty-two patients with DCS from 1,128 patients from a cervical kMRI database. OUTCOME MEASURES:T1 slope, C2-C7 angle, sagittal vertical axis C2-C7 (SVA C2-C7), cranial tilt, cervical tilt, neck tilt, and thoracic inlet angle (TIA). METHODS:Cervical spine kMRIs of 52 patients with DCS (mean age 51.7±standard deviation) were analyzed in neutral, flexion, and extension positions. Patients with DCS were divided into two groups: anterolisthesis (N=33) and retrolisthesis (N=19). Each listhesis group was subclassified into grade 1 (slip 2-3 mm) and grade 2 (slip>3 mm). RESULTS:Grade 2 retrolisthesis had the largest T1 slope followed by grade 1 retrolisthesis, grade 2 anterolisthesis, and grade 1 anterolisthesis. Significant differences were found between the anterolisthesis and the retrolisthesis groups in the neutral position (p=.025). The flexion position had the largest T1 slope and showed a significant difference with anterolisthesis in the neutral position (p=.041). Sagittal vertical axis C2-C7 showed strong correlation with cranial tilt in all DCS groups and all positions. CONCLUSIONS:In our study, T1 slope was larger in grade 2 DCS, and the retrolisthesis group had larger T1 slope than the anterolisthesis group. Presence of larger T1 slope was significantly correlated with larger cervical lordosis curvature. Furthermore, cranial tilt was strongly correlated with SVA C2-C7.
PMID: 28456677
ISSN: 1878-1632
CID: 5185952
Analysis of the relationship between the facet fluid sign and lumbar spine motion of degenerative spondylolytic segment using Kinematic MRI
Wang, Dalin; Yuan, Haifeng; Liu, An; Li, Changqing; Yang, Kaixiang; Zheng, Shengnai; Wang, Liming; Wang, Jeffrey C; Buser, Zorica
PURPOSE/OBJECTIVE:To investigate the relationship between the facet fluid sign (FFS) and kinematics of affected lumbar segment in patients with low-grade, single-level lumbar degenerative spondylolisthesis using kinematic magnetic resonance imaging (kMRI).Materials and methods Ninety-two patients diagnosed with low-grade (Grade 1 or 2), single level lumbar degenerative spondylolisthesis L3 to S1. Angular and translational motion, whole lumbar motion, slip percentage, and facet angle were measured. Disc degeneration and degrees of osteoarthritis were graded, facet effusion was evaluated and classified as Positive or Negative FFS (PosFFS or NegFFS).Results There were significant differences in the facet degeneration, translational motion, percentage of total angular motion, and flexion-extension slip difference between the PosFFS and NegFFS group. 28.3% of the patients in PosFFS group had anterolisthesis in flexion, but not extension.There was a significant difference in the incidence of FFS between the dynamic and static spondylolisthesis (75% vs 35%, p < 0.001). If FFS was present on kMRI, a positive predictive value for dynamic spondylolisthesis was 75.6%. with the sensitivity and specificity of 0.75 and 0.65 for posFFS to diagnose dynamic DS. The likelihood ratio for dynamic slips in the presence of FFS was 2.1, and the likelihood ratio for static slips in the presence of FFS was 1.1.Conclusion Facet fluid sign was present in weight-bearing neutral position, and the presence of FFS in kMRI increased the probability of having dynamic spondylolisthesis.
PMID: 28941762
ISSN: 1872-7727
CID: 5186052
Evaluation of changes in lumbar neuroforaminal dimensions in symptomatic young adults using positional MRI
Ren, Zhiwei; Liu, An; Yang, Kaixiang; Wang, Dalin; Buser, Zorica; Wang, Jeffrey C
PURPOSE:To investigate the changes of lumbar neural foramina size during dynamic motion using positional MRI. METHODS:Two hundred and fifty neural foramina from 50 patients were analyzed. Lumbar foraminal height, width, and area parameters from L1 to S1 were evaluated for changes in extension, neutral, and flexion positions on T2 parasagittal positional MRI images, and were correlated to lumbar angular motion. One-way analysis of variance (ANOVA) and post hoc analysis were used to examine the differences between levels and positions. RESULTS:Compared to the neutral position, almost all lumbar foraminal parameters (height, width at inferior level, and area) increased in flexion and decreased in extension at all levels, except for L5-S1 foraminal width at superior and middle levels. The foraminal height and area in all lumbar segments except L5-S1 increased as the lumbar angular motion changed from extension to flexion in <40° group. The foraminal width increased significantly at L3-4 and L4-5 among all groups. CONCLUSION:Lumbar foraminal dimensions increased in flexion compared to neutral and extension positions. Lumbar angular motion contributed to the changes of foraminal height and area at most of the segments, while it affected foraminal width only at L3-4 and L4-5. This information can be useful in the understanding of patient symptoms and the correlation with the imaging studies with dynamic foraminal stenosis. Furthermore, data from our study may help with patient positioning for foraminal injections or endoscopic surgery.
PMID: 28116511
ISSN: 1432-0932
CID: 5185862
Utility of Intraoperative Neuromonitoring for Lumbar Pedicle Screw Placement Is Questionable: A Review of 9957 Cases
Ajiboye, Remi M; Zoller, Stephen D; D'Oro, Anthony; Burke, Zachary D; Sheppard, William; Wang, Christopher; Buser, Zorica; Wang, Jeffrey C; Pourtaheri, Sina
STUDY DESIGN/METHODS:A retrospective database study. OBJECTIVE:The goal of this study was to (1) evaluate the trends in the use of electromyography (EMG) for instrumented posterolateral lumbar fusions (PLFs) in the United States and (2) assess the risk of neurological injury following PLFs with and without EMG. SUMMARY OF BACKGROUND DATA/BACKGROUND:Neurologic injuries from iatrogenic pedicle wall breaches during screw placement are known complications of PLFs. The routine use of intraoperative neuromonitoring (ION) such as EMG during PLF to improve the accuracy and safety of pedicle screw implantation remains controversial. METHODS:A retrospective review was performed using the PearlDiver Database to identify patients who had PLF surgery with and without EMG for lumbar disorders from years 2007 to 2015. Patients undergoing concomitant interbody fusions or spinal deformity surgery were excluded. Demographic trends and risk of neurological injuries were assessed. RESULTS:During the study period, 2007 to 2015, 9957 patients underwent PLFs. Overall, EMG was used in 2495 (25.1%) of these patients. There was a steady increase in the use of EMG from 14.9% in 2007 to 28.7% in 2009, followed by a steady decrease to 21.9% in 2015 (P < 0.0001). The risk of postoperative neurological injuries following PLFs was 1.35% (134/9957) with a risk of 1.36% (34/2495) with EMG and 1.34% (100/7462) without EMG (P = 0.932). EMG is used most commonly for PLFs in the Southern part of the United States. CONCLUSION/CONCLUSIONS:In this retrospective national database review, we found that there was a steady increase in the routine use of EMG for PLFs followed by a steady decline. Regional differences were observed in the utility of EMG for PLFs. The risk of neurological complications following PLF in the absence of spinal deformity is low and the routine use of EMG for PLF may not decrease the risk. LEVEL OF EVIDENCE/METHODS:4.
PMCID:5552371
PMID: 27851660
ISSN: 1528-1159
CID: 5185812
Level of conus medullaris termination in adult population analyzed by kinetic magnetic resonance imaging
Liu, An; Yang, Kaixiang; Wang, Daling; Li, Changqing; Ren, Zhiwei; Yan, Shigui; Buser, Zorica; Wang, Jeffrey C
PURPOSE/OBJECTIVE:To investigate the change of conus medullaris termination (CMT) level in neutral, flexion and extension positions and to analyze the effects of age and gender on the CMT level. METHODS:The midline sagittal T2-weighted kinetic magnetic resonance imaging (kMRI) study of 585 patients was retrospectively reviewed to identify the level of CMT. All patients were in an upright position. A straight line perpendicular to the long axis of the cord was drawn from the tip of the cord and then subtended to the adjacent vertebra or disk space. The CMT level was labeled in relation to the upper, middle and lower segments of adjacent vertebra or disk space and assigned values from 0 to 12 [0 = upper third of T12 (T12U), and 12 = upper third of L3 (L3U)]. All parameters were collected for neutral, flexion and extension positions. RESULTS:The level of CMT had the highest incidence (17.61%) at L1 lower (L1L) in neutral position, 17.44% at L1 upper (L1U) in flexion, and 16.92% at L1 middle (L1M) in extension with no significant differences among three positions (p > 0.05) in weight-bearing status. Moreover, the level of CMT was not correlated with age (p > 0.05). In terms of gender, the level of CMT was lower in women than in men in neutral position, flexion, and extension (p < 0.05). Furthermore, when divided by age in decades, there was a significant difference between females and males in the age group 60-69 years in neutral, flexion and extension position, respectively (p < 0.05). CONCLUSIONS:The level of CMT in the neutral position was in accordance with previous cadaveric and supine-position MRI studies, and it did not change with flexion and extension. Women had lower CMT level than men, especially in the older population. This information can be very valuable when performing spinal anesthesia and spinal punctures.
PMID: 28091734
ISSN: 1279-8517
CID: 5185852
Low-magnitude mechanical signals and the spine: A review of current and future applications
Pham, Martin H; Buser, Zorica; Wang, Jeffrey C; Acosta, Frank L
Animal and human studies demonstrate the anabolic properties of low-magnitude mechanical stimulation (LMMS) in its ability to improve bone formation by enhancing the proliferation of mesenchymal stem cells and their subsequent commitment down an osteoblastic lineage. Response to mechanical strains as low as 10μɛ have been seen, illustrating the sensitivity of mechanosensory cells to mechanotransduction pathways. Applications to the spine include treatment of osteoporosis in preparation for instrumented fusion, fracture reduction in spinal cord injury patients to slow bone mineral density loss, and bone tissue engineering and enhancement of bone-implant osseointegration for pseudarthrosis and hardware failure. This review provides an overview of the fundamentals of LMMS, highlights the cellular basis and biomechanics of how mechanical strain is translated into bone formation, and then discusses current and potential applications of these concepts to spinal disorders. Mechanical signals represent a key regulatory mechanism in the maintenance and formation of bone. Developing practical clinical applications of these mechanotransduction pathways continues to be an important area of investigation in its relation to spinal pathology.
PMID: 28089422
ISSN: 1532-2653
CID: 5185842