Lancet
-
Multicenter Study Clinical Trial
Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study.
Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. ⋯ JenaValve Technology.
-
WHO has determined a public health emergency of international concern (PHEIC) seven times, and beyond this nomenclature declared COVID-19 to be a pandemic. Under the International Health Regulations (IHR), and through their operationalisation in the joint external evaluation (JEE), governments are urged to create suitable legislation to be able to enact a response to a public health emergency. Whether the pandemic declaration had a greater effect than a PHEIC in encouraging goverments to act, however, remains conjecture, as there is no systemic analysis of what each term means in practice and whether either has meaningful legal implications at the national level. ⋯ This finding paints a weakened picture of the IHR and PHEIC mechanisms. Having such legalese enshrined in legislation might enhance the interaction between WHO determining a PHEIC or declaring a pandemic and resulting action to mitigate transnational spread of disease and enhance health security. Given the ongoing negotiations at WHO in relation to the amendments to the IHR and creation of the pandemic accord, both of which deal with this declaratory power of the PHEIC and pandemic language, negotiators should understand the possible implications of any changes to these proclamations at the national level and for global health security.
-
There are concerns that current gestational weight gain recommendations for women with obesity are too high and that guidelines should differ on the basis of severity of obesity. In this study we investigated the safety of gestational weight gain below current recommendations or weight loss in pregnancies with obesity, and evaluated whether separate guidelines are needed for different obesity classes. ⋯ Karolinska Institutet and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
-
Afamitresgene autoleucel (afami-cel) showed acceptable safety and promising efficacy in a phase 1 trial (NCT03132922). The aim of this study was to further evaluate the efficacy of afami-cel for the treatment of patients with HLA-A*02 and MAGE-A4-expressing advanced synovial sarcoma or myxoid round cell liposarcoma. ⋯ Adaptimmune.