207 results on '"Saumoy, M."'
Search Results
52. Biliary and pancreatic stents.
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Han S, Obando JV, Bhatt A, Bucobo JC, Chen D, Copland AP, Das KK, Girotra M, Kahn A, Krishnan K, Sakaria SS, Saumoy M, Trikudanathan G, Trindade AJ, Yang J, Law RJ, and Lichtenstein DR
- Subjects
- Humans, Pancreas, Stents, Cholestasis etiology, Cholestasis surgery, Biliary Tract, Pancreatic Neoplasms
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- 2023
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53. Detecting anal human papillomavirus infection in men who have sex with men living with HIV: implications of assay variability.
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Torres M, Silva-Klug A, Ferrer E, Saumoy M, Trenti L, Tous S, Esteban A, Baixeras N, Catala I, Vidal A, G Bravo I, Podzamczer D, and de Sanjose S
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- Male, Humans, Homosexuality, Male, Human Papillomavirus Viruses, Human papillomavirus 16, Human papillomavirus 18, Anal Canal, Papillomaviridae genetics, Prevalence, Papillomavirus Infections complications, Papillomavirus Infections diagnosis, Papillomavirus Infections epidemiology, Sexual and Gender Minorities, Anus Neoplasms diagnosis, Anus Neoplasms epidemiology, Anus Neoplasms pathology, HIV Infections complications, HIV Infections epidemiology
- Abstract
Background: Incidence of anal cancer (AC) caused by persistent human papillomavirus (HPV) infection has risen in the last years in men who have sex with men (MSM) living with HIV. There is consensus that this population should be screened for anal precancerous lesions, but the role of HPV DNA testing in AC screening programmes is still under debate., Objectives: This study employed two molecular test to detect anal HPV DNA and compared assay performance and prognostic value for the diagnosis of histology proven high-grade intraepithelial anal lesions., Methods: MSM living with HIV attended their regular check-up visits consisting of detection of anal HPV infection, anal cytology, digital anorectal examination and high resolution anoscopy. HPV DNA was detected using Hybrid Capture 2 High-Risk test (HC2, total assay) and LINEAR ARRAY HPV Genotyping Test (LA, type-specific assay) RESULTS: Among 274 participant, prevalence of HPV DNA was 48.5% by HC2 and 89.4% by LA. HPV16 (30.6%) and HPV6 (19.6%) were the most common genotypes identified. Prevalence of multiple HPV infections was 56.2%. Agreement between HPV DNA assays was 75.2% (κ=0.51; 95% CI 0.42 to 0.60). Total HPV detection demonstrated high sensitivity (90%; 95% CI 68.3 to 98.8) and moderate specificity (58.4%; 95% CI 50.2 to 66.3), while type-specific HPV16/18 genotyping provided an increase in specificity and showed the highest area under the curve (0.81; 95% CI 0.74 to 0.89) and Youden's index (0.63)., Conclusions: Both methodologies identified a high prevalence of anal HPV infection and multiple HPV infections in MSM living with HIV, showing a moderate overall agreement between them. Either total HPV detection or type-specific HPV16/18 detection together with a threshold ≥atypical squamous cells of undetermined significance for abnormal cytology showed an acceptable diagnostic accuracy., Competing Interests: Competing interests: Cancer Epidemiology Research Program (ST, AE, SdS and MT) has received sponsorship for grants from Merck and Co, GlaxoSmithKline, Hologic and Seegene., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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54. Association of Statin Usage and the Development of Diabetes Mellitus after Acute Pancreatitis.
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Thiruvengadam NR, Schaubel DE, Forde K, Lee P, Saumoy M, and Kochman ML
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- Humans, Prospective Studies, Acute Disease, Retrospective Studies, Pancreatitis epidemiology, Pancreatitis prevention & control, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology
- Abstract
Background: Patients with acute pancreatitis (AP) have at least a 2-fold higher risk for developing postpancreatitis diabetes mellitus (PPDM). No therapies have prevented PPDM. Statins were demonstrated to possibly lower the incidence and severity of AP but have not been studied to prevent PPDM., Methods: Data from a commercial insurance claim database (Optum Clinformatics) were used to assess the impact of statins on patients without pre-existing DM admitted for a first episode of AP in 118,479 patients. Regular statin usage was defined as filled statin prescriptions for at least 80% of the year prior to AP. The primary outcome was defined as PPDM. We constructed a propensity score and applied inverse probability of treatment weighting to balance baseline characteristics between groups. Using Cox proportional hazards regression modeling, we estimated the risk of PPDM, accounting for competing events., Results: With a median of 3.5 years of follow-up, the 5-year cumulative incidence of PPDM was 7.5% (95% confidence interval [CI], 6.9% to 8.0%) among regular statin users and 12.7% (95% CI, 12.4% to 12.9%) among nonusers. Regular statin users had a 42% lower risk of developing PPDM compared with nonusers (hazard ratio, 0.58; 95% CI, 0.52 to 0.65; P < .001). Irregular statin users had a 15% lower risk of PPDM (hazard ratio, 0.85; 95% CI, 0.81 to 0.89; P < .001). Similar benefits were seen with low, moderate, and high statin doses., Conclusions: In a large database-based study, statin usage reduced the risk of developing DM after acute pancreatitis. Further prospective studies with long-term follow-up are needed to study the impact of statins on acute pancreatitis and prevention of PPDM., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2023
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55. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity.
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Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, and Kochman ML
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- Humans, Prospective Studies, Acute Disease, Quality of Life, Morbidity, Patient Reported Outcome Measures, Risk Factors, Retrospective Studies, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Cholangiopancreatography, Endoscopic Retrograde methods, Pancreatitis diagnosis, Pancreatitis epidemiology, Pancreatitis etiology
- Abstract
Background & Aims: The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity., Methods: We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM., Results: A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68-10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29-2.45) had the highest odds of elevated PROM., Conclusions: A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP., Clinicaltrials: gov number, NCT05310409., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2023
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56. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model.
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Thiruvengadam NR, Coté GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, and Saumoy M
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- Humans, Cost-Benefit Analysis, Colonoscopy, Early Detection of Cancer, Computers, Colorectal Neoplasms diagnostic imaging, Colorectal Neoplasms epidemiology, Adenoma diagnosis
- Abstract
Background & Aims: The use of computer-aided detection (CAD) increases the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance. This study aimed to evaluate the requirements for CAD to be cost-effective and the impact of CAD on adenoma detection by endoscopists with different ADRs., Methods: We developed a semi-Markov microsimulation model to compare the effectiveness of traditional colonoscopy (mean ADR, 26%) to colonoscopy with CAD (mean ADR, 37%). CAD was modeled as having a $75 per-procedure cost. Extensive 1-way sensitivity and threshold analysis were performed to vary cost and ADR of CAD. Multiple scenarios evaluated the potential effect of CAD on endoscopists' ADRs. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay threshold of $100,000/quality-adjusted life year., Results: When modeling CAD improved ADR for all endoscopists, the CAD cohort had 79 and 34 fewer lifetime CRC cases and deaths, respectively, per 10,000 persons. This scenario was dominant with a cost savings of $143 and incremental effectiveness of 0.01 quality-adjusted life years. Threshold analysis demonstrated that CAD would be cost-effective up to an additional cost of $579 per colonoscopy, or if it increases ADR from 26% to at least 30%. CAD reduced CRC incidence and mortality when limited to improving ADRs for low-ADR endoscopists (ADR <25%), with 67 fewer CRC cases and 28 CRC deaths per 10,000 persons compared with traditional colonoscopy., Conclusions: As CAD is implemented clinically, it needs to improve mean ADR from 26% to at least 30% or cost less than $579 per colonoscopy to be cost-effective when compared with traditional colonoscopy. Further studies are needed to understand the impact of CAD when used in community practice., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2023
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57. Identifying the needs of older people living with HIV (≥ 50 years old) from multiple centres over the world: a descriptive analysis.
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Grosso TM, Hernández-Sánchez D, Dragovic G, Vasylyev M, Saumoy M, Blanco JR, García D, Koval T, Loste C, Westerhof T, Clotet B, Sued O, Cahn P, and Negredo E
- Subjects
- Humans, Aged, Middle Aged, Quality of Life, Cross-Sectional Studies, Aging, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections psychology, Acquired Immunodeficiency Syndrome
- Abstract
Background: Older People Living with HIV (OPWH) combine both aging and HIV-infection features, resulting in ageism, stigma, social isolation, and low quality of life. This context brings up new challenges for healthcare professionals, who now must aid patients with a significant comorbidity burden and polypharmacy treatments. OPWH opinion on their health management is hardly ever considered as a variable to study, though it would help to understand their needs on dissimilar settings., Methods: We performed a cross-sectional, comparative study including patients living with HIV aged ≥50 years old from multiple centers worldwide and gave them a survey addressing their perception on overall health issues, psychological problems, social activities, geriatric conditions, and opinions on healthcare. Data was analyzed through Chisquared tests sorting by geographical regions, age groups, or both., Results: We organized 680 participants data by location (Center and South America [CSA], Western Europe [WE], Africa, Eastern Europe and Israel [EEI]) and by age groups (50- 55, 56-65, 66-75, >75). In EEI, HIV serostatus socializing and reaching undetectable viral load were the main problems. CSA participants are the least satisfied regarding their healthcare, and a great part of them are not retired. Africans show the best health perception, have financial problems, and fancy their HIV doctors. WE is the most developed region studied and their participants report the best scores. Moreover, older age groups tend to live alone, have a lower perception of psychological problems, and reduced social life., Conclusions: Patients' opinions outline region- and age-specific unmet needs. In EEI, socializing HIV and reaching undetectable viral load were the main concerns. CSA low satisfaction outcomes might reflect high expectations or profound inequities in the region. African participants results mirror a system where general health is hard to achieve, but HIV clinics are much more appealing to them. WE is the most satisfied region about their healthcare. In this context, age-specific information, education and counseling programs (i.e. Patient Reported Outcomes, Patient Centered Care, multidisciplinary teams) are needed to promote physical and mental health among older adults living with HIV/AIDS. This is crucial for improving health-related quality of life and patient's satisfaction., (© 2022. The Author(s).)
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- 2023
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58. Fully Covered Self-expanding Stents are Cost-effective at Remediating Biliary Strictures in Patients With Chronic Pancreatitis.
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Thiruvengadam NR, Saumoy M, Schneider Y, and Kochman ML
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- Humans, Constriction, Pathologic surgery, Cost-Benefit Analysis, Stents, Cholangiopancreatography, Endoscopic Retrograde methods, Treatment Outcome, Cholestasis etiology, Cholestasis surgery, Pancreatitis, Chronic complications, Self Expandable Metallic Stents
- Abstract
Benign biliary strictures (BBS) develop in up to 10% to 30% of patients with chronic pancreatitis (CP).
1 Endoscopic endoprosthetics via endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for remediating these strictures. Seventy percent to eighty percent of these strictures resolve with sequential or concurrent placement of multiple plastic stents (MPS).1 , 2 More recently, placement of fully covered self-expanding metal stents (FCSEMS) have been shown to have similar outcomes as MPS.3-6 FCSEMS provide a larger radial diameter and require fewer procedures, but may have drawbacks, including a higher risk of migration, cholecystitis, delamination, and tissue ingrowth. A recent study demonstrated that FCSEMS with a 12-month indwell had similar outcomes to MPS with fewer ERCP needed.7 However, the cost-effectiveness of either strategy for managing BBS has not been assessed previously nor has the impact of additional reimbursement to cover the cost of FCSEMS on the cost-effectiveness of FCSEMS utilization., (Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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59. Cost-effectiveness of polatuzumab vedotin combined with chemoimmunotherapy in untreated diffuse large B-cell lymphoma.
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Kambhampati S, Saumoy M, Schneider Y, Pak S, Budde LE, Mei MG, Siddiqi T, Popplewell LL, Wen YP, Zain J, Forman SJ, Kwak LW, Rosen ST, Danilov AV, Herrera AF, and Thiruvengadam NR
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- Adult, Humans, Aged, Rituximab therapeutic use, Cost-Benefit Analysis, Prednisone therapeutic use, Vincristine adverse effects, Cyclophosphamide adverse effects, Doxorubicin adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Lymphoma, Large B-Cell, Diffuse drug therapy
- Abstract
In patients with treatment-naive diffuse large B-cell lymphoma (DLBCL), the POLARIX study (A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone [R-CHP] Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [R-CHOP] in Participants With Diffuse Large B-Cell Lymphoma) reported a 6.5% improvement in the 2-year progression-free survival (PFS), with no difference in overall survival (OS) or safety using polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) compared with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We evaluated the cost-effectiveness of pola-R-CHP for DLBCL. We modeled a hypothetical cohort of US adults (mean age, 65 years) with treatment-naive DLBCL by developing a Markov model (lifetime horizon) to model the cost-effectiveness of pola-R-CHP and R-CHOP using a range of plausible long-term outcomes. Progression rates and OS were estimated from POLARIX. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $150 000 per quality-adjusted life-year (QALY). Assuming a 5-year PFS of 69.6% with pola-R-CHP and 62.7% with R-CHOP, pola-R-CHP was cost-effective at a WTP of $150 000 (incremental cost-effectiveness ratio, $84 308/QALY). pola-R-CHP was no longer cost-effective if its 5-year PFS was 66.1% or lower. One-way sensitivity analysis revealed that pola-R-CHP is cost-effective up to a cost of $276 312 at a WTP of $150 000. pola-R-CHP was the cost-effective strategy in 56.6% of the 10 000 Monte Carlo iterations at a WTP of $150 000. If the absolute benefit in PFS is maintained over time, pola-R-CHP is cost-effective compared with R-CHOP at a WTP of $150 000/QALY. However, its cost-effectiveness is highly dependent on its long-term outcomes and costs of chimeric antigen receptor T-cell therapy. Routine usage of pola-R-CHP would add significantly to health care expenditures. Price reductions or identification of subgroups that have maximal benefit would improve cost-effectiveness., (© 2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
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- 2022
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60. Doravirine Concentrations and Human Immunodeficiency Virus Type 1 RNA in the Genital Fluids of Virologically Suppressed Adults Switching to Doravirine Plus Emtricitabine/Tenofovir Alafenamide.
- Author
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Scévola S, Imaz A, Cottrell ML, Niubo J, Van Horne B, Tiraboschi J, Saumoy M, Morenilla S, Soriano I, Kashuba ADM, and Podzamczer D
- Subjects
- Adult, Humans, Emtricitabine therapeutic use, RNA therapeutic use, Genitalia, HIV-1 genetics, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
Doravirine (DOR) concentrations and HIV-1 RNA were evaluated in genital fluids from adults with HIV on stable therapy who switched to DOR + FTC/TAF. High protein-unbound DOR concentrations were observed in both seminal plasma and cervicovaginal fluid. DOR + FTC/TAF maintained viral suppression in genital fluids in all but 1 participant., Competing Interests: Potential conflicts of interest. S. S. has received financial compensation for educational activities as well as research funding from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare and has received support for attending meetings and/or travel from Janssen. A. I. has received financial compensation for consultancy work and educational activities from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, Thera Technologies, and ViiV Healthcare; has received research funding from Gilead Sciences, Merck Sharp & Dohme, and ViiV Healthcare; has received payment for expert testimony from ViiV Healthcare; has received support for attending meetings and/or travel from Gilead Sciences, Janssen, and ViiV Healthcare; has participated on a data and safety monitoring board (DSMB) or advisory board for Gilead Sciences and ViiV Healthcare; and received a drug for use within a study from Gilead Sciences and MSD. J. T. has received financial compensation for consultancy work, support for attending meetings and/or travel, and educational activities from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare and has received research funding from Gilead Sciences and Merck Sharp & Dohme. M. S. has received compensation for educational activities from Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare; has received support for attending meetings and/or travel from Janssen-Cilag and Gilead Sciences; and has received a grant from the Gilead Fellowship Program. A. D. M. K. is the principal investigator of a clinical study sponsored by Merck & Co, grant funding for that study was received by the University of North Carolina at Chapel Hill. D. P. has received research grants from Gilead, MSD, and ViiV; has received honoraria for serving on advisory boards and/or for lectures from Gilead, Merck Sharp & Dohme, ViiV, and Janssen; has received consulting fees from MSD, Janssen, Gilead, and ViiV; has received payment or honoraria from Janssen and Gilead; and has participated on a DSMB or advisory board for MSD, ViiV, Janssen, and Gilead. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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61. Cost-effectiveness of second-line axicabtagene ciloleucel in relapsed refractory diffuse large B-cell lymphoma.
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Kambhampati S, Saumoy M, Schneider Y, Serrao S, Solaimani P, Budde LE, Mei MG, Popplewell LL, Siddiqi T, Zain J, Forman SJ, Kwak LW, Rosen ST, Danilov AV, Herrera AF, and Thiruvengadam NR
- Subjects
- Adult, Humans, United States, Aged, Cost-Benefit Analysis, Antigens, CD19 therapeutic use, Immunotherapy, Adoptive, Receptors, Chimeric Antigen, Lymphoma, Large B-Cell, Diffuse pathology
- Abstract
The ZUMA-7 (Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma) study showed that axicabtagene ciloleucel (axi-cel) improved event-free survival (EFS) compared with standard of care (SOC) salvage chemoimmunotherapy followed by autologous stem cell transplant in primary refractory/early relapsed diffuse large B-cell lymphoma (DLBCL); this led to its recent US Food and Drug Administration approval in this setting. We modeled a hypothetical cohort of US adults (mean age, 65 years) with primary refractory/early relapsed DLBCL by developing a Markov model (lifetime horizon) to model the cost-effectiveness of second-line axi-cel compared with SOC using a range of plausible long-term outcomes. EFS and OS were estimated from ZUMA-7. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $150 000 per quality-adjusted life-year (QALY). Assuming a 5-year EFS of 35% with second-line axi-cel and 10% with SOC, axi-cel was cost-effective at a WTP of $150 000 per QALY ($93 547 per QALY). axi-cel was no longer cost-effective if its 5-year EFS was ≤26.4% or if it cost more than $972 061 at a WTP of $150 000. Second-line axi-cel was the cost-effective strategy in 73% of the 10 000 Monte Carlo iterations at a WTP of $150 000. If the absolute benefit in EFS is maintained over time, second-line axi-cel for aggressive relapsed/refractory DLBCL is cost-effective compared with SOC at a WTP of $150 000 per QALY. However, its cost-effectiveness is highly dependent on long-term outcomes. Routine use of second-line chimeric antigen receptor T-cell therapy would add significantly to health care expenditures in the United States (more than $1 billion each year), even when used in a high-risk subpopulation. Further reductions in the cost of chimeric antigen receptor T-cell therapy are needed to be affordable in many regions of the world., (© 2022 by The American Society of Hematology.)
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- 2022
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62. Atherogenicity of low-density lipoproteins after switching from a protease inhibitor to dolutegravir: a substudy of the NEAT022 study.
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Saumoy M, Sánchez-Quesada JL, Assoumou L, Gatell JM, González-Cordón A, Guaraldi G, Domingo P, Giacomelli A, Connault J, Katlama C, Masiá M, Ordónez-Llanos J, Pozniak A, Martínez E, and Podzamczer D
- Subjects
- 1-Alkyl-2-acetylglycerophosphocholine Esterase therapeutic use, Female, Heterocyclic Compounds, 3-Ring, Humans, Male, Middle Aged, Oxazines, Piperazines, Protease Inhibitors therapeutic use, Pyridones, Anti-HIV Agents therapeutic use, Atherosclerosis, HIV Infections drug therapy, Lipoproteins, LDL metabolism
- Abstract
Background: The aim of this study was to investigate whether switching from a ritonavir-boosted PI-based regimen to a dolutegravir-based regimen improved the atherogenic properties of LDL particles in patients with HIV., Methods: This was a substudy of the NEAT022 study (ClinicalTrials.gov NCT02098837). Adults with HIV with a Framingham score >10% or aged >50 years and being treated with a stable boosted PI-based regimen were randomized to either switch to dolutegravir or continue with boosted PI. At baseline and Week 48, we assessed atherogenic LDL properties: LDL particle size and phenotype (A, intermediate, B), oxidized LDL (ox-LDL) and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity., Results: Eighty-six participants (dolutegravir 44; PI 42) were included. Participants had a median (IQR) age of 54 (51-57) years and 79.1% were male. In the dolutegravir arm, after 48 weeks, we observed: (1) an increase in LDL size [median 1.65 Å (IQR -0.60 to 4.20); P = 0.007], correlated with the decrease in triglyceride concentration [Spearman correlation = -0.352 (P = 0.001)], with a corresponding decrease of subjects with atherogenic LDL phenotype B (36.4% to 20.5%; P = 0.039); (2) a decrease in Lp-PLA2 activity [median 1.39 μmol/min/mL (IQR -2.3 to 0.54); P = 0.002]; and (3) a decrease in ox-LDL [median 14 U/L (IQR -102 to 13); P = 0.006]. In the PI arm, none of these favourable lipid modifications was observed., Conclusions: Forty-eight weeks after switching from a PI-based to a dolutegravir-based regimen, patients with Framingham score >10% or aged >50 years showed improvement of several atherogenic lipid features, including LDL particle phenotype, ox-LDL and Lp-PLA2., (© The Author(s) 2022. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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63. Total and Unbound Doravirine Concentrations and Viral Suppression in CSF.
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Tiraboschi J, Scévola S, Penchala SD, Challenger E, Else L, Prieto P, Saumoy M, Imaz A, Silva-Klug A, Niubó J, Soriano I, Khoo S, Rigo-Bonin R, and Podzamczer D
- Subjects
- Humans, Pyridones pharmacology, Triazoles pharmacology, Triazoles therapeutic use, Virus Replication, HIV Infections drug therapy, HIV-1
- Abstract
We determined total and unbound concentrations of doravirine (DOR) in cerebrospinal fluid and blood plasma. Total and unbound DOR concentrations in cerebrospinal fluid exceeded the half-maximal effective concentration against wild-type virus (5.1 ng/mL) in all patients, suggesting that DOR may contribute to inhibit viral replication in this compartment., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
- Published
- 2022
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64. Zenker's peroral endoscopic myotomy, or flexible or rigid septotomy for Zenker's diverticulum: a multicenter retrospective comparison.
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Al Ghamdi SS, Farha J, Moran RA, Pioche M, Moll F, Yang DJ, Hernández Mondragón OV, Ujiki M, Wong H, Tantau A, Sedarat A, Fejleh MP, Chang K, Lee DP, Nieto JM, Andrawes S, Ginsberg GG, Saumoy M, Bapaye A, Dashatwar P, Aghaie Meybodi M, Lopez AC, Sanaei O, Yousaf MN, Jovani M, Ichkhanian Y, Brewer Gutierrez OI, Kumbhari V, O'Rourke AK, Lentsch EJ, Elmunzer BJ, and Khashab MA
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- Aged, Esophagoscopy adverse effects, Female, Humans, Male, Prospective Studies, Retrospective Studies, Treatment Outcome, Myotomy adverse effects, Myotomy methods, Zenker Diverticulum surgery
- Abstract
Background: Treatment of Zenker's diverticulum has evolved from open surgery to endoscopic techniques, including flexible and rigid endoscopic septotomy, and more recently, peroral endoscopic myotomy (Z-POEM). This study compared the effectiveness of flexible and rigid endoscopic septotomy with that of Z-POEM., Methods: Consecutive patients who underwent endoscopic septotomy (flexible/rigid) or Z-POEM for Zenker's diverticulum between 1/2016 and 9/2019 were included. Primary outcomes were clinical success (decrease in Dakkak and Bennett dysphagia score to ≤ 1), clinical failure, and clinical recurrence. Secondary outcomes included technical success and rate/severity of adverse events., Results: 245 patients (110 females, mean age 72.63 years, standard deviation [SD] 12.37 years) from 12 centers were included. Z-POEM was the most common management modality (n = 119), followed by flexible (n = 86) and rigid (n = 40) endoscopic septotomy. Clinical success was 92.7 % for Z-POEM, 89.2 % for rigid septotomy, and 86.7 % for flexible septotomy ( P = 0.26). Symptoms recurred in 24 patients (15 Z-POEM during a mean follow-up of 282.04 [SD 300.48] days, 6 flexible, 3 rigid [ P = 0.47]). Adverse events occurred in 30.0 % rigid septotomy patients, 16.8 % Z-POEM patients, and 2.3 % flexible septotomy patients ( P < 0.05)., Conclusions: There was no difference in outcomes between the three treatment approaches for symptomatic Zenker's diverticulum. Rigid endoscopic septotomy was associated with the highest rate of complications, while flexible endoscopic septotomy appeared to be the safest. Recurrence following Z-POEM was similar to flexible and rigid endoscopic septotomy. Prospective studies with long-term follow-up are required., Competing Interests: M.A. Khashab is a consultant for Boston Scientific, Olympus, Medtronic, GI Supply, and Triton. B.J. Elmunzer is a consultant for Takeda Pharmaceuticals. V. Kumbhari is a consultant for Apollo Endosurgery, Boston Scientific, Medtronic, FuijFilm, Pentax Medical, ReShape Lifesciences, and Obalon, and has received research support from ERBE and Apollo Endosurgery. D.J. Yang is a consultant for Boston Scientific, Lumendi, and Steris. G.G. Ginsberg is a consultant for Olympus Inc. and Boston Scientific. M. Ujiki is a consultant for Olympus, Boston Scientific, and Cook, and receives grant funding from Medtronic; he is also a speaker for Medtronic and Gore, and receives fellowship funding from Boston Scientific. J.M. Nieto is a consultant for Boston Scientific and ERBE. S. Andrawes is a consultant for Olympus. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
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- 2022
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65. Short-term Neuropsychiatric and Body Weight Changes in Patients Switching From EVG/Cobi/FTC/TAF to BIC/FTC/TAF (PreEC/RIS69).
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Tiraboschi J, Prieto P, Saumoy M, Silva A, Imaz A, Scevola S, Fernandez G, Navarro A, Piatti C, and Podzamczer D
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- Body Weight, Emtricitabine therapeutic use, Female, Humans, Male, Tenofovir therapeutic use, Anti-HIV Agents therapeutic use, HIV Infections drug therapy
- Abstract
Background: We report NP, clinical and laboratory changes in patients switching from EVG/Cobi/FTC/TAF to BIC/FTC/TAF in clinical practice., Methods: A group of subjects switching from EVG/Cobi/FTC/TAF to BIC/F/TAF was prospectively followed. A validated sleep quality questionnaire (Pittsburgh Sleep Quality Index), as well as the Hospital Anxiety and Depression Scale (HADS), were administered after 4 weeks from the treatment switch. Adverse events, side effects and discontinuation were recorded at weeks 4 and 24. Pretreatment switch and week 24 body weight and laboratory data were compared., Results: A total of 96 virologically suppressed patients (86% male) were included. All patients received EVG/Cobi/FTC/TAF at least 1 year before the treatment switch. Median (IQR) nadir CD4 was 367 (263). The most common comorbidities were dyslipidemia, HTA and diabetes, 26%, 14% and 7%, respectively. Depression was reported by 8%. Five patients discontinued BIC/FTC/TAF before week 4 due to intolerance (2 insomnia, 1 headache and 2 GI symptoms). No changes in sleep quality, anxiety and depression outcomes were observed at week 4 (p = 0.1, p = 0.1 and p = 0.3, respectively). After 6 months, the median body weight change was statistically significant (0.6 kg, p = 0.003). All patients maintained HIV suppression., Conclusion: Except in a few cases, sleep quality, anxiety and depression symptoms remain stable in HIV virologically suppressed patients on EVG/Cobi/FTC/TAF who switch to BIC/F/TAF. NPAEs are mild and tend to occur in those with previous neuropsychiatric symptoms. Weight gain tends to be small but statistically significant. Long-term follow-up in "real-life" cohorts would be needed to confirm these findings., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
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- 2022
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66. Anesthesia for Advanced Endoscopic Procedures.
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Goudra B and Saumoy M
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The gastrointestinal endoscopy paradigm is rapidly changing, and technological advancements are largely responsible. In tandem, anesthesia providers are adapting to the changing needs and demands. The challenges are unique. Complications arising from the procedures are both routine, such as aspiration and hypoxia, and procedure specific, such as bleeding, pneumothorax, pneumopericardium, and pneumoperitoneum. It is crucial for the anesthesia provider to have a good understanding of the techniques employed by the endoscopist. A higher index of suspicion is also essential to diagnose and appropriately manage many of the complications. In this review, an effort is made to discuss both procedural aspects and anesthesia challenges. We hope that both endoscopists and anesthesia providers will benefit from this review.
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- 2022
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67. Devices for esophageal function testing.
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Pannala R, Krishnan K, Watson RR, Vela MF, Abu Dayyeh BK, Bhatt A, Bhutani MS, Bucobo JC, Chandrasekhara V, Copland AP, Jirapinyo P, Kumta NA, Law RJ, Maple JT, Melson J, Parsi MA, Rahimi EF, Saumoy M, Sethi A, Trikudanathan G, Trindade AJ, Yang J, and Lichtenstein DR
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- Humans, Manometry, Esophageal pH Monitoring, Esophagus diagnostic imaging
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- 2022
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68. A Cost-Effectiveness Analysis for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis Prophylaxis in the United States.
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Thiruvengadam NR, Saumoy M, Schneider Y, Attala S, Triggs J, Lee P, and Kochman ML
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- Administration, Rectal, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Cost-Benefit Analysis, Humans, United States, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Pancreatitis epidemiology, Pancreatitis etiology, Pancreatitis prevention & control
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Background & Aims: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common adverse event after endoscopic retrograde cholangiopancreatography, and is responsible for substantial morbidity and health care expenditures of at least $200 million. Therapies for PEP prevention include pancreatic stent placement (PSP), rectal indomethacin, sublingual nitrates, and aggressive lactated Ringer's hydration. Our objective was to determine which PEP prophylactic strategies are cost effective., Methods: We developed 2 separate decision trees to evaluate PEP prophylactic strategies. The first, in high-risk patients, compared rectal indomethacin, PSP, PSP with indomethacin, sublingual nitrates, aggressive hydration with lactated Ringer's, and no prophylaxis. The second, in average-risk patients, compared rectal indomethacin, sublingual nitrates, aggressive hydration, and no prophylaxis. We used incidence rates, transition probabilities, and costs from publications and public data sources. Outcome measures were reported as incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $100,000/quality-adjusted life years (QALYs)., Results: Compared with no prophylaxis, all strategies were cost effective at a WTP of $100,000 in preventing PEP in high-risk patients. When directly compared with each other, rectal indomethacin was the cost-effective strategy in high-risk patients ($31,589/QALYs). In average-risk patients, indomethacin and sublingual nitrates were cost effective at a WTP of $100,000/QALYs compared with no prophylaxis. When directly compared with each other, rectal indomethacin was the cost-effective strategy ($53,016/QALYs)., Conclusions: Rectal indomethacin was the cost-effective strategy for preventing PEP in both average-risk and high-risk patients undergoing endoscopic retrograde cholangiopancreatography. All strategies were cost effective when compared with no prophylaxis in high-risk patients, whereas all strategies except for aggressive hydration with lactated Ringer's were cost effective in average-risk patients. Further studies are needed to improve the utilization of PEP prevention strategies., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2022
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69. Cardiovascular Risk and Health Among People With Human Immunodeficiency Virus (HIV) Eligible for Primary Prevention: Insights From the REPRIEVE Trial.
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Douglas PS, Umbleja T, Bloomfield GS, Fichtenbaum CJ, Zanni MV, Overton ET, Fitch KV, Kileel EM, Aberg JA, Currier J, Sponseller CA, Melbourne K, Avihingsanon A, Bustorff F, Estrada V, Ruxrungtham K, Saumoy M, Navar AM, Hoffmann U, Ribaudo HJ, and Grinspoon S
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- Blood Glucose, Body Mass Index, Female, HIV, Heart Disease Risk Factors, Humans, Male, Risk Factors, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology
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Background: In addition to traditional cardiovascular (CV) risk factors, antiretroviral therapy, lifestyle, and human immunodeficiency virus (HIV)-related factors may contribute to future CV events in persons with HIV (PWH)., Methods: Among participants in the global REPRIEVE randomized trial, we characterized demographics and HIV characteristics relative to ACC/AHA pooled cohort equations (PCE) for atherosclerotic CV disease predicted risk and CV health evaluated by Life's Simple 7 (LS7; includes smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and glucose)., Results: Among 7382 REPRIEVE participants (31% women, 45% Black), the median PCE risk score was 4.5% (lower and upper quartiles Q1, Q3: 2.2, 7.2); 29% had a PCE score <2.5%, and 9% scored above 10%. PCE score was related closely to known CV risk factors and modestly (<1% difference in risk score) to immune function and HIV parameters. The median LS7 score was 9 (Q1, Q3: 7, 10) of a possible 14. Only 24 participants (0.3%) had 7/7 ideal components, and 36% had ≤2 ideal components; 90% had <5 ideal components. The distribution of LS7 did not vary by age or natal sex, although ideal health was more common in low sociodemographic index countries and among Asians. Poor dietary and physical activity patterns on LS7 were seen across all PCE scores, including the lowest risk categories., Conclusions: Poor CV health by LS7 was common among REPRIEVE participants, regardless of PCE. This suggests a critical and independent role for lifestyle interventions in conjunction with conventional treatment to improve CV outcomes in PWH. Clinical Trials Registration: NCT02344290. AIDS Clinical Trials Group study number: A5332., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)
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- 2021
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70. Late HIV diagnosis among immigrants in Spain vs. native-born Spaniards, 2010-15.
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Gogishvili M, Huang TT, Costa SA, Florez K, Mateu-Gelabert P, Valls MRA, Rivero M, Saumoy M, Samperiz G, Cervero M, Pulido F, and Pérez JA
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- Humans, Indigenous Peoples, Spain epidemiology, Emigrants and Immigrants, HIV Infections diagnosis, HIV Infections epidemiology, Undocumented Immigrants
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Background: In 2012, the central government of Spain enacted Royal Decree-Law (RDL) 16/2012 and Royal Decree (RD) 1192/2012, which abolished universal healthcare coverage, thus limiting access to care for undocumented immigrants. Free health care was also no longer granted to anyone who has never been employed. In this context, this study investigated the prevalence of late HIV diagnoses (LHDs) among immigrants living in Spain vs. native-born Spaniards., Methods: Data (n = 5943) from the 2010 to 2015 Cohort of the Spanish AIDs Research Network were used, including HIV-positive and antiretroviral therapy (ART)-naïve patients throughout Spain. Multivariate logistic models were fitted to compare the prevalence of LHD among the groups, adjusting for covariates., Results: The prevalence of LHD in the total sample was 39.5%. Compared with native-born Spaniards (n = 4445), immigrants (n = 1488) were more likely to have LHD (37.4% vs. 45.7%, respectively; P < 0.001). Multivariate analysis showed that the prevalence ratio of LHD among immigrants vs. native-born Spaniards was 1.15 [95% confidence interval (CI), 1.02-1.28], after adjusting for covariates. This disparity widened from 2010 to 2011 (APR = 1.14, 95% CI, 1.02-1.29) to 2012-15 (APR = 1.28, 95% CI, 1.17-1.39), although the change was not statistically significant., Conclusions: Immigrants in Spain had a higher risk of LHD compared with native-born counterparts. LHD is an important healthcare marker due to the positive benefits of early HIV diagnosis, including prevention, improvements in health outcomes and decreases in overall cost of treatment. More research is needed on the causes of the disparity and potential social and policy interventions to reduce the prevalence of LHD among immigrants., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)
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- 2021
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71. Devices for esophageal function testing.
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Pannala R, Krishnan K, Watson RR, Vela MF, Abu Dayyeh BK, Bhatt A, Bhutani MS, Bucobo JC, Chandrasekhara V, Copland AP, Jirapinyo P, Kumta NA, Law RJ, Maple JT, Melson J, Parsi MA, Rahimi EF, Saumoy M, Sethi A, Trikudanathan G, Trindade AJ, Yang J, and Lichtenstein DR
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Background and Aims: Esophageal function testing is an integral component of the evaluation of refractory GERD and esophageal motility disorders. This review summarizes the current technologies available for esophageal function testing, including the functional luminal imaging probe (FLIP), high-resolution esophageal manometry (HRM), and multichannel intraluminal impedance (MII) and pH monitoring., Methods: We performed a MEDLINE, PubMed, and MAUDE database literature search to identify pertinent clinical studies through March 2021 using the following key words: esophageal manometry, HRM, esophageal impedance, FLIP, MII, and esophageal pH testing. Technical data were gathered from traditional and web-based publications, proprietary publications, and informal communications with pertinent vendors. The report was drafted, reviewed, and edited by the American Society for Gastrointestinal Endoscopy Technology Committee and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy., Results: FLIP is a high-resolution impedance planimetry system used for pressure and dimension measurement in the esophagus, pylorus, and anal sphincter. FLIP provides complementary information to HRM for esophageal motility disorders, especially achalasia. The Chicago classification, based on HRM data, is a widely adopted algorithmic scheme used to diagnose esophageal motility disorders. MII detects intraluminal bolus movement and, combined with pH measurement or manometry, provides information on acid and non-acid gastroesophageal reflux and bolus transit in patients with refractory GERD and for preoperative evaluation for anti-reflux procedures., Conclusions: Esophageal function testing techniques (FLIP, HRM, and MII-pH) have diagnostic and prognostic value in the evaluation of esophageal motility disorders and refractory GERD. Newer technologies and classification systems have enabled an increased understanding of these diseases., (© 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)
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- 2021
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72. Endoscopic therapies for gallbladder drainage.
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Saumoy M, Yang J, Bhatt A, Bucobo JC, Chandrasekhara V, Copland AP, Krishnan K, Kumta NA, Law RJ, Pannala R, Parsi MA, Rahimi EF, Trikudanathan G, Trindade AJ, and Lichtenstein DR
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- Drainage, Endosonography, Gallbladder surgery, Humans, Quality of Life, Cholecystitis, Acute surgery, Cholecystostomy
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Background and Aims: Endoscopic management of acute cholecystitis has expanded in patients who are considered nonoperative candidates. Traditionally managed with percutaneous cholecystostomy (PC), improvement in techniques and devices has led to increased use of endoscopic methods for gallbladder drainage. This document reviews technical aspects of endoscopic transpapillary gallbladder drainage (ET-GBD) and EUS-guided GBD (EUS-GBD) as well as their respective technical/clinical success and adverse event rates. Available comparative data are also reviewed among nonsurgical gallbladder drainage techniques (PC, ET-GBD, and EUS-GBD)., Methods: The MEDLINE database was searched through March 2021 for relevant articles by using keywords including "acute cholecystitis," "interventional EUS," "percutaneous cholecystostomy," "transpapillary gallbladder drainage," "EUS-guided gallbladder drainage," "lumen-apposing metal stent," "gallbladder stenting," and "endoscopic gallbladder drainage." The manuscript was drafted by 2 authors and reviewed by members of the American Society for Gastrointestinal Endoscopy Technology Committee and subsequently by the American Society for Gastrointestinal Endoscopy Governing Board., Results: Multiple studies have demonstrated acceptable outcomes comparing PC and both endoscopic gallbladder drainage techniques, ET-GBD and EUS-GBD. Published data suggest that endoscopic gallbladder drainage techniques may be associated with lower rates of adverse events and improved quality of life. However, there are important clinical considerations for choosing among these treatment options, requiring a multidisciplinary and collaborative approach to therapeutic decision-making in these patients., Conclusions: The implementation of EUS-GBD and ET-GBD in high-risk surgical patients with acute cholecystitis may result in favorable outcomes when compared with PC. Further improvements in techniques and training should lead to more widespread acceptance and dissemination of these treatment options., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2021
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73. Lumen-apposing metal stents (with videos).
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Law RJ, Chandrasekhara V, Bhatt A, Bucobo JC, Copland AP, Krishnan K, Kumta NA, Pannala R, Parsi MA, Rahimi EF, Saumoy M, Trikudanathan G, Trindade AJ, Yang J, and Lichtenstein DR
- Subjects
- Drainage, Endosonography, Gallbladder, Humans, Stents, Treatment Outcome, Pancreatic Pseudocyst, Pancreatitis, Acute Necrotizing
- Abstract
Background and Aims: Lumen-apposing metal stents (LAMSs) are a novel class of devices that have expanded the spectrum of endoscopic GI interventions. LAMSs with their dumbbell configuration, short saddle length, and large inner luminal diameter provide favorable stent characteristics to facilitate anastomosis formation between the gut lumen and adjacent structures., Methods: The MEDLINE database was searched through April 2021 for articles related to LAMSs by using additional relevant keywords such as "walled-off pancreatic necrosis," "pseudocysts," "pancreatic fluid collection," "cholecystitis," "gastroenterostomy," in addition to "endoscopic treatment" and "endoscopic management," among others., Results: This technology review describes the full spectrum of LAMS designs and delivery systems, techniques for deployment, procedural outcomes, safety, training issues, and financial considerations., Conclusions: Although LAMSs were initially introduced for drainage of pancreatic pseudocysts and walled-off necrosis, the versatility of these devices has led to a variety of off-label uses including gallbladder drainage, enteric bypass with the creation of gastroenterostomies, and treatment of luminal GI strictures., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2021
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74. Comparison of two sample collection devices for anal cytology in HIV-positive men who have sex with men: Cytology brush and Dacron swab.
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Silva-Klug AC, Saumoy M, Baixeras N, Trenti L, Catala I, Vidal A, Torres M, Alemany L, Videla S, De San Jose S, and Podzamczer D
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- Adult, Anus Neoplasms diagnosis, Anus Neoplasms virology, Biopsy methods, Cytodiagnosis methods, Cytological Techniques methods, HIV Infections diagnosis, HIV Seropositivity diagnosis, Homosexuality, Male, Humans, Male, Middle Aged, Papillomaviridae pathogenicity, Papillomavirus Infections diagnosis, Papillomavirus Infections pathology, Prospective Studies, Retrospective Studies, Sensitivity and Specificity, Squamous Intraepithelial Lesions diagnosis, Squamous Intraepithelial Lesions pathology, Anal Canal pathology, Anus Neoplasms pathology, HIV Infections pathology, HIV Seropositivity pathology, Specimen Handling methods
- Abstract
Objective: HIV-positive men who have sex with men (MSM) are a vulnerable group for anal cancer (AC), a cancer with a well-described precursor lesion, which can be detected early in screening programs using anal liquid-based cytology (aLBC). We aim to compare two aLBC sample collection devices: cytology brush (CB) and Dacron swab (DS)., Methods: Retrospective analysis of two consecutive study periods, the first using CB and the second DS. Participants underwent an aLBC, a human papillomavirus (HPV) DNA test and a high-resolution anoscopy (HRA), and a biopsy was performed for suspicious lesions. The sensitivity and specificity of aLBC, area under the receiver operating characteristic (ROC) curve (AUC), and concordance between cytology and HRA were assessed using Cohen's kappa coefficient., Results: A total of 239 participants were enrolled (CB group, 120; DS group, 119). aLBC was benign in 46% of samples, and high-grade squamous intraepithelial lesion (HSIL) was detected in 11.7%. Prevalence of biopsy-proven HSIL was 15.3%. No differences in cytological and histological results were observed between the groups. aLBC-HRA concordance was weak for benign results (CB group, k = 0.309; DS group, k = 0.350) as well as for HSIL (k = 0.321 and 0.387, respectively). Sensitivity and specificity were 100% and 51.4%, respectively, in the CB group and 88% and 54.3% in the DS group (AUC = 0.711 and 0.759, respectively, P-value = .514). Representation of the transformation zone (TZ) was adequate in 83.3% of samples in the CB group and 50.4% in the DS group (P-value <.001)., Conclusion: Our data suggest that both devices had similar accuracy to detect anal HSIL, although samples collected with CB are more likely to have an adequate TZ representation, the presence of which could be an indicator of sample quality., (© 2021 John Wiley & Sons Ltd.)
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- 2021
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75. Do All Integrase Strand Transfer Inhibitors Have the Same Lipid Profile? Review of Randomised Controlled Trials in Naïve and Switch Scenarios in HIV-Infected Patients.
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Saumoy M, Sanchez-Quesada JL, Ordoñez-Llanos J, and Podzamczer D
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In this study, we aim to explore the effects on lipids of integrase strand transfer inhibitors (INSTIs) in naïve and switch randomised controlled trials, and compare them with protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). We reviewed phase 3/4 randomised clinical trials in the Cochrane and PubMed databases that compare an INSTI with a boosted PI, an NNRTI, or another INSTI plus one or two nucleoside/nucleotide reverse transcriptase inhibitors (NtRTIs) in naïve patients and switching strategies in HIV-infected patients. We reported the baseline plasma concentration of total cholesterol (TC), low and high-density lipoprotein cholesterol (LDL-c, HDL-c), triglycerides (TG), and the TC/HDL-c ratio, as well as the change at weeks 48 and 96, when available. In naïve HIV-infected patients, raltegravir (RAL) and dolutegravir (DTG) have a more favourable lipid profile compared with NNRTI and boosted PI. Elvitegravir (EVG/c) has a superior lipid profile compared with efavirenz and is similar to that observed with ritonavir-boosted atazanavir except in TG, which increases less with EVG/c. In naïve patients, RAL, DTG, and bictegravir (BIC) produce a similar, slight increase in lipids. In switching trials, the regimen change based on a boosted PI or efavirenz to RAL, DTG, or BIC is associated with clinically significant decreases in lipids that are minor when the change is executed on EVG/c. No changes were observed in lipids by switching trials between INSTIs. In summary, RAL, DTG, and BIC have superior lipid profiles compared with boosted-PI, efavirenz, and EVG/c, in studies conducted in naïve participants, and they are associated with a clinically significant decrease in lipoproteins by switching studies.
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- 2021
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76. Impact of prior treatment on feasibility and outcomes of Zenker's peroral endoscopic myotomy (Z-POEM).
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Sanaei O, Ichkhanian Y, Mondragón OVH, Nieto J, Krishnan A, Tantau M, Tantau A, Desai PN, Ginsberg GG, Saumoy M, Deshmukh A, Attaar M, Farha J, Jovani M, Al-Ghamdi SS, Ujiki M, and Khashab MA
- Subjects
- Feasibility Studies, Humans, Retrospective Studies, Treatment Outcome, Myotomy, Zenker Diverticulum surgery
- Abstract
Background: Zenker's peroral endoscopic myotomy (Z-POEM) is a novel procedure for the management of symptomatic Zenker's diverticulum. This study aims to report the technical feasibility and outcomes of Z-POEM in the management of Zenker's diverticulum after prior failed interventions., Methods: Patients with persistent or recurrent symptoms after prior endoscopic and/or surgical intervention for Zenker's diverticulum were retrospectively included. The primary outcome was clinical success, defined as complete or near complete resolution of dysphagia (dysphagia score of 0 or 1) without the need for repeat endoscopic or surgical intervention during follow-up., Results: Z-POEM was technically successful in 30/32 patients (93.8 %). Clinical success was achieved in 29/30 patients (96.7 %), and Z-POEM significantly reduced the median (interquartile range [IQR]) dysphagia score of patients from 2 (1 - 2) to 0 (0) (P < 0.001) over a median duration of follow up of 166 days (IQR 39 - 566). Four patients (12.5 %) had adverse events (two inadvertent mucosotomies and two leaks found on post-procedural esophagrams)., Conclusion: Z-POEM is feasible, safe, and effective in the majority of patients with recurrent symptoms after prior surgical or endoscopic interventions., Competing Interests: J. Nieto is a consultant and speaker for Boston Scientific and ERBE; P. Desai is a trainer for Olympus and ERBE India; G.G. Ginsberg is a consultant for Olympus and Cook Medical; M. Saumoy is a consultant for Boston Scientific, Olympus, and Takeda pharmaceuticals; M. Ujiki is a consultant for Boston Scientific, Olympus, Coviden LP, and Apollo Endosurgery; M.A. Khashab is a consultant for Boston Scientific, Olympus, and Medtronic. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
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- 2021
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77. Threshold Analysis of the Cost-effectiveness of Endoscopic Ultrasound in Patients at High Risk for Pancreatic Ductal Adenocarcinoma.
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Kumar S, Saumoy M, Oh A, Schneider Y, Brand RE, Chak A, Ginsberg GG, Kochman ML, Canto MI, Goggins MG, Hur C, Kastrinos F, Katona BW, and Rustgi AK
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- Cohort Studies, Cost-Benefit Analysis economics, Early Detection of Cancer economics, Endosonography economics, Female, Humans, Male, Middle Aged, Models, Economic, Pancreas pathology, Risk Factors, Sensitivity and Specificity, Carcinoma, Pancreatic Ductal diagnosis, Cost-Benefit Analysis methods, Early Detection of Cancer methods, Endosonography methods, Pancreas diagnostic imaging, Pancreatic Neoplasms diagnosis
- Abstract
Objectives: Data from the International Cancer of the Pancreas Screening Consortium studies have demonstrated that screening for pancreatic ductal adenocarcinoma can be effective and that surveillance improves survival in high-risk individuals. Endoscopic ultrasound (EUS) and cross-sectional imaging are both used, although there is some suggestion that EUS is superior. Demonstration of the cost-effectiveness of screening is important to implement screening in high-risk groups., Methods: Results from centers with EUS-predominant screening were pooled to evaluate efficacy of index EUS in screening. A decision analysis model simulated the outcome of high-risk patients who undergo screening and evaluated the parameters that would make screening cost-effective at a US $100,000 per quality-adjusted life-year willingness to pay., Results: One-time index EUS has a sensitivity of 71.25% and specificity of 99.82% to detection to detect high-risk lesions. Screening with index EUS was cost-effective, particularly at lifetime pancreatic cancer probabilities of greater than 10.8%, or at lower probabilities if life expectancy after resection of a lesion that was at least 16 years, and if missed, lesion rates on index EUS are 5% or less., Conclusions: Pancreatic cancer screening can be cost-effective through index EUS, particularly for those individuals at high-lifetime risk of cancer., Competing Interests: S.K. received travel support from the Boston Scientific Corporation and Olympus. B.W.K, is a consultant of Exact Sciences and received travel support from Janssen. M.L.K. is a consultant of Boston Scientific, Olympus, and Pentax. Equity MAB: Dark Canyon Laboratories, VIRGO. The other authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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78. Type II achalasia is associated with a comparably favorable outcome following per oral endoscopic myotomy.
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Tomizawa Y, Mahmud N, Dasher K, Triggs JR, Saumoy M, Falk GW, and Ginsberg GG
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- Dilatation, Esophageal Sphincter, Lower, Female, Humans, Infant, Newborn, Male, Retrospective Studies, Treatment Outcome, Esophageal Achalasia surgery, Heller Myotomy, Natural Orifice Endoscopic Surgery
- Abstract
Per oral endoscopic myotomy (POEM) is a safe and effective treatment for esophageal motility disorder in treatment-naïve patients as well as salvage therapy. Though type II achalasia, compared to other subtypes, is reported to have a more favorable outcome with pneumatic dilation (PD) or Heller myotomy (HM), it is unclear whether achalasia subtype predicts symptom response to POEM. We aimed to evaluate whether type II achalasia is associated with a comparably favorable outcome following POEM. We performed a retrospective review of patients with esophageal motility disorder who were referred for POEM from April 2014 to June 2017. The main outcome was clinical success based on Eckardt score ≤3 and its association with subtype and safety. A total of 63 patients (mean age 51 years [SD 15]; 63% male) underwent a total of 68 POEMs with median of 263 days follow-up. Of these, 45 (71.3%) patients were type II achalasia. In all, 29 (46%) patients were treatment-naïve and 34 (54%) patients had previous endoscopic or surgical therapy including botulinum toxin injection in 16 (25%), PD in 10 (16%), both botulinum toxin injection and PD in 8 (13%) and HM in 3 (5%). Technical success was 100% and clinical success was achieved in 51 (81%) patients. The rate of clinical success was higher in patients with type II achalasia compared to the other subtypes (88.9% vs. 61.1% [P = 0.028]) and type II achalasia patients required fewer redo POEM (2.2% vs. 22.2% [P = 0.021]). Multivariate logistic regression analysis demonstrated the positive prediction of clinical success for type II achalasia following POEM (P = 0.046). As observed with PD and HM, type II achalasia was associated with a favorable clinical outcome following POEM., (© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2021
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79. ERCP improves mortality in acute biliary pancreatitis without cholangitis.
- Author
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Novikov AA, Fieber JH, Saumoy M, Rosenblatt R, Mekelburg SAC, Shah SL, and Crawford CV Jr
- Abstract
Background and study aims Acute pancreatitis (AP) is an increasingly common indication for hospitalization in the United States. The necessity for endoscopic retrograde cholangiopancreatography (ERCP) and the timing of ERCP in acute gallstone-related pancreatitis without cholangitis (AGPNC) is controversial. The aim of this study was to evaluate the association of ERCP and its performance during admission with mortality and length of stay (LOS) in patients with AGPNC. Patients and methods We queried the Nationwide Inpatient Sample (NIS) from 2004 to 2014 to identify all patients with admissions for gallstone AP. We excluded patients with chronic pancreatitis or concurrent cholangitis, and those who were transferred from elsewhere for treatment. Our primary outcome measure was inpatient mortality. Our secondary outcome measure was hospital length of stay (LOS). Results We identified 491,011 records eligible for analysis. Of the patients, 30.6 % (150,101) had AGPNC. There were 1.34 deaths per 100 admissions in patients with AGPNC. The average LOS was 5.88 (± 6.38) days with a median stay of 4 days (range, 3-7). When adjusted for age, Elixhauser Comorbidity Index, and severe pancreatitis, patients with ERCP during admission were 43 % less likely to die. ERCP performed between Days 3 and 9 of hospitalization resulted in a significant mortality benefit. Among those who had ERCP, a shorter wait time for ERCP was associated with a shorter LOS after adjustment for demographics and severity of illness. Conclusion ERCP performed during inpatient admission for AGPNC was associated with decreased mortality. These data support early ERCP in patients with acute gallstone pancreatitis without cholangitis., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
- Published
- 2021
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80. Single-use duodenoscopes and duodenoscopes with disposable end caps.
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Trindade AJ, Copland A, Bhatt A, Bucobo JC, Chandrasekhara V, Krishnan K, Parsi MA, Kumta N, Law R, Pannala R, Rahimi EF, Saumoy M, Trikudanathan G, Yang J, and Lichtenstein DR
- Subjects
- Cholangiopancreatography, Endoscopic Retrograde adverse effects, Disease Outbreaks, Disinfection, Equipment Contamination prevention & control, Humans, Cross Infection prevention & control, Duodenoscopes
- Abstract
Background and Aims: Multidrug-resistant infectious outbreaks associated with duodenoscopes have been documented internationally. Single-use duodenoscopes, disposable distal ends, or distal end cap sealants could eliminate or reduce exogenous patient-to-patient infection associated with ERCP., Methods: This document reviews technologies that have been developed to help reduce or eliminate exogenous infections because of duodenoscopes., Results: Four duodenoscopes with disposable end caps, 1 end sheath, and 2 disposable duodenoscopes are reviewed in this document. The evidence regarding their efficacy in procedural success rates, reduction of duodenoscope bacterial contamination, clinical outcomes associated with these devices, safety, and the financial considerations are discussed., Conclusions: Several technologies discussed in this document are anticipated to eliminate or reduce exogenous infections during endoscopy requiring a duodenoscope. Although disposable duodenoscopes can eliminate exogenous ERCP-related risk of infection, data regarding effectiveness are needed outside of expert centers. Additionally, with more widespread adoption of these new technologies, more data regarding functionality, medical economics, and environmental impact will accrue. Disposable distal end caps facilitate duodenoscope reprocessing; postmarketing surveillance culture studies and real-life patient infection analyses are important areas of future research., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2021
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81. Improvement in insulin resistance and estimated hepatic steatosis and fibrosis after endoscopic sleeve gastroplasty.
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Hajifathalian K, Mehta A, Ang B, Skaf D, Shah SL, Saumoy M, Dawod Q, Dawod E, Shukla A, Aronne L, Brown RS, Cohen DE, Dannenberg AJ, Fortune B, Kumar S, and Sharaiha RZ
- Subjects
- Fibrosis, Humans, Liver Cirrhosis surgery, Prospective Studies, Gastroplasty, Insulin Resistance, Non-alcoholic Fatty Liver Disease surgery
- Abstract
Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is closely associated with obesity and insulin resistance (IR). Weight loss is the best treatment for NAFLD. Endoscopic sleeve gastroplasty (ESG) is a promising endoscopic procedure for treatment of obesity. Our aim is to evaluate the change in IR and estimated hepatic steatosis and fibrosis after ESG., Methods: One hundred eighteen patients with obesity and NAFLD underwent ESG and were followed for 2 years. Weight loss was evaluated as % total body weight loss. IR was evaluated using the homeostasis model assessment of insulin resistance (HOMA-IR). The previously validated hepatic steatosis index and NAFLD fibrosis score were used to estimate hepatic steatosis and risk of fibrosis., Results: Patients' mean body mass index was 40 ± 7 kg/m
2 at baseline. Eighty-four percent of patients completed 2 years of follow-up. At 2 years, the mean total body weight loss was 15.5% (95% confidence interval, 13.3%-17.8%). Patients' HOMA-IR improved significantly from 6.7 ± 11 to 3.0 ± 1.6 after only 1 week from ESG (P = .019) with continued improvement up to 2 years (P = .03). Patients' hepatic steatosis index score improved significantly, decreasing by 4 points per year (P for trend, <.001). Patients' NAFLD fibrosis score improved significantly, decreasing by 0.3 point per year (P for trend, .034). Twenty-four patients (20%) improved their risk of hepatic fibrosis from F3-F4 or indeterminate to F0-F2, whereas only 1 patient (1%) experienced an increase in the estimated risk of fibrosis (P = .02)., Conclusions: Our results suggest a significant and sustained improvement in estimated hepatic steatosis and fibrosis after ESG in patients with NAFLD. Importantly, we showed an early and weight-independent improvement in insulin resistance, which lasted for 2 years after the procedure., (Copyright © 2021. Published by Elsevier Inc.)- Published
- 2021
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82. Spotlight: Intragastric Balloons in the Management of Obesity.
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Shah R, Davitkov P, Abu Dayyeh BK, Saumoy M, and Murad MH
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- Algorithms, Clinical Decision Rules, Clinical Decision-Making, Consensus, Evidence-Based Medicine standards, Gastric Balloon adverse effects, Humans, Obesity diagnosis, Obesity physiopathology, Risk Assessment, Risk Factors, Treatment Outcome, Weight Loss, Gastric Balloon standards, Gastroenterology standards, Obesity therapy
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- 2021
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83. AGA Technical Review on Intragastric Balloons in the Management of Obesity.
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Shah R, Davitkov P, Abu Dayyeh BK, Saumoy M, and Murad MH
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- Algorithms, Clinical Decision Rules, Clinical Decision-Making, Consensus, Evidence-Based Medicine standards, Gastric Balloon adverse effects, Humans, Obesity diagnosis, Obesity physiopathology, Risk Assessment, Risk Factors, Treatment Outcome, Weight Loss, Gastric Balloon standards, Gastroenterology standards, Obesity therapy
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Several strategies are available to address the obesity epidemic and range from noninvasive lifestyle interventions to medications and bariatric surgical procedures. Endoscopic bariatric techniques, such as intragastric balloons, have become an attractive alternative as a tool for weight loss that can augment the effect of lifestyle interventions. This technical review includes multiple systematic reviews performed to support a clinical practice guideline by the American Gastroenterological Association on the role of intragastric balloons as a tool for weight loss. The systematic reviews targeted a priori selected clinical questions about the effectiveness and periprocedural care of intragastric balloons and concomitant and subsequent weight-loss strategies., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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84. Association for Bariatric Endoscopy systematic review and meta-analysis assessing the American Society for Gastrointestinal Endoscopy Preservation and Incorporation of Valuable Endoscopic Innovations thresholds for aspiration therapy.
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Jirapinyo P, Kumar N, Saumoy M, Copland A, and Sullivan S
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- Humans, United States, Bariatrics, Endoscopy, Gastrointestinal
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A subcommittee of the Association for Bariatric Endoscopy, a division of the American Society for Gastrointestinal Endoscopy (ASGE) comprising experts in the subject area, performed this systematic review and meta-analysis. The systematic review and meta-analysis was reviewed by the ASGE Technology Committee and was ultimately submitted to the ASGE Governing Board for approval. The systematic review and meta-analysis underwent peer review by outside experts in statistics and meta-analysis before receiving final ASGE Governing Board approval. The Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) initiative is an ASGE program whose objectives are to identify important clinical questions related to endoscopy and to establish a priori diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these clinical questions. Once endoscopic technologies meet an established PIVI threshold, those technologies are appropriate to incorporate into clinical practice, presuming the appropriate training in that endoscopic technology has been achieved. ASGE encourages and supports the appropriate use of technologies that meet its established PIVI thresholds., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
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- 2021
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85. Endoscopy for Gastric Cancer Screening Is Cost Effective for Asian Americans in the United States.
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Shah SC, Canakis A, Peek RM Jr, and Saumoy M
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- Cost-Benefit Analysis, Early Detection of Cancer, Gastroscopy, Humans, Mass Screening, Middle Aged, Quality-Adjusted Life Years, United States, Asian, Stomach Neoplasms diagnosis
- Abstract
Background & Aims: Endoscopic screening for gastric cancer is routine in some countries with high incidence and is associated with reduced gastric cancer-related mortality. Immigrants from countries of high incidence to low incidence of gastric cancer retain their elevated risk, but no screening recommendations have been made for these groups in the United States. We aimed to determine the cost effectiveness of different endoscopic screening strategies for noncardia gastric cancer, compared with no screening, among Chinese, Filipino, Southeast Asian, Vietnamese, Korean, and Japanese Americans., Methods: We generated a decision-analytic Markov model to simulate a cohort of asymptomatic 50-year-old Asian Americans. The cost effectiveness of 2 distinct strategies for endoscopic gastric cancer screening was compared with no screening for each group, stratified by sex. Outcome measures were reported in incremental cost-effectiveness ratios (ICERs), with a willingness-to-pay threshold of $100,000/quality-adjusted life-year (QALY). Extensive sensitivity analyses were performed., Results: Compared with performing no endoscopic gastric cancer screening, performing a 1-time upper endoscopy with biopsies, with continued endoscopic surveillance if gastric intestinal metaplasia was identified, was cost effective, whereas performing ongoing biennial endoscopies, even for patients with normal findings from endoscopy and histopathology, was not. The lowest ICERs were observed for Chinese, Japanese, and Korean Americans (all <$73,748/QALY)., Conclusions: Endoscopic screening for gastric cancer with ongoing surveillance of gastric preneoplasia is cost effective for Asian Americans ages 50 years or older in the United States. The lowest ICERs were for Chinese, Japanese, and Korean Americans (all <$73,748/QALY)., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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86. Clinical and pathological features of Kaposi sarcoma herpesvirus-associated inflammatory cytokine syndrome.
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Piñeiro F, Climent F, Imaz A, Gudiol C, Niubó J, Palomar-Muñoz A, Serrano T, Saumoy M, and Podzamczer D
- Subjects
- Adult, Antiretroviral Therapy, Highly Active, Cytokines blood, HIV Infections drug therapy, Herpesvirus 8, Human immunology, Homosexuality, Male, Humans, Inflammation complications, Inflammation virology, Interleukin-10, Interleukin-6, Male, Sarcoma, Kaposi complications, Sarcoma, Kaposi pathology, Treatment Outcome, Antineoplastic Agents, Phytogenic therapeutic use, Cytokines adverse effects, HIV Infections complications, Herpesvirus 8, Human isolation & purification, Inflammation drug therapy, Sarcoma, Kaposi drug therapy, Sarcoma, Kaposi virology
- Abstract
: Kaposi sarcoma Herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS) is an uncommon but aggressive human Kaposi sarcoma herpesvirus associated disorder that is mostly reported in people living with HIV. The diagnosis of KICS is based on clinical criteria, and, in contrast to other KSHV-related malignancies, characteristic pathological features have not yet been described. We report novel clinical and pathological features in an HIV-1 infected patient diagnosed with KICS.
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- 2020
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87. Switching from boosted PIs to dolutegravir in HIV-infected patients with high cardiovascular risk: 48 week effects on subclinical cardiovascular disease.
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Gonzalez-Cordon A, Assoumou L, Camafort M, Domenech M, Guaraldi G, Domingo P, Rusconi S, Raffi F, Katlama C, Masia M, Bernardino JI, Saumoy M, Pozniak A, Gatell JM, and Martinez E
- Subjects
- Adult, Carotid Intima-Media Thickness, Heart Disease Risk Factors, Heterocyclic Compounds, 3-Ring, Humans, Oxazines, Piperazines, Pulse Wave Analysis, Pyridones, Risk Factors, Viral Load, Anti-HIV Agents adverse effects, Cardiovascular Diseases, HIV Infections complications, HIV Infections drug therapy
- Abstract
Background: Switching from boosted PIs to dolutegravir in virologically suppressed HIV-infected patients with high cardiovascular risk significantly decreased total cholesterol and other proatherogenic lipid fractions at 48 weeks. The impact of this strategy on subclinical cardiovascular disease is unknown., Methods: NEAT022 is a European, multicentre, open-label, randomized, non-inferiority trial. HIV-infected adults aged >50 years or with a Framingham score >10% were eligible if plasma HIV RNA was <50 copies/mL for >24 weeks on a boosted PI-based regimen. Patients were randomized 1:1 to switch from boosted PIs to dolutegravir or to continue on boosted PIs. Common carotid arteries intima-media thickness (CIMT) and pulse wave velocity (PWV) were measured following a standardized protocol in a subgroup of NEAT022 study participants at baseline and at Week 48., Results: One hundred and fifty-six patients participated in the ultrasonography and arterial stiffness substudies, respectively. In each substudy, population characteristics did not differ between arms and matched those of the main study. At 48 weeks, patients who switched to dolutegravir had lower mean progression of both right (+4 versus +14.6 μm) and left (-6.1 versus +1.6 μm) CIMT and also a smaller increase in mean PWV (+0.18 versus +0.39 m/s) than patients continuing on boosted PIs, although differences were not statistically significant. CIMT trends were consistent across Framingham score, age and country. Inconsistent effects were seen in arterial stiffness., Conclusions: Relative to continuing on boosted PIs, switching to dolutegravir in virologically suppressed patients with high cardiovascular risk showed consistent favourable although non-significant trends on CIMT progression at 48 weeks., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2020
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88. Lipids, biomarkers, and subclinical atherosclerosis in treatment-naive HIV patients starting or not starting antiretroviral therapy: Comparison with a healthy control group in a 2-year prospective study.
- Author
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Di Yacovo S, Saumoy M, Sánchez-Quesada JL, Navarro A, Sviridov D, Javaloyas M, Vila R, Vernet A, Low H, Peñafiel J, García B, Ordoñez-Llanos J, and Podzamczer D
- Subjects
- Adult, Anti-Retroviral Agents administration & dosage, Anti-Retroviral Agents blood, Antiretroviral Therapy, Highly Active adverse effects, Atherosclerosis drug therapy, Atherosclerosis virology, C-Reactive Protein metabolism, Carotid Intima-Media Thickness, Cholesterol blood, Control Groups, Female, HIV Infections drug therapy, HIV Infections virology, Humans, Inflammation blood, Inflammation drug therapy, Inflammation virology, Lipoproteins, LDL blood, Male, Prospective Studies, Atherosclerosis blood, Biomarkers blood, HIV Infections blood, Lipids blood
- Abstract
Objective: To assess the effect of HIV infection and combined antiretroviral therapy (c-ART) on various proatherogenic biomarkers and lipids and to investigate their relationship with subclinical atherosclerosis in a cohort of treatment-naive HIV-infected patients., Methods: We performed a prospective, comparative, multicenter study of 2 groups of treatment-naive HIV-infected patients (group A, CD4>500 cells/μL, not starting c-ART; and group B, CD4<500 cells/μL, starting c-ART at baseline) and a healthy control group. Laboratory analyses and carotid ultrasound were performed at baseline and at months 12 and 24. The parameters measured were low-density lipoprotein (LDL) particle phenotype, lipoprotein-associated phospholipase A2 (Lp-PLA2), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), sCD14, sCD163, monocyte chemoattractant protein-1(MCP-1), and asymmetric dimethylarginine (ADMA). A linear mixed model based on patient clusters was used to assess differences in biomarkers between the study groups and over time., Results: The study population comprised 62 HIV-infected patients (group A, n = 31; group B, n = 31) and 22 controls. Age was 37 (30-43) years, and 81% were men. At baseline, the HIV-infected patients had a worse LDL particle phenotype and higher plasma concentration of sCD14, sCD163, hs-CRP, and LDL-Lp-PLA2 than the controls. At month 12, there was an increase in total cholesterol (p = 0.002), HDL-c (p = 0.003), and Apo A-I (p = 0.049) and a decrease in sCD14 (p = <0.001) and sCD163 (p<0.001), although only in group B. LDL particle size increased in group B at month 24 (p = 0.038). No changes were observed in group A or in the healthy controls. Common carotid intima-media thickness increased in HIV-infected patients at month 24 (Group A p = 0.053; group B p = 0.048). Plasma levels of sCD14, sCD163, and hs-CRP correlated with lipid values., Conclusions: In treatment-naive HIV-infected patients, initiation of c-ART was associated with an improvement in LDL particle phenotype and inflammatory/immune biomarkers, reaching values similar to those of the controls. HIV infection was associated with progression of carotid intima-media thickness., Competing Interests: The authors have declared that no competing interst exist.
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- 2020
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89. Ligation-assisted endoscopic mucosal resection for esophageal granular cell tumors is safe and effective.
- Author
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Kumar S, Chandrasekhara V, Kochman ML, Ahmad N, Attalla S, Ho IK, Jaffe DL, Lee PJ, Panganamamula KV, Saumoy M, Fortuna D, and Ginsberg GG
- Subjects
- Female, Humans, Infant, Newborn, Neoplasm Recurrence, Local surgery, Retrospective Studies, Treatment Outcome, Endoscopic Mucosal Resection adverse effects, Esophageal Neoplasms surgery, Granular Cell Tumor diagnostic imaging, Granular Cell Tumor surgery
- Abstract
Given their malignant potential, resection of esophageal granular cell tumors (GCTs) is often undertaken, yet the optimal technique is unknown. We present a large series of dedicated endoscopic resection using band ligation (EMR-B) of esophageal GCTs. Patients diagnosed with esophageal GCTs between 2002 and 2019 were identified using a prospectively collected pathology database. Endoscopic reports were reviewed, and patients who underwent dedicated EMR-B of esophageal GCTs were included. Medical records were queried for demographics, findings, adverse events, and follow-up. We identified 21 patients who underwent dedicated EMR-B for previously identified esophageal GCT. Median age was 39 years; 16 (76%) were female. Eight (38%) had preceding signs or symptoms, potentially attributable to the GCT. Upon endoscopic evaluation, 12 (57%) were found in the distal esophagus. Endoscopic ultrasound was used in 15 cases (71%). Median lesion size was 7 mm, interquartile range 4 mm-8 mm. The largest lesion was 12 mm. A total of 20 (95%) had en bloc resection confirmed with pathologic examination. The only patient with tumor extending to the resection margin underwent surveillance endoscopy that showed no residual tumor. No patients experienced bleeding, perforation, or stricturing in our series. No patients have had known recurrence of their esophageal GCT. EMR-B of esophageal GCT achieves complete histopathologic resection with minimal adverse events. EMR-B is safe and effective and seems prudent compared with observation for what could be an aggressive and malignant tumor. EMR-B should be considered first-line therapy when resecting esophageal GCT up to 12 mm in diameter., (© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2020
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90. Decision model analyses of upper endoscopy for gastric cancer screening and preneoplasia surveillance: a systematic review.
- Author
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Canakis A, Pani E, Saumoy M, and Shah SC
- Abstract
Aims: Gastric cancer (GC) is the third leading cause of cancer death worldwide, but the burden of disease is not distributed evenly. GC screening routinely occurs in some high-incidence regions/countries and is generally cost-effective, which is attributed largely to the associated GC mortality reduction. In regions of low-intermediate incidence, less is known about the outcomes of GC screening and gastric precancer surveillance, including cost-effectiveness, since there are no comparative clinical studies. Decision analytic studies are informative in such instances where logistical limitations preclude "gold standard" study designs. We therefore aimed to conduct a systematic review of decision model analyses focused on endoscopic GC screening or precancer surveillance., Methods: We identified decision model analyses, including cost effectiveness and cost utility studies, of GC screening or preneoplasia surveillance. At minimum, articles were evaluated for: study country; analytic design; population and health states; time horizon; model assumptions; outcomes; threshold value(s) for "cost-effective" determination; and sensitivity analyses. Quality appraisal was performed using a modified Drummond's analytic scoring system. Data sources were PubMed, Web of Science, Embase, and the Cochrane Library., Results: We identified 17 studies (8 screening, 4 surveillance, and 5 screening and surveillance) that met full inclusion criteria. Endoscopic screening in countries of high GC incidence was cost-effective across all studies; targeted screening of high-risk populations within otherwise low-intermediate incidence countries was also generally cost-effective. Surveillance of gastric precancer, including atrophic gastritis or gastric intestinal metaplasia, was generally cost-effective. Most studies had high appraisal scores, with 4 (24%) studies achieving perfect scores on the Drummond scale., Conclusion: Decision model analyses offer a unique mechanism with which to efficiently explore the cost benefit of various prevention and early detection strategies. Based on this comprehensive systematic review, upper endoscopy for GC screening and gastric precancer surveillance might be cost-effective depending on the population and protocol. Focused efforts are especially needed not only to define the optimal approach, but also to define the populations within otherwise low-intermediate regions/countries who might benefit most., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest., (© The Author(s), 2020.)
- Published
- 2020
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91. Acute inflammatory demyelinating polyneuropathy following interruption of antiretroviral treatment and HIV rebound.
- Author
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Malano D, Tiraboschi J, Saumoy M, and Podzamczer D
- Subjects
- Anti-Retroviral Agents therapeutic use, Humans, Anti-HIV Agents adverse effects, Guillain-Barre Syndrome drug therapy, HIV Infections drug therapy
- Published
- 2020
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92. Total and Unbound Bictegravir Concentrations and Viral Suppression in Cerebrospinal Fluid of Human Immunodeficiency Virus-Infected Patients (Spanish HIV/AIDS Research Network, PreEC/RIS 56).
- Author
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Tiraboschi J, Imaz A, Khoo S, Niubo J, Prieto P, Saumoy M, Penchala SD, Garcia B, Padilla C, Videla S, and Podzamczer D
- Subjects
- Adult, Amides, Cross-Sectional Studies, Female, HIV Integrase Inhibitors cerebrospinal fluid, HIV Integrase Inhibitors therapeutic use, HIV-1 drug effects, HIV-1 physiology, Heterocyclic Compounds, 3-Ring, Heterocyclic Compounds, 4 or More Rings cerebrospinal fluid, Heterocyclic Compounds, 4 or More Rings therapeutic use, Humans, Male, Middle Aged, Pilot Projects, Piperazines, Pyridones, Virus Replication drug effects, Young Adult, HIV Infections drug therapy, HIV Integrase Inhibitors pharmacokinetics, Heterocyclic Compounds, 4 or More Rings pharmacokinetics
- Abstract
We determined total and unbound concentrations of bictegravir (BIC) in cerebrospinal fluid (CSF) in 15 asymptomatic, virologically suppressed patients. The median plasma and CSF total BIC concentrations were 1837.1 ng/mL (interquartile range [IQR], 1237.2-2586.7) and 6.9 (IQR, 4.8-10.9), respectively. Median unbound BIC concentration was 2.48 ng/mL (IQR, 1.6-3.7). Total and unbound BIC CSF concentrations were above the half-maximal effective concentration value in all patients, and all subjects had human immunodeficiency virus viral suppression in plasma and CSF. Bictegravir may contribute to inhibit viral replication in this compartment., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
- Published
- 2020
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93. Deep-sequencing reveals broad subtype-specific HCV resistance mutations associated with treatment failure.
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Chen Q, Perales C, Soria ME, García-Cehic D, Gregori J, Rodríguez-Frías F, Buti M, Crespo J, Calleja JL, Tabernero D, Vila M, Lázaro F, Rando-Segura A, Nieto-Aponte L, Llorens-Revull M, Cortese MF, Fernandez-Alonso I, Castellote J, Niubó J, Imaz A, Xiol X, Castells L, Riveiro-Barciela M, Llaneras J, Navarro J, Vargas-Blasco V, Augustin S, Conde I, Rubín Á, Prieto M, Torras X, Margall N, Forns X, Mariño Z, Lens S, Bonacci M, Pérez-Del-Pulgar S, Londoño MC, García-Buey ML, Sanz-Cameno P, Morillas R, Martró E, Saludes V, Masnou-Ridaura H, Salmerón J, Quíles R, Carrión JA, Forné M, Rosinach M, Fernández I, García-Samaniego J, Madejón A, Castillo-Grau P, López-Núñez C, Ferri MJ, Durández R, Sáez-Royuela F, Diago M, Gimeno C, Medina R, Buenestado J, Bernet A, Turnes J, Trigo-Daporta M, Hernández-Guerra M, Delgado-Blanco M, Cañizares A, Arenas JI, Gomez-Alonso MJ, Rodríguez M, Deig E, Olivé G, Río OD, Cabezas J, Quiñones I, Roget M, Montoliu S, García-Costa J, Force L, Blanch S, Miralbés M, López-de-Goicoechea MJ, García-Flores A, Saumoy M, Casanovas T, Baliellas C, Gilabert P, Martin-Cardona A, Roca R, Barenys M, Villaverde J, Salord S, Camps B, Silvan di Yacovo M, Ocaña I, Sauleda S, Bes M, Carbonell J, Vargas-Accarino E, Ruzo SP, Guerrero-Murillo M, Von Massow G, Costafreda MI, López RM, González-Moreno L, Real Y, Acero-Fernández D, Viroles S, Pamplona X, Cairó M, Ocete MD, Macías-Sánchez JF, Estébanez A, Quer JC, Mena-de-Cea Á, Otero A, Castro-Iglesias Á, Suárez F, Vázquez Á, Vieito D, López-Calvo S, Vázquez-Rodríguez P, Martínez-Cerezo FJ, Rodríguez R, Macenlle R, Cachero A, Mereish G, Mora-Moruny C, Fábregas S, Sacristán B, Albillos A, Sánchez-Ruano JJ, Baluja-Pino R, Fernández-Fernández J, González-Portela C, García-Martin C, Sánchez-Antolín G, Andrade RJ, Simón MA, Pascasio JM, Romero-Gómez M, Antonio Del-Campo J, Domingo E, Esteban R, Esteban JI, and Quer J
- Subjects
- Antiviral Agents pharmacology, Cohort Studies, Drug Therapy, Combination, Genotype, Hepatitis C drug therapy, High-Throughput Nucleotide Sequencing, Humans, Spain, Treatment Failure, Antiviral Agents therapeutic use, Drug Resistance, Multiple, Viral genetics, Hepacivirus drug effects, Hepacivirus genetics, Mutation
- Abstract
A percentage of hepatitis C virus (HCV)-infected patients fail direct acting antiviral (DAA)-based treatment regimens, often because of drug resistance-associated substitutions (RAS). The aim of this study was to characterize the resistance profile of a large cohort of patients failing DAA-based treatments, and investigate the relationship between HCV subtype and failure, as an aid to optimizing management of these patients. A new, standardized HCV-RAS testing protocol based on deep sequencing was designed and applied to 220 previously subtyped samples from patients failing DAA treatment, collected in 39 Spanish hospitals. The majority had received DAA-based interferon (IFN) α-free regimens; 79% had failed sofosbuvir-containing therapy. Genomic regions encoding the nonstructural protein (NS) 3, NS5A, and NS5B (DAA target regions) were analyzed using subtype-specific primers. Viral subtype distribution was as follows: genotype (G) 1, 62.7%; G3a, 21.4%; G4d, 12.3%; G2, 1.8%; and mixed infections 1.8%. Overall, 88.6% of patients carried at least 1 RAS, and 19% carried RAS at frequencies below 20% in the mutant spectrum. There were no differences in RAS selection between treatments with and without ribavirin. Regardless of the treatment received, each HCV subtype showed specific types of RAS. Of note, no RAS were detected in the target proteins of 18.6% of patients failing treatment, and 30.4% of patients had RAS in proteins that were not targets of the inhibitors they received. HCV patients failing DAA therapy showed a high diversity of RAS. Ribavirin use did not influence the type or number of RAS at failure. The subtype-specific pattern of RAS emergence underscores the importance of accurate HCV subtyping. The frequency of "extra-target" RAS suggests the need for RAS screening in all three DAA target regions., Competing Interests: Declaration of competing interest We declare that no public or private company has had any role in the study design, data collection, experimental work, data analysis, decision to publish, or preparation of the manuscript. Roche Diagnostics S.L. provided support in the form of a salary for one of the authors [Josep Gregori], but the company did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. No other Competing Interests to declare. Thus, our adherence to Antiviral Research policies on sharing data and materials is not altered., (Copyright © 2019 Elsevier B.V. All rights reserved.)
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- 2020
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94. Correction to: An Approach to Obesity Management for Gastroenterologists and Hepatologists.
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Briscoe J, Saumoy M, and Pickett-Blakely O
- Abstract
The original article unfortunately contained a mistake., (© Springer Science+Business Media, LLC, part of Springer Nature 2020)
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- 2020
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95. Use of a vacuum sponge to expedite healing of a large peripancreatic collection.
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Hajifathalian K, Tafesh ZH, Dawod Q, Saumoy M, Krisko T, Carr-Locke D, and Sharaiha RZ
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- Humans, Vacuum, Surgical Sponges, Wound Healing
- Abstract
Competing Interests: Drs. Carr-Locke and Sharaiha are consultants for Boston Scientific, Olympus, and Medtronic.
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- 2020
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96. An Approach to Obesity Management for Gastroenterologists and Hepatologists.
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Briscoe J, Saumoy M, and Pickett-Blakely O
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Purpose of Review: Obesity is associated with multiple gastrointestinal and liver diseases such as gastroesophageal reflux disease, Barrett's esophagus, esophageal adenocarcinoma, cholelithiasis, colon polyps, and fatty liver disease. To effectively manage obesity, it is imperative to understand current and emerging therapies and procedures., Findings: Obesity is becoming increasingly prevalent and is associated with a growing monetary health care burden. Cardiac disease, cerebrovascular disease, and diabetes are among the leading causes of preventable and premature death of Americans related to obesity. In addition to behavioral modification (diet and exercise) and bariatric surgery, multiple pharmacotherapies and endoscopic procedures are newly approved and available for the management of obesity. This paper reviews the current literature on the treatments available for the management of obesity including behavior modification, pharmacotherapy, endoscopic weight loss procedures (endobariatrics), and bariatric surgery.
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- 2019
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97. POEM in Latin America: The Rise of a New Standard.
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Kahaleh M, Xu MM, Zamarripa F, Martínez G, Arantes VN, Rodriguez FC, Castillo B, Andalib I, Tyberg A, Lambroza A, Saumoy M, Carames JC, Baptista A, Robles-Medranda C, Lukashok H, Gaidhane M, Valencia JMB, Moura ETHD, and Moura EGHD
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- Adolescent, Adult, Aged, Child, Child, Preschool, Cohort Studies, Esophageal Achalasia surgery, Esophageal Sphincter, Lower surgery, Female, Humans, Infant, Latin America epidemiology, Male, Middle Aged, Retrospective Studies, Young Adult, Esophageal Achalasia epidemiology, Natural Orifice Endoscopic Surgery statistics & numerical data
- Abstract
Background: Per-oral endoscopic myotomy (POEM) has become the preferred alternative treatment to standard Heller myotomy for patients with esophageal achalasia, in Latin American countries. The aim of our study was to evaluate the efficacy and safety of a POEM in the management of achalasia with and without Chagas disease in patients receiving POEM., Methods: Patients who underwent POEM from tertiary centers in Latin America were included in a dedicated registry. Countries included Brazil, Colombia, Ecuador, Mexico, Nicaragua, and Venezuela. Patients enrolled needed to have a preoperative manometry and swallow contrast study confirming achalasia. Clinical success was defined as significant improvement in Eckardt score after therapy., Results: POEM was technically successful in 81/89 (91%) patients (mean age, 44 y). There was a significant decrease in preprocedure and postprocedure Eckardt score from 8.7 (range, 3 to 12) to 2.15 (0 to 10) (P<0.001), preprocedure and postprocedure barium swallow evaluation (98% vs. 89%; P=0.017), and preprocedure and postprocedure lower esophageal sphincter pressure measurement (from 35 to 13.8 mm Hg; P<0.001). Clinical success was achieved in 93% of patients. Patients with Chagas disease (n=58) were 9.5 times more likely to respond to POEM (P=0.0020; odds ratio, 9.5)., Conclusions: POEM is an efficacious and safe therapeutic modality for treatment of achalasia in Latin America. Chagas disease-related achalasia seems to particularly respond better to POEM when it is performed by experienced endoscopists.
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- 2019
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98. Efficacy of Endoscopic Interventions for the Management of Obesity: a Meta-analysis to Compare Endoscopic Sleeve Gastroplasty, AspireAssist, and Primary Obesity Surgery Endolumenal.
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Khan Z, Khan MA, Hajifathalian K, Shah S, Abdul M, Saumoy M, Aronne L, Lee W, and Sharaiha RZ
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- Humans, Treatment Outcome, Weight Loss, Bariatric Surgery adverse effects, Bariatric Surgery methods, Bariatric Surgery statistics & numerical data, Endoscopy adverse effects, Endoscopy methods, Endoscopy statistics & numerical data, Gastroplasty adverse effects, Gastroplasty methods, Gastroplasty statistics & numerical data, Obesity surgery
- Abstract
Background and Aims: Novel endoscopic procedures (endoscopic sleeve gastroplasty (ESG), AspireAssist (AA), and primary obesity surgery endolumenal (POSE)) have been developed for treatment of obesity. We aimed to conduct a systematic review and meta-analysis to evaluate and compare the efficacy of these three endoscopic procedures., Methods: Main outcomes of interest were percent excess weight loss (%EWL) and percent total body weight loss (%TBWL). Weighted pooled means (WPMs) were calculated and analyzed using random effects model. Mean differences (MDs) were calculated to compare these procedures., Results: Twelve studies with 1149 patients were included. WPMs for %EWL at 6 and 12 months with ESG were 49.67 (45.67, 53.66) and 52.75 (43.52, 61.98), respectively, while %TBWLs at 6 and 12 months with ESG were 16.01 (15.10, 16.92) and 17.41 (17.08, 17.74), respectively. WPMs for %EWL at 6 and 12 months with POSE were 43.79 (40.17, 47.42) and 44.91 (40.90, 48.92), respectively. WPM for %EWL at 12 months with AA was 50.85 (46.03, 55.68). While comparing ESG and POSE, at 6 months and 12 months, MD for %EWL was 6.17 (1.07, 11.26; P = 0.01) and 7.84 (- 2.05, 17.71; P = 0.06) in favor of ESG. No difference in %EWL was observed while comparing ESG with AA (P = 0.29). Likewise, MD for %EWL to compare AA and POSE was not significant (P = 0.68)., Conclusions: During a follow-up of 6-12 months, both AA and ESG had excellent efficacy in achieving significant and sustained weight loss; however, ESG was found to be superior in terms of weight loss when compared with POSE.
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- 2019
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99. Lack of benefit with omega-3 fatty acid supplementation in HIV patients: A randomized pilot study.
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Navarro-Alcaraz A, Tiraboschi J, Gómez C, Candas-Estébanez B, Saumoy M, Imaz A, and Podzamczer D
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Objective: To assess the effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation on bone metabolism in HIV-infected patients presenting with hypertriglyceridemia. Methods: Patients were randomized 1:1 to receive 2 g of n-3 PUFA or fenofibrate (FF). The primary endpoint was % change in bone mineral density (BMD) from baseline to month 24 in lumbar spine (LS) and femoral neck (FN). Secondary endpoints were changes in Z-score, calcitriol, calcitonin, parathyroid hormone, osteocalcin, and C-terminal telopeptide of type I collagen (CTX-I) at 12 and 24 months. Differences in continuous variables were evaluated using the t test or Mann-Whitney U -test for independent samples and differences in means of intra- and inter-subject continuous variables using a general linear model. Categorical variables were compared by the chi-squared or Fisher's exact test. Results: 30 patients were included in each arm; 23 in the n-3 PUFA arm and 22 in the FF arm completed follow-up. No significant differences between arms were observed after 24 months in either region (FN: -12.51% ± 7.89 in the n-3 PUFA arm and -8.18% ± 7.72 in the FF arm, p = .07; LS: 2.94% ± 6.63 in the n-3 PUFA arm, -3.07% ± 16.85 in the FF arm, p = .07), although the BMD reduction in the FN region after 24 months was noticeable in both arms (n-3 PUFA: -12.51% ± 7.89%, p =< .001; FF: -8.183% ± 7.72%, p =< .001). There was a significant difference in calcitriol changes between arms after 96 weeks. No differences in Z-score or bone turnover markers were observed between the two arms. Conclusions: Omega-3 fatty acid supplementation resulted in no beneficial changes in BMD or bone turnover markers. n-3 PUFA supplementation achieved similar reductions in triglyceride levels as FF.
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- 2019
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100. HIV disease, metabolic dysfunction and atherosclerosis: A three year prospective study.
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Low H, Hoang A, Pushkarsky T, Dubrovsky L, Dewar E, Di Yacovo MS, Mukhamedova N, Cheng L, Downs C, Simon G, Saumoy M, Hill AF, Fitzgerald ML, Nestel P, Dart A, Hoy J, Bukrinsky M, and Sviridov D
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- Adult, Atherosclerosis prevention & control, Female, HIV Infections drug therapy, Humans, Hypoalphalipoproteinemias prevention & control, Male, MicroRNAs blood, Middle Aged, Prospective Studies, Anti-Retroviral Agents administration & dosage, Atherosclerosis blood, HIV Infections blood, HIV-1, Hypoalphalipoproteinemias blood, Lipids blood
- Abstract
HIV infection is known to be associated with cardiometabolic abnormalities; here we investigated the progression and causes of these abnormalities. Three groups of participants were recruited: HIV-negative subjects and two groups of treatment-naïve HIV-positive subjects, one group initiating antiretroviral treatment, the other remaining untreated. Intima-media thickness (cIMT) increased in HIV-positive untreated group compared to HIV-negative group, but treatment mitigated the difference. We found no increase in diabetes-related metabolic markers or in the level of inflammation in any of the groups. Total cholesterol, low density lipoprotein cholesterol and apoB levels were lower in HIV-positive groups, while triglyceride and Lp(a) levels did not differ between the groups. We found a statistically significant negative association between viral load and plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol, apoA-I and apoB. HIV-positive patients had hypoalphalipoproteinemia at baseline, and we found a redistribution of sub-populations of high density lipoprotein (HDL) particles with increased proportion of smaller HDL in HIV-positive untreated patients, which may result from increased levels of plasma cholesteryl ester transfer protein in this group. HDL functionality declined in the HIV-negative and HIV-positive untreated groups, but not in HIV-positive treated group. We also found differences between HIV-positive and negative groups in plasma abundance of several microRNAs involved in lipid metabolism. Our data support a hypothesis that cardiometabolic abnormalities in HIV infection are caused by HIV and that antiretroviral treatment itself does not influence key cardiometabolic parameters, but mitigates those affected by HIV., Competing Interests: The authors have declared that no competing interests exist.
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- 2019
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