Publications by authors named "Sapna Desai"

58 Publications

BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension.

Pulm Circ 2022 Apr 7;12(2):e12063. Epub 2022 Apr 7.

Pulmonology, Greater Los Angeles VA Healthcare System Cardiology Section, and David Geffen UCLA School of Medicine Los Angeles California USA.

Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty-one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six-minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ-ITD]), PAH Symptoms and Impact (PAH-SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug-related serious AEs. Statistically significant improvements occurred in 6MWD, PQ-ITD, and PAH-SYMPACT. Forty-nine patients completed the 3-week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well-tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient-reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739).
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http://dx.doi.org/10.1002/pul2.12063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9063953PMC
April 2022

Preimplant hyponatremia does not predict adverse outcomes in patient with left ventricular assist devices.

Curr Probl Cardiol 2022 May 2:101239. Epub 2022 May 2.

Division of Cardiology, John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, LA; Section of Cardiomyopathy & Heart Transplantation, John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, LA; The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA.

Background: Hyponatremia is a well-established marker of adverse outcomes in chronic heart failure (HF) but not well studied in patients with left ventricular assist device (LVAD).

Methods: This is a retrospective study, single center study of HM3 [Abbott, USA] LVAD implants. We divided our population based on their sodium prior to LVAD implantation - hyponatremia if <135 mEq/L and normal sodium if 135 - 145 mEq/L. We compared postoperative and long-term outcomes.

Results: A total of 195 patients were included, preimplant hyponatremia was present in 40% with a sodium of 132.1±2.1 vs. 137.8±1.9 mEq/L in the normal sodium group. No differences were observed in the postoperative or long-term outcomes.

Conclusion: Preimplant hyponatremia was not associated with mortality or HF admissions, likely due to adequate left ventricular unloading and resolution of the mechanisms that lead to hyponatremia. These results suggest that optimization of mild hyponatremia may not be critical and should not delay LVAD placement.
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http://dx.doi.org/10.1016/j.cpcardiol.2022.101239DOI Listing
May 2022

Matching Intent With Intensity: Implementation Research on the Intensity of Health and Nutrition Programs With Women's Self-Help Groups in India.

Glob Health Sci Pract 2022 Apr 29;10(2). Epub 2022 Apr 29.

Population Council, New Delhi, India.

Introduction: In India, a large network of self-help groups (SHGs) implements interventions to improve women's and children's health and nutrition. There is growing evidence on the effectiveness of women's group interventions to improve health but limited information on implementation intensity, including how often groups meet, for how long, and with whom, despite this often being cited as a key factor for success. We aimed to assess the implementation intensity of large SHG-based health and nutrition interventions with rural, low-income women, to inform program design, delivery, and measurement.

Methods: We synthesized process data from surveys, meeting observations, and process evaluations across 8 maternal and child health and nutrition interventions in India. We examined the implementation intensity of 3 common intervention delivery channels: group meetings, home visits, and community-level activities.

Results: SHG members spent approximately 30 minutes in monthly meetings discussing health or nutrition. SHG dissolution or limited participation in meetings was a common challenge. Beyond group meetings, home visits reached approximately 1 in 3 households with an SHG member. Pregnant and breastfeeding women's participation in community events varied across interventions.

Discussion: Interventions that aim to capitalize on existing networks of financial women's groups not specifically formed for health and nutrition objectives, such as SHGs, will need to have an implementation intensity that matches the ambition of their health objectives: substantial changes in behavioral or mortality outcomes are unlikely to be achieved with relatively light intensity. Interventions that require sustained interactions with members to achieve health outcomes need to ensure adequate community and individual outreach to supplement group meetings, as well as improved participation through more intensive community mobilization approaches. Evaluations of group-based interventions should report on implementation intensity to support the interpretation of evaluation evidence and to inform further scale-up.
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http://dx.doi.org/10.9745/GHSP-D-21-00383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9053147PMC
April 2022

Six-month outcomes in postapproval HeartMate3 patients: A single-center US experience.

J Card Surg 2022 Apr 6. Epub 2022 Apr 6.

Section of Cardiothoracic Surgery, Department of Surgery, Ochsner Clinic Foundation, New Orleans, Louisiana, USA.

Background: The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval.

Methods: This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection.

Results: A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group.

Conclusion: In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
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http://dx.doi.org/10.1111/jocs.16452DOI Listing
April 2022

Is living in a region with high groundwater arsenic contamination associated with adverse reproductive health outcomes? An analysis using nationally representative data from India.

Int J Hyg Environ Health 2022 01 24;239:113883. Epub 2021 Nov 24.

Evidence 4 Global Impact, LLC, New Jersey, 07052, USA.

Background: Exposure to groundwater arsenic via drinking water is common in certain geographies, such as parts of India, and causes a range of negative health effects, potentially including adverse reproductive health outcomes.

Methods: We conducted an ecological analysis of self-reported rates of stillbirth, recurrent pregnancy loss, and infertility in relation to groundwater arsenic levels in India. We used a gridded, modeled dataset of the probability of groundwater arsenic exceeding 10 μg/L (World Health Organization drinking water limit) to calculate mean probabilities at the district level (n = 599 districts). A spatial integration approach was used to merge these estimates with the third India District-Level Health Survey (DLHS-3) conducted in 2007-08 (n = 643,944 women of reproductive age). Maps of district level arsenic levels and rates of each of the three outcomes were created to visualize the patterns across India. To adjust for significant spatial autocorrelation, spatial error models were fit.

Findings: District-level analysis showed that the average level of stillbirth was 4.3%, recurrent pregnancy loss was 3.3%, and infertility was 8.1%. The average district-level probability of groundwater arsenic levels exceeding 10 μg/L was 42%. After adjustment for sociodemographic factors, and accounting for spatial dependence, at the district level, for each percentage point increase in predicted arsenic levels exceeding 10 μg/L increased, the rates of stillbirths was 4.5% higher (95% confidence interval (CI) 2.4-6.6, p < 0.0001), the rates of RPL are 4.2% higher (95% CI 2.5-5.9, p < 0.0001), and the rates of infertility are 4.4% higher (95% CI 1.2-7.7, p=<0.0001).).

Conclusions: While arsenic exposure has been implicated with a range of adverse health outcomes, this is one of the first population-level studies to document an association between arsenic and three adverse reproductive pregnancy outcomes. The high levels of spatial correlation suggest that further and targeted efforts to mitigate arsenic in groundwater are needed.
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http://dx.doi.org/10.1016/j.ijheh.2021.113883DOI Listing
January 2022

Exploring experiences of infertility amongst women and men in low-income and middle-income countries: protocol for a qualitative systematic review.

BMJ Open 2021 11 17;11(11):e050528. Epub 2021 Nov 17.

Population Council, New York, New York, USA.

Introduction: Infertility is increasingly recognised as a global public health issue for women and men that merits further investigation to support policy and programming. While research in high-income settings has examined the consequences of infertility and access to services, there has been limited synthesis of how individuals experience infertility in low-income and middle-income countries (LMICs). This protocol describes a systematic review that will synthesise qualitative evidence on experiences of infertility among women and men in LMICs.

Methods And Analysis: The review will follow the Enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) guidelines for reporting on qualitative evidence syntheses. The study team will search for published literature in PubMed, CINAHL and Scopus and PsycINFO databases and review available grey literature. Using Covidence software, two independent reviewers will conduct title and abstract screening based on inclusion and exclusion criteria, followed by full-text reviews and extraction by a larger team. Quality will be appraised using an adapted version of the Critical Appraisal Skills Programme guidelines. We will conduct thematic synthesis to characterise individual experiences and related factors at the individual, interpersonal, community and health system levels. We will develop a conceptual framework to describe evidence on experiences of infertility in LMICs and to help inform interventions across settings.

Ethics And Dissemination: This protocol has been internally approved as exempt by the Institutional Review Board of the Population Council, as it does not involve contact with human subjects or personally identifying data. Results of the review will be published in a peer-reviewed journal and will be used to inform future infertility research and programming in LMICs.

Prospero Registration Number: CRD42021227742.
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http://dx.doi.org/10.1136/bmjopen-2021-050528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8601060PMC
November 2021

Feasibility and Safety of Coronary Angiography via Radial Approach in Cardiac Transplant Recipients: A Single Center Experience.

Curr Probl Cardiol 2021 Jul 24:100935. Epub 2021 Jul 24.

John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA; The University of Queensland Ochsner Clinical School, Faculty of Medicine, The University of Queensland, New Orleans, LA. Electronic address:

Coronary angiography remains the gold standard post-transplant screening test for cardiac allograft vasculopathy. This procedure has traditionally been performed via femoral approach. Data on safety and efficacy of radial approach in cardiac transplant patients remains scarce. Single center retrospective study including all cardiac transplant patients who underwent coronary angiography via transradial approach (TRA) or transfemoral approach (TFA). Safety and efficacy outcomes were compared between the 2 groups. Primary end points included major bleeding, vascular complications, crossover to femoral approach, contrast use and radiation exposure. A total of 201 patients were included. 96 patients (47.8%) underwent angiography via TRA. At baseline, no significant differences with regards to age, gender, or traditional risk factors such as HTN, DM, hyperlipidemia were noted between the 2 groups. Most patients underwent intravascular ultrasound (n = 179, 89%) with no statistically significant differences between the 2 groups (TRA: 90.6% vs TFA: 87.6%, P = 0.5). Additionally, there were no statistically significant differences in radiation exposure, amount of contrast use and fluoroscopy time between the 2 groups. Although there were trends toward increased bleeding among TFA group, these were not statistically significant and were mostly driven by access site hematomas. Use of TRA increased over time and Conversion from TRA to TFA was low (n = 4, 4.2%). Coronary angiography via the radial approach in cardiac transplant recipients is feasible, safe and is associated with low a risk of bleeding with no significant increase in radiation exposure when compared to the traditional femoral approach.
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http://dx.doi.org/10.1016/j.cpcardiol.2021.100935DOI Listing
July 2021

Triple Antithrombotic Therapy in Patients With Left Ventricular Assist Devices.

Curr Probl Cardiol 2021 Jul 24:100940. Epub 2021 Jul 24.

Section of Cardiomyopathy & Heart Transplantation, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA; The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, LA.

Data on the efficacy and safety of the combination of warfarin and dual-antiplatelet therapy compared with warfarin and mono-antiplatelet therapy (MAPT) in patients with left ventricular assist devices (LVAD) remains scarce. Single-center study of 130 consecutive patients with durable LVAD. Baseline demographics, antithrombotic and antiplatelet regimen, and outcomes were compared between patients receiving warfarin plus dual-antiplatelet therapy (Group 1) and warfarin plus MAPT (Group 2). Antiplatelet therapy was assessed at hospital discharge post-LVAD implant and included aspirin, clopidogrel and dipyridamole. Outcomes at 1-year were assessed in each group. All patients were on aspirin and warfarin. No significant differences with regards to age, gender or ethnicity were noted at baseline between the two groups. Group 1 was more likely to have higher lactate dehydrogenase LDH levels at discharge and a history of stroke. No significant differences in international normalized ratio INR, hemoglobin or hematocrit were noted at discharge. During the study period, 48 patients had gastrointestinal bleeding events: 28 of 68 (41.2%) in Group 1 vs 20 of 62 (32.2%) in Group 2 (P = 0.293). At 1year, no statistically significant differences were noted in gastrointestinal bleeding (Group 1=27.90% vs Group 2 = 25.80, P = 0.784), ischemic stroke (Group 1 = 8.8% vs group 2 = 6.5%, P = 0.612), hemorrhagic stroke (Group 1 = 4.4% vs group 2 = 3.2%, P = 0.725) or mortality (Group 1 = 5.9% vs Group 2 = 1.6%, P = 0.206). Rates of pump thrombosis however were lower in Group 1 (Group 1 = 0% vs Group 2 = 6.5%, P = 0.033). Our study showed a high prevalence of triple-therapy antithrombotic use in LVAD patients with no significant differences in bleeding, stroke or survival. However, the risk for pump thrombosis was lower at 1-year when compared to patient receiving MAPT.
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http://dx.doi.org/10.1016/j.cpcardiol.2021.100940DOI Listing
July 2021

Use of TandemHeart as Bridge to Recovery for Antibody-Mediated Rejection in a Heart Transplant Patient.

JACC Case Rep 2020 Dec 16;2(15):2358-2362. Epub 2020 Dec 16.

Section of Cardiomyopathy and Heart Transplantation, Division of Cardiology, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, The University of Queensland School of Medicine, New Orleans, Louisiana, USA.

Antibody-mediated rejection is a major cause of graft failure, mortality, and morbidity among cardiac transplant recipients. We present the first reported case of TandemHeart (LivaNova, Pittsburgh, Pennsylvania) used in the management of antibody-mediated rejection associated with cardiogenic shock. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.11.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8305082PMC
December 2020

Effects of integrated economic and health interventions with women's groups on health-related knowledge, behaviours and outcomes in low-income and middle-income countries: a systematic review protocol.

BMJ Open 2021 07 12;11(7):e046856. Epub 2021 Jul 12.

Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA

Introduction: Economic groups, such as microfinance or self-help groups are widely implemented in low-income and middle-income countries (LMICs). Women's groups are voluntary groups, which aim to improve the well-being of members through activities, such as joint savings, credit, livelihoods development and/or health activities. Health interventions are increasingly added on to existing women's economic groups as a public health intervention for women and their families. Here, we present the protocol for a mixed-methods systematic review we will conduct of the evidence on integrated economic and health interventions on women's groups to assess whether and how they improve health-related knowledge, behaviour and outcomes in LMICs.

Methods And Analysis: We will search seven electronic databases for published literature, along with manual searches and consultation. The review will include (1) randomised trials and non-randomised quasiexperimental studies of intervention effects of integrated economic and health interventions delivered through women's groups in LMICs, and (2) sibling studies that examine factors related to intervention content, context, implementation processes and costs. We will appraise risk of bias and study quality using standard tools. High and moderate quality studies will be grouped by health domain and synthesised without meta-analysis. Qualitative evidence will be thematically synthesised and integrated into the quantitative synthesis using a matrix approach.

Ethics And Dissemination: This protocol was reviewed and deemed exempt by the institutional review board at the American Institutes for Research. Findings will be shared through peer-reviewed publication and disseminated with programme implementers and policymakers engaged with women's groups.

Prospero Registration Number: CRD42020199998.
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http://dx.doi.org/10.1136/bmjopen-2020-046856DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276287PMC
July 2021

Rabbit Antithymocyte Globulin Induction in Heart Transplant Recipients at High Risk for Rejection.

Ochsner J 2021 ;21(2):133-138

Section of Cardiomyopathy and Heart Transplantation, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA.

Induction with lymphocyte-depleting antibodies may improve allograft outcomes in heart transplant recipients who are at high immunologic risk for rejection. We conducted a single-center retrospective cohort study that compared outcomes between adult patients receiving rabbit antithymocyte globulin (rATG) induction vs no induction from 2011 through 2017. Key exclusion criteria were patients who did not receive tacrolimus and mycophenolate and patients who did not meet high immunologic risk criteria. A total of 50 patients were included in the analysis. At 1 year, the composite primary outcome of ≥2R rejection as defined by the International Society for Heart and Lung Transplantation, any treated rejection, development of cardiac allograft vasculopathy, or graft loss was not different between groups (=0.474). Serious infections were also similar between groups (=0.963). In accordance with institutional guidelines, prednisone exposure was decreased in the rATG induction group at 1 month (24.04 mg ± 13.74 vs 35.18 mg ± 16.95; =0.014). These results suggest that while rATG induction does not improve heart allograft outcomes, it may enable reducing early corticosteroid exposure in patients at high immunologic risk.
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http://dx.doi.org/10.31486/toj.20.0024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238107PMC
January 2021

Gender inequities in treatment-seeking for sexual and reproductive health amongst adolescents: Findings from a cross-sectional survey in India.

SSM Popul Health 2021 Jun 2;14:100777. Epub 2021 Apr 2.

Population Council, New Delhi, India.

Context: India's adolescent health policy aims to improve sexual and reproductive health, especially amongst the most vulnerable. There is limited evidence on how gender influences treatment-seeking patterns amongst unmarried adolescents.

Methods: We analyzed data from 11,651 unmarried adolescent boys and girls aged 15-19 from a cross-sectional survey conducted in two large states of India. We conducted sex-disaggregated analyses to estimate the prevalence of symptoms of genital infections and compare treatment-seeking patterns. We identified correlates through multivariable regression and used a conceptual framework to explore structural, household, social and individual factors that influence gender inequities in adolescent sexual and reproductive health.

Results: One in five unmarried adolescents reported symptoms of genital infections, such as burning or discharge, in the past three months. Factors associated with reporting symptoms varied between boys and girls, except for a common correlation with symptoms of depression. At least two-thirds of boys sought treatment, compared to approximately one in four girls (rural: 66.2% boys, 23.1% girls; urban: 69.4% boys, 30.7% girls). Boys primarily sought care from medical shops or private facilities, while girls used both private and government services. Amongst boys, having friends and being in school was associated with seeking treatment (aOR: 11.47; 95% CI: 2.75, 47.87; aOR: 1.95; 95% CI: 1.24, 3.07, respectively). Odds of seeking treatment were higher amongst girls with exposure to any mass media (aOR: 1.93; 95% CI: 1.25, 2.99) and who had discussed puberty with a parent (aOR: 1.98; 95% CI: 1.32, 2.98).

Conclusion: Stark sex differentials in factors associated with symptoms and in treatment-seeking illustrate how structural gender inequities, such as access to economic resources and education, influence sexual and reproductive health amongst adolescents. Along with health system interventions, addressing gender inequities calls for strategies to strengthen parental engagement, social support and girls' access to resources.
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http://dx.doi.org/10.1016/j.ssmph.2021.100777DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8095180PMC
June 2021

Ruptured hemorrhagic bulla in a patient with a HeartMate 3 treated with an Amplatzer device.

Arch Cardiol Mex 2021 Mar 24. Epub 2021 Mar 24.

Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, LA, USA; Ochsner Clinical School, Faculty of Medicine, The University of Queensland, New Orleans, LA, USA.

A 60-year-old female with underlying emphysema and left ventricular assist device (LVAD) HeartMate 3 presented with progressive hemoptysis, dyspnea, and right chest pain. Baseline hemoglobin was 11.1 g/dL and INR 2.9.
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http://dx.doi.org/10.24875/ACM.20000331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351646PMC
March 2021

Survival Benefit of Aspirin in Patients With Congestive Heart Failure: A Meta-Analysis.

J Clin Med Res 2021 Jan 12;13(1):38-47. Epub 2021 Jan 12.

Louisiana State University Health Sciences Center - Center for Cardiovascular Diseases and Sciences, Shreveport, LA, USA.

Background: There is no clear consensus on the use of aspirin (ASA) in patients with congestive heart failure (CHF) due to its reported interaction with other cardio-prudent medications. The aim was to evaluate the effect of ASA on all-cause mortality and the frequency of hospitalization for heart failure in patients with CHF using meta-analysis, as well as to study the potential variables interacting with this effect.

Methods: Eligible studies were identified via a PubMed search, the "related article" feature and a manual search of references. Studies were included if they had a study population with CHF of any etiology, compared ASA to no ASA or placebo, and reported one or both of the following outcomes: 1) all-cause mortality and 2) the frequency of hospitalization for heart failure. Data were extracted and verified. We used the inverse variance method in a random-effects model to combine effect sizes.

Results: A total of 14 studies with a combined study population of 64,550 patients were included in the final analysis. All-cause mortality was found to be significantly lower in patients who were taking ASA (P = 0.003). When examining the use of ASA, no significant difference was found in the frequency of hospitalization for heart failure. ASA use was demonstrated to be more beneficial against mortality in studies with a larger percentage of patients on nitrates (P = 0.008) and oral anticoagulants (P = 0.04). A significantly lower rate of hospitalization for heart failure was observed in patients who used oral anticoagulants and ASA concurrently (P = 0.02).

Conclusions: ASA may have beneficial effects on mortality in patients with heart failure of all etiologies.
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http://dx.doi.org/10.14740/jocmr4389DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7869561PMC
January 2021

Community interventions with women's groups to improve women's and children's health in India: a mixed-methods systematic review of effects, enablers and barriers.

BMJ Glob Health 2020 12;5(12)

University College London Institute of Child Health, London, UK.

Introduction: India is home to over 6 million women's groups, including self-help groups. There has been no evidence synthesis on whether and how such groups improve women's and children's health.

Methods: We did a mixed-methods systematic review of quantitative and qualitative studies on women's groups in India to examine effects on women and children's health and to identify enablers and barriers to achieving outcomes. We searched 10 databases and included studies published in English from 2000 to 2019 measuring health knowledge, behaviours or outcomes. Our study population included adult women and children under 5 years. We appraised studies using standard risk of bias assessments. We compared intervention effects by level of community participation, scope of capability strengthening (individual, group or community), type of women's group and social and behaviour change techniques employed. We synthesised quantitative and qualitative studies to identify barriers and enablers related to context, intervention design and implementation, and outcome characteristics.

Findings: We screened 21 380 studies and included 99: 19 randomised controlled trial reports, 25 quasi-experimental study reports and 55 non-experimental studies (27 quantitative and 28 qualitative). Experimental studies provided moderate-quality evidence that health interventions with women's groups can improve perinatal practices, neonatal survival, immunisation rates and women's and children's dietary diversity, and help control vector-borne diseases. Evidence of positive effects was strongest for community mobilisation interventions that built communities' capabilities and went beyond sharing information. Key enablers were inclusion of vulnerable community members, outcomes that could be reasonably expected to change through community interventions and intensity proportionate to ambition. Barriers included limited time or focus on health, outcomes not relevant to group members and health system constraints.

Conclusion: Interventions with women's groups can improve women's and children's health in India. The most effective interventions go beyond using groups to disseminate health information and seek to build communities' capabilities.

Trial Registration Number: The review was registered with PROSPERO: CRD42019130633.
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http://dx.doi.org/10.1136/bmjgh-2020-003304DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745316PMC
December 2020

Classroom, club or collective? Three types of community-based group intervention and why they matter for health.

BMJ Glob Health 2020 12;5(12)

Institute for Global Health, Department of Population Health Sciences, University College London, London, UK.

Interventions involving groups of laywomen, men and adolescents to promote health are increasingly popular, but past research has rarely distinguished between different types of intervention with groups. We introduce a simple typology that distinguishes three ideal types: and Classrooms treat groups as a platform for reaching a population with didactic behaviour change strategies. Clubs seek to build, strengthen and leverage relationships between group members to promote health. Collectives engage whole communities in assuming ownership over a health problem and taking action to address it. We argue that this distinction goes a long way towards explaining differences in achievable health outcomes using interventions with groups. First, classrooms and clubs are appropriate when policymakers primarily care about improving the health of group members, but collectives are better placed to achieve population-level impact. Second, classroom interventions implicitly assume bottleneck behaviours preventing a health outcome from being achieved can be reliably identified by experts, whereas collectives make use of local knowledge, skill and creativity to tackle complexity. Third, classroom interventions assume individual participants can address health issues largely on their own, while clubs and collectives are required to engender collective action in support of health. We invite public health researchers and policymakers to use our framework to align their own and communities' ambitions with appropriate group-based interventions to test and implement for their context. We caution that our typology is meant to apply to groups of laypeople rather than professionalised groups such as whole civil society organisations.
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http://dx.doi.org/10.1136/bmjgh-2020-003302DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745328PMC
December 2020

Laparoscopic sleeve gastrectomy in obese patients with ventricular assist devices: a data note.

BMC Res Notes 2020 Sep 17;13(1):439. Epub 2020 Sep 17.

The John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA, USA.

Objectives: Patients with end-stage heart failure (ESHF) treated with ventricular assist devices (VADs) tend to gain weight after implantation, which is associated with higher complication rates and is a contraindication for heart transplantation (HT). The objective was to analyze the outcomes of obese patients with ESHF and VADs who underwent laparoscopic sleeve gastrectomy (LSG) at Ochsner Medical Center in New Orleans, which is the only program performing VADs and HT in the State of Louisiana, and also one of the largest VAD centers in the USA.

Data Description: This dataset contains detailed baseline, perioperative, and long-term data of patients with VADs undergoing LSG. These variables were collected retrospectively from electronic medical records. Patients who achieved ≥ 50% excess BMI loss, BMI ≤ 35 kg/m, listing for HT, HT, or myocardial recovery were identified and the timing to each of these milestones was documented. These data can be used alone or in combination with other datasets to achieve a larger sample size with more power for further analysis of these variables, which include the most important, standard, and objective bariatric and ESHF outcomes of patients with VADs undergoing LSG. Elaboration of composite outcomes is feasible.
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http://dx.doi.org/10.1186/s13104-020-05272-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496210PMC
September 2020

Laparoscopic Sleeve Gastrectomy in Patients with Obesity and Ventricular Assist Devices: a Comprehensive Outcome Analysis.

Obes Surg 2021 02 25;31(2):884-890. Epub 2020 Aug 25.

John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation, New Orleans, LA, USA.

We analyzed in detail the outcomes of eight patients with ventricular assist devices (VADs) and obesity who underwent laparoscopic sleeve gastrectomy (LSG) at a single heart transplant (HT) center. This comprehensive analysis included body mass index (BMI) trends from VAD implantation to the time of LSG; BMI and percentage of excess BMI lost during follow-up; adverse outcomes; and changes in echocardiographic parameters, fasting lipids, unplanned hospitalizations, and functional status. We also identified the patients who achieved the following outcomes: listing for HT, HT, 50% excess BMI loss, and BMI < 35 kg/m. Laparoscopic sleeve gastrectomy seems to be a reasonable and effective intervention to help patients with VADs and obesity to decrease excess BMI and become candidates for HT.
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http://dx.doi.org/10.1007/s11695-020-04948-9DOI Listing
February 2021

Services for women's sexual and reproductive health in India: an analysis of treatment-seeking for symptoms of reproductive tract infections in a nationally representative survey.

BMC Womens Health 2020 07 28;20(1):156. Epub 2020 Jul 28.

Population Council, Zone 5A, Habitat Centre, New Delhi, India.

Background: Women's health policy in India has had a longstanding focus on maternal health and family planning. Recent policy highlights the importance of expanding women's access to a broader range of sexual and reproductive health services. However, there has been very limited analysis of national survey data to examine the current status of treatment utilisation, variation across states and progress over time.

Methods: This paper examines women's treatment patterns for reproductive tract infections in India, based on data collected in the National Family Health Survey, a cross-sectional, nationally representative household survey conducted between 2015-16. The survey covered 699,686 women between the ages 15 and 49, of which 91,818 ever sexually active women responded to questions related to symptoms of reproductive tract infections. We estimate prevalence of reported symptoms and treatment-seeking, describe regional variation and utilise multivariable logistic regression to identify factors associated with women's treatment-seeking patterns.

Results: Thirty-nine percent of women who reported symptoms of reproductive tract infections sought any advice or treatment. Women's reported treatment-seeking in India has not changed since the last national survey a decade earlier. Reported symptoms and treatment-seeking varied widely across India, ranging from 64% in Punjab to 8% in Nagaland, with no clear regional pattern that emerged. Seventeen percent of symptomatic women sought services in the public sector, an improvement from 11% in 2005-06. Twenty-two percent utilised the private sector, with wide variation by states. National-level multivariable logistic regression indicated that treatment-seeking was associated with age, higher education, higher household wealth and having been employed in the past year. Women in the 25-35 age group had higher odds (aOR1.27; 95% CI: 1.10,1.50) of seeking treatment compared to both younger (15-19 years) and older (35 years and above) women, along with women with more than eight years of schooling (aOR: 1.23; 95% CI: 1.05,1.44) and from richer wealth quintiles (aOR: 1.53; 95% CI: 1.35,1.83).

Conclusion: Women's use of services for reproductive tract infections remains a challenge in most parts of India. Our findings highlight the need to address barriers to seeking care and to improve measurement of gynaecological ailments in national surveys.
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http://dx.doi.org/10.1186/s12905-020-01024-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388457PMC
July 2020

Characterization and Management of Inflammatory Eye Disease in Patients with Hidradenitis Suppurativa.

Ocul Immunol Inflamm 2021 Nov 7;29(7-8):1318-1323. Epub 2020 Apr 7.

Department of Ophthalmology & Visual Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

: To assess the spectrum and treatment outcomes of inflammatory eye disease (IED) in subjects with hidradenitis suppurativa (HS).: We conducted a single center retrospective chart review of 236 patients with HS seen for ophthalmic examination between 2013 and 2018.: Of 236 subjects with HS, 22 subjects (9.3%) were found to have IED. Seven of 22 subjects had more than one IED diagnosis. Anterior uveitis was the most common type of IED (40.9% of subjects with IED). Episcleritis, optic neuritis, keratitis, scleritis, intermediate and posterior uveitis, trochleitis, and dacryoadenitis were also observed. Of subjects with HS and IED, 59.1% did not have any other inflammatory or autoimmune disease that could explain the etiology of their IED. Eleven patients with IED were treated with systemic immunosuppression, with IED as the principal factor directing treatment in three patients.: IED may be independently associated with HS and may benefit from systemic immunosuppression.
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http://dx.doi.org/10.1080/09273948.2020.1739718DOI Listing
November 2021

Author Correction: G Protein-Coupling of Adhesion GPCRs ADGRE2/EMR2 and ADGRE5/CD97, and Activation of G Protein Signalling by an Anti-EMR2 Antibody.

Sci Rep 2020 Mar 17;10(1):5097. Epub 2020 Mar 17.

Medicinal Science and Technology, GlaxoSmithKline, Stevenage, UK.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41598-020-62011-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078178PMC
March 2020

G Protein-Coupling of Adhesion GPCRs ADGRE2/EMR2 and ADGRE5/CD97, and Activation of G Protein Signalling by an Anti-EMR2 Antibody.

Sci Rep 2020 01 22;10(1):1004. Epub 2020 Jan 22.

Medicinal Science and Technology, GlaxoSmithKline, Stevenage, UK.

The experimental evidence that Adhesion G Protein-Coupled Receptors (aGPCRs) functionally couple to heterotrimeric G proteins has been emerging in incremental steps, but attributing biological significance to their G protein signalling function still presents a major challenge. Here, utilising activated truncated forms of the receptors, we show that ADGRE2/EMR2 and ADGRE5/CD97 are G protein-coupled in a variety of recombinant systems. In a yeast-based assay, where heterologous GPCRs are coupled to chimeric G proteins, EMR2 showed broad G protein-coupling, whereas CD97 coupled more specifically to G, G, G and G chimeras. Both receptors induced pertussis-toxin (PTX) insensitive inhibition of cyclic AMP (cAMP) levels in mammalian cells, suggesting coupling to G. EMR2 was shown to signal via G, and via a G/G chimera, to stimulate IP accumulation. Finally, using an NFAT reporter assay, we identified a polyclonal antibody that activates EMR2 G protein signalling in vitro. Our results highlight the potential for the development of soluble agonists to understand further the biological effects and therapeutic opportunities for ADGRE receptor-mediated G protein signalling.
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http://dx.doi.org/10.1038/s41598-020-57989-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976652PMC
January 2020

Metachronous vulvar ectopic breast cancer, a case report and literature review.

Gynecol Oncol Rep 2019 Nov 16;30:100515. Epub 2019 Nov 16.

Department of Obstetrics and Gynecology, Danbury Hospital, Western Connecticut Health Network Danbury, CT, USA.

•When two or more primary tumors arise at the same time, they are considered synchronous.•A metachronous tumor in a new primary that develops after an initial cancer diagnosis.•The diagnosis of vulvar breast cancer is primarily histopathologic, based on morphology and immunostaining.•Identifying a cancer as a metastasis versus as synchronous/metachronous significantly impacts staging and treatment.
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http://dx.doi.org/10.1016/j.gore.2019.100515DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6890968PMC
November 2019

MrgX2 is a promiscuous receptor for basic peptides causing mast cell pseudo-allergic and anaphylactoid reactions.

Pharmacol Res Perspect 2019 12 2;7(6):e00547. Epub 2019 Dec 2.

Medicines Research Centre GlaxoSmithKline R&D Ltd Stevenage United Kingdom.

Activation of MrgX2, an orphan G protein-coupled receptor expressed on mast cells, leads to degranulation and histamine release. Human MrgX2 binds promiscuously to structurally diverse peptides and small molecules that tend to have basic properties (basic secretagogues), resulting in acute histamine-like adverse drug reactions of injected therapeutic agents. We set out to identify MrgX2 orthologues from other mammalian species used in nonclinical stages of drug development. Previously, the only known orthologue of human MrgX2 was from mouse, encoded by . MrgX2 genes of rat, dog (beagle), minipig, pig, and Rhesus and cynomolgus monkey were identified by bioinformatic approaches and verified by their ability to mediate calcium mobilization in transfected cells in response to the classical MrgX2 agonist, compound 48/80. The peptide GSK3212448 is an inhibitor of the PRC2 epigenetic regulator that caused profound anaphylactoid reactions upon intravenous infusion to rat. We showed GSK3212448 to be a potent MrgX2 agonist particularly at rat MrgX2. We screened sets of drug-like molecules and peptides to confirm the highly promiscuous nature of MrgX2. Approximately 20% of drug-like molecules activated MrgX2 (pEC ranging from 4.5 to 6), with the principle determinant being basicity. All peptides tested of net charge +3 or greater exhibited agonist activity, including the cell penetrating peptides polyarginine (acetyl-Arg-amide) and TAT (49-60), a fragment of HIV-1 TAT protein. Finally, we showed that the glycopeptide antibiotic vancomycin, which is associated with clinical pseudo-allergic reactions known as red man syndrome, is an agonist of MrgX2.
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http://dx.doi.org/10.1002/prp2.547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887720PMC
December 2019

Use of the Heartmate 3 for biventricular support as a bridge to heart transplant-first US implant.

J Card Surg 2019 Dec 14;34(12):1629-1631. Epub 2019 Oct 14.

Section of Cardiothoracic Surgery, Ochsner Clinic Foundation, New Orleans, Louisiana.

Right ventricular failure continues to be the Achilles heel in the management of heart failure patients. Traditionally, either high doses of inotropes and inhaled nitric oxide or jerry-rigged temporary mechanical devices have been used to support failing right ventricles. No durable implantable right ventricular assist device has been developed to address this long-standing concern. Because of this vacuum of innovation, surgeons have started using the third-generation LVADs to support the right ventricle. The HeartMate 3 (Abbott) LVAD is a safe and effective therapy for the management of biventricular failure.
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http://dx.doi.org/10.1111/jocs.14290DOI Listing
December 2019

Right Heart Failure in Different Left Ventricular Assist Devices: Single-Center Experience.

Ochsner J 2019 ;19(3):194-198

Department of Cardiothoracic Surgery, University of Iowa Health Care, Iowa City, IA.

Right heart failure (RHF) following left ventricular assist device (LVAD) implantation increases morbidity and mortality for those who develop this complication. The purpose of this study was to assess the differences in incidence of RHF and outcomes between 2 types of continuous-flow LVADs at a single center. From January 2012 through June 2016, 184 patients were implanted with a continuous-flow LVAD (161 patients with the HeartMate II and 23 patients with the HeartWare device) either as a bridge to transplant or as destination therapy. Preoperative demographics, medical history, laboratory values, hemodynamics, and device type were analyzed to determine the variables associated with RHF and mortality. Preoperative variables between the 2 groups were homogeneous. Most patients were Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (92%) and New York Heart Association class IV (81%). More patients in the HeartMate II group had the indication of destination therapy (54% vs 30%), while more patients in the HeartWare group were implanted as bridge to transplant (70% vs 46%). RHF occurred in 57% of HeartWare patients compared to 16% of patients who received the HeartMate II (=0.0001). After propensity score analysis, patients receiving the HeartWare device had increased odds for RHF (=0.0013) and renal failure requiring dialysis (=0.0135). The HeartMate II patient survival rate exceeded the HeartWare patient survival rate at 1 year (82.1% vs 67.2%) and at 2 years (74.6% vs 61.7%), but this difference did not achieve statistical significance (log-rank =0.087). These results indicate that device type may affect RHF incidence and mortality. Studies at other centers are needed to replicate these findings.
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http://dx.doi.org/10.31486/toj.19.0025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6735599PMC
January 2019

First pediatric HeartMate 3 implantation: US experience.

J Card Surg 2019 Nov 17;34(11):1383-1386. Epub 2019 Aug 17.

Section of Heart Failure, Ochsner Clinic Foundation, New Orleans, Louisiana.

Children with heart failure have few mechanical circulatory support options and have a high incidence of embolic events. The favorable hemocompatibility and smaller profile of HeartMate 3 may provide more long-term options for the pediatric population.
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http://dx.doi.org/10.1111/jocs.14216DOI Listing
November 2019

Morpholine Based Diazenyl Chalcones: Synthesis, Antimicrobial Screening and Cytotoxicity Study.

Anticancer Agents Med Chem 2018 ;18(15):2193-2205

Department of Pharmaceutical Sciences, M.D University, Rohtak, Haryana 124001, India.

Background: Microbial infections have been the major cause of morbidity and mortality for the centuries and continue to present the formidable challenge to the human health. Several studies have been performed to explore the antimicrobial potential of various synthesized chalcone derivatives. The morpholine derivatives are also gaining considerable importance due to diverse biological activities. Hybridization of morpholine and chalcone moiety together can be the useful approach for the development of new effective antimicrobial agents.

Methods: A new series of morpholine based heterocyclic diazenyl chalcones (MD1-MD21) was synthesized, characterized and evaluated for antimicrobial potential by tube dilution and agar diffusion methods. The most active derivatives were also evaluated for cytotoxicity towards mouse fibroblast cell line (L929) and the human lung cancer cell line (A549) and for haemolysis to check the toxicity on human red blood cells.

Results: MD-6 was found highly active against different microbial strains, particularly and having the MIC in the range of 1.95 µg/ml to 3.91 µg/ml. MD-9 and MD-21 were also found to have good antimicrobial activity. The most active diazenyl derivatives exhibited very low cytotoxicity towards L929 cell line (IC ranges from 360 µg/ml - 902.3 µg/ml) and A549 cell line (IC ranges from 35.42 µg/ml - 216.4 µg/ml) as compared to the standard drug 5-FU (IC ranges from 1 µg/ml - 2 μg/ml) against these cell lines. The active derivatives showed haemolysis of 10-15% up to 150 µg/ml concentration.

Conclusion: MD-6, MD-9 and MD-21 were found to be most active antimicrobial agents. These derivatives demonstrated high safety profile by exhibiting very low cytotoxicity and also revealed their safety for human blood cells with haemolysis of 0.2-5.5% at their antimicrobial concentration.
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http://dx.doi.org/10.2174/1871520618666180830152701DOI Listing
August 2019

Sexual and reproductive health and rights for all: translating the Guttmacher-Lancet Commission's global report to local action.

Reprod Health Matters 2018 12;26(52):1487621

a Associate Editor, Reproductive Health Matters.

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http://dx.doi.org/10.1080/09688080.2018.1487621DOI Listing
December 2018
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