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Women's groups are a widely implemented and researched development intervention, particularly in South Asia and Africa. Groups encompass many models and aim to address a range of objectives. However, there is no consistent approach to describing their varied implementation models, which hinders the accurate interpretation of evidence and construct validity. Drawing from three recent evidence reviews and research experience with groups, we propose a typology and common reporting indicators to describe women's groups. As large-scale investments in women's groups grow, these tools can support the interpretation and transferability of evidence across models and settings. [ABSTRACT FROM AUTHOR]

Purpose: To assess the spectrum and treatment outcomes of inflammatory eye disease (IED) in subjects with hidradenitis suppurativa (HS). Methods: We conducted a single center retrospective chart review of 236 patients with HS seen for ophthalmic examination between 2013 and 2018. Results: 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. Conclusions: IED may be independently associated with HS and may benefit from systemic immunosuppression. [ABSTRACT FROM AUTHOR]

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 Mrgprb2. 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 (pEC50 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-Arg9-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. [ABSTRACT FROM AUTHOR]

Hysterectomy appears to be on the rise amongst low-income, rural women in India as routine treatment for gynaecological ailments. This paper explores the individual, household, socio-economic and health system factors that influenced women's decisions to undergo hysterectomy in rural Gujarat, with a focus on women's perspectives. Interviews were conducted with 35 rural, low-income women who had undergone hysterectomy, local gynaecologists and other key informants, alongside observation of daily life and health-related activities. Inductive, open coding was conducted within a framework analysis to identify thematic influences on the decision to undergo hysterectomy. Women underwent hysterectomy at an average age of 36, as treatment for typically severe gynaecological ailments. I argue that women, faced with embedded social inequality in the form of gender biases, lack of labour security and a maternal-centric health system, demonstrated pragmatic agency in their decision to remove the uterus. When they experienced gynaecological ailments, most sought two to three opinions and negotiated financial and logistical concerns. The health system offered few non-invasive services for non-maternal health issues. Moreover, women and health care providers believed there is limited utility of the uterus beyond childbearing. Women's responsibilities as caretakers, workers and producers drove them to seek permanent solutions that would secure their long-term work and health security. Thus, hysterectomy emerged as a normalised treatment for gynaecological ailments, particularly for low-income women with limited resources or awareness of potential side effects. In this setting, hysterectomy reflects the power structures and social inequalities in which women negotiated medical treatment – and the need to reverse a culture of permanent solutions for low-income women. [ABSTRACT FROM AUTHOR]

Background: Community-based health insurance has been associated with increased hospitalisation in low-income settings, but with limited analysis of the illnesses for which claims are submitted. A review of claims submitted to VimoSEWA, an inpatient insurance scheme in Gujarat, India, found that fever, diarrhoea and hysterectomy, the latter at a mean age of 37 years, were the leading reasons for claims by adult women. We compared the morbidity, outpatient treatment-seeking and hospitalisation patterns of VimoSEWA-insured women with uninsured women. Methods: We utilised data from a cross-sectional survey of 1,934 insured and uninsured women in Gujarat, India. Multivariable logistic regression identified predictors of insurance coverage and the association of insurance with hospitalisation. Self-reported data on morbidity, outpatient care and hospitalisation were compared between insured and uninsured women. Results: Age, marital status and occupation of adult women were associated with insurance status. Reported recent morbidity, type of illness and outpatient treatment were similar among insured and uninsured women. Multivariable analysis revealed strong evidence of a higher odds of hospitalisation amongst the insured (OR = 2.7; 95% ci. 1.6, 4.7). The leading reason for hospitalisation for uninsured and insured women was hysterectomy, at a similar mean age of 36, followed by common ailments such as fever and diarrhoea. Insured women appeared to have a higher probability of being hospitalised than uninsured women for all causes, rather than specifically for fever, diarrhoea or hysterectomy. Length of stay was similar while choice of hospital differed between insured and uninsured women. Conclusions: Despite similar reported morbidity patterns and initial treatment-seeking behaviour, VimoSEWA members were more likely to be hospitalised. The data did not provide strong evidence that inpatient hospitalisation replaced outpatient treatment for common illnesses or that insurance was the primary inducement for hysterectomy in the population. Rather, it appears that VimoSEWA members behaved differently in deciding if, and where, to be hospitalised for any condition. Further research is required to explore this decision-making process and roles, if any, played by adverse selection and moral hazard. Lastly, these hospitalisation patterns raise concerns regarding population health needs and access to quality preventive and outpatient services. [ABSTRACT FROM AUTHOR]

Sepsis is an increasing cause of decompensation in patients with chronic heart failure with reduced or preserved ejection fraction. Sepsis and decompensated heart failure results in a mixed septic-cardiogenic shock that poses several therapeutic dilemmas: Rapid fluid resuscitation is the cornerstone of sepsis management, while loop diuretics are the main stay of decompensated heart failure treatment. Whether inotropic therapy with dobutamine or inodilators improves microvascular alterations remains unsettled in sepsis. When to resume loop diuretic therapy in patients with sepsis and decompensated heart failure is unclear. In the absence of relevant guidelines, we review vasopressor therapy, the timing and volume of fluid resuscitation, and the need for inotropic therapy in patients who, with sepsis and decompensated heart failure, present with a mixed septic-cardiogenic shock. [ABSTRACT FROM AUTHOR]

This paper presents findings on hysterectomy prevalence from a 2010 cross-sectional household survey of 2,214 rural and 1,641 urban, insured and uninsured women in low-income households in Ahmedabad city and district in Gujarat, India. The study investigated why hysterectomy was a leading reason for use of health insurance by women insured by SEWA, a women's organisation that operates a community-based health insurance scheme. Of insured women, 9.8% of rural women and 5.3% of urban women had had a hysterectomy, compared to 7.2% and 4.0%, respectively, of uninsured women. Approximately one-third of all hysterectomies were in women younger than 35 years of age. Rural women used the private sector more often for hysterectomy, while urban use was almost evenly split between the public and private sectors. SEWA's community health workers suggested that such young women underwent hysterectomies due to difficulties with menstruation and a range of gynaecological morbidities. The extent of these and of unnecessary hysterectomy, as well as providers' attitudes, require further investigation. We recommend the provision of information on hysterectomy as part of community health education for women, and better provision of basic gynaecological care as areas for advocacy and action by SEWA and the public health community in India. L'article présente les conclusions d'une enquête transversale sur la prévalence de l'hystérectomie auprès de femmes (2214 rurales et 1641 urbaines) assurées et non assurées dans des ménages à faible revenu de la ville et du district d'Ahmedabad à Gujarat, Inde. L'étude souhaitait déterminer pourquoi l'hystérectomie était une raison majeure de recours à l'assurance maladie de la part des femmes assurées chez SEWA, une organisation féminine qui gère un plan communautaire d'assurance maladie. Parmi les assurées, 9,8% des femmes rurales et 5,3% des femmes urbaines avaient subi une hystérectomie, contre 7,2% et 4,0% respectivement des femmes non assurées. Environ un tiers des hystérectomies avait été réalisées chez des femmes de moins de 35 ans. Les femmes rurales utilisaient plus souvent le secteur privé pour l'hystérectomie, alors qu'en ville, l'utilisation était répartie de manière égale entre les secteur public et privé. Les agents de santé communautaire de SEWA ont suggéré que ces jeunes femmes avaient subi une hystérectomie pour des troubles de la menstruation et différentes morbidités gynécologiques. Il convient de réaliser des recherches complémentaires sur l'étendue de ces interventions et des hystérectomies inutiles, ainsi que sur les attitudes des prestataires. Nous recommandons la diffusion d'informations sur l'hystérectomie dans le cadre de l'éducation sanitaire communautaire des femmes, et de meilleurs soins gynécologiques essentiels comme domaines de plaidoyer et d'action de SEWA et de la communauté de santé publique en Inde. En este artículo se presentan los hallazgos sobre la prevalencia de la histerectomía de una encuesta domiciliaria transversal, realizada en 2010, de 2214 mujeres rurales y 1641 urbanas aseguradas y no aseguradas, en viviendas de bajos ingresos en la ciudad y el distrito de Ahmedabad, en Gujarat, India. El estudio investigó por qué la histerectomía era una razón principal para el uso de seguro médico por mujeres aseguradas por SEWA, una organización de mujeres que administra un plan de seguro médico comunitario. De las mujeres aseguradas, el 9.8% de las mujeres rurales y el 5.3% de las urbanas habían tenido una histerectomía, comparado con el 7.2% y el 4.0%, respectivamente, de las mujeres no aseguradas. Aproximadamente una tercera parte de todas las histerectomías se efectuaron en mujeres menores de 35 años de edad. Las mujeres rurales acudieron al sector privado con más frecuencia para una histerectomía, mientras que las urbanas se dividieron casi exactamente por la mitad entre los sectores público y privado. Los trabajadores comunitarios de la salud empleados por SEWA sugirieron que estas jóvenes tuvieron histerectomías debido a sus dificultades con la menstruación y una variedad de morbilidades ginecológicas. La gravedad de éstas y la frecuencia de histerectomías innecesarias, así como las actitudes del personal de salud, requieren más investigación. Recomendamos el suministro de información sobre la histerectomía como parte de la educación de las mujeres comunitarias sobre la salud, y mejor prestación de los servicios ginecológicos básicos, como áreas de promoción y defensa y acción por parte de SEWA y la comunidad de salud pública en India. [ABSTRACT FROM AUTHOR]

An amendment to this paper has been published and can be accessed via a link at the top of the paper. [ABSTRACT FROM AUTHOR]

Four years have passed since the institution of the cease-fire in Yugoslavia, and questions remain as to how Kosovar women are faring in the country's postwar reconstruction. Reports, albeit fragmented, suggest that violence against women began to increase in 1998 and 1999. This trend continued through 2001, even while rates of other major crimes decreased. Despite considerable local efforts to address the conditions of women, there remains a lack of systematic data documenting the scope and frequency of violent acts committed against women. A centralized surveillance system focused on tracking human rights abuses needs to be established to address this critical need for empirically based reports and to ultimately guide reform efforts. (Am J Public Health. 2004;94:1304-1307). [ABSTRACT FROM AUTHOR]

Hypertension remains a leading cause of cardiovascular and kidney diseases. Failure to control blood pressure with ≥ 3 medications or control requiring ≥ 4 medications is classified as resistant hypertension (rHTN) and new therapies are needed to reduce the resulting increased risk of morbidity and mortality. Here, we report genetic evidence that relaxin family peptide receptor 2 (RXFP2) is associated with rHTN in men, but not in women. This study shows that adrenal gland gene expression of RXFP2 is increased in men with hypertension and the RXFP2 natural ligand, INSL3, increases adrenal steroidogenesis and corticosteroid secretion in human adrenal cells. To address the hypothesis that RXFP2 activation is an important mechanism in rHTN, we discovered and characterized small molecule and monoclonal antibody (mAb) blockers of RXFP2. The novel chemical entities and mAbs show potent, selective inhibition of RXFP2 and reduce aldosterone and cortisol synthesis and release. The RXFP2 mAbs have suitable rat pharmacokinetic profiles to evaluate the role of RXFP2 in the development and maintenance of rHTN. Overall, we identified RXFP2 activity as a potential new mechanism in rHTN and discovered RXFP2 antagonists for the future interrogation of RXFP2 in cardiovascular and renal diseases. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Intimate partner violence (IPV) is a major health and social issue that affects around 30 percent of women globally. This study investigates the relationships through which witnessing IPV in adolescence may impact the labor force participation and employment prospects of women in early adulthood, using a unique dataset from Bihar (India), which surveyed youth (primarily girls) in adolescence and again nine years later. The study examined the relationship between exposure to IPV and labor market outcomes among young women, including intermediate factors likely to influence their employment prospects, such as educational attainment, self‐efficacy, mental health, and soft skills. Witnessing IPV as an adolescent had a negative effect on educational attainment, mental health, and social and behavioral aspects of young women almost nine years later. IPV was not associated with the likelihood of paid employment or participation in skilled work among women, although it was associated with higher levels of labor force participation. These findings suggest that witnessing IPV should be considered one of multiple forms of violence that may expose young women to longer term vulnerability related to poorer educational and employment prospects, mental health, and social networks, with implications for economic and social development far beyond the family. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Community-based health insurance has been associated with increased hospitalisation in low-income settings, but with limited analysis of the illnesses for which claims are submitted. A review of claims submitted to VimoSEWA, an inpatient insurance scheme in Gujarat, India, found that fever, diarrhoea and hysterectomy, the latter at a mean age of 37 years, were the leading reasons for claims by adult women. We compared the morbidity, outpatient treatment-seeking and hospitalisation patterns of VimoSEWA-insured women with uninsured women.Methods: We utilised data from a cross-sectional survey of 1,934 insured and uninsured women in Gujarat, India. Multivariable logistic regression identified predictors of insurance coverage and the association of insurance with hospitalisation. Self-reported data on morbidity, outpatient care and hospitalisation were compared between insured and uninsured women.Results: Age, marital status and occupation of adult women were associated with insurance status. Reported recent morbidity, type of illness and outpatient treatment were similar among insured and uninsured women. Multivariable analysis revealed strong evidence of a higher odds of hospitalisation amongst the insured (OR = 2.7; 95% ci. 1.6, 4.7). The leading reason for hospitalisation for uninsured and insured women was hysterectomy, at a similar mean age of 36, followed by common ailments such as fever and diarrhoea. Insured women appeared to have a higher probability of being hospitalised than uninsured women for all causes, rather than specifically for fever, diarrhoea or hysterectomy. Length of stay was similar while choice of hospital differed between insured and uninsured women.Conclusions: Despite similar reported morbidity patterns and initial treatment-seeking behaviour, VimoSEWA members were more likely to be hospitalised. The data did not provide strong evidence that inpatient hospitalisation replaced outpatient treatment for common illnesses or that insurance was the primary inducement for hysterectomy in the population. Rather, it appears that VimoSEWA members behaved differently in deciding if, and where, to be hospitalised for any condition. Further research is required to explore this decision-making process and roles, if any, played by adverse selection and moral hazard. Lastly, these hospitalisation patterns raise concerns regarding population health needs and access to quality preventive and outpatient services. [ABSTRACT FROM AUTHOR]

Drawing on interviews conducted in 2019–2020, across twenty villages in India, this paper unpacks how people with chronic illness navigate complex care-seeking terrain. We show how the act of seeking care involves navigating through personal, family, social, economic, cultural, and most importantly, difficult health systems spaces—and entails making difficult social, moral, and financial choices. We show how the absence of reliable and accessible points of first contact for primary care results in people running from pillar to post, taking wrong turns, and becoming disappointed, frustrated, and, sometimes, impoverished. We reveal the complex individual and social dynamics of hope and misplaced and misguided expectations, as well as social obligations and their performance that animate the act of navigating care in rural India. We shine light on how a health system with weak primary care and poor regulation amplifies the medical, social, and financial consequences of an otherwise manageable chronic illness, and how these consequences are the worst for those with the least social, network and economic capital. Crucially we highlight the problematic normalisation of the absence of reliable primary care services for chronic illness in India, in rural India specifically. We signpost implications for research, and for policy and practice in India and similar health system contexts, i.e. those with weak primary care and poor regulation of the private sector. We argue that in India, having in place accessible, good quality, and trustworthy sources of advice and care for chronic illness at the first point of call, for all, is critical. We contend that this first point of call should be quality, public primary care services. We conclude that if such arrangements are in place in public services, people will use them. • Lack of reliable, trustworthy advice and care is a big gap in India's health system. • Being misled and suffering catastrophic consequences of ill-health is the result. • People need to be protected from bad actors in their care-seeking journeys. • People want reliable, trustworthy advice and care, at their first point of call. • India's health system must urgently act to ensure appropriate care at all levels. [ABSTRACT FROM AUTHOR]

Introduction: Current guidelines for cardiac resynchronization therapy (CRT) device implant are the same across both sexes however women have been traditionally underrepresented in randomized controlled trials (RCTs). We aimed to identify if the number of women included in CRT trials is representative of the real‐world burden of heart failure (HF) in women. Methods: RCTs evaluating the benefit of CRT in HF patients referenced in the 2012 EHRA/HRS expert consensus statement on CRT in HF were included. Studies were evaluated for gender representation, baseline variables, and gender‐based analysis of outcomes. Results: A total of 10 CRT trials including 8107 patients were studied. Of the total patient population in these RCTs, only 23% were women. Analysis of outcomes based on sex was reported only in 5 out of 10 trials. Of these five trials reporting sex‐based outcomes, multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT‐CRT) and resynchronization–defibrillation for ambulatory heart failure trial (RAFT) showed a greater benefit in women compared to men. Both MADIT and RAFT trials had a lower ejection fraction (EF) cut‐off in the inclusion criteria (EF ≤ 30%) compared to the studies that did not find gender‐based differences in the outcome (inclusion criteria: EF ≤ 35% or 40%). Additionally, women had less ischemic cardiomyopathy and more left bundle branch block (LBBB) compared to men in these two trials. Conclusion: Women are underrepresented in CRT trials; however, they have been shown to derive a greater benefit from CRT compared to men. Appropriate measures should be taken in future studies to enhance the participation of women in clinical trials for more generalizable evidence. [ABSTRACT FROM AUTHOR]

Background: Hospital admission for the treatment of acute decompensated heart failure is an unfortunate certainty in the vast majority of patients with heart failure. Regardless of the etiology, inpatient treatment for acute decompensated heart failure portends a worsening prognosis. Methods: This review identifies patients with heart failure who need inpatient therapy and provides an overview of recommended therapies and management of these patients in the hospital setting. Results: Inpatient therapy for patients with acute decompensated heart failure should be directed at decongestion and symptom improvement. Clinicians should also treat possible precipitating events, identify comorbid conditions that may exacerbate heart failure, evaluate and update current guideline-directed medical therapy, and perform risk stratification for all patients. Finally, efforts should be made to educate patients about the importance of restricting salt and fluid, monitoring daily weights, and adhering to a graded exercise program. Conclusion: Early discharge follow-up and continued optimization of guideline-directed medical therapy are key to preventing future heart failure readmissions. [ABSTRACT FROM AUTHOR]

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 [PQITD]), 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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Induction with lymphocyte-depleting antibodies may improve allograft outcomes in heart transplant recipients who are at high immunologic risk for rejection. Methods: 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. Results: 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 (P=0.474). Serious infections were also similar between groups (P=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; P=0.014). Conclusion: 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Right heart failure (RHF) following left ventricular assist device (LVAD) implantation increases morbidity andmortality for thosewho 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. Methods: 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. Results: 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 Heart-Mate II group had the indication of destination therapy (54% vs 30%), while more patients in the HeartWare groupwere 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 (P=0.0001). After propensity score analysis, patients receiving the HeartWare device had increased odds for RHF (P=0.0013) and renal failure requiring dialysis (P=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 P=0.087). Conclusion: These results indicate that device type may affect RHF incidence and mortality. Studies at other centers are needed to replicate these findings. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Oral Submucous Fibrosis (OSMF) is a premalignant condition with potential malignant behaviour characterized by juxta-epithelial fibrosis of the oral cavity. In the process of collagen synthesis, iron gets utilized, by the hydroxylation of proline and lysine, leading to decreased serum iron levels. The trace element like iron is receiving much attention in the detection of oral cancer and precancerous condition like OSMF as it was found to be significantly altered in these conditions. Aim: The aim of this study was to compare the haemoglobin and serum iron values of OSMF subjects with that of iron deficiency anaemia subjects. Materials and Methods: Total of 120 subjects were included, 40 subjects with the OSMF, 40 with the iron deficiency anemia without tobacco chewing habit, 40 healthy control subjects without OSMF and iron deficiency anaemia. A total of 5ml of venous blood was withdrawn from all the subjects and serum iron and haemoglobin levels were estimated for all the subjects. Estimation of iron was done using Ferrozine method and haemoglobin by Sahli's method. The statistical method applied were Kruskal Wallis, Mann Whitney and Pearson correlation coefficient test. Results: There was a statistically significant difference in serum iron and haemoglobin level in all three groups (p<0.05). The serum iron level was lowest in OSMF group and haemoglobin was lowest in iron deficiency anaemia group. A progressive decrease in serum iron and haemoglobin levels from Stage I of OSMF to the Stage IV of OSMF was also observed. The iron deficiency anaemia group was not found to be suffering from OSMF in the absence of areca-nut or tobacco chewing habits, but OSMF patients with chewing habits were found to be suffering from iron deficiency anaemia. Conclusion: There is a progressive decrease in serum iron and haemoglobin levels from Stage I of OSMF to the Stage IV of OSMF so it can be used as an auxillary test in assessment of prognosis of the disease. [ABSTRACT FROM AUTHOR]

Background: Outcomes of traditional mechanical support paradigms (extracorporeal membrane oxygenation, intraaortic balloon pump [IABP], and permanent left ventricular assist device [LVAD]) in acute decompensated heart failure have generally been suboptimal. Novel approaches, such as minimally invasive LVAD therapy (Impella 5.0 device), promise less invasive but equivalent hemodynamic support. However, it is yet unknown whether the outcomes with such devices support widespread acceptance of this new technology. We recently started utilizing the right subclavian artery (RSA) for Impella 5.0 implantation and report our early experience and outcomes with this novel approach. Methods: A single-center retrospective review was performed of 24 patients with acute on chronic decompensated heart failure who received the Impella 5.0 via the RSA from June 2011 to May 2014. The device was implanted via a cutdown through an 8-mm vascular graft sewn to the RSA. The device was positioned with fluoroscopy and transesophageal echocardiography. Results: The mean age of the patients was 51.29 years, and 75% were male. At implantation, all patients were mechanically ventilated on at least 2 inotropes with persistent cardiogenic shock, and 17 (70.8%) were on IABP support. Postimplantation, 21 (87.5%) tolerated extubation, and all 17 of the patients with IABPs tolerated discontinuation of IABP support. The reduction in the Model for End-Stage Liver Disease score preimplantation vs postimplantation was statistically significant (21.17 vs 14.88, P=0.0014), suggesting improvement in end organ function. A significant decrease was also seen in creatinine levels before and after implantation (2.17 mg/dL vs 1.50 mg/dL, P=0.0043). The endpoint of support included recovery in 6 patients (25.0%), permanent LVAD in 9 (37.5%), and heart transplantation in 2 (8.3%). Death occurred in 7 patients (29.2%) as a result of multisystem organ failure, infection, or patient withdrawal of care. Conclusion: Minimally invasive LVAD therapy using the Impella 5.0 via the RSA cutdown is an attractive option in acute on chronic decompensated heart failure. Improvement in end organ function allows for transition to recovery or to advanced surgical therapies such as permanent LVAD and heart transplantation. Significant advantages to this approach include improved left ventricular unloading, lower anticoagulation need, and the potential for ambulation and physical therapy. [ABSTRACT FROM AUTHOR]

2-Amino-2-(4-octylphenethyl)propane-1,3-diol 1(fingolimod, FTY720) has been recently marketed in the United States for the treatment of patients with remitting relapsing multiple sclerosis (RRMS). Its efficacy has been primarily linked to the agonism on T cells of S1P1, one of the five sphingosine 1-phosphate (S1P) G-protein-coupled receptors, while its cardiovascular side effects have been associated with activity at S1P3. Emerging data suggest that the ability of this molecule to cross the blood-brain barrier and to interact with both S1P1and S1P5in the central nervous system (CNS) may contribute to its efficacy in treating patients with RRMS. We have recently disclosed the structure of an advanced, first generation S1P3-sparing S1P1agonist, a zwitterion with limited CNS exposure. In this Article, we highlight our strategy toward the identification of CNS-penetrant S1P3-sparing S1P1and S1P5agonists resulting in the discovery of 5-(3-{2-[2-hydroxy-1-(hydroxymethyl)ethyl]-5-methyl-1,2,3,4-tetrahydro-6-isoquinolinyl}-1,2,4-oxadiazol-5-yl)-2-[(1-methylethyl)oxy]benzonitrile 15. Its exceptional in vivo potency and good pharmacokinetic properties translate into a very low predicted therapeutic dose in human (<1 mg p.o. once daily). [ABSTRACT FROM AUTHOR]

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/m2, 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. [ABSTRACT FROM AUTHOR]