steamsteel1
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BACKGROUND U.S. value framework developers such as the Institute for Clinical and Economic Review (ICER) use cost-effectiveness analysis to value new health care technologies. Often, these value assessment frameworks use a health system perspective without fully accounting for societal and broader benefits and costs of an intervention. Although there is ongoing debate about the most appropriate methods for including broader value elements in value assessment, it remains unclear whether the inclusion of these value elements is likely to affect the quantitative estimates of treatment value. OBJECTIVE To assess variations in the relevance of broader value elements to cost-effectiveness analysis across diseases. METHODS Thirty-two broader value elements (e.g., caregiver burden, health equity, real option value, productivity) not traditionally included in health technology assessments were identified through a targeted literature review. Evidence reports published by ICER between July 2017 and January 2020 were evs for and reports receiving consulting fees from Novartis Pharmaceutical Corporation and is a site principal investigator on studies funded by Novartis Pharmaceutical Corporation. Kantar also reports support from Sickle Cell Disease Association of America Inc. and National Heart, Lung, and Blood Institute, unrelated to this work. Neumann reports advisory boards or consulting fees from Novartis Pharmaceutical Corporation and PRECISIONheor, as well as advisory boards or consulting fees unrelated to this study from AbbVie, Amgen, Avexis, Bayer, Congressional Budget Office, Janssen, Merck, Novartis, Novo Nordisk, Precision Health Economics, Veritech, Vertex; funding from The CEA Registry Sponsors by various pharmaceutical and medical device companies; and grants from Amgen, Lundbeck, Bill and Melinda Gates Foundation, National Pharmaceutical Council, Alzheimer's Association, and the National Institutes for Health.Background Limited clinical evidence and literature are available about the potential impact of sex on permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). The aim of this work was to evaluate the relationship between sexes and atrioventricular conduction disturbances requiring PPI after TAVI. Methods and Results Data were obtained from 46 studies from PubMed reporting information about the impact of patient sex on PPI after TAVI. Total proportions with 95% Cls were reported. Funnel plot and Egger test were used for estimation of publication bias. The primary end point was 30-day or in-hospital PPI after TAVI, with odds ratios and 95% CIs extracted. A total of 70 313 patients were included, with a cumulative proportion of 51.5% of women (35 691 patients; 95% CI, 50.2-52.7). The proportion of women undergoing TAVI dropped significantly over time (P less then 0.0001). The cumulative PPI rate was 15.6% (95% CI, 13.3-18.3). The cumulative rate of PPI in women was 14.9% (95% CI, 12.6-17.6), lower than in men (16.6%; 95% CI, 14.2-19.4). The risk for post-TAVI PPI was lower in women (odds ratio, 0.90; 95% CI, 0.84-0.96 [P=0.0022]). By meta-regression analysis, age (P=0.874) and ventricular function (P=0.302) were not significantly associated with PPI among the sexes. Balloon-expandable TAVI significantly decrease the advantage of women for PPI, approaching the same rate as in men (P=0.0061). Conclusions Female sex is associated with a reduced rate of PPI after TAVI, without influence of age or ventricular function. Balloon-expandable devices attenuate this advantage in favor of women. Additional investigations are warranted to elucidate sex-based differences in developing conduction disturbances after TAVI.Background Perivascular adipose tissue (PVAT) is associated with metabolically driven chronic inflammation called metaflammation, which contributes to vascular function and the pathogenesis of vascular disease. The saphenous vein (SV) is commonly used as an essential conduit in coronary artery bypass grafting, but the long-term patency of SV grafts is a crucial issue. IACS-13909 The use of the novel "no-touch" technique of SV harvesting together with its surrounding tissue has been reported to result in good long‑term graft patency of SV grafts. Herein, we investigated whether PVAT surrounding the SV (SV-PVAT) has distinct phenotypes compared with other PVATs of vessels. Methods and Results Fat pads were sampled from 48 patients (male/female, 32/16; age, 72±8 years) with coronary artery disease who underwent elective coronary artery bypass grafting. Adipocyte size in SV-PVAT was significantly larger than the sizes in PVATs surrounding the internal thoracic artery, coronary artery, and aorta. SV-PVAT and PVAT surrounding the internal thoracic artery had smaller extents of fibrosis, decreased gene expression levels of fibrosis-related markers, and less metaflammation, as indicated by a significantly smaller extent of cluster of differentiation 11c-positive M1 macrophage infiltration, higher gene expression level of adiponectin, and lower gene expression levels of inflammatory cytokines, than did PVATs surrounding the coronary artery and aorta. Expression patterns of adipocyte developmental and pattern-forming genes were totally different among the PVATs of the vessels. Conclusions The phenotype of SV-PVAT, which may result from inherent differences in adipocytes, is closer to that of PVAT surrounding the internal thoracic artery than that of PVAT surrounding the coronary artery or that of PVAT surrounding the aorta. SV-PVAT has less metaflammation and consecutive adipose tissue remodeling, which may contribute to high long-term patency of grafting when the no-touch technique of SV harvesting is used.Background The menopausal transition is characterized by increased cardiovascular risk, weight gain, and increased adiposity for many women. The adipose-derived secretory proteins adiponectin and leptin are associated with insulin resistance, metabolic syndrome, and cardiovascular disease but their role in subclinical atherosclerotic disease is unclear. This cross-sectional study evaluated the associations of adiponectin and leptin with carotid artery intima-media thickness, adventitial diameter, presence of carotid plaques, and brachial-ankle pulse wave velocity (baPWV) in women aged 54 to 65 years. Methods and Results Participants were 1399 women from SWAN (Study of Women's Health Across the Nation), a community-based study of women transitioning through menopause. Carotid ultrasound and baPWV measures were obtained at SWAN follow-up visits 12 or 13, when 97% of participants were post-menopausal. Adipokines were assayed from serum specimens obtained concurrently at these visits. Linear and logistic regression models were used to evaluate adiponectin or leptin, both log-transformed attributable to skewness, in relationship to carotid artery intima-media thickness, adventitial diameter, baPWV, and presence of carotid plaque.

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