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Randomized Controlled Trial
. 2024 Nov;17(11):e014018.
doi: 10.1161/CIRCINTERVENTIONS.124.014018. Epub 2024 Oct 18.

Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients

Thomas Modine  1 , Didier Tchétché  2 , Nicolas M Van Mieghem  3 , G Michael Deeb  4 , Stanley J Chetcuti  5 , Steven J Yakubov  6 , Paul Sorajja  7 , Hemal Gada  8 , Mubashir Mumtaz  8 , Basel Ramlawi  9 , Tanvir Bajwa  10 , John Crouch  10 , Paul S Teirstein  11 , Neal S Kleiman  12 , Ayman Iskander  13 , Rodrigo Bagur  14 , Michael W A Chu  14 , Pierre Berthoumieu  2 , Arnaud Sudre  15 , Rik Adrichem  3 , Saki Ito  16 , Jian Huang  17 , Jeffrey J Popma  17 , John K Forrest  18 , Michael J Reardon  12
Affiliations
Randomized Controlled Trial

Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients

Thomas Modine et al. Circ Cardiovasc Interv. 2024 Nov.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.

Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.

Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.

Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Keywords: aortic valve stenosis; humans; incidence; stroke; transcatheter aortic valve replacement.

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Conflict of interest statement

Dr Modine is a consultant and Senior Advisory Board member for Medtronic. Dr Tchétché is a consultant for Medtronic. Dr Van Mieghem receives grants from Medtronic during the conduct of the trial and grants from Abbott Vascular, Edwards Lifesciences, Boston Scientific, Abiomed, PulseCath BV, and Daiichi Sankyo outside the submitted work. Dr Chetcuti receives personal fees from Medtronic; grants from Edwards, Boston Scientific, and Jena (paid to institution) during conduct of trial; and on an advisory board for Biotrace and Jena valve without remuneration. Dr Yakubov receives grants from Boston Scientific and Medtronic (paid to institution) and personal fees from Medtronic during the conduct of the trial. Dr Sorajja is a consultant to Boston Scientific and Medtronic. Dr Gada receives personal fees from Medtronic, Abbott Vascular, Becton Dickenson, and Boston Scientific outside the submitted work. Dr Mumtaz is a consultant and has received honoraria and research grants from Medtronic, Edwards, Atricure, Teleflex, Foldax, Japanese Organization for Medical Device Development, and Abbott. Dr Ramlawi receives grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr Bajwa is a consultant for Medtronic. Dr Teirstein receives research grant and honoraria from Abbott, Boston Scientific, Cordis, and Medtronic, and serves on an advisory board for Boston Scientific and Medtronic. Dr Kleiman receives clinical trial reimbursement to his institution (Houston Methodist DeBakey Heart and Vascular Center) during the conduct of the trial. Dr Bagur serves as a consultant for Medtronic. Dr Chu receives Speakers’ honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic and Artivion. Dr Huang is an employee and shareholder of Medtronic, plc. Dr Popma is a full-time employee and shareholder for Medtronic. Dr Forrest receives grant support/research contracts and consultant fees/honoraria/Speakers Bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon receives grants from Medtronic (paid to institution) during conduct of trial, and consulting fees from Abbott, Boston Scientific, and Gore Medical (paid to institution) outside of the submitted work. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Clinical outcomes in young patients undergoing transcatheter aortic valve replacement (TAVR) or surgery. Kaplan-Meier time-to-event curves and log-rank P values through 3 years for clinical outcomes in TAVR and surgery patients. A, Three-year all-cause mortality or disabling stroke in patients <75 years undergoing TAVR or surgery. B, Three-year all-cause mortality in patients <75 years undergoing TAVR or surgery. C, Three-year disabling stroke in patients <75 years undergoing TAVR or surgery. D, Three-year all-cause mortality, disabling stroke, or aortic valve hospitalization in patients <75 years undergoing TAVR or surgery. AV indicates aortic valve; and HR, hazard ratio.
Figure 2.
Figure 2.
Hemodynamic valve performance. Three-year echocardiography core laboratory findings. Mean±SDs are reported for each time point. A, Effective orifice area and mean gradients in patients <75 years undergoing transcatheter aortic valve replacement (TAVR) or surgery. B, The rates of residual paravalvular regurgitation in patients <75 years undergoing TAVR or surgery. EOA indicates effective orifice area; and MG, mean gradient.
Figure 3.
Figure 3.
Three-year functional status in patients treated with transcatheter aortic valve replacement (TAVR) or surgery. Ordinal variables are presented as frequencies and continuous variables are expressed as mean±SDs. A, Change in the New York Heart Association class for symptoms of heart failure in patients <75 years undergoing TAVR or surgery. B, Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score over time in patients <75 years undergoing TAVR or surgery.
See this image and copyright information in PMC

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