✓Posterior dynamic stabilization in the lumbar spine is performed in an attempt to reduce loading across the intervertebral disc for the purpose of relieving pain and limiting degeneration while preserving motion. The AccuFlex rod system (Globus Medical, Inc.), a first-generation device, achieves this by changing the properties of the rod within the Protex pedicle screw–based rigid rod system. Helical cuts that have been created in the standard 6.5-mm rod allow for a limited range of motion while providing a posterior tension band that relieves a significant amount of disc loading. The AccuFlex rod system has been approved by the Food and Drug Administration for single-level fusion when used in conjunction with an interbody graft. In a study involving 170 patients who underwent fusion surgery for back pain, the 54 who received the AccuFlex construct had statistically similar fusion rates and outcomes (as assessed by visual analog scale and Short Form-16 scores) when compared with 116 patients treated with rigid rod fixation after 1 year of follow up. Future clinical studies will examine and provide information regarding the impact of AccuFlex on the incidence of adjacent-level disease. Information gained through the clinical experience with AccuFlex will serve as a foundation for the development of a stand-alone dynamic construct.
Christopher E. Mandigo, Prakash Sampath and Michael G. Kaiser
Michael D. Martin, Christopher M. Boxell and David G. Malone
Lumbar disc degeneration occurs because of a variety of factors and results in a multitude of conditions. Alterations in the vertebral endplate cause loss of disc nutrition and disc degeneration. Aging, apoptosis, abnormalities in collagen, vascular ingrowth, loads placed on the disc, and abnormal proteoglycan all contribute to disc degeneration. Some forms of disc degeneration lead to loss of height of the motion segment with concomitant changes in biomechanics of the segment. Disc herniation with radiculopathy and chronic discogenic pain are the result of this degenerative process.
Michael J. Rauzzino, Christopher I. Shaffrey, Russ P. Nockels, Gregory C. Wiggins, Jack Rock and James Wagner
The authors report their experience with 42 patients in whom anterior lumbar fusion was performed using titanium cages as a versatile adjunct to treat a wide variety of spinal deformity and pathological conditions. These conditions included congenital, degenerative, iatrogenic, infectious, traumatic, and malignant disorders of the thoracolumbar spine. Fusion rates and complications are compared with data previously reported in the literature.
Between July 1996 and July 1999 the senior authors (C.I.S., R.P.N., and M.J.R.) treated 42 patients by means of a transabdominal extraperitoneal (13 cases) or an anterolateral extraperitoneal approach (29 cases), 51 vertebral levels were fused using titanium cages packed with autologous bone. All vertebrectomies (27 cases) were reconstructed using a Miami Moss titanium mesh cage and Kaneda instrumentation. Interbody fusion (15 cases) was performed with either the BAK titanium threaded interbody cage (in 13 patients) or a Miami Moss titanium mesh cage (in two patients). The average follow-up period was 14.3 months. Seventeen patients had sustained a thoracolumbar burst fracture, 12 patients presented with degenerative spinal disorders, six with metastatic tumor, four with spinal deformity (one congenital and three iatrogenic), and three patients presented with spinal infections. In five patients anterior lumbar interbody fusion (ALIF) was supplemented with posterior segmental fixation at the time of the initial procedure. Of the 51 vertebral levels treated, solid arthrodesis was achieved in 49, a 96% fusion rate. One case of pseudarthrosis occurred in the group treated with BAK cages; the diagnosis was made based on the patient's continued mechanical back pain after undergoing L4–5 ALIF. The patient was treated with supplemental posterior fixation, and successful fusion occurred uneventfully with resolution of her back pain. In the group in which vertebrectomy was performed there was one case of fusion failure in a patient with metastatic breast cancer who had undergone an L-3 corpectomy with placement of a mesh cage. Although her back pain was immediately resolved, she died of systemic disease 3 months after surgery and before fusion could occur.
Complications related to the anterior approach included two vascular injuries (two left common iliac vein lacerations); one injury to the sympathetic plexus; one case of superficial phlebitis; two cases of prolonged ileus (greater than 48 hours postoperatively); one anterior femoral cutaneous nerve palsy; and one superficial wound infection. No deaths were directly related to the surgical procedure. There were no cases of dural laceration and no nerve root injury. There were no cases of deep venous thrombosis, pulmonary embolus, retrograde ejaculation, abdominal hernia, bowel or ureteral injury, or deep wound infection. Fusion-related complications included an iliac crest hematoma and prolonged donor-site pain in one patient. There were no complications related to placement or migration of the cages, but there was one case of screw fracture of the Kaneda device that did not require revision.
The authors conclude that anterior lumbar fusion performed using titanium interbody or mesh cages, packed with autologous bone, is an effective, safe method to achieve fusion in a wide variety of pathological conditions of the thoracolumbar spine. The fusion rate of 96% compares favorably with results reported in the literature. The complication rate mirrors the low morbidity rate associated with the anterior approach. A detailed study of clinical outcomes is in progress. Patient selection and strategies for avoiding complication are discussed.
Michael J. Rauzzino, Christopher I. Shaffrey, James Wagner, Russ Nockels and Mark Abel
The indications for surgical intervention in patients with idiopathic scoliosis have been well defined. The goals of surgery are to achieve fusion and arrest progressive curvature while restoring normal coronal and sagittal balance. As first introduced by Harrington, posterior fusion, the gold standard of treatment, has a proven record of success. More recently, anterior techniques for performing fusion procedures via either a thoracotomy or a retroperitoneal approach have been popularized in attempts to achieve better correction of curvature, preserve motion segments, and avoid some of the complications of posterior fusion such as the development of the flat-back syndrome. Anterior instrumentation alone, although effective, can be kyphogenic and has been shown to be associated with complications such as pseudarthrosis and instrumentation failure. Performing a combined approach in patients with scoliosis and other deformities has become an increasingly popular procedure to achieve superior correction of deformity and to minimize later complications. Indications for a combined approach (usually consisting of anterior release, arthrodesis with or without use of instrumentation, and posterior segmental fusion) include: prevention of crankshaft phenomenon in juvenile or skeletally immature adolescents; correction of large curves (75°) or excessively rigid curves in skeletally mature or immature patients; correction of curves with large sagittal-plane deformities such as thoracic kyphosis (> 90°) or thoracic lordosis (> 20°); and correction of thoracolumbar curves that need to be fused to the sacrum. Surgery may be performed either in a staged proceedure or, more commonly, in a single sitting. The authors discuss techniques for combined surgery and complication avoidance.
Shivanand P. Lad, Chirag G. Patil, Christopher Ho, Michael S. B. Edwards and Maxwell Boakye
Previous investigations of health outcome after spinal surgery for tethered cord syndrome (TCS) have been single-institution studies. The aim of this study was to report inpatient complications and outcomes on a nationwide level.
The Nationwide Inpatient Sample (NIS) was used to identify patients who underwent spinal surgery for TCS in the US between 1993 and 2002. Patients who had a primary diagnosis of TCS (ICD-9 742.59) and also underwent spinal laminectomies were included in this study. Multivariate analysis was performed to analyze the effects of patient and hospital characteristics on variables such as mortality rate, nonfatal complications, LOS, and adverse outcomes in general (defined as death or discharge to an institution rather than home).
The NIS sample included data on 9733 patients with TCS who underwent surgery. The means for mortality rate, complication rate, and LOS, respectively, were 0.0005%, 9.48%, and 5.6 days. Postoperative hemorrhages or hematomas (mean rate 2.3%) were the most common complications reported. Age and complications were the only significant predictors of adverse outcome on multivariate analysis. Patients older than 65 years had a threefold increase in risk of adverse outcome compared with patients 18 to 44 years of age. On average, one postoperative complication led to a 3-day increase in mean LOS and added more than $9000 to hospital charges.
This study provides a national perspective on inpatient complications and outcomes after spinal surgery for TCS in the United States. The authors have demonstrated the impact of age, complications, and medical comorbidities on the outcome of surgery for patients with this common disorder.
Michael M. Safaee, Cecilia L. Dalle Ore, Corinna C. Zygourakis, Vedat Deviren and Christopher P. Ames
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.
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.
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.
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.
Michael M. McDowell, Christopher P. Kellner, Sunjay M. Barton, Charles B. Mikell, Eric S. Sussman, Simon G. Heuts and E. Sander Connolly
In this report, the authors sought to summarize existing literature to provide an overview of the currently available techniques and to critically assess the evidence for or against their application in intracerebral hemorrhage (ICH) for management, prognostication, and research. Functional imaging in ICH represents a potential major step forward in the ability of physicians to assess patients suffering from this devastating illness due to the advantages over standing imaging modalities focused on general tissue structure alone, but its use is highly controversial due to the relative paucity of literature and the lack of consolidation of the predominantly small data sets that are currently in existence. Current data support that diffusion tensor imaging and tractography, diffusion-perfusion weighted MRI techniques, and functional MRI all possess major potential in the areas of highlighting motor deficits, motor recovery, and network reorganization. Novel clinical studies designed to objectively assess the value of each of these modalities on a wider scale in conjunction with other methods of investigation and management will allow for their rapid incorporation into standard practice.
Anna Terry, Gregory Zipfel, Eric Milner, DeWitte T. Cross III, Christopher J. Moran, Michael N. Diringer, Ralph G. Dacey Jr. and Colin P. Derdeyn
Over the past decade, low-pressure, flow-directed balloons have been replaced by over-the-wire balloons in the treatment of vasospasm induced by subarachnoid hemorrhage (SAH). The authors assess the procedural safety and technical efficacy of these newer devices.
Seventy-five patients who underwent 85 balloon angioplasty procedures for the treatment of SAH-induced vasospasm were identified from a prospective quality-assurance database. Medical records and angiographic reports were reviewed for evidence of procedural complications and technical efficacy.
No vessel rupture or perforation occurred, but thromboembolic complications were noted in four (4.7%) of the 85 procedures. Balloon angioplasty was frequently attempted and successfully accomplished in the distal internal carotid (100%), proximal middle cerebral (94%), vertebral (73%), and basilar (88%) arteries. Severe narrowing was present in 89 proximal anterior cerebral arteries. Angioplasty was attempted in 41 of these vessels and was successful in only 14 (34%). In 19 of the 27 unsuccessful attempts, the balloon could not be advanced over the wire due to severe vasospasm or unfavorable vessel angle. Follow-up angiography in a subset of patients demonstrated that severe recurrent vasospasm occurred in 15 (13%) of 116 vessels studied after angioplasty.
Over-the-wire balloons involve a low risk for vessel rupture. The anterior cerebral artery remains difficult to access and successfully treat with current devices. Further improvements in balloon design, such as smaller inflated diameters and better tracking, are necessary. Finally, thromboembolic complications remain an important concern, and severe vasospasm may recur after balloon angioplasty.
Ian McCarthy, Michael O'Brien, Christopher Ames, Chessie Robinson, Thomas Errico, David W. Polly Jr. and Richard Hostin
Incremental cost-effectiveness analysis is critical to the efficient allocation of health care resources; however, the incremental cost-effectiveness ratio (ICER) of surgical versus nonsurgical treatment for adult spinal deformity (ASD) has eluded the literature, due in part to inherent empirical difficulties when comparing surgical and nonsurgical patients. Using observed preoperative health-related quality of life (HRQOL) for patients who later underwent surgery, this study builds a statistical model to predict hypothetical quality-adjusted life years (QALYs) without surgical treatment. The analysis compares predicted QALYs to observed postoperative QALYs and forms the resulting ICER.
This was a single-center (Baylor Scoliosis Center) retrospective analysis of consecutive patients undergoing primary surgery for ASD. Total costs (expressed in 2010 dollars) incurred by the hospital for each episode of surgical care were collected from administrative data and QALYs were calculated from the 6-dimensional Short-Form Health Survey, each discounted at 3.5% per year. Regression analysis was used to predict hypothetical QALYs without surgery based on preoperative longitudinal data for 124 crossover surgical patients with similar diagnoses, baseline HRQOL, age, and sex compared with the surgical cohort. Results were projected through 10-year follow-up, and the cost-effectiveness acceptability curve (CEAC) was estimated using nonparametric bootstrap methods.
Three-year follow-up was available for 120 (66%) of 181 eligible patients, who were predominantly female (89%) with average age of 50. With discounting, total costs averaged $125,407, including readmissions, with average QALYs of 1.93 at 3-year follow-up. Average QALYs without surgery were predicted to be 1.6 after 3 years. At 3- and 5-year follow-up, the ICER was $375,000 and $198,000, respectively. Projecting through 10-year follow-up, the ICER was $80,000. The 10-year CEAC revealed a 40% probability that the ICER was $80,000 or less, a 90% probability that the ICER was $90,000 or less, and a 100% probability that the ICER was less than $100,000.
Based on the WHO's suggested upper threshold for cost-effectiveness (3 times per capita GDP, or $140,000 in 2010 dollars), the analysis reveals that surgical treatment for ASD is cost-effective after a 10-year period based on predicted deterioration in HRQOL without surgery. The ICER well exceeds the WHO threshold at earlier follow-up intervals, highlighting the importance of the durability of surgical treatment in assessing the value of surgical intervention. Due to the study's methodology, the results are dependent on the predicted deterioration in HRQOL without surgery. As such, the results may not extend to patients whose HRQOL would remain steady without surgery. Future research should therefore pursue a direct comparison of QALYs for surgical and nonsurgical patients to better understand the cost-effectiveness of surgery for the average ASD patient.
Gregory C. Wiggins, Michael J. Rauzzino, Christopher I. Shaffrey, Russ P. Nockels, Richard Whitehill, Mark E. Shaffrey, James Wagner and Tord D. Alden
This study was conducted to determine the safety, efficacy, and complication rate associated with the anterior approach in the use of a new titanium mesh interbody fusion cage for the treatment of unstable thoracolumbar burst fractures. The experience with this technique is compared with the senior authors' (C.S., R.W., and M.S.) previously published results in the management of patients with unstable thoracolumbar burst fractures.
Between 1996 and 1999, 21 patients with unstable thoracolumbar (T12-L3) burst fractures underwent an anterolateral decompressive procedure in which a titanium cage and Kaneda device were used. Eleven of the 21 patients had sustained a neurological deficit, and all patients improved at least one Frankel grade (average 1.2 grades). There was improvement in outcome in terms of blood loss, correction of kyphosis, and pain, as measured on the Denis Pain and Work Scale, in our current group of patients treated via an anterior approach when compared with the results in those who underwent a posterior approach.
In our current study the anterior approach was demonstrated to be a safe and effective technique for the management of unstable thoracolumbar burst fractures. It offers superior results compared with the posterior approach. The addition of the new titanium mesh interbody cage to our previous anterior technique allows the patient's own bone to be harvested from the corpectomy site and used as a substrate for fusion, thereby obviating the need for iliac crest harvest. The use of the cage in association with the Kaneda device allows for improved correction of kyphosis and restoration of normal sagittal alignment in addition to improved functional outcomes.