Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy.

INTRODUCTION: Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery. METHODS AND ANALYSIS: This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts. ETHICS AND DISSEMINATION: This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04549662.

The impact of anxiety and depression on lumbar spine surgical outcomes: a Michigan Spine Surgery Improvement Collaborative study.

OBJECTIVE: The presence of depression and anxiety has been associated with negative outcomes in spine surgery patients. While it seems evident that a history of depression or anxiety can negatively influence outcome, the exact additive effect of both has not been extensively studied in a multicenter trial. The purpose of this study was to investigate the relationship between a patient's history of anxiety and depression and their patient-reported outcomes (PROs) after lumbar surgery. METHODS: Patients in the Michigan Spine Surgery Improvement Collaborative registry undergoing lumbar spine surgery between July 2016 and December 2021 were grouped into four cohorts: those with a history of anxiety only, those with a history of depression only, those with both, and those with neither. Primary outcomes were achieving the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System Physical Function 4-item Short Form (PROMIS PF), EQ-5D, and numeric rating scale (NRS) back pain and leg pain, and North American Spine Society patient satisfaction. Secondary outcomes included surgical site infection, hospital readmission, and return to the operating room. Multivariate Poisson generalized estimating equation models were used to report incidence rate ratios (IRRs) from patient baseline variables. RESULTS: Of the 45,565 patients identified, 3941 reported a history of anxiety, 5017 reported a history of depression, 9570 reported both, and 27,037 reported neither. Compared with those who reported having neither, patients with both anxiety and depression had lower patient satisfaction at 90 days (p = 0.002) and 1 year (p = 0.021); PROMIS PF MCID at 90 days (p < 0.001), 1 year (p < 0.001), and 2 years (p = 0.006); EQ-5D MCID at 90 days (p < 0.001), 1 year (p < 0.001), and 2 years (p < 0.001); NRS back pain MCID at 90 days (p < 0.001) and 1 year (p < 0.001); and NRS leg pain MCID at 90 days (p < 0.001), 1 year (p = 0.024), and 2 years (p = 0.027). Patients with anxiety only (p < 0.001), depression only (p < 0.001), or both (p < 0.001) were more likely to be readmitted within 90 days. Additionally, patients with anxiety only (p = 0.015) and both anxiety and depression (p = 0.015) had higher rates of surgical site infection. Patients with anxiety only (p = 0.006) and depression only (p = 0.021) also had higher rates of return to the operating room. CONCLUSIONS: The authors observed an association between a history of anxiety and depression and negative outcome after lumbar spine surgery. In addition, they found an additive effect of a history of both anxiety and depression with an increased risk of negative outcome when compared with either anxiety or depression alone.

Risk factors of emergency department visits following elective cervical and lumbar surgical procedures: a multi-institution analysis from the Michigan Spine Surgery Improvement Collaborative.

OBJECTIVE: Emergency department visits 90 days after elective spinal surgery are relatively common, with rates ranging from 9% to 29%. Emergency visits are very costly, so their reduction is of importance. This study's objective was to evaluate the reasons for emergency department visits and determine potentially modifiable risk factors. METHODS: This study retrospectively reviewed data queried from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry from July 2020 to November 2021. MSSIC is a multicenter (28-hospital) registry of patients undergoing cervical and lumbar degenerative spinal surgery. Adult patients treated for elective cervical and/or lumbar spine surgery for degenerative pathology (spondylosis, intervertebral disc disease, low-grade spondylolisthesis) were included. Emergency department visits within 90 days of surgery (outcome measure) were analyzed utilizing univariate and multivariate regression analyses. RESULTS: Of 16,224 patients, 2024 (12.5%) presented to the emergency department during the study period, most commonly for pain related to spinal surgery (31.5%), abdominal problems (15.8%), and pain unrelated to the spinal surgery (12.8%). On multivariate analysis, age (per 5-year increase) (relative risk [RR] 0.94, 95% CI 0.92-0.95), college education (RR 0.82, 95% CI 0.69-0.96), private insurance (RR 0.79, 95% CI 0.70-0.89), and preoperative ambulation status (RR 0.88, 95% CI 0.79-0.97) were associated with decreased emergency visits. Conversely, Black race (RR 1.30, 95% CI 1.13-1.51), current diabetes (RR 1.13, 95% CI 1.01-1.26), history of deep venous thromboembolism (RR 1.28, 95% CI 1.16-1.43), history of depression (RR 1.13, 95% CI 1.03-1.25), history of anxiety (RR 1.32, 95% CI 1.19-1.46), history of osteoporosis (RR 1.21, 95% CI 1.09-1.34), history of chronic obstructive pulmonary disease (RR 1.19, 95% CI 1.06-1.34), American Society of Anesthesiologists class > II (RR 1.18, 95% CI 1.08-1.29), and length of stay > 3 days (RR 1.29, 95% CI 1.16-1.44) were associated with increased emergency visits. CONCLUSIONS: The most common reasons for emergency department visits were surgical pain, abdominal dysfunction, and pain unrelated to index spinal surgery. Increased focus on postoperative pain management and bowel regimen can potentially reduce emergency visits. The risks of diabetes, history of osteoporosis, depression, and anxiety are areas for additional preoperative screening.

One-stop transcatheter aortic valve replacement and fenestrated endovascular aortic aneurysm repair: A case report.

The management of patients with severe aortic valve stenosis and an abdominal aortic aneurysm is a real therapeutic challenge. Minimally invasive treatment is more beneficial than open surgery for treating both aortic valve stenosis and abdominal aortic aneurysm. We present a case of a 77-year-old male initially treated with a 26 mm Sapien 3 transcatheter aortic valve replacement. Subsequently, using the same femoral access points, a custom fenestrated endoprosthesis and stents in digestive trunks and renal arteries were implanted. Follow-up imaging revealed no dysfunction of the valve, endoprosthesis, or stents. This is the first reported successful concomitant management of significant aortic valve stenosis and infrarenal abdominal aortic aneurysm through transcatheter aortic valve replacement and fenestrated endovascular aortic aneurysm repair.

Does Tighter Glycemic Control Beyond Hemoglobin A1c of 8% Improve Outcome for Lumbar Spine Surgery? A MSSIC Study.

BACKGROUND AND OBJECTIVES: Diabetes mellitus is associated with increased risk of postoperative adverse outcomes. Previous studies have emphasized the role of glycemic control in postoperative complications. This study aims to ascertain whether controlling hemoglobin A1c (HbA1c) lower than 8% preoperatively results in meaningful risk reduction or improved outcomes. METHODS: We used patient-level data from the Michigan Spine Surgery Improvement Collaborative registry, focusing on patients who underwent elective lumbar spine surgery between 2018 and 2021. The primary outcomes were length of stay and the occurrence of postoperative adverse events. Secondary outcomes included patient satisfaction, achievement of a minimum clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System-Physical Function, the EuroQol-5D and NRS of leg and back pain, and return to work. RESULTS: A total of 11 348 patients were included in this analysis. Patients with HbA1c above the thresholds before surgery had significantly higher risks of urinary retention for all 3 possible threshold values (incidence rate ratio [IRR] = 1.30, P = .015; IRR = 1.35, P = .001; IRR = 1.25, P = .011 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively). They also had longer hospital stay (IRR = 1.04, P = .002; IRR = 1.03, P = .001; IRR = 1.03, P < .001 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and had higher risks of developing any complication with HbA1c cutoff of 7.5% (IRR = 1.09, P = .010) and 7% (IRR = 1.12, P = .001). Diabetics with preoperative HbA1c above all 3 thresholds were less likely to achieve Patient-Reported Outcomes Measurement Information System MCID at the 90-day follow-up (IRR = .81, P < .001; IRR = .86, P < .001; IRR = .90, P = .007 for the HbA1c cutoffs of 8%, 7.5%, and 7%, respectively) and less likely to achieve EuroQol-5D MCID at the 2-year follow-up (IRR = .87, P = .027; IRR = .84, P = .005 for the HbA1c cutoffs of 7.5% and 7%, respectively). CONCLUSION: Our study suggests that reducing HbA1c below 8% may have diminishing returns regarding reducing complications after spine surgery.

Cervical disc arthroplasty versus anterior cervical discectomy and fusion: an analysis of the Michigan Spine Surgery Improvement Collaborative Database.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) are established surgical options for the treatment of cervical radiculopathy, myelopathy, and cervical degenerative disc disease. However, current literature does not demonstrate a clear superiority between ACDF and CDA. PURPOSE: To investigate procedural and patient-reported outcomes of ACDF and CDA among patients included in the Michigan Spine Surgery Improvement Collaborative (MSSIC) database. DESIGN: Retrospective study of prospectively collected outcomes registry data. PATIENT SAMPLE: Individuals within the MSSIC database presenting with radiculopathy, myelopathy, or cervical spondylosis refractory to typical conservative care undergoing primary ACDF or CDA from January 4, 2016, to November 5, 2021. OUTCOME MEASURES: Perioperative measures (including surgery length, length of stay, return to OR, any complications), patient-reported functional outcomes at 2-year follow-up (including return to work, patient satisfaction, PROMIS, EQ-5D, mJOA). METHODS: Patients undergoing ACDF were matched 4:1 with those undergoing CDA; propensity analysis performed on operative levels (1- and 2- level procedures), presenting condition, demographics, and comorbidities. Initial comparisons performed with univariate testing and multivariate analysis performed with Poisson generalized estimating equation models clustering on hospital. RESULTS: A total of 2,208 patients with ACDF and 552 patients with CDA were included. Baseline demographics were similar, with younger patients undergoing CDA (45.6 vs 48.6 years; p<.001). Myelopathy was more frequent in ACDF patients (30% vs 25%; p=.015). CDA was more frequently planned as an outpatient procedure. Length of stay was increased in ACDF (1.3 vs 1.0 days; p<.001). Functional outcomes were similar, with comparable proportions of patients meeting minimal clinically important difference thresholds in neck pain, arm pain, PROMIS, EQ-5D, and mJOA score. After multivariate regression, no significant differences were seen in surgical or functional outcomes. CONCLUSIONS: This study demonstrates similar outcomes for those undergoing ACDF and CDA at 2 years. Previous meta-analyses of CDA clinical trial data adhere to strict inclusion and exclusion criteria required by clinical studies; this registry data provides "real world" clinical outcomes reflecting current practices for ACDF and CDA patient selection.

The Duration of Symptoms Influences Outcomes After Lumbar Microdiscectomies: A Michigan Spine Surgery Improvement Collaborative.

STUDY DESIGN: Retrospective Cohort. OBJECTIVE: We investigate whether duration of symptoms a patient experiences prior to lumbar microdiscectomy affects pain, lifestyle, and return to work metrics after surgery. METHODS: A retrospective review of patients with a diagnosis of lumbar radiculopathy undergoing microdiscectomy was conducted using a statewide registry. Patients were grouped based on self-reported duration of symptoms prior to surgical intervention (Group 1: symptoms less than 3 months; Group 2: symptoms between 3 months and 1 year; and Group 3: symptoms greater than 1 year). Radicular pain scores, PROMIS PF Physical Function measure (PROMIS PF), EQ-5D scores, and return to work rates at 90 days, 1 year, and 2 years after surgery were compared using univariate and multivariate analysis. RESULTS: There were 2408 patients who underwent microdiscectomy for lumbar disc herniation for radiculopathy with 532, 910, and 955 in Groups 1, 2, and 3, respectively. Postoperative leg pain was lower for Group 1 at 90 days, 1 year, and 2 years compared to Groups 2 and 3 (P < .05). Postoperative PROMIS PF and EQ-5D scores were higher for Group 1 at 90 days, 1 year, and 2 years compared to Groups 2 and 3 (P < .05). CONCLUSION: Patients with prolonged symptoms prior to surgical intervention experience smaller improvements in postoperative leg pain, PROMIS PF, and EQ-5D than those who undergo surgery earlier. Patients undergoing surgery within 3 months of symptom onset have the highest rates of return to work at 1 year after surgery.

Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

Langerhans Cell Histiocytosis in the Pediatric Spine Requiring Stabilization: A Literature Review and Report of 3 Cases.

CASE: This report describes 3 cases of Langerhans cell histiocytosis (LCH) of the cervical and thoracic spine in patients aged 4 to 10 years. Each patient had painful lytic spinal lesions with vertebral body collapse and posterior involvement suggesting instability requiring corpectomy, grafting, and fusion. All 3 patients were doing well at their most recent follow-up without pain or recurrence. CONCLUSION: Although LCH of the pediatric spine is usually successfully treated non-operatively, we recommend corpectomy and fusion when there is instability of the spinal column and/or severe stenosis. Posterior element involvement occurred in all 3 cases and may lead to instability.

Association of prolonged symptom duration with poor outcomes in lumbar spine surgery: a Michigan Spine Surgery Improvement Collaborative study.

OBJECTIVE: There is a scarcity of large multicenter data on how preoperative lumbar symptom duration relates to postoperative patient-reported outcomes (PROs). The objective of this study was to determine the effect of preoperative and baseline symptom duration on PROs at 90 days, 1 year, and 2 years after lumbar spine surgery. METHODS: The Michigan Spine Surgery Improvement Collaborative registry was queried for all lumbar spine operations between January 1, 2017, to December 31, 2021, with a follow-up of 2 years. Patients were stratified into three subgroups based on symptom duration: < 3 months, 3 months to < 1 year, and ≥ 1 year. The primary outcomes were reaching the minimal clinically important difference (MCID) for the PROs (i.e., leg pain, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), EQ-5D, North American Spine Society satisfaction, and return to work). The EQ-5D score was also analyzed as a continuous variable to calculate quality-adjusted life years. Multivariable Poisson generalized estimating equation models were used to report adjusted risk ratios, with the < 3-month cohort used as the reference. RESULTS: There were 37,223 patients (4670 with < 3-month duration, 9356 with 3-month to < 1-year duration, and 23,197 with ≥ 1-year duration) available for analysis. Compared with patients with a symptom duration of < 1 year, patients with a symptom duration of ≥ 1 year were significantly less likely to achieve an MCID in PROMIS PF, EQ-5D, back pain relief, and leg pain relief at 90 days, 1 year, and 2 years postoperatively. Similar trends were observed for patient satisfaction and return to work. With the EQ-5D score as a continuous variable, a symptom duration of ≥ 1 year was associated with 0.04, 0.05, and 0.03 (p < 0.001) decreases in EQ-5D score at 90 days, 1 year, and 2 years after surgery, respectively. CONCLUSIONS: A symptom duration of ≥ 1 year was associated with poorer outcomes on several outcome metrics. This suggests that timely referral and surgery for degenerative lumbar pathology may optimize patient outcome.

Preservation of Motion in Spine Surgery.

The number of spinal procedures and spinal fusions continues to grow. Although fusion procedures have a high success rate, they have inherent risks such as pseudarthrosis and adjacent segment disease. New innovations in spine techniques have sought to eliminate these complications by preserving motion in the spinal column. Several techniques and devices have been developed in the cervical and lumbar spine including cervical laminoplasty, cervical disk ADA, posterior lumbar motion preservation devices, and lumbar disk ADA. In this review, advantages and disadvantages of each technique will be discussed.

Vertebral Augmentation in Spine Surgery.

Vertebral augmentation has been a well-studied adjunct percutaneous procedure in spine surgery. Cement augmentation has been used in the treatment of compression fractures through kyphoplasties or vertebroplasties. Historically, data have shown no difference between treating compression fractures conservatively versus with percutaneous cement augmentation procedures. Recent literature has shown improvement in patient outcomes and increase in mobility with percutaneous cement augmentation procedures. Cement augmentation has been used in treating patients with spinal column fractures in higher energy trauma. Cement augmentation has shown to have a reduction in local kyphosis, improved pain, and significant height restoration of the anterior column in patients with burst fractures. Augmentation has been used in spinal deformity surgery, specifically to attempt to reduce the risk of proximal junctional kyphosis and to decrease the risk of screw pullout with cement augmented fenestrated screws in patients with osteoporosis. In pathologic compression fractures, cement augmentation is a safe, viable intervention to improve pain control in these patients. This review will go into the new advances of vertebral augmentation and indications for use in treatment today.

The Potential Negative Effects of Smoking on Cervical and Lumbar Surgery Beyond Pseudarthrosis: A Michigan Spine Surgery Improvement Collaborative Study.

OBJECTIVE: To review the Michigan Spine Surgery Improvement Collaborative registry to investigate the long-term associations between current smoking status and outcomes after elective cervical and lumbar spine surgery. METHODS: Using the Michigan Spine Surgery Improvement Collaborative, we captured all cases from January 1, 2017, to November 21, 2020, with outcomes data available; 19,251 lumbar cases and 7936 cervical cases were included. Multivariate regression analyses were performed to assess the relationship of smoking with the clinical outcomes. RESULTS: Current smoking status was associated with lower urinary retention and satisfaction for patients after lumbar surgery and was associated with less likelihood of achieving minimal clinically important difference in primary outcome measures including Patient-Reported Outcomes Measurement Information System, back pain, leg pain, and EuroQol-5D at 90 days and 1 year after surgery. Current smokers were also less likely to return to work at 90 days and 1 year after surgery. Among patients who underwent cervical surgery, current smokers were less likely to have urinary retention and dysphagia postoperatively. They were less likely to be satisfied with the surgery outcome at 1 year. Current smoking was associated with lower likelihood of achieving minimal clinically important difference in Patient-Reported Outcomes Measurement Information System, neck pain, arm pain, and EuroQol-5D at various time points. There was no difference in return-to-work status. CONCLUSIONS: Our analysis suggests that smoking is negatively associated with functional improvement, patient satisfaction, and return-to-work after elective spine surgery.

Feasibility and Safety of a "Shared Care" Model in Complex Hepatopancreatobiliary Surgery: A 5-year Observational Study of Outcomes in Pancreaticoduodenectomy.

OBJECTIVE: To determine the safety of a fully functioning shared care model (SCM) in hepatopancreatobiliary surgery through evaluating outcomes in pancreaticoduodenectomy. BACKGROUND: SCMs, where a team of surgeons share in care delivery and resource utilization, represent a surgeon-level opportunity to improve system efficiency and peer support, but concerns around clinical safety remain, especially in complex elective surgery. METHODS: Patients who underwent pancreaticoduodenectomy between 2016 and 2020 were included. Adoption of shared care was demonstrated by analyzing shared care measures, including the number of surgeons encountered by patients during their care cycle, the proportion of patients with different consenting versus primary operating surgeon (POS), and the proportion of patients who met their POS on the day of surgery. Outcomes, including 30-day mortality, readmission, unplanned reoperation, sepsis, and length of stay, were collected from the institution's National Surgical Quality Improvement Program (NSQIP) database and compared with peer hospitals contributing to the pancreatectomy-specific NSQIP collaborative. RESULTS: Of the 174 patients included, a median of 3 surgeons was involved throughout the patients' care cycle, 69.0% of patients had different consenting versus POS and 57.5% met their POS on the day of surgery. Major outcomes, including mortality (1.1%), sepsis (5.2%), and reoperation (7.5%), were comparable between the study group and NSQIP peer hospitals. Length of stay (10 day) was higher in place of lower readmission (13.2%) in the study group compared with peer hospitals. CONCLUSIONS: SCMs are feasible in complex elective surgery without compromising patient outcomes, and wider adoption may be encouraged.

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial.

INTRODUCTION: Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS: This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION: The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.

Correlation of mJOA, PROMIS physical function, and patient satisfaction in patients with cervical myelopathy: an analysis of the Michigan Spine Surgery Improvement Collaborative (MSSIC) database.

BACKGROUND CONTEXT: Patient-reported outcomes (PROs) are increasingly utilized to evaluate the efficacy and value of spinal procedures. Among patients with cervical myelopathy, the modified Japanese Orthopaedic Association (mJOA) remains the standard instrument, with Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and patient satisfaction also frequently assessed. These outcomes have not all been directly compared using a large spine registry at 2 years follow-up for cervical myelopathic patients undergoing surgery. PURPOSE: To determine the correlation and association of PROMIS PF, mJOA, and patient satisfaction outcomes in patients undergoing surgery for cervical myelopathy. STUDY DESIGN/SETTING: Retrospective review of a multicenter spine registry database. PATIENT SAMPLE: Adult patients with cervical myelopathy who underwent cervical spine surgery between 2/26/2018 and 4/17/2021. OUTCOME MEASURES: PROMIS PF, mJOA, and North American Spine Society (NASS) patient satisfaction index. METHODS: The MSSIC database was accessed to gather pre- and postoperative outcome data on patients with cervical myelopathy. Spearman's correlation coefficients relating mJOA and PROMIS PF were quantified up to 2 years postoperatively. The correlations between patient satisfaction with mJOA and PROMIS were determined. Kappa statistics were used to evaluate for agreement between those reaching the minimum clinically important difference (MCID) for mJOA and PROMIS PF. Odds ratios were calculated to determine the association between patient satisfaction and those reaching MCID for mJOA and PROMIS PF. Support for MSSIC is provided by BCBSM and Blue Care Network as part of the BCBSM Value Partnerships program. RESULTS: Data from 2,023 patients were included. Moderate to strong correlations were found between mJOA and PROMIS PF at all time points (p<.001). These outcomes had fair agreement at all postoperative time points when comparing those who reached MCID. Satisfaction was strongly related to changes from baseline for both mJOA and PROMIS PF at all time points (p<.001). Odds ratios associating satisfaction with PROMIS PF MCID were higher at all time points compared with mJOA, although the differences were not significant. CONCLUSIONS: PROMIS PF has a strong positive correlation with mJOA up to 2 years postoperatively in patients undergoing surgery for cervical myelopathy, with similar odds of achieving MCID with both instruments. Patient satisfaction is predicted similarly by these outcome measures by 2 years postoperatively. These results affirm the validity of PROMIS PF in the cervical myelopathic population. Given its generalizability and ease of use, PROMIS PF may be a more practical outcome measure for clinical use compared with mJOA.

Should Cell Salvage Be Used in Liver Resection and Transplantation? A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate the effect of intraoperative blood cell salvage and autotransfusion (IBSA) use on red blood cell (RBC) transfusion and postoperative outcomes in liver surgery. BACKGROUND: Intraoperative RBC transfusions are common in liver surgery and associated with increased morbidity. IBSA can be utilized to minimize allogeneic transfusion. A theoretical risk of cancer dissemination has limited IBSA adoption in oncologic surgery. METHODS: Electronic databases were searched from inception until May 2021. All studies comparing IBSA use with control in liver surgery were included. Screening, data extraction, and risk of bias assessment were conducted independently, in duplicate. The primary outcome was intraoperative allogeneic RBC transfusion (proportion of patients and volume of blood transfused). Core secondary outcomes included: overall survival and disease-free survival, transfusion-related complications, length of hospital stay, and hospitalization costs. Data from transplant and resection studies were analyzed separately. Random effects models were used for meta-analysis. RESULTS: Twenty-one observational studies were included (16 transplant, 5 resection, n=3433 patients). Seventeen studies incorporated oncologic indications. In transplant, IBSA was associated with decreased allogeneic RBC transfusion [mean difference -1.81, 95% confidence interval (-3.22, -0.40), P =0.01, I 2 =86%, very-low certainty]. Few resection studies reported on transfusion for meta-analysis. No significant difference existed in overall survival or disease-free survival in liver transplant [hazard ratio (HR)=1.12 (0.75, 1.68), P =0.59, I 2 =0%; HR=0.93 (0.57, 1.48), P =0.75, I 2 =0%] and liver resection [HR=0.69 (0.45, 1.05), P =0.08, I 2 =0%; HR=0.93 (0.59, 1.45), P =0.74, I 2 =0%]. CONCLUSION: IBSA may reduce intraoperative allogeneic RBC transfusion without compromising oncologic outcomes. The current evidence base is limited in size and quality, and high-quality randomized controlled trials are needed.

Rates and reasons for reoperation within 30 and 90 days following cervical spine surgery: a retrospective cohort analysis of the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry.

BACKGROUND CONTEXT: Reoperation following cervical spinal surgery negatively impacts patient outcomes and increases health care system burden. To date, most studies have evaluated reoperations within 30 days after spine surgery and have been limited in scope and focus. Evaluation within the 90-day period, however, allows a more comprehensive assessment of factors associated with reoperation. PURPOSE: The purpose of this study is to assess the rates and reasons for reoperations after cervical spine surgery within 30 and 90 days. DESIGN: We performed a retrospective analysis of a state-wide prospective, multi-center, spine-specific database of patients surgically treated for degenerative disease. PATIENT SAMPLE: Patients 18 years of age or older who underwent cervical spine surgery for degenerative pathologies from February 2014 to May 2019. Operative criteria included all degenerative cervical spine procedures, including those with cervical fusions with contiguous extension down to T3. OUTCOME MEASURES: We determined causes for reoperation and independent surgical and demographic risk factors impacting reoperation. METHODS: Patient-specific and surgery-specific data was extracted from the registry using ICD-10-DM codes. Reoperations data was obtained through abstraction of medical records through 90 days. Univariate analysis was done using chi-square tests for categorical variables, t-tests for normally distributed variables, and Wilcoxon rank-sum tests for variables with skewed distributions. Odds ratios for return to the operating room (OR) were evaluated in multivariate analysis. RESULTS: A total of 13,435 and 13,440 patients underwent cervical spine surgery and were included in the 30 and 90-day analysis, respectively. The overall reoperation rate was 1.24% and 3.30% within 30 and 90 days, respectively. Multivariate analysis showed within 30 days, procedures involving four or more levels, posterior only approach, and longer length of stay had increased odds of returning to the OR (p<.05), whereas private insurance had a decreased odds of return to OR (p<.05). Within 90 days, male sex, coronary artery disease (CAD), previous spine surgery, procedures with 4 or more levels, and longer length of stay had significantly increased odds of returning to the OR (p<.05). Non-white race, independent ambulatory status pre-operatively, and having private insurance had decreased odds of return to the OR (p<.05). The most common specified reasons for return to the OR within 30 days was hematoma (19%), infection (17%), and wound dehiscence (11%). Within 90 days, reoperation reasons were pain (10%), infection (9%), and hematoma (8%). CONCLUSION: Reoperation rates after elective cervical spine surgery are 1.24% and 3.30% within 30 and 90 days, respectively. Within 30 days, four or more levels, posterior approach, and longer length of stay were risk factors for reoperation. Within 90 days, male sex, CAD, four or more levels, and longer length of hospital stay were risk factors for reoperation. Non-white demographic and independent preoperative ambulatory status were associated with decreased reoperation rates.

Postoperative opioid prescription and patient-reported outcomes after elective spine surgery: a Michigan Spine Surgery Improvement Collaborative study.

OBJECTIVE: This study was designed to assess how postoperative opioid prescription dosage could affect patient-reported outcomes after elective spine surgery. METHODS: Patients enrolled in the Michigan Spine Surgery Improvement Collaborative (MSSIC) from January 2020 to September 2021 were included in this study. Opioid prescriptions at discharge were converted to total morphine milligram equivalents (MME). A reference value of 225 MME per week was used as a cutoff. Patients were divided into two cohorts based on prescribed total MME: ≤ 225 MME and > 225 MME. Primary outcomes included patient satisfaction, return to work status after surgery, and whether improvement of the minimal clinically important difference (MCID) of the Patient-Reported Outcomes Measurement Information System 4-question short form for physical function (PROMIS PF) and EQ-5D was met. Generalized estimated equations were used for multivariate analysis. RESULTS: Regression analysis revealed that patients who had postoperative opioids prescribed with > 225 MME were less likely to be satisfied with surgery (adjusted OR [aOR] 0.81) and achieve PROMIS PF MCID (aOR 0.88). They were also more likely to be opioid dependent at 90 days after elective spine surgery (aOR 1.56). CONCLUSIONS: The opioid epidemic is a serious threat to national public health, and spine surgeons must practice conscientious postoperative opioid prescribing to achieve adequate pain control. The authors' analysis illustrates that a postoperative opioid prescription of 225 MME or less is associated with improved patient satisfaction, greater improvement in physical function, and decreased opioid dependence compared with those who had > 225 MME prescribed.