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33. Comparison of bone morphogenetic protein and allogeneic stem cells in lateral interbody lumbar fusion [Meeting Abstract]

Lord, E L; Manning, J H; Wang, E; Vasquez-Montes, D; Jain, D; Protopsaltis, T S; Fischer, C R; Buckland, A J; Goldstein, J A; Passias, P G; Kim, Y H; Bendo, J A
BACKGROUND CONTEXT: Lateral interbody fusion (LLIF) is often performed with biologic adjuvants to promote fusion. Commercially available bone allograft containing allogeneic stem cells (ASC) and bone morphogenetic protein-2 (BMP) are designed to promote fusion while avoiding the morbidity of iliac crest autograft; however, no study to date has directly compared the two in LLIF. The ASC studied is Osteocel Pro (NuVasive, Inc). PURPOSE: This non-industry funded study compares fusion rate, complications, and costs between LLIF with BMP and ASC. STUDY DESIGN/SETTING: Single center retrospective comparative study. PATIENT SAMPLE: Patients with 1-3 lumbar levels treated with LLIF. OUTCOME MEASURES: Outcomes measures are fusion at 1 year postoperative, complication rates, length of stay, and costs.
METHOD(S): A retrospective chart review was conducted to identify patients treated with LLIF and ASC or BMP from February 2012 through September 2017. Patients were included who had from 1-3 lumbar levels treated with LLIF and at least 1 year of radiographic follow up. Interbody fusion was assessed on lumbar X-ray images using a validated scale.
RESULT(S): A total of 94 patients were included representing 162 levels fused. Of these, 74 patients and 133 levels were treated with BMP; 20 patients and 29 levels were treated with ASC. Comparing patients treated with BMP or ASC, there were no differences in age [61.6 vs 60.4, p=0.7], BMI [29.8 vs 28.3, p=0.3], gender [60.8% vs 55.0% female], smoking status [12.2% vs 10.0%, p=1], diabetes [28.4% vs 15.0%, p=0.2], Charleston Comorbidity Index [4.3 vs 3.5, p=0.2], revision status [47.3% vs 45.0%, p=0.9], intraoperative complications [4.1% vs 5.0%, p=1], postoperative complications [37.8% vs 30.0%, p=0.5], or blood loss [881 vs 528ml, p=0.2]. More levels were fused in the BMP group (1.8 vs 1.45, p=0.04) and the BMP group tended toward a longer length of stay [4.8 vs 3.8 days, p=0.06]. There was a nonsignificant trend toward a higher fusion rate with BMP vs ASC[98.5% vs 93.1%, p=0.1]. The average amount of rhBMP used per level was 2.0 cc compared to 5.9 cc of ASC. There was no difference in the cost of the BMP per level compared with ASC [4.45% vs 4.80%, p=0.33], but the BMP group tended toward a higher cost of total care [103.5% vs 87.6%, p=0.1].
CONCLUSION(S): ASC and BMP are both acceptable adjuvants in LLIF that demonstrate comparable fusion rates at 1 year with comparable cost in the setting of similar groups of patients. The radiographic fusion rate seen in our study compares to previous reports in the literature using ASC. Cost considerations are becoming ever more cogent in spine surgery; the results of this study can inform decision making regarding which biologic adjuvant to use in lumbar interbody fusion. FDA DEVICE/DRUG STATUS: Osteocel (Approved for this indication), rhBMP (Infuse) (Not approved for this indication)
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EMBASE:2002164963
ISSN: 1878-1632
CID: 4052002

Pre-operative Assessment of Bone Quality in Spine Deformity Surgery: Correlation with Clinical Practice and Published Recommendations

Kuprys, Tomas K; Steinmetz, Leah M; Fischer, Charla R; Protopsaltis, Themistocles S; Passias, Peter G; Goldstein, Jeffrey A; Bendo, John A; Errico, Thomas J; Buckland, Aaron J
STUDY DESIGN/METHODS:Retrospective cohort study. OBJECTIVE:The goals of this study were to (1) evaluate pre-operative bone quality assessment and intervention practice over time and (2) review the current evidence for bone evaluation in spine fusion surgery. SUMMARY OF BACKGROUND DATA/BACKGROUND:Deformity spine surgery has demonstrated improved quality of life in patients however its cost has made it controversial. If pre-operative bone quality can be optimized then potentially these treatments could be more durable however, at present, no clinical practice guidelines have been published by professional spine surgical organizations. METHODS:A retrospective cohort review was performed on patients who underwent a minimum five-level primary or revision fusion. Pre-operative bone quality metrics were evaluated over time from 2012 - 2017 to find potential trends. Sub-group analysis was conducted based on age, gender, pre-operative diagnosis, and spine fusion region. RESULTS:Patient characteristics including pre-operative rates of pseudarthrosis and junctional failure did not change. An increasing trend of physician bone health documentation was noted (p = 0.045) but changes in other metrics were not significant. A gender bias favored females who had higher rates of pre-operative DXA studies (p = 0.001), Vitamin D 25-OH serum labs (p = 0.005), Vitamin D supplementation (p = 0.022), calcium supplementation (p < 0.001), antiresorptive therapy (p = 0.016), and surgeon clinical documentation of bone health (p = 0.008) compared to men. CONCLUSION/CONCLUSIONS:Our spine surgeons have increased documentation of bone health discussions but this has not affected bone quality interventions. A discrepancy exists favoring females over males in nearly all pre-operative bone quality assessment metrics. Pre-operative vitamin D level and BMD assessment should be considered in patients undergoing long fusion constructs however the data for bone anabolic and resorptive agents has less support. Clinical practice guidelines on pre-operative bone quality assessment spine patients should be defined. LEVEL OF EVIDENCE/METHODS:4.
PMID: 30540720
ISSN: 1528-1159
CID: 3679032

Institution-Wide Blood Management Protocol Reduces Transfusion Rates Following Spine Surgery

Alfonso, Allyson R; Hutzler, Lorraine; Lajam, Claudette; Bosco, Joseph; Goldstein, Jeffrey
Background/UNASSIGNED:Spine surgery is associated with significant intraoperative blood loss, often leading to transfusion. Patients who receive transfusions have an increased length of stay and risk of perioperative complications. To decrease the transfusion rate, we implemented an evidence-based institution-wide restrictive transfusion blood management guideline. The goal of this study is to describe the impact of this guideline on our spine surgery patients. Methods/UNASSIGNED:We analyzed the incidence of transfusion following 3709 single-institution, inpatient spine procedures before and after implementation of a revised blood transfusion protocol. The baseline period (1742 patients) from January 2014 to March 2015 was compared to the study period (1967 patients) of April 2015 to July 2016. One patient was excluded because of incomplete medical records. The revised protocol included establishing a postoperative blood transfusion trigger at hemoglobin < 7g/dL, instituting a computerized provider order entry, and appointing a physician champion to monitor and report progress. Results/UNASSIGNED: = .01). There was no significant difference in total hospital costs following protocol implementation. Conclusions/UNASSIGNED:Implementation of a restrictive transfusion protocol through use of a computerized provider order entry and a physician champion to oversee clinician compliance led to a 40.1% reduction in blood transfusion following spine surgery. Behavior changes were visible with a 40.7% increase in hemoglobin documentation before transfusion, and patients benefited from a reduction in length of stay and postsurgical infection rate. Future study is encouraged to understand the long-term impact of this intervention and its role in hospital expenditure.
PMCID:6625709
PMID: 31328091
ISSN: 2211-4599
CID: 3987882

Association Between Nonmodifiable Demographic Factors and Patient Satisfaction Scores in Spine Surgery Clinics

Johnson, Bradley C; Vasquez-Montes, Dennis; Steinmetz, Leah; Buckland, Aaron J; Bendo, John A; Goldstein, Jeffrey A; Errico, Thomas J; Fischer, Charla R
The Press Ganey survey is the most widely used instrument for measuring patient satisfaction. Understanding the factors that influence these surveys may permit better use of survey results and may direct interventions to increase patient satisfaction. Press Ganey Clinician and Group Consumer Assessment of Healthcare Providers and Systems surveys administered to ambulatory spine surgery clinic patients within a large tertiary care network from May 2016 to September 2017 were retrospectively reviewed. Mean comparison testing was performed to measure associations between patient demographics and responses to "overall provider rating" and "recommend this provider's office" survey questions. Mean difference to achieve significance was set at α<0.05. A multivariate analysis was performed to determine independent factors. A total of 1400 survey responses from the offices of 11 orthopedic spine surgeons were included. Patients 18 to 34 years old had significantly lower responses to the overall provider rating question than older patients (P<.001), and increasing patient age was correlated with improved ratings. Highest education level was inversely correlated with satisfaction scores, with patients who had attained graduate level education having the lowest satisfaction scores (P=.001). Those with commercial insurance had significantly lower ratings for recommend this provider's office (P=.042) and overall provider rating (P=.022) questions than those with other insurance types. Patients administered the survey on paper had significantly lower ratings than those administered the survey online (P=.006). Provider ratings were significantly higher when the sex and ethnicity of the patient were concordant with the provider (P=.021). This study showed that independent, nonmodifiable factors such as age, education level, and survey mode were significantly associated with the satisfaction of ambulatory spine surgery clinic patients. [Orthopedics. 2019; 42(3):143-148.].
PMID: 31099879
ISSN: 1938-2367
CID: 3920042

Alcoholism as a predictor for pseudarthrosis in primary spine fusion: An analysis of risk factors and 30-day outcomes for 52,402 patients from 2005 to 2013

Passias, Peter G; Bortz, Cole; Alas, Haddy; Segreto, Frank A; Horn, Samantha R; Ihejirika, Yael U; Vasquez-Montes, Dennis; Pierce, Katherine E; Brown, Avery E; Shenoy, Kartik; DelSole, Edward M; Johnson, Bradley; Oh, Cheongeun; Zhou, Peter L; Deflorimonte, Chloe; Dhillon, Ekhamjeet S; Jankowski, Pawel P; Diebo, Bassel G; Lafage, Virginie; Lafage, Renaud; Vira, Shaleen N; Bendo, John A; Goldstein, Jeffrey A; Schwab, Frank J; Gerling, Michael C
Introduction/UNASSIGNED:This study assessed the incidence and risk factors for pseudarthrosis among primary spine fusion patients. Methods/UNASSIGNED:-tests. Binary logistic regression assessed patient-related and procedure-related predictors for pseudarthrosis. Results/UNASSIGNED:=0.026). Conclusions/UNASSIGNED:Alcoholism and surgical revision are major risk factors for pseudarthrosis in patients undergoing spine fusion.
PMCID:6324756
PMID: 30662235
ISSN: 0972-978x
CID: 3609882

Modifiable and nonmodifiable factors associated with patient satisfaction in spine surgery and other orthopaedic subspecialties: A retrospective survey analysis

Steinmetz, Leah; Vasquez-Montes, Dennis; Johnson, Bradley C.; Buckland, Aaron J.; Goldstein, Jeffrey A.; Bendo, John A.; Errico, Thomas J.; Fischer, Charla R.
ISI:000494780100011
ISSN: 1940-7041
CID: 4193642

Fat necrosis after abdominal surgery: A pitfall in interpretation of FDG-PET/CT

Davidson, Tima; Lotan, Eyal; Klang, Eyal; Nissan, Johnatan; Goldstein, Jeffrey; Goshen, Elinor; Ben-Haim, Simona; Apter, Sara; Chikman, Bar
OBJECTIVE:We describe FDG-PET/CT findings of postoperative fat necrosis in patients following abdominal surgery, and evaluate their changes in size and FDG uptake over time. METHODS:FDG-PET/CT scans from January 2007-January 2016 containing the term 'fat necrosis' were reviewed. Lesions meeting radiological criteria of fat necrosis in patients with prior abdominal surgery were included. RESULTS:Forty-four patients, 30 males, mean age 68.4 ± 11.0 years. Surgeries: laparotomy (n=37; 84.1 %), laparoscopy (n=3; 6.8 %), unknown (n=4; 9.1 %). CTs of all lesions included hyperdense well-defined rims surrounding a heterogeneous fatty core. Sites: peritoneum (n=34; 77 %), omental fat (n=19; 43 %), subcutaneous fat (n=8; 18 %), retroperitoneum (n=2; 5 %). Mean lesion long axis: 33.6±24.9 mm (range: 13.0-140.0). Mean SUVmax: 2.6±1.1 (range: 0.6-5.1). On serial CTs (n=34), lesions decreased in size (p=0.022). Serial FDG-PET/CT (n=24) showed no significant change in FDG-avidity (p=0.110). Mean SUVmax did not correlate with time from surgery (p=0.558) or lesion size (p=0.259). CONCLUSION/CONCLUSIONS:Postsurgical fat necrosis demonstrated characteristic CT features and may demonstrate increased FDG uptake. However, follow-up of subsequent imaging scans showed no increases in size or FDG-avidity. Awareness of this entity is important to avoid misinterpretation of findings as recurrent cancer. KEY POINTS/CONCLUSIONS:• Postsurgical fat necrosis may mimic cancer in FDG-PET/CT. • Follow-up of fat necrosis showed no increase in FDG intensity. • CT follow-up showed a decrease in lesion size. • FDG uptake did not correlate with time lapsed from surgery.
PMID: 29264635
ISSN: 1432-1084
CID: 3063532

Do Prostate Cancer Patients With Markedly Elevated PSA Benefit From Radiation Therapy?: A Population-based Study

Lawrence, Yaacov R; Samueli, Benzion; Levitin, Ronald; Pail, Orrin; Spieler, Benjamin; Pfeffer, Raphael; Goldstein, Jeffrey; Den, Robert B; Symon, Zvi
OBJECTIVES/OBJECTIVE:Patients with clinically localized prostate cancer but markedly elevated prostate-specific antigen (PSA) are often treated with systemic agents alone. We hypothesized that they would benefit from radiation therapy. METHODS:We utilized the Survival, Epidemiology and End Results (SEER) Database for patients diagnosed with nonmetastatic prostate cancer from 2004 to 2008. Patients treated surgically or with brachytherapy were excluded. Survival was analyzed using the Kaplan-Meier method and Cox proportional hazard models. Propensity score was used to adjust for the nonrandomized assignment of local therapies. RESULTS:A total of 75,539 nonmetastatic prostate cancer patients were identified who received either radiotherapy or no local treatment. Median age was 70 years. Median follow-up of alive subjects was 60 months, with an interquartile range of 47 to 77 months. Estimated 4-year overall survival of entire population was 88%. Significant prognostic variables for overall survival on multivariate analysis included age, grade, PSA level, T stage, and use of radiation therapy. Use of radiation therapy was the most powerful predictor of both cause-specific and overall survival (HR=0.41 and 0.46, respectively, P<0.001). The benefit conferred by local treatment was seen even in subjects with PSA≥75 ng/mL. Four-year cancer-specific survival was 93.8% in those receiving radiation treatments versus 76.5% in those who did not receive any local treatment. CONCLUSIONS:Survival was significantly improved by radiotherapy for localized prostate cancer. Extremely high PSA levels (≥25 ng/mL) should not be considered a contraindication to local treatment.
PMID: 26125304
ISSN: 1537-453x
CID: 4507092

Psychometric findings and normative values for the CLEFT-Q based on 2,434 children and young adult patients with cleft lip and/or palate from 12 countries [Meeting Abstract]

Klassen, A F; Riff, K W; Longmire, N M; Albert, A; Baker, S B; Cano, S J; Chan, A J; Courtemanche, D J; Dreise, M; Goldstein, J A; Goodacre, T; Harman, K; Munill, M; Aguilera, M P; Peterson, P; Pusic, A L; Slator, R; Stiernman, M; Tsangaris, E; Tholpady, S S; Vargas, F; Forrest, C
Aims: Patients with cleft lip and/or palate (CL/P) can undergo numerous procedures to improve appearance, speech, dentition and hearing. We developed a cleft-specific patient-reported outcome (PRO) instrument to facilitate rigorous international measurement and benchmarking. Methods: Data were collected from patients aged 8 to 29 years with CL/P at 30 hospitals in 12 countries between October 2014 and November 2016. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine reliability and validity. Normative CLEFT-Q values were computed for age, gender and cleft type. Results: Analysis led to the refinement of an eating/drinking checklist and 12 scales measuring appearance of the face, nose, nostrils, teeth, lips, jaws and cleft lip scar), health-related quality of life psychological, social, school, speech-related distress) and speech function. All scales met the requirements of the Rasch model. Analysis to explore differential item function by age, gender and country provided evidence to support the use of a common scoring algorithm for each scale for international use. Hypotheses that poorer outcomes would be associated with having a speech problem, being unhappy with facial appearance, and needing future cleft-related treatments were supported. Normative values for age, gender and cleft type showed poorer outcomes associated with older age, female gender and having a visible cleft. Conclusions: The CLEFT-Q represents a rigorously developed PRO instrument that can be used internationally to collect and compare evidence-based outcomes data from patients aged 8 to 29 years of age with CL/P
EMBASE:618778790
ISSN: 1573-2649
CID: 2781032

Does Choline PET/CT Change the Management of Prostate Cancer Patients With Biochemical Failure?

Goldstein, Jeffrey; Even-Sapir, Einat; Ben-Haim, Simona; Saad, Akram; Spieler, Benjamin; Davidson, Tima; Berger, Raanan; Weiss, Ilana; Appel, Sarit; Lawrence, Yaacov R; Symon, Zvi
PURPOSE:: The FDA approved C-11 choline PET/computed tomography (CT) for imaging patients with recurrent prostate cancer in 2012. Subsequently, the 2014 NCCN guidelines have introduced labeled choline PET/CT in the imaging algorithm of patients with suspected recurrent disease. However, there is only scarce data on the impact of labeled choline PET/CT findings on disease management. We hypothesized that labeled-choline PET/CT studies showing local or regional recurrence or distant metastases will have a direct role in selection of appropriate patient management and improve radiation planning in patients with disease that can be controlled using this mode of therapy. METHODS:: This retrospective study was approved by the Tel Aviv Sourasky and Sheba Medical Center's Helsinki ethical review committees. Patient characteristics including age, PSA, stage, prior treatments, and pre-PET choline treatment recommendations based on NCCN guidelines were recorded. Patients with biochemical failure and without evidence of recurrence on physical examination or standard imaging were offered the option of additional imaging with labeled choline PET/CT. Treatment recommendations post-PET/CT were compared with pre-PET/CT ones. Pathologic confirmation was obtained before prostate retreatment. A nonparametric chi test was used to compare the initial and final treatment recommendations following choline PET/CT. RESULTS:: Between June 2010 and January 2014, 34 labeled-choline PET/CT studies were performed on 33 patients with biochemical failure following radical prostatectomy (RP) (n=6), radiation therapy (RT) (n=6), brachytherapy (n=2), RP+salvage prostate fossa RT (n=14), and RP+salvage prostate fossa/lymph node RT (n=6). Median PSA level before imaging was 2 ng/mL (range, 0.16 to 79). Labeled choline PET/CT showed prostate, prostate fossa, or pelvic lymph node increased uptake in 17 studies, remote metastatic disease in 9 studies, and failed to identify the cause for biochemical failure in 7 scans.PET/CT altered treatment approach in 18 of 33 (55%) patients (P=0.05). Sixteen of 27 patients (59%) treated previously with radiation were retreated with RT and delayed or eliminated androgen deprivation therapy: 1 received salvage brachytherapy, 10 received salvage pelvic lymph node or prostate fossa irradiation, 2 brachytherapy failures received salvage prostate and lymph nodes IMRT, and 3 with solitary bone metastasis were treated with radiosurgery. Eleven of 16 patients retreated responded to salvage therapy with a significant PSA response (<0.2 ng/mL), 2 patients had partial biochemical responses, and 3 patients failed. The median duration of response was 500+/-447 days. Two of 6 patients with no prior RT were referred for salvage prostatic fossa RT: 1 received dose escalation for disease identified in the prostate fossa and another had inclusion of "hot" pelvic lymph nodes in the treatment volume. CONCLUSIONS:: These early results suggest that labeled choline PET/CT imaging performed according to current NCCN guidelines may change management and improve care in prostate cancer patients with biochemical failure by identifying patients for referral for salvage radiation therapy, improving radiation planning, and delaying or avoiding use of androgen deprivation therapy.
PMID: 25319322
ISSN: 1537-453x
CID: 1518392