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Michael M. Safaee, Cecilia L. Dalle Ore, Corinna C. Zygourakis, Vedat Deviren and Christopher P. Ames

OBJECTIVE

Proximal junctional kyphosis (PJK) is a well-recognized complication of surgery for adult spinal deformity and is characterized by increased kyphosis at the upper instrumented vertebra (UIV). PJK prevention strategies have the potential to decrease morbidity and cost by reducing rates of proximal junctional failure (PJF), which the authors define as radiographic PJK plus clinical sequelae requiring revision surgery.

METHODS

The authors performed an analysis of 195 consecutive patients with adult spinal deformity. Age, sex, levels fused, upper instrumented vertebra (UIV), use of 3-column osteotomy, pelvic fixation, and mean time to follow-up were collected. The authors also reviewed operative reports to assess for the use of surgical adjuncts targeted toward PJK prevention, including ligament augmentation, hook fixation, and vertebroplasty. The cost of surgery, including direct and total costs, was also assessed at index surgery and revision surgery. Only revision surgery for PJF was included.

RESULTS

The mean age of the cohort was 64 years (range 25–84 years); 135 (69%) patients were female. The mean number of levels fused was 10 (range 2–18) with the UIV as follows: 2 cervical (1%), 73 upper thoracic (37%), 108 lower thoracic (55%), and 12 lumbar (6%). Ligament augmentation was used in 99 cases (51%), hook fixation in 60 cases (31%), and vertebroplasty in 71 cases (36%). PJF occurred in 18 cases (9%). Univariate analysis found that ligament augmentation and hook fixation were associated with decreased rates of PJF. However, in a multivariate model that also incorporated age, sex, and UIV, only ligament augmentation maintained a significant association with PJF reduction (OR 0.196, 95% CI 0.050–0.774; p = 0.020). Patients with ligament augmentation, compared with those without, had a higher cost of index surgery, but ligament augmentation was overall cost effective and produced significant cost savings. In sensitivity analyses in which we independently varied the reduction in PJF, cost of ligament augmentation, and cost of reoperation by ± 50%, ligament augmentation remained a cost-effective strategy for PJF prevention.

CONCLUSIONS

Prevention strategies for PJK/PJF are limited, and their cost-effectiveness has yet to be established. The authors present the results of 195 patients with adult spinal deformity and show that ligament augmentation is associated with significant reductions in PJF in both univariate and multivariate analyses, and that this intervention is cost-effective. Future studies will need to determine if these clinical results are reproducible, but for high-risk cases, these data suggest an important role of ligament augmentation for PJF prevention and cost savings.

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Junseok Bae, Alexander A. Theologis, Russell Strom, Bobby Tay, Shane Burch, Sigurd Berven, Praveen V. Mummaneni, Dean Chou, Christopher P. Ames and Vedat Deviren

OBJECTIVE

Surgical treatment of adult spinal deformity (ASD) is an effective endeavor that can be accomplished using a variety of surgical strategies. Here, the authors assess and compare radiographic data, complications, and health-related quality-of-life (HRQoL) outcome scores among patients with ASD who underwent a posterior spinal fixation (PSF)–only approach, a posterior approach combined with lateral lumbar interbody fusion (LLIF+PSF), or a posterior approach combined with anterior lumbar interbody fusion (ALIF+PSF).

METHODS

The medical records of consecutive adults who underwent thoracolumbar fusion for ASD between 2003 and 2013 at a single institution were reviewed. Included were patients who underwent instrumentation from the pelvis to L-1 or above, had a sagittal vertical axis (SVA) of < 10 cm, and underwent a minimum of 2 years’ follow-up. Those who underwent a 3-column osteotomy were excluded. Three groups of patients were compared on the basis of the procedure performed, LLIF+PSF, ALIF+PSF, and PSF only. Perioperative spinal deformity parameters, complications, and HRQoL outcome scores (Oswestry Disability Index [ODI], Scoliosis Research Society 22-question Questionnaire [SRS-22], 36-Item Short Form Health Survey [SF-36], visual analog scale [VAS] for back/leg pain) from each group were assessed and compared with each other using ANOVA. The minimal clinically important differences used were −1.2 (VAS back pain), −1.6 (VAS leg pain), −15 (ODI), 0.587/0.375/0.8/0.42 (SRS-22 pain/function/self-image/mental health), and 5.2 (SF-36, physical component summary).

RESULTS

A total of 221 patients (58 LLIF, 91 ALIF, 72 PSF only) met the inclusion criteria. Average deformities consisted of a SVA of < 10 cm, a pelvic incidence–lumbar lordosis (LL) mismatch of > 10°, a pelvic tilt of > 20°, a lumbar Cobb angle of > 20°, and a thoracic Cobb angle of > 15°. Preoperative SVA, LL, pelvic incidence–LL mismatch, and lumbar and thoracic Cobb angles were similar among the groups. Patients in the PSF-only group had more comorbidities, those in the ALIF+PSF group were, on average, younger and had a lower body mass index than those in the LLIF+PSF group, and patients in the LLIF+PSF group had a significantly higher mean number of interbody fusion levels than those in the ALIF+PSF and PSF-only groups. At final follow-up, all radiographic parameters and the mean numbers of complications were similar among the groups. Patients in the LLIF+PSF group had proximal junctional kyphosis that required revision surgery significantly less often and fewer proximal junctional fractures and vertebral slips. All preoperative HRQoL scores were similar among the groups. After surgery, the LLIF+PSF group had a significantly lower ODI score, higher SRS-22 self-image/total scores, and greater achievement of the minimal clinically important difference for the SRS-22 pain score.

CONCLUSIONS

Satisfactory radiographic outcomes can be achieved similarly and adequately with these 3 surgical approaches for patients with ASD with mild to moderate sagittal deformity. Compared with patients treated with an ALIF+PSF or PSF-only surgical strategy, patients who underwent LLIF+PSF had lower rates of proximal junctional kyphosis and mechanical failure at the upper instrumented vertebra and less back pain, less disability, and better SRS-22 scores.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

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Alexander A. Theologis, Gregory M. Mundis Jr., Stacie Nguyen, David O. Okonkwo, Praveen V. Mummaneni, Justin S. Smith, Christopher I. Shaffrey, Richard Fessler, Shay Bess, Frank Schwab, Bassel G. Diebo, Douglas Burton, Robert Hart, Vedat Deviren and Christopher Ames

OBJECTIVE

The aim of this study was to evaluate the utility of supplementing long thoracolumbar posterior instrumented fusion (posterior spinal fusion, PSF) with lateral interbody fusion (LIF) of the lumbar/thoracolumbar coronal curve apex in adult spinal deformity (ASD).

METHODS

Two multicenter databases were evaluated. Adults who had undergone multilevel LIF of the coronal curve apex in addition to PSF with L5–S1 interbody fusion (LS+Apex group) were matched by number of posterior levels fused with patients who had undergone PSF with L5–S1 interbody fusion without LIF (LS-Only group). All patients had at least 2 years of follow-up. Percutaneous PSF and 3-column osteotomy (3CO) were excluded. Demographics, perioperative details, radiographic spinal deformity measurements, and HRQoL data were analyzed.

RESULTS

Thirty-two patients were matched (LS+Apex: 16; LS: 16) (6 men, 26 women; mean age 63 ± 10 years). Overall, the average values for measures of deformity were as follows: Cobb angle > 40°, sagittal vertical axis (SVA) > 6 cm, pelvic tilt (PT) > 25°, and mismatch between pelvic incidence (PI) and lumbar lordosis (LL) > 15°. There were no significant intergroup differences in preoperative radiographic parameters, although patients in the LS+Apex group had greater Cobb angles and less LL. Patients in the LS+Apex group had significantly more anterior levels fused (4.6 vs 1), longer operative times (859 vs 379 minutes), and longer length of stay (12 vs 7.5 days) (all p < 0.01). For patients in the LS+Apex group, Cobb angle, pelvic tilt (PT), lumbar lordosis (LL), PI-LL (lumbopelvic mismatch), Oswestry Disability Index (ODI) scores, and visual analog scale (VAS) scores for back and leg pain improved significantly (p < 0.05). For patients in the LS-Only group, there were significant improvements in Cobb angle, ODI score, and VAS scores for back and leg pain. The LS+Apex group had better correction of Cobb angles (56% vs 33%, p = 0.02), SVA (43% vs 5%, p = 0.46), LL (62% vs 13%, p = 0.35), and PI-LL (68% vs 33%, p = 0.32). Despite more LS+Apex patients having major complications (56% vs 13%; p = 0.02) and postoperative leg weakness (31% vs 6%, p = 0.07), there were no intergroup differences in 2-year outcomes.

CONCLUSIONS

Long open posterior instrumented fusion with or without multilevel LIF is used to treat a variety of coronal and sagittal adult thoracolumbar deformities. The addition of multilevel LIF to open PSF with L5–S1 interbody support in this small cohort was often used in more severe coronal and/or lumbopelvic sagittal deformities and offered better correction of major Cobb angles, lumbopelvic parameters, and SVA than posterior-only operations. As these advantages came at the expense of more major complications, more leg weakness, greater blood loss, and longer operative times and hospital stays without an improvement in 2-year outcomes, future investigations should aim to more clearly define deformities that warrant the addition of multilevel LIF to open PSF and L5–S1 interbody fusion.

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Russell G. Strom, Junseok Bae, Jun Mizutani, Frank Valone III, Christopher P. Ames and Vedat Deviren

OBJECTIVE

Lateral interbody fusion (LIF) with percutaneous screw fixation can treat adult spinal deformity (ASD) in the coronal plane, but sagittal correction is limited. The authors combined LIF with open posterior (OP) surgery using facet osteotomies and a rod-cantilever technique to enhance lumbar lordosis (LL). It is unclear how this hybrid strategy compares to OP surgery alone. The goal of this study was to evaluate the combination of LIF and OP surgery (LIF+OP) for ASD.

METHODS

All thoracolumbar ASD cases from 2009 to 2014 were reviewed. Patients with < 6 months follow-up, prior fusion, severe sagittal imbalance (sagittal vertical axis > 200 mm or pelvic incidence-LL > 40°), and those undergoing anterior lumbar interbody fusion were excluded. Deformity correction, complications, and outcomes were compared between LIF+OP and OP-only surgery patients.

RESULTS

LIF+OP (n = 32) and OP-only patients (n = 60) had similar baseline features and posterior fusion levels. On average, 3.8 LIFs were performed. Patients who underwent LIF+OP had less blood loss (1129 vs 1833 ml, p = 0.016) and lower durotomy rates (0% vs 23%, p = 0.002). Patients in the LIF+OP group required less ICU care (0.7 vs 2.8 days, p < 0.001) and inpatient rehabilitation (63% vs 87%, p = 0.015). The incidence of new leg pain, numbness, or weakness was similar between groups (28% vs 22%, p = 0.609). All leg symptoms resolved within 6 months, except in 1 OP-only patient. Follow-up duration was similar (28 vs 25 months, p = 0.462). LIF+OP patients had significantly less pseudarthrosis (6% vs 27%, p = 0.026) and greater improvement in visual analog scale back pain (mean decrease 4.0 vs 1.9, p = 0.046) and Oswestry Disability Index (mean decrease 21 vs 12, p = 0.035) scores. Lumbar coronal correction was greater with LIF+OP surgery (mean [± SD] 22° ± 13° vs 14° ± 13°, p = 0.010). LL restoration was 22° ± 13°, intermediately between OP-only with facet osteotomies (11° ± 7°, p < 0.001) and pedicle subtraction osteotomy (29° ± 10°, p = 0.045).

CONCLUSIONS

LIF+OP is an effective strategy for ASD of moderate severity. Compared with the authors' OP-only operations, LIF+OP was associated with faster recovery, fewer complications, and greater relief of pain and disability.

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Darryl Lau, Andrew K. Chan, Alexander A. Theologis, Dean Chou, Praveen V. Mummaneni, Shane Burch, Sigurd Berven, Vedat Deviren and Christopher Ames

OBJECTIVE

Because the surgical strategies for primary and metastatic spinal tumors are different, the respective associated costs and morbidities associated with those treatments likely vary. This study compares the direct costs and 90-day readmission rates between the resection of extradural metastatic and primary spinal tumors. The factors associated with cost and readmission are identified.

METHODS

Adults (age 18 years or older) who underwent the resection of spinal tumors between 2008 and 2013 were included in the study. Patients with intradural tumors were excluded. The direct costs of index hospitalization and 90-day readmission hospitalization were evaluated. The direct costs were compared between patients who were treated surgically for primary and metastatic spinal tumors. The independent factors associated with costs and readmissions were identified using multivariate analysis.

RESULTS

A total of 181 patients with spinal tumors were included (63 primary and 118 metastatic tumors). Overall, the mean index hospital admission cost for the surgical management of spinal tumors was $52,083. There was no significant difference in the cost of hospitalization between primary ($55,801) and metastatic ($50,098) tumors (p = 0.426). The independent factors associated with higher cost were male sex (p = 0.032), preoperative inability to ambulate (p = 0.002), having more than 3 comorbidities (p = 0.037), undergoing corpectomy (p = 0.021), instrumentation greater than 7 levels (p < 0.001), combined anterior-posterior approach (p < 0.001), presence of a perioperative complication (p < 0.001), and longer hospital stay (p < 0.001). The perioperative complication rate was 21.0%. Of this cohort, 11.6% of patients were readmitted within 90 days, and the mean hospitalization cost of that readmission was $20,078. Readmission rates after surgical treatment for primary and metastatic tumors were similar (11.1% vs 11.9%, respectively) (p = 0.880). Prior hospital stay greater than 15 days (OR 6.62, p = 0.016) and diagnosis of lung metastasis (OR 52.99, p = 0.007) were independent predictors of readmission.

CONCLUSIONS

Primary and metastatic spinal tumors are comparable with regard to the direct costs of the index surgical hospitalization and readmission rate within 90 days. The factors independently associated with costs are related to preoperative health status, type and complexity of surgery, and postoperative course.

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Khoi D. Than, Paul Park, Kai-Ming Fu, Stacie Nguyen, Michael Y. Wang, Dean Chou, Pierce D. Nunley, Neel Anand, Richard G. Fessler, Christopher I. Shaffrey, Shay Bess, Behrooz A. Akbarnia, Vedat Deviren, Juan S. Uribe, Frank La Marca, Adam S. Kanter, David O. Okonkwo, Gregory M. Mundis Jr., Praveen V. Mummaneni and the International Spine Study Group

OBJECTIVE

Minimally invasive surgery (MIS) techniques are increasingly used to treat adult spinal deformity. However, standard minimally invasive spinal deformity techniques have a more limited ability to restore sagittal balance and match the pelvic incidence–lumbar lordosis (PI-LL) than traditional open surgery. This study sought to compare “best” versus “worst” outcomes of MIS to identify variables that may predispose patients to postoperative success.

METHODS

A retrospective review of minimally invasive spinal deformity surgery cases was performed to identify parameters in the 20% of patients who had the greatest improvement in Oswestry Disability Index (ODI) scores versus those in the 20% of patients who had the least improvement in ODI scores at 2 years' follow-up.

RESULTS

One hundred four patients met the inclusion criteria, and the top 20% of patients in terms of ODI improvement at 2 years (best group, 22 patients) were compared with the bottom 20% (worst group, 21 patients). There were no statistically significant differences in age, body mass index, pre- and postoperative Cobb angles, pelvic tilt, pelvic incidence, levels fused, operating room time, and blood loss between the best and worst groups. However, the mean preoperative ODI score was significantly higher (worse disability) at baseline in the group that had the greatest improvement in ODI score (58.2 vs 39.7, p < 0.001). There was no difference in preoperative PI-LL mismatch (12.8° best vs 19.5° worst, p = 0.298). The best group had significantly less postoperative sagittal vertical axis (SVA; 3.4 vs 6.9 cm, p = 0.043) and postoperative PI-LL mismatch (10.4° vs 19.4°, p = 0.027) than the worst group. The best group also had better postoperative visual analog scale back and leg pain scores (p = 0.001 and p = 0.046, respectively).

CONCLUSIONS

The authors recommend that spinal deformity surgeons using MIS techniques focus on correcting a patient's PI-LL mismatch to within 10° and restoring SVA to < 5 cm. Restoration of these parameters seems to impact which patients will attain the greatest degree of improvement in ODI outcomes, while the spines of patients who do the worst are not appropriately corrected and may be fused into a fixed sagittal plane deformity.

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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.