Browsing by Author "O'Brien, Michael"
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Item Open Access Does recombinant human bone morphogenetic protein-2 use in adult spinal deformity increase complications and are complications associated with location of rhBMP-2 use? A prospective, multicenter study of 279 consecutive patients.(Spine, 2014-02) Bess, Shay; Line, Breton G; Lafage, Virginie; Schwab, Frank; Shaffrey, Christopher I; Hart, Robert A; Boachie-Adjei, Oheneba; Akbarnia, Behrooz A; Ames, Christopher P; Burton, Douglas C; Deverin, Vedat; Fu, Kai-Ming G; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Klineberg, Eric; Mundis, Gregory; O'Brien, Michael; Shelokov, Alexis; Smith, Justin S; International Spine Study Group ISSGStudy design
Multicenter, prospective analysis of consecutive patients with adult spinal deformity (ASD).Objective
Evaluate complications associated with recombinant human bone morphogenetic protein-2 (rhBMP-2) use in ASD.Summary of background data
Off-label rhBMP-2 use is common; however, underreporting of rhBMP-2 associated complications has been recently scrutinized.Methods
Patients with ASD consecutively enrolled into a prospective, multicenter database were evaluated for type and timing of acute perioperative complications.Inclusion criteria
age 18 years and older, ASD, spinal arthrodesis of more than 4 levels, and 3 or more months of follow-up. Patients were divided into those receiving rhBMP-2 (BMP) or no rhBMP-2 (NOBMP). BMP divided into location of use: posterior (PBMP), interbody (IBMP), and interbody + posterior spine (I + PBMP). Correlations between acute perioperative complications and rhBMP-2 use including total dose, dose/level, and location of use were evaluated.Results
A total of 279 patients (mean age: 57 yr; mean spinal levels fused: 12.0; and mean follow-up: 28.8 mo) met inclusion criteria. BMP (n = 172; average posterior dose = 2.5 mg/level, average interbody dose = 5 mg/level) had similar age, smoking history, previous spine surgery, total spinal levels fused, estimated blood loss, and duration of hospital stay as NOBMP (n = 107; P > 0.05). BMP had greater Charlson Comorbidity Index (1.9 vs. 1.2), greater scoliosis (43° vs. 38°), longer operative time (488.2 vs. 414.6 min), more osteotomies per patient (4.0 vs. 1.6), and greater percentage of anteroposterior fusion (APSF; 20.9% vs. 8.4%) than NOBMP, respectively (P < 0.05). BMP had more total complications per patient (1.4 vs. 0.6) and more minor complications per patient (0.9 vs. 0.2) than NOBMP, respectively (P < 0.05). NOBMP had more complications requiring surgery per patient than BMP (0.3 vs. 0.2; P < 0.05). Major, neurological, wound, and infectious complications were similar for NOBMP, BMP, PBMP, IBMP, and I + PBMP (P > 0.05). Multivariate analysis demonstrated small to nonexistent correlations between rhBMP-2 use and complications.Conclusion
RhBMP-2 use and location of rhBMP-2 use in ASD surgery, at reported doses, do not increase acute major, neurological, or wound complications. Research is needed for higher rhBMP-2 dosing and long-term follow-up.Level of evidence
2.Item Open Access Peak Timing for Complications After Adult Spinal Deformity Surgery.(World neurosurgery, 2018-07) Daniels, Alan H; Bess, Shay; Line, Breton; Eltorai, Adam EM; Reid, Daniel BC; Lafage, Virginie; Akbarnia, Behrooz A; Ames, Christopher P; Boachie-Adjei, Oheneba; Burton, Douglas C; Deviren, Vedat; Kim, Han Jo; Hart, Robert A; Kebaish, Khaled M; Klineberg, Eric O; Gupta, Munish; Mundis, Gregory M; Hostin, Richard A; O'Brien, Michael; Schwab, Frank J; Shaffrey, Christopher I; Smith, Justin S; International Spine Study Group FoundationOverall complication rates for adult spinal deformity (ASD) surgery have been reported; however, little data exist on the peak timing associated with specific complications. This study quantifies the peak timing for multiple complication types in an ASD cohort at minimum 2-year follow-up.Multicenter, prospective analysis of all complications after ASD surgery in a consecutively enrolled cohort was performed. Inclusion criteria were ASD, age ≥18 years, spinal fusion ≥4 levels, and minimum 2-year follow-up. Complications included major and minor and specific complication types. Peak timing of specific complications was identified and described. Regression analysis was performed to assess correlation between patient/surgical factors and complication timing.There were 280 patients who met the inclusion criteria. Mean follow-up time was 2.9 years (range, 2-5 years). Of the patients, 209 (74.6%) had at least 1 complication, accounting for 529 total complications (258 minor and 271 major). Both major and minor complications peaked at <3 months. Infection and neurologic complications peaked at <3 months. Proximal junctional kyphosis had bimodal peaks at <3 and >24 months. Implant failure peaked at 12-24 and >24 months. There was a significant positive correlation between preoperative sagittal vertical axis and total complications at 6-12 months, major complications at 24 months, and reoperation. Body mass index was associated with total complications and implant failure at 12-24 and >24 months.The peak timing of specific complications after ASD surgery is identifiable. Understanding when these complications are likely to occur may improve patient counseling, early diagnosis, and prophylactic interventions and may help inform future reimbursement models.Item Open Access Reliability assessment of a novel cervical spine deformity classification system.(Journal of neurosurgery. Spine, 2015-12) Ames, Christopher P; Smith, Justin S; Eastlack, Robert; Blaskiewicz, Donald J; Shaffrey, Christopher I; Schwab, Frank; Bess, Shay; Kim, Han Jo; Mundis, Gregory M; Klineberg, Eric; Gupta, Munish; O'Brien, Michael; Hostin, Richard; Scheer, Justin K; Protopsaltis, Themistocles S; Fu, Kai-Ming G; Hart, Robert; Albert, Todd J; Riew, K Daniel; Fehlings, Michael G; Deviren, Vedat; Lafage, Virginie; International Spine Study GroupObject
Despite the complexity of cervical spine deformity (CSD) and its significant impact on patient quality of life, there exists no comprehensive classification system. The objective of this study was to develop a novel classification system based on a modified Delphi approach and to characterize the intra- and interobserver reliability of this classification.Methods
Based on an extensive literature review and a modified Delphi approach with an expert panel, a CSD classification system was generated. The classification system included a deformity descriptor and 5 modifiers that incorporated sagittal, regional, and global spinopelvic alignment and neurological status. The descriptors included: "C," "CT," and "T" for primary cervical kyphotic deformities with an apex in the cervical spine, cervicothoracic junction, or thoracic spine, respectively; "S" for primary coronal deformity with a coronal Cobb angle ≥ 15°; and "CVJ" for primary craniovertebral junction deformity. The modifiers included C2-7 sagittal vertical axis (SVA), horizontal gaze (chin-brow to vertical angle [CBVA]), T1 slope (TS) minus C2-7 lordosis (TS-CL), myelopathy (modified Japanese Orthopaedic Association [mJOA] scale score), and the Scoliosis Research Society (SRS)-Schwab classification for thoracolumbar deformity. Application of the classification system requires the following: 1) full-length standing posteroanterior (PA) and lateral spine radiographs that include the cervical spine and femoral heads; 2) standing PA and lateral cervical spine radiographs; 3) completed and scored mJOA questionnaire; and 4) a clinical photograph or radiograph that includes the skull for measurement of the CBVA. A series of 10 CSD cases, broadly representative of the classification system, were selected and sufficient radiographic and clinical history to enable classification were assembled. A panel of spinal deformity surgeons was queried to classify each case twice, with a minimum of 1 intervening week. Inter- and intrarater reliability measures were based on calculations of Fleiss k coefficient values.Results
Twenty spinal deformity surgeons participated in this study. Interrater reliability (Fleiss k coefficients) for the deformity descriptor rounds 1 and 2 were 0.489 and 0.280, respectively, and mean intrarater reliability was 0.584. For the modifiers, including the SRS-Schwab components, the interrater (round 1/round 2) and intrarater reliabilities (Fleiss k coefficients) were: C2-7 SVA (0.338/0.412, 0.584), horizontal gaze (0.779/0.430, 0.768), TS-CL (0.721/0.567, 0.720), myelopathy (0.602/0.477, 0.746), SRS-Schwab curve type (0.590/0.433, 0.564), pelvic incidence-lumbar lordosis (0.554/0.386, 0.826), pelvic tilt (0.714/0.627, 0.633), and C7-S1 SVA (0.071/0.064, 0.233), respectively. The parameter with the poorest reliability was the C7-S1 SVA, which may have resulted from differences in interpretation of positive and negative measurements.Conclusions
The proposed classification provides a mechanism to assess CSD within the framework of global spinopelvic malalignment and clinically relevant parameters. The intra- and interobserver reliabilities suggest moderate agreement and serve as the basis for subsequent improvement and study of the proposed classification.Item Open Access The health impact of adult cervical deformity in patients presenting for surgical treatment: Comparison to United States population norms and chronic disease states based on the EuroQuol-5 dimensions questionnaire(Clinical Neurosurgery, 2017-05-01) Smith, Justin S; Line, Breton; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; Mundis, Gregory; Scheer, Justin K; Klineberg, Eric; O'Brien, Michael; Hostin, Richard; Gupta, Munish; Daniels, Alan; Kelly, Michael; Gum, Jeffrey L; Schwab, Frank J; Lafage, Virginie; Lafage, Renaud; Ailon, Tamir; Passias, Peter; Protopsaltis, Themistocles; Albert, Todd J; Riew, K Daniel; Hart, Robert; Burton, Doug; Deviren, Vedat; Ames, Christopher P; Group, International Spine StudyBACKGROUND: Although adult cervical spine deformity (ACSD) is associated with pain and disability, its health impact has not been quantified in comparison to other chronic diseases. OBJECTIVE: To perform a comparative analysis of the health impact of symptomatic ACSD to US normative and chronic disease values using EQ-5D (EuroQuol-5 Dimensions questionnaire) scores. METHODS: ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Baseline demographics and EQ-5D scores were collected and compared with US normative and disease state values. RESULTS: Of 121 ACSD patients, 115 (95%) completed the EQ-5D (60% women, mean age 61 years, previous spine surgery in 44%). Diagnoses included kyphosis with mid-cervical (63.4%), cervico-thoracic (23.5%), or thoracic (8.7%) apex and primary coronal deformity (4.3%). The mean ACSD EQ-5D index was 0.511 (standard definition = 0.224), which is 34% below the bottom 25th percentile (0.780) for similar age- and gender-matched US normative populations. Mean ACSD EQ-5D index values were worse than the bottom 25th percentile for several other disease states, including chronic ischemic heart disease (0.708), malignant breast cancer (0.708), and malignant prostate cancer (0.708). ACSD mean index values were comparable to the bottom 25th percentile values for blindness/low vision (0.543), emphysema (0.508), renal failure (0.506), and stroke (0.463). EQ-5D scores did not significantly differ based on cervical deformity type (P =.66). CONCLUSION: The health impact of symptomatic ACSD is substantial, with negative impact across all EQ-5D domains. The mean ACSD EQ-5D index was comparable to the bottom 25th percentile values for blindness/low vision, emphysema, renal failure, and stroke.