Eng Marvin H, Abbas Amr E, Hahn Rebecca T, Lee James, Wang Dee Dee, Eleid Mackram F, O'Neill William W
Department of Medicine, Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan, USA.
Department of Cardiovascular Medicine, Beaumont Health, Royal Oak, Michigan, USA.
Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1185-1192. doi: 10.1002/ccd.29756. Epub 2021 May 13.
OBJECTIVE/BACKGROUND: Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics.
Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality.
After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality.
SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization.
目的/背景：与较大尺寸的瓣膜相比，小型球囊可扩张瓣膜的超声心动图跨瓣压差和人工瓣膜-患者不匹配（PPM）发生率更高。然而，这些超声心动图表现对临床结局的影响尚不清楚。我们试图确定20毫米SAPIEN 3（S3 BEV）与较大尺寸S3 BEV相比，在超声心动图血流动力学方面的临床结局。
利用STS/ACC经导管瓣膜注册研究，我们对经股动脉、球囊扩张植入20毫米和≥23毫米S3 BEV治疗原发性主动脉瓣狭窄的患者进行了倾向匹配比较。分析了基线和手术特征、超声心动图变量及生存率。采用多变量逻辑回归确定1年死亡率的预测因素。
对20毫米和≥23毫米SAPIEN 3瓣膜进行倾向匹配后，确定了3931对具有可比基线特征的配对。小型瓣膜在出院时的超声心动图压差显著更高（15.7±7.1 mmHg对11.7±5.5 mmHg，p<0.0001），重度PPM发生率也更高（21.5%对9.7%，p<0.0001）。两组之间1年全因死亡率（20毫米：13.0%对≥23毫米：12.7%，p = 0.72）或其他主要不良事件发生率及结局无显著差异。基于多变量分析，出院时平均压差升高（>20 mmHg）、重度PPM以及使用20毫米瓣膜与≥23毫米瓣膜并非1年死亡率的独立预测因素。
与较大尺寸瓣膜相比，20毫米SAPIEN 3瓣膜的超声心动图压差更高，重度PPM发生率也更高，但这些因素与1年全因死亡率或再次住院的显著差异无关。
