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Good Results, But Small Numbers With JenaValve Trilogy in Severe AR

Excluded from Pivotal Trials, Low-risk Complex Patients Warrant Caution

January 22, 2021 A significant proportion of real-world patients with severe aortic stenosis and low surgical risk have an additional valvular or CV condition that was never accounted for in pivotal trials of TAVI versus SAVR and that requires a serious discussion by the heart team, Canadian research shows. In the study of primarily low-risk patients who underwent SAVR between 2000 and 2019, 40.8% had at least one of the following conditions: non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), concomitant mitral/tricuspid valve (CMTV), or concomitant ascending aorta replacement (CAAR). All four of those patient subgroups were routinely excluded from RCTs of TAVI compared with SAVR.

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