TY - JOUR
T1 - First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System
AU - Zaid, Syed
AU - Attizzani, Guilherme F.
AU - Krishnamoorthy, Parasuram
AU - Yoon, Sung Han
AU - Palma Dallan, Luis A.
AU - Chetcuti, Stanley
AU - Fukuhara, Shinichi
AU - Grossman, P. Michael
AU - Goel, Sachin S.
AU - Atkins, Marvin D.
AU - Kleiman, Neal S.
AU - Puri, Rishi
AU - Bakhtadze, Beka
AU - Byrne, Timothy
AU - Ibrahim, Akram W.
AU - Grubb, Kendra J.
AU - Tully, Andy
AU - Herrmann, Howard C.
AU - Faggioni, Michela
AU - Ramlawi, Basel
AU - Khera, Sahil
AU - Lerakis, Stamatios
AU - Dangas, George D.
AU - Kini, Annapoorna S.
AU - Sharma, Samin K.
AU - Reardon, Michael J.
AU - Tang, Gilbert H.L.
N1 - Publisher Copyright:
© 2023 American College of Cardiology Foundation
PY - 2023/7/10
Y1 - 2023/7/10
N2 - BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited.OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience.METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported.RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001).CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.
AB - BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited.OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience.METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported.RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001).CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.
KW - commissural alignment
KW - Evolut FX
KW - TAVR
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Humans
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
KW - Retrospective Studies
KW - Catheters
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U2 - 10.1016/j.jcin.2023.05.004
DO - 10.1016/j.jcin.2023.05.004
M3 - Article
C2 - 37438029
AN - SCOPUS:85163461476
SN - 1936-8798
VL - 16
SP - 1626
EP - 1635
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 13
ER -