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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

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

A cost utility analysis of treating different adult spinal deformity frailty states

Brown, Avery E; Lebovic, Jordan; Alas, Haddy; Pierce, Katherine E; Bortz, Cole A; Ahmad, Waleed; Naessig, Sara; Hassanzadeh, Hamid; Labaran, Lawal A; Puvanesarajah, Varun; Vasquez-Montes, Dennis; Wang, Erik; Raman, Tina; Diebo, Bassel G; Vira, Shaleen; Protopsaltis, Themistocles S; Lafage, Virginie; Lafage, Renaud; Buckland, Aaron J; Gerling, Michael C; Passias, Peter G
The aim of this study was to investigate the cost utility of treating non-frail versus frail or severely frail adult spinal deformity (ASD) patients. 79 surgical ASD patients >18 years with available frailty and ODI data at baseline and 2-years post-surgery (2Y) were included. Utility data was calculated using the ODI converted to the SF-6D. QALYs utilized a 3% discount rate to account for decline to life expectancy (LE). Costs were calculated using the PearlDiver database. ICER was compared between non-operative (non-op.) and operative (op.) NF and F/SF patients at 2Y and LE. When compared to non-operative ASD, the ICER was $447,943.96 vs. $313,211.01 for NF and F/SF at 2Y, and $68,311.35 vs. $47,764.61 for NF and F/SF at LE. Frail and severely frail patients had lower cost per QALY compared to not frail patients at 2Y and life expectancy, and had lower ICER values when compared to a non-operative cohort of ASD patients. While these results support operative correction of frail and severely frail patients, it is important to note that these patients are often at worse baseline disability, which is closely related to frailty scores, and have more opportunity to improve postoperatively. Furthermore, there may be a threshold of frailty that is not operable due to the risk of severe complications that is not captured by this analysis. While future research should investigate economic outcomes at extended follow up times, these findings support the cost effectiveness of ASD surgery at all frailty states.
PMID: 33099349
ISSN: 1532-2653
CID: 4645652

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

Obesity Alters Spinopelvic Alignment Changes From Standing to Relaxed Sitting: the Influence of the Soft-tissue Envelope

Buckland, Aaron J; Burapachaisri, Aonnicha; Stekas, Nicholas; Vasquez-Montes, Dennis; Protopsaltis, Themistocles; Vigdorchik, Jonathan
Background/UNASSIGNED:Changes in spinopelvic and lower extremity alignment between standing and relaxed sitting have important clinical implications with regard to stability of total hip arthroplasty. This study aimed to analyze the effect of body mass index (BMI) on lumbopelvic alignment and motion at the hip joint. Methods/UNASSIGNED:A retrospective review of patients who underwent full-body stereoradiographs in standing and relaxed sitting for total hip arthroplasty planning was conducted. Spinopelvic parameters measured included spinopelvic tilt (SPT), pelvic incidence (PI), lumbar lordosis (LL), PI minus LL (PI-LL), proximal femoral shaft angle (PFSA), and standing-to-sitting hip range of motion. Propensity score matching controlled for age, gender, PI, and hip ostoarthritis grade. Patients were stratified into normal (NORMAL; BMI, 18.5-24.9), overweight (OW; 25.0-29.9), and obese (OB; 30.0-34.9) groups. Alignment parameters were compared using one-way analysis of variance. Results/UNASSIGNED:< .001). Conclusions/UNASSIGNED:Significant differences in sitting and standing-to-sitting change in lumbopelvic alignment based on BMI suggest obese patients recruit more posterior spinopelvic tilt when sitting to compensate for soft-tissue impingement that occurs anterior to the hip joint and limiting hip flexion.
PMCID:7502584
PMID: 32995406
ISSN: 2352-3441
CID: 4615822

208. Low pelvic incidence (PI) patients are at high risk of over correction following ASD surgery [Meeting Abstract]

Soroceanu, A; Protopsaltis, T S; Mundis, G M; Smith, J S; Kelly, M P; Daniels, A H; Klineberg, E O; Ames, C P; Hart, R A; Bess, S; Shaffrey, C I; Schwab, F J; Lafage, V; Gupta, M C; International, Spine Study Group
BACKGROUND CONTEXT: Age and pelvic incidence (PI) optimal alignment has been shown to minimize mechanical complications such as PJK. Low PI patients may be susceptible to overcorrection because PI specific alignment is not always prioritized. PURPOSE: The purpose of this study is to examine the incidence of over-correction in low PI ASD patients undergoing surgical intervention, and to quantify the impact of over-correction on radiographic PJK in this patient population. STUDY DESIGN/SETTING: Retrospective analysis of a prospective, multicenter database. PATIENT SAMPLE: Surgical ASD patients with low pelvic incidence. OUTCOME MEASURES: PJK defined as 1) proximal junctional angle (PJA, U
EMBASE:2007747286
ISSN: 1878-1632
CID: 4597462

P80. Demographic differences and health impact of severe global sagittal, coronal, and mixed spinal deformity in symptomatic adults [Meeting Abstract]

Buell, T; Smith, J S; Shaffrey, C I; Kim, H J; Klineberg, E O; Lafage, V; Lafage, R; Protopsaltis, T S; Passias, P G; Mundis, G M; Eastlack, R K; Deviren, V; Kelly, M P; Daniels, A H; Gum, J L; Soroceanu, A; Hamilton, D K; Gupta, M C; Burton, D C; Hostin, R A; Kebaish, K M; Hart, R A; Schwab, F J; Bess, S; Ames, C P
BACKGROUND CONTEXT: Prior studies demonstrated that symptomatic adult spinal deformity (SASD) is a heterogeneous condition with varying degrees of negative health impact depending on the specific type and severity of deformity. Currently, there is some controversy regarding the subset of SASD with global coronal malalignment (GCM) and its associated health impact. Moreover, few reports have assessed the health impact of this global coronal parameter in comparison to other deformity types. A comparative study of deformity types with severe global malalignment (eg, severe GCM) may provide clinically relevant insights and identify potential differences in demographics and health impact. PURPOSE: To compare demographics and health impact of SASD patients with severe global malalignment (primary sagittal [SAG-only] vs primary coronal [COR-only] vs sagittal+coronal [MIX]). STUDY DESIGN/SETTING: Retrospective analysis of a prospective multicenter database. PATIENT SAMPLE: Enrollment required age >=18 yrs and one of the following: scoliosis >=20degree, sagittal vertical axis (SVA) >=5cm, pelvic tilt >=25degree, and/or thoracic kyphosis >=60degree. OUTCOME MEASURES: Short Form-36 (SF-36) PCS score.
METHOD(S): Consecutive SASD patients from a prospective multicenter database were evaluated for type and severity of global malalignment. Severe alignment thresholds included SVA >=10cm (SAG-only), GCM >=6cm (COR-only), or both SVA >=10cm and GCM >=6cm (MIX). SF-36 PCS scores were compared with U.S. normative values.
RESULT(S): Of 492 SASD patients that met threshold alignment criteria, 463 (94%) completed the SF-36 and were included (78% women, mean age 65 years, mean BMI 28.6 kg/m2, previous spine surgery in 65%). Deformity types were SAG-only (58%), COR-only (19%) and MIX (23%). COR-only had more women (94%, p<0.001), younger age (61 years, p=0.004), and lower BMI (26 kg/m2, p<0.001). Charlson Comorbity Index (CCI) scores and total number of comorbidities were comparable among the deformity types (p>0.05). All deformity types were 'frail' based on ASD-Frailty Index scores (SAG-only [3.9], COR-only [3.1], MIX [4.0]). Overall mean PCS was lower compared to similar age- and gender-matched U.S. normative values (29.0 vs 45.3, p<0.001). Mean PCS was significantly different between deformity types (p<0.001): SAG-only (28.5) vs COR-only (33.1) vs MIX (27.0). PCS offsets from normative population scores were significantly different between deformity types (p=0.001): SAG-only (-16.6) vs COR-only (-13.4) vs MIX (-18.2).
CONCLUSION(S): Demographic comparisons demonstrated significantly more women, younger age, and lower BMI in the COR-only deformity type. Severe global malalignment (SVA >=10cm and/or GCM >=6cm) had substantial debilitating impact on health, with MIX deformity type (i.e., severe global sagittal and coronal malalignment) experiencing the greatest health impact. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747201
ISSN: 1878-1632
CID: 4597612

P70. A combined anterior-posterior approach in select cervical deformity corrections has potential for superior cost effectiveness driven by outcomes [Meeting Abstract]

Pierce, K E; Passias, P G; Lafage, R; Lafage, V; Mundis, G M; Eastlack, R K; Kelly, M P; Protopsaltis, T S; Carreon, L Y; Line, B; Hart, R A; Burton, D C; Bess, S; Schwab, F J; Shaffrey, C I; Smith, J S; Ames, C P
BACKGROUND CONTEXT: The choice of surgical approach in CD surgery is often dictated by surgeon preference and experience. This choice could significantly impact the costs and outcomes of an operation, therefore the approaches should be analyzed in order to determine the optimal approach from a cost-utility perspective. The cost utility of different surgical approaches in cervical deformity (CD) has not been investigated in the literature. PURPOSE: Investigate the cost utility of differing approaches in operative CD patients. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter cervical deformity database. PATIENT SAMPLE: A total of 105 CD patients. OUTCOME MEASURES: Costs, EuroQol-5D (EQ-5D), Quality adjusted life years (QALYs), Cost per quality adjusted life years.
METHOD(S): Included CD patients (C2-C7 Cobb>10degreeor CK>10degree, cSVA>4cm or CBVA>25degree) >18yr with follow-up (1-year) surgical and health related quality of life scores. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims. QALYs and cost per QALY were calculated using a 3% discount rate to account for residual decline to life expectancy (78.7 years). After accounting for complications, LOS, revisions, and death, cost per QALY at 1Y and life expectancy [LE] were calculated for surgical approach (anterior-only, posterior-only [excluding PSO and VCR to account for differences in instrumentation], combined). In a subanalysis, approach groups were propensity-score matched for TS-CL to account for baseline (BL) deformity.
RESULT(S): A total of 105 CD patients met inclusion criteria (61.9 yrs, 63% female, 28.6kg/m2, CCI: 0.97). By approach, 21.9% underwent anterior only, 37.1% posterior only and 41% combined approaches. Average number of levels fused was 6.9, with a mean EBL of 948 ml and total operative time of 544.2 minutes. Mean EQ5D at BL was 0.74+/-0.07 and at 1Y was 0.79+/-0.08 (a difference of 0.05+/-0.08). Average difference in EQ5D from BL to 1Y was significant (p=0.002) across approach: 0.093 anterior-only, 0.021 posterior-only, 0.044 combined. 13% (3) of anterior-only patients underwent a revision, 10.3% (4) of posterior and 13.9% (6) of combined approaches. The average costs per surgery for CD patients at 1-year undergoing surgery by anterior approach was $27,640.75, $38,499.44 posterior-only, and $36,553.41 combined approach (p>0.05).The cost per QALY was higher for posterior-only patients at 1-year ($948,946.81) compared to anterior-only ($152,616.65) and combined ($424,110.14), p<0.001. If the utility gained was sustained to life expectancy, the cost per QALY for the anterior-only group was $21,665.87, posterior-only was $134,715.06 and combined approach was $60,207.82., p<0.001. After PSM for TS-CL, 15 patients remained in each group. The cost per QALY remained higher for posterior-only patients at 1-year and LE (both p<0.050).
CONCLUSION(S): After accounting for comorbidities, complications, revisions, and death, all surgical approaches showed improvement in postoperative EQ5D scores, however posterior approach demonstrated overall lower cost effectiveness. CD patients who underwent anterior-only approach had the lowest average costs for CD corrective surgery, as well as the lowest cost per QALY (best cost-effectiveness) compared to posterior and combined approaches. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
Copyright
EMBASE:2007747179
ISSN: 1878-1632
CID: 4597682