The Lotus Valve
Can It Float Above the Muddy Waters?
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Article, see p 2557
Transcatheter aortic valve replacement (TAVR) has rapidly emerged as the treatment of choice in inoperable patients and a reasonable alternative to surgical aortic valve replacement in patients at high and intermediate surgical risk.1 The success of this technology is in large part because of the rigor with which quantitative echocardiography by core laboratories has been used to assess native and prosthetic aortic valve function. The initial PARTNER I trial (Placement of Aortic Transcatheter Valves) was a model for echo core laboratory best practices, and serial measurements using consistent methodology have led to reassurances of transcatheter heart valve (THV) durability.2 In addition, because of the meticulousness with which echocardiographic core labs record and maintain their data, one of the early concerns of TAVR, inconsistent reporting of the incidence and prognostic significance of paravalvular regurgitation (PVR), could be rigorously investigated. The investigation became the basis for a new proposed grading scheme,3 which has led to studies that clarify the role of PVR on TAVR outcomes.4
As new transcatheter valves are developed to address the shortcomings of current iterations of THV, differences in procedural and hemodynamic success may allow clinicians to make decisions about valve choice for their patients. One of the first trials comparing different THV devices was the CHOICE trial (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT).5 It is important to note that echocardiographic results were not core laboratory-assessed but site-reported, raising questions about the validity of the comparison. In fact, the incidence of moderate/severe PVR by echocardiography did not correlate with either angiography or cardiac magnetic resonance imaging for the CoreValve (while correlating relatively well for the balloon-expandable valve). Nonetheless, this trial reported greater PVR with the self-expanding valve …