Publications by authors named "Ambuj Kumar"

243 Publications

Primary Immunodeficiency in Children With Autoimmune Cytopenias: Retrospective 154-Patient Cohort.

Front Immunol 2021 22;12:649182. Epub 2021 Apr 22.

Division of Allergy and Immunology, Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, United States.

Background: Primary immunodeficiency is common among patients with autoimmune cytopenia.

Objective: The purpose of this study is to retrospectively identify key clinical features and biomarkers of primary immunodeficiency (PID) in pediatric patients with autoimmune cytopenias (AIC) so as to facilitate early diagnosis and targeted therapy.

Methods: Electronic medical records at a pediatric tertiary care center were reviewed. We selected 154 patients with both AIC and PID (n=17), or AIC alone (n=137) for inclusion in two cohorts. Immunoglobulin levels, vaccine titers, lymphocyte subsets (T, B and NK cells), autoantibodies, clinical characteristics, and response to treatment were recorded.

Results: Clinical features associated with AIC-PID included splenomegaly, short stature, and recurrent or chronic infections. PID patients were more likely to have autoimmune hemolytic anemia (AIHA) or Evans syndrome than AIC-only patients. The AIC-PID group was also distinguished by low T cells (CD3 and CD8), low immunoglobulins (IgG and IgA), and higher prevalence of autoantibodies to red blood cells, platelets or neutrophils. AIC diagnosis preceded PID diagnosis by 3 years on average, except among those with partial DiGeorge syndrome. AIC-PID patients were more likely to fail first-line treatment.

Conclusions: AIC patients, especially those with Evans syndrome or AIHA, should be evaluated for PID. Lymphocyte subsets and immune globulins serve as a rapid screen for underlying PID. Early detection of patients with comorbid PID and AIC may improve treatment outcomes. Prospective studies are needed to confirm the diagnostic clues identified and to guide targeted therapy.
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http://dx.doi.org/10.3389/fimmu.2021.649182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8100326PMC
April 2021

Systematic Review/Meta-Analysis on Efficacy of Allogeneic Hematopoietic Cell Transplantation in Sickle Cell Disease: An International Effort on Behalf of the Pediatric Diseases Working Party of European Society for Blood and Marrow Transplantation and the Sickle Cell Transplantation International Consortium.

Transplant Cell Ther 2021 Feb 10;27(2):167.e1-167.e12. Epub 2020 Dec 10.

Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapy Program, Mayo Clinic, Jacksonville, Florida. Electronic address:

Sickle cell disease (SCD) affects more than 300,000 children annually worldwide. Despite improved supportive care, long-term prognosis remains poor. Allogeneic hematopoietic cell transplantation (allo-HCT) is the sole validated curative option, resulting in sustained resolution of the clinical phenotype. The medical literature on allo-HCT for SCD is largely limited to children. Recent studies have evaluated allo-HCT efficacy in adults. Here, we conducted a systematic review/meta-analysis to assess the totality of evidence on the efficacy, or lack thereof, of allo-HCT in treating SCD. We performed a comprehensive literature search using PubMed/Medline, Embase, and Cochrane library databases on November 13, 2019. Four authors independently extracted data on clinical outcomes related to benefits (overall survival [OS] and disease-free survival [DFS]) and harms (acute graft-versus-host disease [aGVHD], chronic graft-versus-host disease [cGVHD], nonrelapse mortality [NRM], and graft failure [GF]). Our search identified a total of 1906 references. Only 33 studies (n= 2853 patients) met our inclusion criteria. We also performed a subset analysis by age. Analyses of all-age groups showed pooled rates of 96% for OS, 90% for DFS, 20% for aGVHD, 10% for cGVHD, 4% for NRM, and 5% for GF. In the pediatric population, pooled rates for OS, DFS, aGVHD, cGVHD, NRM, and GF were 97%, 91%, 26%, 11%, 5%, and 3%, respectively. In adults, pooled rates for OS, DFS, aGVHD, cGVHD, NRM, and GF were 98%, 90%, 7%, 1%, 0%, and 14%, respectively. Our data show that allo-HCT is safe and effective, yielding pooled OS rates exceeding 90%. The high GF rate of 14% in adults is concerning and emphasizes the need to evaluate new strategies.
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http://dx.doi.org/10.1016/j.jtct.2020.10.007DOI Listing
February 2021

Efficacy of allogeneic hematopoietic cell transplantation in patients with chronic phase CML resistant or intolerant to tyrosine kinase inhibitors.

Hematol Oncol Stem Cell Ther 2021 Mar 11. Epub 2021 Mar 11.

Division of Hematology-Oncology and Blood and Marrow Transplantation and Cellular Therapies Program, Mayo Clinic Florida, Jacksonville, FL, USA. Electronic address:

Approximately 15-20% of chronic myeloid leukemia (CML) patients fail tyrosine kinase inhibitor (TKI) therapy secondary to resistance or intolerance. In the pre-TKI era, front-line allogeneic hematopoietic cell transplantation (allo-HCT) represented the standard approach for patients with chronic phase-CML (CP-CML) who were deemed fit to tolerate the procedure and had a human leukocyte antigen compatible donor available. Currently, CP-CML patients are eligible for allo-HCT only if they fail more than one TKI and/or are intolerant to the drug. We performed a systematic review/meta-analysis of the available literature to assess the evidence regarding allo-HCT efficacy in CP-CML patients. Data from eligible studies were extracted in relation to benefits (overall survival [OS], progression-free survival, disease-free survival [DFS], complete remission [CR], and molecular response [MR]) and harms (nonrelapse mortality [NRM], relapse, and acute and chronic graft-versus-host disease), and stratified by age into adult and pediatric groups. For adult allo-HCT recipients, the pooled OS, DFS, CR and, MR were 84% [95% confidence interval (CI) 59-99%], 66% (95% CI 59-73%), 56% (95% CI 30-80%), and 88% (95% CI 62-98%), respectively. Pooled NRM and relapse were 20% (95% CI 15-26%) and 19% (95% CI 10-28%), respectively. For the pediatric group, the OS rate was reported in one study and was 91% (95% CI 72-99%). Our results suggest that allo-HCT is an effective treatment for TKI-resistant or TKI-intolerant CP-CML. Post-transplant strategies are still needed to further mitigate the risk of relapse.
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http://dx.doi.org/10.1016/j.hemonc.2021.02.003DOI Listing
March 2021

Incidence and Management of Effusions Before and After CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy in Large B Cell Lymphoma.

Transplant Cell Ther 2021 Mar 27;27(3):242.e1-242.e6. Epub 2020 Dec 27.

Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida; Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, Florida. Electronic address:

In patients with lymphoma, third-space fluid accumulations may develop or worsen during cytokine release syndrome (CRS) associated with chimeric antigen receptor (CAR) T cell therapy. Pre-existing symptomatic pleural effusions were excluded by the ZUMA-1 trial of axicabtagene ciloleucel for large B cell lymphoma (LBCL) and variants. The incidence and management of effusions during CAR T cell therapy for LBCL are unknown. We performed a single-center retrospective study evaluating 148 patients receiving CD19-directed CAR T cell therapy for LBCL between May 2015 and September 2019. We retrospectively identified patients who had radiographic pleural, pericardial, or peritoneal effusions that were present prior to the time of CAR T infusion (pre-CAR T) or that newly developed during the first 30 days after CAR T-cell infusion (post-CAR T). Of 148 patients, 19 patients had a pre-CAR T effusion, 17 patients without pre-existing effusion developed a new infusion after CAR T, and 112 patients had no effusions. Comparing pre-CAR T effusions to new effusions post-CAR T, pre-CAR T effusions were more often malignant (84% versus 12%), persistent beyond 30 days (95% versus 18%), and required interventional drainage after CAR T infusion (79% versus 0%). Compared to patients with no effusion, patients with pre-CAR T therapy effusions had a higher frequency of high-risk baseline characteristics, such as bulky disease and high International Prognostic Index. Similarly, patients with pre-CAR T therapy effusions had a higher rate of toxicity with grade 3 or higher CRS occurring in 32% of patients. On multivariate analysis adjusting for age, Eastern Cooperative Oncology Group status, bulky disease, albumin, and lactate dehydrogenase, a pre-CAR T therapy effusion was associated with reduced overall survival (hazard ratio, 2.34; 95% confidence interval, 1.09 to 5.03; P = .03). Moreover, there was higher non-relapse mortality (11% versus 1%; P = .005). Post-CAR T effusions were not associated with significant difference in survival. Effusions commonly complicate CAR T cell therapy for lymphoma. Malignant effusions that occur prior to CAR T therapy are frequently persistent and require therapeutic intervention, and patients have a higher rate of toxicity and death. Effusions that newly occur after CAR T therapy can generally be managed medically and tend not to persist.
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http://dx.doi.org/10.1016/j.jtct.2020.12.025DOI Listing
March 2021

Influential Factors on Risk-reduction Mastectomy in a High-risk Breast Cancer Population With Genetic Predispositions.

Clin Breast Cancer 2021 Jan 19. Epub 2021 Jan 19.

GeneHome Hereditary Cancer Screening Clinic, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL. Electronic address:

Background: Carriers of deleterious mutations in breast cancer predisposition genes are presented with critical choices regarding cancer risk management. Risk-reduction mastectomy is a major preventative strategy in this population. Understanding the decision-making process for prophylactic mastectomy is essential in patient-centered care for high-risk carriers and patients with breast cancer. We sought to provide insight into influential factors underlying preventative surgery decisions among individuals with high breast cancer risk.

Materials And Methods: We conducted a retrospective chart review of pathogenic carriers of high-risk breast cancer genes who presented to the Moffitt GeneHome clinic between March 2017 and June 2020. Associations between preventative mastectomy choice and influence variables were analyzed via unadjusted and adjusted logistic regression models.

Results: Of 258 high-risk mutation carriers, 104 (40.3%) underwent risk-reduction mastectomy. A significantly higher proportion of mastectomy patients reported prior history of breast cancer (68.9% vs. 16.5%; P < .001) and history of other risk-reduction or noncancer-related surgeries (61.7% vs. 25.8%; P < .001). Significant predictors affecting surgery decision included previous breast cancer history (adjusted odds ratio [aOR], 10.48; 95% confidence interval [CI], 5.59-19.63; P < .0001), other risk-reduction or noncancer-related surgical history (aOR, 4.65; 95% CI, 2.28-9.47; P < .0001), and age at presentation to the genetics clinic (< 35 years old: aOR, 2.77; 95% CI, 1.04-7.4; P = .042; 35-55 years old: aOR, 2.48; 95% CI, 1.19-5.18; P = .016).

Conclusions: Preventive mastectomy decisions are highly personal and complex. In our sample, we observed prior history or concurrent breast cancer, history of other risk-reduction surgery or noncancer-related surgery, and younger age at presentation to the GeneHome clinic to be predictive of mastectomy uptake.
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http://dx.doi.org/10.1016/j.clbc.2021.01.008DOI Listing
January 2021

Morphometric analysis of thoracolumbar junction (T11-L2) in central Indian population: A computerized tomography based study of 800 vertebrae.

J Clin Orthop Trauma 2021 Apr 13;15:139-144. Epub 2020 Sep 13.

Department of Neurosurgery, Superspeciality Hospital, NSCB Medical College, Jabalpur, India.

Objective: To determine various morphometric parameters like transverse and sagittal pedicle width; interpedicular distance; antero-posterior and transverse canal diameter and canal surface area at thoracolumbar junction (T11, T12, L1, L2) in central Indian population and compare results with similar studies available in literature.

Material And Methods: A prospective, computerized tomography scan based morphometric analysis of thoracolumbar junction was conducted at medical college and tertiary care centre in central India. All asymptomatic cases more than 18 years age with normal lateral radiograph and CT scan of thoracolumbar junction and free from any spinal pathology or trauma were included in the study. Parameters measured were transverse and sagittal pedicle width; interpedicular distance; antero-posterior and transverse canal diameter and canal surface area at thoracolumbar junction (T11, T12, L1, L2).

Results: Mean transverse pedicle width was maximum at T11 and minimum at L1 in both males and females, whereas sagittal width was maximum at T11 and minimum at L2 in both the groups. Interpedicular distance was largest at L1 in both the groups. All the measurements were significantly different (P < 0.05) in males and females. Mean antero-posterior and transverse diameter was maximum at T12 and L2 respectively in both male and female study population. Canal surface area was maximum at L1 among males (230.10 mm) as well as females (209.02 mm).

Conclusion: There is significant variation in morphometric parameters of thoracolumbar junction in different races and population. Thorough knowledge of morphometry of a particular population is essential for dealing with pathology or trauma of thoracolumbar junction.
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http://dx.doi.org/10.1016/j.jcot.2020.09.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919963PMC
April 2021

Association of pharmacist counseling with adherence, 30-day readmission, and mortality: A systematic review and meta-analysis of randomized trials.

J Am Pharm Assoc (2003) 2021 May-Jun;61(3):340-350.e5. Epub 2021 Mar 5.

Objective(s): To determine the association of pharmacist medication counseling with medication adherence, 30-day hospital readmission, and mortality.

Methods: The initial search identified 21,590 citations. After applying the inclusion and exclusion criteria, 62 randomized controlled trials (RCTs) (49 for the meta-analysis) were included in the final analysis. Data were pooled using a random-effects model.

Results: The participants in most of the studies were older patients with chronic diseases who, therefore, were taking many drugs. The overall methodologic quality of evidence ranged from low to very low. Pharmacist medication counseling versus no such counseling was associated with a statistically significant 30% increase in relative risk (RR) for medication adherence, a 24% RR reduction in 30-day hospital readmission (number needed to treat = 4.2), and a 30% RR reduction in emergency department visits. RR reductions for primary care visits and mortality were not statistically significant.

Conclusion: The evidence supports pharmacist medication counseling to increase medication adherence and to reduce 30-day hospital readmissions and emergency department visits. However, higher-quality RCT studies are needed to confirm or refute these findings.
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http://dx.doi.org/10.1016/j.japh.2021.01.028DOI Listing
March 2021

Diagnostic Accuracy of an Esophageal Screening Protocol Interpreted by the Speech-Language Pathologist.

Dysphagia 2021 Feb 20. Epub 2021 Feb 20.

Center for Swallowing Disorders, University of South Florida, 13330 USF Laurel Drive, Tampa, FL, 33612, USA.

Oropharyngeal and esophageal dysphagia may occur simultaneously. However, symptoms are often evaluated separately. Few standardized, multi-texture esophageal screening protocols exist as an addition to the modified barium swallow study (MBSS). Given the gap in MBSS evaluation standards, providers may be lacking information needed to fully assess the swallowing process and create appropriate dysphagia management plans. The aim was to assess the diagnostic accuracy of a standardized esophageal screening protocol performed by an SLP compared to formal reference esophageal examinations. A cross-sectional analytic study was performed. Consecutively referred patients who underwent same-day consultation with the SLP and a gastroenterologist were included. MBSS with a standardized esophageal screen was performed. Same-day formal esophageal testing was completed and included timed barium emptying study or high-resolution manometry. Summary diagnostic accuracy measures were calculated. Seventy-three patients matched the inclusion criteria. Median age was 62.5 years (25-87), 55% were female. Sensitivity of the esophageal screen for the detection of esophageal abnormality was 83.7% (95% CI 70-91.9%); specificity was 73.7% (95% CI 55.6-85.8%). The positive likelihood ratio was 3.14 (95% CI 1.71-5.77), whereas the negative likelihood ratio was 0.22 (95% CI 0.11-0.45). Positive and negative predictive values were 82% and 76%, respectively. Use of a systematic, multi-texture esophageal screen protocol interpreted by SLPs accurately identifies multiphase dysphagia and should be considered in addition to standard MBSS testing. Inclusion of a cursory esophageal view may more adequately assess dysphagia symptoms and help to promote multidisciplinary care.
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http://dx.doi.org/10.1007/s00455-020-10239-3DOI Listing
February 2021

Preservation of the Implant in Nipple-Sparing Mastectomies: A Retrospective Cohort Study.

Ann Plast Surg 2021 Feb 1. Epub 2021 Feb 1.

From the Department of Plastic Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL Yale School of Public Health, New Haven, CT Department of Women's Oncology, Breast Program, Moffitt Cancer Center Department of Health Outcomes and Behavior, University of South Florida, Morsani College of Medicine, Tampa, FL.

Background: Mastectomies are an integral part of breast cancer treatment for many patients.1 Of those patients, a significant number have previously undergone breast augmentation before being diagnosed with breast cancer. Therefore, we developed the novel technique of performing nipple- and implant-sparing mastectomies (NISMs) for women with prior breast augmentations. This study will assess the plausibility of using NISMs versus nipple-sparing mastectomies (NSMs) in this subgroup of patients by comparing the complication rates.

Methods: Data were collected on age, tumor size, tumor grade, receptors, and the interval between mastectomy and implant exchange for both groups. Descriptive statistics were used to summarize patient characteristics. Independent samples t tests, χ2 tests, and Fisher exact tests were used to compare the NISM and NSM cohorts. Logistic regression was used to assess the association between complications and mastectomy type and was summarized as an odds ratio with a 95% confidence interval.

Results: Fifteen patients underwent an NISM and 35 patients underwent an NSM. The overall rate of complications was less in NISM cases than in NSM cases (20% vs 27%). However, this difference was not statistically significant (odds ratio, 0.54; 95% confidence interval, 0.18-1.64; P = 0.278).

Conclusions: The overall complication rate was lower with NISMs compared with NSMs. Nipple- and implant-sparing mastectomy is a novel, viable, and safe option for patients with breast cancer and a history of submuscular breast augmentation.
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http://dx.doi.org/10.1097/SAP.0000000000002696DOI Listing
February 2021

Neoadjuvant Chemotherapy for Intrahepatic Cholangiocarcinoma: A Propensity Score Survival Analysis Supporting Use in Patients with High-Risk Disease.

Ann Surg Oncol 2021 Apr 7;28(4):1939-1949. Epub 2021 Jan 7.

Section of Hepatobiliary Tumors, Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Background: Upfront surgery is the current standard for resectable intrahepatic cholangiocarcinoma (ICC) despite high treatment failure with this approach. We sought to examine the use of neoadjuvant chemotherapy (NAC) as an alternative strategy for this population.

Methods: The National Cancer Database was used to identify patients with resectable ICC undergoing curative-intent surgery (2006-2014). Utilization trends were examined and survival estimates between NAC and upfront surgery were compared; propensity score-matched models were used to examine the association of NAC with overall survival (OS) for all patients and risk-stratified cohorts. Models accounted for clustering within hospitals, and results represent findings from a complete-case analysis.

Results: Among 881 patients with ICC, 8.3% received NAC, with no changes over time (Cochran-Armitage p = 0.7). Median follow-up was 50.9 months, with no difference in unadjusted survival with NAC versus upfront surgery (median OS 51.8 vs. 35.6 months, and 5-year OS rates of 38.2% vs. 36.6%; log rank p = 0.51), and no survival benefit in the propensity score-matched analysis (hazard ratio [HR] 0.78, 95% CI 0.54-1.11; p = 0.16). However, for patients with stage II-III disease, NAC was associated with a trend towards improved survival (median OS of 47.6 months vs. 25.9 months, and 5-year OS rates of 34% vs. 25.7%; log-rank p = 0.10) and a statistically significant survival benefit in the propensity score-matched analysis. (HR 0.58, 95% CI 0.37-0.91; p = 0.02).

Conclusion: NAC is associated with improved OS over upfront surgery in patients with resectable ICC and high-risk of treatment failure. These data support the need for prospective studies to examine NAC as an alternative strategy to improve OS in this population.
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http://dx.doi.org/10.1245/s10434-020-09478-3DOI Listing
April 2021

Addressing Gender Disparity: Increase in Female Leadership Increases Gender Equality in Program Director and Fellow Ranks.

Dig Dis Sci 2021 Jan 6. Epub 2021 Jan 6.

Department of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, 12901 Bruce B. Downs Blvd, MDC 82, Tampa, FL, 33612, USA.

Introduction: Women make up 15% of the total number of practicing gastroenterology (GI) physicians in the US. Despite this disparity, only 33% of the current GI fellows are female. Increasing female GIs is a major goal of all four GI societies. It is known that gender disparity exists in the field of gastroenterology, and women are underrepresented in the leadership ranks and trainee level at academic programs. Whether an increase in female leadership in academic medicine is associated with an increase in female program directors and trainees is unknown. The aim of this study was to assess this relationship in GI.

Materials And Methods: Data were collected via a standardized protocol from all 173 US gastroenterology fellowship programs up until October 2018 from program websites and supplemented by online surveys completed by program coordinators. Any missing information was collected by calling the program coordinators. Data were collected on gender and academic rank of the program director, associate program director, division chief, chair of medicine, program size, academic center affiliation, number, and academic rank of female faculty and geographic region. The association was assessed using a Chi-square test or independent samples t test.

Results: In leadership positions, men were listed as comprising 86% of chairs, 82% of division chiefs, 76% of program directors and 63% of associate program directors. Forty-three percent of programs did not have female representation at any leadership level. The presence of a female program director or female associate program director was associated with an increase in the number of female fellows (4.03 vs 3.20; p = 0.076; 4.26 vs 3.36; p = 0.041), respectively. Overall, the presence of a female in any leadership position led to an increase in the number of female fellows (4.04 females vs 2.87 females; p = 0.007) enrolled in a program. If a GI division chief was male, the program director was more likely to be male as well (81% male vs. 18.8% female). Conversely, having a female division chief was likely to lead to a more equitable program director representation, 54% female to 48% male (p value < 0.0001, OR 5.03 95% CI 2.04-12.3). Furthermore, if either the internal medicine department chair or GI chief was female, the proportion of female program directors increased to 41% as compared to 19% if both were male (p value < 0.0001, OR 2.99 95% CI 1.34-6.6).

Conclusion: Women are significantly underrepresented in the number of practicing gastroenterologists, at all levels of leadership in GI fellowship programs, and at the fellow level. Increasing the number of women in fellowship leadership positions is associated with an increase in female program directors and trainees. Per our knowledge, this is the first study to examine the relationship between female leadership in fellowship programs and the gender of trainees. Increasing female representation in leadership positions would not only address current gender disparity, but it may also increase the number of female future GI trainees.
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http://dx.doi.org/10.1007/s10620-020-06686-5DOI Listing
January 2021

Impact of mind-body treatment interventions on quality of life in neurofibromatosis patients: A systematic review and meta-analysis.

Dermatol Ther 2021 Jan 7;34(1):e14613. Epub 2020 Dec 7.

Research Methodology and Biostatistics Core, Office of Research, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.

Individuals with neurofibromatosis (NF) experience poorer quality of life (QoL), in part contributed by the clinical manifestations of NF, such as functional disability, chronic pain, and altered physical appearance. Mind-body therapies (MBTs) tailored to NF have been developed, and have demonstrated promising potential to improve QoL in this population. We sought to systematically review current evidence on the effectiveness of MBTs in addressing QoL deficits in NF patients. Databases were reviewed between the date of inception and June 2020, using search terms: neurofibromatosis, schwannomatosis, psychotherapy, mind-body, mindfulness, meditation, resiliency, and behavioral therapy. Quality appraisal was assessed using the Cochrane Risk of Bias Tools and National Institutes of Health Study Quality Assessment Tools. We conducted a meta-analysis of mean differences and reported aggregate effect estimates with 95% confidence intervals. A total of 10 articles, including randomized-controlled trials and pre-post studies, were identified. Meta-analytic results of randomized-controlled trial data from six citations demonstrated MBTs were associated with improved physical (MD = 13.63, 95%CI 6.95-20.30, P < .0001, I = 24%), psychological (MD = 14.11, 95%CI 6.44-21.78, P = .0003, I = 38%), social (MD = 9.63, 95%CI 2.93-16.33, P = .005, I = 0%), and environmental QoL (MD = 14.14, 95%CI 8.28-20.00, P < .00001. I = 0%) in NF patients. These associations were maintained at 6-months follow-up for physical, psychological, and environmental QoL (P < .05). Our findings suggest that NF-adapted MBT strategies are associated with improving QoL in diverse NF populations, including NF2 patients experiencing deafness and youth NF patients. Providers and caregivers for NF should be aware of the potential benefits of MBT in chronic NF management.
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http://dx.doi.org/10.1111/dth.14613DOI Listing
January 2021

Impact of Metformin on Statin Persistence: a Post Hoc Analysis of a Large Randomized Controlled Trial.

J Gen Intern Med 2020 Nov 18. Epub 2020 Nov 18.

Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.

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http://dx.doi.org/10.1007/s11606-020-06344-6DOI Listing
November 2020

High-Flow Bypass with Radial Artery Graft for Cavernous Carotid Aneurysm.

Asian J Neurosurg 2020 Jul-Sep;15(3):678-682. Epub 2020 Aug 28.

Department of Neurosurgery, Bantane Hospital, Fujita Health University, Nagoya, Japan.

Cavernous carotid aneurysms can be managed by different surgical as well as endovascular methods. The aim of treatment is to exclude the aneurysm from circulation and maintain normal cerebral blood flow. We are reporting a case of incidentally detected CCA managed by high flow bypass with radial artery graft. We discuss the surgical technique and nuances of high flow bypass surgery.
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http://dx.doi.org/10.4103/ajns.AJNS_82_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591167PMC
August 2020

Institutional Experience of Microsurgical Management in Posterior Circulation Aneurysm.

Asian J Neurosurg 2020 Jul-Sep;15(3):484-493. Epub 2020 Aug 28.

Department of Neurosurgery, Bantane Hospital, Fujita Health University, Nagoya, Japan.

Introduction: Posterior circulation aneurysm constitutes 15%-20% of all intracerebral aneurysms. With the advancement of endovascular techniques, the microsurgery for posterior circulation aneurysms has been pushed back a little. Even the International Subarachnoid Aneurysmal Trial gave support to the concepts of endovascular procedures, but microsurgical modality should not be discouraged. We present our institutional experience of microsurgical techniques on posterior circulation aneurysms.

Materials And Methods: We performed a retrospective analysis of 37 patients of posterior circulation aneurysm from 2015 to 2019, referred to Bantane Hospital, Japan. We included all posterior circulation aneurysms such as basilar tip, basilar trunk, and vertebral artery-posterior inferior cerebellar artery (VA-PICA) aneurysms, admitted and treated with clipping or bypass and trapping. We assessed the outcome as measured by modified Rankin Score (mRS), complications, and mortality.

Results: Out of 37 patients, 10 cases were a basilar tip, one case was the basilar trunk, and 26 cases were VA-PICA aneurysm. Intraoperatively, neuromonitoring, indocyanine green dye, dual-image videoangiography (DIVA), and neuro endoscope were used. Two patients of basilar tip aneurysm developed third cranial nerve paresis and six patients of VA-PICA aneurysm developed lower cranial nerve paresis which resolved spontaneously. All the patients were discharged with mRS of 0 or 1. No mortality was recorded in our study.

Conclusion: Microsurgical clipping of posterior circulation aneurysm is safe in unruptured aneurysm with a very low risk of mortality and morbidity under experienced hands. All postoperative complications in our study were transient and resolved with time with no residual deficits. Preoperative simulation, intraoperative neuromonitoring, DIVA, and neuro endoscope help achieve complete obliteration of aneurysmal sac and avoid complications.
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http://dx.doi.org/10.4103/ajns.AJNS_69_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591165PMC
August 2020

Relationship between clinical trials and disease burden of India: A cross-sectional study.

J Pharm Bioallied Sci 2020 Jul-Sep;12(3):269-276. Epub 2020 Jul 18.

Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Research Methodology and Biostatistics Core, Office of Research, Tampa, Florida, USA.

Background: Research output/efforts in a country should be reflective of the disease burden. India is a site for several national and multinational clinical trials. However, whether clinical trials performed in India reflect the disease burden is not well known.

Objectives: The aim of this study was to evaluate the relationship between disease burden and clinical trials performed in India.

Materials And Methods: We extracted data on the disease burden from the World Health Organization (WHO) website and on characteristics of clinical trials performed in India from the Clinical Trial Registry of India (CRTI). The correlation between disease burden parameters of overall mortality, disability-adjusted life years (DALYs), years lost due to disability (YLD) and years of life lost (YLL), and the frequency of clinical trials associated with a particular disease was assessed. Additional subgroup analysis according to the number of trial centers, study phase, and medicine type was also performed.

Results: Only 18% of clinical trials addressed top 10 diseases associated with 68.3% of overall mortality, and 8% of clinical trials addressed top 10 diseases associated with 52.3% of DALYs. Similarly, 16% of clinical trials addressed top 10 diseases associated with 53.2% YLDs. Furthermore, top 10 diseases associated with 65.9% of YLLs were addressed in only 8% of ongoing clinical trials. The overall correlation between any disease burden parameters with the diseases being explored in clinical trials was poor.

Conclusion: There is a mismatch between diseases for which clinical trials are happening in the India and the disease burden of India. Measures need to be taken to fulfill this gap between demand and need.
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http://dx.doi.org/10.4103/jpbs.JPBS_197_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7574753PMC
July 2020

Pre-clerkship physical examination assessment rubric.

Clin Teach 2021 Feb 2;18(1):69-72. Epub 2020 Oct 2.

Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.

Introduction: The physical examination is a core competency in the training of pre-clerkship medical students. It is important to certify proficiency in the physical examination before students start their clinical rotations. Many institutions use home grown assessment tools for this purpose; however, there currently are no validated rubrics designed to assess the performance a head to toe physical examination by a pre-clerkship medical student. The goal of this study is to assess the reliability (inter-rater and intra-rater) of our institutionally developed rubric.

Methods: Clinical faculty with various levels of teaching experience watched videos of students doing a head to toe physical examination and scored the students using our assessment rubric. These scores were evaluated for intra-rater and inter-rater reliability.

Results: A total of 15 student videos were reviewed by five faculty members with varying levels of teaching experience. The degree of inter-rater agreement (between raters) for single and average measure was excellent and the degree of intra-rater agreement (same rater twice) for single and average measure was excellent.

Discussion: We conclude that our institutionally developed physical examination assessment rubric is a reliable means to certify proficiency in the physical examination before students start their clinical clerkships.
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http://dx.doi.org/10.1111/tct.13276DOI Listing
February 2021

Outcomes in Renal Cell Carcinoma With IVC Thrombectomy: A Multiteam Analysis Between an NCI-Designated Cancer Center and a Quaternary Care Teaching Hospital.

Am Surg 2020 Aug;86(8):1005-1009

Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA.

Introduction: Interteam performance and Clavien-Dindo (C-D) complications in renal cell carcinoma with inferior vena cava thrombectomy (RCC-IVCT) have not been reported. We aimed to describe complications by the degree of complexity and surgical teams in a collaborative effort between a National Cancer Institute-designated Comprehensive Cancer Center and a Quaternary Care Teaching Hospital.

Methods: Between January 2011 and May 2019, 73 consecutive RCC-IVCT were included. C-D grades III or higher were captured. Teams involved were urologic-oncology, vascular, hepatobiliary/transplant, and cardiothoracic. The Mayo Clinic tumor thrombus classification was used.

Results: Overall complication rate was 42% (n = 31). Nineteen percent had grade III, 18% had grade IV, and 6% had grade V complications. Patients with level IV thrombus had the highest in-hospital mortality rate (75%). Thrombus level did not show a correlation to complication rates (14% level I, 45% level II, 32% level III, 42% level IV). A positive correlation found between the number of teams involved and complication rates (35% with 2-team, 59% with 3-team, = .059). Thromboembolic events (6% vs 24%, = .02) and disposition other than home (22% vs 48%, = .01) were statistically lower for the 2-team groups. Two-team in-hospital mortality was 1/51 (2%) versus 3-team (3/22,14%, ( = .07). No statistical differences were found in infections, thromboembolic events, and grades of complications between surgical teams.

Conclusions: Despite similar interteam performance, the consistency of surgeons in high complexity cases could improve outcomes further. Complexity was higher for hepatobiliary/transplant and cardiothoracic teams. A combination of intraoperative events and patient selection (comorbidities and age) contributed to death. Overall, in-hospital mortality was lower than in most reported series.
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http://dx.doi.org/10.1177/0003134820942172DOI Listing
August 2020

Timed barium swallow for assessing long-term treatment response in patients with achalasia: Absolute cutoff versus percent change - A cross-sectional analytic study.

Neurogastroenterol Motil 2021 03 29;33(3):e14005. Epub 2020 Sep 29.

Joy McCann Culverhouse Center for Swallowing Disorders, Division of Digestive Diseases and Nutrition, University of South Florida Morsani College of Medicine, Tampa, FL, USA.

Background: Timed barium swallow (TBS) assesses esophageal emptying before and after therapy in patients with achalasia. Our aim was to compare the accuracy of percent change in barium height with traditional absolute cutoff of <5 cm on post-treatment TBS.

Materials And Methods: Consecutive patients with treatment naïve achalasia treated with either PD, HM, or POEM between 1/2012 and 7/2017 were eligible for inclusion. The accuracy of percent change in pre- and post-treatment barium height at 5 minutes versus an absolute <5 cm cutoff for assessing treatment response was assessed using the receiver operating curve analysis (ROC).

Results: Eighty-one patients met the inclusion criteria. The median percent change in barium heights at five minutes in patients who did not improve was 6 percent increase (n = 10; mean 10.6) versus 78 percent decrease (n = 71; mean 64) in patients who improved (P = 0.0001). The AUC for percent change in TBS 5 minutes height was 76% (95% CI 48% to 90%), and a 3% decrease from baseline as a cutoff had a sensitivity of 60% and specificity of 99%. The AUC for post-treatment TBS 5 minutes height was 79% (95% CI 53% to 91%), and the 5 cm cutoff had a sensitivity of 70% and specificity of 75%.

Conclusions: The results show that 3% percent improvement in pre- and post-treatment barium height at 5 minutes rather than absolute cutoff value of <5 cm on post-treatment TBS is a better indicator of treatment success in achalasia patients. These findings indicate the need for reassessment of tools to identify treatment response.
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http://dx.doi.org/10.1111/nmo.14005DOI Listing
March 2021

Anatomical feasibility of anastomosing intercostal nerves (D10&D11) and subcostal nerve (D12) to S2 ventral root and lumbar plexus for management of bladder function after spinal cord injury.

J Clin Orthop Trauma 2020 Sep-Oct;11(5):900-904. Epub 2020 Jan 2.

Department of Surgery, NSCB Government Medical College, Jabalpur, MP, 482003, India.

Objective: The transfer of peripheral nerves originating above the level of injured spinal cord into the nerves/roots below the injury is a promising approach. It facilitates the functional recovery in lower extremity, bladder/bowel and sexual function in paraplegics. We assessed anatomical feasibility of transfer of lower intercostal nerves to S2 ventral root in human cadaver for management of neurogenic bladder dysfunction in patients with spinal cord injury.

Methods: Study was performed in five formalin fixed cadavers. Cadavers were placed in prone position. A transverse incision was made along 11th ribs on both sides and 10th, 11th Intercostal nerves (ICN) and subcostal nerve were harvested up to maximum possible length. In four cadavers the ventral root of S2 was exposed by endoscope and in one by the standard open laminectomy. Intercostal nerves were brought down to lumbo-sacral region, S2 ventral root was cut cranially and feasibility of intercostal to S2 anastomosis was assessed.

Results: The mean length of intercostal nerves was 18.4 cm for the 10th 19.5 cm for the 11th and 22.15 cm for the subcostal nerve. The length of harvested nerve and the nerve length necessary to perform sacral roots neurotization were possible in all cases by only by subcostal nerve while T11 and T10 ICN fall short of the required length.

Conclusion: For Spinal cord lesions located at the conus, subcostal nerve could be connected to ventral root of S2 in an attempt to restore bladder function while 10th and 11th ICN had enough length to neurotize lumbar plexus.
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http://dx.doi.org/10.1016/j.jcot.2019.12.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452297PMC
January 2020

Accuracy of Achalasia Quality of Life and Eckardt scores for assessment of clinical improvement post treatment for achalasia.

Dis Esophagus 2021 Feb;34(2)

Division of Digestive Diseases and Nutrition.

Achalasia Quality of Life (ASQ) and Eckardt scores are two patient-reported instruments widely used to assess symptom severity in achalasia patients. ASQ is validated and reliable. Although Eckardt is commonly used, it has not been rigorously assessed for validity or reliability. This study aims to evaluate (i) the accuracy of Eckardt and ASQ for assessing improvement post-treatment (predictive validity), (ii) accuracy of Eckardt and ASQ for assessing improvement post-treatment with pneumatic dilatation (PD) versus surgical myotomy (predictive validity), and (iii) convergent validity of Eckardt and ASQ tools. Patients with achalasia treated between 2011 and 2018 were eligible. Both instruments were administered by telephone. Treatment failure was determined by the review of medical records by two clinicians. The predictive ability of ASQ and Eckardt instruments in identifying treatment successes and failures was determined using receiver operating characteristics analysis and summarized as area under the curve (AUC). A total of 106 patients met inclusion criteria with 39 PD, 51 Heller myotomy, and 16 per-oral endoscopic myotomy. A review of medical records and esophageal testing revealed 13 failures (12%). AUC for Eckardt was 0.96 (95% confidence interval [CI] 0.87-0.99] and ASQ 0.97 (95% CI 0.92-0.99). The Eckardt cutoff 4, and ASQ, cutoff 15, were 94% and 87% accurate in identifying treatment successes versus failures, respectively. The correlation coefficient between the two tools was 0.85. In conclusions, (i) ASQ and Eckardt scores are valid and reliable tools to assess symptom severity in achalasia patients, (ii) both instruments accurately classify treatment successes versus failures, and (iii) the choice of tool should be informed by the physicians and patients' values and preferences and repeat physiologic testing may be reserved for treatment failures with either instrument and patients classified, as treatment successes may be spared routine physiologic testing in the long term.
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http://dx.doi.org/10.1093/dote/doaa080DOI Listing
February 2021

The Impact of Virtual Crossmatch on Cold Ischemic Times and Outcomes Following Kidney Transplantation.

Am Surg 2021 Jan 24;87(1):109-113. Epub 2020 Aug 24.

Department of Transplant Surgery, Tampa General Medical Group, Tampa, FL, USA.

Background: Prolonged cold ischemic time (CIT) in deceased donor kidney transplantation (DDKT) has been associated with adverse graft outcomes. Virtual crossmatch (VXM) facilitates reliable prediction of crossmatch results based on the profile of human leukocyte antigen antibodies of the recipient and the donor in reduced time compared with a physical crossmatch (PXM). We hypothesized a shorter CIT since the implementation of the VXM in recipients of DDKT.

Methods: We conducted a retrospective cohort study of consecutive adult recipients of DDKT. The data were analyzed for differences in CIT before and after the implementation of VXM.

Results: After the exclusion of 59 recipients (age less than 18 years and/or CIT ≥ 20 hours), our study compared outcomes of 81 PXMs from February to June 2018 against 68 VXMs from February to June 2019. There were no statistical differences between groups based on donor age ( = .09), donor type ( = .38), kidney donor profile index ( = .43), or delayed graft function ( = .20). Recipients with VXM were older (58 vs 51 years = .002) and had a higher estimated post-transplant survival score (59% vs 46% = .01). The CIT was significantly lower for the VXM group ( = .04).

Conclusion: Our study demonstrated a significantly shorter CIT with VXM in DDKT recipients. Our study was limited with small sample size, but the trend of increased graft survival with higher estimated post-transplant scores and older recipients is encouraging as the donor pool expands with marginal kidneys and national sharing.
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http://dx.doi.org/10.1177/0003134820942180DOI Listing
January 2021

Hepatitis C and Racial Disparity in Liver Transplant Waitlist Additions : Separate Not Equal.

Am Surg 2020 Aug 20;86(8):985-990. Epub 2020 Aug 20.

Department of Transplant Hepatology, Tampa General Medical Group, Tampa, FL, USA.

Background: In 2014, direct-acting antivirals (DAAs) became available for hepatitis C virus (HCV) with successful results. Since their implementation, the rate of HCV waitlist (WL) for liver transplantation (LT) has decreased, but significant ethnic disparities exist. We hypothesized that the rate of decline for HCV WL for LT is different across the various racial groups.

Methods: We conducted a retrospective cohort study using Organ Procurement and Transplantation Network data reports of adult LT candidates from 2014 to 2018.

Results: Overall, there was a decline in HCV WL rates for all ethnic groups (Caucasians, African Americans [AA], and Hispanics). However, the WL rates were significantly higher in AA compared with Caucasians each year, and this trend was continuous across the 5-year period. There were no differences in WL rates between Caucasians and Hispanics.

Discussion: The results show that health care disparities related to HCV disproportionately affect AA. The factors associated with this disparity need to be explored further to develop mechanisms to address these differences. By understanding the HCV treatment disparities across racial groups, modifications to HCV treatment nationwide can be adopted. Additional emphasis should be placed on AA to help reduce their WL rate, as well as redistributing resources to promote health care equity.
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http://dx.doi.org/10.1177/0003134820942178DOI Listing
August 2020

The Association Between Alcoholic Liver Disease and Alcohol Tax.

Am Surg 2021 Jan 19;87(1):92-96. Epub 2020 Aug 19.

7829Department of Transplant Hepatology, Tampa General Medical Group, Tampa, FL, USA.

Background: The incidence of alcoholic liver disease (ALD) has increased, causing it to become a primary indication for liver transplantation in the United States. We hypothesized an association between alcohol taxation and prevalence of ALD.

Methods: We conducted a retrospective study of united network for organ sharing (UNOS) waitlist additions for liver transplantation between January 2007 and December 2016. We also analyzed the average excise tax (2007-2016) for beer, wine, and spirits in listing states of liver transplant waitlist additions (LTWA).

Results: There were 104 805 adult UNOS LTWA with assigned diagnoses, an annual increase from 22% to 28%. There were 24 316 LTWA with ALD diagnosis. The mean value for beer tax was significantly lower for ALD patients than for non-ALD patients across all age groups ( < .001). The analysis demonstrated significantly more ALD in waitlisted patients 35-54 years of age (30%), compared with 18-34 years (10%) and ≥55 years (20%), < .001. The data confirmed significantly more ALD Medicaid patients in the 35-54 year age group (28%) compared with other age groups, < .001.

Discussion: Our research demonstrated an association between lower beer tax and higher ALD prevalence across all age groups. We found a larger percentage of middle-aged (35-54 years) Medicaid patients listed with ALD. These findings raise the need for further investigation of a potential public health concern for an association between ALD and beer tax, especially for middle-aged patients of lower socioeconomic status.
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http://dx.doi.org/10.1177/0003134820945223DOI Listing
January 2021

HCC Liver Transplantation Wait List Dropout Rates Before and After the Mandated 6-Month Wait Time.

Am Surg 2020 Nov 19;86(11):1592-1595. Epub 2020 Aug 19.

Department of Transplant Surgery, Tampa General Medical Group, Tampa, FL, USA.

Background: Studies have shown significant improvement in hepatocellular carcinoma (HCC) recurrence rates after liver transplantation since the united network of organ sharing (UNOS) implementation of a 6-month wait period prior to accrued exception model for end-stage liver disease (MELD) points enacted on October 8, 2015. However, few have examined the impact on HCC dropout rates for patients awaiting liver transplant. Our objective is to evaluate the outcomes of HCC dropout rates before and after the mandatory 6-month wait policy enacted.

Methods: We conducted a retrospective cohort study on adult patients added to the liver transplant wait list between January 1, 2012, and March 8, 2019 (n = 767). Information was obtained through electronic medical records and organ procurement and transplant network (OPTN) publicly available national data reports.

Results: In response to the 2015 UNOS-mandated 6-month wait time, dropout rates in the HCC patient population at our center increased from 12% pre-mandate to 20.8% post-mandate This increase was similarly reflected in the national dropout rate, which also increased from 26.3% pre-mandate to 29.0% post-mandate.

Discussion: From these changes, it is evident that the UNOS mandate achieved its goal of increasing equity of liver organ allocation, but HCC patients are nonetheless dropping off of the wait list at an increased rate and are therefore disadvantaged.
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http://dx.doi.org/10.1177/0003134820942165DOI Listing
November 2020

Efficacy of proteasome inhibitor-based maintenance following autologous transplantation in multiple myeloma: A systematic review and meta-analysis.

Eur J Haematol 2021 Jan 16;106(1):40-48. Epub 2020 Oct 16.

Division of Hematology-Oncology and Blood and Marrow Transplantation Program, Mayo Clinic, Jacksonville, FL, USA.

Introduction: Lenalidomide maintenance, commonly prescribed in the postautologous transplantation (AHCT) setting for multiple myeloma (MM), is associated with development of secondary primary malignancies (SPM). Proteasome inhibitor maintenance (PIM) has also been evaluated in MM. We conduct a systematic review/meta-analysis to assess the efficacy of PIM in MM.

Methods: Performing a comprehensive search of the medical literature using PubMed/Medline and EMBASE on September 11, 2019, we extracted data on clinical outcomes related to benefits (OS, PFS, and depth of hematologic response [DOHR]) and harms (SPM and adverse events). 2144 references were identified; three studies were eligible for inclusion.

Results: A total of 1760 patients were included in the analysis; 507 patients received bortezomib and 395 received ixazomib maintenance. Control arms were either placebo (n = 261) or thalidomide (n = 358). PIM did not improve OS (HR 0.88, 95% CI 0.73-1.05, P = .15) but improved PFS (HR 0.77, 95% CI 0.69-0.86, P ≤ .00001) and DOHR (HR 0.88, 95% CI 0.79-0.98, P = .02) compared with control. There were no significant differences between PIM and control regarding SPM (p = NS) and ≥grade 3 peripheral neuropathy (PN) (p = NS).

Conclusions: PIM following AHCT in MM improves PFS and DOHR without an increase in development of SPM or severe PN compared with placebo/thalidomide.
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http://dx.doi.org/10.1111/ejh.13506DOI Listing
January 2021

Pre-Liver Transplant Coronary Artery Disease Workup for Low-Risk Patients.

Am Surg 2020 Aug 7;86(8):976-980. Epub 2020 Aug 7.

Department of Transplant Hepatology, Tampa General Medical Group, Tampa, FL, USA.

Background: Coronary artery disease (CAD) is a leading cause of mortality following orthotopic liver transplant, yet there is no standardized protocol for pre-liver-transplant coronary artery disease assessment. The main objective of this study was to determine the agreement between 2 methods of cardiac risk assessment: dobutamine stress echocardiogram (DSE) and coronary calcium score (CCS) and to determine which test was best able to predict coronary calcification in low-risk patients.

Methods: A retrospective study was performed using the medical records of 436 patients who received cardiac clearance for a liver transplant. A total of 152 patients' medical records were included based on the inclusion of patients who had received both DSE and CCS. A kappa coefficient was calculated to determine the agreement between the DSE and CCS results. In addition, the positive predictive values (PPVs) of both the CCS and DSE along with cardiac catheterization indicating abdominal occlusion were analyzed to compare the accuracy of the 2 tests.

Results: It was determined that there was a 12% agreement between DSE results and CCS. It was found that the DSE had a PPV of 56% and the CCS had a PPV of 80%.

Conclusion: From this data, it was concluded that there was no agreement between the results of the CCS and the DSE. While neither the CCS nor the DSE presents an optimal method of risk assessment, the CCS had a much higher PPV and was therefore determined to be the more accurate test.
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http://dx.doi.org/10.1177/0003134820942169DOI Listing
August 2020

Cost Utilization and the Use of Pulmonary Function Tests in Preoperative Liver Transplant Patients.

Am Surg 2020 Aug 7;86(8):996-1000. Epub 2020 Aug 7.

Department of Transplant Hepatology, Tampa General Medical Group, Tampa, FL, USA.

Background: Pulmonary function tests (PFTs) are currently recommended for liver transplant candidates. We hypothesized that PFTs may not provide added clinical value to the evaluation of liver transplant patients.

Methods: We conducted a retrospective cohort study of adult cadaveric liver transplants from 2012 to 2018. Abnormal PFTs were defined as restrictive disease of diffusing capacity of the lungs for carbon monoxide (DLCO) <80% or obstructive disease of ratio of forced expiratory volume in the first 1 second to the first vital capacity of the lungs (FEV1/FVC) <70%.

Results: We analyzed data on 415 liver transplant patients (358 abnormal PFT results and 57 normal results). The liver transplant patients with abnormal PFTs had no difference in number of intensive care unit (ICU) days ( = .68), length of stay ( = .24), or intubation days ( = .33). There were no differences in pulmonary complications including pleural effusion ( = .30), hemo/pneumothorax ( = .74), pneumonia ( = .66), acute respiratory distress syndrome ( = .57), or pulmonary edema ( = .73). The significant finding between groups was a higher rate of reintubation in liver transplant patients with normal PFTs ( = .02). There was no difference in graft survival ( = .53) or patient survival ( = .42).

Discussion: Abnormal PFTs, found in 86% of liver transplant patients, did not correlate with complications, graft failure, or mortality. PFTs contribute to the high cost of liver transplants but do not help predict which patients are at risk of postoperative complications.
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http://dx.doi.org/10.1177/0003134820942159DOI Listing
August 2020

Elucidation of S-Allylcysteine Role in Inducing Apoptosis by Inhibiting PD-L1 Expression in Human Lung Cancer Cells.

Anticancer Agents Med Chem 2021 ;21(4):532-541

Noida Institute of Engineering & Technology (Pharmacy Institute), 19, Knowledge Park-II, Institutional Area, Greater Noida, 201306, India.

Aim: The aim of this study is to explore the therapeutic potential of S-allylcysteine (SAC) organosulphur compound as a potent immune checkpoint inhibitor PD-L1.

Background: Natural compounds have been showing tremendous anticancerous potential via suppressing the expression of genes involved in the development and progression of several carcinomas. This has further motivated us to explore the therapeutic potential of organosulphur compounds as potent immune checkpoint inhibitors.

Objective: Our study was designed to elucidate the potential of S-allylcysteine (SAC) as significant PD-L1 (immune checkpoint) inhibitor in human lung cancer A549 cancer cell line by using both the in vitro and in silico approaches.

Methods: Anticancerous effect of the SAC on lung cancer cells was determined by using the MTT cell viability. Apoptotic induction was confirmed by Hoechst staining, percent caspase-3 activity as well as gene expression analysis by real time PCR. Reactive Oxygen Species (ROS) was estimated by DCFDA method. Additionally, ligand-target protein interaction was analysed by molecular docking.

Result: Cell growth and proliferation was significantly reduced in SAC treated A549 cells in a concentration and time.dependent manner. The effect of SAC on apoptotic induction was analyzed by enhanced nuclear condensation, increased percent caspase-3 activity as well as modulation of apoptotic genes. Furthermore, SAC treatment also resulted in reduced expression of PD-L1 and HIF-1α. Additionally, in silico analysis also supported the in vitro findings by showing efficient docking with PD-L1 immune checkpoint target.

Conclusion: Therefore, our results clearly suggested that SAC could serve as a novel chemotherapeutic candidate for the treatment of lung cancer by inhibiting immune checkpoint target PD-L1 in human lung cancer cells. Additionally, our study also explained a novel molecular mechanism of its antitumor activity.
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http://dx.doi.org/10.2174/1871520620666200728121929DOI Listing
January 2021