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182. Radiation exposure in posterior lumbar fusion: a comparison of CT image-guided navigation, robotic assistance and intraoperative fluoroscopy [Meeting Abstract]

Wang, E; Manning, J H; Varlotta, C; Woo, D; Ayres, E W; Egers, M; Abotsi, E J; Vasquez-Montes, D; Protopsaltis, T S; Goldstein, J A; Frempong-Boadu, A K; Passias, P G; Buckland, A J
BACKGROUND CONTEXT: Intraoperative CT image-guided navigation (IGN) and robotic assistance have been increasingly implemented during spine surgery to improve accuracy in pedicle screw positioning. However, studies have shown that they increase operative time and ionizing radiation exposure, and it remains controversial whether they improve patient outcomes. PURPOSE: Assess use of IGN and robotic assistance in posterior lumbar surgery and their relationship with patient radiation exposure and perioperative outcomes. STUDY DESIGN/SETTING: Retrospective cohort study at single institution. PATIENT SAMPLE: A total of 165 patients undergoing 1- or 2-level posterior spinal fusion, with or without TLIF. OUTCOME MEASURES: Preoperative CT scan utilization and radiation dose, intraoperative radiation dose (fluoroscopy and/or CT) and total-procedure radiation dose (sum of preoperative CT and intraoperative radiation doses), levels fused, operative time, estimated blood loss (EBL), length of stay (LOS), postoperative complications.
METHOD(S): Patients >=18 years old undergoing 1- or 2-level posterior spinal fusion, with or without TLIF, in a 12-month period included. Chart review performed for pre- and intraoperative data on radiation dose and perioperative outcomes. All radiation doses quantified in milli-Grays (mGy). Univariate analysis and multivariate logistic regression analysis for categorical variables and one-way ANOVA for continuous variables utilized, with significance set at p<0.05.
RESULT(S): A total of 165 patients (51.83% F, 59.13+/-13.18yrs, BMI 29.43+/-6.72, Charlson comorbidity index [CCI] 1.20+/-1.56) were assessed: 12 IGN, 62 robotic, 56 open, 35 MIS without IGN/robotics. Lower proportion of women in open and MIS group (66.67% F IGN, 64.52% robotic, 38.18% open, 45.71% MIS, p=0.010). Younger patients in MIS group (63.42 yrs IGN, 61.74 robotic, 60.63 open, 50.63 MIS, p<0.001). MIS group had lowest mean posterior levels fused (1.42 IGN, 1.27 robotic, 1.32 open, 1.06 MIS, p=0.015). Total-procedure radiation (50.21mGy IGN, 59.84 robotic, 22.56 open, 82.02 MIS), total-procedure radiation/level fused (41.88mGy IGN, 51.18 robotic, 18.56 open, 79.41 MIS) and intraop radiation (44.69mGy IGN, 44.85 robotic, 14.81 open, 80.28 MIS) were lowest in the open group and highest in the MIS group compared to IGN and robotic (all p<0.001). A higher proportion of robotic and lower proportion MIS patients had preop CT (25% IGN, 82.26% robotic, 37.5% open, 8.57% MIS, p<0.001). EBL (441.67mL IGN, 380.24 robotic, 355.36 open, 162.14 MIS, p=0.002) and LOS (4.75 days IGN, 3.89 robotic, 3.89 open, 2.83 MIS, p=0.039) were lowest in the MIS group. Highest operative time for IGN patients (303.5 min vs 264.85 robotic, 229.91 open, 213.43 MIS p<0.001). No differences in BMI, CCI, postoperative complications (p=0.313, 0.051, 0.644, respectively).
CONCLUSION(S): IGN and robotic assistance in posterior lumbar fusion were associated with higher intraoperative and total-procedure radiation exposure than open cases without IGN/robotics, but significantly less than MIS without IGN/robotics, without differences in perioperative outcomes. While MIS procedures reported highest radiation exposure to patient, of more concern is that the proportion of total radiation dose applied to surgeon would also be considerably higher in MIS group. FDA DEVICE/DRUG STATUS: Brainlab Airo Mobile Intraoperative CT scanner (Approved for this indication).
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EMBASE:2002167654
ISSN: 1878-1632
CID: 4051832

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

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

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

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

Minimally Invasive versus Open Spine Surgery: What Does the Best Evidence Tell Us?

McClelland, Shearwood 3rd; Goldstein, Jeffrey A
BACKGROUND: Spine surgery has been transformed significantly by the growth of minimally invasive surgery (MIS) procedures. Easily marketable to patients as less invasive with smaller incisions, MIS is often perceived as superior to traditional open spine surgery. The highest quality evidence comparing MIS with open spine surgery was examined. METHODS: A systematic review of randomized controlled trials (RCTs) involving MIS versus open spine surgery was performed using the Entrez gateway of the PubMed database for articles published in English up to December 28, 2015. RCTs and systematic reviews of RCTs of MIS versus open spine surgery were evaluated for three particular entities: Cervical disc herniation, lumbar disc herniation, and posterior lumbar fusion. RESULTS: A total of 17 RCTs were identified, along with six systematic reviews. For cervical disc herniation, MIS provided no difference in overall function, arm pain relief, or long-term neck pain. In lumbar disc herniation, MIS was inferior in providing leg/low back pain relief, rehospitalization rates, quality of life improvement, and exposed the surgeon to >10 times more radiation in return for shorter hospital stay and less surgical site infection. In posterior lumbar fusion, MIS transforaminal lumbar interbody fusion (TLIF) had significantly reduced 2-year societal cost, fewer medical complications, reduced time to return to work, and improved short-term Oswestry Disability Index scores at the cost of higher revision rates, higher readmission rates, and more than twice the amount of intraoperative fluoroscopy. CONCLUSION: The highest levels of evidence do not support MIS over open surgery for cervical or lumbar disc herniation. However, MIS TLIF demonstrates advantages along with higher revision/readmission rates. Regardless of patient indication, MIS exposes the surgeon to significantly more radiation; it is unclear how this impacts patients. These results should optimize informed decision-making regarding MIS versus open spine surgery, particularly in the current advertising climate greatly favoring MIS.
PMCID:5402483
PMID: 28479791
ISSN: 0976-3147
CID: 2548812

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