ABSTRACT
STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To assess the impact of Enhanced recovery after surgery (ERAS) protocols on peri-operative course in adult cervical deformity (ACD) corrective surgery. METHODS: Patients ≥18 yrs with complete pre-(BL) and up to 2-year (2Y) radiographic and clinical outcome data were stratified by enrollment in an ERAS protocol that commenced in 2020. Differences in demographics, clinical outcomes, radiographic alignment targets, peri-operative factors and complication rates were assessed via means comparison analysis. Logistic regression analysed differences while controlling for baseline disability and deformity. RESULTS: We included 220 patients (average age 58.1 ± 11.9 years, 48% female). 20% were treated using the ERAS protocol (ERAS+). Disability was similar between both groups at baseline. When controlling for baseline disability and myelopathy, ERAS- patients were more likely to utilize opioids than ERAS+ (OR 1.79, 95% CI: 1.45-2.50, P = .016). Peri-operatively, ERAS+ had significantly lower operative time (P < .021), lower EBL (583.48 vs 246.51, P < .001), and required significantly lower doses of propofol intra-operatively than ERAS- patients (P = .020). ERAS+ patients also reported lower mean LOS overall (4.33 vs 5.84, P = .393), and were more likely to be discharged directly to home (χ2(1) = 4.974, P = .028). ERAS+ patients were less likely to require steroids after surgery (P = .045), were less likely to develop neuromuscular complications overall (P = .025), and less likely experience venous complications or be diagnosed with venous disease post-operatively (P = .025). CONCLUSIONS: Enhanced recovery after surgery programs in ACD surgery demonstrate significant benefit in terms of peri-operative outcomes for patients.
ABSTRACT
STUDY DESIGN: Retrospective cohort. OBJECTIVE: To investigate the impact of evolving Enhanced Recovery After Surgery (ERAS) protocols on outcomes after cervical deformity (CD) surgery. BACKGROUND: ERAS can help accelerate patient recovery and assist hospitals in maximizing the incentives of bundled payment models while maintaining high-quality patient care. However, there remains a paucity of literature assessing how developments have impacted outcomes after adult CD surgery. METHODS: Patients with operative CD 18 years or older with pre-baseline and 2 years (2Y) postoperative data, who underwent ERAS protocols, were stratified by increasing implantation of ERAS components: (1) early (multimodal pain program), (2) intermediate (early protocol + paraspinal blocks, early ambulation), and (3) late (early/intermediate protocols + comprehensive prehabilitation). Differences in demographics, clinical outcomes, radiographic alignment targets, perioperative factors, and complication rates were assessed through Bonferroni-adjusted means comparison analysis. RESULTS: A total of 131 patients were included (59.4 ± 11.7 y, 45% females, 28.8 ± 6.0 kg/m 2 ). Of these patients, 38.9% were considered "early," 36.6% were "intermediate," and 24.4% were "late." Perioperatively, rates of intraoperative complications were lower in the late group ( P = 0.036). Postoperatively, discharge disposition differed significantly between cohorts, with late patients more likely to be discharged to home versus early or intermediate cohorts [χ 2 (2) = 37.973, P < 0.001]. In terms of postoperative disability recovery, intermediate and late patients demonstrated incrementally improved 6 W modified Japanese Orthopedic Association scores ( P = 0.004), and late patients maintained significantly higher mean Euro-QOL 5-Dimension Questionnaire and modified Japanese Orthopedic Association scores by 1 year ( P < 0.001, P = 0.026). By 2Y, cohorts demonstrated incrementally increasing SWAL-QOL scores (all domains P < 0.028) domain scores versus early or intermediate cohorts. By 2Y, incrementally decreasing reoperation was observed in early versus intermediate versus late cohorts ( P = 0.034). CONCLUSIONS: The present study demonstrates that patients enrolled in an evolving ERAS program demonstrate incremental improvement in preoperative optimization and candidate selection, greater likelihood of discharge to home, decreased postoperative disability and dysphasia burden, and decreased likelihood of intraoperative complications and reoperation rates.
Subject(s)
Cervical Vertebrae , Enhanced Recovery After Surgery , Humans , Female , Middle Aged , Male , Cervical Vertebrae/surgery , Treatment Outcome , Adult , Aged , Retrospective StudiesABSTRACT
OBJECTIVE: To assess the financial impact of Enhanced Recovery After Surgery (ERAS) protocols and cost-effectiveness in cervical deformity corrective surgery. STUDY DESIGN: Retrospective review of prospective CD database. BACKGROUND: Enhanced Recovery After Surgery (ERAS) can help accelerate patient recovery and assist hospitals in maximizing the incentives of bundled payment models while maintaining high-quality patient care. However, the economic benefit of ERAS protocols, nor the heterogeneous components that make up such protocols, has not been established. METHODS: Operative CD patients ≥18 y with complete pre-(BL) and up to 2-year(2Y) postop radiographic/HRQL data were stratified by enrollment in Standard-of-Care ERAS beginning in 2020. Differences in demographics, clinical outcomes, radiographic alignment targets, perioperative factors, and complication rates were assessed through means comparison analysis. Costs were calculated using PearlDiver database estimates from Medicare pay scales. QALY was calculated using NDI mapped to SF6D using validated methodology with a 3% discount rate to account for a residual decline in life expectancy. RESULTS: In all, 127 patients were included (59.07±11.16 y, 54% female, 29.08±6.43 kg/m 2 ) in the analysis. Of these patients, 54 (20.0%) received the ERAS protocol. Per cost analysis, ERAS+ patients reported a lower mean total 2Y cost of 35049 USD compared with ERAS- patients at 37553 ( P <0.001). Furthermore, ERAS+ patients demonstrated lower cost of reoperation by 2Y ( P <0.001). Controlling for age, surgical invasiveness, and deformity per BL TS-CL, ERAS+ patients below 70 years old were significantly more likely to achieve a cost-effective outcome by 2Y compared with their ERAS- counterparts (OR: 1.011 [1.001-1.999, P =0.048]. CONCLUSIONS: Patients undergoing ERAS protocols experience improved cost-effectiveness and reduced total cost by 2Y post-operatively. Due to the potential economic benefit of ERAS for patients incorporation of ERAS into practice for eligible patients should be considered.
Subject(s)
Cost-Benefit Analysis , Enhanced Recovery After Surgery , Humans , Female , Male , Middle Aged , Cervical Vertebrae/surgery , Aged , Adult , Treatment Outcome , Quality-Adjusted Life Years , Retrospective StudiesABSTRACT
PURPOSE: To investigate the effect of a prehabilitation program on peri- and post-operative outcomes in adult cervical deformity (CD) surgery. METHODS: Operative CD patients ≥ 18 years with complete baseline (BL) and 2-year (2Y) data were stratified by enrollment in a prehabilitation program beginning in 2019. Patients were stratified as having undergone prehabilitation (Prehab+) or not (Prehab-). Differences in pre and post-op factors were assessed via means comparison analysis. Costs were calculated using PearlDiver database estimates from Medicare pay-scales. RESULTS: 115 patients were included (age: 61 years, 70% female, BMI: 28 kg/m2). Of these patients, 57 (49%) were classified as Prehab+. At baseline, groups were comparable in age, gender, BMI, CCI, and frailty. Surgically, Prehab+ were able to undergo longer procedures (p = 0.017) with equivalent EBL (p = 0.627), and shorter SICU stay (p < 0.001). Post-operatively, Prehab+ patients reported greater reduction in pain scores and greater improvement in quality of life metrics at both 1Y and 2Y than Prehab- patients (all p < 0.05). Prehab+ patients reported significantly less complications overall, as well as less need for reoperation (all p < 0.05). CONCLUSION: Introducing prehabilitation protocols in adult cervical deformity surgery may aid in improving patient physiological status, enabling patients to undergo longer surgeries with lessened risk of peri- and post-operative complications.
Subject(s)
Preoperative Exercise , Humans , Female , Middle Aged , Male , Treatment Outcome , Cervical Vertebrae/surgery , Aged , Quality of Life , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Period , Spinal Curvatures/surgery , AdultABSTRACT
OBJECTIVE: Recent debate has arisen between whether to use a three-column osteotomy (3CO) or multilevel low-grade (MLG) techniques to treat severe sagittal malalignment in adult spinal deformity (ASD) surgery. The goal of this study was to compare the outcomes of 3CO and MLG techniques performed in corrective surgeries for ASD. METHODS: ASD patients who had a baseline PI-LL > 30° and 2-year follow-up data were included. Patients underwent either 3CO or MLG (thoracolumbar posterior column osteotomies at ≥ 3 levels or anterior lumbar interbody fusion at ≥ 3 levels with no 3CO). The segmental utility ratio was used to assess relative segmental correction (segmental correction divided by overall correction in lordosis divided by the number of thoracolumbar interventions [interbody fusion, thoracolumbar posterior column osteotomies, and 3CO]). The paired t-test was used to assess lordotic distribution by differences in lordosis between adjacent lumbar disc spaces (e.g., L1-2 to L2-3). Multivariate analysis, controlling for age, sex, BMI, osteoporosis, baseline pelvic incidence, and T1 pelvic angle, was used to evaluate the complication rates and radiographic and patient-reported outcomes between the groups. RESULTS: A total of 93 patients were included, 53% of whom underwent MLG and 47% of whom underwent 3CO. The MLG group had a lower BMI (p < 0.05). MLG patients received fewer previous fusions than 3CO patients (31% vs 80%, p < 0.001). MLG patients had 24% less blood loss but a 22% longer operative time (565 vs 419 minutes, p = 0.008). Using adjusted analysis, the 3CO group had greater segmental and relative correction at each level (segmental utility ratio mean 69% for 3CO vs 23% for MLG, p < 0.001). However, the 3CO group had lordotic differences between two adjacent lumbar disc pairs (range -0.5° to 9.0°, p = 0.009), while MLG was more harmonious (range 2.2°-6.5°, p > 0.4). MLG patients were more likely to undergo realignment to age-adjusted standards (OR 5.6, 95% CI 1.2-46.4; p = 0.033). MLG patients were less likely to develop neurological complications or undergo reoperation (OR 0.4, 95% CI 0.1-0.9; p = 0.041). Adjusted analysis revealed that MLG patients more often met a substantial clinical benefit in the Oswestry Disability Index score (OR 5.3, 95% CI 1.1-26.8; p = 0.043). CONCLUSIONS: MLG techniques showed better utility in lumbar distribution and age-adjusted global correction while minimizing neurological complications and reoperation rates by 2 years postoperatively. In selected instances, these techniques may offer the spine deformity surgeon a safer alternative when correcting severe adult spinal deformity.
Subject(s)
Lordosis , Lumbar Vertebrae , Osteotomy , Spinal Fusion , Humans , Osteotomy/methods , Female , Male , Middle Aged , Spinal Fusion/methods , Lumbar Vertebrae/surgery , Treatment Outcome , Lordosis/surgery , Thoracic Vertebrae/surgery , Adult , Aged , Retrospective Studies , Follow-Up Studies , Spinal Curvatures/surgery , Spinal Curvatures/diagnostic imaging , Postoperative Complications/etiologyABSTRACT
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.
Subject(s)
Lordosis , Scoliosis , Adult , Humans , Middle Aged , Aged , Quality of Life , Follow-Up Studies , Lordosis/diagnostic imaging , Lordosis/surgery , Scoliosis/surgery , Postoperative Complications/epidemiology , Lower Extremity/surgery , Retrospective StudiesABSTRACT
BACKGROUND: Previous studies have demonstrated that adult cervical deformity patients may be at increased risk of death in conjunction with increased frailty or a weakened physiologic state. However, such studies have often been limited by follow-up duration, and longer-term studies are needed to better assess temporal changes in ACD patients and associated mortality risk. PURPOSE: To assess if patients with decreased comorbidities and physiologic burden will be at lessened risk of death for a greater length of time after undergoing adult cervical deformity surgery. STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: Two hundred ninety ACD patients. OUTCOME MEASURES: Morbidity and mortality data. METHODS: Operative ACD patients ≥18 years with pre-(BL) and 10-year (10Y) data were included. Patients were stratified as expired versus living, as well as temporally grouped by Expiration prior to 5Y or between 5Y and 10Y. Group differences were assessed via means comparison analysis. Backstep logistic regression identified mortality predictors. Kaplan-Meier analysis assessed survivorship of expired patients. Log rank analysis determined differences in survival distribution groups. RESULTS: Sixty-six total patients were included (60.97±10.19 years, 48% female, 28.03±7.28 kg/m2). Within 10Y, 12 (18.2% of ACD cohort) expired. At baseline, patients were comparable in age, gender, BMI, and CCI total on average (all p>.05). Furthermore, patients were comparable in BL HRQLs (all p>.05). However, patients who expired between 5Y and 10Y demonstrated higher BL EQ5D and mJOA scores than their earlier expired counterparts at 2Y (p<.021). Furthermore, patients who presented with no CCI markers at BL were significantly more likely to survive until the 5Y-10Y follow-up window. Surgically, the only differences observed between patients who survived until 5Y was in undergoing osteotomy, with longer survival seen in those who did not require it (p=.003). Logistic regression revealed independent predictors of death prior to 5Y to be increased BMI, increased frailty, and increased levels fused (model p<.001). KM analysis found that by Passias et al frailty, not frail patients had mean survival time of 170.56 weeks, versus 158.00 in frail patients (p=.949). CONCLUSIONS: Our study demonstrates that long-term survival after cervical deformity surgery may be predicted by baseline surgical factors. By optimizing BMI, frailty status, and minimizing fusion length when appropriate, surgeons may be able to further assist ACD patients in increasing their survivability postoperatively.
Subject(s)
Frailty , Adult , Humans , Female , Male , Follow-Up Studies , Retrospective Studies , Patients , Kaplan-Meier EstimateABSTRACT
STUDY DESIGN: A retrospective cohort review. OBJECTIVE: To develop a scoring system for predicting increased risk of postoperative complications in adult spinal deformity (ASD) surgery based on baseline nutritional and metabolic factors. BACKGROUND: Endocrine and metabolic conditions have been shown to adversely influence patient outcomes and may increase the likelihood of postoperative complications. The impact of these conditions has not been effectively evaluated in patients undergoing ASD surgery. MATERIALS AND METHODS: ASD patients 18 years or above with baseline and two-year data were included. An internally cross-validated weighted equation using preoperative laboratory and comorbidity data correlating to increased perioperative complications was developed via Poisson regression. Body mass index (BMI) categorization (normal, over/underweight, and obese) and diabetes classification (normal, prediabetic, and diabetic) were used per the Centers for Disease Control and Prevention and the American Diabetes Associates parameters. A novel ASD-specific nutritional and metabolic burden score (ASD-NMBS) was calculated via Beta-Sullivan adjustment, and Conditional Inference Tree determined the score threshold for experiencing ≥1 complication. Cohorts were stratified into low-risk and high-risk groups for comparison. Logistic regression assessed correlations between increasing burden score and complications. RESULTS: Two hundred one ASD patients were included (mean age: 58.60±15.4, sex: 48% female, BMI: 29.95±14.31, Charlson Comorbidity Index: 3.75±2.40). Significant factors were determined to be age (+1/yr), hypertension (+18), peripheral vascular disease (+37), smoking status (+21), anemia (+1), VitD hydroxyl (+1/ng/mL), BMI (+13/cat), and diabetes (+4/cat) (model: P <0.001, area under the curve: 92.9%). Conditional Inference Tree determined scores above 175 correlated with ≥1 post-op complication ( P <0.001). Furthermore, HIGH patients reported higher rates of postoperative cardiac complications ( P =0.045) and were more likely to require reoperation ( P =0.024) compared with low patients. CONCLUSIONS: The development of a validated novel nutritional and metabolic burden score (ASD-NMBS) demonstrated that patients with higher scores are at greater risk of increased postoperative complications and course. As such, surgeons should consider the reduction of nutritional and metabolic burden preoperatively to enhance outcomes and reduce complications in ASD patients.
Subject(s)
Diabetes Mellitus , Quality of Life , Adult , Humans , Middle Aged , Aged , Retrospective Studies , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Reoperation/adverse effects , Diabetes Mellitus/epidemiologyABSTRACT
OBJECTIVE: The objective of this study was to adjust the sagittal age-adjusted score (SAAS) to accommodate frailty in alignment considerations and thereby increase the predictability of clinical outcomes and junctional failure. METHODS: Surgical adult spinal deformity (ASD) patients with 2-year data were included. Frailty was assessed with the continuous ASD modified frailty index (ASD-mFI). Two-year outcomes were proximal junctional kyphosis (PJK), proximal junctional failure (PJF), major mechanical complications, and best clinical outcome (BCO), defined as Oswestry Disability Index (ODI) score < 15 and Scoliosis Research Society outcomes questionnaire total score > 4.5 by 2 years. Linear regression analysis established a 6-week score based on the component scores of SAAS, frailty, and US normal values for ODI score. Logistic regression analysis followed by conditional inference tree run forest analysis generated categorical thresholds. Multivariate analysis, controlling for age, baseline deformity, and history of revision, was used to compare outcome rates, and logistic regression generated odds ratios for the continuous score. Thirty percent of the cohort was used as a random sample for internal validation. RESULTS: In total, 412 patients were included (mean ± SD age 60.1 ± 14.2 years, 80% female, BMI 26.9 ± 5.4 kg/m2). Baseline frailty categories were as follows: 57% not frail, 30% frail, and 14% severely frail. Overall, by 2 years, 39% of patients had developed PJK, 8% PJF, and 21% mechanical complications; 22% had undergone a reoperation; and 15% met BCO. When the cohort as a whole was assessed, the 6-week SAAS had a correlation with the development of PJK and PJF, but not mechanical complications, reoperation, or BCO. Development of mechanical complications, PJF, reoperation, and BCO demonstrated correlations with ASD-mFI (all p < 0.05). Regression analysis modifying SAAS on the basis of ODI norms and frailty generated the following equation: frailty-adjusted SAAS (FAS) = 0.108 × T1 pelvic angle + 0.162 × pelvic tilt - 0.39 × pelvic incidence - lumbar lordosis - 0.03 × ASD-mFI - 1.6771. With conditional inference tree analysis, thresholds were derived for FAS: aligned < 1.7, offset 1.7-2.2, and severely offset > 2.2. Significance between FAS categories was found for PJK, PJF, mechanical complications, reoperation, and BCO by 2 years. Binary logistic regression, controlling for baseline deformity and revision status, demonstrated significance between FAS and all 5 outcome variables (all p < 0.01). Internal validation saw each outcome variable maintain significance between categories, with even greater odds for PJF (OR 13.4, 95% CI 4.7-38.3, p < 0.001). CONCLUSIONS: Consideration of physiological age, in addition to chronological age, may be beneficial in the management of operative goals to maximize clinical outcomes while minimizing junctional failure. This combination enables the spine surgeon to fortify a surgical plan for even the most challenging patients undergoing ASD corrective surgery.
Subject(s)
Frailty , Kyphosis , Spinal Fusion , Humans , Adult , Middle Aged , Aged , Frailty/complications , Frailty/surgery , Goals , Retrospective Studies , Spine/surgery , Kyphosis/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Spinal Fusion/adverse effectsABSTRACT
OBJECTIVE: The objective of this study was to assess whether delaying surgical management of cervical deformity (CD) in patients with concomitant mild myelopathy increases the risk of suboptimal outcomes. METHODS: Patients aged ≥ 18 years who had a baseline diagnosis of mild myelopathy with baseline and up to 2 years of postoperative data were assessed. Patients were categorized as having CD (CD+) or not (CD-) at baseline. Patients with symptoms of myelopathy for more than 1 year after the initial visit prior to surgery were considered delayed. Clinical and radiographic data were assessed using means comparison analyses. Multivariate regression analysis assessed correlations between increasing time to surgery and peri- and postoperative outcomes adjusted for baseline age and frailty score. Backstep logistic regression analysis assessed the risk of complications or reoperation, while controlling for baseline T1 slope minus cervical lordosis (TS-CL). RESULTS: One hundred six patients were included (mean age 58.11 ± 11.97 years, 48% female, mean BMI 29.13 ± 6.89). Of the patients with baseline mild myelopathy, 22 (20.8%) were CD- while 84 (79.2%) were CD+. Overall, 9.5% of patients were considered to have delayed surgery. Linear regression revealed that both CD- and CD+ patients were more likely to require reoperation when there was more time between the initial visit and surgical admission (p < 0.001). Additionally, an adjusted logistic regression indicated that CD+ patients who had a greater length of time to surgery had a higher likelihood for major complications (p < 0.001). Conversely, CD+ patients who were operated on within 30 days of the initial visit had a significantly lower risk for a major complication (OR 0.901, 95% CI 0.889-1.105, p = 0.043), and a lower risk for reoperation (OR 0.954, 95% CI 0.877-1.090, p = 0.043), while controlling for the severity of deformity based on baseline TS-CL. CONCLUSIONS: The findings of this study demonstrate that a delay in surgery after the initial visit significantly increases the risk for major complications and reoperation in patients with CD with associated mild baseline myelopathy. Early operative treatment in this patient population may lower the risk of postoperative complications.
Subject(s)
Frailty , Animals , Humans , Adult , Female , Middle Aged , Aged , Male , Retrospective Studies , Reoperation , Hospitalization , Multivariate AnalysisABSTRACT
OBJECTIVE: The aim of this study was to investigate whether surgery for high-risk patients is being optimized over time and if poor outcomes are being minimized. METHODS: Patients who underwent surgery for cervical deformity (CD) and were ≥ 18 years with baseline and 2-year data were stratified by year of surgery from 2013 to 2018. The cohort was divided into two groups based on when the surgery was performed. Patients in the early cohort underwent surgery between 2013 and 2015 and those in the recent cohort underwent surgery between 2016 and 2018. High-risk patients met at least 2 of the following criteria: 1) baseline C2-7 Cobb angle > 15°, mismatch between T1 slope and cervical lordosis ≥ 35°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°; 2) age ≥ 70 years; 3) severe baseline frailty (Miller index); 4) Charlson Comorbidity Index (CCI) ≥ 1 SD above the mean; 5) three-column osteotomy as treatment; and 6) fusion > 10 levels or > 7 levels for elderly patients. The mean comparison analysis assessed differences between groups. Stepwise multivariable linear regression described associations between increasing year of surgery and complications. RESULTS: Eighty-two CD patients met high-risk criteria (mean age 62.11 ± 10.87 years, 63.7% female, mean BMI 29.70 ± 8.16 kg/m2, and mean CCI 1.07 ± 1.45). The proportion of high-risk patients increased with time, with 41.8% of patients in the early cohort classified as high risk compared with 47.6% of patients in the recent cohort (p > 0.05). Recent high-risk patients were more likely to be female (p = 0.008), have a lower BMI (p = 0.038), and have a higher baseline CCI (p = 0.013). Surgically, high-risk patients in the recent cohort were more likely to undergo low-grade osteotomy (p = 0.003). By postoperative complications, recent high-risk patients were less likely to experience any postoperative adverse events overall (p = 0.020) or complications such as dysphagia (p = 0.045) at 2 years. Regression analysis revealed increasing year of surgery to be correlated with decreasing minor complication rates (p = 0.030), as well as lowered rates of distal junctional kyphosis by 2 years (p = 0.048). CONCLUSIONS: Over time, high-risk CD patients have an increase in frequency and comorbidity rates but have demonstrated improved postoperative outcomes. These findings suggest that spine surgeons have improved over time in optimizing selection and reducing potential adverse events in high-risk patients.
Subject(s)
Kyphosis , Lordosis , Humans , Adult , Female , Aged , Middle Aged , Male , Cervical Vertebrae/surgery , Lordosis/surgery , Kyphosis/surgery , Osteotomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective StudiesABSTRACT
STUDYDESIGN: Retrospective cohort study of a prospectively collected multi-center adult spinal deformity (ASD) database. OBJECTIVE: To compare staged procedures to same-day interventions and identify the optimal time interval between staged surgeries for treatment of ASD. BACKGROUND: Surgical intervention for ASD is invasive and complex procedure that surgeons often elect to perform on different days (staging). Yet, there remains a paucity of literature on the timing and effects of the interval between stages. METHODS: ASD patients with two-year (2Y) data undergoing an anterior/posterior (A/P) fusion to the ilium were included. Propensity score matching (PSM) was performed for number of levels fused, number of interbody devices, surgical approaches, number of osteotomies/three-column osteotomy (3CO), frailty, Oswestry Disability Index (ODI), Charlson Comorbidity Index (CCI), revisions, sagittal vertical axis (SVA), pelvic incidence-lumbar lordosis (PI-LL), and UIV to create balanced cohorts of Same-Day and Staged surgical patients. Staged patients were stratified by intervening time-period between surgeries, using quartiles. RESULTS: 176 PSM patients were included. Median interval between A/P staged procedures was 3 days. Staged patients had greater operative time and lower ICU stays postop (P<0.05). At 2Y, staged compared to same day showed a greater improvement in T1 slope - cervical lordosis (TS-CL), C2 sacral slope (C2SS), and SRS-Schwab SVA (P<0.05). Staged patients had higher rates of minimal clinically-important difference (MCID) for 1Y SRS-Appearance and 2Y physical component summary (PCS) scores. Assessing different intervals of staging, patients at the 75th percentile interval showed greater improvement in 1Y SRS Pain and Total postop as well as SRS Activity, Pain, Satisfaction, and Total scores (P<0.05) compared to patients in lower quartiles. Compared to the 25th percentile, patients reaching the 50th percentile interval were associated with increased odds of improvement in Global Alignment and Proportion (GAP) score proportionality (9.3[1.6-53.2], P=0.01). CONCLUSIONS: This investigation is among the first to compare multicenter staged and same day surgery anterior/posterior adult spinal deformity patients fused to ilium using propensity-matching. Staged procedures resulted in significant improvement radiographically, reduced ICU admissions, and superior patient reported outcomes compared to same day procedures. An interval of at least three days between staged procedures is associated with superior outcomes in terms of GAP score proportionality.
ABSTRACT
OBJECTIVE: The objective of this study was to calibrate an updated predictive model incorporating novel clinical, radiographic, and prophylactic measures to assess the risk of proximal junctional kyphosis (PJK) and failure (PJF). METHODS: Operative patients with adult spinal deformity (ASD) and baseline and 2-year postoperative data were included. PJK was defined as ≥ 10° in sagittal Cobb angle between the inferior uppermost instrumented vertebra (UIV) endplate and superior endplate of the UIV + 2 vertebrae. PJF was radiographically defined as a proximal junctional sagittal Cobb angle ≥ 15° with the presence of structural failure and/or mechanical instability, or PJK with reoperation. Backstep conditional binary supervised learning models assessed baseline demographic, clinical, and surgical information to predict the occurrence of PJK and PJF. Internal cross validation of the model was performed via a 70%/30% cohort split. Conditional inference tree analysis determined thresholds at an alpha level of 0.05. RESULTS: Seven hundred seventy-nine patients with ASD (mean 59.87 ± 14.24 years, 78% female, mean BMI 27.78 ± 6.02 kg/m2, mean Charlson Comorbidity Index 1.74 ± 1.71) were included. PJK developed in 50.2% of patients, and 10.5% developed PJF by their last recorded visit. The six most significant demographic, radiographic, surgical, and postoperative predictors of PJK/PJF were baseline age ≥ 74 years, baseline sagittal age-adjusted score (SAAS) T1 pelvic angle modifier > 1, baseline SAAS pelvic tilt modifier > 0, levels fused > 10, nonuse of prophylaxis measures, and 6-week SAAS pelvic incidence minus lumbar lordosis modifier > 1 (all p < 0.015). Overall, the model was deemed significant (p < 0.001), and internally validated receiver operating characteristic analysis returned an area under the curve of 0.923, indicating robust model fit. CONCLUSIONS: PJK and PJF remain critical concerns in ASD surgery, and efforts to reduce the occurrence of PJK and PJF have resulted in the development of novel prophylactic techniques and enhanced clinical and radiographic selection criteria. This study demonstrates a validated model incorporating such techniques that may allow for the prediction of clinically significant PJK and PJF, and thus assist in optimizing patient selection, enhancing intraoperative decision making, and reducing postoperative complications in ASD surgery.
Subject(s)
Kyphosis , Lordosis , Spinal Fusion , Humans , Adult , Aged , Infant, Newborn , Calibration , Goals , Follow-Up Studies , Kyphosis/diagnostic imaging , Kyphosis/surgery , Kyphosis/etiology , Lordosis/surgery , Postoperative Complications/diagnostic imaging , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Spinal Fusion/methods , Retrospective Studies , Risk FactorsABSTRACT
OBJECTIVE: Management of adult spinal deformity (ASD) has increasingly favored operative intervention; however, the incidence of complications and reoperations is high, and patients may fail to achieve idealized postsurgical results. This study compared health-related quality of life (HRQOL) metrics between patients with suboptimal surgical outcomes and those who underwent nonoperative management as a proxy for the natural history (NH) of ASD. METHODS: ASD patients with 2-year data were included. Patients who were offered surgery but declined were considered nonoperative (i.e., NH) patients. Operative patients with suboptimal outcome (SOp)-defined as any reoperation, major complication, or ≥ 2 severe Scoliosis Research Society (SRS)-Schwab modifiers at follow-up-were selected for comparison. Propensity score matching (PSM) on the basis of baseline age, deformity, SRS-22 Total, and Charlson Comorbidity Index score was used to match the groups. ANCOVA and stepwise logistic regression analysis were used to assess outcomes between groups at 2 years. RESULTS: In total, 441 patients were included (267 SOp and 174 NH patients). After PSM, 142 patients remained (71 SOp 71 and 71 NH patients). At baseline, the SOp and NH groups had similar demographic characteristics, HRQOL, and deformity (all p > 0.05). At 2 years, ANCOVA determined that NH patients had worse deformity as measured with sagittal vertical axis (36.7 mm vs 21.3 mm, p = 0.025), mismatch between pelvic incidence and lumbar lordosis (11.9° vs 2.9°, p < 0.001), and pelvic tilt (PT) (23.1° vs 20.7°, p = 0.019). The adjusted regression analysis found that SOp patients had higher odds of reaching the minimal clinically important differences in Oswestry Disability Index score (OR [95% CI] 4.5 [1.7-11.5], p = 0.002), SRS-22 Activity (OR [95% CI] 3.2 [1.5-6.8], p = 0.002), SRS-22 Pain (OR [95% CI] 2.8 [1.4-5.9], p = 0.005), and SRS-22 Total (OR [95% CI] 11.0 [3.5-34.4], p < 0.001). CONCLUSIONS: Operative patients with SOp still experience greater improvements in deformity and HRQOL relative to the progressive radiographic and functional deterioration associated with the NH of ASD. The NH of nonoperative management should be accounted for when weighing the risks and benefits of operative intervention for ASD.
Subject(s)
Lordosis , Quality of Life , Humans , Adult , Treatment Outcome , Retrospective Studies , Lordosis/surgery , PainABSTRACT
OBJECTIVE: Circumferential minimally invasive surgery (cMIS) may provide incremental benefits compared with open surgery for patients with increasing frailty status by decreasing peri- and postoperative complications. METHODS: Operative patients with adult spinal deformity (ASD) ≥ 18 years old with baseline and 2-year postoperative data were assessed. With propensity score matching, patients who underwent cMIS (cMIS group) were matched with similar patients who underwent open surgery (open group) based on baseline BMI, C7-S1 sagittal vertical axis, pelvic incidence to lumbar lordosis mismatch, and S1 pelvic tilt. The Passias modified ASD frailty index (mASD-FI) was used to determine patient frailty stratification as not frail, frail, or severely frail. Baseline and postoperative factors were assessed using two-way analysis of covariance (ANCOVA) and multivariate ANCOVA while controlling for baseline age, Charlson Comorbidity Index (CCI) score, and number of levels fused. RESULTS: After propensity score matching, 170 ASD patients (mean age 62.71 ± 13.64 years, 75.0% female, mean BMI 29.25 ± 6.60 kg/m2) were included, split evenly between the cMIS and open groups. Surgically, patients in the open group had higher numbers of posterior levels fused (p = 0.021) and were more likely to undergo three-column osteotomies (p > 0.05). Perioperatively, cMIS patients had lower intraoperative blood loss and decreased use of cell saver across frailty groups (with adjustment for baseline age, CCI score, and levels fused), as well as fewer perioperative complications (p < 0.001). Adjusted analysis also revealed that compared to open patients, increasingly frail patients in the cMIS group were also more likely to demonstrate greater improvement in 1- and 2-year postoperative scores for the Oswestry Disability Index, SRS-36 (total), EQ-5D and SF-36 (all p < 0.05). With regard to postoperative complications, increasingly frail patients in the cMIS group were also noted to experience significantly fewer complications overall (p = 0.036) and fewer major intraoperative complications (p = 0.039). The cMIS patients were also less likely to need a reoperation than their open group counterparts (p = 0.043). CONCLUSIONS: Surgery performed with a cMIS technique may offer acceptable outcomes, with diminishment of perioperative complications and mitigation of catastrophic outcomes, in increasingly frail patients who may not be candidates for surgery using traditional open techniques. However, further studies should be performed to investigate the long-term impact of less optimal alignment in this population.
Subject(s)
Frailty , Spinal Fusion , Humans , Adult , Female , Middle Aged , Aged , Adolescent , Male , Frailty/surgery , Treatment Outcome , Retrospective Studies , Spinal Fusion/methods , Minimally Invasive Surgical Procedures/methods , Postoperative Complications/epidemiology , Postoperative Complications/etiologyABSTRACT
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Assess whether modifying spinal alignment goals to accommodate frailty considerations will decrease mechanical complications and maximize clinical outcomes. SUMMARY OF BACKGROUND DATA: The Global Alignment and Proportion (GAP) score was developed to assist in reducing mechanical complications, but has had less success predicting such events in external validation. Higher frailty and many of its components have been linked to the development of implant failure. Therefore, modifying the GAP score with frailty may strengthen its ability to predict mechanical complications. MATERIALS AND METHODS: We included 412 surgical ASD patients with two-year follow-up. Frailty was quantified using the modified Adult Spinal Deformity Frailty Index (mASD-FI). Outcomes: proximal junctional kyphosis and proximal junctional failure (PJF), major mechanical complications, and "Best Clinical Outcome" (BCO), defined as Oswestry Disability Index<15 and Scoliosis Research Society 22-item Questionnaire Total>4.5. Logistic regression analysis established a six-week score based on GAP score, frailty, and Oswestry Disability Index US Norms. Logistic regression followed by conditional inference tree analysis generated categorical thresholds. Multivariable logistic regression analysis controlling for confounders was used to assess the performance of the frailty-modified GAP score. RESULTS: Baseline frailty categories: 57% not frail, 30% frail, 14% severely frail. Overall, 39 of patients developed proximal junctional kyphosis, 8% PJF, 21% mechanical complications, 22% underwent reoperation, and 15% met BCO. The mASD-FI demonstrated a correlation with developing PJF, mechanical complications, undergoing reoperation, and meeting BCO at two years (all P <0.05). Regression analysis generated the following equation: Frailty-Adjusted Realignment Score (FAR Score)=0.49×mASD-FI+0.38×GAP Score. Thresholds for the FAR score (0-13): proportioned: <3.5, moderately disproportioned: 3.5-7.5, severely disproportioned: >7.5. Multivariable logistic regression assessing FAR score demonstrated associations with mechanical complications, reoperation, and meeting BCO by two years (all P <0.05), whereas the original GAP score was only significant for reoperation. CONCLUSION: This study demonstrated adjusting alignment goals in adult spinal deformity surgery for a patient's baseline frailty status and disability may be useful in minimizing the risk of complications and adverse events, outperforming the original GAP score in terms of prognostic capacity. LEVEL OF EVIDENCE: III.
Subject(s)
Frailty , Kyphosis , Spinal Fusion , Humans , Adult , Retrospective Studies , Frailty/diagnosis , Frailty/epidemiology , Frailty/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Spinal Fusion/adverse effects , Kyphosis/surgery , Kyphosis/etiologyABSTRACT
Vertebral osteomyelitis (VOM), which includes the clinical entities of spinal osteomyelitis, spondylodiscitis, or pyogenic spondylitis, describes a complex inflammatory reaction within the vertebral column in the setting of microbial infection [...].