Spine Adverse Events Research Articles

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P111. Significant differences in morbidity when comparing adverse events for cervical and lumbar spine surgery prospectively graded with SAVES

BACKGROUND CONTEXT Most studies on complications in spinal surgery have been retrospective, and the reporting of adverse events (AEs) has been inconsistent, regarding definitions and severity grading. Furthermore, to our knowledge no studies have reported on prospectively registered AEs comparing cervical with lumbar surgery at a single major spine surgical centre.The SpineAdVerse Events Severity (SAVES) system is a validated standardization of the prospective registration and classification of spine surgery AEs. PURPOSE To describe and compare the incidence of AEs, using the SAVES system, in patients undergoing lumbar surgery with patients undergoing cervical surgery for degenerative spinal diseases at one major tertiary spine centre. STUDY DESIGN/SETTING A prospective, consecutive cohort study. PATIENT SAMPLE All patients undergoing cervical or lumbar spine surgery during the inclusion period at one major tertiary surgical centre for degenerative spinal diseases. A signed agreement was obtained from all included patients. OUTCOME MEASURES Outcome measures were (a) all AEs registered according to the SAVES system, (b) length of stay (LOS), (c) readmission rate at 30 at 90days, (d) unplanned second surgery during index admission and (e) wound infections requiring revision. The primary outcome measure, comparing lumbar with cervical surgery, was the number of adverse events. METHODS All patients undergoing spinal surgery at our academic tertiary surgical centre were consecutively included from 010216 to 311017. Using the SAVES grading system an independent research coordinator, not involved in the treatment of the patients, prospectively collected all intra- and perioperative data. Once a week all patient charts were reviewed with a senior surgeon for validation of the data. The patients were grouped according to cervical or lumbar surgery. The Student t -test was used for comparing mean LOS, the Mann-Whitney U test for comparing AEs and Pearson chi-square test for comparisons of incidence between groups. RESULTS A total of 1,692 consecutive cases were included with 100% data completion, of which 1400 underwent lumbar, 287 underwent cervical, and 5 were excluded due to thoracic spine surgery. A total of 1,398 lumbar AEs (402 intra- and 996 perioperative) and 232 cervical AEs (84 intra- and 148 perioperative) were registered, resulting in a mean of 1.00 AEs per lumbar patient and 0.81 AEs per cervical patient (p CONCLUSIONS The results show significant fewer AEs and significant shorter length of stay in hospital when undergoing cervical compared to lumbar spine surgery. However, the data also show that the incidence of unplanned secondary surgery was significantly higher in the cervical group.

Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases

The reporting of adverse events (AEs) in neurosurgery uses inconsistent definitions and subjective grading systems. A standardized system for recording and describing AEs would allow valid comparisons to be drawn between different institutions, using different technologies, at different times. The Spinal Adverse Events Severity System - Neuro (SAVES-N) system is a modification of the well-validated SAVES-V2 system that encompasses complications from both cranial and spinal surgery. The objective of this study was to assess the interobserver reliability of SAVES-N in spinal and cranial neurosurgery. Ten vignettes, including cranial and spinal neurosurgical cases, were assessed by groups of consultant neurosurgeons (n= 5) and neurosurgical registrars (n= 5) using the SAVES-N system. Interobserver reliability for the presence of AEs, the type of AE, and the SAVES severity grade of the AE were calculated using Gwet's AC2 and Fleiss' kappa and were interpreted using the thresholds described by Landis and Koch. Neurosurgeons had almost-perfect agreement (Gwet AC2= 0.93), whereas registrars had substantial agreement (Gwet's AC2= 0.74) in determining the presence or absence of AEs. Both neurosurgeons (Fleiss' kappa= 0.78) and registrars (Fleiss' kappa= 0.70) demonstrated substantial agreement within their groups as to the type of AE. Similarly, neurosurgeons (Gwet's AC2= 0.94) and registrars (Gwet's AC2= 0.81) both graded the severity of the AE with almost perfect agreement. The results of this study demonstrate that the scope of the well-validated SAVES-V2 system maybe broadened to cranial neurosurgical cases by SAVES-N with substantial to almost-perfect interobserver reliability.

Impact of the Spinal Instability Neoplastic Score on Surgical Referral Patterns and Outcomes.

The Spinal Instability Neoplastic Score (sins) was developed to identify patients with spinal metastases who may benefit from surgical consultation. We aimed to assess the distribution of sins in a population-based cohort of patients undergoing palliative spine radiotherapy (rt) and referral rates to spinal surgery pre-rt. Secondary outcomes included referral to a spine surgeon post-rt, overall survival, maintenance of ambulation, need for re-intervention, and presence of spinal adverse events. We retrospectively reviewed ct simulation scans and charts of consecutive patients receiving palliative spine rt between 2012 and 2013. Data were analyzed using Student's t-test, Chi-squared, Fisher's exact, and Kaplan-Meier log-rank tests. Patients were stratified into low (<7) and high (≥7) sins groups. We included 195 patients with a follow-up of 6.1 months. The median sins was 7. The score was 0 to 6 (low, no referral recommended), 7 to 12 (intermediate, consider referral), and 13 to 18 (high, referral suggested) in 34%, 59%, and 7% of patients, respectively. Eleven patients had pre-rt referral to spine surgery, with a surgery performed in 0 of 1 patient with sins 0 to 6, 1 of 7 with sins 7 to 12, and 1 of 3 with sins 13 to 18. Seven patients were referred to a surgeon post-rt with salvage surgery performed in two of those patients. Primary and secondary outcomes did not differ between low and high sins groups. Higher sins was associated with pre-rt referral to a spine surgeon, but most patients with high sins were not referred. Higher sins was not associated with shorter survival or worse outcome following rt.

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study.

Adverse events (AEs) are common during care in patients with traumatic spinal cord injury (tSCI). Increased risk of AEs is linked to patient factors including pre-existing comorbidities. Our aim was to examine the relationships between patient factors and common post-injury AEs, and identify potentially modifiable comorbidities. Adults with tSCI admitted to a Level I acute specialized spine center between 2006 and 2014 who were enrolled in the Rick Hansen SCI Registry (RHSCIR) and had AE data collected using the Spine Adverse Events Severity system were included. Patient demographic, neurological injury, and comorbidities data were obtained from RHSCIR. Potentially modifiable comorbidities were grouped into health-related conditions, substance use/withdrawal, and psychiatric conditions. Negative binomial regression and multiple logistic regression were used to model the impact of patient factors on the number of AEs experienced and the occurrence of the five previously identified common AEs, respectively. Of the 444 patients included in the study, 24.8% reported a health-related condition, 15.3% had a substance use/withdrawal condition, 8% reported having a psychiatric condition; and 79.3% experienced one or more AEs. Older age (p = 0.004) and more severe injuries (p < 0.001) were nonmodifiable independent variables significantly associated with increased AEs. The AEs experienced by patients were urinary tract infections (42.8%), pneumonia (39.2%), neuropathic pain (31.5%), delirium (18.2%), and pressure ulcers (11.0%). Risk of delirium increased in those with substance use/withdrawal; and pneumonia risk increased with psychiatric comorbidities. Opportunity exists to develop clinical algorithms that include these types of risk factors to reduce the incidence and impact of AEs.

P39 - Morbidity and Mortality of Major Adult Spinal Surgery: An Ambispective Cohort Analysis of 977 Patients

BACKGROUND CONTEXT: Patients admitted at our institution with lumbar spinal stenosis from January 2009 to December 2015 were identified. Patients with full spine adverse events severity system (SAVES) data were included.

CORR Insights®: Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES?

CORR Insights®: Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES?

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES?

Physicians have consistently shown poor adverse-event reporting practices in the literature and yet they have the clinical acumen to properly stratify and appraise these events. The Spine Adverse Events Severity System (SAVES) and Orthopaedic Surgical Adverse Events Severity System (OrthoSAVES) are standardized assessment tools designed to record adverse events in orthopaedic patients. These tools provide a list of prespecified adverse events for users to choose from-an aid that may improve adverse-event reporting by physicians. The primary objective was to compare surgeons' adverse-event reporting with reporting by independent clinical reviewers using SAVES Version 2 (SAVES V2) and OrthoSAVES in elective orthopaedic procedures. This was a 10-week prospective study where SAVES V2 and OrthoSAVES were used by six orthopaedic surgeons and two independent, non-MD clinical reviewers to record adverse events after all elective procedures to the point of patient discharge. Neither surgeons nor reviewers received specific training on adverse-event reporting. Surgeons were aware of the ongoing study, and reported adverse events based on their clinical interactions with the patients. Reviewers recorded adverse events by reviewing clinical notes by surgeons and other healthcare professionals (such as nurses and physiotherapists). Adverse events were graded using the severity-grading system included in SAVES V2 and OrthoSAVES. At discharge, adverse events recorded by surgeons and reviewers were recorded in our database. Adverse-event data for 164 patients were collected (48 patients who had spine surgery, 51 who had hip surgery, 34 who had knee surgery, and 31 who had shoulder surgery). Overall, 99 adverse events were captured by the reviewers, compared with 14 captured by the surgeons (p < 0.001). Surgeons adequately captured major adverse events, but failed to record minor events that were captured by the reviewers. A total of 93 of 99 (94%) adverse events reported by reviewers required only simple or minor treatment and had no long-term adverse effect. Three patients experienced adverse events that resulted in use of invasive or complex treatment that had a temporary adverse effect on outcome. Using SAVES V2 and OrthoSAVES, independent reviewers reported more minor adverse events compared with surgeons. The value of third-party reviewers requires further investigation in a detailed cost-benefit analysis. Level II, therapeutic study.

Spinal Adverse Events Severity System, version 2 (SAVES-V2): inter- and intraobserver reliability assessment.

OBJECTIVE Reporting of adverse events (AEs) in spinal surgery uses inconsistent definitions and severity grading, making it difficult to compare results between studies. The Spinal Adverse Events Severity System, version 2 (SAVES-V2) aims to standardize the classification of spine surgery AEs; however, its inter- and intraobserver reliability are unknown. The objective of this study was to assess inter- and intraobserver reliability of the SAVES-V2 grading system for assessing AEs in spinal surgery. METHODS Two multinational, multicenter surgical study groups assessed surgical case vignettes (10 trauma and 12 degenerative cases) for AE occurrence by using SAVES-V2. Thirty-four members of the Spine Trauma Study Group (STSG) and 17 members of the Degenerative Spine Study Group (DSSG) participated in the first round of case vignettes. Six months later, the same case vignettes were randomly reorganized and presented in an otherwise identical manner. Inter- and intraobserver agreement on the presence, severity, number, and type of AE, as well as the impact of the AE on length of stay (LOS) were assessed using intraclass correlation (ICC), Cohen's kappa value, and the percentage of participants in agreement. RESULTS Agreement on the presence of AEs ranged from 97% to 100% in the 2 groups. Severity classification showed substantial interobserver (ICC = 0.75 for both groups) and intraobserver (ICC = 0.70 in DSSG, 0.71 in STSG) agreement. Judgments on the number of AEs showed high interobserver agreement and moderate intraobserver agreement in both groups. Both the STSG and DSSG had high intraobserver agreement on the type of AE; interobserver agreement for AE type was high in the STSG and fair in the DSSG. Agreement on impact of the AE on LOS was excellent in the DSSG and fair in the STSG. CONCLUSIONS There was good agreement on the presence, severity, and number of AEs in both trauma and degenerative cases in using the SAVES-V2. This grading system is a simple, reliable tool for identifying and capturing AEs in spinal surgery.

Morbidity and mortality of complex spine surgery: a prospective cohort study in 679 patients validating the Spine AdVerse Event Severity (SAVES) system in a European population

Background ContextMost literature on complications in spine surgery has been retrospective or based on national databases with few variables. The Spine AdVerse Events Severity (SAVES) system has been found reliable and valid in two Canadian centers, providing precise information regarding all adverse events (AEs). PurposeThis study aimed to determine the mortality and examine the incidence of morbidity in patients undergoing complex spinal surgery, including pediatric patients, and to validate the SAVES system in a European population. Study designA prospective, consecutive cohort study was conducted using the SAVES version 2010 in the period from January 1, 2013 until December 31, 2013. A retrospective analysis was performed on all patients operated from November 1, 2011 until October 31, 2012 for comparison. Patient samplePatients undergoing spinal surgery at a tertiary referral center comprised the patient sample. Outcome measuresMorbidity and mortality were determined according to the newest version of the SAVES system and compared with the Canadian cohort. Other outcomes were length of stay, readmission, unplanned second surgery during index admission, as well as wound infections requiring revision. MethodsAll patients undergoing spinal surgery at an academic tertiary referral center in the study period were prospectively included. The newest version of SAVES system was used, and a research coordinator collected all intraoperative and perioperative data prospectively. Once a week all patients were reviewed for additional events, validation of the data, and clarification of any questions. Patients were grouped according to the type of admission (elective of emergency) and age, and subgrouped according to a major diagnostic group. The survival status was registered on January 31, 2014 to obtain 30-day survival. ResultsA total of 679 consecutive cases were included with 100% data completion. The in-hospital mortality was 1.3% and the 30-day mortality was 2.7%; all occurring after emergency procedures. The number of intraoperative AEs was 162 (overall incidence 20%), and the number of postoperative AEs was 1,415 (overall incidence 77%). Of the patients, 2.2% had postoperative infections requiring surgical revision. ConclusionsA prospective registration improves AE recognition, and our data confirm the generalizability of the SAVES system to pediatric and non-Canadian populations.

Radiotherapy for neuropathic pain due to bone metastases.

Neuropathic bone pain (NBP) due to bone metastases is estimated to affect about 15-25% of cancer patients experiencing pain. Numerous randomized trials have shown that single or multiple fraction radiotherapy (RT) for painful bone metastases produces intention-to-treat overall response rates (RRs) of approximately 60%, but there are few data on RT for NBP, per se. One randomized trial, Trans Tasman Radiation Oncology Group (TROG) 96.05 showed similar outcomes for NBP, although a single 8 Gy fraction was not proven to be as effective as fractionated treatment (20 Gy in five fractions), with RRs of 53% and 61%, respectively. A recent small, single institution series reported a comparable overall RR for NBP using a variety of fractionation schedules. Although TROG 96.05 found no statistically significant difference in the rates of re-treatment, spinal cord compression, or pathological fracture at the index site by arm, one subsequent single institution retrospective review cautioned against using single fractions for spine (the skeletal site causing the vast majority of NBP), particularly in the presence of high "spinal instability" scores. In that study, single fractions were associated with more spinal adverse events (including symptomatic vertebral compression fracture and spinal cord compression) than fractionated schedules. Although re-irradiation of bone metastases is feasible and moderately effective, there are no outcome data specific to re-treatment of NBP. In summary, NBP may appropriately be treated with fractionated RT, although single fractions may also be reasonable for patients with poor performance status and/or limited expected survival, and in centers with prolonged waiting times for fractionated treatment, given that re-treatment is possible for either. In addition, multiple fractions may be preferable for vertebral metastases in the setting of high "spinal instability" risk.

Incidence, Impact, and Risk Factors of Adverse Events in Thoracic and Lumbar Spine Fractures: An Ambispective Cohort Analysis of 390 Patients

Background Context Adverse events (AEs) in thoracic and lumbar spine fractures are common but little is known about the type of AEs that are specific to this population. Further, very little is known about the incidence and clinical impact of these AEs on patients in the presence of traumatic spinal cord injury (TSCI) and whether they are treated operatively or nonoperatively. Purpose To determine the incidence of AEs in patients with thoracic or lumbar spine fractures treated both operatively and nonoperatively and determine their impact on length of stay (LOS). Secondly, determine the difference in incidence of AEs in both neurologically intact and compromised patients. Study Design/Setting Ambispective cohort study at a quaternary referral center. Patient Sample Patients admitted at our institution with thoracic or lumbar fractures from January 2009 to December 2013 were identified. Patients with full spine adverse events severity system data (SAVES) were included. Outcome Measures Number and type of AEs collected from SAVES were assessed. Impact of AE on acute LOS was also determined. Materials and Methods No funding was received or used in this study. Data on intra-, pre-, and postoperative AEs were prospectively collected using the SAVES data collection. Logistic regression was used to model the likelihood of experiencing at least one AE based on patient characteristics. The impact of the total number of AEs experienced by a patient and that of each of the most common AEs on LOS was determined using Poisson regression. Results A total of 390 patients were included in final analysis. Total, 276 patients (70.8%) were treated operatively. Overall 140 patients (36%) experienced neurological deficit as a result of their initial injury. AEs occurred in operatively treated patients 56% of the time and only 13% of the time in the nonoperative group. The presence of neurological deficit increased the risk of AEs especially in high thoracic (T1–T6) trauma increasing the odds of having an adverse event by 12.1 ( p &lt; 0.0001). The most common AEs were urinary tract infections (UTIs) (19.7%), neuropathic pain (12.3%), pneumonias (11.8%), delirium (10.5%), and ileus (6.2%). LOS increased significantly with pneumonia ( p &lt; 0.0001) and delirium ( p = 0.0001). Conclusions The presence of neurological injury and the need for operative fixation of thoracic or lumbar injuries leads to a greater risk of adverse events. Only pneumonia and delirium consistently increase LOS.

Intraoperative Cone Beam CT (O-Arm) and Stereotactic Navigation (StealthStation) System in Complex Adult Spine Surgery: Early Experience and Learning Curve

Introduction Computer-assisted navigation and intraoperative imaging systems have been shown to improve pedicle screw accuracy in a variety of instrumented spine surgeries. There is limited data evaluating the clinical learning curve for surgeons and its relationship to patient outcomes when using intraoperative navigation and imaging systems. We examined the clinical learning curve and patient outcomes of using O-Arm and StealthStation for six fellowship-trained spine surgeons at our institution, a single quaternary referral center, from 2009 to 2013. Materials and Methods This ambispective study examined 231 surgical cases where O-arm and StealthStation were used to facilitate pedicle instrumentation. The learning curve was determined by examining the year-by-year total operative time and blood loss, operative time and blood loss per surgical level, and the incidence of surgery-related adverse events. Adverse events were prospectively collected using the spine adverse events severity system (SAVES). Results O-arm and StealthStation were acquired at our institution in late 2008 and all spine surgeons were using this navigation system by the beginning of 2009. A total of 231 patients had screws placed using the O-arm and StealthStation between January 1, 2009 and December 31, 2012. There were 430 screws placed in 27 cases in 2009, 556 screws in 54 cases in 2010, 674 screws in 59 cases in 2011, and 758 screws in 75 cases in 2012, p &lt; 0.05. The average estimated blood loss (EBL) decreased from 1,229 mL in 2009 to 907 mL in 2012, p &lt; 0.05. The EBL per case per number of levels instrumented decreased from 5.72 mL in 2008 to 2.39 mL in 2012, p &lt; 0.05. Mean operating time decreased from 407 minutes to 378 minutes from 2009 to 2012, p &lt; 0.05. The number of misplaced screws per case decreased from 0.78 to 0.54 from 2009 to 2012, p &lt; 0.05. There were no significant differences in incidences of dural tear, surgical site infection, or other surgical adverse events during the study period. Conclusion Our results demonstrate that there is a learning curve to the use of intraoperative CT-based navigation, as measured by OR time, intraoperative blood loss, and screw malposition. There were no significant differences in surgical adverse events during this learning period.

Adverse events in surgically treated cervical spondylopathic myelopathy: a prospective validated observational study.

Prospective observational study. Using validated tools to accurately identify and quantify incidence of and risks for inpatient adverse events (AEs) associated with surgical management of cervical spondylopathic myelopathy (CSM) with the goal of assisting physicians and patients in decision making. To identify patient-/disease-/technique-specific, independent risk factors for developing AEs perioperatively and affecting length of stay for patients treated surgically for CSM. Previous studies have reported an overall perioperative complication rate between 15.6% and 18.52%. A total of 104 patients underwent surgery for CSM in our academic quaternary referral center. The average age was 60.3 years (range, 34-86 yr) with a male preponderance (n = 77, 74%). The severity of myelopathy and significant comorbidities was measured and was in keeping with previously assessed populations. Surgical approach was anterior-alone (39.4%), posterior-alone (55.8%), or combined (4.8%) surgery. Inpatient AE data were collected in a rigorous, contemporaneous fashion using the previously validated Spine Adverse Events Severity System (SAVES) tool. A total AE rate of 42.3% was documented in surgically managed patients with CSM (intraoperative = 13.5%, postoperative = 37.5%). Statistically significant risk factors for postoperative AEs were identified, including number of comorbidities (P = 0.012), anterior surgical approach (P = 0.003), and number of levels operated on (P = 0.031). Multiple risk factors for length of stay were also identified, including number of AEs (P < 0.0001), Nurick Score (P < 0.0001), number of levels operated on (P = 0.006), and occurrence of deep wound infection (P < 0.0001). We report higher perioperative AE rates than previously recognized, due to the use of a validated, rigorous data collection tool. Multiple novel patient/disease severity/surgical factors with high statistical significance on perioperative AEs have been identified. 3.

Incidence, impact, and risk factors of adverse events in thoracic and lumbar spine fractures: an ambispective cohort analysis of 390 patients

Background contextAdverse events (AEs) in thoracic and lumbar spine fractures are common, but little is known about the type of AEs that are specific to this population. Furthermore, very little is known about the incidence and clinical impact of these AEs on patients in the presence of traumatic spinal cord injury and whether they are treated operatively or nonoperatively. PurposeThe purpose of this study was to determine primarily the incidence of AEs in patients with thoracic or lumbar spine fractures treated both operatively and nonoperatively and their impact on length of stay (LOS) and secondarily the difference in the incidence of AEs in both neurologically intact and compromised patients. Study design/settingThis is an ambispective cohort study at a quaternary referral center. Patient samplePatients admitted at our institution with thoracic or lumbar fractures from January 2009 to December 2013 were identified. Patients with full Spine Adverse Events Severity System (SAVES) data were included. Outcome measuresNumber and type of AEs collected from SAVES were assessed. Impact of AE on acute LOS was also determined. MethodsData on intraoperative, preoperative, and postoperative AEs were prospectively collected using the SAVES data collection. Logistic regression was used to model the likelihood of experiencing at least one AE based on the patient characteristics. The impact of the total number of AEs experienced by a patient and that of each of the most common AEs on LOS was determined using Poisson regression. ResultsThree hundred and ninety patients were included in the final analysis. Two hundred and seventy-six patients (70.8%) were treated operatively. One hundred and forty patients (36%) experienced neurologic deficit as a result of their initial injury. Adverse events occurred 56% of the time in the operatively treated patients and only 13% of the time in the nonoperative group. The presence of neurologic deficit increased the risk of AEs especially in high thoracic (T1–T6) trauma increasing the odds of having an AE by 12.1 (p<.0001). The most common AEs were urinary tract infections (19.7%), neuropathic pain (12.3%), pneumonias (11.8%), delirium (10.5%), and ileus (6.2%). Length of hospital stay increased significantly with pneumonia (p<.0001) and delirium (p=.0001). ConclusionsThe presence of neurologic injury and the need for operative fixation of thoracic or lumbar injuries lead to a greater risk of AEs. Only pneumonia and delirium consistently increase LOS.

Use of the Spine AdVerse Events Severity (SAVES) System to Categorize and Report Adverse Events in Spine Surgery

Use of the Spine AdVerse Events Severity (SAVES) System to Categorize and Report Adverse Events in Spine Surgery

Adverse events in emergency oncological spine surgery: a prospective analysis.

Most descriptions of spine surgery morbidity and mortality in the literature are retrospective. Emerging prospective analyses of adverse events (AEs) demonstrate significantly higher rates, suggesting underreporting in retrospective and prospective studies that do not include AEs as a targeted outcome. Emergency oncological spine surgeries are generally palliative to reduce pain and improve patients' neurology and health-related quality of life. In individuals with limited life expectancy, AEs can have catastrophic implications; therefore, an accurate AE incidence must be considered in the surgical decision-making process. The purpose of this study was to determine the true incidence of AEs associated with emergency oncological spine surgery. The authors carried out a prospective cohort study in a quaternary care referral center that included consecutive patients admitted between January 1, 2009, and December 31, 2012. Inclusion criteria were all patients undergoing emergency surgery for metastatic spine disease. AE data were reported and collected on standardized AE forms (Spine AdVerse Events Severity System, version 2 [SAVES V2] forms) at weekly dedicated morbidity and mortality rounds attended by attending surgeons, residents, fellows, and nursing staff. A total of 101 patients (50 males, 51 females) met the inclusion criteria and had complete data. Seventy-six patients (76.2%) had at least 1 AE, and 11 patients (10.9%) died during their admission. Intraoperative surgical AEs were observed in 32% of patients (9.9% incidental durotomy, 16.8% blood loss > 2 L). Transient neurological deterioration occurred in 6 patients (5.9%). Infectious complications in this patient population were significant (surgical site 6%, other 50.5%). Delirium complicated the postoperative period in 20.8% of cases. When evaluated in a rigorous prospective manner, metastatic spine surgery is associated with a higher morbidity rate than previously reported. This AE incidence must be considered by the patient, oncologist, and surgeon to determine appropriate management and preventative strategies to reduce AEs in this fragile patient population.

Reliability of the spine adverse events severity system (SAVES) for individuals with traumatic spinal cord injury.

Test-retest analysis. To determine the intra- and inter-rater reliability of the Spine Adverse Events Severity System for Spinal Cord Injury (SAVES-SCI) in patients with traumatic SCI. Quaternary care spine program in Vancouver, Canada. Ten hypothetical patient cases were developed. The cases were completed by 10 raters (seven physicians, one nurse, one physiotherapist and one researcher) who were asked to identify and grade the severity of adverse events using SAVES-SCI twice with 1-week interval. Intra- and inter-rater reliability were calculated using kappa statistics and intraclass correlation coefficients (ICC). Intra-rater reliability for both identifying and grading AEs were high with all AEs (kappa greater than 0.6) except for bone implant, diathermy burn, massive blood loss, myocardial infarction, neurological deterioration, pressure ulcer, return to operating room and tracheostomy requirement. The inter-rater reliability measured with ICC were all above 0.6 for identifying and grading intraoperative, pre and postoperative AEs and consequences of SCI. The SAVES-SCI demonstrated acceptable intra-and inter-rater reliability for a majority of the AEs. Further clarification and definition of some of the AEs as well as provision of sample training cases for clinicians would assist in reducing measurement errors. The SAVES-SCI is a useful tool to assess and capture AEs in patients with acute traumatic SCI.

Operative and nonoperative adverse events in the management of traumatic fractures of the thoracolumbar spine: a systematic review.

Thoracolumbar spine injuries are commonly encountered in patients with trauma, accounting for almost 90% of all spinal fractures. Thoracolumbar burst fractures comprise a high percentage of these traumatic fractures (45%), and approximately half of the patients with this injury pattern are neurologically intact. However, a debate over complication rates associated with operative versus nonoperative management of various thoracolumbar fracture morphologies is ongoing, particularly concerning those patients presenting without a neurological deficit. A MEDLINE search for pertinent literature published between 1966 and December 2013 was conducted by 2 authors (G.G. and R.D.), who used 2 broad search terms to maximize the initial pool of manuscripts for screening. These terms were "operative lumbar spine adverse events" and "nonoperative lumbar spine adverse events." In an advanced MEDLINE search of the term "operative lumbar spine adverse events" on January 8, 2014, 1459 results were obtained. In a search of "nonoperative lumbar spine adverse events," 150 results were obtained. After a review of all abstracts for relevance to traumatic thoracolumbar spinal injuries, 62 abstracts were reviewed for the "operative" group and 21 abstracts were reviewed for the "nonoperative" group. A total of 14 manuscripts that met inclusion criteria for the operative group and 5 manuscripts that met criteria for the nonoperative group were included. There were a total of 919 and 436 patients in the operative and nonoperative treatment groups, respectively. There were no statistically significant differences between the groups with respect to age, sex, and length of stay. The mean ages were 43.17 years in the operative and 34.68 years in the nonoperative groups. The majority of patients in both groups were Frankel Grade E (342 and 319 in operative and nonoperative groups, respectively). Among the studies that reported the data, the mean length of stay was 14 days in the operative group and 20.75 in the nonoperative group. The incidence of all complications in the operative and nonoperative groups was 300 (32.6%) and 21 (4.8%), respectively (p = 0.1065). There was no significant difference between the 2 groups with respect to the incidence of pulmonary, thromboembolic, cardiac, and gastrointestinal complications. However, the incidence of infections (pneumonia, urinary tract infection, wound infection, and sepsis) was significantly higher in the operative group (p = 0.000875). The incidence of instrumentation failure and need for revision surgery was 4.35% (40 of 919), a significant morbidity, and an event unique to the operative category (p = 0.00396). Due to the limited number of high-quality studies, conclusions related to complication rates of operative and nonoperative management of thoracolumbar traumatic injuries cannot be definitively made. Further prospective, randomized studies of operative versus nonoperative management of thoracolumbar and lumbar spine trauma, with standardized definitions of complications and matched patient cohorts, will aid in properly defining the risk-benefit ratio of surgery for thoracolumbar spine fractures.

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI

Background contextAdverse events (AEs) with significant resultant morbidity are common during the acute hospital care of patients with traumatic spinal cord injury (TSCI). The Rick Hansen SCI Registry (RHSCIR) collects Canada-wide data on patients with TSCI, such as sociodemographic, injury, diagnosis, intervention, and health outcome details. These data contribute to an evidence base for informing best practice and improving SCI care. As the RHSCIR captures data on patients from prehospital to community phases of care, it is an invaluable resource for providing information on health outcomes resulting from TSCI, including outcomes related to AEs. PurposeTo determine the incidence and types of AEs occurring in patients with TSCI during acute care and the impact on length of stay (LOS) and health-related quality of life (HRQOL). Study design/settingProspective cohort study at an academic quaternary referral center. Patient samplePatients with TSCI discharged from our institution between 2008 and 2010 were identified using the RHSCIR. The RHSCIR includes patients admitted to one of the participating centers across Canada, who have been clinically diagnosed with an acute TSCI or classified as AIS A, B, C, D, or cauda equina. Outcome measuresAcute-phase LOS and HRQOL were assessed for impact resulting from the number and type of AEs experienced. Health-related quality of life was determined using the short-form 36 (SF-36) physical and mental component summary scores and functional independence measure. MethodsData related to patients' injury, diagnoses, hospital admission, and SF-36 scores were obtained from the local RHSCIR. Data on intra-, pre-, and postoperative AEs were collected prospectively using the Spine Adverse Events Severity System data collection system, documenting all AEs experienced by each patient. Multivariate analyses were performed to determine whether patient and injury characteristics were associated with the number and type of AEs experienced and whether these were associated with LOS and HRQOL determined on follow-up. ResultsOne hundred seventy-one patients with TSCI were included, 81.3% were men and mean age at injury was 47.2±20.3 years. Adverse events occurred in 77.2% of patients, 14.6% experienced an intraoperative and 73.7% experienced a pre/postoperative event. The most frequent pre/postoperative AEs were urinary tract infections (UTIs) (32.2%), pneumonias (32.8%), neuropathic pain (15.2%), decubitus ulcers (14.6%), and delirium (18.7%). Length of stay was significantly affected by decubitus ulcers, delirium, pneumonias, and UTIs (p<.01), increasing 1.7 (UTIs) to 2.2 (decubitus ulcers) times compared with patients without the specific AEs. Health-related quality of life was not affected by acute care AEs but rather those identified at 1-year follow-up. ConclusionsThis prospective study found that more than 77% of patients with TSCI sustain an AE during acute hospital care, significantly higher than previously reported. We demonstrate the utility of a dedicated AE collection system and the effect of these events on health status.

Acute adverse events associated with ventral slot decompression in 546 dogs with cervical intervertebral disc disease

To report the frequency, types, and risk factors for acute perioperative adverse events (AEs) in dogs that had ventral slot decompression (VSD) for cervical intervertebral disc disease (IVDD). Retrospective, case-control study. Dogs (n = 546) with cervical IVDD treated by VSD; 54 cases experiencing AE and 492 controls. Historical, clinical, diagnostic, operative, and outcome data were collected. AE were graded using a Spine Adverse Events Severity (SAVES) system. Associations between the development of AE and hypothesized risk factors were analyzed using bi- and multi-variable analyses. AE were observed in 54 dogs (9.9%). Minor AE (SAVES Grade 1-2) occurred in 3.5% (19 dogs) and major (SAVES Grades 3-5) AE in 6.4% (35 dogs). Deterioration in neurologic status (n = 13), persistent pain (12), and intraoperative hemorrhage (7) were common major AE. NSAID administration, surgeon experience, C7-T1 disc location, and intraoperative hypotension were significantly associated with AE in multivariate analyses. Improvement of AE occurred in 48/54 (88.9%) of cases, although reoperative neurosurgery was required in 48.5% (17/35) of dogs experiencing major AE. Dogs with major AE had significantly longer hospitalization and worse outcomes than dogs with minor AE or controls. No fatal AE occurred, although 0.7% (4/546) of dogs were euthanatized postoperatively. AE occurred in 9.9% of dogs that had VSD, and were significantly associated with perioperative hypotension, C7-T1 disc extrusions, surgeon experience, and NSAID usage. Identification of a major postoperative AE is an indication for immediate diagnostic imaging studies, as 50% of dogs experiencing major AE required reoperation.