Browsing by Author "Segreto, Frank"

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    ItemOpen Access
    Cost-utility analysis of cervical deformity surgeries using 1-year outcome.
    (The spine journal : official journal of the North American Spine Society, 2018-09) Poorman, Gregory W; Passias, Peter G; Qureshi, Rabia; Hassanzadeh, Hamid; Horn, Samantha; Bortz, Cole; Segreto, Frank; Jain, Amit; Kelly, Michael; Hostin, Richard; Ames, Christopher; Smith, Justin; LaFage, Virginie; Burton, Douglas; Bess, Shay; Shaffrey, Chris; Schwab, Frank; Gupta, Munish

    Background context

    Cost-utility analysis, a special case of cost-effectiveness analysis, estimates the ratio between the cost of an intervention to the benefit it produces in number of quality-adjusted life years. Cervical deformity correction has not been evaluated in terms of cost-utility and in the context of value-based health care. Our objective, therefore, was to determine the cost-utility ratio of cervical deformity correction.

    Study design

    This is a retrospective review of a prospective, multicenter cervical deformity database. Patients with 1-year follow-up after surgical correction for cervical deformity were included. Cervical deformity was defined as the presence of at least one of the following: kyphosis (C2-C7 Cobb angle >10°), cervical scoliosis (coronal Cobb angle >10°), positive cervical sagittal malalignment (C2-C7 sagittal vertical axis >4 cm or T1-C6 >10°), or horizontal gaze impairment (chin-brow vertical angle >25°). Quality-adjusted life years were calculated by both EuroQol 5D (EQ5D) quality of life and Neck Disability Index (NDI) mapped to short form six dimensions (SF6D) index. Costs were assigned using Medicare 1-year average reimbursement for: 9+ level posterior fusions (PF), 4-8 level PF, 4-8 level PF with anterior fusion (AF), 2-3 level PF with AF, 4-8 level AF, and 4-8 level posterior refusion. Reoperations and deaths were added to cost and subtracted from utility, respectively. Quality-adjusted life year per dollar spent was calculated using standardized methodology at 1-year time point and subsequent time points relying on maintenance of 1-year utility.

    Results

    Eighty-four patients (average age: 61.2 years, 60% female, body mass index [BMI]: 30.1) were analyzed after cervical deformity correction (average levels fused: 7.2, osteotomy used: 50%). Costs associated with index procedures were 9+ level PF ($76,617), 4-8 level PF ($40,596), 4-8 level PF with AF ($67,098), 4-8 level AF ($31,392), and 4-8 level posterior refusion ($35,371). Average 1-year reimbursement of surgery was $55,097 at 1 year with eight revisions and three deaths accounted for. Cost per quality-adjusted life year (QALY) gained to 1-year follow-up was $646,958 by EQ5D and $477,316 by NDI SF6D. If 1-year benefit is sustained, upper threshold of cost-effectiveness is reached 3-4.5 years after intervention.

    Conclusions

    Medicare 1-year average reimbursement compared with 1-year QALYdescribed $646,958 by EQ5D and $477,316 by NDI SF6D. Cervical deformity surgeries reach accepted cost-effectiveness thresholds when benefit is sustained 3-4.5 years. Longer follow-up is needed for a more definitive cost-analysis, but these data are an important first step in justifying cost-utility ratio for cervical deformity correction.
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    ItemOpen Access
    Drivers of Cervical Deformity Have a Strong Influence on Achieving Optimal Radiographic and Clinical Outcomes at 1 Year After Cervical Deformity Surgery.
    (World neurosurgery, 2018-04) Passias, Peter G; Bortz, Cole; Horn, Samantha; Segreto, Frank; Poorman, Gregory; Jalai, Cyrus; Daniels, Alan; Hamilton, D Kojo; Kim, Han Jo; Sciubba, Daniel; Smith, Justin S; Neuman, Brian; Shaffrey, Christopher; Lafage, Virginie; Lafage, Renaud; Protopsaltis, Themistocles; Ames, Christopher; Hart, Robert; Mundis, Gregory; Eastlack, Robert; International Spine Study Group
    The primary driver (PD) of cervical malalignment is important in characterizing cervical deformity (CD) and should be included in fusion to achieve alignment and quality-of-life goals. This study aims to define how PDs improve understanding of the mechanisms of CD and assesses the impact of driver region on realignment/outcomes.Inclusion: radiographic CD, age >18 years, 1 year follow-up. PD apex was classified by spinal region: cervical, cervicothoracic junction (CTJ), thoracic, or spinopelvic by a panel of spine deformity surgeons. Primary analysis evaluated PD groups meeting alignment goals (by Ames modifiers cervical sagittal vertical axis/T1 slope minus cervical lordosis/chin-brow vergical angle/modified Japanese Orthopaedics Association questionnaire) and health-related quality of life (HRQL) goals (EuroQol-5 Dimensions questionnaire/Neck Disability Index/modified Japanese Orthopaedics Association questionnaire) using t tests. Secondary analysis grouped interventions by fusion constructs including the primary or secondary apex based on lowest instrumented vertebra: cervical, lowest instrumented vertebra (LIV) ≤C7; CTJ, LIV ≤T3; and thoracic, LIV ≤T12.A total of 73 patients (mean age, 61.8 years; 59% female) were evaluated with the following PDs of their sagittal cervical deformity: cervical, 49.3%; CTJ, 31.5%; thoracic, 13.7%; and spinopelvic, 2.7%. Cervical drivers (n = 36) showed the greatest 1-year postoperative cervical and global alignment changes (improvement in T1S, CL, C0-C2, C1 slope). Thoracic drivers were more likely to have persistent severe T1 slope minus cervical lordosis modifier grade at 1 year (0, 20.0%; +, 0.0%; ++, 80.0%). Cervical deformity modifiers tended to improve in cervical patients whose construct included the PD apex (included, 26%; not, 0%; P = 0.068). Thoracic and cervicothoracic PD apex patients did not improve in HRQL goals when PD apex was not treated.CD structural drivers have an important effect on treatment and 1-year postoperative outcomes. Cervical or thoracic drivers not included in the construct result in residual deformity and inferior HRQL goals. These factors should be considered when discussing treatment plans for patients with CD.
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    Effect of Obesity on Radiographic Alignment and Short-Term Complications After Surgical Treatment of Adult Cervical Deformity.
    (World neurosurgery, 2019-05) Passias, Peter G; Poorman, Gregory W; Horn, Samantha R; Jalai, Cyrus M; Bortz, Cole; Segreto, Frank; Diebo, Bassel M; Daniels, Alan; Hamilton, D Kojo; Sciubba, Daniel; Smith, Justin; Neuman, Brian; Shaffrey, Christopher I; LaFage, Virginie; LaFage, Renaud; Schwab, Frank; Bess, Shay; Ames, Christopher; Hart, Robert; Soroceanu, Alexandra; Mundis, Gregory; Eastlack, Robert; International Spine Study Group

    Objective

    We investigated the 30-day complication incidence and 1-year radiographic correction in obese patients undergoing surgical treatment of cervical deformity.

    Methods

    The patients were stratified according to World Health Organization's definition for obesity: obese, patients with a body mass index of ≥30 kg/m2; and nonobese, patients with a body mass index of <30 kg/m2. The patients had undergone surgery for the treatment of cervical deformity. The patient baseline demographic, comorbidity, and radiographic data were compared between the 2 groups at baseline and 1 year postoperatively. The 30-day complication incidence was stratified according to complication severity (any, major, or minor), and type (cardiopulmonary, dysphagia, infection, neurological, and operative). Binary logistic regression models were used to assess the effect of obesity on developing those complications, with adjustment for patient age and levels fused.

    Results

    A total of 124 patients were included, 53 obese and 71 nonobese patients. The 2 groups had a similar T1 slope minus cervical lordosis (obese, 37.2° vs. nonobese, 36.9°; P = 0.932) and a similar C2-C7 (-5.9° vs. -7.3°; P = 0.718) and C2-C7 (50.1 mm vs. 44.1 mm; P = 0.184) sagittal vertical axis. At the 1-year follow-up examination, the T1 pelvic angle (1.0° vs. -3.1°; P = 0.021) and C2-S1 sagittal vertical axis (-5.9 mm vs. -35.0 mm; P = 0.036) were different, and the T1 spinopelvic inclination (-1.0° vs. -2.9°; P = 0.123) was similar. The obese patients had a greater risk of overall short-term complications (odds ratio, 2.5; 95% confidence interval, 1.1-6.1) and infectious complications (odds ratio, 5.0; 95% confidence interval, 1.0-25.6).

    Conclusions

    Obese patients had a 5 times greater odds of developing infections after surgery for adult cervical deformity. Obese patients also showed significantly greater pelvic anteversion after cervical correction.
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    Identifying Subsets of Patients With Adult Spinal Deformity Who Maintained a Positive Response to Nonoperative Management.
    (Neurosurgery, 2023-03) Passias, Peter G; Ahmad, Waleed; Tretiakov, Peter; Krol, Oscar; Segreto, Frank; Lafage, Renaud; Lafage, Virginie; Soroceanu, Alex; Daniels, Alan; Gum, Jeffrey; Line, Breton; Schoenfeld, Andrew J; Vira, Shaleen; Hart, Robert; Burton, Douglas; Smith, Justin S; Ames, Christopher P; Shaffrey, Christopher; Schwab, Frank; Bess, Shay; International Spine Study Group

    Background

    Adult spinal deformity (ASD) represents a major cause of disability in the elderly population in the United States. Surgical intervention has been shown to reduce disability and pain in properly indicated patients. However, there is a small subset of patients in whom nonoperative treatment is also able to durably maintain or improve symptoms.

    Objective

    To examine the factors associated with successful nonoperative management in patients with ASD.

    Methods

    We retrospectively evaluated a cohort of 207 patients with nonoperative ASD, stratified into 3 groups: (1) success, (2) no change, and (3) failure. Success was defined as a gain in minimal clinically importance difference in both Oswestry Disability Index and Scoliosis Research Society-Pain. Logistic regression model and conditional inference decision trees established cutoffs for success according to baseline (BL) frailty and sagittal vertical axis.

    Results

    In our cohort, 44.9% of patients experienced successful nonoperative treatment, 22.7% exhibited no change, and 32.4% failed. Successful nonoperative patients at BL were significantly younger, had a lower body mass index, decreased Charlson Comorbidity Index, lower frailty scores, lower rates of hypertension, obesity, depression, and neurological dysfunction (all P < .05) and significantly higher rates of grade 0 deformity for all Schwab modifiers (all P < .05). Conditional inference decision tree analysis determined that patients with a BL ASD-frailty index ≤ 1.579 (odds ratio: 8.3 [4.0-17.5], P < .001) were significantly more likely to achieve nonoperative success.

    Conclusion

    Success of nonoperative treatment was more frequent among younger patients and those with less severe deformity and frailty at BL, with BL frailty the most important determinant factor. The factors presented here may be useful in informing preoperative discussion and clinical decision-making regarding treatment strategies.
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    Indicators for Nonroutine Discharge Following Cervical Deformity-Corrective Surgery: Radiographic, Surgical, and Patient-Related Factors.
    (Neurosurgery, 2019-09) Bortz, Cole A; Passias, Peter G; Segreto, Frank; Horn, Samantha R; Lafage, Virginie; Smith, Justin S; Line, Breton; Mundis, Gregory M; Kebaish, Khaled M; Kelly, Michael P; Protopsaltis, Themistocles; Sciubba, Daniel M; Soroceanu, Alexandra; Klineberg, Eric O; Burton, Douglas C; Hart, Robert A; Schwab, Frank J; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P

    Background

    Nonroutine discharge, including discharge to inpatient rehab and skilled nursing facilities, is associated with increased cost-of-care. Given the rising prevalence of cervical deformity (CD)-corrective surgery and the necessity of value-based healthcare, it is important to identify indicators for nonroutine discharge.

    Objective

    To identify factors associated with nonroutine discharge after CD-corrective surgery using a statistical learning algorithm.

    Methods

    A retrospective review of patients ≥18 yr with discharge and baseline (BL) radiographic data. Conditional inference decision trees identified factors associated with nonroutine discharge and cut-off points at which factors were significantly associated with discharge status. A conditional variable importance table used nonreplacement sampling set of 10 000 conditional inference trees to identify influential patient/surgical factors. The binary logistic regression indicated odds of nonroutine discharge for patients with influential factors at significant cut-off points.

    Results

    Of 138 patients (61 yr, 63% female) undergoing surgery for CD (8 ± 5 levels; 49% posterior approach, 16% anterior, and 35% combined), 29% experienced nonroutine discharge. BL cervical/upper-cervical malalignment showed the strongest relationship with nonroutine discharge: C1 slope ≥ 14°, C2 slope ≥ 57°, TS-CL ≥ 57°. Patient-related factors associated with nonroutine discharge included BL gait impairment, age ≥ 59 yr and apex of CD primary driver ≥ C7. The only surgical factor associated with nonroutine discharge was fusion ≥ 8 levels. There was no relationship between nonhome discharge and reoperation within 6 mo or 1 yr (both P > .05) of index procedure. Despite no differences in BL EQ-5D (P = .946), nonroutine discharge patients had inferior 1-yr postoperative EQ-5D scores (P = .044).

    Conclusion

    Severe preoperative cervical malalignment was strongly associated with nonroutine discharge following CD-corrective surgery. Age, deformity driver, and ≥ 8 level fusions were also associated with nonroutine discharge and should be taken into account to improve patient counseling and health care resource allocation.
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    Limited morbidity and possible radiographic benefit of C2 vs. subaxial cervical upper-most instrumented vertebrae
    (Journal of Spine Surgery, 2019-06-29) Passias, Peter G; Bortz, Cole A; Segreto, Frank; Horn, Samantha; Pierce, Katherine E; Alas, Haddy; Brown, Avery E; Lafage, Renaud; Lafage, Virginie; Smith, Justin S; Line, Breton; Eastlack, Robert; Sciubba, Daniel M; Klineberg, Eric O; Soroceanu, Alexandra; Burton, Douglas C; Schwab, Frank J; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P
    Background: The study aims to evaluate differences in alignment and clinical outcomes between surgical cervical deformity (CD) patients with a subaxial upper-most instrumented vertebra (UIV) and patients with a UIV at C2. Use of CD-corrective instrumentation in the subaxial cervical spine is considered risky due to narrow subaxial pedicles and vertebral artery anatomy. While C2 fixation provides increased stability, the literature lacks guidelines indicating extension of CD-corrective fusion from the subaxial spine to C2. Methods: Included: operative CD patients with baseline (BL) and 1-year postop (1Y) radiographic data, cervical UIV ≥ C2. Patients were grouped by UIV: C2 or subaxial (C3-C7) and propensity score matched (PSM) for BL cSVA. Mean comparison tests assessed differences in BL and 1Y patient-related, radiographic, and surgical data between UIV groups, and BL-1Y changes in alignment and clinical outcomes. Results: Following PSM, 31 C2 UIV and 31 subaxial UIV patients undergoing CD-corrective surgery were included. Groups did not differ in BL comorbidity burden (P=0.175) or cSVA (P=0.401). C2 patients were older (64 vs. 58 yrs, P=0.010) and had longer fusions (9 vs. 6 levels, P=0.002). Overall, patients showed BL-1Y improvements in TS-CL (P<0.001), cSVA (P=0.005), McGS (P=0.004). Cervical flexibility was maintained at 1Y regardless of UIV, assessed by CL flexion (−0.2° vs. 6.0°, P=0.115) and extension (13.9° vs. 9.9°, P=0.366). While both subaxial and C2 patients showed BL-1Y improvements in McGS (both P<0.030), C2 patients improved to a larger degree (7.3° vs. 6.2°). Between UIV groups, there were no differences in BL-1Y changes in HRQLs, overall complication rates, or operative complication rates (all P>0.05). Conclusions: C2 UIV patients showed similar cervical range of motion and baseline to 1-year functional outcomes as patients with a subaxial UIV. C2 UIV patients also showed greater baseline to 1-year horizontal gaze improvement and had complication profiles similar to subaxial UIV patients, demonstrating the radiographic benefit and minimal functional loss associated with extending fusion constructs to C2. In the treatment of adult cervical deformities, extension of the reconstruction construct to the axis may allow for certain clinical benefits with less morbidity than previously acknowledged.
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    Predictive model for achieving good clinical and radiographic outcomes at one-year following surgical correction of adult cervical deformity.
    (Journal of craniovertebral junction & spine, 2021-07) Passias, Peter Gust; Horn, Samantha R; Oh, Cheongeun; Poorman, Gregory W; Bortz, Cole; Segreto, Frank; Lafage, Renaud; Diebo, Bassel; Scheer, Justin K; Smith, Justin S; Shaffrey, Christopher I; Eastlack, Robert; Sciubba, Daniel M; Protopsaltis, Themistocles; Kim, Han Jo; Hart, Robert A; Lafage, Virginie; Ames, Christopher P; International Spine Study Group

    Background

    For cervical deformity (CD) surgery, goals include realignment, improved patient quality of life, and improved clinical outcomes. There is limited research identifying patients most likely to achieve all three.

    Objective

    The objective is to create a model predicting good 1-year postoperative realignment, quality of life, and clinical outcomes following CD surgery using baseline demographic, clinical, and radiographic factors.

    Methods

    Retrospective review of a multicenter CD database. CD patients were defined as having one of the following radiographic criteria: Cervical sagittal vertical axis (cSVA) >4 cm, cervical kyphosis/scoliosis >10°° or chin-brow vertical angle >25°. The outcome assessed was whether a patient achieved both a good radiographic and clinical outcome. The primary analysis was stepwise regression models which generated a dataset-specific prediction model for achieving a good radiographic and clinical outcome. Model internal validation was achieved by bootstrapping and calculating the area under the curve (AUC) of the final model with 95% confidence intervals.

    Results

    Seventy-three CD patients were included (61.8 years, 58.9% F). The final model predicting the achievement of a good overall outcome (radiographic and clinical) yielded an AUC of 73.5% and included the following baseline demographic, clinical, and radiographic factors: mild-moderate myelopathy (Modified Japanese Orthopedic Association >12), no pedicle subtraction osteotomy, no prior cervical spine surgery, posterior lowest instrumented vertebra (LIV) at T1 or above, thoracic kyphosis >33°°, T1 slope <16 and cSVA <20 mm.

    Conclusions

    Achievement of a positive outcome in radiographic and clinical outcomes following surgical correction of CD can be predicted with high accuracy using a combination of demographic, clinical, radiographic, and surgical factors, with the top factors being baseline cSVA <20 mm, no prior cervical surgery, and posterior LIV at T1 or above.
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    Predictive model for distal junctional kyphosis after cervical deformity surgery.
    (The spine journal : official journal of the North American Spine Society, 2018-12) Passias, Peter G; Vasquez-Montes, Dennis; Poorman, Gregory W; Protopsaltis, Themistocles; Horn, Samantha R; Bortz, Cole A; Segreto, Frank; Diebo, Bassel; Ames, Chris; Smith, Justin; LaFage, Virginie; LaFage, Renaud; Klineberg, Eric; Shaffrey, Chris; Bess, Shay; Schwab, Frank; ISSG

    Background context

    Distal junctional kyphosis (DJK) is a primary concern of surgeons correcting cervical deformity. Identifying patients and procedures at higher risk of developing this condition is paramount in improving patient selection and care.

    Purpose

    The present study aimed to develop a risk index for DJK development in the first year after surgery.

    Study design/setting

    This is a retrospective review of a prospective multicenter cervical deformity database.

    Patient sample

    Patients over the age of 18 meeting one of the following deformities were included in the study: cervical kyphosis (C2-7 Cobb angle>10°), cervical scoliosis (coronal Cobb angle>10°), positive cervical sagittal imbalance (C2-C7 sagittal vertical axis (SVA)>4 cm or T1-C6>10°), or horizontal gaze impairment (chin-brow vertical angle>25°).

    Outcome measures

    Development of DJK at any time before 1 year.

    Methods

    Distal junctional kyphosis was defined by both clinical diagnosis (by enrolling surgeon) and post hoc identification of development of an angle<-10° from the end of fusion construct to the second distal vertebra, as well as a change in this angle by <-10° from baseline. Conditional Inference Decision Trees were used to identify factors predictive of DJK incidence and the cut-off points at which they have an effect. A conditional Variable-Importance table was constructed based on a non-replacement sampling set of 2,000 Conditional Inference Trees. Twelve influencing factors were found; binary logistic regression for each variable at significant cutoffs indicated their effect size.

    Results

    Statistical analysis included 101 surgical patients (average age: 60.1 years, 58.3% female, body mass index: 30.2) undergoing long cervical deformity correction (mean levels fused: 7.1, osteotomy used: 49.5%, approach: 46.5% posterior, 17.8% anterior, 35.7% combined). In 2 years after surgery, 6% of patients were diagnosed with clinical DJK; however, 23.8% of patients met radiographic definition for DJK. Patients with neurologic symptoms were at risk of DJK (odds ratio [OR]: 3.71, confidence interval [CI]: 0.11-0.63). However, no significant relationship was found between osteoporosis, age, and ambulatory status with DJK incidence. Baseline radiographic malalignments were the most numerous and strong predictors for DJK: (1) C2-T1 tilt>5.33 (OR: 6.94, CI: 2.99-16.14); (2) kyphosis<-50.6° (OR: 5.89, CI: 0.07-0.43); (3) C2-C7 lordosis<-12° (OR: 5.7, CI: 0.08-0.41); (4) T1 slope minus cervical lordosis>36.4 (OR: 5.6, CI: 2.28-13.57); (5) C2-C7 SVA>56.3° (OR: 5.4, CI: 2.20-13.23); and (6) C4_Tilt>56.7 (OR: 5.0, CI: 1.90-13.1). Clinically, combined approaches (OR: 2.67, CI: 1.21-5.89) and usage of Smith-Petersen osteotomy (OR: 2.55, CI: 1.02-6.34) were the most important predictors of DJK.

    Conclusions

    In a surgical cohort of patients with cervical deformity, we found a 23.8% incidence of DJK. Different procedures and patient malalignment predicted incidence of DJK up to 1 year. Preoperative T1 slope-cervical lordosis, cervical kyphosis, SVA, and cervical lordosis all strongly predicted DJK at specific cut-off points. Knowledge of these factors will potentially help direct future study and strategy aimed at minimizing this potentially dramatic occurrence.