Searched for: in-biosketch:true
person:passip01
Probability of Severe Frailty Development among Operative and Non-Operative Adult Spinal Deformity Patients: An Actuarial Survivorship Analysis over a 3-year Period
Passias, Peter G; Segreto, Frank A; Bortz, Cole A; Horn, Samantha R; Pierce, Katherine E; Naessig, Sara; Brown, Avery E; Jackson-Fowl, Brendan; Ahmad, Waleed; Oh, Cheongeun; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Daniels, Alan H; Line, Breton G; Kim, Han Jo; Uribe, Juan S; Eastlack, Robert K; Hamilton, D Kojo; Klineberg, Eric O; Burton, Douglas C; A Hart, Robert A; Schwab, Frank J; Shaffrey, Christopher I; Ames, Christopher P; Bess, Shay
BACKGROUND:Little is known of how frailty, a dynamic measure of physiological age, progresses relative to age or disability status. Operative treatment of adult spinal deformity (ASD) may play a role in frailty remediation and maintenance. PURPOSE/OBJECTIVE:Compare frailty status, severe frailty development, and factors influencing severe frailty development among ASD patients undergoing operative or non-operative treatment. DESIGN/METHODS:Retrospective review with maximum follow up of 3 years. SETTING/METHODS:Prospective, multicenter, ASD database. PARTICIPANTS/METHODS:Patients were consecutively enrolled from 13 participating centers. INCLUSION CRITERIA/METHODS:≥18 years undergoing either operative or non-operative treatment for ASD, exclusion criteria: spinal deformity of neuromuscular etiology, presence of active infection, or malignancy. The mean age of the participants analyzed were 54.9 for the operative cohort and 55.0 for the non-operative cohort. MAIN OUTCOMES/RESULTS:Frailty status, severe frailty development and factors influencing severe frailty development. METHODS:ASD patients (coronal scoliosis≥20°, sagittal vertical axis (SVA)≥5cm, Pelvic Tilt (PT)≥25°, or thoracic kyphosis≥60°) >18y/o, with Base Line (BL) frailty scores were included. Frailty was scored from 0-1 (not frail: <0.3, frail 0.3-0.5, severe frailty >0.5) through the use of ASD-FI which has been validated using the International Spine Study Group (ISSG) ASD database, European Spine Study Group (ESSG) ASD database, and the Scoli-RISK-1 Patient Database. The International Spine Study Group (ISSG) is funded through research grants from DePuy Synthes and individual donations, and supported the current work. Operative (Op) and Non-Operative (Non-Op) patients were propensity matched. T-tests compared frailty among treatment groups and BL, 1Y, 2Y, and ≥3Y. An actuarial Kaplan-Meier survivorship analysis with Log Rank (Mantel-Cox) test, adjusting for patients lost to follow-up, determined probability of severe frailty development. Multivariate Cox Regressions gauged the effect of sagittal malalignment, patient and surgical details on severe frailty development. RESULTS:The analysis includes 472 patients (236 Op, 236 Non-Op) selected by propensity score matching from a cohort of 1172. Demographics and comorbidities were similar between groups (p>0.05). Op exhibited decreased frailty at all follow up intervals compared to BL (BL:0.22 vs Y1:0.18; Y2:0.16; Y3:0.15, all p<0.001). Non-Op displayed similar frailty from BL to 2Y follow up, and increased frailty at 3Y follow up (0.23 vs 0.25, p=0.014). Compared to Non-Op, Op had lower frailty at 1Y (0.18 vs 0.24), 2Y (0.16 vs 0.23) and 3Y (0.15 vs 0.25) (all p<0.001). Cumulative probability of maintaining non-severe frailty was (Op:97.7%, Non-Op:94.5%) at 1Y, (Op:95.1%, Non-Op:90.4%) at 2Y, and (Op:95.1%, Non-Op:89.1%) at ≥3Y, (p=0.018). Amongst all patients, baseline depression (HR: 2.688[1.172-6.167], p=0.020), NRS back pain scores (HR: 1.247[1.012-1.537], p=0.039), and non-operative treatment (HR: 2.785[1.167-6.659], p=0.021) predicted severe frailty development with having a HR>1.0 and p-value<0.05. Among operative patients, 6-week postoperative residual SVA malalignment (SRS-Schwab SVA + modifier) (HR: 15.034[1.922-116.940], p=0.010) predicted severe frailty development indicated by having a HR>1.0 and p-value <0.05. CONCLUSIONS:Non-Op patients were more likely to develop severe frailty, and at a quicker rate. Baseline depression, increased NRS back pain scores, non-operative treatment, and postoperative sagittal malalignment at 6-week follow-up significantly predicted severe frailty development. Operative intervention and postoperative sagittal balance appear to play significant roles in frailty remediation and maintenance in adult spinal deformity patients. Frailty is one factor, in a multifactorial conservation, that may be considered when determining operative or non-operative values for ASD patients. Operating before the onset of severe frailty, may result in a lower complication risk and better long term clinical outcomes. LEVEL OF EVIDENCE/METHODS:III.
PMID: 32320862
ISSN: 1878-1632
CID: 4402262
Scoring System to Triage Patients for Spine Surgery in the Setting of Limited Resources: Application to the Coronavirus Disease 2019 (COVID-19) Pandemic and Beyond
Sciubba, Daniel M; Ehresman, Jeff; Pennington, Zach; Lubelski, Daniel; Feghali, James; Bydon, Ali; Chou, Dean; Elder, Benjamin D; Elsamadicy, Aladine A; Goodwin, C Rory; Goodwin, Matthew L; Harrop, James; Klineberg, Eric O; Laufer, Ilya; Lo, Sheng-Fu L; Neuman, Brian J; Passias, Peter G; Protopsaltis, Themistocles; Shin, John H; Theodore, Nicholas; Witham, Timothy F; Benzel, Edward C
BACKGROUND:As of May 4, 2020, the coronavirus disease 2019 (COVID-19) pandemic has affected >3.5 million people and touched every inhabited continent. Accordingly, it has stressed health systems worldwide, leading to the cancellation of elective surgical cases and discussions regarding health care resource rationing. It is expected that rationing of surgical resources will continue even after the pandemic peak and may recur with future pandemics, creating a need for a means of triaging patients for emergent and elective spine surgery. METHODS:Using a modified Delphi technique, a cohort of 16 fellowship-trained spine surgeons from 10 academic medical centers constructed a scoring system for the triage and prioritization of emergent and elective spine surgeries. Three separate rounds of videoconferencing and written correspondence were used to reach a final scoring system. Sixteen test cases were used to optimize the scoring system so that it could categorize cases as requiring emergent, urgent, high-priority elective, or low-priority elective scheduling. RESULTS:The devised scoring system included 8 independent components: neurologic status, underlying spine stability, presentation of a high-risk postoperative complication, patient medical comorbidities, expected hospital course, expected discharge disposition, facility resource limitations, and local disease burden. The resultant calculator was deployed as a freely available Web-based calculator (https://jhuspine3.shinyapps.io/SpineUrgencyCalculator/). CONCLUSIONS:We present the first quantitative urgency scoring system for the triage and prioritizing of spine surgery cases in resource-limited settings. We believe that our scoring system, although not all encompassing, has potential value as a guide for triaging spine surgical cases during the COVID pandemic and post-COVID period.
PMCID:7256646
PMID: 32479913
ISSN: 1878-8769
CID: 4510342
Complication Risk in Primary and Revision Minimally Invasive Lumbar Interbody Fusion: A Comparable Alternative to Conventional Open Techniques?
Bortz, Cole; Alas, Haddy; Segreto, Frank; Horn, Samantha R; Varlotta, Christopher; Brown, Avery E; Pierce, Katherine E; Ge, David H; Vasquez-Montes, Dennis; Lafage, Virginie; Lafage, Renaud; Fischer, Charla R; Gerling, Michael C; Protopsaltis, Themistocles S; Buckland, Aaron J; Sciubba, Daniel M; De La Garza-Ramos, Rafael; Passias, Peter G
STUDY DESIGN/UNASSIGNED:Retrospective cohort study of prospective patients undergoing minimally invasive lumbar fusion at a single academic institution. OBJECTIVE/UNASSIGNED:To assess differences in perioperative outcomes between primary and revision MIS (minimally invasive surgical) lumbar interbody fusion patients and compare with those undergoing corresponding open procedures. METHODS/UNASSIGNED:Patients ≥18 years old undergoing lumbar interbody fusion were grouped by surgical technique: MIS or open. Patients within each group were propensity score matched for comorbidities and levels fused. Patient demographics, surgical factors, and perioperative complication incidences were compared between primary and revision cases using means comparison tests, as appropriate. RESULTS/UNASSIGNED:< .05). CONCLUSIONS/UNASSIGNED:Clinical outcomes of revision MIS lumbar interbody fusion were similar to those of primary surgery. Additionally, MIS techniques were associated with less EBL, shorter LOS, and fewer perioperative complications than corresponding open revisions.
PMID: 32677572
ISSN: 2192-5682
CID: 4528572
Classifying Complications: Assessing Adult Spinal Deformity 2-Year Surgical Outcomes
Klineberg, Eric O; Passias, Peter G; Poorman, Gregory W; Jalai, Cyrus M; Atanda, Abiola; Worley, Nancy; Horn, Samantha; Sciubba, Daniel M; Hamilton, D Kojo; Burton, Douglas C; Gupta, Munish Chandra; Smith, Justin S; Soroceanu, Alexandra; Hart, Robert A; Neuman, Brian; Ames, Christopher P; Schwab, Frank J; Lafage, Virginie
STUDY DESIGN/UNASSIGNED:Retrospective review of prospective database. OBJECTIVE/UNASSIGNED:Complication rates for adult spinal deformity (ASD) surgery vary widely because there is no accepted system for categorization. Our objective was to identify the impact of complication occurrence, minor-major complication, and Clavien-Dindo complication classification (Cc) on clinical variables and patient-reported outcomes. METHODS/UNASSIGNED:Complications in surgical ASD patients with complete baseline and 2-year data were considered intraoperatively, perioperatively (<6 weeks), and postoperatively (>6 weeks). Primary outcome measures were complication timing and severity according to 3 scales: complication presence (yes/no), minor-major, and Cc score. Secondary outcomes were surgical outcomes (estimated blood loss [EBL], length of stay [LOS], reoperation) and health-related quality of life (HRQL) scores. Univariate analyses determined complication presence, type, and Cc grade impact on operative variables and on HRQL scores. RESULTS/UNASSIGNED:< .05). CONCLUSION/UNASSIGNED:The Cc Scale was most useful in predicting changes in patient outcomes; at 2 years, patients with raised perioperative Cc scores and postoperative complications saw reduced HRQL improvement. Intraoperative and perioperative complications were associated with worse short-term surgical and inpatient outcomes.
PMID: 32730730
ISSN: 2192-5682
CID: 4574052
Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery
Jain, Amit; Yeramaneni, Samrat; Kebaish, Khaled M; Raad, Michael; Gum, Jeffrey L; Klineberg, Eric O; Hassanzadeh, Hamid; Kelly, Michael P; Passias, Peter G; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Bess, Shay; Lafage, Virginie; Glassman, Steve; Carreon, Leah Y; Hostin, Richard A
STUDY DESIGN/METHODS:Economic modeling of data from a multicenter, prospective registry. OBJECTIVE:To analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA/BACKGROUND:ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis. METHODS:Of 522 ASD patients with fusion of 5 or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP vs. no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates. Alpha = 0.05. RESULTS:BMP was used in the index surgery for 267 patients (73%). The mean (± standard deviation) direct cost of BMP for the index surgery was $14,000 ± $6,400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ± $17,000) than for patients without pseudarthrosis ($61,000 ± $25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients. CONCLUSIONS:BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research. LEVEL OF EVIDENCE/METHODS:2.
PMID: 32097274
ISSN: 1528-1159
CID: 4343682
Assessment of Patient Outcomes and Proximal Junctional Failure Rate of Adult Spinal Deformity Patients Undergoing Caudal Extension of Previous Spinal Fusion
Daniels, Alan H; Reid, Daniel Bc; Durand, Wesley M; Line, Breton; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A
OBJECT/OBJECTIVE:This case series examined patients undergoing caudal extension of prior fusion without alteration of the prior UIV to assess patient outcomes and rates of PJK/PJF. METHODS:Patients eligible for 2-year minimum follow-up undergoing caudal extension of prior fusion with unchanged UIVs were identified. These patients were evaluated for PJK/PJF, and patient reported outcomes were recorded. RESULTS:In total, 40 patients were included. Mean follow-up duration was 2.2 years (SD 0.3). Patients in this cohort had poor preoperative sagittal alignment (PI-LL 26.7°, TPA 29.0°, SVA 93.4mm) and achieved substantial sagittal correction (ΔSVA -62.2mm, ΔPI-LL -19.8°, ΔTPA -11.1°) following caudal extension surgery. At final follow-up, there was a 0% rate of PJF among patients undergoing caudal extension of previous fusion without creation of a new UIV, but 27.5% of patients experienced PJK. Patients experienced significant improvement in both ODI and SRS-22r total score at 2-years post-operatively (p<0.05). In total, 7.5% (n=3) of patients underwent further revision, at an average of 1.1 years (SD 0.54) after the surgery with unaltered UIV. All three of these patients underwent revision for rod fracture with no revisions for PJK/PJF. CONCLUSIONS:Patients undergoing caudal extension of previous fusions for sagittal alignment correction have high rates of clinical success, low revision surgery rates, and very low rates of PJF. Minimizing repetitive tissue trauma at the UIV may result in decreased PJF risk, as the PJF rate in this cohort of unaltered UIV patients is below historical PJF rates of patients undergoing sagittal balance correction.
PMID: 32305603
ISSN: 1878-8769
CID: 4401992
Sexual Dysfunction Secondary to Lumbar Stiffness in Adult Spinal Deformity Patients before and after Long-Segment Spinal Fusion
Daniels, Alan H; Reid, Daniel; Durand, Wesley; Disilvestro, Kevin; Hamilton, David K; Passias, Peter; Kim, Han Jo; Protopsaltis, Themistocles; LaFage, Virginie; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert
OBJECT/OBJECTIVE:Sexual function is an important factor which contributes to quality of life. ASD patients may have sexual limitations due to lumbar spinal stiffness which may be affected by long-segment fusion. METHODS:This study utilized a multi-center, prospectively defined, consecutive cohort of ASD patients. The primary outcome in this study was the LSDI question 10: "Choose the statement that best describes the effect of low back stiffness on your ability to engage in sexual intercourse". RESULTS:In total, 368 patients were included in this study, including 76 males and 292 females of which 80.7% (n=293) underwent 9 or more level fusion and 74.4% (n=270) had pelvic fixation. Baseline LSDI sexual function scores averaged 1.7 (SD 1.3), which improved to 1.3 (SD 1.2) at 2-year follow-up (p = 0.0008). After adjusting for confounding factors, worse LSDI sexual function score was strongly associated with worse ODI, SRS total, and SF-36 PCS and MCS scores at both baseline and 2-year follow-up (p<0.05 for all comparisons). Predictors of poorer baseline sexual function included older age, increased SVA, and increased back pain (p<0.05 for all comparisons). Predictors of improvement in sexual function at 2-year follow-up included SVA improvement (p=0.0032) and decreased postoperative back pain (p<0.0001). CONCLUSIONS:This study found that sexual dysfunction scores due to lumbar stiffness significantly improved following surgery for ASD. Additionally, lumbar stiffness related sexual dysfunction is strongly related to overall outcome measured by ODI and SRS total score, highlighting the importance of sexual health on overall outcome in ASD patients.
PMID: 32311559
ISSN: 1878-8769
CID: 4402102
Defining an algorithm of treatment for severe cervical deformity using surgeon survey and treatment patterns
Virk, Sohrab; Elysee, Jonathan; Gupta, Munish; Klineberg, Eric; Schwab, Frank; Kim, Han Jo; Burton, Douglas; Passias, Peter; Protopsaltis, Themistocles; Smith, Justin; Ames, Christopher; Lafage, Renaud; Lafage, Virginie
OBJECTIVE:Our aim was to define a treatment strategy for patients with severe cervical deformity(sCD). METHODS:Surgical patients with sCD were isolated based on preop radiographic parameters. We sent 10 sCD cases to 7 surgeons to find consensus on approach, upper instrumented vertebrae (UIV), lower instrumented vertebrae (LIV), osteotomy. We performed a descriptive analysis and created a treatment algorithm from the survey then analyzed a database of surgical patients to find the frequency of following our algorithm. RESULTS:We found consensus on 7 cases for posterior approach due to cervicothoracic deformity and of 15 patients within our sCD database that had cervicothoracic deformity, 13/15 had posterior approach. There was consensus on 2 cases for antero-posterior approach due to local kyphosis and of 25 patients that had local kyphosis, 18/25 had an anterior approach. In 4 cases there was consensus of UIV of C2 and of 35 cases that had posterior fusion >6 levels, 20/35 had a UIV of C2. In 3 cases there was consensus of a LIV below a previously fused spine. Of 36 patients that had a fusion of T6 or higher, 34 had a LIV below the previous UIV. In 6 cases there was consensus against an osteotomy due to cervical spine flexibility and 9/12 patients that had an osteotomy in our database had no flexibility on dynamic radiographs. CONCLUSION/CONCLUSIONS:We outline here an algorithm for deciding approach, UIV, LIV and whether to do an osteotomy for patients with sCD based on consensus recommendations amongst spine surgeons.
PMID: 32339741
ISSN: 1878-8769
CID: 4427662
Determinants of Chiari I progression in pregnancy
Janjua, M Burhan; Haynie, Alexus E; Bansal, Vibhav; Bhattacharia, Soumolindra; Grant, Tamila; McQuillan, Daniel; Passias, Peter G; Ozturk, Ali K; Hwang, Steven W
Chiari Malformation type 1 (CM-I) is congenital or an acquired anomaly of the hind brain; develops when the cerebellar tonsils recede downwards below the foramen magnum. Recurrent post tussive suboccipital headache is the common presentation in a pregnant woman and the diagnosis is usually missed or delayed due to lack of formal understanding of this neurological pathology. Much has been written regarding presentation, morphology and the treatment of CM-I; however, little is known when the etiology is acquired or an iatrogenic in its evolution. Similarly, unknown is the progression of CM-I (diagnosed or undiagnosed) in pregnancy. The objective of this study is to elucidate the causes of progression of CM-I in pregnancy, and how this can be avoided. A detailed literature review has been conducted to find the case reports or case studies on association of CM-I in pregnancy; therefore, the risk factors regarding the progression have been sought. There is a lack of literature on timing, mode of anesthesia, and the management of CM-I. Moreover, authors have sought a questionnaire to screen these patients at pre-conception, intrapartum visits if, the initial diagnosis is delayed. Crucial points of concern including but not limited to the diagnosis, pre-conception counseling, timing of intervention during pregnancy, and mode of anesthesia, have been discussed in detail. In summary, a formal management algorithm has been proposed to avoid the rapid progression of this complex neurological pathology especially, in women of child bearing age and/or during pregnancy.
PMID: 32414621
ISSN: 1532-2653
CID: 4438352
Prospective multicenter assessment of complication rates associated with adult cervical deformity surgery in 133 patients with minimum 1-year follow-up
Smith, Justin S; Buell, Thomas J; Shaffrey, Christopher I; Kim, Han Jo; Klineberg, Eric; Protopsaltis, Themistocles; Passias, Peter; Mundis, Gregory M; Eastlack, Robert; Deviren, Vedat; Kelly, Michael P; Daniels, Alan H; Gum, Jeffrey L; Soroceanu, Alex; Gupta, Munish; Burton, Doug; Hostin, Richard; Hart, Robert; Lafage, Virginie; Lafage, Renaud; Schwab, Frank J; Bess, Shay; Ames, Christopher P
OBJECTIVE:Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically. METHODS:A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30-90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°. RESULTS:Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively). CONCLUSIONS:This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.
PMID: 32559746
ISSN: 1547-5646
CID: 4514322