The effect of myelography dye on bone density measurements utilizing Hounsfield units on CT.

OBJECTIVE: Hounsfield unit (HU) measurements of bone density on CT are increasingly used for preoperative planning in spine surgery. Postmyelogram CT is another common preoperative diagnostic study. However, there is no current literature evaluating whether HU measurements on CT are affected by the presence of myelography dye. The purpose of the current study was to determine if the presence of myelography dye affects HU measurements of bone density in CT studies. METHODS: Twenty-nine preoperative spine surgery patients who underwent both standard and postmyelography CT performed within 6 months of each other were identified. HU measurements were obtained from an elliptical region of interest using the available software on a standard PACS. Measurements were obtained on the axial cut at the midvertebral body on all lumbar vertebrae on three separate occasions and an average value was calculated for comparative analysis. A 6-week gap was used between measurements of the CT scans and the CT myelograms to diminish bias. RESULTS: The mean age of the cohort was 69 years and the average BMI was 32 kg/m2. Five patients were male and 24 were female. Six of the patients had instrumentation placed prior to the initial CT scan. The average HU measurements for CT levels L1-5 were 165, 171, 145, 154, and 225, respectively, whereas HU measurements for CT myelography of levels L1-5 were 168, 177, 148, 170, and 239, respectively. Strong correlations were noted between the HU measured on CT and CT myelography for L1 (r2 = 0.951), L2 (r2 = 0.966), L4 (r2 = 0.820), and L5 (r2 = 0.900), and moderate for L3 (r2 = 0.668). CONCLUSIONS: The presence of myelography dye had no clear effect on CT HU measurements of bone density. The results of this study support the use of CT myelograms for bone density assessment in the absence of standard CT images.

Risk Factors for Medial Breach During Robotic-Assisted Cortical Bone Trajectory Screw Insertion.

OBJECTIVE: We describe the incidence of, and identify the risk factors for, a medial breach of the pedicle wall during robotic-assisted cortical bone trajectory (RA-CBT) screw insertion. METHODS: We analyzed a consecutive series of adult patients who underwent RA-CBT screw placement from January 2019 to July 2022. To assess the pedicle wall medial breach, postoperative computed tomography (CT) images were analyzed. Patient demographic data and screw data were compared between patients with and without a medial breach. The Hounsfield units (HUs) on the L1 midvertebral axial CT scan was used to evaluate bone quality. RESULTS: Of 784 CBT screws in 145 patients, 30 (3.8%) had a medial breach in 23 patients (15.9%). One screw was grade 2, and the others were grade 1. Patients with a medial breach had a lower HU value compared with the patients without a medial breach (123.3 vs. 150.5; P = 0.027). A medial breach was more common in the right than left side (5.5% vs. 2.0%; P = 0.014). More than one half of the screws with a medial breach were found in the upper instrumented vertebra (UIV) compared with the middle construct or lowest instrumented vertebra (6.7% vs. 1.3% vs. 2.7%; P = 0.003). Binary logistic regression showed that low HU values, right-sided screw placement, and UIV were associated with a medial breach. No patients returned to the operating room for screw malposition. No differences were found in the clinical outcomes between patients with and without a medial breach. CONCLUSIONS: The incidence of pedicle wall medial breach was 3.8% of RA-CBT screws in the postoperative CT images. A low HU value measured in the L1 axial image, right-sided screw placement, and UIV were associated with an increased risk of medial breach for RA-CBT screw placement.

Accuracy of Phantomless Calibration of Routine Computed Tomography Scans for Opportunistic Osteoporosis Screening in the Spine Clinic.

STUDY DESIGN: Diagnostic accuracy study. OBJECTIVE: To establish a simple method of phantomless bone mineral density (BMD) measurement by using preoperative lumbar Computed Tomography (CT) scans, and compare the accuracy of reference tissue combinations to diagnose low BMD against uncalibrated Hounsfield units (HUs). SUMMARY OF BACKGROUND DATA: HUs are used as a measure of BMD; however, associations between HU and T-scores vary widely. Quantitative CT (qCT) scans are more accurate, but they require density calibration with an object of known density (phantom), which limits feasibility. As an emerging technique, phantomless (internal) calibration of routine CT scans may provide a good opportunity for screening. METHODS: Patients who were scheduled to undergo lumbar surgery, with a preoperative CT scan, and a dual-energy x-ray absorptiometry (DXA) scan within six months were included. Four tissues were selected for calibration: subcutaneous adipose (A), erector spinae (ES), psoas (P) and aortic blood (AB). The HUs of these tissues were used in linear regression against ground-truth values. Calibrations were performed by using two different internal tissues at a time to maintain simplicity and in-office applicability.Volumetric bone mineral densities (vBMD) derived from internally calibrated CT scans were analyzed for new threshold values for low bone density. Areas under the curve (AUC) were calculated with 95% confidence intervals (CI). RESULTS: 45 patients were included (M/F=10/35, mean age:63.3). Calibrated vBMDs had stronger correlations with DXA T-scores when compared with HUs, with L2 exhibiting the highest coefficients. Calibration by using A and ES with the threshold of 162 mg/cm3 had a sensitivity of 90% in detecting low BMD (AUC=0.671). CONCLUSIONS: This novel method allows simple, in-office calibration of routine preoperative CT scans without the use of a phantom. Calibration using adipose and erector spinae with a threshold of 162 mg/cm3 is proposed for low bone density screening with high sensitivity (90%). LEVEL OF EVIDENCE: Level III.

Immediate Postoperative Change in the Upper Instrumented Screw-Vertebra Angle Is a Predictor for Proximal Junctional Kyphosis and Failure.

STUDY DESIGN: Retrospective review. OBJECTIVES: To determine if change in position of upper instrumented vertebral (UIV) screw between intraoperative prone and immediate postoperative standing radiographs is a predictor for proximal junctional kyphosis or failure (PJK/PJF). SUMMARY OF BACKGROUND DATA: Cranially directed UIV screws on post-operative radiographs have been found to be associated with PJK. Change in the screw position between intraoperative and immediate postoperative radiographs has not been studied. METHODS: Patients with posterior fusion ≥3 levels and UIV at or distal to T8, and minimum 2-year follow-up were identified from a single center database. Primary outcomes were radiographic PJK/PJF or revision for PJK/PJF. Demographic, surgical and radiographic variables, including intraoperative screw-vertebra (S-V) angle, change in S-V angle, direction of UIV screw (cranial-neutral-caudal) and rod-vertebra (R-V) angle were collected. RESULTS: 143 cases from 110 patients were included with a mean age of 62.9 years and a follow-up of 3.5 years. 54 (38%) cases developed PJK/PJF, of whom 30 required a revision. Mean S-V angle was -0.9°±5.5° intraoperative and -2.8°±5.5° postoperative. The group with PJK/PJF had a mean S-V angle change of -2.5°±2.4 while the rest had a change of -1.0°±1.6 (P=0.010). When the change in S-V angle was <5°, 33% developed PJK, this increased to 80% when it was ≥5° (P=0.001). Revision for PJK/PJF increased from 16% to 60% when S-V angle changed ≥5° (P=0.001). Regression analysis showed S-V angle change as a significant risk factor for PJK/PJF (P=0.047, OR=1.58) and for revision due to PJK/PJF (P=0.009, OR=2.21). CONCLUSIONS: Change in the S-V angle from intraop prone to immediate postop standing radiograph is a strong predictor for PJK/PJF and for revision. For each degree of S-V angle change, odds of revision for PJK/PJF increases by 2.2x. A change of 5° should alert the surgeon to the likely development of PJK/PJF requiring revision.

Comparison of No Tap (two-step) and tapping robotic assisted cortical bone trajectory screw insertion.

Workflow for cortical bone trajectory (CBT) screws includes tapping line-to-line or under tapping by 1 mm. We describe a non-tapping, two-step workflow for CBT screw placement, and compare the safety profile and time savings to the Tap (three-step) workflow. Patients undergoing robotic assisted 1-3 level posterior fusion with CBT screws for degenerative conditions were identified and separated into either a No-Tap or Tap workflow. Number of total screws, screw-related complications, estimated blood loss, operative time, robotic time, and return to the operating room were collected and analyzed. There were 91 cases (458 screws) in the No-Tap and 88 cases (466 screws) in the Tap groups, with no difference in demographics, revision status, ASA grade, approach, number of levels fused or diagnosis between cohorts. Total robotic time was lower in the No-Tap (26.7 min) versus the Tap group (30.3 min, p = 0.053). There was no difference in the number of malpositioned screws identified intraoperatively (10 vs 6, p = 0.427), screws converted to freehand (3 vs 3, p = 0.699), or screws abandoned (3 vs 2, p = 1.000). No pedicle/pars fracture or fixation failure was seen in the No-Tap cohort and one in the Tap cohort (p = 1.00). No patients in either cohort were returned to OR for malpositioned screws. This study showed that the No-Tap screw insertion workflow for robot-assisted CBT reduces robotic time without increasing complications.

Intra-Operative Hypotension is an Important Modifiable Risk Factor for Major Complications in Spinal Fusion Surgery.

STUDY DESIGN: Retrospective observational cohort. OBJECTIVES: This study explores the impact of Intraoperative hypotension (IOH)on post-op complications for major thoracolumbar spine fusion procedures. SUMMARY OF BACKGROUND DATA: IOH with mean arterial pressure (MAP) < 65 mmHg is associated with post-op acute kidney injury (AKI) in general surgery. In spinal deformity surgery, IOH is a contributing factor to MEP changes and spinal cord dysfunction with deformity correction. METHODS: 539 thoracolumbar fusion cases, > 6 surgical levels and > 3 hours duration were identified. Anesthetic/surgical data included OR time, fluid volume, blood loss, blood product replacement and use of vasopressors. Arterial-line based MAP data was collected at 1 min intervals. Cummulative duration of MAP < 65 mmHg was recorded. IOH within the first hour of surgery vs. the entire case was determined. Post-op course and complications including SSI, GI complications, pulmonary complications, MI, DVT, PE, AKI and encephalopathy were noted. Cumulative complications were grouped as none, 1-2 complications, or >3 complications. RESULTS: There was a significant association between occurrence of complications and duration of IOH within the first hour of surgery (8.2 vs. 5.6 min, P<0.001) and across the entire procedure (28.1 vs. 19.3 min, P=0.008). This association persisted for individual major complications including SSI, acute respiratory failure, PE, ileus requiring NGT and post-operative cognitive dysfunction. Comparison of patients with 0 vs. 1-2 vs. 3 or more complications demonstrated that patients with 3 or more complications had a longer duration of IOH in the first hour of the surgery and that patients who had no complications received less vasopressor than patients who had 1-2 or 3 or more complications. CONCLUSION: This study identifies duration of IOH during the first hour of surgery as a previously unrecognized modifiable risk associated with major complications for multi-level lumbar fusion surgery.

Proximal Junctional Degeneration and Failure Modes: A Novel Classification and Clinical Implications.

STUDY DESIGN: Case-control study. OBJECTIVE: To introduce a classification system that will include the major types of degenerative changes and failures related to the proximal junction, and to determine the clinical course and characteristics for the different types of proximal junctional degeneration (PJD). SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis (PJK) and failures are well recognized after adult spinal fusion, however, a standardized classification is lacking. METHODS: The proposed system identified four different patterns of PJD: Type 1 (multi-level symmetrical collapse), Type 2 (Single adjacent level collapse), Type 3 (fracture) and Type 4 (spondylolisthesis). A single center database was reviewed from 2018 to 2021. Patients ≥18 years of age, who underwent posterior spinal fusion of ≥3 levels with an upper instrumented vertebral level between T8-L2, and a follow-up of ≥2 years were included. Radiographic measurements, revision surgery and time to revision were the primary outcomes. RESULTS: 150 patients were included with a mean age of 65.1 (±9.8) years and a mean follow-up of 3.2 (±1) years. 69 patients (46%) developed significant degenerative changes in the proximal junction, and were classified accordingly. 20 (13%) were Type 1, 17 (11%) were Type 2, 22 (15%) were Type 3 and 10 (7%) were Type 4. Type 3 had a significantly shorter time to revision with a mean of 0.9 (±0.9) years. Types 3 and 4 had greater preoperative sagittal vertical axis, and Types 1 and 3 had greater final follow-up lumbar lordosis. Bone density measured by Hounsfield units showed lower measurements for Type 3. Types 1 and 4 had lower rates of developing PJK. Type 1 had the lowest revision rate with 40% (types 2, 3 and 4 were 77%, 73% and 80%, respectively, P=0.045). CONCLUSION: This novel classification system defines different modes of degeneration and failures at the proximal junction, and future studies with larger sample sizes are needed for validation. LEVEL OF EVIDENCE: 3.

Opioid-sparing Anesthesia Decreases In-hospital and 1-year Postoperative Opioid Consumption Compared With Traditional Anesthesia: A Propensity-matched Cohort Study.

STUDY DESIGN: Propensity-matched cohort. OBJECTIVE: The aim of this study was to determine if opioid-sparing anesthesia (OSA) reduces in-hospital and 1-year postoperative opioid consumption. SUMMARY OF BACKGROUND DATA: The recent opioid crisis highlights the need to reduce opioid exposure. We developed an OSA protocol for lumbar spinal fusion surgery to mitigate opioid exposure. MATERIALS AND METHODS: Patients undergoing lumbar fusion for degenerative conditions over one to four levels were identified. Patients taking opioids preoperatively were excluded. OSA patients were propensity-matched to non-OSA patients based on age, sex, smoking status, body mass index, American Society of Anesthesiologists grade, and revision versus primary procedure. Standard demographic and surgical data, daily in-hospital opioid consumption, and opioid prescriptions 1 year after surgery were compared. RESULTS: Of 296 OSA patients meeting inclusion criteria, 172 were propensity-matched to non-OSA patients. Demographics were similar between cohorts (OSA: 77 males, mean age=57.69 yr; non-OSA: 67 males, mean age=58.94 yr). OSA patients had lower blood loss (326 mL vs. 399 mL, P =0.014), surgical time (201 vs. 233 min, P <0.001) emergence to extubation time (9.1 vs. 14.2 min, P< 0.001), and recovery room time (119 vs. 140 min, P =0.0.012) compared with non-OSA patients. Fewer OSA patients required nonhome discharge (18 vs. 41, P =0.001) compared with the non-OSA cohort, but no difference in length of stay (90.3 vs. 98.5 h, P =0.204). Daily opioid consumption was lower in the OSA versus the non-OSA cohort from postoperative day 2 (223 vs. 185 morphine milligram equivalents, P =0.017) and maintained each day with lower total consumption (293 vs. 225 morphine milligram equivalents, P =0.003) throughout postoperative day 4. The number of patients with active opioid prescriptions at 1, 3, 6, and 12 months postoperative was statistically fewer in the OSA compared with the non-OSA patients. CONCLUSIONS: OSA for lumbar spinal fusion surgery decreases in-hospital and 1-year postoperative opioid consumption. The minimal use of opioids may also lead to shorter emergence to extubation times, shorter recovery room stays, and fewer discharges to nonhome facilities.

The Incremental Clinical Benefit of Adding Layers of Complexity to the Planning and Execution of Adult Spinal Deformity Corrective Surgery.

BACKGROUND AND OBJECTIVES: For patients with surgical adult spinal deformity (ASD), our understanding of alignment has evolved, especially in the last 20 years. Determination of optimal restoration of alignment and spinal shape has been increasingly studied, yet the assessment of how these alignment schematics have incrementally added benefit to outcomes remains to be evaluated. METHODS: Patients with ASD with baseline and 2-year were included, classified by 4 alignment measures: Scoliosis Research Society (SRS)-Schwab, Age-Adjusted, Roussouly, and Global Alignment and Proportion (GAP). The incremental benefits of alignment schemas were assessed in chronological order as our understanding of optimal alignment progressed. Alignment was considered improved from baseline based on SRS-Schwab 0 or decrease in severity, Age-Adjusted ideal match, Roussouly current (based on sacral slope) matching theoretical (pelvic incidence-based), and decrease in proportion. Patients separated into 4 first improving in SRS-Schwab at 2-year, second Schwab improvement and matching Age-Adjusted, third two prior with Roussouly, and fourth improvement in all four. Comparison was accomplished with means comparison tests and χ2 analyses. RESULTS: Sevenhundredthirty-two. patients met inclusion. SRS-Schwab BL: pelvic incidence-lumbar lordosis mismatch (++:32.9%), sagittal vertical axis (++: 23%), pelvic tilt (++:24.6%). 640 (87.4%) met criteria for first, 517 (70.6%) second, 176 (24%) third, and 55 (7.5%) fourth. The addition of Roussouly (third) resulted in lower rates of mechanical complications and proximal junctional kyphosis (48.3%) and higher rates of meeting minimal clinically important difference (MCID) for physical component summary and SRS-Mental (P < .05) compared with the second. Fourth compared with the third had higher rates of MCID for ODI (44.2% vs third: 28.3%, P = .011) and SRS-Appearance (70.6% vs 44.8%, P < .001). Mechanical complications and proximal junctional kyphosis were lower with the addition of Roussouly (P = .024), while the addition of GAP had higher rates of meeting MCID for SRS-22 Appearance (P = .002) and Oswestry Disability Index (P = .085). CONCLUSION: Our evaluation of the incremental benefit that alignment schemas have provided in ASD corrective surgery suggests that the addition of Roussouly provided the greatest reduction in mechanical complications, while the incorporation of GAP provided the most significant improvement in patient-reported outcomes.

Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. METHODS: Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. RESULT: Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. CONCLUSIONS: In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Contemporary utilization of three-column osteotomy techniques in a prospective complex spinal deformity multicenter database: implications on full-body alignment and perioperative course.

BACKGROUND: Research has focused on the increased correction from a three-column osteotomy (3CO) during adult spinal deformity (ASD) surgery. However, an in-depth analysis on the performance of a 3CO in a cohort of complex spinal deformity cases has not been described. STUDY DESIGN/SETTING: This is a retrospective study on a prospectively enrolled, complex ASD database. PURPOSE: This study aimed to determine if three-column osteotomies demonstrate superior benefit in correction of complex sagittal deformity at the cost of increased perioperative complications. METHODS: Surgical complex adult spinal deformity patients were included and grouped into thoracolumbar 3COs compared to those who did not have a 3CO (No 3CO) (remaining cohort). Rigid deformity was defined as ΔLL less than 33% from standing to supine. Severe deformity was defined as global (SVA > 70 mm) or C7-PL > 70 mm, or lumbopelvic (PI-LL > 30°). Means comparison tests assessed correction by 3CO grade/location. Multivariate analysis controlling for baseline deformity evaluated outcomes up to six weeks compared to No 3CO. RESULTS: 648 patients were included (Mean age 61 ± 14.6 years, BMI 27.55 ± 5.8 kg/m2, levels fused: 12.6 ± 3.8). 126 underwent 3CO, a 20% higher usage than historical cohorts. 3COs were older, frail, and more likely to undergo revision (OR 5.2, 95% CI [2.6-10.6]; p < .001). 3COs were more likely to present with both severe global/lumbopelvic deformity (OR 4), 62.4% being rigid. 3COs had greater use of secondary rods (OR 4st) and incurred 4 times greater risk for: massive blood loss (> 3500 mL), longer LOS, SICU admission, perioperative wound and spine-related complications, and neurologic complications when performed below L3. 3COs had similar HRQL benefit, but higher perioperative opioid use. Mean segmental correction increased by grade (G3-21; G4-24; G5-27) and was 4 × greater than low-grade osteotomies, especially below L3 (OR 12). 3COs achieved 2 × greater spinopelvic correction. Higher grades properly distributed lordosis 50% of the time except L5. Pelvic compensation and non-response were relieved more often with increasing grade, with greater correction in all lower extremity parameters (p < .01). Due to the increased rate of complications, 3COs trended toward higher perioperative cost ($42,806 vs. $40,046, p = .086). CONCLUSION: Three-column osteotomy usage in contemporary complex spinal deformities is generally limited to more disabled individuals undergoing the most severe sagittal and coronal realignment procedures. While there is an increased perioperative cost and prolongation of length of stay with usage, these techniques represent the most powerful realignment techniques available with a dramatic impact on normalization at operative levels and reciprocal changes.

Expectations of clinical improvement following corrective surgery for adult cervical deformity based on functional disability at presentation.

PURPOSE: To assess impact of baseline disability on HRQL outcomes. METHODS: CD patients with baseline (BL) and 2 year (2Y) data included, and ranked into quartiles by baseline NDI, from lowest/best score (Q1) to highest/worst score (Q4). Means comparison tests analyzed differences between quartiles. ANCOVA and logistic regressions assessed differences in outcomes while accounting for covariates (BL deformity, comorbidities, HRQLs, surgical details and complications). RESULTS: One hundred and sixteen patients met inclusion (Age:60.97 ± 10.45 years, BMI: 28.73 ± 7.59 kg/m2, CCI: 0.94 ± 1.31). The cohort mean cSVA was 38.54 ± 19.43 mm and TS-CL: 37.34 ± 19.73. Mean BL NDI by quartile was: Q1: 25.04 ± 8.19, Q2: 41.61 ± 2.77, Q3: 53.31 ± 4.32, and Q4: 69.52 ± 8.35. Q2 demonstrated greatest improvement in NRS Neck at 2Y (-3.93), compared to Q3 (-1.61, p = .032) and Q4 (-1.41, p = .015). Q2 demonstrated greater improvement in NRS Back (-1.71), compared to Q4 (+ 0.84, p = .010). Q2 met MCID in NRS Neck at the highest rates (69.9%), especially compared to Q4 (30.3%), p = .039. Q2 had the greatest improvement in EQ-5D (+ 0.082), compared to Q1 (+ 0.073), Q3 (+ 0.022), and Q4 (+ 0.014), p = .034. Q2 also had the greatest mJOA improvement (+ 1.517), p = .042. CONCLUSIONS: Patients in Q2, with mean BL NDI of 42, consistently demonstrated the greatest improvement in HRQLs whereas those in Q4, (NDI 70), saw the least. BL NDI between 39 and 44 may represent a disability "Sweet Spot," within which operative intervention maximizes patient-reported outcomes. Furthermore, delaying intervention until patients are severely disabled, beyond an NDI of 61, may limit the benefits of surgery.

Thoracolumbar fusions for adult lumbar deformity show superior QALY gain and lower costs compared with upper thoracic fusions.

PURPOSE: Adult spinal deformity (ASD) patients with sagittal plane deformity (N) or structural lumbar/thoraco-lumbar (TL) curves can be treated with fusions stopping at the TL junction or extending to the upper thoracic (UT) spine. This study evaluates the impact on cost/cumulative quality-adjusted life year (QALY) in patients treated with TL vs UT fusion. METHODS: ASD patients with > 4-level fusion and 2-year follow-up were included. Index and total episode-of-care costs were estimated using average itemized direct costs obtained from hospital records. Cumulative QALY gained were calculated from preoperative to 2-year postoperative change in Short Form Six-Dimension (SF-6D) scores. The TL and UT groups comprised patients with upper instrumented vertebrae (UIV) at T9-T12 and T2-T5, respectively. RESULTS: Of 566 patients with type N or L curves, mean age was 63.2 ± 12.1 years, 72% were female and 93% Caucasians. Patients in the TL group had better sagittal vertical axis (7.3 ± 6.9 vs. 9.2 ± 8.1 cm, p = 0.01), lower surgical invasiveness (- 30; p < 0.001), and shorter OR time (- 35 min; p = 0.01). Index and total costs were 20% lower in the TL than in the UT group (p < 0.001). Cost/QALY was 65% lower (492,174.6 vs. 963,391.4), and 2-year QALY gain was 40% higher, in the TL than UT group (0.15 vs. 0.10; p = 0.02). Multivariate model showed TL fusions had lower total cost (p = 0.001) and higher QALY gain (p = 0.03) than UT fusions. CONCLUSION: In Schwab type N or L curves, TL fusions showed lower 2-year cost and improved QALY gain without increased reoperation rates or length of stay than UT fusions. LEVEL OF EVIDENCE: III.

Factors Associated with the Maintenance of Cost-Effectiveness at 5 Years in Adult Spinal Deformity Corrective Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To evaluate factors associated with the long-term durability of cost-effectiveness (CE) in ASD patients. BACKGROUND: A substantial increase in costs associated with the surgical treatment for adult spinal deformity (ASD) has given precedence to scrutinize the value and utility it provides. METHODS: We included 327 operative ASD patients with 5-year (5 Y) follow-up. Published methods were used to determine costs based on CMS.gov definitions and were based on the average DRG reimbursement rates. Utility was calculated using quality-adjusted life-years (QALY) utilizing the Oswestry Disability Index (ODI) converted to Short-Form Six-Dimension (SF-6D), with a 3% discount applied for its decline with life expectancy. The CE threshold of $150,000 was used for primary analysis. RESULTS: Major and minor complication rates were 11% and 47% respectively, with 26% undergoing reoperation by 5 Y. The mean cost associated with surgery was $91,095±$47,003, with a utility gain of 0.091±0.086 at 1Y, QALY gained at 2 Y of 0.171±0.183, and at 5 Y of 0.42±0.43. The cost per QALY at 2 Y was $414,885, which decreased to $142,058 at 5 Y.With the threshold of $150,000 for CE, 19% met CE at 2 Y and 56% at 5 Y. In those in which revision was avoided, 87% met cumulative CE till life expectancy. Controlling analysis depicted higher baseline CCI and pelvic tilt (PT) to be the strongest predictors for not maintaining durable CE to 5 Y (CCI OR: 1.821 [1.159-2.862], P=0.009) (PT OR: 1.079 [1.007-1.155], P=0.030). CONCLUSIONS: Most patients achieved cost-effectiveness after four years postoperatively, with 56% meeting at five years postoperatively. When revision was avoided, 87% of patients met cumulative cost-effectiveness till life expectancy. Mechanical complications were predictive of failure to achieve cost-effectiveness at 2 Y, while comorbidity burden and medical complications were at 5 Y.

Predictors of pelvic tilt normalization: a multicenter study on the impact of regional and lower-extremity compensation on pelvic alignment after complex adult spinal deformity surgery.

OBJECTIVE: The objective was to determine the degree of regional decompensation to pelvic tilt (PT) normalization after complex adult spinal deformity (ASD) surgery. METHODS: Operative ASD patients with 1 year of PT measurements were included. Patients with normalized PT at baseline were excluded. Predicted PT was compared to actual PT, tested for change from baseline, and then compared against age-adjusted, Scoliosis Research Society-Schwab, and global alignment and proportion (GAP) scores. Lower-extremity (LE) parameters included the cranial-hip-sacrum angle, cranial-knee-sacrum angle, and cranial-ankle-sacrum angle. LE compensation was set as the 1-year upper tertile compared with intraoperative baseline. Univariate analyses were used to compare normalized and nonnormalized data against alignment outcomes. Multivariable logistic regression analyses were used to develop a model consisting of significant predictors for normalization related to regional compensation. RESULTS: In total, 156 patients met the inclusion criteria (mean ± SD age 64.6 ± 9.1 years, BMI 27.9 ± 5.6 kg/m2, Charlson Comorbidity Index 1.9 ± 1.6). Patients with normalized PT were more likely to have overcorrected pelvic incidence minus lumbar lordosis and sagittal vertical axis at 6 weeks (p < 0.05). GAP score at 6 weeks was greater for patients with nonnormalized PT (0.6 vs 1.3, p = 0.08). At baseline, 58.5% of patients had compensation in the thoracic and cervical regions. Postoperatively, compensation was maintained by 42% with no change after matching in age-adjusted or GAP score. The patients with nonnormalized PT had increased rates of thoracic and cervical compensation (p < 0.05). Compensation in thoracic kyphosis differed between patients with normalized PT at 6 weeks and those with normalized PT at 1 year (69% vs 35%, p < 0.05). Those who compensated had increased rates of implant complications by 1 year (OR [95% CI] 2.08 [1.32-6.56], p < 0.05). Cervical compensation was maintained at 6 weeks and 1 year (56% vs 43%, p = 0.12), with no difference in implant complications (OR 1.31 [95% CI -2.34 to 1.03], p = 0.09). For the lower extremities at baseline, 61% were compensating. Matching age-adjusted alignment did not eliminate compensation at any joint (all p > 0.05). Patients with nonnormalized PT had higher rates of LE compensation across joints (all p < 0.01). Overall, patients with normalized PT at 1 year had the greatest odds of resolving LE compensation (OR 9.6, p < 0.001). Patients with normalized PT at 1 year had lower rates of implant failure (8.9% vs 19.5%, p < 0.05), rod breakage (1.3% vs 13.8%, p < 0.05), and pseudarthrosis (0% vs 4.6%, p < 0.05) compared with patients with nonnormalized PT. The complication rate was significantly lower for patients with normalized PT at 1 year (56.7% vs 66.1%, p = 0.02), despite comparable health-related quality of life scores. CONCLUSIONS: Patients with PT normalization had greater rates of resolution in thoracic and LE compensation, leading to lower rates of complications by 1 year. Thus, consideration of both the lower extremities and thoracic regions in surgical planning is vital to preventing adverse outcomes and maintaining pelvic alignment.

Impact of Self-Reported Loss of Balance and Gait Disturbance on Outcomes following Adult Spinal Deformity Surgery.

Background: The objective of this study was to evaluate if imbalance influences complication rates, radiological outcomes, and patient-reported outcomes (PROMs) following adult spinal deformity (ASD) surgery. Methods: ASD patients with baseline and 2-year radiographic and PROMs were included. Patients were grouped according to whether they answered yes or no to a recent history of pre-operative loss of balance. The groups were propensity-matched by age, pelvic incidence-lumbar lordosis (PI-LL), and surgical invasiveness score. Results: In total, 212 patients were examined (106 in each group). Patients with gait imbalance had worse baseline PROM measures, including Oswestry disability index (45.2 vs. 36.6), SF-36 mental component score (44 vs. 51.8), and SF-36 physical component score (p < 0.001 for all). After 2 years, patients with gait imbalance had less pelvic tilt correction (-1.2 vs. -3.6°, p = 0.039) for a comparable PI-LL correction (-11.9 vs. -15.1°, p = 0.144). Gait imbalance patients had higher rates of radiographic proximal junctional kyphosis (PJK) (26.4% vs. 14.2%) and implant-related complications (47.2% vs. 34.0%). After controlling for age, baseline sagittal parameters, PI-LL correction, and comorbidities, patients with imbalance had 2.2-times-increased odds of PJK after 2 years. Conclusions: Patients with a self-reported loss of balance/unsteady gait have significantly worse PROMs and higher risk of PJK.

Restoring L4-S1 Lordosis Shape in Severe Sagittal Deformity: Impact of Correction Techniques on Alignment and Complication Profile.

BACKGROUND: Severe sagittal plane deformity with loss of L4-S1 lordosis is disabling and can be improved through various surgical techniques. However, data are limited on the differing ability of anterior lumbar interbody fusion (ALIF), pedicle subtraction osteotomy (PSO), and transforaminal lumbar interbody fusion (TLIF) to achieve alignment goals in severely malaligned patients. METHODS: Severe adult spinal deformity patients with preoperative PI-LL >20°, L4-S1 lordosis <30°, and full body radiographs and PROMs at baseline and 6-week postoperative visit were included. Patients were grouped into ALIF (1-2 level ALIF at L4-S1), PSO (L4/L5 PSO), and TLIF (1-2 level TLIF at L4-S1). Comparative analyses were performed on demographics, radiographic spinopelvic parameters, complications, and PROMs. RESULTS: Among the 96 included patients, 40 underwent ALIF, 27 underwent PSO, and 29 underwent TLIF. At baseline, cohorts had comparable age, sex, race, Edmonton frailty scores, and radiographic spinopelvic parameters (P > 0.05). However, PSO was performed more often in revision cases (P < 0.001). Following surgery, L4-S1 lordosis correction (P = 0.001) was comparable among ALIF and PSO patients and caudal lordotic apex migration (P = 0.044) was highest among ALIF patients. PSO patients had higher intraoperative estimated blood loss (P < 0.001) and motor deficits (P = 0.049), and in-hospital ICU admission (P = 0.022) and blood products given (P = 0.004), but were otherwise comparable in terms of length of stay, blood transfusion given, and postoperative admission to rehab. Likewise, 90-day postoperative complication profiles and 6-week PROMs were comparable as well. CONCLUSIONS: ALIF can restore L4-S1 sagittal alignment as powerfully as PSO, with fewer intraoperative and in-hospital complications. When feasible, ALIF is a suitable alternative to PSO and likely superior to TLIF for correcting L4-S1 lordosis among patients with severe sagittal malalignment.

Machine learning clustering of adult spinal deformity patients identifies four prognostic phenotypes: a multicenter prospective cohort analysis with single surgeon external validation.

BACKGROUND CONTEXT: Among adult spinal deformity (ASD) patients, heterogeneity in patient pathology, surgical expectations, baseline impairments, and frailty complicates comparisons in clinical outcomes and research. This study aims to qualitatively segment ASD patients using machine learning-based clustering on a large, multicenter, prospectively gathered ASD cohort. PURPOSE: To qualitatively segment adult spinal deformity patients using machine learning-based clustering on a large, multicenter, prospectively gathered cohort. STUDY DESIGN/SETTING: Machine learning algorithm using patients from a prospective multicenter study and a validation cohort from a retrospective single center, single surgeon cohort with complete 2-year follow up. PATIENT SAMPLE: About 805 ASD patients; 563 patients from a prospective multicenter study and 242 from a single center to be used as a validation cohort. OUTCOME MEASURES: To validate and extend the Ames-ISSG/ESSG classification using machine learning-based clustering analysis on a large, complex, multicenter, prospectively gathered ASD cohort. METHODS: We analyzed a training cohort of 563 ASD patients from a prospective multicenter study and a validation cohort of 242 ASD patients from a retrospective single center/surgeon cohort with complete two-year patient-reported outcomes (PROs) and clinical/radiographic follow-up. Using k-means clustering, a machine learning algorithm, we clustered patients based on baseline PROs, Edmonton frailty, age, surgical history, and overall health. Baseline differences in clusters identified using the training cohort were assessed using Chi-Squared and ANOVA with pairwise comparisons. To evaluate the classification system's ability to discern postoperative trajectories, a second machine learning algorithm assigned the single-center/surgeon patients to the same 4 clusters, and we compared the clusters' two-year PROs and clinical outcomes. RESULTS: K-means clustering revealed four distinct phenotypes from the multicenter training cohort based on age, frailty, and mental health: Old/Frail/Content (OFC, 27.7%), Old/Frail/Distressed (OFD, 33.2%), Old/Resilient/Content (ORC, 27.2%), and Young/Resilient/Content (YRC, 11.9%). OFC and OFD clusters had the highest frailty scores (OFC: 3.76, OFD: 4.72) and a higher proportion of patients with prior thoracolumbar fusion (OFC: 47.4%, OFD: 49.2%). ORC and YRC clusters exhibited lower frailty scores and fewest patients with prior thoracolumbar procedures (ORC: 2.10, 36.6%; YRC: 0.84, 19.4%). OFC had 69.9% of patients with global sagittal deformity and the highest T1PA (29.0), while YRC had 70.2% exhibiting coronal deformity, the highest mean coronal Cobb Angle (54.0), and the lowest T1PA (11.9). OFD and ORC had similar alignment phenotypes with intermediate values for Coronal Cobb Angle (OFD: 33.7; ORC: 40.0) and T1PA (OFD: 24.9; ORC: 24.6) between OFC (worst sagittal alignment) and YRC (worst coronal alignment). In the single surgeon validation cohort, the OFC cluster experienced the greatest increase in SRS Function scores (1.34 points, 95%CI 1.01-1.67) compared to OFD (0.5 points, 95%CI 0.245-0.755), ORC (0.7 points, 95%CI 0.415-0.985), and YRC (0.24 points, 95%CI -0.024-0.504) clusters. OFD cluster patients improved the least over 2 years. Multivariable Cox regression analysis demonstrated that the OFD cohort had significantly worse reoperation outcomes compared to other clusters (HR: 3.303, 95%CI: 1.085-8.390). CONCLUSION: Machine-learning clustering found four different ASD patient qualitative phenotypes, defined by their age, frailty, physical functioning, and mental health upon presentation, which primarily determines their ability to improve their PROs following surgery. This reaffirms that these qualitative measures must be assessed in addition to the radiographic variables when counseling ASD patients regarding their expected surgical outcomes.

Stronger association of objective physical metrics with baseline patient-reported outcome measures than preoperative standing sagittal parameters for adult spinal deformity patients.

OBJECTIVE: Sagittal alignment measured on standing radiography remains a fundamental component of surgical planning for adult spinal deformity (ASD). However, the relationship between classic sagittal alignment parameters and objective metrics, such as walking time (WT) and grip strength (GS), remains unknown. The objective of this work was to determine if ASD patients with worse baseline sagittal malalignment have worse objective physical metrics and if those metrics have a stronger relationship to patient-reported outcome metrics (PROMs) than standing alignment. METHODS: The authors conducted a retrospective review of a multicenter ASD cohort. ASD patients underwent baseline testing with the timed up-and-go 6-m walk test (seconds) and for GS (pounds). Baseline PROMs were surveyed, including Oswestry Disability Index (ODI), Patient-Reported Outcomes Measurement Information System (PROMIS), Scoliosis Research Society (SRS)-22r, and Veterans RAND 12 (VR-12) scores. Standard spinopelvic measurements were obtained (sagittal vertical axis [SVA], pelvic tilt [PT], and mismatch between pelvic incidence and lumbar lordosis [PI-LL], and SRS-Schwab ASD classification). Univariate and multivariable linear regression modeling was performed to interrogate associations between objective physical metrics, sagittal parameters, and PROMs. RESULTS: In total, 494 patients were included, with mean ± SD age 61 ± 14 years, and 68% were female. Average WT was 11.2 ± 6.1 seconds and average GS was 56.6 ± 24.9 lbs. With increasing PT, PI-LL, and SVA quartiles, WT significantly increased (p < 0.05). SRS-Schwab type N patients demonstrated a significantly longer average WT (12.5 ± 6.2 seconds), and type T patients had a significantly shorter WT time (7.9 ± 2.7 seconds, p = 0.03). With increasing PT quartiles, GS significantly decreased (p < 0.05). SRS-Schwab type T patients had a significantly higher average GS (68.8 ± 27.8 lbs), and type L patients had a significantly lower average GS (51.6 ± 20.4 lbs, p = 0.03). In the frailty-adjusted multivariable linear regression analyses, WT was more strongly associated with PROMs than sagittal parameters. GS was more strongly associated with ODI and PROMIS Physical Function scores. CONCLUSIONS: The authors observed that increasing baseline sagittal malalignment is associated with slower WT, and possibly weaker GS, in ASD patients. WT has a stronger relationship to PROMs than standing alignment parameters. Objective physical metrics likely offer added value to standard spinopelvic measurements in ASD evaluation and surgical planning.

Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?

OBJECTIVE: Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors. METHODS: Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA. RESULTS: Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications. CONCLUSIONS: Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.