Publications by authors named "Andrew Hersh"

35 Publications

Plastic surgery wound closure following resection of spinal metastases.

Clin Neurol Neurosurg 2021 Jul 9;207:106800. Epub 2021 Jul 9.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY 11030, USA. Electronic address:

Objective: Surgical site infection and dehiscence are devastating complications of surgery for spinal metastases. Wound closure involving plastic surgeons has been proposed as a strategy to lower post-operative complications. Here we investigated whether plastic surgery closure is associated with lower rates of wound complications, wound infection, and wound reoperation compared to simple closure by spine surgeons.

Methods: Patients surgically treated for metastatic tumors at a single comprehensive cancer center between April 2013-2020 were retrospectively identified. Primary pathology, demographic information, clinical characteristics, pre-operative laboratory values, tumor location, operative characteristics, and post-operative outcomes were collected. Univariable analyses used student t-tests for continuous variables and χ tests for categorical variables. Multivariable regressions were performed to control for confounders.

Results: We included 317 patients, of which 56 underwent closure by plastic surgeons and 291 by neurosurgeons. Patients in the plastic surgery cohort were more likely to have received prior radiation to the surgical site, more often on long-term corticosteroid therapy, and more likely to have sacrococcygeal tumors. Operations involving plastic surgeons were more likely to be revision surgeries, corpectomies, and to involve a staged approach. Additionally, patients in the plastic surgery cohort had longer incision lengths, longer surgeries, greater intraoperative blood loss (IOBL), were more likely to receive transfusions, and had longer hospitalizations. Local paraspinous advancement flaps were the most common complex wound closure technique. Plastic surgery closure was not significantly associated with a difference in rates of post-operative wound complications, wound infection, or wound-related reoperations compared to simple wound closure.

Conclusion: We identified that patients undergoing plastic surgery wound closure had worse baseline risk, longer surgeries, greater IOBL, and longer hospitalizations compared to patients receiving simple closure. Despite their increased risk, complex wound closure did not significantly alter the rates of post-operative wound complications, wound infection, or wound-related reoperations. Consideration may be given to plastic surgery closure in patients at high risk of wound complications or with extensive wound defects.
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http://dx.doi.org/10.1016/j.clineuro.2021.106800DOI Listing
July 2021

Interrater and Intra-rater Reliability of the Vertebral Bone Quality Score.

World Neurosurg 2021 Jul 9. Epub 2021 Jul 9.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD USA 21287; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY USA 11030. Electronic address:

Background: Vertebral bone quality had a significant impact on postoperative outcomes in spinal fusion surgery. New MRI-based measures, such as the Vertebral Bone Quality (VBQ) score may allow for bone quality assessment without the radiation associated with conventional testing. In the present study, we sought to assess the intra- and interrater reliability of VBQ scores calculated by medical professionals and trainees.

Methods: Thirteen reviewers of various specialties and levels of training were recruited and asked to calculate VBQ scores for 30 patients at two time points separated by 2-months. Scored volumes were acquired from patients treated for both degenerative and oncologic indications. Intra-rater and interrater agreement, quantified by intraclass correlation coefficient (ICC), was assessed using two-way random effects modeling. Square-weight Cohen's κ and Kendall's Tau-b were used to determine whether raters assigned similar scores during both evaluations.

Results: All raters showed moderate to excellent reliability for VBQ score (ICC 0.667-0.957; κ0.648-0.921) and excellent reliability for all constituent components used to calculate VBQ score (ICC all ≥0.97). Interrater reliability was also found to be good for VBQ score on both the first (ICC=0.818) and second (ICC=0.800) rounds of assessment; scores for the constituent component all had ICC values ≥0.97 for the constituent components.

Conclusions: The VBQ score appears to have both good intra-rater and interrater reliability. Additionally, there appeared to be no correlation between score reliability and level of training. External validation and further investigations of its ability to accurately model bone biomechanical properties are necessary.
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http://dx.doi.org/10.1016/j.wneu.2021.07.020DOI Listing
July 2021

Removal of instrumentation for postoperative spine infection: systematic review.

J Neurosurg Spine 2021 Jul 9:1-13. Epub 2021 Jul 9.

Objective: Currently, no consensus exists as to whether patients who develop infection of the surgical site after undergoing instrumented fusion should have their implants removed at the time of wound debridement. Instrumentation removal may eliminate a potential infection nidus, but removal may also destabilize the patient's spine. The authors sought to summarize the existing evidence by systematically reviewing published studies that compare outcomes between patients undergoing wound washout and instrumentation removal with outcomes of patients undergoing wound washout alone. The primary objectives were to determine 1) whether instrumentation removal from an infected wound facilitates infection clearance and lowers morbidity, and 2) whether the chronicity of the underlying infection affects the decision to remove instrumentation.

Methods: PRISMA guidelines were used to review the PubMed/MEDLINE, Embase, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov databases to identify studies that compared patients with implants removed and patients with implants retained. Outcomes of interest included mortality, rate of repeat wound washout, and loss of correction.

Results: Fifteen articles were included. Of 878 patients examined in these studies, 292 (33%) had instrumentation removed. Patient populations were highly heterogeneous, and outcome data were limited. Available data suggested that rates of reoperation, pseudarthrosis, and death were higher in patients who underwent instrumentation removal at the time of initial washout. Three studies recommended that instrumentation be uniformly removed at the time of wound washout. Five studies favored retaining the original instrumentation. Six studies favored retention in early infections but removal in late infections.

Conclusions: The data on this topic remain heterogeneous and low in quality. Retention may be preferred in the setting of early infection, when the risk of underlying spine instability is still high and the risk of mature biofilm formation on the implants is low. However, late infections likely favor instrumentation removal. Higher-quality evidence from large, multicenter, prospective studies is needed to reach generalizable conclusions capable of guiding clinical practice.
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http://dx.doi.org/10.3171/2020.12.SPINE201300DOI Listing
July 2021

Impact of Multidisciplinary Intraoperative Teams on Thirty-Day Complications After Sacral Tumor Resection.

World Neurosurg 2021 Jun 16. Epub 2021 Jun 16.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Electronic address:

Objective: To evaluate the impact of multidisciplinary intraoperative teams on surgical complications in patients undergoing sacral tumor resection.

Methods: We reviewed all patients with primary or metastatic sacral tumors managed at a single comprehensive cancer center over a 7-year period. Perioperative complication rates were compared between those treated by an unassisted spinal oncologist and those treated with the assistance of at least 1 other surgical specialty. Statistical analysis involved univariable and stepwise multivariable logistic regression models to identify predictors of multidisciplinary management and 30-day complications.

Results: A total of 107 patients underwent 132 operations for sacral tumors; 92 operations involved multidisciplinary teams, including 54% of metastatic tumor operations and 74% of primary tumor operations. Patients receiving multidisciplinary management had higher body mass indexes (29.8 vs. 26.3 kg/m; P = 0.008), larger tumors (258 vs. 55 cm³; P < 0.001), and higher American Society of Anesthesiologists scores (3 vs. 2; P = 0.049). Only larger tumor volume (odds ratio [OR], 1.007 per cm³; P < 0.001) and undergoing treatment for a malignant primary versus a metastatic tumor (OR, 23.4; P < 0.001) or benign primary tumor (OR, 29.3; P < 0.001) were predictive of multidisciplinary management. Although operations involving multidisciplinary teams were longer (467 vs. 231 minutes; P < 0.001) and had higher blood loss (1698 vs. 774 mL; P = 0.004), 30-day complication rates were similar (37 vs. 27%; P = 0.39). On multivariable analysis, only larger tumor volume (OR, 1.004 per cm³; P = 0.005) and longer surgical duration (OR, 1.002 per minute; P = 0.03) independently predicted higher 30-day complications.

Conclusions: Although patients managed with multidisciplinary teams had larger tumors and worse baseline health, 30-day complications were similar. This finding suggests that the use of multidisciplinary teams may help to mitigate surgical morbidity in those with high baseline risk.
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http://dx.doi.org/10.1016/j.wneu.2021.06.040DOI Listing
June 2021

Giant Myxoid Spindle Cell Neoplasm Presenting with Abdominal Swelling and Concurrent Weight Loss.

World Neurosurg 2021 May 28;152:1-2. Epub 2021 May 28.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, New York, USA. Electronic address:

Retroperitoneal sarcomas may grow extremely large before becoming clinically symptomatic, and curative resection often has high associated morbidity. An 83-year-old man presented with insidious-onset abdominal pain and weight loss owing to a 16.3 × 13.1 × 25.8-cm retroperitoneal high-grade myxoid spindle cell sarcoma. The patient was ultimately deemed to be unfit for surgery before rapidly succumbing to his disease. This case illustrates both the indolent growth seen in these lesions and the importance of proper patient selection. Older patients with large, high-grade lesions and multiple associated comorbidities are often poor surgical candidates, as the associated surgical morbidity outweighs the potential survival benefit. While the ultimate treatment plan relies on shared decision making by the patient and the healthcare provider, the decision to pursue surgical intervention should take into consideration the patient's broader clinical condition.
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http://dx.doi.org/10.1016/j.wneu.2021.05.084DOI Listing
May 2021

Radiotherapy and Surgical Advances in the Treatment of Metastatic Spine Tumors: A Narrative Review.

World Neurosurg 2021 Jul 21;151:147-154. Epub 2021 May 21.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, New York, USA. Electronic address:

Spine tumors encompass a wide range of diseases with a commensurately broad spectrum of available treatments, ranging from radiation for spinal metastases to highly invasive en bloc resection for primary vertebral column malignancies. This high variability in treatment approaches stems both from variability in the goals of surgery (e.g., oncologic cure vs. symptom palliation) and from the significant advancements in surgical technologies that have been made over the past 2 decades. Among these advancements are improvements in surgical technique, namely minimally invasive approaches, increased availability of focused radiation modalities (e.g., proton therapy and linear accelerator devices), and new surgical technologies, such as carbon fiber-reinforced polyether ether ketone rods. In addition, several groups have described nonsurgical interventions, such as vertebroplasty and kyphoplasty for spinal instability secondary to pathologic fracture, and lesion ablation with spinal laser interstitial thermoablation, radiofrequency ablation, or cryoablation. We provide an overview of the latest technological advancements in spinal oncology and their potential usefulness for modern spinal oncologists.
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http://dx.doi.org/10.1016/j.wneu.2021.05.032DOI Listing
July 2021

Fenestrated pedicle screws for thoracolumbar instrumentation in patients with poor bone quality: Case series and systematic review of the literature.

Clin Neurol Neurosurg 2021 Jul 11;206:106675. Epub 2021 May 11.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY 11030, USA. Electronic address:

Objective: To describe the results of a single-surgeon series and systematically review the literature on cement-augmented instrumented fusion with fenestrated pedicle screws.

Methods: All patients treated by the senior surgeon using fenestrated screws between 2017 and 2019 with a minimum of 6-months of clinical and radiographic follow-up were included. For the systematic review, we used PRISMA guidelines to identify all prior descriptions of cement-augmented instrumented fusion with fenestrated pedicle screws in the English literature. Endpoints of interest included hardware loosening, cement leakage, and pulmonary cement embolism (PCE).

Results: Our series included 38 patients (mean follow-up 14.8 months) who underwent cement-augmented instrumentation for tumor (47.3%), deformity/degenerative disease (39.5%), or osteoporotic fracture (13.2%). Asymptomatic screw lucency was seen in 2.6%, cement leakage in 445, and pulmonary cement embolism (PCE) in 5.2%. Our literature review identified 23 studies (n = 1526 patients), with low reported rates of hardware loosening (0.2%) and symptomatic PCE (1.0%). Cement leakage, while common (55.6%), produced symptoms in fewer than 1% of patients. Indications for cement-augmentation in this cohort included: spine metastasis with or without pathologic fracture (n = 18; 47.3%), degenerative spine disease or fixed deformity with poor underlying bone quality (n = 15; 39.5%), and osteoporotic fracture (n = 5; 13.2%).

Conclusion: Cement-augmented fusion with fenestrated screws appears to be a safe, effective means of treating patients with poor underlying bone quality secondary to tumor or osteoporosis. High-quality evidence with direct comparisons to non-augmented patients is needed.
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http://dx.doi.org/10.1016/j.clineuro.2021.106675DOI Listing
July 2021

Sacrectomy for sacral tumors: Perioperative outcomes in a large-volume comprehensive cancer center.

Spine J 2021 May 14. Epub 2021 May 14.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY 11030, USA. Electronic address:

Background Context: Sacral tumors are incredibly rare lesions affecting fewer than one in every 10,000 persons. Reported perioperative morbidity rates range widely, varying from 30% to 70%, due to the relatively low volumes seen by most centers. Factors affecting perioperative outcome following sacrectomy remain ill-defined.

Purpose: To characterize perioperative outcomes of sacral tumor patients undergoing sacrectomy and identify independent risk factors of perioperative morbidity STUDY DESIGN/SETTING: Retrospective cohort study at a single comprehensive cancer center PATIENT SAMPLE: Consecutively treated sacral tumor patients (primary or metastatic) undergoing sacrectomy for oncologic resection between April 2013 and April 2020 OUTCOME MEASURES: Perioperative complications, hospital length of stay, non-home discharge, 30-day readmission, and 30-day reoperation METHODS: Details were gathered about tumor pathology and morphology, surgery performed, baseline medical comorbidities, preoperative lab data, and patient demographics. Stepwise multivariable regressions were conducted to identify independent risk factors of perioperative outcomes while evaluating predictive accuracy.

Results: 57 sacral tumor patients were included (mean age 55.5±13.0 years; 60% female). The complication, non-home discharge, 30-day readmission, and 30-day reoperation rates were 39%, 56%, 16%, and 14%, respectively. Independent predictors of perioperative complications included ASA>2 (OR=10.7; 95%CI [1.3, 86.0]; p=0.026), radicular pain (OR=10.9; p=0.014), platelet count (OR=0.989 per 10³/μL; p=0.049), and instrumentation (OR=10.7; p=0.009). Independent predictors of length of stay included iliac vessel involvement (β=15.8; p=0.005), larger tumor volume (β=0.027 per cm³; p<0.001), a staged procedure (β=10.0; p=0.018), and S1 nerve root sacrifice (OR=15.8; p=.011). The optimal model predictive of non-home discharge included bilateral S3-S5 or higher nerve root sacrifice (OR=3.9; p=0.054), instrumentation (OR=8.6; p=0.005), and vertical rectus abdominis musculocutaneous flap closure (OR=5.3; p=0.067). 30-day readmission was independently predicted by history of chronic kidney disease (OR=26.7; p=0.021), radicular pain (OR=8.1; p=0.039), and preoperative saddle anesthesia (OR=12.6; p=0.026). All multivariable models achieved good discrimination (AUC>0.8 and R>0.7).

Conclusion: Clinical and operative factors were important predictors of complications and 30-day readmission, while tumor-related and operative factors accounted for most of the variability in length of stay and non-home discharge.
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http://dx.doi.org/10.1016/j.spinee.2021.05.004DOI Listing
May 2021

Prolonged Seizure Activity Followed by Severe Hyperphosphatemia and Hypocalcemia in a Pediatric Patient.

Cureus 2021 Apr 7;13(4):e14338. Epub 2021 Apr 7.

Pediatric Nephrology, University of Louisville School of Medicine, Louisville, USA.

Seizures secondary to hypocalcemia have been well documented and studied. There are various causes of hypocalcemia described in the literature, but a prolonged seizure episode leading to cell lysis, severe hyperphosphatemia, and hypocalcemia is rarely reported. We present the case of a 3-year-old male with severe hyperphosphatemia and hypocalcemia secondary to the likely presence of cell lysis from prolonged seizure activity. Our case illustrates the importance of a thorough evaluation of the possible differentials of hypocalcemia and hyperphosphatemia in a challenging presentation.
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http://dx.doi.org/10.7759/cureus.14338DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8103793PMC
April 2021

Prediction Models in Degenerative Spine Surgery: A Systematic Review.

Global Spine J 2021 Apr;11(1_suppl):79S-88S

1500Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Study Design: Systematic review.

Objectives: To review the existing literature of prediction models in degenerative spinal surgery.

Methods: Review of PubMed/Medline and Embase databases was conducted to identify articles between January 1, 2000 and March 1, 2020 that reported prediction model performance for outcomes following elective degenerative spine surgery.

Results: Thirty-one articles were included. Twenty studies were of thoracolumbar, 5 were of cervical, and 6 included all spine patients. Five studies were externally validated. Prediction models were developed using machine learning (42%) and logistic regression (42%) as well as other techniques. Web-based calculators were included in 45% of published articles. Various outcomes were investigated, including complications, infection, length of stay, discharge disposition, reoperation, readmission, disability score, back pain, leg pain, return to work, and opioid dependence.

Conclusions: Significant heterogeneity exists in methods used to develop prediction models of postoperative outcomes after degenerative spine surgery. Most internally validate their scores, but a few have been externally validated. Areas under the curve for most models range from 0.6 to 0.9. Techniques for development are becoming increasingly sophisticated with different machine learning tools. With further external validation, these models can be deployed online for patient, physician, and administrative use, and have the potential to optimize outcomes and maximize value in spine surgery.
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http://dx.doi.org/10.1177/2192568220959037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076813PMC
April 2021

Translocation of Cervical Vertebral Body Replacement Device into the Esophagus.

World Neurosurg 2021 Jun 2;150:144-146. Epub 2021 Apr 2.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Electronic address:

Expandable vertebrectomy devices are a key technology that has facilitated the adoption of minimally invasive approaches to spine oncology surgery. However, advanced technology still requires proper attention to surgical fundamentals. Here we illustrate a cage of a misplaced expandable vertebrectomy device causing esophageal perforation. Examination of the postoperative radiographs suggests that haptic feedback from the expandable technology may have given the false impression of bony engagement. This case highlights the need for proper mortise work and complete visualization of the segments to be instrumented even during minimally invasive surgery.
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http://dx.doi.org/10.1016/j.wneu.2021.03.136DOI Listing
June 2021

Low-Intensity Pulsed Ultrasound as a Potential Adjuvant Therapy to Promote Spinal Fusion: Systematic Review and Meta-analysis of the Available Data.

J Ultrasound Med 2020 Dec 8. Epub 2020 Dec 8.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Despite extensive research, nonunion continues to affect a nontrivial proportion of patients undergoing spinal fusion. Recently, preclinical studies have suggested that low-intensity pulsed ultrasound (LIPUS) may increase rates of spinal fusion. In this study, we summarized the available in vivo literature evaluating the effect of LIPUS on spinal fusion and performed a meta-analysis of the available data to estimate the degree to which LIPUS may mediate higher fusion rates. Across 13 preclinical studies, LIPUS was associated with a 9-fold increase in the odds of successful spinal fusion. Future studies are necessary to establish the benefit of LIPUS on spinal fusion in clinical populations.
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http://dx.doi.org/10.1002/jum.15587DOI Listing
December 2020

Predicting nonroutine discharge in patients undergoing surgery for vertebral column tumors.

J Neurosurg Spine 2020 Nov 20:1-10. Epub 2020 Nov 20.

Objective: More than 8000 patients are treated annually for vertebral column tumors, of whom roughly two-thirds will be discharged to an inpatient facility (nonroutine discharge). Nonroutine discharge is associated with increased care costs as well as delays in discharge and poorer patient outcomes. In this study, the authors sought to develop a prediction model of nonroutine discharge in the population of vertebral column tumor patients.

Methods: Patients treated for primary or metastatic vertebral column tumors at a single comprehensive cancer center were identified for inclusion. Data were gathered regarding surgical procedure, patient demographics, insurance status, and medical comorbidities. Frailty was assessed using the modified 5-item Frailty Index (mFI-5) and medical complexity was assessed using the modified Charlson Comorbidity Index (mCCI). Multivariable logistic regression was used to identify independent predictors of nonroutine discharge, and multivariable linear regression was used to identify predictors of prolonged length of stay (LOS). The discharge model was internally validated using 1000 bootstrapped samples.

Results: The authors identified 350 patients (mean age 57.0 ± 13.6 years, 53.1% male, and 67.1% treated for metastatic vs primary disease). Significant predictors of prolonged LOS included higher mCCI score (β = 0.74; p = 0.026), higher serum absolute neutrophil count (β = 0.35; p = 0.001), lower hematocrit (β = -0.34; p = 0.001), use of a staged operation (β = 4.99; p < 0.001), occurrence of postoperative pulmonary embolism (β = 3.93; p = 0.004), and surgical site infection (β = 9.93; p < 0.001). Significant predictors of nonroutine discharge included emergency admission (OR 3.09; p = 0.001), higher mFI-5 score (OR 1.90; p = 0.001), lower serum albumin level (OR 0.43 per g/dL; p < 0.001), and operations with multiple stages (OR 4.10; p < 0.001). The resulting statistical model was deployed as a web-based calculator (https://jhuspine4.shinyapps.io/Nonroutine_Discharge_Tumor/).

Conclusions: The authors found that nonroutine discharge of patients with surgically treated vertebral column tumors was predicted by emergency admission, increased frailty, lower serum albumin level, and staged surgical procedures. The resulting web-based calculator tool may be useful clinically to aid in discharge planning for spinal oncology patients by preoperatively identifying patients likely to require placement in an inpatient facility postoperatively.
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http://dx.doi.org/10.3171/2020.6.SPINE201024DOI Listing
November 2020

A clinical calculator for predicting intraoperative blood loss and transfusion risk in spine tumor patients.

Spine J 2021 02 30;21(2):302-311. Epub 2020 Sep 30.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287 USA. Electronic address:

Background Context: Surgery for vertebral column tumors is commonly associated with intraoperative blood loss (IOBL) exceeding 2 liters and the need for transfusion of allogeneic blood products. Transfusion of allogeneic blood, while necessary, is not benign, and has been associated with increased rates of wound complication, venous thromboembolism, delirium, and death.

Purpose: To develop a prediction tool capable of predicting IOBL and risk of requiring allogeneic transfusion in patients undergoing surgery for vertebral column tumors.

Study Design/setting: Retrospective, single-center study.

Patient Sample: Consecutive series of 274 patients undergoing 350 unique operations for primary or metastatic spinal column tumors over a 46-month period at a comprehensive cancer center OUTCOME MEASURES: IOBL (in mL), use of intraoperative blood products, and intraoperative blood products transfused.

Methods: We identified IOBL and transfusions, along with demographic data, preoperative laboratory data, and surgical procedures performed. Independent predictors of IOBL and transfusion risk were identified using multivariable regression.

Results: Mean age at surgery was 57.0±13.6 years, 53.1% were male, and 67.1% were treated for metastatic lesions. Independent predictors of IOBL included en bloc resection (p<.001), surgical invasiveness (β=25.43 per point; p<0.001), and preoperative albumin (β=-244.86 per g/dL; p=0.011). Predictors of transfusion risk included preoperative hematocrit (odds ratio [OR]=0.88 per %; 95% confidence interval [CI, 0.84, 0.93]; p<0.001), preoperative MCHgb (OR=0.88 per pg; 95% CI [0.78, 1.00]; p=0.048), preoperative red cell distribution width (OR=1.32 per %; 95% CI [1.13, 1.55]; p<0.001), en bloc resection (OR=3.17; 95%CI [1.33, 7.54]; p=0.009), and surgical invasiveness (OR=1.08 per point; [1.06; 1.11]; p<0.001). The transfusion model showed a good fit of the data with an optimism-corrected area under the curve of 0.819. A freely available, web-based calculator was developed for the transfusion risk model (https://jhuspine3.shinyapps.io/TRUST/).

Conclusions: Here we present the first clinical calculator for intraoperative blood loss and transfusion risk in patients being treated for primary or metastatic vertebral column tumors. Surgical invasiveness and preoperative microcytic anemia most strongly predict transfusion risk. The resultant calculators may prove clinically useful for surgeons counseling patients about their individual risk of requiring allogeneic transfusion.
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http://dx.doi.org/10.1016/j.spinee.2020.09.011DOI Listing
February 2021

Incidental durotomy: predictive risk model and external validation of natural language process identification algorithm.

J Neurosurg Spine 2020 May 1:1-7. Epub 2020 May 1.

1Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland; and.

Objective: Incidental durotomy is a common complication of elective lumbar spine surgery seen in up to 11% of cases. Prior studies have suggested patient age and body habitus along with a history of prior surgery as being associated with an increased risk of dural tear. To date, no calculator has been developed for quantifying risk. Here, the authors' aim was to identify independent predictors of incidental durotomy, present a novel predictive calculator, and externally validate a novel method to identify incidental durotomies using natural language processing (NLP).

Methods: The authors retrospectively reviewed all patients who underwent elective lumbar spine procedures at a tertiary academic hospital for degenerative pathologies between July 2016 and November 2018. Data were collected regarding surgical details, patient demographic information, and patient medical comorbidities. The primary outcome was incidental durotomy, which was identified both through manual extraction and the NLP algorithm. Multivariable logistic regression was used to identify independent predictors of incidental durotomy. Bootstrapping was then employed to estimate optimism in the model, which was corrected for; this model was converted to a calculator and deployed online.

Results: Of the 1279 elective lumbar surgery patients included in this study, incidental durotomy occurred in 108 (8.4%). Risk factors for incidental durotomy on multivariable logistic regression were increased surgical duration, older age, revision versus index surgery, and case starts after 4 pm. This model had an area under curve (AUC) of 0.73 in predicting incidental durotomies. The previously established NLP method was used to identify cases of incidental durotomy, of which it demonstrated excellent discrimination (AUC 0.97).

Conclusions: Using multivariable analysis, the authors found that increased surgical duration, older patient age, cases started after 4 pm, and a history of prior spine surgery are all independent positive predictors of incidental durotomy in patients undergoing elective lumbar surgery. Additionally, the authors put forth the first version of a clinical calculator for durotomy risk that could be used prospectively by spine surgeons when counseling patients about their surgical risk. Lastly, the authors presented an external validation of an NLP algorithm used to identify incidental durotomies through the review of free-text operative notes. The authors believe that these tools can aid clinicians and researchers in their efforts to prevent this costly complication in spine surgery.
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http://dx.doi.org/10.3171/2020.2.SPINE20127DOI Listing
May 2020

Percentage of Time in Range 70 to 139 mg/dL Is Associated With Reduced Mortality Among Critically Ill Patients Receiving IV Insulin Infusion.

Chest 2019 11 12;156(5):878-886. Epub 2019 Jun 12.

Division of Pulmonary and Critical Care, Intermountain Medical Center, Murray, UT; Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, UT; Division of Pediatric Critical Care, Department of Pediatrics, University of Utah, Salt Lake City, UT.

Background: In addition to hyperglycemia, hypoglycemia, and glycemic variability, reduced time in targeted blood glucose range (TIR) is associated with increased risk of death in critically ill patients. This relation between TIR and mortality may be confounded by diabetic status and antecedent glycemic control.

Methods: This study retrospectively analyzed critically ill patients managed with the same IV insulin protocol at multiple centers. The percentage of TIR between 70 and 139 mg/dL was calculated. Patients with diabetic ketoacidosis, patients who had < 10 blood glucose readings, and patients with repeat admissions were excluded. The highest recorded glycosylated hemoglobin value in the preceding 3 months or up to 1 month following admission were used as a surrogate for the patient's preexisting glucose control. Stratified regression analyses were performed for 30-day mortality, with covariates of age, sex, TIR ≥ 80%, Acute Physiology Score, and Charlson Comorbidity Index.

Results: A total of 9,028 patients, 53.2% of whom had diabetes, were studied. Median TIR was 84.1% for nondiabetic patients and 64.5% for patients with diabetes. Mortality was lower in those with TIR > 80% compared with those with TIR ≤ 80% (12.4% vs 19.2%; P < .001). TIR > 80% was independently associated with reduced mortality in nondiabetic patients (OR, 0.52; P < .001), patients with diabetes (OR, 0.69; P = .001), and patients with well-controlled disease (OR, 0.50; P < .001) but not in patients with poorly controlled disease (OR, 0.86; P = .40).

Conclusions: TIR was independently associated with mortality in critically ill patients, particularly those with good antecedent glucose control.
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http://dx.doi.org/10.1016/j.chest.2019.05.016DOI Listing
November 2019

Use of Mortality as an Endpoint in Noninferiority Trials May Lead to Ethically Problematic Conclusions.

J Gen Intern Med 2019 04 12;34(4):618-623. Epub 2019 Feb 12.

Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, UT, USA.

Background: Noninferiority trials are becoming more common. Their design often requires investigators to "trade" a secondary benefit for efficacy. Use of mortality as an outcome of interest leads to important ethical conflicts whereby researchers must establish a minimal clinically important difference for mortality, a process which has the potential to result in problematic conclusions.

Objective: We sought to investigate the frequency of the use of mortality as an outcome in noninferiority trials, as well as to determine the average pre-specified noninferiority ("delta") values.

Design: We searched MEDLINE for reports of parallel-group randomized controlled noninferiority trials published in five high-impact general medical journals.

Main Outcome Measures: Data abstracted from articles including trial design parameters, results, and interpretation of results based on CONSORT recommendations.

Results: One hundred seventy-three manuscripts reporting 196 noninferiority comparisons were included in our analysis. Of these, over a third (67 trials) used mortality either as their sole endpoint (11 trials) or as part of a composite endpoint (56 trials). Nine trials were consort A, 21 trials consort B, 19 trials consort C, 12 were consort F, 4 consort G, and 2 were consort H. Four analyses showed statistically significant more deaths in the new treatment arm, while meeting consort criteria as "inconclusive" (consort G), (Behringer et al. in Lancet. 385(9976):1418-1427, 2015; Kaul et al. in N Engl J Med. 373(18):1709-1719, 2015; Bwakura-Dangarembizi et al. in N Engl J Med. 370(1):41-53, 2014) and thirteen trials utilizing mortality as an endpoint and had an absolute increase of > 3%, and six had an absolute increase of > 5%.

Conclusions: The use of mortality as an outcome in noninferiority trials is not rare and scenarios where the new treatment is statistically worse, but a conclusion of noninferiority or inconclusive do occur. We highlight these issues and propose simple steps to reduce the risk of ethically dubious conclusions.
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http://dx.doi.org/10.1007/s11606-018-4813-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445912PMC
April 2019

A Comparison of Global Lung Initiative 2012 with Third National Health and Nutrition Examination Survey Spirometry Reference Values. Implications in Defining Obstruction.

Ann Am Thorac Soc 2019 02;16(2):225-230

1 Pulmonary and Critical Care Service, Department of Medicine, and.

Rationale: Obstructive lung disease is diagnosed by a decreased ratio of forced expiratory volume in 1 second (FEV) to forced vital capacity (FVC); however, there is no universally accepted lower limit of normal for the FEV/FVC ratio. Current established reference values use the Third National Health and Nutrition Examination Survey (NHANES III) database. In 2012, the Global Lung Initiative (GLI) introduced GLI12, which is a compilation reference set that uses standard deviation values to define normal spirometry.

Objectives: To evaluate the changes in classification of obstructive spirometry with use of GLI12 compared with NHANES III in a heterogeneous, multiracial population.

Methods: We evaluated the spirometry studies conducted in our pulmonary function laboratory between January 2005 and December 2015. NHANES III reference equations were calculated to predict lower limits of normal for FEV, FVC, and FEV/FVC. GLI12 values were established using European Respiratory Society published computer software. FEV severity was graded using 2005 American Thoracic Society guidelines for NHANES III and using z-score-based criteria for GLI12. Asymmetric partition analysis evaluated agreement between the reference sets.

Results: A total of 11,888 studies were evaluated. Obstruction was diagnosed in 2,857 studies using NHANES III versus 2,489 studies using GLI12. Agreement regarding the presence or absence of obstruction occurred in 2,483 of studies with obstruction and 9,025 studies without obstruction (agreement, 96.8%; κ = 0.91). Of the studies with obstruction, 1,595 had agreement in severity grading. Overall, agreement regarding obstruction and severity grading occurred in 10,620 studies, representing 89.3% of all studies. A total of 380 studies (3.2%) had discordance regarding the presence or absence of obstruction, 34.0% (844 of the 2,483 obstruction studies) had a one-degree of change in FEV disease severity scoring, with 44 cases (1.8%) that had changes of two categories in FEV severity scores. No studies had greater than two degrees of change. Asymmetric partition analysis suggested that the highest clinically significant changes were seen in older individuals, particularly African American men older than 65.

Conclusions: Our evaluation suggests that there is moderate overall agreement between NHANES III and GLI12. We found a 3.2% change in classification of obstruction when transitioning from NHANES III to GLI12. When incorporating a z-score-based FEV and GLI12 reference set, 10.7% of the spirometry studies had a change in their categorization. The disagreement between the two datasets was most pronounced in elderly subjects. Although we cannot endorse one reference set over the other, we highlight the potential implications of adopting the GLI12 reference sets and suggest caution when interpreting spirometry in the elderly.
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http://dx.doi.org/10.1513/AnnalsATS.201805-317OCDOI Listing
February 2019

The Difficulty of Predicting Intensive Care Unit Mortality in Resource-limited Settings.

Ann Am Thorac Soc 2018 11;15(11):1282-1284

2 Pulmonary Division Intermountain Medical Center Salt Lake City, Utah and.

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http://dx.doi.org/10.1513/AnnalsATS.201808-580EDDOI Listing
November 2018

Effect of a pulmonary nodule fact sheet on patient anxiety and knowledge: a quality improvement initiative.

BMJ Open Qual 2018 14;7(3):e000437. Epub 2018 Sep 14.

San Antonio Military Medical Center, Fort Sam Houston, Texas, USA.

Introduction: The utilisation of chest CT for the evaluation of pulmonary disorders, including low-dose CT for lung cancer screening, is increasing in the USA. As a result, the discovery of both screening-detected and incidental pulmonary nodules has become more frequent. Despite an overall low risk of malignancy, pulmonary nodules are a common cause of emotional distress among adult patients.

Methods: We conducted a multi-institutional quality improvement (QI) initiative involving 101 participants to determine the effect of a pulmonary nodule fact sheet on patient knowledge and anxiety. Males and females aged 35 years or older, who had a history of either screening-detected or incidental solid pulmonary nodule(s) sized 3-8 mm, were included. Prior to an internal medicine or pulmonary medicine clinic visit, participants were given a packet containing a pre-fact sheet survey, a pulmonary nodule fact sheet and a post-fact sheet survey.

Results: Of 101 patients, 61 (60.4%) worried about their pulmonary nodule at least once per month with 18 (17.8%) worrying daily. The majority 67/101 (66.3%) selected chemotherapy, chemotherapy and radiation, or radiation as the best method to cure early-stage lung cancer. Despite ongoing radiographic surveillance, 16/101 (15.8%) stated they would not be interested in an intervention if lung cancer was diagnosed. Following review of the pulmonary nodule fact sheet, 84/101 (83.2%) reported improved anxiety and 96/101 (95.0%) reported an improved understanding of their health situation. Patient understanding significantly improved from 4.2/10.0 to 8.1/10.0 (p<0.01).

Conclusion: The incorporation of a standardised fact sheet for subcentimeter solid pulmonary nodules improves patient understanding and alleviates anxiety. We plan to implement pulmonary nodule fact sheets into the care of our patients with low-risk subcentimeter pulmonary nodules.
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http://dx.doi.org/10.1136/bmjoq-2018-000437DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6144906PMC
September 2018

Descriptive epidemiology of snakebites in the Veraguas province of Panama, 2007-2008.

Trans R Soc Trop Med Hyg 2018 10;112(10):463-466

Department of Medicine, Division of Infectious Diseases, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, USA.

Background: Panama has the highest incidence of snakebites in Central America, however, few studies have looked at the epidemiology of human snakebites in Panama.

Methods: This retrospective, single-center study reviewed individuals who sustained a snakebite from 2007-2008. Demographic data, disease severity, species of snake, treatment, infectious complications and antibiotic usage were collected from the hospital records.

Results: Data were collected over a 2-y period, with a total of 390 records of snakebites. Bothrops asper was responsible for 43.8% of cases and the majority of the cases occurred during the rainy season. The majority of bites (74.7%) occurred on the hands, feet or toes. Antivenom was used in 55% of patients and 67% of patients received tetanus toxoid. Only 8.7% of individuals presented to the hospital within 1 h of envenomation and more than 25% presented >6 h after envenomation.

Conclusions: B. asper is responsible for the majority of snakebites in the Veraguas province of Panama. Snakebites tend to occur during the rainy season, with the majority of bites occurring on the feet. Several management factors need to improve in Panama: time to presentation, which is prolonged in the majority of cases, and antivenom, antibiotic and tetanus toxoid delivery should be standardized to optimize care.
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http://dx.doi.org/10.1093/trstmh/try076DOI Listing
October 2018

Design and Interpretation of Noninferiority Trials.

J Gen Intern Med 2018 08;33(8):1217

Brooke Army Medical Center, San Antonio, TX, USA.

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http://dx.doi.org/10.1007/s11606-018-4505-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082219PMC
August 2018

Lower Glucose Target Is Associated With Improved 30-Day Mortality in Cardiac and Cardiothoracic Patients.

Chest 2018 11 26;154(5):1044-1051. Epub 2018 Apr 26.

Division of Pulmonary and Critical Care, Intermountain Medical Center, Murray, UT; Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, UT.

Background: Practice guidelines recommend against intensive insulin therapy in patients who are critically ill based on trials that had high rates of severe hypoglycemia. Intermountain Healthcare uses a computerized IV insulin protocol that allows choice of blood glucose (BG) targets (80-110 vs 90-140 mg/dL) and has low rates of severe hypoglycemia. We sought to study the effects of BG target on mortality in adult patients in cardiac ICUs that have very low rates of severe hypoglycemia.

Methods: Critically ill patients receiving IV insulin were treated with either of two BG targets (80-110 vs 90-140 mg/dL). We created a propensity score for BG target using factors thought to have influenced clinicians' choice, and then we performed a propensity score-adjusted regression analysis for 30-day mortality.

Results: There were 1,809 patients who met inclusion criteria. Baseline patient characteristics were similar. Median glucose was lower in the 80-110 mg/dL group (104 vs 122 mg/dL, P < .001). Severe hypoglycemia occurred at very low rates in both groups (1.16% vs 0.35%, P = .051). Unadjusted 30-day mortality was lower in the 80-110 mg/dL group (4.3% vs 9.2%, P < .001). This remained after propensity score-adjusted regression (OR, 0.65; 95% CI, 0.43-0.98; P = .04).

Conclusions: Tight glucose control can be achieved with low rates of severe hypoglycemia and is associated with decreased 30-day mortality in a cohort of largely patients in cardiac ICUs. Although such findings should not be used to guide clinical practice at present, the use of tight glucose control should be reexamined using a protocol that has low rates of severe hypoglycemia.
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http://dx.doi.org/10.1016/j.chest.2018.04.025DOI Listing
November 2018

Do non-inferiority trials of reduced intensity therapies show reduced effects? A descriptive analysis.

BMJ Open 2018 03 2;8(3):e019494. Epub 2018 Mar 2.

The University of Utah, Salt Lake City, Utah, USA.

Objectives: To identify non-inferiority trials within a cohort where the experimental therapy is the same as the active control comparator but at a reduced intensity and determine if these non-inferiority trials of reduced intensity therapies have less favourable results than other non-inferiority trials in the cohort. Such a finding would provide suggestive evidence of biocreep in these trials.

Design: This metaresearch study used a cohort of non-inferiority trials published in the five highest impact general medical journals during a 5-year period. Data relating to the characteristics and results of the trials were abstracted.

Primary Outcome Measures: Proportions of trials with a declaration of superiority, non-inferiority and point estimates favouring the experimental therapy and mean absolute risk differences for trials with outcomes expressed as a proportion.

Results: Our search yielded 163 trials reporting 182 non-inferiority comparisons; 36 comparisons from 31 trials were between the same therapy at reduced and full intensity. Compared with trials not evaluating reduced intensity therapies, fewer comparisons of reduced intensity therapies demonstrated a favourable result (non-inferiority or superiority) (58.3%vs82.2%; P=0.002) and fewer demonstrated superiority (2.8%vs18.5%; P=0.019). Likewise, point estimates for reduced intensity therapies more often favoured active control than those for other trials (77.8%vs39.7%; P<0.001) as did mean absolute risk differences (+2.5% vs -0.7%; P=0.018).

Conclusions: Non-inferiority trials comparing a therapy at reduced intensity to the same therapy at full intensity showed reduced effects compared with other non-inferiority trials. This suggests these trials may have a high rate of type 1 errors and biocreep, with significant implications for the design and interpretation of future non-inferiority trials.
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http://dx.doi.org/10.1136/bmjopen-2017-019494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855198PMC
March 2018

Reply: Zika-associated Shock and Multiorgan Dysfunction.

Ann Am Thorac Soc 2018 03;15(3):391-392

2 University of Utah Salt Lake City, Utah and.

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http://dx.doi.org/10.1513/AnnalsATS.201711-903LEDOI Listing
March 2018

Zika-associated Shock and Multi-Organ Dysfunction.

Ann Am Thorac Soc 2017 11;14(11):1706-1708

1 Division of Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, Utah.

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http://dx.doi.org/10.1513/AnnalsATS.201612-988CCDOI Listing
November 2017

Empirical Consequences of Current Recommendations for the Design and Interpretation of Noninferiority Trials.

J Gen Intern Med 2018 01 5;33(1):88-96. Epub 2017 Sep 5.

Division of Epidemiology, University of Utah School of Medicine, 30 N 1900 E, Salt Lake City, UT, 84108, USA.

Background: Noninferiority trials are increasingly common, though they have less standardized designs and their interpretation is less familiar to clinicians than superiority trials.

Objective: To empirically evaluate a cohort of noninferiority trials to determine 1) their interpretation as recommended by CONSORT, 2) choice of alpha threshold and its sidedness, and 3) differences between methods of analysis such as intention-to-treat and per-protocol.

Design: We searched MEDLINE for parallel-group randomized controlled noninferiority trials published in the five highest-impact general medical journals between 2011 and 2016.

Main Measures: Data abstracted included trial design parameters, results, and interpretation of results based on CONSORT recommendations.

Key Results: One hundred sixty-three trials and 182 noninferiority comparisons were included in our analysis. Based on CONSORT-recommended interpretation, 79% of experimental therapies met criteria for noninferiority, 13% met criteria for superiority, 20% were declared inconclusive, and 2% met criteria for inferiority. However, for 12% of trials, the experimental therapy was statistically significantly worse than the active control, but CONSORT recommended an interpretation of inconclusive or noninferior. A two-sided alpha equivalent of greater than 0.05 was used in 34% of the trials, and in five of these trials, the use of a standard two-sided alpha of 0.05 led to changes in the interpretation of results that disfavored the experimental therapy. In four of the five comparisons where different methods of analysis (e.g., intention-to-treat and per-protocol) yielded different results, the intention-to-treat analysis was the more conservative. In 11% of trials, a secondary advantage of the new therapy was neither reported nor could it be inferred by reviewers.

Conclusions: In this cohort, the design and interpretation of noninferiority trials led to significant and systematic bias in favor of the experimental therapy. Clinicians should exercise caution when interpreting these trials. Future trials may be more reliable if design parameters are standardized.
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http://dx.doi.org/10.1007/s11606-017-4161-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5756156PMC
January 2018

Intrathecal Baclofen Therapy for the Treatment of Spasticity in Sjögren-Larsson Syndrome.

J Child Neurol 2017 01 6;32(1):100-103. Epub 2016 Oct 6.

1 Division of Pediatric Neurosurgery, Department of Neurosurgery, NYU Langone Medical Center, NY, USA.

Intrathecal baclofen therapy is widely accepted as a treatment option for patients with severe spasticity. The current treatment of spasticity in patients with Sjögren-Larsson syndrome is largely symptomatic, given that no effective causal therapy treatments are available. We report the outcome of 2 patients with Sjögren-Larsson syndrome who had pump implantation for intrathecal baclofen. We observed a positive response, with a decrease of spasticity, reflecting in the Modified Ashworth Scale, and parents and caregivers observed a functional improvement in both patients. One patient experienced skin irritation 15 months after surgery, necessitating pump repositioning. No infection occurred. Our report shows that intrathecal baclofen therapy can have a positive therapeutic effect on spasticity in patients with Sjögren-Larsson syndrome, and therefore may be a promising addition to current treatments.
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http://dx.doi.org/10.1177/0883073816671440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5339737PMC
January 2017

N-Terminal Pro-Brain Natriuretic Peptide Trial Design.

Am J Respir Crit Care Med 2017 08;196(4):530

1 University of Utah Salt Lake City, Utah.

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http://dx.doi.org/10.1164/rccm.201610-2139LEDOI Listing
August 2017

Associations among left ventricular systolic function, tachycardia, and cardiac preload in septic patients.

Ann Intensive Care 2017 Dec 17;7(1):17. Epub 2017 Feb 17.

Critical Care Echocardiography Service, Intermountain Medical Center, 5121 S Cottonwood St, Murray, UT, 84157, USA.

Background: In sepsis, tachycardia may indicate low preload, adrenergic stimulation, or both. Adrenergic overstimulation is associated with septic cardiomyopathy. We sought to determine whether tachycardia was associated with left ventricular longitudinal strain, a measure of cardiac dysfunction. We hypothesized an association would primarily exist in patients with high preload.

Methods: We prospectively observed septic patients admitted to three study ICUs, who underwent early transthoracic echocardiography. We measured longitudinal strain using speckle tracking echocardiography and estimated preload status with an echocardiographic surrogate (E/e'). We assessed correlation between strain and heart rate in patients with low preload (E/e' < 8), intermediate preload (E/e' 8-14), and high preload (E/e' > 14), adjusting for disease severity and vasopressor dependence.

Results: We studied 452 patients, of whom 298 had both measurable strain and preload. Abnormal strain (defined as >-17%) was present in 54%. Patients with abnormal strain had higher heart rates (100 vs. 93 beat/min, p = 0.001). After adjusting for vasopressor dependence, disease severity, and cardiac preload, we observed an association between heart rate and longitudinal strain (β = 0.05, p = 0.003). This association persisted among patients with high preload (β = 0.07, p = 0.016) and in patients with shock (β = 0.07, p = 0.01), but was absent in patients with low or intermediate preload and those not in shock.

Conclusions: Tachycardia is associated with abnormal left ventricular strain in septic patients with high preload. This association was not apparent in patients with low or intermediate preload.
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http://dx.doi.org/10.1186/s13613-017-0240-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315651PMC
December 2017