From the Quebec Heart and Lung Institute, Quebec City, Quebec, Canada (J.-R.C., P.P., E.D.); Mayo Clinic, Rochester, MN (R.M.S.); Columbia University Medical Center/NewYork Presbyterian Hospital (S.K., R.T.H., M.B.L.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.); Cleveland Clinic, OH (L.G.S.); and Cardiovascular Research Foundation, New York, NY (K.X.).
Circ Cardiovasc Interv. 2014 Oct;7(5):701-11. doi: 10.1161/CIRCINTERVENTIONS.114.001681. Epub 2014 Sep 30.
The objective was to evaluate the effects of aortic annulus size on valve hemodynamics and clinical outcomes in those patients included in the Placement of Aortic Transcatheter Valves (PARTNER) randomized controlled trial cohort A and the nonrandomized continued access cohort.
Patients included the randomized controlled trial (n=574) and nonrandomized continued access (n=1358) cohorts were divided in tertiles according to aortic annulus diameter (small aortic annulus tertile, medium aortic annulus tertile, and large aortic annulus tertile [LAA], respectively) as measured by transthoracic echocardiography. Severe prosthesis-patient mismatch was defined as an effective aortic orifice area of <0.65 cm(2)/m(2). In the randomized controlled trial cohort, patients in the small aortic annulus tertile who underwent transcatheter aortic valve replacement had a lower incidence of severe prosthesis-patient mismatch (19.7% versus 37.5%; P=0.03) and only a trend toward a higher incidence of moderate-to-severe paravalvular leaks compared with surgical aortic valve replacement (5.7% versus 0%; P=0.06). In the LAA tertile, there were no differences in the rate of prosthesis-patient mismatch between groups, and a significant increase in moderate-to-severe paravalvular leaks was associated with transcatheter aortic valve replacement (9% versus 0%; P=0.01). There were no differences in mortality between transcatheter aortic valve replacement and surgical aortic valve replacement. In the nonrandomized continued access cohort, there were no differences in prosthesis-patient mismatch between the small aortic annulus and LAA tertiles, but a higher rate of moderate-to-severe paravalvular leaks was observed in the LAA tertile (5.9% versus 11.5%; P=0.009). Patients in the LAA tertile had a higher mortality rate at 1-year follow-up (P=0.02), and differences persisted in multivariable analysis (P=0.048 for LAA versus medium aortic annulus tertile, P=0.035 for LAA versus small aortic annulus tertile).
Aortic annulus size had a major impact on valve hemodynamics and clinical outcomes after transcatheter aortic valve replacement and surgical aortic valve replacement. This study highlights the importance of considering aortic annulus size in the evaluation of high-risk patients who are candidates for aortic valve replacement.
http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
本研究旨在评估主动脉瓣环大小对接受经导管主动脉瓣置换术（PARTNER）随机对照试验队列 A 和非随机继续治疗队列患者的瓣膜血流动力学和临床结局的影响。
根据经胸超声心动图测量的主动脉瓣环直径（小主动脉瓣环环组、中主动脉瓣环环组和大主动脉瓣环环组[LAA]），将纳入的随机对照试验（n=574）和非随机继续治疗（n=1358）队列患者分为三分位。重度假体-患者不匹配定义为有效主动脉瓣口面积<0.65 cm²/m²。在随机对照试验队列中，接受经导管主动脉瓣置换术的小主动脉瓣环环组患者严重假体-患者不匹配的发生率较低（19.7% vs. 37.5%；P=0.03），且仅与外科主动脉瓣置换术相比，中重度瓣周漏的发生率有升高趋势（5.7% vs. 0%；P=0.06）。在 LAA 三分位组中，两组之间的假体-患者不匹配发生率无差异，且与经导管主动脉瓣置换术相关的中重度瓣周漏显著增加（9% vs. 0%；P=0.01）。经导管主动脉瓣置换术与外科主动脉瓣置换术之间的死亡率无差异。在非随机继续治疗队列中，小主动脉瓣环环组和 LAA 三分位组之间的假体-患者不匹配无差异，但 LAA 三分位组中中重度瓣周漏的发生率较高（5.9% vs. 11.5%；P=0.009）。LAA 三分位组患者在 1 年随访时死亡率较高（P=0.02），且多变量分析中差异仍存在（LAA 与中主动脉瓣环环三分位相比，P=0.048；LAA 与小主动脉瓣环环三分位相比，P=0.035）。
主动脉瓣环大小对经导管主动脉瓣置换术和外科主动脉瓣置换术后瓣膜血流动力学和临床结局有重大影响。本研究强调了在评估高危主动脉瓣置换候选患者时，考虑主动脉瓣环大小的重要性。
