An Kang, Zhang Fengwen, Ouyang Wenbin, Pan Xiangbin
Department of Structural Heart Disease, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, China & Fuwai Hospital, Beijing, China.
National Health Commission Key Laboratory of Cardiovascular Regeneration Medicine, Beijing, China.
J Thorac Dis. 2023 Sep 28;15(9):4826-4835. doi: 10.21037/jtd-23-364. Epub 2023 Aug 30.
Limited studies have focused on the performance of self-expandable valves (SEVs) and balloon-expandable valves (BEVs) in patients with dilatated ascending aorta (AA) undergoing transcatheter aortic valve replacement (TAVR). The present study compared the performance of widely used Edwards BEVs and domestic SEVs in patients with dilatated AA among Chinese population.
We identified and reviewed 207 patients who had baseline AA diameter ≥40 mm and underwent transfemoral TAVR. Patients were divided into two groups: SEV and BEV. The SEVs were locally manufactured valves that have received Chinese regulatory approval (Venus-A, Taurus One, and VitaFlow), while the BEVs were Edwards Sapien XT and Sapien3. Procedural device success and post-procedural changes of AA diameters were compared.
The sample size of SEV group was larger than that of BEV group because BEVs were not available in China in the early clinical practice. The overall device success was slightly lower in SEV group compared with BEV group (84.2% . 95.8%, P=0.213). However, in the univariable and multivariable logistic regression analyses, only bicuspid aortic valve (BAV) was found to be an independent risk factor for device failure (OR: 2.632, CI: 1.107-6.257, P=0.029). During the median follow-up of 21 months, no statistical difference was found between the two groups regarding the overall survival (83.1%±4.7% . 95.8%±4.1%, P=0.533), and no aortic dissection nor rupture was observed. In a subgroup of patients who had follow-up CTs ≥12-month intervals, the AA diameter appeared to remain stable in SEV group with an aortic expansion rate of 0 (-0.4 to 0.8) mm (P=0.102), while it slightly enlarged in BEV group with an aortic expansion rate of 0.4 (-0.4 to 0.6) mm/y (P=0.038). In addition, the AA diameter also slightly enlarged in patients with BAV [0.2 (0 to 1.0) mm/y, P=0.015], while it remained stable in patients with tricuspid aortic valve (TAV) [0 (-0.8 to 0.6) mm/y, P=0.640].
In patients with dilatated AA who underwent TAVR, the type of THVs did not affect the procedural device success. BAV appeared to be a risk factor for both device failure and higher aortic expansion rate in these patients.
关于经导管主动脉瓣置换术（TAVR）治疗升主动脉扩张（AA）患者时自膨胀瓣膜（SEV）和球囊扩张瓣膜（BEV）性能的研究有限。本研究比较了中国人群中广泛使用的爱德华兹BEV和国产SEV在AA扩张患者中的性能。
我们确定并回顾了207例基线AA直径≥40mm且接受经股动脉TAVR的患者。患者分为两组：SEV组和BEV组。SEV为已获得中国监管批准的国产瓣膜（Venus-A、Taurus One和VitaFlow），而BEV为爱德华兹Sapien XT和Sapien3。比较手术器械成功率和术后AA直径的变化。
由于早期临床实践中中国无法获得BEV，SEV组的样本量大于BEV组。与BEV组相比，SEV组的总体器械成功率略低（84.2%对95.8%，P = 0.213）。然而，在单变量和多变量逻辑回归分析中，仅发现二叶式主动脉瓣（BAV）是器械失败的独立危险因素（OR：2.632，CI：1.107 - 6.257，P = 0.029）。在21个月的中位随访期内，两组在总生存率方面无统计学差异（83.1%±4.7%对95.8%±4.1%，P = 0.533），且未观察到主动脉夹层或破裂。在随访CT间隔≥12个月的患者亚组中，SEV组的AA直径似乎保持稳定，主动脉扩张率为0（-0.4至0.8）mm（P = 0.102），而BEV组的AA直径略有增大，主动脉扩张率为0.4（-0.4至0.6）mm/年（P = 0.038）。此外，BAV患者的AA直径也略有增大[0.2（0至1.0）mm/年，P = 0.015]，而三叶式主动脉瓣（TAV）患者的AA直径保持稳定[0（-0.8至0.6）mm/年，P = 0.640]。
在接受TAVR的AA扩张患者中，经导管心脏瓣膜（THV）的类型不影响手术器械成功率。BAV似乎是这些患者器械失败和较高主动脉扩张率的危险因素。
