第三代和第四代球囊扩张式经导管主动脉瓣窦内和下游的血流动力学。
Flow dynamics in the sinus and downstream of third and fourth generation balloon expandable transcatheter aortic valves.
机构信息
Department of Biomedical Engineering, Michigan Technological University, Houghton, MI, USA.
Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
出版信息
J Mech Behav Biomed Mater. 2022 Mar;127:105092. doi: 10.1016/j.jmbbm.2022.105092. Epub 2022 Jan 17.
OBJECTIVE
The early success of transcatheter aortic valve (TAV) replacement (TAVR) has fueled further innovations in the field leading to the emergence multiple iterations of TAV designs. Whether these newer designs are associated with similar hemodynamic outcomes remains unknown. Recently, the SAPIEN 3 Ultra valve received FDA approval for use in patients with published clinical outcomes. The aim of this study is (1) to evaluate and compare the flow dynamics downstream of the SAPIEN 3 Ultra and a SAPIEN 3 (2) and to evaluate and compare the resulting sinus hemodynamics and washout characteristics for a complete hemodynamic characterization.
METHODS
The hemodynamic assessment was performed in a pulse duplicating system and particle image velocimetry was used to assess the flow dynamics. Pressure gradient (ΔP), effective orifice area (EOA), leakage fraction (LF), velocity in the flow downstream and the sinus, viscous shear stress (VSS) downstream and adjacent to the leaflet in the sinus, and sinus washout were calculated.
RESULTS
EOA for the SAPIEN 3 Ultra was 1.81 ± 0.05 cm and 1.86 ± 0.05 cm with the SAPIEN 3, ΔP with the SAPIEN 3 Ultra was 10.56 ± 0.62 mmHg and 14.73 ± 0.79 mmHg with the SAPIEN 3, and LF with the SAPIEN 3 Ultra was 10.4 ± 0.5% and 9.7 ± 0.4% with the SAPIEN 3 (p<0.05). The instantaneous VSS for both valves ≤15 Pa, which is not sufficient to induce hemolysis, but may lead to platelet activation. RSS - an indicator of blood damage - exceeded 100 Pa at peak systole with both TAVs. The sinus velocity at peak systole was 0.24 ± 0.08 m/s with the SAPIEN 3 Ultra and 0.22 ± 0.10 m/s with the SAPIEN 3. VSS range reached 3.9 Pa with the SAPIEN 3 Ultra and 4.0 Pa with the SAPIEN 3. Complete sinus washout was achieved in ∼1.5 and ∼2.4 cardiac cycles for the SAPIEN 3 Ultra and SAPIEN 3, respectively.
CONCLUSION
Compared to its predecessor, the hemodynamic performance and sinus hemodynamics of SAPIEN 3 Ultra are comparable.
目的
经导管主动脉瓣置换术（TAVR）的早期成功推动了该领域的进一步创新，出现了多种经导管主动脉瓣设计的迭代。这些新设计是否与类似的血流动力学结果相关仍不得而知。最近，SAPIEN 3 Ultra 瓣膜获得了 FDA 批准用于有公布临床结果的患者。本研究的目的是：（1）评估和比较 SAPIEN 3 Ultra 和 SAPIEN 3 下游的血流动力学；（2）评估和比较窦内血流动力学和冲洗特性，以进行完整的血流动力学特征描述。
方法
血流动力学评估在脉动复制系统中进行，并使用粒子图像测速法评估流场动力学。计算压力梯度（ΔP）、有效开口面积（EOA）、泄漏分数（LF）、下游和窦内的流速、窦内和瓣叶附近的粘性剪切应力（VSS）以及窦内冲洗。
结果
SAPIEN 3 Ultra 的 EOA 为 1.81±0.05cm，SAPIEN 3 的 EOA 为 1.86±0.05cm，SAPIEN 3 Ultra 的 ΔP 为 10.56±0.62mmHg，SAPIEN 3 的 ΔP 为 14.73±0.79mmHg，SAPIEN 3 Ultra 的 LF 为 10.4±0.5%，SAPIEN 3 的 LF 为 9.7±0.4%（p<0.05）。两种瓣膜的瞬时 VSS 均≤15Pa，不足以诱导溶血，但可能导致血小板激活。RSS（血液损伤的指标）在两种 TAV 中均在收缩期峰值时超过 100Pa。SAPIEN 3 Ultra 在收缩期峰值时窦内速度为 0.24±0.08m/s，SAPIEN 3 为 0.22±0.10m/s。SAPIEN 3 Ultra 的 VSS 范围达到 3.9Pa，SAPIEN 3 为 4.0Pa。SAPIEN 3 Ultra 和 SAPIEN 3 的窦完全冲洗分别在约 1.5 和 2.4 个心动周期内完成。
结论
与前代产品相比，SAPIEN 3 Ultra 的血流动力学性能和窦内血流动力学性能相当。
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