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Spinal stereotactic body radiotherapy in the United States: A decade-long nationwide analysis of patient demographics, practice patterns, and trends over time
McClelland, Shearwood 3rd; Kim, Ellen; Passias, Peter G; Murphy, James D; Attia, Albert; Jaboin, Jerry J
Nationwide utilization of spinal stereotactic body radiotherapy (SBRT) is not known; to address this void, the National Cancer Data Base (NCDB) from 2004 to 2013 was used for analysis. Spinal SBRT was defined as 1-5 fractions (14-32Gy) delivered to the cervical, thoracic, lumbar or sacral spine. From 2004 to 2013, 1044 patients received spinal SBRT, most commonly in single-fraction (38%), three-fraction (26%) and five-fractions (25%). Metastatic spinal disease most commonly originated from the lung (34%), kidney (14%), and blood (9%). The most common insurance status receiving spinal SBRT was private (44%) followed by Medicare (43%), with Medicaid (8%) a distant third. Fifty-six percent of patients were male, and 55% of patients were younger than age 65. 80% of patients were Caucasian, with 13% being African-American. The vast majority (74%) of patients had no Charlson/Deyo comorbidities. The incidence of spinal SBRT gradually increased over time, rising from 2% to 20% of cases from 2004 to 2013. Comprising only 1.4% of spinal metastases radiation in 2004, SBRT rose to a 5.8% share in 2013. In conclusion, SBRT for spine metastases in the United States has more than quadrupled in utilization over a recent ten-year span. Although the majority of spinal SBRT is multi-fraction, the most popular fractionation scheme was single-fraction. It has been most commonly used for Caucasian men under age 65 with private/Medicare insurance and no comorbidities. By far the most common origin of spinal metastases treated by SBRT was the lung, followed by renal cancer. These results provide a baseline for further prospective investigation.
PMID: 28864408
ISSN: 1532-2653
CID: 2679532
A novel index for quantifying the risk of early complications for patients undergoing cervical spine surgeries
Passias, Peter G; Diebo, Bassel G; Marascalchi, Bryan J; Jalai, Cyrus M; Horn, Samantha R; Zhou, Peter L; Paltoo, Karen; Bono, Olivia J; Worley, Nancy; Poorman, Gregory W; Challier, Vincent; Dixit, Anant; Paulino, Carl; Lafage, Virginie
OBJECTIVE It is becoming increasingly necessary for surgeons to provide evidence supporting cost-effectiveness of surgical treatment for cervical spine pathology. Anticipating surgical risk is critical in accurately evaluating the risk/benefit balance of such treatment. Determining the risk and cost-effectiveness of surgery, complications, revision procedures, and mortality rates are the most significant limitations. The purpose of this study was to determine independent risk factors for medical complications (MCs), surgical complications (SCs), revisions, and mortality rates following surgery for patients with cervical spine pathology. The most relevant risk factors were used to structure an index that will help quantify risk and anticipate failure for such procedures. METHODS The authors of this study performed a retrospective review of the National Inpatient Sample (NIS) database for patients treated surgically for cervical spine pathology between 2001 and 2010. Multivariate models were performed to calculate the odds ratio (OR) of the independent risk factors that led to MCs and repeated for SCs, revisions, and mortality. The models controlled for age (< and > 65 years old), sex, race, revision status (except for revision analysis), surgical approach, number of levels fused/re-fused (2-3, 4-8, >/= 9), and osteotomy utilization. ORs were weighted based on their predictive category: 2 times for revision surgery predictors and 4 times for mortality predictors. Fifty points were distributed among the predictors based on their cumulative OR to establish a risk index. RESULTS Discharges for 362,989 patients with cervical spine pathology were identified. The mean age was 52.65 years, and 49.47% of patients were women. Independent risk factors included medical comorbidities, surgical parameters, and demographic factors. Medical comorbidities included the following: pulmonary circulation disorder, coagulopathy, metastatic cancer, renal failure, congestive heart failure, alcohol abuse, neurological disorder, nonmetastatic cancer, liver disease, rheumatoid arthritis/collagen vascular diseases, and chronic blood loss/anemia. Surgical parameters included posterior approach to fusion/re-fusion, >/= 9 levels fused/re-fused, corpectomy, 4-8 levels fused/re-fused, and osteotomy; demographic variables included age >/= 65 years. These factors increased the risk of at least 1 of MC, SC, revision, or mortality (risk of death). A total of 50 points were distributed among the factors based on the cumulative risk ratio of every factor in proportion to the total risk ratios. CONCLUSIONS This study proposed an index to quantify the potential risk of morbidity and mortality prior to surgical intervention for patients with cervical spine pathology. This index may be useful for surgeons in patient counseling efforts as well as for health insurance companies and future socioeconomics studies in assessing surgical risks and benefits for patients undergoing surgical treatment of the cervical spine.
PMID: 28841106
ISSN: 1547-5646
CID: 2676562
Incidence of perioperative medical complications and mortality among elderly patients undergoing surgery for spinal deformity: analysis of 3519 patients
Jain, Amit; Hassanzadeh, Hamid; Puvanesarajah, Varun; Klineberg, Eric O; Sciubba, Daniel M; Kelly, Michael P; Hamilton, D Kojo; Lafage, Virginie; Buckland, Aaron J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Renaud; Smith, Justin S; Shaffrey, Christopher I; Kebaish, Khaled M
OBJECTIVE Using 2 complication-reporting methods, the authors investigated the incidence of major medical complications and mortality in elderly patients after surgery for adult spinal deformity (ASD) during a 2-year follow-up period. METHODS The authors queried a multicenter, prospective, surgeon-maintained database (SMD) to identify patients 65 years or older who underwent surgical correction of ASD from 2008 through 2014 and had a minimum 2 years of follow-up (n = 153). They also queried a Centers for Medicare & Medicaid Services claims database (MCD) for patients 65 years or older who underwent fusion of 8 or more vertebral levels from 2005 through 2012 (n = 3366). They calculated cumulative rates of the following complications during the first 6 weeks after surgery: cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pneumonia, and pulmonary embolism. Significance was set at p < 0.05. RESULTS During the perioperative period, rates of major medical complications were 5.9% for pneumonia, 4.1% for deep venous thrombosis, 3.2% for pulmonary embolism, 2.1% for cerebrovascular accident, 1.8% for myocardial infarction, and 1.0% for congestive heart failure. Mortality rates were 0.9% at 6 weeks and 1.8% at 2 years. When comparing the SMD with the MCD, there were no significant differences in the perioperative rates of major medical complications except pneumonia. Furthermore, there were no significant intergroup differences in the mortality rates at 6 weeks or 2 years. The SMD provided greater detail with respect to deformity characteristics and surgical variables than the MCD. CONCLUSIONS The incidence of most major medical complications in the elderly after surgery for ASD was similar between the SMD and the MCD and ranged from 1% for congestive heart failure to 5.9% for pneumonia. These complications data can be valuable for preoperative patient counseling and informed consent.
PMID: 28820363
ISSN: 1547-5646
CID: 2670702
Three-column osteotomy for correction of cervical and cervicothoracic deformities: alignment changes and early complications in a multicenter prospective series of 23 patients
Smith, Justin S; Shaffrey, Christopher I; Lafage, Renaud; Lafage, Virginie; Schwab, Frank J; Kim, Han Jo; Scheer, Justin K; Protopsaltis, Themistocles; Passias, Peter; Mundis, Gregory; Hart, Robert; Neuman, Brian; Klineberg, Eric; Hostin, Richard; Bess, Shay; Deviren, Vedat; Ames, Christopher P
PURPOSE: Three-column osteotomy (3CO), including pedicle subtraction osteotomy (PSO) and vertebral column resection (VCR), can provide powerful alignment correction for adult cervical deformity (ACD). Our objective was to assess alignment changes and early complications associated with 3CO for ACD. METHODS: ACD patients treated with 3CO with minimum 90-day follow-up were identified from a prospectively collected multicenter ACD database. Complications within 90-days of surgery and pre- and postoperative radiographs were collected. RESULTS: All 23 ACD patients treated with 3CO (14 PSO/9 VCR) had minimum 90-day follow-up (mean age 62.3 years, previous cervical/cervicothoracic instrumentation in 52.2% and thoracic/thoracolumbar instrumentation in 47.8%). The primary diagnosis was kyphosis in 91.3% and coronal deformity in 8.7%. The mean number of fusion levels was 12 (range 6-18). The most common 3CO levels were T1 (39.1%), T2 (30.4%) and T3 (21.7%). Eighteen (12 major/6 minor) complications affected 13 (56.5%) patients. The most common complications were neurologic deficit (17.4%), wound infection (8.7%), distal junctional kyphosis (DJK 8.7%), and cardiorespiratory failure (8.7%). Three (13.0%) patients required re-operation within 90-days (1 each for nerve root motor deficit, DJK, and implant pain/prominence). Cervical alignment improved significantly following 3CO, including cervical lordosis (-2.8 degrees to -12.9 degrees , p = 0.036), C2-7 sagittal vertical axis (64.6-42.3 mm, p < 0.001), and T1 slope minus cervical lordosis (46.4 degrees -27.0 degrees , p < 0.001). CONCLUSIONS: Among 23 ACD patients treated with 3CO, cervical alignment improved significantly following surgery. Thirteen (56.5%) patients had at least one complication. The most common complications were neurologic deficit, infection, DJK, and cardiorespiratory failure.
PMID: 28361367
ISSN: 1432-0932
CID: 2663372
National Administrative Databases in Adult Spinal Deformity Surgery: A Cautionary Tale
Buckland, Aaron J; Poorman, Gregory; Freitag, Robert; Jalai, Cyrus; Klineberg, Eric O; Kelly, Michael; Passias, Peter G
STUDY DESIGN: Comparison between national administrative databases and a prospective multicenter physician managed database. OBJECTIVES: This study aims to assess the applicability of National Administrative Databases (NADs) in adult spinal deformity (ASD). Our hypothesis is that NADs do not include comparable patients as in a physician-managed database (PMD) for surgical outcomes in adult spinal deformity. SUMMARY OF BACKGROUND DATA: NADs such as National Inpatient Sample (NIS) and National Surgical Quality Improvement Program (NSQIP) provide large numbers of publications owing to ease of data access and lack of IRB approval requirement. These databases utilize billing codes, not clinical inclusion criteria, and have not been validated against PMDs in ASD surgery. METHODS: The NIS was searched for years 2002 to 2012 and NSQIP for years 2006 to 2013 using validated spinal deformity diagnostic codes. Procedural codes (ICD-9 and CPT) were then applied to each database. A multicenter PMD including years 2008 to 2015 was used for comparison. Databases were assessed for levels fused, osteotomies, decompressed levels, and invasiveness. Database comparisons for surgical details were made in all patients, and also for patients with >/= 5 level spinal fusions. RESULTS: Approximately, 37,368 NIS, 1291 NSQIP, and 737 PMD patients were identified. NADs showed an increased use of deformity billing codes over the study period (NIS doubled, 68x NSQIP, P < 0.001), but ASD remained stable in the PMD.Surgical invasiveness, levels fused and use of 3-column osteotomy (3-CO) were significantly lower for all patients in the NIS (11.4-13.7) and NSQIP databases (6.4-12.7) compared with PMD (27.5-32.3). When limited to patients with >/=5 levels, invasiveness, levels fused, and use of 3-CO remained significantly higher in the PMD compared with NADs (P < 0.001). CONCLUSION: National databases NIS and NSQIP do not capture the same patient population as is captured in PMDs in ASD. Physicians should remain cautious in interpreting conclusions drawn from these databases. LEVEL OF EVIDENCE: 4.
PMID: 28067697
ISSN: 1528-1159
CID: 2663302
Inpatient versus Outpatient Anterior Cervical Discectomy and Fusion: A Perioperative Complication Analysis of 259,414 Patients From the Healthcare Cost and Utilization Project Databases
McClelland Iii, Shearwood; Passias, Peter G; Errico, Thomas J; Bess, R Shay; Protopsaltis, Themistocles S
BACKGROUND: Anterior cervical discectomy and fusion (ACDF) is one of the most common operations utilized to address pathology of the cervical spine. Few reports have attempted to compare complications associated with inpatient versus outpatient ACDF. METHODS: The Nationwide Inpatient Sample (NIS) from 2001-2012 and the State Ambulatory Services Database (SASD) for New Jersey (NJ) from 2003-2012 were used for analysis. Patients receiving ACDF (defined as anterior cervical fusion (ICD-0 code=81.02) + excision of intervertebral disc (80.51)) were segmented into an inpatient group derived from the NIS, and an outpatient group derived from the NJ SASD. Patients receiving > 2 levels fused (ICD-9 codes 81.63-81.64), or surgery for cancer (ICD-9 codes 140-239), or trauma (ICD-9 codes=805.0-806.9) were excluded. Propensity score matching (PSM) was used to adjust the analysis for patient age, race, sex, primary payer for care, and number of medical diagnoses. RESULTS: Of the 94,492,438 inpatients comprising the NIS from 2001-2012, 257,398 received ACDF. Of the 4,194,207 outpatients comprising the NJ SASD, 2,016 received ACDF. PSM of 10,080 patients (all 2,016 SASD and 8,064 from NIS) was performed, and subsequent analysis revealed that durotomy (P=0.001;OR=0.81), paraplegia, postoperative infection, hematoma/seroma (OR=0.14), respiratory complications, acute posthemorrhagic anemia and red blood cell transfusion (all P<0.001) were less frequent in outpatient versus inpatient ACDF (p<0.05). These results were similar to an unmatched analysis involving all of the NIS patients. CONCLUSION: Accepting the limitations of the NIS and SASD (inability to distinguish between one and two-level fusions, no long-term follow-up, potential selection bias, disparities between inpatient and outpatient ACDF populations), these findings indicate that for 1-2 level ACDF, perioperative complications, including durotomy, paraplegia, hematoma, and acute posthemorrhagic anemia were more commonly reported following inpatient ACDF. Future studies involving outpatient analysis of several states will be necessary to determine whether these results of outpatient ACDF are applicable nationwide.
PMCID:5537979
PMID: 28765795
ISSN: 2211-4599
CID: 2655762
Diabetes as an Independent Predictor for Extended Length of Hospital Stay and Increased Adverse Post-Operative Events in Patients Treated Surgically for Cervical Spondylotic Myelopathy
Worley, Nancy; Buza, John; Jalai, Cyrus M; Poorman, Gregory W; Day, Louis M; Vira, Shaleen; McClelland Iii, Shearwood; Lafage, Virginie; Passias, Peter G
BACKGROUND: Diabetes as an independent driver of peri-operative outcomes, and whether its severity impacts indications is conflicted in the research. The purpose of this study is to evaluate diabetes as a predictor for postoperative outcomes in cervical spondylotic myelopathy (CSM) patients. METHODS: A retrospective review was performed of patients treated surgically for CSM (ICD-9 721.1) from 2010-2012 in the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. Outcome measures were length of stay, and the presence of complications. Diabetic patients were stratified based on whether or not their diabetes was insulin- or non-insulin-dependent. RESULTS: A total of 5,904 surgical CSM patients were included, 1101 (19%) had diabetes. 722 (65%) were non-insulin-dependent diabetics, and 381 (35%) were insulin-dependent diabetics. Diabetes was found to be an independent predictor of extended LOS (OR: 1.878[2.262-1.559], p<0.001) as well as of developing a complication (OR: 1.666[2.217-1.253], p<0.001) after controlling for associated variables like BMI. Type of diabetes (insulin- vs. non-insulin-dependent) showed little significant difference between the groups (p>0.05), however, patients with insulin-dependent diabetes were associated with an increased incidence of wound complications (p=0.027); severity of diabetes was not associated with any other individual complications. CONCLUSIONS: Type and severity of diabetes is not a predictor for complication. Diabetes is associated with extended LOS and peri-operative morbidity. Level of evidence: Class 2b. Clinical relevance: Our findings support the view of many spine surgeons, who believe that diabetes has a negative impact on the outcome of surgery for CSM. Our findings support those cohort studies that found an association between diabetes and worst post-operative outcomes following surgical treatment of CSM. These findings lend support to the importance of monitoring preoperative serum glucose levels, as prevention of peri-operative hyperglycemia has been linked to improved postoperative outcomes in spine, joint and colon surgery.
PMCID:5537976
PMID: 28765794
ISSN: 2211-4599
CID: 2656692
Comparative Analysis of Perioperative Outcomes Using Nationally Derived Hospital Discharge Data Relative to a Prospective Multicenter Surgical Database of Adult Spinal Deformity Surgery
Poorman, Gregory W; Passias, Peter G; Buckland, Aaron J; Jalai, Cyrus M; Kelly, Michael; Sciubba, Daniel M; Neuman, Brian J; Hamilton, D Kojo; Jain, Amit; Diebo, Bassel; Lafage, Virginie; Bess, Shay; Klineberg, Eric O
STUDY DESIGN: Retrospective analysis of three prospectively collected databases. OBJECTIVE: To compare perioperative outcomes in Adult Spinal Deformity (ASD) surgeries in a surgeon-run (SR-ASD) and two national databases: the Nationwide Inpatient Sample (NIS) and the National Surgical Quality Improvement Program (NSQIP). SUMMARY OF BACKGROUND DATA: Much has been learned on the treatment of ASD in the last decade with prospective multicenter collaborative research focusing on this specific condition. Nondisease specific national databases are being used for hypothesis and quality control testing on a large number of ASD patients. Their accuracy and applicability remains unevaluated. METHODS: Patients were identified on each respective database undergoing lumbar spine fusion for ASD. Propensity score matching established cohorts of patients on each database with similar procedures being performed. Complication prevalence and relative risk was compared on the NIS and NSQIP against SR-ASD. Secondary outcome measures included hospital-stay characteristics, surgical invasiveness, patient demographics, and patient comorbidities. RESULTS: Two hundred fifty-five patients were identified on each database 1:1:1 with similar overall surgical intensity. Querying the databases using ICD-9 codes, CPT codes, and surgeon-reports resulted in different complication incidences: overall complication rates were 17.65% on NIS, 24.31% on NSQIP, and 68.24% on SR-ASD. The relative risk of a medical complication in SR-ASD was 1.87 (1.42-2.48) relative to NIS and 1.91 (1.44-2.54) relative to NSQIP. The relative risk of a surgical complication was 5.45 (2.69-11.05) compared with NIS and 12.05 (3.98-36.49) compared with NSQIP. CONCLUSION: After selecting patients using the same criteria and diagnosis, NIS, NSQIP, and SR-ASD databases captured different patient populations and different complication incidences. There were total absences of certain complications contrary to usual literature rates in all three databases. Faithful reporting necessitates understanding database limitations, and careful evaluation of database strengths and weaknesses is paramount to accurate reports. LEVEL OF EVIDENCE: 3.
PMID: 28742736
ISSN: 1528-1159
CID: 2653892
Two-Year Results of the Prospective Spine Treatment Outcomes Study: An Analysis of Complication Rates, Predictors of Their Development, and Effect on Patient Derived Outcomes at 2 Years for Surgical Management of Cervical Spondylotic Myelopathy
Gerling, Michael C; Passias, Peter; Radcliff, Kris; Isaacs, Robert; Bianco, Kristina; Jalai, Cyrus M; Worley, Nancy J; Parmar, Jaspreet; Poorman, Gregory W; Horn, Samantha R; Moon, John Y; Arnold, Paul M; Vaccaro, Alexander R
PMID: 28673888
ISSN: 1878-8769
CID: 2652062
Novel Angular Measures of Cervical Deformity Account for Upper Cervical Compensation and Sagittal Alignment
Protopsaltis, Themistocles S; Lafage, Renaud; Vira, Shaleen; Sciubba, Daniel; Soroceanu, Alex; Hamilton, Kojo; Smith, Justin; Passias, Peter G; Mundis, Gregory; Hart, Robert; Schwab, Frank; Klineberg, Eric; Shaffrey, Christopher; Lafage, Virginie; Ames, Christopher
STUDY DESIGN: This is a retrospective review of a prospective multicenter database. OBJECTIVE: This study introduces 2 new cervical alignment measures accounting for both cervical deformity (CD) and upper cervical compensation. SUMMARY OF BACKGROUND DATA: Current descriptions of CD like the C2-C7 sagittal vertical axis (cSVA) do not account for compensatory mechanisms such as C0-C2 lordosis and pelvic tilt, which makes surgical planning difficult. The craniocervical angle (CCA) combines the slope of McGregor's line and the inclination from C7 to the hard palate. The C2-pelvic tilt (CPT) combines C2 tilt and pelvic tilt. Like the T1 pelvic angle, CPT is less affected by lower extremity and pelvic compensation. METHODS: Novel and existing CD measures were correlated in 781 patients from a thoracolumbar deformity (TLD) database and 61 patients from a prospective CD database. CD patients were subanalyzed by region of deformity driver: cervical or cervico-thoracic junction. TLD patients were substratified according to whether or not they had CD as well, where CD was defined as cSVA>4 cm or T1 slope minus cervical lordosis mismatch (TS-CL) >20. RESULTS: TLD cohort: mean cSVA was 31.7+/-17.8 mm. Subanalysis of TLD patients with CD versus no-CD demonstrated significant differences in CCA (56.2 vs. 60.6, P<0.001) and CPT (32.6 vs. 19.3, P<0.001). CCA and CPT correlated with cSVA (r=-0.488/r=0.418, P<0.001) and C0-C2 lordosis (r=-0.630/r=0.289,P<0.001). CD cohort: mean cSVA was 47.3+/-32.2 mm. CCA and CPT correlated with cSVA (r=-0.811/r=0.657, P<0.001) and C0-C2 lordosis (r=-0.656/r=0.610, P<0.001). CD cohort subanalysis indicated that CT patients were significantly more deformed by cSVA (71.3 vs 24.0 mm, P<0.001), CCA (47.1 vs 59.1 degrees, P<0.001), and CPT (63.3 vs 43.8 degrees, P=0.002). Using linear regression analysis, cSVA of 4 cm corresponded to CCA of 53.2 degrees (r=0.5) and CPT of 48.5 degrees (r=0.4). CONCLUSIONS: CCA and CPT account for both cervical sagittal alignment and upper cervical compensation and can be utilized in assessment of cervical alignment.
PMID: 28650879
ISSN: 2380-0194
CID: 2652202