Tim Adamson, Saniya S. Godil, Melissa Mehrlich, Stephen Mendenhall, Anthony L. Asher and Matthew J. McGirt
In an era of escalating health care costs and pressure to improve efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed, and the frequency of its performance is rapidly increasing as the aging population grows. Although ASCs offer significant cost advantages over hospital-based surgical centers, concern over the safety of outpatient ACDF has slowed its adoption. The authors intended to 1) determine the safety of the first 1000 consecutive ACDF surgeries performed in their outpatient ASC, and 2) compare the safety of these outpatient ACDFs with that of consecutive ACDFs performed during the same time period in the hospital setting.
A total of 1000 consecutive patients who underwent ACDF in an ACS (outpatient ACDF) and 484 consecutive patients who underwent ACDF at Vanderbilt University Hospital (inpatient ACDF) from 2006 to 2013 were included in this retrospective study of patients' medical records. Data were collected on patient demographics, comorbidities, operative details, and perioperative and 90-day morbidity. Perioperative morbidity and hospital readmission were compared between the outpatient and inpatient ACDF groups.
Of the first 1000 outpatient ACDF cases performed in the authors' ASC, 629 (62.9%) were 1-level and 365 (36.5%) were 2-level ACDFs. Mean patient age was 49.5 ± 8.6, and 484 (48.4%) were males. All patients were observed postoperatively at the ASC postanesthesia care unit (PACU) for 4 hours before being discharged home. Eight patients (0.8%) were transferred from the surgery center to the hospital postoperatively (for pain control [n = 3], chest pain and electrocardiogram changes [n = 2], intraoperative CSF leak [n = 1], postoperative hematoma [n = 1], and profound postoperative weakness and surgical reexploration [n = 1]). No perioperative deaths occurred. The 30-day hospital readmission rate was 2.2%. All 90-day surgical morbidity was similar between outpatient and inpatient cohorts for both 1-level and 2-level ACDFs.
An analysis of 1000 consecutive patients who underwent ACDF in an outpatient setting demonstrates that surgical complications occur at a low rate (1%) and can be appropriately diagnosed and managed in a 4-hour ASC PACU window. Comparison with an inpatient ACDF surgery cohort demonstrated similar results, highlighting that ACDF can be safely performed in the outpatient ambulatory surgery setting without compromising surgical safety. In an effort to decrease costs of care, surgeons can safely perform 1- and 2-level ACDFs in an ASC environment.
Scott L. Parker, Anthony L. Asher, Saniya S. Godil, Clinton J. Devin and Matthew J. McGirt
The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care.
All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months.
A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity.
In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.
Matthew J. McGirt, Saniya S. Godil, Anthony L. Asher, Scott L. Parker and Clinton J. Devin
In an era of escalating health care cost and universal pressure of improving efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and is rapidly increasing with an expanding aging population. While ASCs offer cost advantages for ACDF, there is a scarcity of evidence that ASCs allow for equivalent quality and thus superior health care value. Therefore, the authors analyzed a nationwide, prospective quality improvement registry (National Surgical Quality Improvement Program [NSQIP]) to compare the quality of ACDF surgery performed in the outpatient ASC versus the inpatient hospital setting.
Patients undergoing ACDF (2005-2011) were identified from the NSQIP database based on the primary Current Procedural Terminology codes. Patients were divided into 2 cohorts (outpatient vs inpatient) based on the acute care setting documented in the NSQIP database. All 30-day surgical morbidity and mortality rates were compared between the 2 groups. Propensity score matching and multivariate logistic regression analysis were used to adjust for confounding factors and to identify the independent association of outpatient ACDF with perioperative outcomes and morbidity.
A total of 7288 ACDF cases were identified (inpatient = 6120, outpatient = 1168). Unadjusted rates of major morbidity (0.94% vs 4.5%, p < 0.001) and return to the operating room (OR) within 30 days (0.3% vs 2.0%, p < 0.001) were significantly lower in outpatient versus inpatient ACDF. After propensity matching 1442 cases (inpatient = 650, outpatient = 792) based on baseline 32 covariates, rates of major morbidity (1.4% vs 3.1%, p = 0.03), and return to the OR (0.34% vs 1.4%, p = 0.04) remained significantly lower after outpatient ACDF. Adjusted comparison using multivariate logistic regression demonstrated that ACDF performed in the outpatient setting had 58% lower odds of having a major morbidity and 80% lower odds of return to the OR within 30 days.
An analysis of a nationwide, prospective quality improvement registry representing more than 250 hospitals demonstrates that 1- to 2-level ACDF can be safely performed in the outpatient ambulatory surgery setting in patients who are appropriate candidates. In an effort to decrease cost of care, surgeons can safely consider performing ACDF in an ASC environment.
Scott L. Parker, Saniya S. Godil, Stephen K. Mendenhall, Scott L. Zuckerman, David N. Shau and Matthew J. McGirt
Current health care reform calls for a reduction of procedures and treatments that are less effective, more costly, and of little value (high cost/low quality). The authors assessed the 2-year cost and effectiveness of comprehensive medical management for lumbar spondylolisthesis, stenosis, and herniation by utilizing a prospective single-center multidisciplinary spine center registry in a real-world practice setting.
Analysis was performed on a prospective longitudinal quality of life spine registry. Patients with lumbar spondylolisthesis (n = 50), stenosis (n = 50), and disc herniation (n = 50) who had symptoms persisting after 6 weeks of medical management and who were eligible for surgical treatment were entered into a prospective registry after deciding on nonsurgical treatment. In all cases, comprehensive medical management included spinal steroid injections, physical therapy, muscle relaxants, antiinflammatory medication, and narcotic oral agents. Two-year patient-reported outcomes, back-related medical resource utilization, and occupational work-day losses were prospectively collected and used to calculate Medicare fee–based direct and indirect costs from the payer and societal perspectives. The maximum health gain associated with medical management was defined as the improvement in pain, disability, and quality of life experienced after 2 years of medical treatment or at the time a patient decided to cross over to surgery.
The maximum health gain in back pain, leg pain, disability, quality of life, depression, and general health state did not achieve statistical significance by 2 years of medical management, except for pain and disability in patients with disc herniation and back pain in patients with lumbar stenosis. Eighteen patients (36%) with spondylolisthesis, 11 (22%) with stenosis, and 17 (34%) with disc herniation eventually required surgical management due to lack of improvement. The 2-year improvement did not achieve a minimum clinically important difference in any outcome measure. The mean 2-year total cost (direct plus indirect) of medical management was $6606 for spondylolisthesis, $7747 for stenosis, and $7097 for herniation.
In an institution-wide, prospective, longitudinal quality of life registry that measures cost and effectiveness of all spine care provided, comprehensive medical management did not result in sustained improvement in pain, disability, or quality of life for patients with surgically eligible degenerative lumbar spondylolisthesis, stenosis, or disc herniation. From both the societal and payer perspective, continued medical management of patients with these lumbar pathologies in whom 6 weeks of conservative therapy failed was of minimal value given its lack of health utility and effectiveness and its health care costs. The findings from this real-world practice setting may more accurately reflect the true value and effectiveness of nonoperative care in surgically eligible patient populations.
Scott L. Parker, Saniya S. Godil, Scott L. Zuckerman, Stephen K. Mendenhall, Noel B. Tulipan and Matthew J. McGirt
Suboccipital decompression is a common procedure for patients with Chiari malformation Type I (CMI). Published studies have reported complication rates ranging from 3% to 40%, with pseudomeningocele being one of the most common complications. To date, there are no studies assessing the effect of this complication on long-term outcome. Therefore, the authors set out to assess the effect of symptomatic pseudomeningocele on patient outcomes following suboccipital decompression for CM-I.
The study comprised 50 adult patients with CM-I who underwent suboccipital craniectomy and C-1 laminectomy with or without duraplasty. Clinical presentation, radiological studies, operative variables, and complications were assessed for each case. Baseline and 1-year postoperative patient-reported outcomes were assessed to determine improvement in pain, disability, and quality of life. The extent of improvement was compared for patients with and without development of a postoperative symptomatic pseudomeningocele.
A symptomatic pseudomeningocele developed postoperatively in 9 patients (18%). There was no difference with regard to clinical, radiological, or operative variables for patients with or without a postoperative pseudomeningocele. Patients without a pseudomeningocele had significant improvement in all 9 patient-reported outcome measures assessed. On the other hand, patients with pseudomeningocele only had significant improvement in headache (as measured on the Numeric Rating Scale) and headache-related disability (as measured on the Headache Disability Index) but no improvement in quality of life. Twenty-nine (71%) of 41 patients without a pseudomeningocele reported improvement in health status postoperatively compared with only 3 (33%) of 9 patients with a postoperative pseudomeningocele (p = 0.05).
Surgical management of CM-I in adults provides significant and sustained improvement in pain, disability, general health, and quality of life. Development of a postoperative symptomatic pseudomeningocele has lingering effects at 1 year, and it significantly diminishes the overall benefit of suboccipital decompression for CM-related symptoms. Further research is needed to accurately predict which patients may benefit from decompression alone without duraplasty.
Comparative effectiveness and cost-benefit analysis of local application of vancomycin powder in posterior spinal fusion for spine trauma
Presented at the 2013 Joint Spine Section Meeting
Saniya S. Godil, Scott L. Parker, Kevin R. O'Neill, Clinton J. Devin and Matthew J. McGirt
Surgical site infection (SSI) is a morbid complication with high cost in spine surgery. In this era of health care reforms, adjuvant therapies that not only improve quality but also decrease cost are considered of highest value. The authors introduced local application of vancomycin powder into their practice of posterior spinal fusion for spine trauma and undertook this study to determine the value and cost benefit of using vancomycin powder in surgical sites to prevent postoperative infections.
A retrospective review of 110 patients with traumatic spine injuries treated with instrumented posterior spine fusions over a 2-year period at a single institution was performed. One group (control group) received standard systemic prophylaxis only, whereas another (treatment group) received 1 g of locally applied vancomycin powder (spread over the surgical wound) in addition to systemic prophylaxis. Data were collected on patient demographic characteristics, clinical variables, surgical variables, and 90-day morbidity. Incidence of infection was the primary outcome evaluated, and billing records were reviewed to determine total infection-related medical cost (cost of reoperation/wound debridement, medications, and diagnostic tests). The payer's cost was estimated to be 70% of the total billing cost.
A total of 110 patients were included in the study. The control (n = 54) and treatment groups (n = 56) were similar at baseline. Use of vancomycin powder led to significant reduction in infection rate (13% infection rate in the control group vs 0% in the treatment group, p = 0.02). There were no adverse effects noted from the use of vancomycin powder. The total mean cost of treating postoperative infection per patient was $33,705. Use of vancomycin powder led to a cost savings of $438,165 per 100 posterior spinal fusions performed for traumatic injuries.
The use of adjuvant vancomycin powder was associated with a significant reduction in the incidence of postoperative infection as well as infection-related medical cost. These findings suggest that use of adjuvant vancomycin powder in high-risk patients undergoing spinal fusion is a cost-saving option for preventing postoperative infections, as it can lead to cost-savings of $438,165 per 100 spinal fusions performed.
Scott L. Parker, Saniya S. Godil, David N. Shau, Stephen K. Mendenhall and Matthew J. McGirt
Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome (PRO) questionnaires. Although these questionnaires assess pain, disability, and general health state, their numerical scores lack direct, clinically significant meaning. Thus, the concept of minimum clinically important difference (MCID) has been introduced, which indicates the smallest change in an outcome measure that reflects clinically meaningful improvement to patients. The authors set out to determine anterior cervical discectomy and fusion (ACDF)–specific MCID values for the visual analog scale (VAS), Neck Disability Index (NDI), 12-Item Short-Form Health Survey (SF-12), and EQ-5D (the EuroQol health survey) in patients undergoing ACDF for cervical radiculopathy.
Data on 69 patients who underwent ACDF for cervical radiculopathy were collected in the authors' web-based, prospective registry during the study enrollment period. Patient-reported outcome questionnaires (VAS–neck pain [NP]), VAS–arm pain [AP], NDI, SF-12, and EQ-5D) were administered preoperatively and 3 months postoperatively, allowing 3-month change scores to be calculated. Four established calculation methods were used to calculate anchor-based MCID values using the North American Spine Society (NASS) patient satisfaction scale as the anchor: 1) average change, 2) minimum detectable change (MDC), 3) change difference, and 4) receiver operating characteristic (ROC) curve analysis.
Sixty-one patients (88%) were available at follow-up. At 3 months postoperatively, statistically significant improvement (p < 0.001) was observed for the following PROs assessed: VAS-NP (2.7 ± 3.3), VAS-AP (3.7 ± 3.6), NDI (23.2% ± 19.7%), SF-12 physical component score (PCS; 10.7 ± 9.7), and EQ-5D (0.20 ± 0.23 QALY). Improvement on the SF-12 mental component score (MCS) trended toward significance (3.4 ± 11.4, p = 0.07). The 4 MCID calculation methods generated a range of MCID values for each of the PROs: VAS-NP 2.6–4.0, VAS-AP 2.4–4.2, NDI 16.0%–27.6%, SF-12 PCS 7.0–12.2, SF-12 MCS 0.0–7.2, and EQ-5D 0.05–0.24 QALY. The maximum area under the curve (AUC) was observed for NDI (0.80), and the minimum AUC was observed for SF-12 MCS (0.66) and EQ-5D (0.67). Based on the MDC approach, the MCID threshold was 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D. The mean improvement in patient scores at 3 months surpassed the MCID threshold for VAS-NP, NDI, and SF-12 PCS but not for VAS-AP, SF-12 MCS, and EQ-5D.
The ACDF-specific MCID is highly variable depending on the calculation technique used. The MDC approach seems to be most appropriate for MCID calculations in the ACDF population, as it provided a threshold value above the 95% confidence interval of nonresponders (greater than the measurement error) and was closest to the average change of most PROs reported by responders. When the MDC method was applied with the NASS patient satisfaction scale as the anchor, the MCID thresholds were 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D.