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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