Kim Won-Keun, Praz Fabien, Blumenstein Johannes, Liebetrau Christoph, Gaede Luise, Van Linden Arnaud, Hamm Christian, Walther Thomas, Windecker Stephan, Möllmann Helge
Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
Department of Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany.
Catheter Cardiovasc Interv. 2017 Jan;89(1):E38-E43. doi: 10.1002/ccd.26464. Epub 2016 Mar 4.
The purpose of the present study was to investigate whether transfemoral implantation of the balloon-expandable Edwards SAPIEN 3 device without prior balloon valvuloplasty is feasible.
Transcatheter aortic valve implantation (TAVI) without predilatation may be advantageous and is feasible with various transcatheter heart valves.
A total of 163 consecutive patients with severe aortic stenosis undergoing transfemoral TAVI were enrolled at two sites. We assessed whether the crossing of the native aortic valve with the prosthesis without prior pre-dilation was feasible and evaluated for procedural success according to VARC-2 criteria.
Direct implantation without pre-dilatation was feasible in 154 patients (94.5%), whereas in nine patients predilatation was required due to difficulties while crossing the native aortic valve. Procedural success was achieved in 85.6%. A large proportion of the procedural failures was mainly driven by increased post-procedural gradients ≥20 mm Hg, which almost exclusively concerned the smaller prostheses sizes (23-mm 10/39 (25.6%) vs. 26-mm 5/72 (6.9%) vs. 29-mm 1/52 (1.9%); P < 0.001). Patients in the pre-ballooning group had higher calcium scores of the aortic valve (5,335 [4,421-7,807] vs. 2,893 [1,879-3,993]), more advanced age, higher transvalvular gradients, and smaller aortic valve area.
The transfemoral implantation of the balloon-expandable SAPIEN 3 prosthesis without pre-dilatation is feasible in the majority of cases. In the presence of severe aortic valve calcification and critical aortic stenosis, however, predilatation may still be necessary. Furthermore, the significance of increased post-procedural gradients requires further verification. © 2016 Wiley Periodicals, Inc.
本研究旨在探讨在不进行球囊瓣膜成形术的情况下经股动脉植入球囊扩张式爱德华兹SAPIEN 3瓣膜装置是否可行。
不进行预扩张的经导管主动脉瓣植入术（TAVI）可能具有优势，并且对于各种经导管心脏瓣膜来说都是可行的。
在两个地点共纳入了163例连续接受经股动脉TAVI的重度主动脉瓣狭窄患者。我们评估了在不进行预扩张的情况下将人工瓣膜穿过天然主动脉瓣是否可行，并根据VARC-2标准评估手术成功率。
154例患者（94.5%）在不进行预扩张的情况下直接植入是可行的，而9例患者由于穿过天然主动脉瓣困难而需要进行预扩张。手术成功率为85.6%。大部分手术失败主要是由于术后梯度增加≥20 mmHg，这几乎完全涉及较小尺寸的人工瓣膜（23 mm的10/39（25.6%） vs. 26 mm的5/72（6.9%） vs. 29 mm的1/52（1.9%）；P < 0.001）。预扩张组患者的主动脉瓣钙积分更高（5335 [4421 - 7807] vs. 2893 [1879 - 3993]），年龄更大，跨瓣梯度更高，主动脉瓣面积更小。
在大多数情况下，不进行预扩张经股动脉植入球囊扩张式SAPIEN 3人工瓣膜是可行的。然而，在存在严重主动脉瓣钙化和严重主动脉瓣狭窄的情况下，预扩张可能仍然是必要的。此外，术后梯度增加的意义需要进一步验证。© 2016威利期刊公司
