Browsing by Subject "spine deformity"

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    ItemOpen Access
    Clinical outcomes and proximal junctional failure in adult spinal deformity patients corrected to normative alignment versus functional alignment.
    (Journal of neurosurgery. Spine, 2023-07) Protopsaltis, Themistocles S; Ani, Fares; Soroceanu, Alexandra; Lafage, Renaud; Kim, Han Jo; Balouch, Eaman; Norris, Zoe; Smith, Justin S; Daniels, Alan H; Klineberg, Eric O; Ames, Christopher P; Hart, Robert; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lenke, Lawrence G; Lafage, Virginie; Gupta, Munish C

    Objective

    The objective of this study was to explore the rate of proximal junctional failure (PJF) and functional outcomes of normative alignment goals compared with alignment targets based on age-appropriate physical function.

    Methods

    Baseline relationships between age, pelvic incidence (PI), and a component of the T1 pelvic angle (TPA) within the fusion were analyzed in adult spinal deformity (ASD) patients and compared with those of asymptomatic patients. Linear regression modeling was used to determine alignment based on PI and age in asymptomatic patients (normative alignment), and in ASD patients, alignment corresponding to age-appropriate functional status (functional alignment). A cohort of 288 ASD patients was split into two groups based on whether the patient was closer to their normative or functional alignment goal at their 6-week postoperative radiographic follow-up. The rates of proximal junctional kyphosis (PJK) and PJF were determined for each cohort.

    Results

    In the 288 ASD patients included in this pre- to postoperative analysis, there was no difference in baseline alignment or health-related quality of life (HRQOL) between the normative alignment and functional alignment groups. At 6 weeks, patients with normative alignment had a smaller TPA (4.45° vs 14.1°) and PI minus lumbar lordosis (-7.24° vs 7.4°) (both p < 0.0001) and higher PJK (40% vs 27.2%, p = 0.03) and PJF (17% vs 6.8%, p = 0.008) rates than patients with functional alignment.

    Conclusions

    Correction in ASD patients to normative alignment resulted in higher rates of PJK and PJF without improvements in HRQOL. Correction in ASD patients to functional alignment that mirrors the physical function of their age-matched asymptomatic peers is recommended.
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    Determining the best vertebra for measuring pelvic incidence and spinopelvic parameters in adult spinal deformity patients with transitional anatomy.
    (Journal of neurosurgery. Spine, 2023-10) Ani, Fares; Protopsaltis, Themistocles S; Parekh, Yesha; Odeh, Khalid; Lafage, Renaud; Smith, Justin S; Eastlack, Robert K; Lenke, Lawrence; Schwab, Frank; Mundis, Gregory M; Gupta, Munish C; Klineberg, Eric O; Lafage, Virginie; Hart, Robert; Burton, Douglas; Ames, Christopher P; Shaffrey, Christopher I; Bess, Shay

    Objective

    The aim of this study was to determine if spinal deformity patients with L5 sacralization should have pelvic incidence (PI) and other spinopelvic parameters measured from the L5 or S1 endplate.

    Methods

    This study was a multicenter retrospective comparative cohort study comprising a large database of adult spinal deformity (ASD) patients and a database of asymptomatic individuals. Linear regression modeling was used to determine normative T1 pelvic angle (TPA) and PI - lumbar lordosis (LL) mismatch (PI-LL) based on PI and age in a database of asymptomatic subjects. In an ASD database, patients with radiographic evidence of L5 sacralization had the PI, LL, and TPA measured from the superior endplate of S1 and then also from L5. The differences in TPA and PI-LL from normative were calculated in the sacralization cohort relative to L5 and S1 and correlated to the Oswestry Disability Index (ODI). Patients were grouped based on the Scoliosis Research Society (SRS)-Schwab PI-LL modifier (0, +, or ++) using the L5 PI-LL and S1 PI-LL. Baseline ODI and SF-36 Physical Component Summary (PCS) scores were compared across and within groups.

    Results

    Among 1179 ASD patients, 276 (23.4%) had transitional anatomy, 176 with sacralized L5 (14.9%) and 100 (8.48%) with lumbarization of S1. The 176 patients with sacralized L5 were analyzed. When measured using the L5 superior endplate, pelvic parameters were significantly smaller than those measured relative to S1 (PI: 24.5° ± 11.0° vs 55.7° ± 12.0°, p = 0.001;TPA: 11.2° ± 12.0° vs 20.3° ± 12.5°, p = 0.001; and PI-LL: 0.67° ± 21.1° vs 11.4° ± 20.8°, p = 0.001). When measured from S1, 76 (43%), 45 (25.6%), and 55 (31.3%) patients had SRS-Schwab PI-LL modifiers of 0, +, and ++, respectively, compared with 124 (70.5%), 22 (12.5%), and 30 (17.0%), respectively, when measured from L5. There were significant differences in ODI and PCS scores as the SRS-Schwab grade increased regardless of L5 or S1 measurement. The L5 group had lower PCS functional scores for SRS-Schwab modifiers 0 and ++ relative to same grades in the S1 group. Offset from normative TPA (0.5° ± 11.1° vs 9.6° ± 10.8°, p = 0.001) and PI-LL (4.5° ± 20.4° vs 15.2° ± 19.3°, p = 0.001) were smaller when measuring from L5. Moreover, S1 measurements were more correlated with health status by ODI (TPA offset from normative: S1, R = 0.326 vs L5, R = 0.285; PI-LL offset from normative: S1, R = 0.318 vs L5, R = 0.274).

    Conclusions

    Measuring the PI and spinopelvic parameters at L5 in sacralized anatomy results in underestimating spinal deformity and is less correlated with health-related quality of life. Surgeons may consider measuring PI and spinopelvic parameters relative to S1 rather than at L5 in patients with a sacralized L5.
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    Failure of nonoperative care in adult symptomatic lumbar scoliosis: incidence, timing, and risk factors for conversion from nonoperative to operative treatment.
    (Journal of neurosurgery. Spine, 2023-06) Clohisy, John CF; Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; LaBore, Adam; Pham, Vy; Bridwell, Keith H

    Objective

    The Adult Symptomatic Lumbar Scoliosis (ASLS) study is a prospective multicenter trial with randomized and observational cohorts comparing operative and nonoperative treatment for ASLS. The objective of the present study was to perform a post hoc analysis of the ASLS trial to examine factors related to failure of nonoperative treatment in ASLS.

    Methods

    Patients from the ASLS trial who initially received at least 6 months of nonoperative treatment were followed for up to 8 years after trial enrollment. Baseline patient-reported outcome measures (Scoliosis Research Society-22 [SRS-22] questionnaire and Oswestry Disability Index), radiographic data, and other clinical characteristics were compared between patients who did and did not convert to operative treatment during follow-up. The incidence of operative treatment was calculated and independent predictors of operative treatment were identified using multivariate regression.

    Results

    Of 135 nonoperative patients, 42 (31%) crossed over to operative treatment after 6 months and 93 (69%) received only nonoperative treatment. In the observational cohort, 23 (22%) of 106 nonoperative patients crossed over to surgery. In the randomized cohort, 19 (66%) of 29 patients randomized to nonoperative treatment crossed over to surgery. The most impactful factors associated with crossover from nonoperative to operative treatment were enrollment in the randomized cohort and baseline SRS-22 subscore < 3.0 at the 2-year follow-up, closer to 3.4 at 8 years. In addition, baseline lumbar lordosis (LL) < 50° was associated with crossover to operative treatment. Each 1-point decrease in baseline SRS-22 subscore was associated with a 233% higher risk of conversion to surgery (hazard ratio [HR] 2.33, 95% confidence interval [CI] 1.14-4.76, p = 0.0212). Each 10° decrease in LL was associated with a 24% increased risk of conversion to operative treatment (HR 1.24, 95% CI 1.03-1.49, p = 0.0232). Enrollment in the randomized cohort was associated with a 337% higher probability of proceeding with operative treatment (HR 3.37, 95% CI 1.54-7.35, p = 0.0024).

    Conclusions

    Enrollment in the randomized cohort, a lower baseline SRS-22 subscore, and lower LL were associated with conversion from nonoperative treatment to surgery in patients (observational and randomized) who were initially managed nonoperatively in the ASLS trial.
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    Impact of congestive heart failure on patients undergoing lumbar spine fusion for adult spine deformity.
    (Journal of craniovertebral junction & spine, 2024-01) Onafowokan, Oluwatobi O; Ahmad, Waleed; McFarland, Kimberly; Williamson, Tyler K; Tretiakov, Peter; Mir, Jamshaid M; Das, Ankita; Bell, Joshua; Naessig, Sara; Vira, Shaleen; Lafage, Virginie; Paulino, Carl; Diebo, Bassel; Schoenfeld, Andrew; Hassanzadeh, Hamid; Jankowski, Pawel P; Hockley, Aaron; Passias, Peter Gust

    Background

    With the increasing amount of elective spine fusion patients presenting with cardiac disease and congestive heart failure, it is becoming difficult to assess when it is safe to proceed with surgery. Assessing the severity of heart failure (HF) through ejection fraction may provide insight into patients' short- and long-term risks.

    Purpose

    The purpose of this study was to assess the severity of HF on perioperative outcomes of spine fusion surgery patients.

    Study design/setting

    This was a retrospective cohort study of the PearlDiver database.

    Patient sample

    We enrolled 670,526 patients undergoing spine fusion surgery.

    Outcome measures

    Thirty-day and 90-day complication rates, discharge destination, length of stay (LOS), physician reimbursement, and hospital costs.

    Methods

    Patients undergoing elective spine fusion surgery were isolated and stratified by preoperative HF with preserved ejection fraction (P-EF) or reduced ejection fraction (R-EF) (International Classification of Diseases-9: 428.32 [chronic diastolic HF] and 428.22 [chronic systolic HF]). Means comparison tests (Chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, comorbidities, procedural characteristics, LOS, 30-day and 90-day complication outcomes, and total hospital charges between those diagnosed with P-EF and those not R-EF. Binary logistic regression assessed the odds of complication associated with HF, controlling for levels fused (odds ratio [OR] [95% confidence interval]). Statistical significance was set at P < 0.05.

    Results

    Totally 670,526 elective spine fusion patients were included. Four thousand and seventy-seven were diagnosed with P-EF and 2758 R-EF. Overall, P-EF patients presented with higher rates of morbid obesity, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and hypertension (all P < 0.001). In relation to No-HF, P-EF patients had higher rates of 30-day major complications including pulmonary embolism, pneumonia, cerebrovascular accident (CVA), myocardial infarctions (MI), sepsis, and death (all P < 0.001). Furthermore, P-EF was associated significantly with increased odds of pneumonia (OR: 2.07 [1.64-2.56], P < 0.001) and sepsis (OR: 2.09 [1.62-2.66], P < 0.001). Relative to No-HF, R-EF was associated with significantly higher odds of MI (OR: 3.66 [2.34-5.47]), CVA (OR: 2.70 [1.67-4.15]), and pneumonia (OR: 1.85 [1.40-2.40]) (all P < 0.001) postoperative within 30 days. Adjusting for prior history of MI, CAD, and the presence of a pacemaker R-EF was a significant predictor of an MI 30 days postoperatively (OR: 2.2 [1.14-4.32], P = 0.021). Further adjusting for history of CABG or stent placement, R-EF was associated with higher odds of CVA (OR: 2.11 [1.09-4.19], P = 0.028) and MI (OR: 2.27 [1.20-4.43], P = 0.013).

    Conclusions

    When evaluating the severity of HF before spine surgery, R-EF was associated with a higher risk of major complications, especially the occurrence of a myocardial infarction 30 days postoperatively. During preoperative risk assessment, congestive HF should be considered thoroughly when thinking of postoperative outcomes with emphasis on R-EF.
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    Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.
    (Journal of neurosurgery. Spine, 2021-04) Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Buell, Thomas J; Lurie, Jon D; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Lafage, Virginie; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Shaffrey, Christopher I; Bridwell, Keith H

    Objective

    Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.

    Methods

    The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.

    Results

    The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.

    Conclusions

    The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.
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    ItemOpen Access
    Patient-reported outcome measure clustering after surgery for adult symptomatic lumbar scoliosis.
    (Journal of neurosurgery. Spine, 2022-01) Wondra, James P; Kelly, Michael P; Yanik, Elizabeth L; Greenberg, Jacob K; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Lenke, Lawrence G; Bridwell, Keith

    Objective

    Adult symptomatic lumbar scoliosis (ASLS) is a widespread and debilitating subset of adult spinal deformity. Although many patients benefit from operative treatment, surgery entails substantial cost and risk for adverse events. Patient-reported outcome measures (PROMs) are patient-centered tools used to evaluate the appropriateness of surgery and to assist in the shared decision-making process. Framing realistic patient expectations should include the possible functional limitation to improvement inherent in surgical intervention, such as multilevel fusion to the sacrum. The authors' objective was to predict postoperative ASLS PROMs by using clustering analysis, generalized longitudinal regression models, percentile analysis, and clinical improvement analysis of preoperative health-related quality-of-life scores for use in surgical counseling.

    Methods

    Operative results from the combined ASLS cohorts were examined. PROM score clustering after surgery investigated limits of surgical improvement. Patients were categorized by baseline disability (mild, moderate, moderate to severe, or severe) according to preoperative Scoliosis Research Society (SRS)-22 and Oswestry Disability Index (ODI) scores. Responder analysis for patients achieving improvement meeting the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) standards was performed using both fixed-threshold and patient-specific values (MCID = 30% of remaining scale, SCB = 50%). Best (top 5%), worst (bottom 5%), and median scores were calculated across disability categories.

    Results

    A total of 171/187 (91%) of patients with ASLS achieved 2-year follow-up. Patients rarely achieved a PROM ceiling for any measure, with 33%-43% of individuals clustering near 4.0 for SRS domains. Patients with severe baseline disability (< 2.0) SRS-pain and SRS-function scores were often left with moderate to severe disability (2.0-2.9), unlike patients with higher (≥ 3.0) initial PROM values. Patients with mild disability according to baseline SRS-function score were unlikely to improve. Crippling baseline ODI disability (> 60) commonly left patients with moderate disability (median ODI = 32). As baseline ODI disability increased, patients were more likely to achieve MCID and SCB (p < 0.001). Compared to fixed threshold values for MCID and SCB, patient-specific values were more sensitive to change for patients with minimal ODI baseline disability (p = 0.008) and less sensitive to change for patients with moderate to severe SRS subscore disability (p = 0.01).

    Conclusions

    These findings suggest that ASLS surgeries have a limit to possible improvement, probably due to both baseline disability and the effects of surgery. The most disabled patients often had moderate to severe disability (SRS < 3, ODI > 30) at 2 years, emphasizing the importance of patient counseling and expectation management.