5-Year Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.
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Hahn Rebecca T, Ternacle Julien, Silva Iria, Giuliani Carlos, Zanuttini Antonela, Théron Alexis, Cristell Nicole, Bernier Mathieu, Skaf Sabah, Beaudoin Jonathan, Kodali Susheel K, Russo Mark, Kapadia Samir R, Malaisrie Chris S, Cohen David J, Leipsic Jonathon, Blanke Philipp, Williams Mathew R, McCabe James M, Brown David L, Babaliaros Vasilis, Goldman Scott, Szeto Wilson Y, Généreux Philippe, Pershad Ashish, Park Brandon, Gunnarsson Marissa, Webb John G, Smith Craig R, Makkar Raj, Thourani Vinod H, Mack Michael J, Leon Martin B, Pibarot Philippe, PARTNER 3 Investigators
Аннотация
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).