Tang Gilbert H L, Sengupta Aditya, Alexis Sophia L, Bapat Vinayak N, Adams David H, Sharma Samin K, Kini Annapoorna S, Kodali Susheel K, Ramlawi Basel, Gada Hemal, Vora Amit N, Forrest John K, Kaple Ryan K, Liu Fang, Reardon Michael J
Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, New York, USA.
Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, New York, USA.
JACC Cardiovasc Interv. 2021 May 10;14(9):964-976. doi: 10.1016/j.jcin.2021.03.040.
The aim of this study was to assess the outcomes of severe prosthesis-patient mismatch (PPM) in the TVT (Transcatheter Valve Therapy) Registry in patients undergoing supra-annular transcatheter aortic valve replacement (TAVR) for de novo stenosis or failed surgical bioprostheses (transcatheter aortic valve [TAV]-in-surgical aortic valve [SAV]).
Severe PPM has been associated with adverse outcomes following TAVR, yet the clinical outcome of severe PPM after supra-annular TAVR is largely unknown.
Supra-annular TAVR was performed in patients enrolled in the TVT Registry with de novo stenosis (n = 42,174) or TAV-in-SAV (n = 5,446). Valve Academic Research Consortium-3 criteria were used to define severe PPM. The clinical impact of severe PPM on 1-year mortality and valve-related readmission was assessed using multivariate regression. A generalized linear mixed model was used to evaluate predictors of severe PPM.
Severe PPM was found in 5.3% of patients undergoing de novo TAVR and 27.0% of patients undergoing TAV-in-SAV. The presence of severe PPM was not significantly associated with 1-year mortality or valve-related readmissions in both groups. Mean aortic gradients were higher in patients with severe PPM than in those without severe PPM at 1 month (9.7 ± 5.7 mm Hg vs. 7.3 ± 4.0 mm Hg; p < 0.001) and 1 year (10.2 ± 6.4 mm Hg vs. 8.0 ± 4.3 mm Hg; p < 0.001). Pre-procedural factors, including a <20-mm aortic annulus, were positive predictors of severe PPM in patients undergoing de novo TAVR (area under the curve = 0.795) and TAV-in-SAV (area under the curve = 0.764).
Severe PPM after supra-annular TAVR was not associated with increased 1-year mortality or valve-related readmissions. Longer-term follow-up is needed to determine if higher residual gradients in patients with severe PPM predict long-term outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
本研究旨在评估经导管瓣膜治疗(TVT)注册研究中,接受瓣环上经导管主动脉瓣置换术(TAVR)治疗原发性狭窄或外科生物瓣膜失败(经导管主动脉瓣 [TAV] 置入外科主动脉瓣 [SAV])的患者发生严重人工瓣膜-患者不匹配(PPM)的结局。
严重PPM与TAVR后的不良结局相关,但瓣环上TAVR后严重PPM的临床结局在很大程度上尚不清楚。
对TVT注册研究中纳入的原发性狭窄患者(n = 42,174)或TAV-in-SAV患者(n = 5,446)进行瓣环上TAVR。采用瓣膜学术研究联盟-3标准定义严重PPM。使用多因素回归评估严重PPM对1年死亡率和瓣膜相关再入院的临床影响。采用广义线性混合模型评估严重PPM的预测因素。
在接受原发性TAVR的患者中5.3%发现严重PPM,在接受TAV-in-SAV的患者中27.0%发现严重PPM。两组中严重PPM的存在与1年死亡率或瓣膜相关再入院均无显著相关性。严重PPM患者在1个月时(9.7±5.7 mmHg对7.3±4.0 mmHg;p<0.001)和1年时(10.2±6.4 mmHg对8.0±4.3 mmHg;p<0.001)的平均主动脉瓣压差高于无严重PPM的患者。术前因素,包括主动脉瓣环<20 mm,是原发性TAVR患者(曲线下面积 = 0.795)和TAV-in-SAV患者(曲线下面积 = 0.764)严重PPM的阳性预测因素。
瓣环上TAVR后严重PPM与1年死亡率增加或瓣膜相关再入院无关。需要进行长期随访以确定严重PPM患者较高的残余压差是否可预测长期结局。(STS/ACC经导管瓣膜治疗注册研究 [TVT注册研究];NCT01737528)