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

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 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥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 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [689–743] and 96.0 mm [94.5–97.9] 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.

The use of semi‐compliant versus non‐compliant balloon systems for predilatation during the implantation of self‐expandable transcatheter aortic valves

“…This finding might be related to generally lower gradients measured during transthoracic echocardiography after implantation of larger THV devices; however, it has to be noted that the implantation of self‐expandable valves in patients with particularly large or elliptical annuli tends to demonstrate generally lower rates of device success compared to balloon‐expandable valves. 15 , 16 , 17 …”

“…In the multivariate logistic regression analysis for the primary endpoint, the only factor associated with higher device success rates was the aortic annulus area measured in CT, indicating that larger annuli displayed higher device success rates in this particular cohort. This finding might be related to generally lower gradients measured during transthoracic echocardiography after implantation of larger THV devices; however, it has to be noted that the implantation of self‐expandable valves in patients with particularly large or elliptical annuli tends to demonstrate generally lower rates of device success compared to balloon‐expandable valves 15‐17 …”

“…This finding might be related to generally lower gradients measured during transthoracic echocardiography after implantation of larger THV devices; however, it has to be noted that the implantation of self-expandable valves in patients with particularly large or elliptical annuli tends to demonstrate generally lower rates of device success compared to balloon-expandable valves. [15][16][17] The principal advantage of NCBs is their ability to exert a more focused effect on highly calcified areas effectively without impacting the surrounding healthy areas. They are thus well-suited to treating severely and diffusely calcified valves, a fact evidenced by the higher median calcium score of NCB patients.…”

Contemporary Practice of Echocardiography in Transcatheter Aortic Valve Replacement

“…Heavy LVOT calcium should lead to the use of a self-expanding valve, while patients with extra-large annular size may benefit from a balloon-expandable valve. 15,16 Intraprocedurally, MAC alone is not an absolute indication for TTE, however a deeper level of sedation may be necessary for TEE, which increases the risk of hemodynamic and airway compromise. Rates of these complications will increase with longer procedure times and certain patient characteristics.…”

Evolving Devices and Material in Transcatheter Aortic Valve Replacement: What to Use and for Whom

“…Of note, the use of any valve is considered off-label in case of very large aortic annulus, and there is a paucity of data on the outcome of patients with very large aortic annulus treated with TAVR, mainly limited to observational studies. The TAVR-LARGE Registry reported promising results in this setting with both the 29-mm Sapien 3 and the 34-mm Evolut R THVs, although valve embolization, need for second valve implantation, and PVL occurred more frequently in patients receiving the 34-mm Evolut R, resulting in lower device success [ 84 ]. A retrospective analysis from the ACC/STS U.S. TVT registry LVOT reporting the outcome of 74 patients with very large aortic annulus treated with the 29-mm Sapien 3 BEV showed consistent findings, with low rate of adverse events and good hemodynamic performance.…”