Comparison of self- and balloon-expandable valves in patients with dilatated ascending aorta undergoing transcatheter aortic valve replacement

Kang An; Fengwen Zhang; Wenbin Ouyang; Xiangbin Pan

doi:10.21037/jtd-23-364

Comparison of self- and balloon-expandable valves in patients with dilatated ascending aorta undergoing transcatheter aortic valve replacement

J Thorac Dis. 2023 Sep 28;15(9):4826-4835. doi: 10.21037/jtd-23-364. Epub 2023 Aug 30.

Authors

Kang An^{1

2

3

4}, Fengwen Zhang^{1

2

3

4}, Wenbin Ouyang^{1

2

3

4}, Xiangbin Pan^{1

2

3

4}

Affiliations

¹ Department of Structural Heart Disease, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences & Peking Union Medical College, China & Fuwai Hospital, Beijing, China.
² National Health Commission Key Laboratory of Cardiovascular Regeneration Medicine, Beijing, China.
³ Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences, Beijing, China.
⁴ National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.

Abstract

Background: 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.

Methods: 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.

Results: 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% vs. 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% vs. 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].

Conclusions: 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.

Keywords: Transcatheter aortic valve replacement (TAVR); aortic expansion rate; ascending aorta (AA); device success.