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Randomized Controlled Trial
. 2025 Jun;18(6):625-640.
doi: 10.1016/j.jcmg.2025.01.015. Epub 2025 Apr 16.

5-Year Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

Affiliations
Randomized Controlled Trial

5-Year Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

Rebecca T Hahn et al. JACC Cardiovasc Imaging. 2025 Jun.

Abstract

Background: The PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis) trial compared SAPIEN 3 transcatheter aortic valve replacement (TAVR) to surgery in low-risk patients with symptomatic, severe aortic stenosis. Echocardiographic outcomes at 5 years are unknown.

Objectives: This study sought to compare 5-year echocardiographic results of TAVR and surgery in the PARTNER 3 trial.

Methods: Echocardiograms for 1,000 randomized patients were obtained at baseline, 30 days, 1 year, and annually through 5 years and were analyzed by a core lab consortium. The composite primary endpoint of death, stroke, or rehospitalization was adjudicated by a clinical events committee.

Results: At 5 years, ≥ mild aortic regurgitation was higher following TAVR vs surgery (24.5% vs 6.3%; P < 0.001), with low ≥ moderate aortic regurgitation in both groups. TAVR patients had higher mean transaortic gradient (12.8 ± 6.5 vs 11.7 ± 5.6 mm Hg; P < 0.001), stroke volume index (44.6 ± 9.7 vs 41.1 ± 9.2; P < 0.0001), and aortic valve area (1.87 ± 0.46 vs 1.82 ± 0.46; P = 0.895). Fewer TAVR patients had low-flow stroke volume index (P < 0.001) and left ventricular hemodynamic burden (valvulo-arterial impedance; P < 0.01). Tricuspid annular plane systolic excursion was also higher with TAVR (P < 0.001), as was right ventricular-to-pulmonary artery coupling (P < 0.0001). In the combined cohorts, 30-day moderate to severe prosthesis-patient mismatch, mild to severe aortic regurgitation, or low stroke volume index were not predictive of clinical outcomes; only low right ventricular-to-pulmonary artery coupling and high valvulo-arterial impedance at 30 days were associated with increased risk of the 5-year composite primary endpoint.

Conclusions: In low-risk patients with severe aortic stenosis, TAVR, compared to surgery, was associated with similar, stable valve hemodynamics at 5 years with less frequent low-flow state, lower valvulo-arterial impedance, and better right ventricular function. (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis [P3]; NCT02675114).

Keywords: TAVR; aortic stenosis; echocardiography; hemodynamics; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures The PARTNER 3 trial was sponsored by Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has received institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic, and Novartis; and has served as Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Ternacle has served as a consultant for Edwards Lifesciences, Abbott, General Electric, and Philips Healthcare. Dr Cristell has served as the Medical Director of the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. Dr Beaudoin has received a research grant from JAMP Pharma. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; consulting fees from Abbott, Anteris Technologies, and Meril Lifesciences; and equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Russo has received an institutional research grant from Edwards Lifesciences, and has served as a consultant and/or proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Kapadia has received a research grant to his institution from Edwards Lifesciences (no direct physician compensation). Dr Malaisrie has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott. Dr Cohen has received consulting income from Edwards Lifesciences, Abbott, and Medtronic, and research grants to his institution from Edwards Lifesciences, Boston Scientific, and Abbott. Dr Leipsic has received research grants from Edwards Lifesciences and Medtronic for computed tomography core lab analyses in transcatheter aortic valve replacement and has served as a consultant for Circle CVI. Dr Blanke has served as a consultant to Edwards Lifesciences and Laralab Imaging. Drs Leipsic and Blanke have provided institutional computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Laboratories, without direct personal compensation. Dr Williams has received research funding from Edwards Lifesciences. Dr McCabe has received honoraria from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Babaliaros has received equity in Transmural Systems and has served as a consultant for Edwards Lifesciences. Dr Goldman has received medical advisory board participation for Edwards Lifesciences. Dr Szeto has received institutional research support and consulting fees from Edwards Lifesciences, Medtronic, Abbott, Terumo Aortic, and Artivion. Dr Généreux has received institutional research support from Edwards Lifesciences and has served as a consultant or on/advisory boards for Edwards, Abbott, Boston Scientific, Cardiovascular Solution Inc, Medtronic, Cordis, Saranas, Pi-Cardia, and Sig.Num. Dr Pershad has served as a consultant for and/or on the Speakers Bureau of Edwards Lifesciences and Medtronic Structural Heart Division. Dr Park and M. Gunnarsson are employees of Edwards Lifesciences. J.G. Webb has served as a proctor and consultant for Edwards Lifesciences. Dr Makkar has received grants from Edwards Lifesciences and Abbott and has served as a consultant for Cordis and Medtronic. Dr Thourani has performed research for and has served as a consultant for Abbott Vascular, Allergen, Boston Scientific, Cryolife, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr Mack has received institutional research support (no direct physician compensation) from Edwards Lifesciences and has served as a consultant for Gore. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott, and has served as a consultant for and/or on the /advisory boards of Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Drs Mack and Leon have served as the National Co-Principal Investigators of the PARTNER 3 trial (no compensation). Dr Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, and Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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