Health and Economic Outcomes of Posterior Spinal Fusion for Children With Neuromuscular Scoliosis.

OBJECTIVES: Neuromuscular scoliosis (NMS) can result in severe disability. Nonoperative management minimally slows scoliosis progression, but operative management with posterior spinal fusion (PSF) carries high risks of morbidity and mortality. In this study, we compare health and economic outcomes of PSF to nonoperative management for children with NMS to identify opportunities to improve care. METHODS: We performed a cost-effectiveness analysis. Our decision analytic model included patients aged 5 to 20 years with NMS and a Cobb angle ≥50°, with a base case of 15-year-old patients. We estimated costs, life expectancy, quality-adjusted life-years (QALYs), and incremental cost-effectiveness from published literature and conducted sensitivity analyses on all model inputs. RESULTS: We estimated that PSF resulted in modestly decreased discounted life expectancy (10.8 years) but longer quality-adjusted life expectancy (4.84 QALYs) than nonoperative management (11.2 years; 3.21 QALYs). PSF costs $75 400 per patient. Under base-case assumptions, PSF costs $50 100 per QALY gained. Our findings were sensitive to quality of life (QoL) and life expectancy, with PSF favored if it significantly increased QoL. CONCLUSIONS: In patients with NMS, whether PSF is cost-effective depends strongly on the degree to which QoL improved, with larger improvements when NMS is the primary cause of debility, but limited data on QoL and life expectancy preclude a definitive assessment. Improved patient-centered outcome assessments are essential to understanding the effectiveness of NMS treatment alternatives. Because the degree to which PSF influences QoL substantially impacts health outcomes and varies by patient, clinicians should consider shared decision-making during PSF-related consultations.

What Are the Costs of Cervical Radiculopathy Prior to Surgical Treatment?

STUDY DESIGN: Retrospective, observational study. OBJECTIVE: To examine the costs associated with nonoperative management (diagnosis and treatment) of cervical radiculopathy in the year prior to anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: While the costs of operative treatment have been previously described, less is known about nonoperative management costs of cervical radiculopathy leading up to surgery. METHODS: The Humana claims dataset (2007-2015) was queried to identify adult patients with cervical radiculopathy that underwent ACDF. Outcome endpoint was assessment of cumulative and per-capita costs for nonoperative diagnostic (x-rays, computed tomographic [CT], magnetic resonance imaging [MRI], electromyogram/nerve conduction studies [EMG/NCS]) and treatment modalities (injections, physical therapy [PT], braces, medications, chiropractic services) in the year preceding surgical intervention. RESULTS: Overall 12,514 patients (52% female) with cervical radiculopathy underwent ACDF. Cumulative costs and per-capita costs for nonoperative management, during the year prior to ACDF was $14.3 million and $1143, respectively. All patients underwent at least one diagnostic test (MRI: 86.7%; x-ray: 57.5%; CT: 35.2%) while 73.3% patients received a nonoperative treatment. Diagnostic testing comprised of over 62% of total nonoperative costs ($8.9 million) with MRI constituting the highest total relative spend ($5.3 million; per-capita: $489) followed by CT ($2.6 million; per-capita: $606), x-rays ($0.54 million; per-capita: $76), and EMG/NCS ($0.39 million; per-capita: $467). Conservative treatments comprised of 37.7% of the total nonoperative costs ($5.4 million) with injections costs constituting the highest relative spend ($3.01 million; per-capita: $988) followed by PT ($1.13 million; per-capita: $510) and medications (narcotics: $0.51 million, per-capita $101; gabapentin: $0.21 million, per-capita $93; NSAIDs: 0.107 million, per-capita $47), bracing ($0.25 million; per-capita: $193), and chiropractic services ($0.137 million; per-capita: $193). CONCLUSION: The study quantifies the cumulative and per-capital costs incurred 1-year prior to ACDF in patients with cervical radiculopathy for nonoperative diagnostic and treatment modalities. Approximately two-thirds of the costs associated with cervical radiculopathy are from diagnostic modalities. As institutions begin entering into bundled payments for cervical spine disease, understanding condition specific costs is a critical first step. LEVEL OF EVIDENCE: 3.

Efficacy and cost-effectiveness of the cell saver system in instrumented posterior fusion with thoracic and lumbar vertebral fractures.

BACKGROUND: The aim of our study was to determine the efficacy and cost-effectiveness of intraoperative autotransfusion that uses the cell saver system (CSS) in patients undergoing posterior instrumentation and fusion of thoracic and lumbar vertebral fractures. METHODS: We divided 121 patients who were to undergo posterior instrumentation and fusion due to thoracic and lumbar vertebral fractures into two groups: 59 patients (23 males and 36 females) were in the cell saver group, and 62 patients (22 males and 40 females) were in the control group. Hemoglobin, hematocrit, and red blood cell (RBC) values were recorded for all patients preoperatively, on the postoperative first, second, and third days, and on the hospital discharge day. Transfusion rates and numbers of allogeneic erythrocyte transfusions, as well as the costs of transfused total auto- and allogeneic transfusions were compared. RESULTS: The numbers of erythrocyte suspensions transfused perioperatively were 0.2±0.6 units in the cell saver group and 0.7±1.4 units in the control group (p=0.01). Statistically significant differences were noted between the two groups on the postoperative first, second, and third days in terms of hemoglobin, hematocrit, and RBC values. These differences had disappeared by the hospital discharge day. The average cost of perioperative blood transfusions was $431±27.4 in the cell saver group and $34.5±66.25 in the control group (p<0.001). CONCLUSION: The use of the CSS was not cost-effective, but it was particularly successful at reducing the rate and the number of units of postoperative allogenic blood transfusions.

A Cost-Effectiveness Analysis of Intradiscal Electrothermal Therapy Compared with Circumferential Lumbar Fusion.

STUDY DESIGN: Cost-effectiveness analysis. OBJECTIVE: To evaluate the cost-effectiveness of intradiscal electrothermal therapy (IDET) relative to circumferential lumbar fusion with femoral ring allograft (FRA) in the United Kingdom. SUMMARY OF BACKGROUND DATA: Circumferential lumbar fusion is an established treatment for discogenic low back pain. However, IDET could be a cost-effective treatment alternative as it can be carried out as a day case. METHODS: Patient-level data were available for patients with discogenic low back pain treated with FRA (n = 37) in a randomized trial of FRA vs. titanium cage, and for patients recruited to a separate study evaluating the use of IDET (n = 85). Both studies were carried out at a single institution in the United Kingdom. Patients were followed-up for 24 months, with data collected on low back disability (Oswestry Disability Index), back and leg pain (visual analog scale), quality of life (Short Form 36), radiographic evaluations, and U.K. National Health Service (NHS) resource use. Cost-effectiveness was measured by the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Both treatments produced statistically significant improvements in outcome at 24-month follow-up. NHS costs were significantly lower with IDET due to a shorter mean procedure time (377.4 minutes vs. 49.9 minutes) and length of stay (7 days vs. 1.2 days). At a threshold of £20,000 per QALY, the probability that IDET is cost effective is high. CONCLUSIONS: Both treatments led to significant improvements in patient outcomes that were sustained for at least 24 months. Costs were lower with IDET, and for appropriate patients IDET is an effective and cost-effective treatment alternative.

Transforaminal lumbar interbody fusion vs. posterolateral instrumented fusion: cost-utility evaluation along side an RCT with a 2-year follow-up.

PURPOSE: Long-lasting low back pain is an increasing problem, and for some patients surgery is the final option for improvement. Several techniques for spinal fusion are available and the optimal technique remains uncertain. The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion (TLIF) compared to posterolateral instrumented fusion (PLF) from the societal perspective. METHODS: 100 Patients were randomized to TLIF or PLF (51/49) and followed for 2 years. Cost data were acquired from national registers, and outcomes were measured using the Oswestry Disability Index and SF-6D questionnaires. Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves. The statistical analysis was based on means and bootstrapped confidence intervals. RESULTS: Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days (2,554) and production loss (1,915) was observed. The probability that TLIF would be cost-effective did not exceed 30 % for any threshold of willingness to pay per quality-adjusted life year. Sensitivity analysis was conducted and supported the statistical model for handling of missing data. CONCLUSION: TLIF does not seem to be a relevant alternative to PLF from a socioeconomic, societal point of view.

Blood salvage produces higher total blood product costs in single-level lumbar spine surgery.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine the incremental cost-effectiveness of cell saver for single-level posterior lumbar decompression and fusion (PLDF). SUMMARY OF BACKGROUND DATA: Intraoperative cell salvage is used during surgery to reduce the need for perioperative allogeneic blood transfusion. Although the use of cell saver may be beneficial in certain circumstances, its utility has not been clearly established for the common procedure of an adult single-level PLDF. METHODS: Randomly selected adult patients treated with a single-level PLDF between July 2010 and June 2011 at a single institution were identified. Patients who had a combined anterior and posterior approach were excluded. The final study sample for analysis consisted of 180 patients. Hospital records were reviewed to determine whether: (1) cell saver was available during surgery, (2) recovered autologous blood was infused, and (3) the patient received intra- or postoperative allogeneic transfusions. Estimated blood loss, levels fused, volume(s) transfused, and all related complications were recorded. Costs included the cost of allogeneic blood transfusion, setting up the cell saver recovery system, and infusing autologous blood from cell saver, whereas effectiveness measures were allogeneic blood transfusions averted and quality adjusted life years. RESULTS: The incremental cost-effectiveness ratio was $55,538 per allogeneic transfusion averted, with a decrease in the transfusion rate from 40.0% to 38.7% associated with the cell saver approach. This translated into an incremental cost-effectiveness ratio of $5,555,380 per quality adjusted life years gained, which is well above the threshold for an intervention to be considered cost-effective ($100,000 per quality adjusted life years gained). CONCLUSION: The use of cell saver during a single-level PLDF does not significantly reduce the need for allogeneic blood transfusion and is not cost-effective. The high cost of cell saver in combination with the low complication rate of allogeneic blood transfusion, suggest that cell saver should not be used for single-level PLDF. Further studies are needed to evaluate the necessity for cell saver among other types of spinal surgery.

Is anterior cervical fusion with a porous tantalum implant a cost-effective method to treat cervical disc disease with radiculopathy?

STUDY DESIGN: Retrospective cost-effectiveness analysis. OBJECTIVE: To determine the relative cost-effectiveness of anterior cervical discectomy with fusion (ACDF) using a porous tantalum implant compared with autograft with plating, for single-level cervical disc disease with radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF with autograft as an interbody spacer is a generally accepted method to treat degenerated cervical discs with radiculopathy. Concerns about donor site morbidity and the structural characteristics of autograft stimulated investigations of alternative materials. Techniques may differ in their operative risks, complications, outcomes, and resource use. METHODS: A retrospective review of clinical outcomes and total cost of illness for 5 years postsurgery was performed for 61 consecutive patients enrolled for this study. Twenty-eight patients were treated with single-level ACDF using either a stand-alone, porous tantalum implant, without graft inside the implant, and 33 patients received autograft and plating. A cost-effectiveness analysis comparing the 2 ACDF treatment methods was conducted. This article reports clinical assessments, quality adjusted life years gained, and an incremental cost-effectiveness ratio analysis. RESULTS: Patients in both cohorts reported improved clinical outcomes, including neck disability index, visual analogue scale, Short-Form 36, Odom's clinical assessment, and patient satisfaction at 5 years postindex surgery. The mean cost of illness for the study period, including preoperative through 5 years postoperative assessments, was 6806 per patient treated with tantalum and 10,143 per patient receiving autograft and plate. Quality-adjusted life years (QALY) gained were 9.41 and 7.14 for the tantalum and control cohorts, respectively. The cost per QALY for the tantalum group was 723 and 1420 for the control group. The incremental cost-effectiveness ratio of ACDF with a porous tantalum implant compared with ACDF with autograft and plate was -1473 per patient per year for the duration of this study. CONCLUSION: This cost-effectiveness analysis reports favorable results for ACDF procedures utilizing a tantalum implant. The data reported suggest that using porous tantalum as a stand-alone device is less costly and more effective than autograft and plate in ACDF procedures.

Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery.

STUDY DESIGN: : Randomized, placebo-controlled trial. OBJECTIVE: : To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery. SUMMARY OF BACKGROUND DATA: : Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited. METHODS: : EACA (100 mg/kg) or placebo was administered to 182 adult patients after the induction of anesthesia followed by an infusion that was continued for 8 hours after surgery. Primary end points included total allogeneic RBC transfusions through postoperative day 8 and postoperative allogeneic plus autologus RBC transfusions through postoperative day 8. RESULTS: : Mean total allogeneic RBC transfusions were not statistically different between the groups (5.9 units EACA vs. 6.9 units placebo; P = 0.17). Mean postoperative RBC transfusions in the EACA group was less (2.0 units vs. 2.8 units placebo; P = 0.03). There was no significantdifference in mean estimated intraoperative estimated-blood loss (2938 cc EACA vs. 3273 cc placebo; P = 0.32). Mean intensive care unit length of stay was decreased (EACA: 1.8 days vs. 2.8 days placebo; P = 0.04). The incidence of thromboembolic complications was similar (2.2% EACA vs. 6.6% placebo; P = 0.15). CONCLUSION: : The difference in total allogeneic RBC transfusions between the groups was not statistically significant. EACA was associated with a 30% (0.8 units) reduction in postoperative RBC transfusions and a 1-day reduction in ICU LOS, without an increased incidence of thromboembolic events. EACA may be considered for patients undergoing major spinal surgery. Larger studies are needed to evaluate the relationship between EACA and total RBC requirements.

Introducing the external link model for studying spine fixation and misalignment: current procedures, costs, and failure rates.

OBJECTIVE: This is the last article in a series of 3 articles introducing a new animal model, the external link model (ELM), that permits reversible, nontraumatic control of the cardinal biomechanical features of the subluxation: fixation and misalignment. A detailed description of current ELM procedures is presented and practical issues are reviewed such as expense (dollars and time) and construct failure rates during and after the surgical implant procedure. METHOD: Descriptive report of current ELM procedures, refinements to the spinous attachment units (SAUs), and tabulation of costs and failure rates drawn from recent studies. RESULTS: In contrast to the older, 1-piece stainless steel SAUs, new 3-piece titanium SAUs may be reimplanted many times without failure. Consequently, the cost per ELM ranges from $579 to $69, depending on whether the SAUs, links, and screws must be purchased or are already available for implanting. The SAU implant procedure requires between 0.5 and 1.25 hours, depending on the experience of the surgeon. The total construct failure rate for the ELM is 24.2% (6.6% at surgery failure + 17.8% postsurgery failures). This rate is consistent with that reported in spine implant studies with other devices. To date, more than 500 male Sprague-Dawley rats (350-450 g) have been implanted with SAUs for ELM studies at the Palmer Center for Chiropractic Research and the National University of Health Sciences. CONCLUSION: It has been our experience that individuals with basic animal research training will become proficient at producing the ELM after observing 3 to 4 implant procedures and performing 4 to 6 procedures on their own.

Trends of spinal fusion surgery in Australia: 1997 to 2006.

BACKGROUND: This study aims to explore the trend in spine fusion surgery in Australia over the past 10 years, and to explore the possible influence of health insurance status (private versus public) on the rate of surgery. METHODS: Data pertaining to the rate of lumbar spine fusion from 1997 to 2006 were collected from Inpatient Statistics Collection of NSW Health, Medicare Australia Statistics and the Australian Bureau of Statistics. Data on total hip and total knee arthroplasties were collected to provide a comparator. RESULTS: The number of publicly performed spinal fusion procedures increased by 2% from 1997 to 2006. In comparison, privately performed spinal fusion procedures increased by 167% over the same 10-year period. In 2006, spine fusion surgery was 10.8 times more likely to be done in the private sector than in the public sector, compared with corresponding figures of 4.2 times and 3.0 times for knee replacement and hip replacement, respectively. Waiting list data showed no increase in demand for spine fusion surgery in the public sector. CONCLUSION: There is a disproportionately high rate of lumbar spine fusion surgery performed in the private sector, given the rate of private insurance. The rate of increase was found to be higher than that for hip or knee arthroplasty procedures. Possible explanations for this difference include: over-servicing in the private sector, under-servicing in the public sector, differences in medical referral patterns, surgeon and patient preferences and financial incentives.

Costs and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine.

UNLABELLED: During the recent years improved operation techniques and administrative procedures have been developed for early rehabilitation. At the same time preoperative lifestyle intervention (prehabilitation) has revealed a large potential for additional risk reduction. The aim was to assess the quality of life and to estimate the cost-effectiveness of standard care versus an integrated programme including prehabilitation and early rehabilitation. METHODS: The analyses were based on the results from 60 patients undergoing lumbar fusion for degenerative lumbar disease; 28 patients were randomised to the integrated programme and 32 to the standard care programme. Data on cost and health related quality of life was collected preoperatively, during hospitalisation and postoperatively. The cost was estimated from multiplication of the resource consumption and price per unit. RESULTS: Overall there was no difference in health related quality of life scores. The patients from the integrated programme obtained their postoperative milestones sooner, returned to work and soaked less primary care after discharge. The integrated programme was 1,625 euros (direct costs 494 euros + indirect costs 1,131 euros) less costly per patient compared to the standard care programme. CONCLUSION: The integrated programme of prehabilitation and early rehabilitation in spine surgery is more cost-effective compared to standard care programme alone.

The Cell Saver in adult lumbar fusion surgery: a cost-benefit outcomes study.

STUDY DESIGN: Review of efficacy of Cell Saver in a nonrandomized group of patients undergoing lumbar fusion. OBJECTIVES: Determine the necessity and cost-effectiveness of the use of Cell Saver for adult lumbar spine fusions. SUMMARY OF BACKGROUND DATA: Specific indications for the use of Cell Saver in adult lumbar fusion surgery have not been clearly determined. In addition to effectiveness in blood replacement, the economic benefits of the Cell Saver have not been evaluated. METHODS: A total of 102 consecutive cases of posterolateral fusion with internal fixation were reviewed retrospectively. There were 56 patients in the Cell Saver group and 46 patients in the control group. Recorded hospital medical and financial data were analyzed for each patient. RESULTS: There was a 38% recovery rate of blood using the Cell Saver. This resulted in a decreased need for postoperative transfusion in the study group (1 U to 36% of patients) relative to the control group (1 U to 50% of patients). Significant predictors for surgery time were the number of levels fused (P < 0.0001), patient's weight (P = 0.0030), and use of Cell Saver (P = 0.0472). Significant indicators of blood loss were the number of levels fused (P < 0.0001) and surgical time (P = 0.0304). The average cost for blood-related charges in the Cell Saver group was 512 dollars versus 270 dollars per patient in the control group. CONCLUSIONS.: While the Cell Saver group did require fewer postoperative transfusions, the difference was not as much as expected. In elective fusions for degenerative conditions of the lumbar spine, blood requirements can usually be satisfied with predonation of autologous blood. With contemporary practices of predonation, the use of the Cell Saver appears to be neither necessary nor cost-effective during most elective lumbar fusions.

Autotransfusion by cell saver technique in surgery of lumbar and thoracic spinal fusion with instrumentation.

OBJECT: The authors used a modern cell saver technique to perform autotransfusion in patients undergoing instrument-assisted lumbar and/or thoracic spinal fusion, in whom significant blood loss was anticipated. The safety and benefits of this procedure as well as its cost effectiveness were analyzed. METHODS: The authors studied 50 patients who underwent lumbar and/or thoracic spinal fusion in which instrumentation was placed between January 1998 and June 2000 and in whom an estimated blood loss of 500 ml or more was expected. All surgeries were conducted by a single neurosurgeon (D.R.S.). During surgery, the Brat 2 cell saver system was used to salvage the autologous blood. The anesthesiologist and surgeon jointly decided, on the basis of hematocrit and clinical stability, whether transfusion was necessary in each patient. Various parameters (hematocrit, plasma and urine hemoglobin, platelet counts, coagulation profile, and serum bilirubin) were measured pre-, intra-, and postoperatively. Thirty-three patients (66%) required transfusion. The mean blood loss in these patients was 1046 ml. The most important factor affecting blood loss was the number of levels fused (p < 0.0001). Only two patients required postoperative homologous transfusion. The mean decrease in hematocrit was 7.82%. The maximum reduction of platelet count was limited to 80,000/mm3. Major complications such as hemoglobinuria, coagulopathy, cardiopulmonary problems, air embolism, and major sepsis were not observed in this study. CONCLUSIONS: Autotransfusion performed using a modern cell saver technique is safe and has many advantages over homologous transfusion. It conserves the homologous blood resources. The costs of the two modes are statistically comparable when greater than 500 ml of red blood cell transfusion is necessary.

Efficacy and cost considerations of intraoperative autologous transfusion in spinal fusion for idiopathic scoliosis with predeposited blood.

STUDY DESIGN: One hundred five patients with adolescent idiopathic scoliosis who underwent posterior spinal instrumentation and fusion with predeposited autologous blood, with or without intraoperative autologous transfusion, were reviewed. OBJECTIVE: To determine the benefit/nonbenefit of intraoperative autologous transfusion in diminishing the need for homologous blood and influencing post-operative hematocrit values in healthy adolescents undergoing spinal fusion for scoliosis. SUMMARY OF BACKGROUND DATA: A steady increase in the use of intraoperative autologous transfusion in recent years has occurred without guidelines regarding which procedures and patient populations would be best served. Previous studies have failed to determine the cost effectiveness and actual reduction in homologous blood exposure attributable to intraoperative autologous transfusion in adolescents who have undergone preoperative phlebotomy. METHODS: Fifty-five adolescents (intraoperative autologous transfusion group) who underwent posterior instrumentation and fusion for idiopathic scoliosis with the use of an intraoperative autologous transfusion device were compared to 50 patients (control group) who underwent the same procedure without the intraoperative autologous transfusion device. RESULTS: The average percent salvage of red blood cells by the intraoperative autologous transfusion device was 35%. The control group utilized significantly more of the predonated autologous blood than the intraoperative autologous transfusion group (1.34 units/case vs. 1.78 units/case, P < 0.05). Homologous blood usage was the same in both groups. Two patients in the intraoperative autologous transfusion group required nondirected homologous blood (total of four units), compared to three patients in the control group (total of four units) (P = 0.048). Using multiple regression analysis, the total number of transfusions was significantly correlated with the estimated blood loss and the duration of surgery in both groups. Postoperative hematocrit levels were slightly higher in the control group, but there was not a significant difference. CONCLUSIONS: The addition of intraoperative autologous transfusion to a preoperative phlebotomy program had no benefit on homologous blood exposure or post-operative hematocrit changes in this population. Blood requirements for this procedure can be met less expensively and more reliably by merely donating one's own blood.