Sulaiman Somani

Frailty is associated with morbidity in adults undergoing elective anterior lumbar interbody fusion (ALIF) surgery

BACKGROUND CONTEXT Prior studies have suggested no significant differences in functional status and postoperative complications of elderly versus nonelderly patients undergoing posterior lumbar interbody fusion; however, similar studies have not been comprehensively investigated in the setting of anterior lumbar interbody fusion (ALIF). PURPOSE The objective was to quantify the ability of the modified Frailty Index (mFI) to predict postoperative events in patients undergoing ALIF. STUDY DESIGN Secondary analysis of prospectively collected data. PATIENT SAMPLE Patients undergoing ALIF in the National Surgical Quality Improvement Program (NSQIP) participant files for the period 2010 through 2014. OUTCOMES MEASURES Outcome measures included any postoperative complication, return to operating room (OR), and length of stay >5 days. METHODS NSQIP participant files from 2010 to 2014 were used to identify patients undergoing ALIF. The mFI used in the present study is an 11-variable assessment that maps 16 NSQIP variables to 11 variables in the Canadian Study of Health and Ageing Frailty Index. Univariate analysis and multivariable logistic regression models were used to compare the relative strength of association between mFI with outcome variables of interest. RESULTS In total, 3,920 ALIF cases were identified and grouped according to their mFI score: 0 (n=2,025), 0.09 (n=1,382), 0.18 (n=464), or ≥0.27 (n=49). As the mFI increased from 0 (no frailty-associated variables) to 0.27 (4 of 11) or higher, there was a significant stepwise increase in any complication from 10.8% to 32.7%. After multivariable regression analysis, no significant association was found between higher mFI scores with urinary tract infections and venous thromboembolism. High frailty scores were significant predictors of any complication (mFI of ≥0.27 [reference: 0]; OR 2.4; p=.040) and pulmonary complications (mFI score ≥0.27; OR 7.5; p=.001). CONCLUSIONS In summary, high mFI scores were found to be independently associated with any complication and pulmonary complications in patients who underwent ALIF. The use of mFI together with traditional risk factors may help better identify high-surgical risk patients, which may be useful for preoperative and postoperative care optimization.

Impact of Age on 30-day Complications after Adult Deformity Surgery.

Study Design. A retrospective analysis. Objective. The aim of this study was to identify whether age is a risk factor for postoperative complications after adult deformity surgery (ADS). Summary of Background Data. Spinal deformity is a prevalent cause of morbidity in the elderly population, occurring in as many as 68% of patients older than 60 years. Given the increasing prevalence of adult spinal deformities and an aging population, understanding the safety of ADS in elderly patients is becoming increasingly important. Methods. A retrospective cohort analysis was performed on the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2010 to 2014. Patients (≥18 years of age) from the NSQIP database undergoing ADS were separated into age-based cohorts (⩽52, 53–61, 62–69, and ≥70 years of age). Age groups were determined by interquartile analysis. Chi-squared, t tests, and multivariate logistic regression models were used to identify independent risk factors. Results. A total of 5805 patients met the inclusion criteria. Age groups 1, 2, 3, and 4 contained 1518 (26.1%), 1478 (25.4%), 1451 (25.0%), and 1358 (23.4%) patients, respectively. Multivariate logistic regression analysis revealed increasing age (relative to age group 1) to be an independent risk factor for prolonged length of stay [odds ratio (OR) 1.39, confidence interval (CI) 1.12–1.69], all complications (OR 1.64, CI 1.35–2.00), renal complications (OR 3.45, CI 1.43–8.33), urinary tract infection (OR 2.70, CI 1.49–4.76), postoperative transfusion (OR 1.47, CI 1.20–1.82), and unplanned readmission (OR 1.64, CI 1.18–2.23). Gradations in ORs existed between the different cohorts, such that the deleterious effect of age was less pronounced in cohort 3 compared with cohort 4, and even more less so between cohort 2 and cohort 4. Conclusion. Age has been shown to be an independent risk factor for increased length of stay, all complications, renal complications, urinary tract infection, transfusion, and unplanned readmission. Level of Evidence: 3

Analysis of Risk Factors for Major Complications Following Elective Posterior Lumbar Fusion

Study Design. Retrospective study of prospectively collected data. Objective. To identify risk factors for the development of any major complication after elective posterior lumbar fusion (PLF). Summary of Background Data. PLF is one of the most performed fusion techniques with utilization rates increasing by 356% between 1993 and 2001. Surgical and anesthetic advances have made the option of surgery more accessible for elderly patients with a larger comorbidity burden. Identifying risk factors for the development of major complications after elective PLF is important for patient risk stratification and patient safety efforts. Methods. The 2011 to 2014 American College of Surgeons National Surgical Quality Improvement Program database was queried using Current Procedural Terminology codes 22612, 22630, and 22633. Patients were divided into two cohorts based on the development of any major complication. Bivariate and multivariate logistic regression analyses were employed to identify predictors for the development of ≥ 1, ≥ 2, and ≥ 3 major complications. Results. A total of 7761 patients met the inclusion criteria for the study of which, 2055 (26.5%) patients developed one major complication, 249 (3.2%) patients developed two major complications, and 151 (1.9%) patients developed three major complications. The most common complication was intra/postoperative red blood cell transfusion (23.2%). Three multivariate logistic regression models were employed to identify factors associated with ≥ 1, ≥ 2, and ≥ 3 major complications. Patient variables present across all three models were osteotomy, pelvic fixation, operation time ≥4 hours, bleeding disorder, and American Society of Anesthesiology Class ≥ 3. Conclusion. Several risk factors were identified for the development of major complications after elective PLF. Identification of these factors can improve the selection of appropriate surgical candidates, patient risk stratification, and patient postoperative safety. Level of Evidence: 3

Hospital Acquired Conditions (HACs) in Adult Spinal Deformity Surgery: Predictors for HACs and Other 30-day Postoperative Outcomes.

Study Design. A retrospective study of prospectively collected data. Objective. The aim of this study was to identify risk factors in developing hospital-acquired conditions (HACs) and association of HACs with other 30-day complications in the adult spinal deformity (ASD) population. Summary of Background Data. HACs are subject to a nonpayment policy by the Center for Medicare and Medicaid Services and provide an incentive for medical institutions to improve patient safety. HACs in the ASD population may further exacerbate the already high rates of postoperative morbidity and mortality. Methods. The 2010 to 2014 ACS-NSQIP database was queried using Current Procedural Terminology (CPT) codes for adults who had fusion for spinal deformity. Patients were divided into two cohorts on the basis of the development of an HAC, as defined as a case of surgical site infection, urinary tract infection, or venous thromboembolism. Univariate and multivariate logistic regression analyses were employed to determine predictors for HACs and association of HACs with other 30-day postoperative outcomes. Results. Five thousand eight hundred nineteen patients met the inclusion criteria for the study of whom 313 (5.4%) had an HAC. Multivariate logistic regression analysis revealed that age 61 to 70 versus ⩽50 years [odds ratio (OR) = 1.58, 1.10–2.27, P = 0.013], 71 to 80 versus ⩽50 years (OR = 1.94, 1.31–2.87, P = 0.001), and >80 versus ⩽50 years (OR = 2.30, 1.21–4.37, P = 0.011), dependent/partially dependent versus independent functional status (OR = 1.74, 1.13–2.68, P = 0.011), combined versus anterior surgical approach (OR = 2.46, 1.43–4.24, P = 0.001), and posterior versus anterior surgical approach (OR = 1.64, 1.19–2.25, P = 0.002), osteotomies (OR = 1.61, 1.22–2.13, P = 0.001), steroid use (OR = 2.19, 1.39–3.45, P = 0.001), obesity (OR = 1.38, 1.09–1.74, P = 0.007), and operation time ≥4 hours (OR = 2.42, 1.82–3.21, P < 0.001) were predictive factors in developing an HAC. Conclusion. Several modifiable and nonmodifiable factors (age, functional status, surgical approach, utilization of osteotomies, steroid use, obesity, and operation time ≥4 hours) were associated with developing an HAC. HACs were also risk factors for other postoperative complications. Level of Evidence: 3

Comparing National Inpatient Sample and National Surgical Quality Improvement Program: An Independent Risk Factor Analysis for Risk Stratification in Anterior Cervical Discectomy and Fusion

Study Design. Retrospective study of prospectively collected data. Objective. To explore interdatabase reliability between National Inpatient Sample (NIS) and National Surgical Quality Improvement Program (NSQIP) for anterior cervical discectomy and fusion (ACDF) in data collection and its impact on subsequent statistical analyses. Summary of Background Data. Clinical studies in orthopedics using national databases are ubiquitous, but analytical differences across databases are largely unexplored. Methods. A retrospective cohort study of patients undergoing ACDF surgery was performed in NIS and NSQIP. Key demographic variables, comorbidities, intraoperative characteristics, and postoperative complications were analyzed via bivariate and multivariate analyses. Results. A total of 112,162 patients were identified from NIS and 10,617 from NSQIP. Bivariate analysis revealed small, but significant, differences between patient demographics, whereas patient comorbidities and ACDF intraoperative variables were largely much more distinct across the two databases. Multivariate analysis identified independent risk factors between NIS and NSQIP for mortality, cardiac complications, and postoperative sepsis, some of which were identified in both but most of which were unique to one database. Identification of independent risk factors from both databases specifically highlights their greater validity and importance in stratifying patient risks. In addition, NSQIP was found to be a more accurate predictor for complications based on the average areas under the receiver-operating curve (CNSQIP = 0.83 vs. CNIS = 0.81) across the multivariate models. Complication rate analysis between inpatient and outpatient settings in NSQIP showed the importance of at least 30-day patient follow up, which was devoid in NIS data tabulation and further marked its weakness compared with NSQIP. Conclusion. Despite having largely similar patient demographics, this study highlights critical risk factors for ACDF and demonstrates how different patient profiles can be across NIS and NSQIP, the impact of such differences on identification of independent risk factors, and how NSQIP is ultimately better suited for adverse-event studies. Level of Evidence: 3

Bone morphogenetic protein use in spine surgery in the united states: how have we responded to the warnings?

BACKGROUND CONTEXT Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely adopted as a fusion adjunct in spine surgery since its approval in 2002. A number of concerns regarding adverse effects and potentially devastating complications of rhBMP-2 use led to a Food and Drug Administration (FDA) advisory issued in 2008 cautioning its use, and a separate warning about its potential complications was published by The Spine Journal in 2011. PURPOSE To compare trends of rhBMP-2 use in spine surgery after the FDA advisory in 2008 and The Spine Journal warning in 2011. STUDY DESIGN Retrospective cross-sectional study using a national database. PATIENT SAMPLE All patients from 2002 to 2013 who underwent spinal fusion surgery at an institution participating in the Nationwide Inpatient Sample (NIS). OUTCOME MEASURES Proportion of spinal fusion surgeries using rhBMP-2. METHODS We queried the NIS from 2002 to 2013 and used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes to identify spinal fusion procedures and those that used rhBMP-2. Procedures were subdivided into primary and revision fusions, and by region of the spine. Cervical and lumbosacral fusions were further stratified into anterior and posterior approaches. The percentage of cases using BMP was plotted across time. A linear regression was fit to the data from quarter 3 of 2008 (FDA advisory) through quarter 1 of 2011, and a separate regression was fit to the data from quarter 2 of 2011 (The Spine Journal warning) onward. The slopes of these regression lines were statistically compared to determine differences in trends. No funding was received to conduct this study, and no authors had any relevant conflicts of interest. RESULTS A total of 4,167,079 patients in the NIS underwent spinal fusion between 2002 and 2013. We found a greater decrease in rhBMP-2 use after The Spine Journal warning compared with the FDA advisory for all fusion procedures (p=.006), primary fusions (p=.006), and revision fusions (p=.004). Lumbosacral procedures also experienced a larger decline in rhBMP-2 use after The Spine Journal article as compared with the FDA warning (p=.0008). This pattern was observed for both anterior and posterior lumbosacral fusions (p≤.0001 for both). Anterior cervical fusion was the only procedure that demonstrated a decline in rhBMP-2 use after the FDA advisory that was statistically greater than after The Spine Journal article (p=.02). CONCLUSIONS Warnings sanctioned through the spine literature may have a greater influence on practice of the spine surgery community as compared with advisories issued by the FDA.Comprehensive guidelines regarding safe and effective use of rhBMP-2 must be established.

Intramedullary Nail Fixation of Atypical Femur Fractures With Bone Marrow Aspirate Concentrate Leads to Faster Union: A Case–control Study

OBJECTIVES High rates of implant failure and nonunion in atypical femur fractures (AFF) have been reported. The aim of this study was to evaluate bone marrow aspirate concentrate (BMAC) use in the treatment of AFF. DESIGN Retrospective Case Control SETTING:: Level 1 Trauma Center PATIENTS:: Complete AFF, defined according to American Society of Bone and Mineral Research (ASBMR) criteria, from September 2009 to April 2015 with minimum 1 year follow up. INTERVENTION Operative treatment with anterograde intramedullary (IM) nails. Beginning June 2014, BMAC from the ipsilateral iliac crest was added to all AFFs. MAIN OUTCOME MEASUREMENTS Time to union as determined by a blinded panel of 3 Attending Orthopaedic Surgeons, union rates, complications. RESULTS 35 patients with 36 AFFs were reviewed, of which 33 AFFs were included and 11 received BMAC. Aledronate was the most commonly prescribed bisphosphonate, with a similar mean duration of use in controls and BMAC cases (5.6 vs 6 years, p=0.79). BMAC use significantly decreased time to union (3.5 vs 6.8 months, p=0.004). Varus malreduction was associated with a significant delay in union (9.7 vs 4.7 months, p=0.04). Overall one year union rate was 86.2%, and nonsignificantly higher in BMAC compared to controls (100.0% vs. 77.3%, p=0.11). Multivariate analysis revealed BMAC and varus malreduction as independent predictors of time to union. There were no complications related to BMAC use. CONCLUSION Our findings support IM nailing of AFF as an effective treatment option with a low surgical complication rate and highlight the importance of avoiding varus malreduction. BMAC use significantly reduced time to fracture union without an increase in surgical complication rates. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.Objectives: To evaluate bone marrow aspirate concentrate (BMAC) use in the treatment of AFF. Design: Retrospective case control. Setting: Level 1 trauma center. Patients: Complete AFF, defined according to American Society of Bone and Mineral Research (ASBMR) criteria, from September 2009 to April 2015 with minimum 1-year follow-up. Intervention: Operative treatment with antegrade intramedullary nails. Beginning June 2014, BMAC from the ipsilateral iliac crest was added to all AFFs. Main Outcome Measurements: Time to union as determined by a blinded panel of 3 attending orthopaedic surgeons, union rates, complications. Results: Thirty-five patients with 36 AFFs were reviewed, of which 33 AFFs were included and 11 received BMAC. Alendronate was the most commonly prescribed bisphosphonate, with a similar mean duration of use in controls and BMAC cases (5.6 versus 6 years, P = 0.79). BMAC use significantly decreased time to union (3.5 versus 6.8 months, P = 0.004). Varus malreduction was associated with a significant delay in union (9.7 versus 4.7 months, P = 0.04). Overall, 1 year union rate was 86.2% and nonsignificantly higher in BMAC compared with controls (100.0% versus 77.3%, P = 0.11). Multivariate analysis revealed BMAC and varus malreduction as independent predictors of time to union. There were no complications related to BMAC use. Conclusion: Our findings support intramedullary nailing of AFFs as an effective treatment option with a low surgical complication rate and highlight the importance of avoiding varus malreduction. BMAC use significantly reduced time to fracture union without an increase in surgical complication rates. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Early Complications and Outcomes in Adult Spinal Deformity Surgery: An NSQIP Study Based on 5803 Patients

Study Design: Retrospective analysis. Objective: The purpose of this study is to determine the incidence, impact, and risk factors for short-term postoperative complications following elective adult spinal deformity (ASD) surgery. Methods: Current Procedural Terminology codes were used to query the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) for adults who underwent spinal deformity surgery from 2010 to 2014. Patients were separated into groups of those with and without complications. Univariate analysis and multivariate logistic regression were used to assess the impact of patient characteristics and operative features on postoperative outcomes. Results: In total, 5803 patients were identified as having undergone ASD surgery in the NSQIP database. The average patient age was 59.5 (±13.5) years, 59.0% were female, and 81.1% were of Caucasian race. The mean body mass index was 29.5(±6.6), with 41.9% of patients having a body mass index of 30 or higher. The most common comorbidities were hypertension requiring medication (54.5%), chronic obstructive pulmonary disease (4.9%), and bleeding disorders (1.2%). Nearly a half of the ASD patients had an operative time >4 hours. The posterior fusion approach was more common (56.9%) than an anterior one (39.6%). The mean total relative value unit was 73.4 (±28.8). Based on multivariate analyses, several patient and operative characteristics were found to be predictive of morbidity. Conclusion: Surgical correction of ASD is associated with substantial risk of intraoperative and postoperative complications. Preoperative and intraoperative variables were associated with increased morbidity and mortality. This data may assist in developing future quality improvement activities and saving costs through measurable improvement in patient safety.

ASA Classification as a Risk Stratification Tool in Adult Spinal Deformity Surgery: A Study of 5805 Patients:

Study Design: Retrospective analysis of prospectively collected data. Objectives: Adult spinal deformity (ASD) surgery is a highly complex procedure that has high complication rates. Risk stratification tools can improve patient management and may lower complication rates and associated costs. The goal of this study was to identify the independent association between American Society of Anesthesiologists (ASA) class and postoperative outcomes following ASD surgery. Methods: The 2010-2014 American College of Surgeons National Surgical Quality Improvement Program database was queried using Current Procedural Terminology and International Classification of Diseases, Ninth Revision, codes relevant to ASD surgery. Patients were divided based on their ASA classification. Bivariate and multivariate logistic regression analyses were employed to quantify the increased risk of 30-day postoperative complications for patients with increased ASA scores. Results: A total of 5805 patients met the inclusion criteria, 2718 (46.8%) of which were ASA class I-II and 3087 (53.2%) were ASA class III-IV. Multivariate logistic regression revealed ASA class to be a significant risk factor for mortality (odds ratio [OR] = 21.0), reoperation within 30 days (OR = 1.6), length of stay ≥5 days (OR = 1.7), overall morbidity (OR = 1.4), wound complications (OR = 1.8), pulmonary complications (OR = 2.3), cardiac complications (OR = 3.7), intra-/postoperative red blood cell transfusion (OR = 1.3), postoperative sepsis (OR = 2.7), and urinary tract infection (OR = 1.6). Conclusions: This is the first study evaluating the role of ASA class in ASD surgery with a large patient database. Use of ASA class as a metric for preoperative health was verified and the association of ASA class with postoperative morbidity and mortality in ASD surgery suggests its utility in refining the risk stratification profile and improving preoperative patient counseling for those individuals undergoing ASD surgery.

High-Risk Subgroup Membership Is a Predictor of 30-Day Morbidity Following Anterior Lumbar Fusion

Study Design: Retrospective cohort study. Objective: To determine if membership in a high-risk subgroup is predictive of morbidity and mortality following anterior lumbar fusion (ALF). Methods: The American College of Surgeons National Surgical Quality Improvement Program database was utilized to identify patients undergoing ALF between 2010 and 2014. Multivariate analysis was utilized to identify high-risk subgroup membership as an independent predictor of postoperative complications. Results: Members of the elderly (≥65 years) (OR = 1.3, P = .02) and non-Caucasian (black, Hispanic, other) (OR = 1.7, P < .0001) subgroups were at greater risk for a LOS ≥5 days. Obese patients (≥30 kg/m2 ) were at greater risk for an operative time ≥4 hours (OR = 1.3, P = .005), and wound complications (OR = 1.8, P = .024) compared with nonobese patients. Emergent procedures had a significantly increased risk for LOS ≥5 days (OR = 4.9, P = .021), sepsis (OR = 14.8, P = .018), and reoperation (OR = 13.4, P < .0001) compared with nonemergent procedures. Disseminated cancer was an independent risk factor for operative time ≥4 hours (OR = 8.4, P < .0001), LOS ≥5 days (OR = 15.2, P < .0001), pulmonary complications (OR = 7.4, P = .019), and postoperative blood transfusion (OR = 3.1, P = .040). Conclusions: High-risk subgroup membership is an independent risk factor for morbidity following ALF. These groups should be targets for aggressive preoperative optimization, and quality improvement initiatives.