2284. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.
作者: Erwan Donal.;Julien Dreyfus.;Guillaume Leurent.;Augustin Coisne.;Pierre-Yves Leroux.;Anne Ganivet.;Catherine Sportouch.;Yoan Lavie-Badie.;Patrice Guerin.;Frédéric Rouleau.;Christelle Diakov.;Jan van der Heyden.;Stéphane Lafitte.;Jean-François Obadia.;Mohammed Nejjari.;Nicole Karam.;Anne Bernard.;Antoinette Neylon.;Romain Pierrard.;Didier Tchetche.;Said Ghostine.;Gregory Ducrocq.;Thiziri Si Moussi.;Antoine Jeu.;Marcel Peltier.;Bernard Cosyns.;Yvan Le Dolley.;Gilbert Habib.;Vincent Auffret.;Florent Le Ven.;François Picard.;Nicolas Piriou.;Thierry Laperche.;Elena Galli.;Sabina Istratoaie.;Jerome Jouan.;Guillaume Bonnet.;Pascal de Groote.;Amedeo Anselmi.;Jean-Noel Trochu.;Emmanuel Oger.; .
来源: JAMA. 2025年333卷2期124-132页
Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes.
2290. Association of Severe Maternal Morbidity With Subsequent Birth.
作者: Eleni Tsamantioti.;Anna Sandström.;Charlotte Lindblad Wollmann.;Jonathan M Snowden.;Neda Razaz.
来源: JAMA. 2025年333卷2期133-142页
Women who experience severe maternal morbidity (SMM) might have lasting health issues, and the association of SMM with the probability of future reproductive intentions is unknown.
2292. Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US.
作者: Olivier J Wouters.;Matthew Vogel.;William B Feldman.;Reed F Beall.;Aaron S Kesselheim.;S Sean Tu.
来源: JAMA. 2024年332卷24期2101-2108页
Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment.
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