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Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames, and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

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Yoji Ogura, Jeffrey L. Gum, Alex Soroceanu, Alan H. Daniels, Breton Line, Themistocles Protopsaltis, Richard A. Hostin, Peter G. Passias, Douglas C. Burton, Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Renaud Lafage, Eric O. Klineberg, Han Jo Kim, Andrew Harris, Khaled Kebaish, Frank Schwab, Shay Bess, Christopher P. Ames, Leah Y. Carreon, and the International Spine Study Group (ISSG)

OBJECTIVE

The shared decision-making (SDM) process provides an opportunity to answer frequently asked questions (FAQs). The authors aimed to present a concise list of answers to FAQs to aid in SDM for adult spinal deformity (ASD) surgery.

METHODS

From a prospective, multicenter ASD database, patients enrolled between 2008 and 2016 who underwent fusions of 5 or more levels with a minimum 2-year follow-up were included. All deformity types were included to provide general applicability. The authors compiled a list of FAQs from patients undergoing ASD surgery and used a retrospective analysis to provide answers. All responses are reported as either the means or the proportions reaching the minimal clinically important difference at the 2-year follow-up interval.

RESULTS

Of 689 patients with ASD who were eligible for 2-year follow-up, 521 (76%) had health-related quality-of-life scores available at the time of that follow-up. The mean age at the initial surgery was 58.2 years, and 78% of patients were female. The majority (73%) underwent surgery with a posterior-only approach. The mean number of fused levels was 12.2. Revision surgery accounted for 48% of patients. The authors answered 12 FAQs as follows:

1. Will my pain improve? Back and leg pain will both be reduced by approximately 50%.

2. Will my activity level improve? Approximately 65% of patients feel improvement in their activity level.

3. Will I feel better about myself? More than 70% of patients feel improvement in their appearance.

4. Is there a chance I will get worse? 4.1% feel worse at 2 years postoperatively.

5. What is the likelihood I will have a complication? 67.8% will have a major or minor complication, with 47.8% having a major complication.

6. Will I need another surgery? 25.0% will have a reoperation within 2 years.

7. Will I regret having surgery? 6.5% would not choose the same treatment.

8. Will I get a blood transfusion? 73.7% require a blood transfusion.

9. How long will I stay in the hospital? You need to stay 8.1 days on average.

10. Will I have to go to the ICU? 76.0% will have to go to the ICU.

11. Will I be able to return to work? More than 70% will be working at 1 year postoperatively.

12. Will I be taller after surgery? You will be 1.1 cm taller on average.

CONCLUSIONS

The above list provides concise, practical answers to FAQs encountered in the SDM process while counseling patients for ASD surgery.

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Peter G. Passias, Haddy Alas, Sara Naessig, Han Jo Kim, Renaud Lafage, Christopher Ames, Eric Klineberg, Katherine Pierce, Waleed Ahmad, Douglas Burton, Bassel Diebo, Shay Bess, D. Kojo Hamilton, Munish Gupta, Paul Park, Breton Line, Christopher I. Shaffrey, Justin S. Smith, Frank Schwab, Virginie Lafage, and the International Spine Study Group

OBJECTIVE

The goal of this study was to assess the conversion rate from baseline cervical alignment to postoperative cervical deformity (CD) and the corresponding proximal junctional kyphosis (PJK) rate in patients undergoing thoracolumbar adult spinal deformity (ASD) surgery.

METHODS

The operative records of patients with ASD with complete radiographic data beginning at baseline up to 3 years were included. Patients with no baseline CD were postoperatively stratified by Ames CD criteria (T1 slope–cervical lordosis mismatch [TS-CL] > 20°, cervical sagittal vertical axis [cSVA] > 40 mm), where CD was defined as fulfilling one or more of the Ames criteria. Severe CD was defined as TS-CL > 30° or cSVA > 60 mm. Follow-up intervals were established after ASD surgery, with 6 weeks postoperatively defined as early; 6 weeks–1 year as intermediate; 1–2 years as late; and 2–3 years as long-term. Descriptive analyses and McNemar tests identified the CD conversion rate, PJK rate (< −10° change in uppermost instrumented vertebra and the superior endplate of the vertebra 2 levels superior to the uppermost instrumented vertebra), and specific alignment parameters that converted.

RESULTS

Two hundred sixty-six patients who underwent ASD surgery (mean age 59.7 years, 77.4% female) met the inclusion criteria; 103 of these converted postoperatively, and the remaining 163 did not meet conversion criteria. Thirty-eight patients converted to CD early, 26 converted at the intermediate time point, 29 converted late, and 10 converted in the long-term. At conversion, the early group had the highest mean TS-CL at 25.4° ± 8.5° and the highest mean cSVA at 33.6 mm—both higher than any other conversion group. The long-term group had the highest mean C2–7 angle at 19.7° and the highest rate of PJK compared to other groups (p = 0.180). The early group had the highest rate of conversion to severe CD, with 9 of 38 patients having severe TS-CL and only 1 patient per group converting to severe cSVA. Seven patients progressed from having only malaligned TS-CL at baseline (with normal cSVA) to CD with both malaligned TS-CL and cSVA by 6 weeks. Conversely, only 2 patients progressed from malaligned cSVA to both malaligned cSVA and TS-CL. By 1 year, the former number increased from 7 to 26 patients, and the latter increased from 2 to 20 patients. The revision rate was highest in the intermediate group at 48.0%, versus the early group at 19.2%, late group at 27.3%, and long-term group at 20% (p = 0.128). A higher pelvic incidence–lumbar lordosis mismatch, lower thoracic kyphosis, and a higher thoracic kyphosis apex immediately postoperatively significantly predicted earlier rather than later conversion (all p < 0.05). Baseline lumbar lordosis, pelvic tilt, and sacral slope were not significant predictors.

CONCLUSIONS

Patients with ASD with normative cervical alignment who converted to CD after thoracolumbar surgery had varying radiographic findings based on timing of conversion. Although the highest number of patients converted within 6 weeks postoperatively, patients who converted in the late or long-term follow-up intervals had higher rates of concurrent PJK and greater radiographic progression.

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Peter G. Passias, Haddy Alas, Shay Bess, Breton G. Line, Virginie Lafage, Renaud Lafage, Christopher P. Ames, Douglas C. Burton, Avery Brown, Cole Bortz, Katherine Pierce, Waleed Ahmad, Sara Naessig, Michael P. Kelly, Richard Hostin, Khaled M. Kebaish, Khoi D. Than, Pierce Nunley, Christopher I. Shaffrey, Eric O. Klineberg, Justin S. Smith, Frank J. Schwab, and the International Spine Study Group

OBJECTIVE

Patients with nonoperative (N-Op) adult spinal deformity (ASD) have inferior long-term spinopelvic alignment and clinical outcomes. Predictors of lower quality-of-life measures in N-Op populations have yet to be sufficiently investigated. The aim of this study was to identify patient-related factors and radiographic parameters associated with inferior health-related quality-of-life (HRQOL) scores in N-Op ASD patients.

METHODS

N-Op ASD patients with complete radiographic and outcome data at baseline and 2 years were included. N-Op patients and operative (Op) patients were propensity score matched for baseline disability and deformity. Patient-related factors and radiographic alignment parameters (pelvic tilt [PT], sagittal vertical axis [SVA], pelvic incidence [PI]–lumbar lordosis [LL] mismatch, mismatch between cervical lordosis and T1 segment slope [TS-CL], cervical-thoracic pelvic angle [PA], and others) at baseline and 2 years were analyzed as predictors for moderate to severe 2-year Oswestry Disability Index (ODI > 20) and failing to meet the minimal clinically importance difference (MCID) for 2-year Scoliosis Research Society Outcomes Questionnaire (SRS) scores (< 0.4 increase from baseline). Conditional inference decision trees identified predictors of each HRQOL measure and established cutoffs at which factors have a global effect. Random forest analysis (RFA) generated 5000 conditional inference trees to compute a variable importance table for top predictors of inferior HRQOL. Statistical significance was set at p < 0.05.

RESULTS

Six hundred sixty-two patients with ASD (331 Op patients and 331 N-Op patients) with complete radiographic and HRQOL data at their 2-year follow-up were included. There were no differences in demographics, ODI, and Schwab deformity modifiers between groups at baseline (all p > 0.05). N-Op patients had higher 2-year ODI scores (27.9 vs 20.3, p < 0.001), higher rates of moderate to severe disability (29.3% vs 22.4%, p = 0.05), lower SRS total scores (3.47 vs 3.91, p < 0.001), and higher rates of failure to reach SRS MCID (35.3% vs 15.7%, p < 0.001) than Op patients at 2 years. RFA ranked the top overall predictors for moderate to severe ODI at 2 years for N-Op patients as follows: 1) frailty index > 2.8, 2) BMI > 35 kg/m, T4PA > 28°, and 4) Charlson Comorbidity Index > 1. Top radiographic predictors were T4PA > 28° and C2–S1 SVA > 93 mm. RFA also ranked the top overall predictors for failure to reach 2-year SRS MCID for N-Op patients, as follows: 1) T12–S1 lordosis > 53°, 2) cervical SVA (cSVA) > 28 mm, 3) C2–S1 angle > 14.5°, 4) TS-CL > 12°, and 5) PT > 23°. The top radiographic predictors were T12–S1 Cobb angle, cSVA, C2–S1 angle, and TS-CL.

CONCLUSIONS

When controlling for baseline deformity in N-Op versus Op patients, subsequent deterioration in frailty, BMI, and radiographic progression over a 2-year follow-up were found to drive suboptimal patient-reported outcome measures in N-Op cohorts as measured by validated ODI and SRS clinical instruments.

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Justin S. Smith, Ellen Shaffrey, Eric Klineberg, Christopher I. Shaffrey, Virginie Lafage, Frank J. Schwab, Themistocles Protopsaltis, Justin K. Scheer, Gregory M. Mundis Jr., Kai-Ming G. Fu, Munish C. Gupta, Richard Hostin, Vedat Deviren, Khaled Kebaish, Robert Hart, Douglas C. Burton, Breton Line, Shay Bess, Christopher P. Ames, and The International Spine Study Group

Object

Improved understanding of rod fracture (RF) following adult spinal deformity (ASD) surgery could prove valuable for surgical planning, patient counseling, and implant design. The objective of this study was to prospectively assess the rates of and risk factors for RF following surgery for ASD.

Methods

This was a prospective, multicenter, consecutive series. Inclusion criteria were ASD, age > 18 years, ≥5 levels posterior instrumented fusion, baseline full-length standing spine radiographs, and either development of RF or full-length standing spine radiographs obtained at least 1 year after surgery that demonstrated lack of RF. ASD was defined as presence of at least one of the following: coronal Cobb angle ≥20°, sagittal vertical axis (SVA) ≥5 cm, pelvic tilt (PT) ≥25°, and thoracic kyphosis ≥60°.

Results

Of 287 patients who otherwise met inclusion criteria, 200 (70%) either demonstrated RF or had radiographic imaging obtained at a minimum of 1 year after surgery showing lack of RF. The patients' mean age was 54.8 ± 15.8 years; 81% were women; 10% were smokers; the mean body mass index (BMI) was 27.1 ± 6.5; the mean number of levels fused was 12.0 ± 3.8; and 50 patients (25%) had a pedicle subtraction osteotomy (PSO). The rod material was cobalt chromium (CC) in 53%, stainless steel (SS), in 26%, or titanium alloy (TA) in 21% of cases; the rod diameters were 5.5 mm (in 68% of cases), 6.0 mm (in 13%), or 6.35 mm (in 19%). RF occurred in 18 cases (9.0%) at a mean of 14.7 months (range 3–27 months); patients without RF had a mean follow-up of 19 months (range 12–24 months). Patients with RF were older (62.3 vs 54.1 years, p = 0.036), had greater BMI (30.6 vs 26.7, p = 0.019), had greater baseline sagittal malalignment (SVA 11.8 vs 5.0 cm, p = 0.001; PT 29.1° vs 21.9°, p = 0.016; and pelvic incidence [PI]–lumbar lordosis [LL] mismatch 29.6° vs 12.0°, p = 0.002), and had greater sagittal alignment correction following surgery (SVA reduction by 9.6 vs 2.8 cm, p < 0.001; and PI-LL mismatch reduction by 26.3° vs 10.9°, p = 0.003). RF occurred in 22.0% of patients with PSO (10 of the 11 fractures occurred adjacent to the PSO level), with rates ranging from 10.0% to 31.6% across centers. CC rods were used in 68% of PSO cases, including all with RF. Smoking, levels fused, and rod diameter did not differ significantly between patients with and without RF (p > 0.05). In cases including a PSO, the rate of RF was significantly higher with CC rods than with TA or SS rods (33% vs 0%, p = 0.010). On multivariate analysis, only PSO was associated with RF (p = 0.001, OR 5.76, 95% CI 2.01–15.8).

Conclusions

Rod fracture occurred in 9.0% of ASD patients and in 22.0% of PSO patients with a minimum of 1-year follow-up. With further follow-up these rates would likely be even higher. There was a substantial range in the rate of RF with PSO across centers, suggesting potential variations in technique that warrant future investigation. Due to higher rates of RF with PSO, alternative instrumentation strategies should be considered for these cases.

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Samantha R. Horn, Peter G. Passias, Cheongeun Oh, Virginie Lafage, Renaud Lafage, Justin S. Smith, Breton Line, Neel Anand, Frank A. Segreto, Cole A. Bortz, Justin K. Scheer, Robert K. Eastlack, Vedat Deviren, Praveen V. Mummaneni, Alan H. Daniels, Paul Park, Pierce D. Nunley, Han Jo Kim, Eric O. Klineberg, Douglas C. Burton, Robert A. Hart, Frank J. Schwab, Shay Bess, Christopher I. Shaffrey, Christopher P. Ames, and the International Spine Study Group

OBJECTIVE

Cervical deformity (CD) correction is clinically challenging. There is a high risk of developing complications with these highly complex procedures. The aim of this study was to use baseline demographic, clinical, and surgical factors to predict a poor outcome following CD surgery.

METHODS

The authors performed a retrospective review of a multicenter prospective CD database. CD was defined as at least one of the following: cervical kyphosis (C2–7 Cobb angle > 10°), cervical scoliosis (coronal Cobb angle > 10°), C2–7 sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle (CBVA) > 25°. Patients were categorized based on having an overall poor outcome or not. Health-related quality of life measures consisted of Neck Disability Index (NDI), EQ-5D, and modified Japanese Orthopaedic Association (mJOA) scale scores. A poor outcome was defined as having all 3 of the following categories met: 1) radiographic poor outcome: deterioration or severe radiographic malalignment 1 year postoperatively for cSVA or T1 slope–cervical lordosis mismatch (TS-CL); 2) clinical poor outcome: failing to meet the minimum clinically important difference (MCID) for NDI or having a severe mJOA Ames modifier; and 3) complications/reoperation poor outcome: major complication, death, or reoperation for a complication other than infection. Univariate logistic regression followed by multivariate regression models was performed, and internal validation was performed by calculating the area under the curve (AUC).

RESULTS

In total, 89 patients with CD were included (mean age 61.9 years, female sex 65.2%, BMI 29.2 kg/m2). By 1 year postoperatively, 18 (20.2%) patients were characterized as having an overall poor outcome. For radiographic poor outcomes, patients’ conditions either deteriorated or remained severe for TS-CL (73% of patients), cSVA (8%), horizontal gaze (34%), and global SVA (28%). For clinical poor outcomes, 80% and 60% of patients did not reach MCID for EQ-5D and NDI, respectively, and 24% of patients had severe symptoms (mJOA score 0–11). For the complications/reoperation poor outcome, 28 patients experienced a major complication, 11 underwent a reoperation, and 1 had a complication-related death. Of patients with a poor clinical outcome, 75% had a poor radiographic outcome; 35% of poor radiographic and 37% of poor clinical outcome patients had a major complication. A poor outcome was predicted by the following combination of factors: osteoporosis, baseline neurological status, use of a transition rod, number of posterior decompressions, baseline pelvic tilt, T2–12 kyphosis, TS-CL, C2–T3 SVA, C2–T1 pelvic angle (C2 slope), global SVA, and number of levels in maximum thoracic kyphosis. The final model predicting a poor outcome (AUC 86%) included the following: osteoporosis (OR 5.9, 95% CI 0.9–39), worse baseline neurological status (OR 11.4, 95% CI 1.8–70.8), baseline pelvic tilt > 20° (OR 0.92, 95% CI 0.85–0.98), > 9 levels in maximum thoracic kyphosis (OR 2.01, 95% CI 1.1–4.1), preoperative C2–T3 SVA > 5.4 cm (OR 1.01, 95% CI 0.9–1.1), and global SVA > 4 cm (OR 3.2, 95% CI 0.09–10.3).

CONCLUSIONS

Of all CD patients in this study, 20.2% had a poor overall outcome, defined by deterioration in radiographic and clinical outcomes, and a major complication. Additionally, 75% of patients with a poor clinical outcome also had a poor radiographic outcome. A poor overall outcome was most strongly predicted by severe baseline neurological deficit, global SVA > 4 cm, and including more of the thoracic maximal kyphosis in the construct.