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A Cost Benefit Analysis of Increasing Surgical Technology in Lumbar Spine Fusion

Passias, Peter G; Brown, Avery E; Alas, Haddy; Bortz, Cole A; Pierce, Katherine E; Hassanzadeh, Hamid; Labaran, Lawal A; Puvanesarajah, Varun; Vasquez-Montes, Dennis; Wang, Erik; Ihejirika, Rivka C; Diebo, Bassel G; Lafage, Virginie; Lafage, Renaud; Sciubba, Daniel M; Janjua, Muhammad Burhan; Protopsaltis, Themistocles S; Buckland, Aaron J; Gerling, Michael C
BACKGROUND CONTEXT/BACKGROUND:Numerous advances have been made in the field of spine fusion, such as minimally invasive (MIS) or robotic-assisted spine surgery. However, it is unknown how these advances have impacted the cost of care. PURPOSE/OBJECTIVE:Compare the economic outcomes of lumbar spine fusion between open, MIS, and robot-assisted surgery patients. STUDY DESIGN/SETTING/METHODS:Retrospective review of a single center spine surgery database. PATIENT SAMPLE/METHODS:360 propensity matched patients. OUTCOME MEASURES/METHODS:Costs, EuroQol-5D (EQ5D), cost per quality adjusted life years (QALY). METHODS:Inclusion criteria: surgical patients >18 years undergoing lumbar fusion surgery. Patients were categorized into 3 groups based on procedure type: open, MIS, or robotic. Open patients undergoing poster spinal fusion were considered as the control group. MIS patients included those undergoing transforaminal or lateral lumbar interbody fusion with percutaneous screws. Robotic patients were those undergoing robot-assisted fusion. Propensity score matching was performed between all groups for the number of levels fused. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims for ICD-9 codes. For robotic cases, costs were reflective of operational fees and initial purchase cost. Complications and comorbidities (CC) and major complications and comorbidities (MCC) were assessed according to CMS.gov manual definitions. QALYs and cost per QALY were calculated using a 3% discount rate to account for residual decline to life expectancy (78.7 years). Costs per QALY were calculated for both 1 year and life expectancy, assuming no loss of benefit. A 10,000 trial Monte Carlo simulation with probabilistic sensitivity analysis (PSA) assessed our model parameters and costs. RESULTS:360 propensity matched patients (120 open, 120 MIS, 120 robotic) met inclusion criteria. Descriptive statistics for the cohort were: age 58.8 ± 13.5, 50% women, BMI 29.4 ± 6.3, operative time 294.4 ± 119.0, LOS 4.56 ± 3.31 days, EBL 515.9 ± 670.0 cc, and 2.3 ± 2.2 average levels fused. Rates of post-op complications were significantly higher in robotic cases versus open and MIS (43% vs. 21% and 22% for open and MIS, p<0.05). However, revision rates were comparable between all groups (3% open, 3% MIS, 5% robotic, p>0.05). After factoring in complications, revisions, and purchasing and operating fees, the costs of robotic cases was significantly higher than both open and MIS surgery ($60,047.01 vs. $42,538.98 open and $41,471.21 MIS). In a subanalysis of 42 patients with baseline (BL) and 1Y EQ5D data, the cost per QALY at 1Y for open, MIS, and robot-assisted cases was $296,624.48, $115,911.69, and $592,734.30. If utility gained was sustained to life expectancy, the cost per QALY was $14,905.75, $5,824.71, $29,785.64 for open, MIS, and robot-assisted cases. Results of the PSA were consistent with MIS surgery having the most incremental cost effectiveness when compared to open and robotic surgery. CONCLUSIONS:Numerous advances have been made in the field of spine surgery, however, there has been limited discussion of the effect these advances have on economic outcomes. When matched for levels fused, robot-assisted surgery patients had significantly higher rates of complications and 30% higher costs of surgery compared to minimally invasive and open spine surgery patients. While 1 year economic outcomes weren't optimal for robotic surgery cases, the projected costs per quality adjusted life years at life expectancy were well below established acceptable thresholds. The above findings may be reflective of an educational learning curve and emerging surgical technologies undergoing progressive refinement.
PMID: 33069859
ISSN: 1878-1632
CID: 4641872

Effect of age-adjusted alignment goals and distal inclination angle on the fate of distal junctional kyphosis in cervical deformity surgery

Passias, Peter Gust; Horn, Samantha R; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Line, Breton G; Protopsaltis, Themistocles S; Soroceanu, Alex; Bortz, Cole; Segreto, Frank A; Ahmad, Waleed; Naessig, Sara; Pierce, Katherine E; Brown, Avery E; Alas, Haddy; Kim, Han Jo; Daniels, Alan H; Klineberg, Eric O; Burton, Douglas C; Hart, Robert A; Schwab, Frank J; Bess, Shay; Shaffrey, Christopher I; Ames, Christopher P
Background/UNASSIGNED:Age-adjusted alignment targets in the context of distal junctional kyphosis (DJK) development have yet to be investigated. Our aim was to assess age-adjusted alignment targets, reciprocal changes, and role of lowest instrumented level orientation in DJK development in cervical deformity (CD) patients. Methods/UNASSIGNED:CD patients were evaluated based on lowest fused level: cervical (C7 or above), upper thoracic (UT: T1-T6), and lower thoracic (LT: T7-T12). Age-adjusted alignment targets were calculated using published formulas for sagittal vertical axis (SVA), pelvic incidence-lumbar lordosis (PI-LL), pelvic tilt (PT), T1 pelvic angle (TPA), and LL-thoracic kyphosis (TK). Outcome measures were cervical and global alignment parameters: Cervical SVA (cSVA), cervical lordosis, C2 slope, C2-T3 angle, C2-T3 SVA, TS-CL, PI-LL, PT, and SVA. Subanalysis matched baseline PI to assess age-adjusted alignment between DJK and non-DJK. Results/UNASSIGNED:< 0.05). The distribution of over/under corrected patients and the offset between actual and ideal alignment for SVA, PT, TPA, PI-LL, and LL-TK were similar between DJK and non-DJK patients. DJK patients requiring reoperation had worse postoperative changes in all cervical parameters and trended toward larger offsets for global parameters. Conclusion/UNASSIGNED:CD patients with severe baseline malalignment went on to develop postoperative DJK. Age-adjusted alignment targets did not capture differences in these populations, suggesting the need for cervical-specific goals.
PMCID:8035585
PMID: 33850384
ISSN: 0974-8237
CID: 4875702

Multicenter assessment of surgical outcomes in adult spinal deformity patients with severe global coronal malalignment: determination of target coronal realignment threshold

Buell, Thomas J; Smith, Justin S; Shaffrey, Christopher I; Kim, Han Jo; Klineberg, Eric O; Lafage, Virginie; Lafage, Renaud; Protopsaltis, Themistocles S; Passias, Peter G; Mundis, Gregory M; Eastlack, Robert K; Deviren, Vedat; Kelly, Michael P; Daniels, Alan H; Gum, Jeffrey L; Soroceanu, Alex; Hamilton, D Kojo; Gupta, Munish C; Burton, Douglas C; Hostin, Richard A; Kebaish, Khaled M; Hart, Robert A; Schwab, Frank J; Bess, Shay; Ames, Christopher P
OBJECTIVE:The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes. METHODS:This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed. RESULTS:Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK). CONCLUSIONS:Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.
PMID: 33276327
ISSN: 1547-5646
CID: 4825652

Trends in Pain Medication Prescriptions and Satisfaction Scores in Spine Surgery Patients at a Single Institution

Wang, Erik; Vasquez-Montes, Dennis; Jain, Deeptee; Hutzler, Lorraine H; Bosco, Joseph A; Protopsaltis, Themistocles S; Buckland, Aaron J; Fischer, Charla R
BACKGROUND:As the opioid crisis has gained national attention, there have been increasing efforts to decrease opioid usage. Simultaneously, patient satisfaction has been a crucial metric in the American health care system and has been closely linked to effective pain management in surgical patients. The purpose of this study was to examine rates of pain medication prescription and concurrent patient satisfaction in spine surgery patients. METHODS:test of independence was used to compare percentages, and 1-way analysis of variance was used to compare means across quarters. RESULTS:value range, .359-.988). CONCLUSIONS:Over the studied time period, opioid use decreased and nonopioid prescriptions increased during hospitalization, whereas satisfaction scores remained unchanged. These findings indicate an increasing effort in reducing opioid use among providers and suggest the ability to do so without affecting overall satisfaction rates. LEVEL OF EVIDENCE/METHODS:4. CLINICAL RELEVANCE/CONCLUSIONS:The opioid epidemic has highlighted the need to reduce opioid usage in orthopedic spine surgery. This study reviews the trends for inpatient management of post-op pain in orthopedic spine surgery patients in relation to patient satisfaction. There was a significant increase in non-opioid analgesic pain medications, and a reduction in opioids during the study period. During this time, patient satisfaction as measured by Press-Ganey surveys did not show a decrease. This demonstrates that treatment of post-operative pain in orthopedic spine surgery patients can be managed with less opioids, more multimodal analgesia, and patient satisfaction will not be affected.
PMID: 33560264
ISSN: 2211-4599
CID: 4779592

A Simpler, Modified Frailty Index Weighted by Complication Occurrence Correlates to Pain and Disability for Adult Spinal Deformity Patients

Passias, Peter G; Bortz, Cole A; Pierce, Katherine E; Alas, Haddy; Brown, Avery; Vasquez-Montes, Dennis; Naessig, Sara; Ahmad, Waleed; Diebo, Bassel G; Raman, Tina; Protopsaltis, Themistocles S; Buckland, Aaron J; Gerling, Michael C; Lafage, Renaud; Lafage, Virginie
BACKGROUND:The Miller et al adult spinal deformity frailty index (ASD-FI) correlates with complication risk; however, its development was not rooted in clinical outcomes, and the 40 factors needed for its calculation limit the index's clinical utility. The present study aimed to develop a simplified, weighted frailty index for ASD patients METHODS: This study is a retrospective review of a single-center database. Component ASD-FI parameters contributing to overall ASD-FI score were assessed via Pearson correlation. Top significant, clinically relevant factors were regressed against ASD-FI score to generate the modified ASD-FI (mASD-FI). Component mASD-FI factors were regressed against incidence of medical complications, and factor weights were calculated from regression of these coefficients. Total mASD-FI score ranged from 0 to 21, and was calculated by summing weights of expressed parameters. Linear regression and published ASD-FI cutoffs generated corresponding mASD-FI frailty cutoffs: not frail (NF, <7), frail (7-12), severely frail (SF, >12). Analysis of variance assessed the relationship between frailty category and validated baseline measures of pain and disability at baseline. RESULTS:= .001). CONCLUSIONS:This study modifies an existing ASD frailty index and proposes a weighted, shorter mASD-FI. The mASD-FI relies less on patient-reported variables, and it weights component factors by their contribution to adverse outcomes. Because increasing mASD-FI score is associated with inferior clinical measures of pain and disability, the mASD-FI may serve as a valuable tool for preoperative risk assessment.
PMID: 33560265
ISSN: 2211-4599
CID: 4779602

Neurological Complications and Recovery Rates of Patients With Adult Cervical Deformity Surgeries

Kim, Han Jo; Yao, Yu-Cheng; Shaffrey, Christopher I; Smith, Justin S; Kelly, Michael P; Gupta, Munish; Albert, Todd J; Protopsaltis, Themistocles S; Mundis, Gregory M; Passias, Peter; Klineberg, Eric; Bess, Shay; Lafage, Virginie; Ames, Christopher P
STUDY DESIGN/UNASSIGNED:Retrospective cohort study. OBJECTIVE/UNASSIGNED:This study aims to report the incidence, risk factors, and recovery rate of neurological complications (NC) in patients with adult cervical deformity (ACD) who underwent corrective surgery. METHODS/UNASSIGNED:ACD patients undergoing surgery from 2013 to 2015 were enrolled in a prospective, multicenter database. Patients were separated into 2 groups according to the presence of neurological complications (NC vs no-NC groups). The types, timing, recovery patterns, and interventions for NC were recorded. Patients' demographics, surgical details, radiographic parameters, and health-related quality of life (HRQOL) scores were compared. RESULTS/UNASSIGNED:106 patients were prospectively included. Average age was 60.8 years with a mean of 18.2 months follow-up. The overall incidence of NC was 18.9%; of these, 68.1% were major complications. Nerve root motor deficit was the most common complication, followed by radiculopathy, sensory deficit, and spinal cord injury. The proportion of complications occurring within 30 days of surgery was 54.5%. The recovery rate from neurological complication was high (90.9%), with most of the recoveries occurring within 6 months and continuing even after 12 months. Only 2 patients (1.9%) had continuous neurological complication. No demographic or preoperative radiographic risk factors could be identified, and anterior corpectomy and posterior foraminotomy were found to be performed less in the NC group. The final HRQOL outcome was not significantly different between the 2 groups. CONCLUSIONS/UNASSIGNED:Our data is valuable to surgeons and patients to better understand the neurological complications before performing or undergoing complex cervical deformity surgery.
PMID: 33222533
ISSN: 2192-5682
CID: 4702292

Surgical Treatment of Complete Foot Drop: Partial Tibial Nerve Transfer to the Motor Branch of the Tibialis Anterior: 2-Dimensional Operative Video

Protopsaltis, Themistocles S; Parekh, Yesha H
This video will be demonstrating the surgical treatment of complete foot drop with partial tibial nerve transfer to the motor branch of the tibialis anterior. Foot drop occurs when there is injury to the deep peroneal nerve that results in the paralysis of the tibialis anterior muscle and subsequent loss of ankle dorsiflexion.1-5 The patient who is the subject of this video is a 27-yr-old female with a 6-mo history of foot drop. She presented with complete loss of ankle dorsiflexion and great toe extension due to traumatic fall on her left knee while running. Upon physical examination, she had all the features of complete foot drop with loss of ankle dorsiflexion and ankle eversion. She also had decreased sensation to light touch over left dorsal foot, left great toe, and left lateral lower leg. The patient has consented to this procedure. The partial tibial nerve transfer to the motor branch of tibialis anterior muscle is the preferred treatment option for foot drop as it restores ankle dorsiflexion with minimal donor site complications. At 12 mo postsurgery, she has regained 4/5 for ankle dorsiflexion on motor testing compared to the 0/5 she had preoperatively.
PMID: 32717024
ISSN: 2332-4260
CID: 5010402

Practical answers to frequently asked questions for shared decision-making in adult spinal deformity surgery

Ogura, Yoji; Gum, Jeffrey L; Soroceanu, Alex; Daniels, Alan H; Line, Breton; Protopsaltis, Themistocles; Hostin, Richard A; Passias, Peter G; Burton, Douglas C; Smith, Justin S; Shaffrey, Christopher I; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric O; Kim, Han Jo; Harris, Andrew; Kebaish, Khaled; Schwab, Frank; Bess, Shay; Ames, Christopher P; Carreon, Leah Y
OBJECTIVE:The shared decision-making (SDM) process provides an opportunity to answer frequently asked questions (FAQs). The authors aimed to present a concise list of answers to FAQs to aid in SDM for adult spinal deformity (ASD) surgery. METHODS:From a prospective, multicenter ASD database, patients enrolled between 2008 and 2016 who underwent fusions of 5 or more levels with a minimum 2-year follow-up were included. All deformity types were included to provide general applicability. The authors compiled a list of FAQs from patients undergoing ASD surgery and used a retrospective analysis to provide answers. All responses are reported as either the means or the proportions reaching the minimal clinically important difference at the 2-year follow-up interval. RESULTS:Of 689 patients with ASD who were eligible for 2-year follow-up, 521 (76%) had health-related quality-of-life scores available at the time of that follow-up. The mean age at the initial surgery was 58.2 years, and 78% of patients were female. The majority (73%) underwent surgery with a posterior-only approach. The mean number of fused levels was 12.2. Revision surgery accounted for 48% of patients. The authors answered 12 FAQs as follows:1. Will my pain improve? Back and leg pain will both be reduced by approximately 50%.2. Will my activity level improve? Approximately 65% of patients feel improvement in their activity level.3. Will I feel better about myself? More than 70% of patients feel improvement in their appearance.4. Is there a chance I will get worse? 4.1% feel worse at 2 years postoperatively.5. What is the likelihood I will have a complication? 67.8% will have a major or minor complication, with 47.8% having a major complication.6. Will I need another surgery? 25.0% will have a reoperation within 2 years.7. Will I regret having surgery? 6.5% would not choose the same treatment.8. Will I get a blood transfusion? 73.7% require a blood transfusion.9. How long will I stay in the hospital? You need to stay 8.1 days on average.10. Will I have to go to the ICU? 76.0% will have to go to the ICU.11. Will I be able to return to work? More than 70% will be working at 1 year postoperatively.12. Will I be taller after surgery? You will be 1.1 cm taller on average. CONCLUSIONS:The above list provides concise, practical answers to FAQs encountered in the SDM process while counseling patients for ASD surgery.
PMID: 33065535
ISSN: 1547-5646
CID: 4798412

Biologics and Minimally Invasive Approach to TLIFs: What Is the Risk of Radiculitis?

Wang, Erik; Stickley, Carolyn; Manning, Jordan; Varlotta, Christopher G; Woo, Dainn; Ayres, Ethan; Abotsi, Edem; Vasquez-Montes, Dennis; Fischer, Charla R; Stieber, Jonathan; Quirno, Martin; Protopsaltis, Themistocles S; Passias, Peter G; Buckland, Aaron J
BACKGROUND: Bone morphogenetic protein (BMP) and allograft containing mesenchymal stem cells (live cell) are popular biologic substitutes for iliac crest autograft used in transforaminal lumbar interbody fusion (TLIF). Use of these agents in the pathogenesis of postoperative radiculitis remains controversial. Recent studies have independently linked minimally invasive (MIS) TLIF with increased radiculitis risk compared to open TLIF. The purpose of this study was to assess the rate of postoperative radiculitis in open and MIS TLIF patients along with its relationship to concurrent biologic adjuvant use. METHODS: Patients ≥18 years undergoing single-level TLIF from June 2012 to December 2018 with minimum 1-year follow-up were included. Outcome measures were rate of radiculitis, intra- and postoperative complications, revision surgery; length of stay (LOS), and estimated blood loss (EBL). RESULTS:= .038, N = 336) compared to other combinations of surgical approach and biologic use. CONCLUSIONS: Neither the MIS approach nor BMP use is an independent risk factor for post-TLIF radiculitis. However, risk of radiculitis significantly increases when they are used in tandem. This should be considered when selecting biological adjuvants for MIS TLIF. LEVEL OF EVIDENCE/METHODS: 3.
PMID: 33046541
ISSN: 2211-4599
CID: 4632542

Mandibular slope: a reproducible and simple measure of horizontal gaze

George, Stephen; Spiegel, Matthew; Protopsaltis, Themistocles; Buckland, Aaron J; Gomez, Jaime A; Ramchandran, Subaraman; Lafage, Renaud; Lafage, Virginie; Errico, Thomas; Lonner, Baron
STUDY DESIGN/METHODS:This study is a single-center retrospective radiographic review. OBJECTIVES/OBJECTIVE:The objective of this study is to evaluate a novel measurement parameter, mandibular slope (MS), as a measure of horizontal gaze. INTRODUCTION/BACKGROUND:Assessment of sagittal spinal alignment is essential in the evaluation of spinal deformity patients. Ability to achieve a horizontal gaze, a parameter of sagittal alignment, is needed for the performance of daily activities. Standard measures of horizontal gaze, including the gold-standard chin-brow to vertical angle (CBVA) and the surrogate measures McGregor's line (McGS) and Chamberlain's line (CS), require high-quality imaging, precise head positioning, and reliance on difficult to view visual landmarks. A novel measurement parameter, MS, utilizing the caudal margin of the mandible on standard lateral spine radiographs is proposed. METHODS:90 radiographs from spine deformity patients with or without spinal implants from a single center were evaluated. Three spine surgery fellows independently measured CBVA, McGS, CS, and MS at two timepoints at least one week apart to assess accuracy and reliability. MS was measured as the angle created by the inferior edge of the mandibular body and the horizontal. Formulas for calculating CBVA based on the above parameters were derived and compared to the actual CBVA. RESULTS:Mean age was 49.7 years, 76 females and 14 males. CBVA correlated with CS, McGS, and MS, r = 0.85, 0.81, and 0.80, respectively (p < 0.001). Standard error between real CBVA and calculated CBVA using CS (0.4 ± 4.79) and McGS (0.4 ± 3.9) was higher than that calculated using MS (- 0.2 ± 4.3). ICC demonstrated the highest inter-observer reliability with MS (0.999). MS had the highest intra-observer reliabilities 0.975, 0.981, and 0.988 (p < 0.001); CS and McGS also demonstrated high intra-observer reliability. CONCLUSIONS:MS is a promising measure of horizontal gaze that correlates highly with CBVA, has excellent intra- and inter-observer reliability with CBVA, and is easily measured using standard lateral spine radiographs.
PMID: 32495207
ISSN: 2212-1358
CID: 4469192