Management of Anticoagulation/Antiplatelet Medication and Venous Thromboembolism Prophylaxis in Elective Spine Surgery: Concise Clinical Recommendations Based on a Modified Delphi Process
Study Design. Delphi method. Objective. To gain consensus on the following questions: (1) When should anticoagulation/antiplatelet (AC/AP) medication be stopped before elective spine surgery?; (2) When should AC/AP medication be restarted after elective spine surgery?; (3) When, how, and in whom should venous thromboembolism (VTE) chemoprophylaxis be started after elective spinal surgery? Summary of Background Data. VTE can lead to significant morbidity after adult spine surgery, yet postoperative VTE prophylaxis practices vary considerably. The management of preoperative AC/AP medication is similarly heterogeneous. Materials and Methods. Delphi method of consensus development consisting of three rounds (January 26, 2021, to June 21, 2021). Results. Twenty-one spine surgeons were invited, and 20 surgeons completed all rounds of questioning. Consensus (>70% agreement) was achieved in 26/27 items. Group consensus stated that preoperative Direct Oral Anticoagulants should be stopped two days before surgery, warfarin stopped five days before surgery, and all remaining AC/AP medication and aspirin should be stopped seven days before surgery. For restarting AC/AP medication postoperatively, consensus was achieved for low-risk/medium-risk/high-risk patients in 5/5 risk factors (VTE history/cardiac/ambulation status/anterior approach/operation). The low/medium/high thresholds were POD7/POD5/POD2, respectively. For VTE chemoprophylaxis, consensus was achieved for low-risk/medium-risk/high-risk patients in 12/13 risk factors (age/BMI/VTE history/cardiac/cancer/hormone therapy/operation/anterior approach/staged separate days/staged same days/operative time/transfusion). The one area that did not gain consensus was same-day staged surgery. The low-threshold/medium-threshold/high-threshold ranges were postoperative day 5 (POD5) or none/POD3-4/POD1-2, respectively. Additional VTE chemoprophylaxis considerations that gained consensus were POD1 defined as the morning after surgery regardless of operating finishing time, enoxaparin as the medication of choice, and standardized, rather than weight-based, dose given once per day. Conclusions. In the first known Delphi study to address anticoagulation/antiplatelet recommendations for elective spine surgery (preoperatively and postoperatively); our Delphi consensus recommendations from 20 spine surgeons achieved consensus on 26/27 items. These results will potentially help standardize the management of preoperative AC/AP medication and VTE chemoprophylaxis after adult elective spine surgery.
Development of new postoperative neck pain at 12 and 24 months after surgery for cervical spondylotic myelopathy: a Quality Outcomes Database study
OBJECTIVE Patients who undergo surgery for cervical spondylotic myelopathy (CSM) will occasionally develop postoperative neck pain that was not present preoperatively, yet the incidence of this phenomenon is unclear. The authors aimed to elucidate patient and surgical factors associated with new-onset sustained pain after CSM surgery. METHODS The authors reviewed data from the Quality Outcomes Database (QOD) CSM module. The presence of neck pain was defined using the neck pain numeric rating scale (NRS). Patients with no neck pain at baseline (neck NRS score ≤ 1) were then stratified based on the presence of new postoperative pain development (neck NRS score ≥ 2) at 12 and 24 months postoperatively. RESULTS Of 1141 patients in the CSM QOD, 224 (19.6%) reported no neck pain at baseline. Among 170 patients with no baseline neck pain and available 12-month follow-up, 46 (27.1%) reported new postoperative pain. Among 184 patients with no baseline neck pain and available 24-month follow-up, 53 (28.8%) reported new postoperative pain. The mean differences in neck NRS scores were 4.3 for those with new postoperative pain compared with those without at 12 months (4.4 ± 2.2 vs 0.1 ± 0.3, p < 0.001) and 3.9 at 24 months (4.1 ± 2.4 vs 0.2 ± 0.4, p < 0.001). The majority of patients reporting new-onset neck pain reported being satisfied with surgery, but their satisfaction was significantly lower compared with patients without pain at the 12-month (66.7% vs 94.3%, p < 0.001) and 24-month (65.4% vs 90.8%, p < 0.001) follow-ups. The baseline Neck Disability Index (NDI) was an independent predictor of new postoperative neck pain at both the 12-month and 24-month time points (adjusted OR [aOR] 1.04, 95% CI 1.01–1.06; p = 0.002; and aOR 1.03, 95% CI 1.01–1.05; p = 0.026, respectively). The total number of levels treated was associated with new-onset neck pain at 12 months (aOR 1.34, 95% CI 1.09–1.64; p = 0.005), and duration of symptoms more than 3 months was a predictor of 24-month neck pain (aOR 3.22, 95% CI 1.01–10.22; p = 0.048). CONCLUSIONS Increased NDI at baseline, number of levels treated surgically, and duration of symptoms longer than 3 months preoperatively correlate positively with the risk of new-onset neck pain following CSM surgery. The majority of patients with new-onset neck pain still report satisfaction from surgery, suggesting that the risk of new-onset neck pain should not hinder indicated operations from being performed.
Correlation of the Modified Japanese Orthopedic Association With Functional and Quality-of-Life Outcomes After Surgery for Degenerative Cervical Myelopathy: A Quality Outcomes Database Study
BACKGROUND: The modified Japanese Orthopedic Association (mJOA) score is a widely used and validated metric for assessing severity of myelopathy. Its relationship to functional and quality-of-life outcomes after surgery has not been fully described. OBJECTIVE: To quantify the association of the mJOA with the Neck Disability Index (NDI) and EuroQol-5 Dimension (EQ-5D) after surgery for degenerative cervical myelopathy. METHODS: The cervical module of the prospectively enrolled Quality Outcomes Database was queried retrospectively for adult patients who underwent single-stage degenerative cervical myelopathy surgery. The mJOA score, NDI, and EQ-5D were assessed preoperatively and 3 and 12 months postoperatively. Improvement in mJOA was used as the independent variable in univariate and multivariable linear and logistic regression models. RESULTS: Across 14 centers, 1121 patients were identified, mean age 60.6 ± 11.8 years, and 52.5% male. Anterior-only operations were performed in 772 patients (68.9%). By univariate linear regression, improvements in mJOA were associated with improvements in NDI and EQ-5D at 3 and 12 months postoperatively (all P < .0001) and with improvements in the 10 NDI items individually. These findings were similar in multivariable regression incorporating potential confounders. The Pearson correlation coefficients for changes in mJOA with changes in NDI were −0.31 and −0.38 at 3 and 12 months postoperatively. The Pearson correlation coefficients for changes in mJOA with changes in EQ-5D were 0.29 and 0.34 at 3 and 12 months. CONCLUSION: Improvements in mJOA correlated weakly with improvements in NDI and EQ-5D, suggesting that changes in mJOA may not be a suitable proxy for functional and quality-of-life outcomes.
Cervical spondylotic myelopathy with severe axial neck pain: is anterior or posterior approach better?
OBJECTIVE The aim of this study was to determine whether multilevel anterior cervical discectomy and fusion (ACDF) or posterior cervical laminectomy and fusion (PCLF) is superior for patients with cervical spondylotic myelopathy (CSM) and high preoperative neck pain. METHODS This was a retrospective study of prospectively collected data using the Quality Outcomes Database (QOD) CSM module. Patients who received a subaxial fusion of 3 or 4 segments and had a visual analog scale (VAS) neck pain score of 7 or greater at baseline were included. The 3-, 12-, and 24-month outcomes were compared for patients undergoing ACDF with those undergoing PCLF. RESULTS Overall, 1141 patients with CSM were included in the database. Of these, 495 (43.4%) presented with severe neck pain (VAS score > 6). After applying inclusion and exclusion criteria, we compared 65 patients (54.6%) undergoing 3- and 4-level ACDF and 54 patients (45.4%) undergoing 3- and 4-level PCLF. Patients undergoing ACDF had worse Neck Disability Index scores at baseline (52.5 ± 15.9 vs 45.9 ± 16.8, p = 0.03) but similar neck pain (p > 0.05). Otherwise, the groups were well matched for the remaining baseline patient-reported outcomes. The rates of 24-month follow-up for ACDF and PCLF were similar (86.2% and 83.3%, respectively). At the 24-month follow-up, both groups demonstrated mean improvements in all outcomes, including neck pain (p < 0.05). In multivariable analyses, there was no significant difference in the degree of neck pain change, rate of neck pain improvement, rate of pain-free achievement, and rate of reaching minimal clinically important difference (MCID) in neck pain between the two groups (adjusted p > 0.05). However, ACDF was associated with a higher 24-month modified Japanese Orthopaedic Association scale (mJOA) score (β = 1.5 [95% CI 0.5–2.6], adjusted p = 0.01), higher EQ-5D score (β = 0.1 [95% CI 0.01–0.2], adjusted p = 0.04), and higher likelihood for return to baseline activities (OR 1.2 [95% CI 1.1–1.4], adjusted p = 0.002). CONCLUSIONS Severe neck pain is prevalent among patients undergoing surgery for CSM, affecting more than 40% of patients. Both ACDF and PCLF achieved comparable postoperative neck pain improvement 3, 12, and 24 months following 3- or 4-segment surgery for patients with CSM and severe neck pain. However, multilevel ACDF was associated with superior functional status, quality of life, and return to baseline activities at 24 months in multivariable adjusted analyses.
Determining the time frame of maximum clinical improvement in surgical decompression for cervical spondylotic myelopathy when stratified by preoperative myelopathy severity: a cervical Quality Outcomes Database study
OBJECTIVE While surgical decompression is an important treatment modality for cervical spondylotic myelopathy (CSM), it remains unclear if the severity of preoperative myelopathy status affects potential benefit from surgical intervention and when maximum postoperative improvement is expected. This investigation sought to determine if retrospective analysis of prospectively collected patient-reported outcomes (PROs) following surgery for CSM differed when stratified by preoperative myelopathy status. Secondary objectives included assessment of the minimal clinically important difference (MCID). METHODS A total of 1151 patients with CSM were prospectively enrolled from the Quality Outcomes Database at 14 US hospitals. Baseline demographics and PROs at baseline and 3 and 12 months were measured. These included the modified Japanese Orthopaedic Association (mJOA) score, Neck Disability Index (NDI), quality-adjusted life-years (QALYs) from the EQ-5D, and visual analog scale from the EQ-5D (EQ-VAS). Patients were stratified by preoperative myelopathy severity using criteria established by the AO Spine study group: mild (mJOA score 15–17), moderate (mJOA score 12–14), or severe (mJOA score < 12). Univariate analysis was used to identify demographic variables that significantly varied between myelopathy groups. Then, multivariate linear regression and linear mixed regression were used to model the effect of severity and time on PROs, respectively. RESULTS For NDI, EQ-VAS, and QALY, patients in all myelopathy cohorts achieved significant, maximal improvement at 3 months without further improvement at 12 months. For mJOA, moderate and severe myelopathy groups demonstrated significant, maximal improvement at 3 months, without further improvement at 12 months. The mild myelopathy group did not demonstrate significant change in mJOA score but did maintain and achieve higher PRO scores overall when compared with more advanced myelopathy cohorts. The MCID threshold was reached in all myelopathy cohorts at 3 months for mJOA, NDI, EQ-VAS, and QALY, with the only exception being mild myelopathy QALY at 3 months. CONCLUSIONS As assessed by statistical regression and MCID analysis, patients with cervical myelopathy experience maximal improvement in their quality of life, neck disability, myelopathy score, and overall health by 3 months after surgical decompression, regardless of their baseline myelopathy severity. An exception was seen for the mJOA score in the mild myelopathy cohort, improvement of which may have been limited by ceiling effect. The data presented here will aid surgeons in patient selection, preoperative counseling, and expected postoperative time courses.
Association of ≥ 12 months of delayed surgical treatment for cervical myelopathy with worsened postoperative outcomes: a multicenter analysis of the Quality Outcomes Database
OBJECTIVE Degenerative cervical myelopathy (DCM) results in significant morbidity. The duration of symptoms prior to surgical intervention may be associated with postoperative surgical outcomes and functional recovery. The authors’ objective was to investigate whether delayed surgical treatment for DCM is associated with worsened postoperative outcomes. METHODS Data from 1036 patients across 14 surgical centers in the Quality Outcomes Database were analyzed. Baseline demographic characteristics and findings of preoperative and postoperative symptom evaluations, including duration of symptoms, were assessed. Postoperative functional outcomes were measured using the Neck Disability Index (NDI) and modified Japanese Orthopaedic Association (mJOA) scale. Symptom duration was classified as either less than 12 months or 12 months or greater. Univariable and multivariable regression were used to evaluate for the associations between symptom duration and postoperative outcomes. RESULTS In this study, 513 patients (49.5%) presented with symptom duration < 12 months, and 523 (50.5%) had symptoms for 12 months or longer. Patients with longer symptom duration had higher BMI and higher prevalence of anxiety and diabetes (all p < 0.05). Symptom duration ≥ 12 months was associated with higher average baseline NDI score (41 vs 36, p < 0.01). However, improvements in NDI scores from baseline were not significantly different between groups at 3 months (p = 0.77) or 12 months (p = 0.51). Likewise, the authors found no significant differences between groups in changes in mJOA scores from baseline to 3 months or 12 months (both p > 0.05). CONCLUSIONS Surgical intervention resulted in improved mJOA and NDI scores at 3 months, and this improvement was sustained in both patients with short and longer initial symptom duration. Patients with DCM can still undergo successful surgical management despite delayed presentation.
Gastrostomy tube placement increases the risk of ventriculoperitoneal shunt infection: a multiinstitutional study
OBJECTIVEGastrostomy tube placement can temporarily seed the peritoneal cavity with bacteria and thus theoretically increases the risk of shunt infection when the two procedures are performed contemporaneously. The authors hypothesized that gastrostomy tube placement would not increase the risk of ventriculoperitoneal shunt infection. The object of this study was to test this hypothesis by utilizing a large patient cohort combined from multiple institutions.METHODSA retrospective study of all adult patients admitted to five institutions with a diagnosis of aneurysmal subarachnoid hemorrhage between January 2005 and January 2015 was performed. The primary outcome of interest was ventriculoperitoneal shunt infection. Variables, including gastrostomy tube placement, were tested for their association with this outcome. Standard statistical methods were utilized.RESULTSThe overall cohort consisted of 432 patients, 47% of whom had undergone placement of a gastrostomy tube. The overall shunt infection rate was 9%. The only variable that predicted shunt infection was gastrostomy tube placement (p = 0.03, OR 2.09, 95% CI 1.07–4.08), which remained significant in the multivariate analysis (p = 0.04, OR 2.03, 95% CI 1.04–3.97). The greatest proportion of shunts that became infected had been placed more than 2 weeks (25%) and 1–2 weeks (18%) prior to gastrostomy tube placement, but the temporal relationship between shunt and gastrostomy was not a significant predictor of shunt infection.CONCLUSIONSGastrostomy tube placement significantly increases the risk of ventriculoperitoneal shunt infection.
C5 Palsy After Cervical Spine Surgery: A Multicenter Retrospective Review of 59 Cases
Study Design: A multicenter, retrospective review of C5 palsy after cervical spine surgery. Objective: Postoperative C5 palsy is a known complication of cervical decompressive spinal surgery. The goal of this study was to review the incidence, patient characteristics, and outcome of C5 palsy in patients undergoing cervical spine surgery. Methods: We conducted a multicenter, retrospective review of 13 946 patients across 21 centers who received cervical spine surgery (levels C2 to C7) between January 1, 2005, and December 31, 2011, inclusive. P values were calculated using 2-sample t test for continuous variables and χ 2 tests or Fisher exact tests for categorical variables. Results: Of the 13 946 cases reviewed, 59 patients experienced a postoperative C5 palsy. The incidence rate across the 21 sites ranged from 0% to 2.5%. At most recent follow-up, 32 patients reported complete resolution of symptoms (54.2%), 15 had symptoms resolve with residual effects (25.4%), 10 patients did not recover (17.0%), and 2 were lost to follow-up (3.4%). Conclusion: C5 palsy occurred in all surgical approaches and across a variety of diagnoses. The majority of patients had full recovery or recovery with residual effects. This study represents the largest series of North American patients reviewed to date.
A Multicenter Study of the Presentation, Treatment, and Outcomes of Cervical Dural Tears
Study Design: Retrospective multicenter case series study. Objective: Because cervical dural tears are rare, most surgeons have limited experience with this complication. A multicenter study was performed to better understand the presentation, treatment, and outcomes following cervical dural tears. Methods: Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. Demographic data and surgical history were obtained. Clinical outcomes following surgery were assessed, and any reoperations were recorded. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), Nurick classification (NuC), and Short-Form 36 (SF36) scores were recorded at baseline and final follow-up at certain centers. All data were collected, collated, and analyzed by a private research organization. Results: There were 109 cases of cervical dural tears among 18 463 surgeries performed. In 101 cases (93%) there was no clinical sequelae following successful dural tear repair. There were statistical improvements ( P < .05) in mJOA and NuC scores, but not NDI or SF36 scores. No specific baseline or operative factors were found to be associated with the occurrence of dural tears. In most cases, no further postoperative treatments of the dural tear were required, while there were 13 patients (12%) that required subsequent treatment of cerebrospinal fluid drainage. Analysis of those requiring further treatments did not identify an optimum treatment strategy for cervical dural tears. Conclusions: In this multicenter study, we report our findings on the largest reported series (n = 109) of cervical dural tears. In a vast majority of cases, no subsequent interventions were required and no clinical sequelae were observed.
Rare Complications of Cervical Spine Surgery: Pseudomeningocoele
Study Design: This study was a retrospective, multicenter cohort study. Objectives: Rare complications of cervical spine surgery are inherently difficult to investigate. Pseudomeningocoele (PMC), an abnormal collection of cerebrospinal fluid that communicates with the subarachnoid space, is one such complication. In order to evaluate and better understand the incidence, presentation, treatment, and outcome of PMC following cervical spine surgery, we conducted a multicenter study to pool our collective experience. Methods: This study was a retrospective, multicenter cohort study of patients who underwent cervical spine surgery at any level(s) from C2 to C7, inclusive; were over 18 years of age; and experienced a postoperative PMC. Results: Thirteen patients (0.08%) developed a postoperative PMC, 6 (46.2%) of whom were female. They had an average age of 48.2 years and stayed in hospital a mean of 11.2 days. Three patients were current smokers, 3 previous smokers, 5 had never smoked, and 2 had unknown smoking status. The majority, 10 (76.9%), were associated with posterior surgery, whereas 3 (23.1%) occurred after an anterior procedure. Myelopathy was the most common indication for operations that were complicated by PMC (46%). Seven patients (53%) required a surgical procedure to address the PMC, whereas the remaining 6 were treated conservatively. All PMCs ultimately resolved or were successfully treated with no residual effects. Conclusions: PMC is a rare complication of cervical surgery with an incidence of less than 0.1%. They prolong hospital stay. PMCs occurred more frequently in association with posterior approaches. Approximately half of PMCs required surgery and all ultimately resolved without residual neurologic or other long-term effects.