TY - JOUR
T1 - Transcatheter Aortic Valve Replacement in Patients With Large and Extra-Large Aortic Annuli: Hemodynamic Performance of New-Generation Balloon- and Self-Expandable Aortic Valves
AU - Armijo Ortiz, German
AU - Tang, Gilbert
AU - Kooistra, Nynke
AU - Urena, Marina
AU - Neto, Alfredo Nunes Ferreira
AU - Toggweiler, Stefan
AU - Amat-Santos, Ignacio
AU - Ahmad, Hasan
AU - Soto, Jose Tafur
AU - Regueiro, Ander
AU - Tirado-Conte, Gabriela
AU - McInerney, Angela
AU - Ahmed, Mohammed
AU - Himbert, Dominique
AU - Nietlispach, Fabian
AU - Stella, Pieter
AU - Dangas, George
AU - Macaya, Carlos
AU - Rodes-Cabau, Josep
AU - Nombela-Franco, Luis
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Background
Currently, only 2 newer-generation transcatheter valves, Sapien-3 (S3) (29 mm) and Evolut-R (ER) (34 mm), are indicated for large-sized aortic annuli. We analyzed short- and mid-term performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥680 mm2 or >92.4 mm) aortic annuli undergoing transcatheter aortic valve replacement.
Methods
A total of 543 patients with symptomatic aortic stenosis and large aortic annulus that underwent TAVR with S3 29 mm (n = 408) and ER 34 mm (n = 135) from 12 centers were included. Clinical, anatomic, and procedural characteristics were collated, and Valve Academic Research Consortium-2 outcomes were reported.
Results
The mean aortic annulus area and perimeter were 623 mm2 (601.0 to 660.0 mm2) and 89.7 mm (87.4 to 92.2 mm), respectively (subgroup with extra-large annulus, area of 692 mm2 [681 to 719 mm2]). Overall device success was 77.7% (S3: 79.2% and ER: 73.3%; p = 0.158) with a 30-day mortality of 3.1%. There was a higher rate of second valve implantation and valve embolization in the ER group (3.7% vs. 0.7%; p = 0.026 and 2.2% vs. 0.2%; p = 0.049, respectively). Prosthetic valve gradient >20 mm Hg (0.8% S3 vs. 0.8% ER; p = 1.0) and aortic regurgitation (AR) ≥3 (2.0% S3 vs. 6.1% ER; p = 0.020) were low in both groups. Although major vascular and bleeding complications favored the ER group, permanent pacemaker implantation and ≥ mild paravalvular AR were lower in the S3 group. Predictors for paravalvular AR were annulus size (p = 0.001) and valve type (p = 0.011). These results remained similar in the extra-large annulus group (n = 96).
Conclusion
In patients with large and extra-large aortic annuli, TAVR with S3 29-mm and ER 34-mm valves is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing TAVR.
AB - Background
Currently, only 2 newer-generation transcatheter valves, Sapien-3 (S3) (29 mm) and Evolut-R (ER) (34 mm), are indicated for large-sized aortic annuli. We analyzed short- and mid-term performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥680 mm2 or >92.4 mm) aortic annuli undergoing transcatheter aortic valve replacement.
Methods
A total of 543 patients with symptomatic aortic stenosis and large aortic annulus that underwent TAVR with S3 29 mm (n = 408) and ER 34 mm (n = 135) from 12 centers were included. Clinical, anatomic, and procedural characteristics were collated, and Valve Academic Research Consortium-2 outcomes were reported.
Results
The mean aortic annulus area and perimeter were 623 mm2 (601.0 to 660.0 mm2) and 89.7 mm (87.4 to 92.2 mm), respectively (subgroup with extra-large annulus, area of 692 mm2 [681 to 719 mm2]). Overall device success was 77.7% (S3: 79.2% and ER: 73.3%; p = 0.158) with a 30-day mortality of 3.1%. There was a higher rate of second valve implantation and valve embolization in the ER group (3.7% vs. 0.7%; p = 0.026 and 2.2% vs. 0.2%; p = 0.049, respectively). Prosthetic valve gradient >20 mm Hg (0.8% S3 vs. 0.8% ER; p = 1.0) and aortic regurgitation (AR) ≥3 (2.0% S3 vs. 6.1% ER; p = 0.020) were low in both groups. Although major vascular and bleeding complications favored the ER group, permanent pacemaker implantation and ≥ mild paravalvular AR were lower in the S3 group. Predictors for paravalvular AR were annulus size (p = 0.001) and valve type (p = 0.011). These results remained similar in the extra-large annulus group (n = 96).
Conclusion
In patients with large and extra-large aortic annuli, TAVR with S3 29-mm and ER 34-mm valves is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing TAVR.
M3 - Meeting Abstract
SN - 0735-1097
VL - 74
SP - B78-B78
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 13
ER -