Spine Adverse Events Severity Research Articles

Mitigating Medical Adverse Events Following Spinal Surgery: The Effectiveness of a Postoperative Quality Improvement (QI) Care Bundle.

Spine surgery is associated with a high incidence of postoperative medical adverse events (AEs). Many of these events are considered "minor" though their cost and effect on outcome may be underestimated. We sought to examine the clinical and cost-effectiveness of a postoperative quality improvement (QI) care bundle in mitigating postoperative medical AEs in adult surgical spine patients. We collected 14-year prospective observational interrupted time series (ITS) with two historical cohorts: 2006 to 2008, pre-implementation of the postoperative QI care bundle; and 2009 to 2019, post-implementation of the postoperative QI care bundle. Adverse Events were identified and graded (Minor I and II) using the previously validated Spine AdVerse Events Severity (SAVES) system. Pearson Correlation tested for changes across patient and surgical variables. Adjusted segmented regression estimated the effect of the postoperative QI care bundle on the annual and absolute incidences of medical AEs between the two periods. A cost model estimated the annual cumulative cost savings through preventing these "minor" medical AEs. We included 13,493 patients over the study period with a mean of 964 per year (SD±73). Mean age, mean Charlson Comorbidity Index (CCI), and mean spine surgical invasiveness index (SSII) increased from 48.4 to 58.1years; 1.7 to 2.6; and 15.4 to 20.5, respectively (p<0.001). Unadjusted analysis confirmed a significant decrease in the annual number of all medical AEs (p<0.01). When adjusting for age, CCI and SSII, segmented regression demonstrated a significant absolute reduction in the annual incidence of cardiac, pulmonary, nausea and medication-related AEs by 9.58%, 7.82%, 11.25% and 15.01%, respectively (p<0.01). The postoperative QI care bundle was not associated with reducing the annual incidence of delirium, electrolyte levels or GI AEs. Annual projected cost savings for preventing Grade I and II medical AEs were $1,808,300 CAD and $11,961,500 CAD. Postoperative QI care bundles are effective for improving patient care and preventing medical care-related AEs, with significant cost savings. Postoperative QI care bundles should be tailored to the specific vulnerability of the surgical population for experiencing AEs.

Generic versus disease-specific adverse event reporting: a comparison of the NSQIP and SAVES databases for the identification of acute care adverse events in adult spine surgery.

The accurate identification and reporting of adverse events (AEs) is crucial for quality improvement. A myriad of AE systems are utilized. There is a lack of understanding of the differences between prospective versus retrospective, disease-specific versus generic, and point-of-care versus chart-abstracted systems. The objective of this study was to compare the benefits and limitations between the prospective, disease-specific, point-of-care Spine Adverse Events Severity System (SAVES) and the retrospective, generic, and chart-abstracted National Surgical Quality Improvement Program (NSQIP) for the identification and reporting of AEs in adult patients undergoing spinal surgery. The authors conducted an observational ambidirectional cohort study of adult patients undergoing spine surgery other than for trauma between 2011 and 2019 in a quaternary spine center. Patients were identified using Current Procedural Terminology codes in the NSQIP database and matched using unique medical record numbers to their corresponding record in SAVES. The incidence of AEs and per-patient AEs as recorded in NSQIP and SAVES was the primary outcome of interest. Comparable AEs were identified by matching NSQIP AEs to equivalent ones in SAVES. Chi-square tests were used to test for significant differences in the incidence of overall and comparable AEs between the databases. There were 2198 patients identified in NSQIP, of whom 2033 also had complete records in SAVES. SAVES identified 5342 individual AEs in 1484 patients (73%) compared with 1291 individual AEs in 807 patients (39.7%) with the NSQIP database (p < 0.001). SAVES identified 250 intraoperative and 422 postoperative spine-specific AEs that NSQIP did not record. NSQIP captured a greater number of AEs beyond 30 days, including prolonged length of stay > 30 days, unplanned readmission, unplanned reoperation, and death later than 30 days after surgery compared with SAVES. SAVES captures a greater incidence of peri- and intraoperative spine-specific AEs than NSQIP, while NSQIP identifies a greater number of AEs beyond 30 days. While a prospective, disease-specific, point-of-care AE system such as SAVES is specific for guiding quality improvement in spine surgery, it incurs greater time and financial costs. Conversely, a retrospective, generic, and chart-abstracted system such as NSQIP provides equivocal cross-institutional comparability with reduced time and financial costs. Specific contextual and aim-specific needs should guide the choice and implementation of an AE system.

Is preoperative S-albumin associated to postoperative complications and readmission in patients with adult spinal deformity: a prospective analysis of 128 patients using the Spine AdVerse Event Severity (SAVES) system.

To assess the association between preoperative S-albumin and postoperative outcome following adult spinal deformity (ASD) surgery. All patients undergoing ASD surgery from February 1, 2017 and January 31, 2018 at a single quaternary referral center were prospectively included. Adverse events (AE) during admission were assessed using the Spine AdVerse Events Severity (SAVES) system. Based on preoperative S-albumin, patients were categorized as "normal" or "abnormal" and compared regarding postoperative outcome, adverse events (AEs), 30- and 90-day readmission, revision surgery, and mortality. A total of 128 patients aged ≥ 18years were included, and S-albumin was available in 88%. Of these, 73% (n = 93) were classified as "normal", 16% (n = 20) as "abnormal", and 12% (n = 15) as "missing". The "normal" albumin group had less comorbidity burden [ASA score 2 (2, 3) vs 3 (2, 3), p = 0.011], higher hemoglobin levels (8.4 (± 0.9) mmol/L vs 7.4 (± 1.1) mmol/L, p < 0.001), and higher S-albumin (38.9 (± 2.7) g/L vs 31.9 (± 4.4) g/L, < 0.001). The rate of 90-day readmission was significantly increased in the "abnormal" group (65% vs 36%), corresponding to a relative risk increase of 1.25 (95% CI 1.02-1.52, p = 0.029). Similar increased risks were found in subsequent logistic regression analyses, although results were not significant in multivariable analysis (p = 0.102). Comparing remaining outcome parameters, point estimates revealed increased AEs, 30-day readmission, and revision in the "abnormal" albumin group, although effects did not reach statistical significance. In a prospective, consecutive, single-center cohort of 128 patients undergoing ASD surgery, we found a significant association between "abnormal" preoperative S-albumin and increased 90-day readmission. Furthermore, although the findings were not statistically significant, we did find that AEs, 30-day readmission, and revision were numerically more frequent in the "abnormal" group, suggesting an expected tendency that should be further investigated. We conclude that nutritional status prior to ASD surgery could be important to consider and suggest validation in larger prospective cohorts. Prognostic II.

National adverse event profile after lumbar spine surgery for lumbar degenerative disorders and comparison of complication rates between hospitals: a CSORN registry study.

Previous works investigating rates of adverse events (AEs) in spine surgery have been retrospective, with data collection from administrative databases, and often from single centers. To date, there have been no prospective reports capturing AEs in spine surgery on a national level, with comparison among centers. The Spine Adverse Events Severity system was used to define the incidence and severity of AEs after spine surgery by using data from the Canadian Spine Outcomes and Research Network (CSORN) prospective registry. Patient data were collected prospectively and during hospital admission for those undergoing elective spine surgery for degenerative conditions. The Spine Adverse Events Severity system defined minor and major AEs as grades 1-2 and 3-6, respectively. There were 3533 patients enrolled in this cohort. There were 85 (2.4%) individual patients with at least one major AE and 680 (19.2%) individual patients with at least one minor AE. There were 25 individual patients with 28 major intraoperative AEs and 260 patients with 275 minor intraoperative AEs. Postoperatively there were 61 patients with a total of 80 major AEs. Of the 487 patients with minor AEs postoperatively there were 698 total AEs. The average enrollment was 321 patients (range 47-1237 patients) per site. The rate of major AEs was consistent among sites (mean 2.9% ± 2.4%, range 0%-9.1%). However, the rate of minor AEs varied widely among sites-from 7.9% to 42.5%, with a mean of 18.8% ± 9.7%. The rate of minor AEs varied depending on how they were reported, with surgeon reporting associated with the lowest rates (p < 0.01). The rate of major AEs after lumbar spine surgery is consistent among different sites but the rate of minor AEs appears to vary substantially. The method by which AEs are reported impacts the rate of minor AEs. These data have implications for the detection and reporting of AEs and the design of strategies aimed at mitigating complications.

P.219 The effect of peri-operative adverse events on long-term patient reported outcomes after lumbar spine surgery

Background: Peri-operative adverse events (AE) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. The purpose of this study is to examine peri-operative AEs and their impact on outcome after lumbar spine surgery. Methods: 3556 consecutive patients undergoing surgery for lumbar degenerative disorders enrolled in the Canadian Spine Outcomes and Research Network were analyzed. AEs were defined using the validated Spine AdVerse Events Severity system. Outcomes at 3,12, and 24 months post-operatively included the Owestry Disability Index (ODI), SF-12 Physical (PCS) and Mental (MCS) scales, visual analog scale (VAS) leg and back, Euroqol-5D (EQ5D), and satisfaction. Results: Adverse events occurred in 767 (21.6%) patients, 85 (2.4%) suffered major AEs. Patients with major AEs had worse OD (physical disability) scores and did not reach minimum clinically important differences at 2 years (no AE 25.7±19.2, major: 36.4±19.1, p&lt;0.001). Major AEs were associated with worse ODI (physical disability) scores on multivariable linear regression (p=0.011). Conclusions: Major AEs after lumbar spine surgery lead to worse functional outcomes and lower satisfaction. This highlights the need to implement strategies aimed at reducing adverse events.

Accuracy of hospital-based surveillance systems for surgical site infection after adult spine surgery: a Bayesian latent class analysis

Surgical site infections (SSIs) of the spine are morbid and costly complications. An accurate surveillance system is required to properly describe the disease burden and the impact of interventions that mitigate SSI risk. Unfortunately, uniform approaches to conducting SSI surveillance are lacking because of varying SSI case definitions, the lack of a perfect reference case definition and heterogeneous data sources. To assess the accuracy of four independent data sources that capture SSIs after spine surgery, with estimation of a measurement-error-adjusted SSI incidence. A Bayesian latent class model assessed the sensitivity/specificity of each data source to identify SSI and to estimate a measurement-error-adjusted incidence. The four data sources used were: the discharge abstract database (DAD), the National Surgical Quality Improvement Program (NSQIP) database, the Infection Prevention and Control Canada (IPAC) database, and the Spine Adverse Events Severity database. A total of 904 patients underwent spine surgery in 2017. The most sensitive data source was DAD (0.799; 95% credible interval (CrI): 0.597-0.943); the least sensitive was NSQIP (0.497; 95% CrI: 0.308-0.694). The most specific data source was IPAC (0.997; 95% CrI: 0.993-1.000) and the least specific was DAD (0.969; 95% CrI: 0.956-0.981). The measurement-error-adjusted SSI incidence was 0.030 (95% CrI: 0.019-0.045). The crude incidence using the DAD overestimated the incidence, and the three other data sources underestimated it. SSI surveillance in the spine surgery population is feasible using several data sources, provided that measurement error is considered.

A Comparison of Mortality and Morbidity Between Complex and Degenerative Spine Surgery in Prospectively Collected Data From 2,280 Procedures.

ObjectiveThe reported incidence of complications and/or adverse events (AEs) following spine surgery varies greatly. A validated, systematic, reproducible reporting system to quantify AEs was used in 2 prospective cohorts, from 2 spine surgery centers, conducting either complex or purely degenerative spine surgery; in a comparative fashion. The aim was to highlight the differences between 2 distinctly different prospective cohorts with patients from the same background population. MethodsAEs were registered according to the predefined AE variables in the SAVES (Spine AdVerse Events Severity) system which was used to record all intra- and perioperative AEs. Additional outcomes, including mortality, length of stay, wound infection requiring revision, readmission, and unplanned revision surgery during the index admission, were also registered. ResultsA total of 593 complex and 1,687 degenerative procedures were consecutively included with 100% data completion. There was a significant difference in morbidity when comparing the total number of AEs between the 2 groups (p < 0.001): with a mean number of 1.42 AEs per patient (n = 845) in the complex cohort, and 0.97 AEs per patient (n = 1,630) in the degenerative cohort. ConclusionIn this prospective study comparing 2 cohorts, we report the rates of AEs related to spine surgery using a validated reproducible grading system for registration. The rates of morbidity and mortality were significantly higher following complex spine surgery compared to surgery for degenerative spine disease.

The Effect of Perioperative Adverse Events on Long-Term Patient-Reported Outcomes After Lumbar Spine Surgery.

Perioperative adverse events (AEs) lead to patient disappointment and greater costs. There is a paucity of data on how AEs affect long-term outcomes. To examine perioperative AEs and their impact on outcome after lumbar spine surgery. A total of 3556 consecutive patients undergoing surgery for lumbar degenerative disorders enrolled in the Canadian Spine Outcomes and Research Network were analyzed. AEs were defined using the validated Spine AdVerse Events Severity system. Outcomes at 3, 12, and 24 mo postoperatively included the Owestry Disability Index (ODI), 12-Item Short-Form Health Survey (SF-12) Physical (PCS) and Mental (MCS) Component Summary scales, visual analog scale (VAS) leg and back, EuroQol-5D (EQ5D), and satisfaction. AEs occurred in 767 (21.6%) patients, and 85 (2.4%) patients suffered major AEs. Patients with major AEs had worse ODI scores and did not reach minimum clinically important differences at 2 yr (no AE: 25.7±19.2, major: 36.4±19.1, P <.001). Major AEs were associated with worse ODI scores on multivariable linear regression (P=.011). PCS scores were lower after major AEs (43.8±9.5, vs 37.7±20.3, P=.002). On VAS leg and back and EQ5D, the 2-yr outcomes were significantly different between the major and no AE groups (<0.01), but these differences were small (VAS leg: 3.4±3.0vs 4.0±3.3; VAS back: 3.5±2.7vs 4.5±2.6; EQ5D: 0.75±0.2vs 0.64±0.2). SF12 MCS scores were not different. Rates of satisfaction were lower after major AEs (no AE: 84.6%, major: 72.3%, P <.05). Major AEs after lumbar spine surgery lead to worse functional outcomes and lower satisfaction. This highlights the need to implement strategies aimed at reducing AEs.

Morbidity and mortality following degenerative spine surgery in a prospective cohort of 1687 consecutive surgical procedures.

Prospective, observational cohort study. To determine the true incidence of adverse events (AEs) in European adults undergoing surgery for degenerative spine diseases. The majority of surgeries performed for degenerative spinal diseases are elective, and the need for adequate estimation of risk-benefit of the intended surgery is imperative. A cumbersome obstacle for adequate estimation of surgery-related risks is that the true incidence of complications or adverse events (AEs) remains unclear. All adult patients (≥ 18 years) undergoing spine surgery at a single center from February 1, 2016, to January 31, 2017, were prospectively and consecutively included. Morbidity and mortality were determined using the Spine AdVerse Events Severity (SAVES) system. Additionally, the correlation between the AEs and length of stay (LOS) and mortality was assessed. A total of 1687 procedures were performed in the study period, and all were included for analysis. Of these, 1399 (83%) were lumbar procedures and 288 (17%) were cervical. The overall incidence of AEs was 47.4%, with a minor AE incidence of 43.2% and a major of 14.5%. Female sex (OR 1.5 [95% CI 1.2-1.9), p < 0.001) and age > 65 years (OR 1.5 [95% CI 1.1-1.7], p = 0.012) were significantly associated with increased odds of having an AE. Based on prospectively registered AEs in this single-center study, we validated the use of the SAVES system in a European population undergoing spine surgery due to degenerative spine disease. We found a higher incidence of AEs than previously reported in retrospective studies. The major AEs registered occurred significantly more often perioperatively and in patients > 65 years.

Readmission following complex spine surgery in a prospective cohort of 679 patients – 2-years follow-up using the Spine AdVerse Event Severity (SAVES) system

BACKGROUND CONTEXTRecent studies suggest that prospective registration more accurately reflects the true incidence of adverse events (AEs). To our knowledge, no previous study has investigated prospectively registered AEs' influence on hospital readmission following spine surgery. PURPOSETo determine the frequency and type of unplanned readmissions after complex spine surgery, and to investigate if prospectively registered AEs can predict readmissions. DESIGNThis is a prospective, consecutive cohort study. PATIENT SAMPLEWe conducted a single-center study of 679 consecutive patients who underwent complex spine surgery defined as conditions deemed too complicated for surgery at a secondary institute, or patients with severe comorbidities requiring multidisciplinary observation and treatment. OUTCOME MEASURESThe outcomes in this study were (1) readmission to any hospital department within 30 days of discharge and (2) readmission to a surgical spine center at any time in follow-up. METHODSAll patients undergoing complex spine surgery, at our tertiary referral center, were consecutively, and prospectively, included from January 1 to December 31, 2013. Demographics and perioperative AEs were registered using the Spine AdVerse Events Severity (SAVES) system. Patients were followed for a minimum of two years. A competing risk survival model was used to estimate rates of readmissions with death as a competing risk. Patient characteristics, surgical parameters and perioperative AEs were analyzed to identify factors associated with readmission. Analyses of 30-day readmission were performed using logistic regression models. A proportional odds model, with death as competing risk, was used for readmissions to a spine center at any time in follow-up. Results were reported as odds ratios with 95% confidence intervals (95% CI). RESULTSWithin 2 years of index discharge, 443 (65%) were readmitted. Only 20% of readmissions were to a spine center. Cumulative incidence (95% CI) of readmission was estimated to 13% (10%–16%) at 30 days, 26% (23%–30%) at 90 days, 50% (46%–54%) at 1 year, and 59% (55%–63%) at 2 years following discharge. Rates were markedly lower for readmissions to a spine center. Increased odds of 30-day readmission were correlated to intraoperative hypotension (p=.02) and major intraoperative blood loss (p<.01). Readmission to a spine center was associated with the number of instrumented vertebrae (p=.047), major intraoperative AE (p=.01), and intraoperative hypotension (p<.01). CONCLUSIONSTo the best of our knowledge, this is the first study to analyze prospectively registered AEs' association to readmission up to 2 years after complex spine surgery. We found that readmissions were more frequent than previously reported when including readmissions to any department or hospital. Factors related to major intraoperative blood loss were associated to increased odds of readmission. This should be considered during planning of postoperative observation and care.

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.

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.

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.

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.

Canadian spine society 15th annual scientific conference.

Canadian spine society 15th annual scientific conference.

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.