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Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Transcatheter Aortic Valve Replacement vs Surgical Replacement in Patients With Pure Aortic Insufficiency The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation Prognostic implications of baseline 6‐min walk test performance in intermediate risk patients undergoing transcatheter aortic valve replacement Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week From organic and inorganic phosphates to valvular and vascular calcifications Cardiac Structural Changes After Transcatheter Aortic Valve Replacement: Systematic Review and Meta-Analysis of Cardiovascular Magnetic Resonance Studies

Original Research2020 Aug;13(8):e009047.

JOURNAL:Circ Cardiovasc Interv . Article Link

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

G Armijo, GHL Tang, N Kooistra et al. Keywords: aortic valve stenosis; cohort studies; hemodynamics; humans; transcatheter aortic valve replacement.

ABSTRACT

BACKGROUND - Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area 575 mm2or perimeter 85 mm) and extra-large (683 mm2or 94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement.

 

METHODS - A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported.

 

RESULTS - Median aortic annulus area and perimeter were 617 mm2(591657) and 89.1 mm (87.092.1), respectively (704 mm2[689743] and 96.0 mm [94.597.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%;P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group.

 

CONCLUSIONS - In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.