Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
University of British Columbia and St. Paul's Hospital, Vancouver, Canada.
JACC Cardiovasc Imaging. 2019 Jan;12(1):25-34. doi: 10.1016/j.jcmg.2018.04.010. Epub 2018 Jun 13.
This study aims to establish parameters for identifying normal function for each of the 3 iterations of balloon-expandable valves and 2 iterations of self-expanding valves.
Expected transthoracic echocardiographic Doppler-derived hemodynamic data for transcatheter aortic valves inform pre-implant decision-making and post-implanted monitoring of longitudinal valve function.
We collected the echocardiography core Lab measured mean gradients and effective orifice area (EOA) from discharge or 30-day echocardiograms from randomized trials; the PARTNER (Placement of Aortic Transcatheter Valves) trials for the balloon-expandable valves and the Medtronic CoreValve US Pivotal trial and Medtronic CoreValve Evolut R United States IDE Clinical Study for the self-expanding valves.
For all SAPIEN (Edwards Lifesciences, Irvine, California) valve sizes, mean EOA is 1.70 ± 0.49 cm with a mean gradient of 9.36 ± 4.13 mm Hg. For all SAPIEN XT valve sizes, mean EOA is 1.67 ± 0.46 cm with a mean gradient of 9.52 ± 3.64 mm Hg. For all SAPIEN 3 valve sizes, the mean EOA is 1.66 ± 0.38 cm with a mean gradient of 11.18 ± 4.35 mm Hg. For all CoreValve valve sizes, the mean EOA is 1.88 ± 0.56 cm with a mean gradient of 8.85 ± 4.14 mm Hg. For all Evolut R valve sizes, the mean EOA is 2.01 ± 0.65 cm with a mean gradient of 7.52 ± 3.19 mm Hg. The SAPIEN 3 post-implant EOA was progressively larger for each quintile of baseline annular area by computed tomography (p < 0.001). Similarly, for the Evolut R valve, post-implantation EOA was significantly larger for each quintile of baseline annular perimeter (p < 0.001).
Tables of expected mean transcatheter aortic valve hemodynamics by valve type and size are essential in evaluating the function of these transcatheter prosthetic valves. Tables of expected EOA by the native annular anatomy may be useful for pre-implantation decision making. Criteria for defining structural valve dysfunction are proposed.
本研究旨在为每个球囊扩张瓣膜的 3 个迭代和 2 个自扩张瓣膜迭代建立识别正常功能的参数。
经导管主动脉瓣的预期经胸超声心动图多普勒衍生血流动力学数据可用于指导植入前决策和植入后监测纵向瓣膜功能。
我们从随机试验的出院或 30 天超声心动图中收集了超声心动图核心实验室测量的平均梯度和有效瓣口面积（EOA）；球囊扩张瓣膜的 PARTNER（放置主动脉经导管瓣膜）试验以及美敦力 CoreValve US 关键试验和美敦力 CoreValve Evolut R 美国 IDE 临床研究的自扩张瓣膜。
对于所有 SAPIEN（爱德华兹生命科学公司，加利福尼亚州欧文）瓣膜尺寸，平均 EOA 为 1.70 ± 0.49 cm，平均梯度为 9.36 ± 4.13 mmHg。对于所有 SAPIEN XT 瓣膜尺寸，平均 EOA 为 1.67 ± 0.46 cm，平均梯度为 9.52 ± 3.64 mmHg。对于所有 SAPIEN 3 瓣膜尺寸，平均 EOA 为 1.66 ± 0.38 cm，平均梯度为 11.18 ± 4.35 mmHg。对于所有 CoreValve 瓣膜尺寸，平均 EOA 为 1.88 ± 0.56 cm，平均梯度为 8.85 ± 4.14 mmHg。对于所有 Evolut R 瓣膜尺寸，平均 EOA 为 2.01 ± 0.65 cm，平均梯度为 7.52 ± 3.19 mmHg。SAPIEN 3 植入后 EOA 随基线瓣环面积的每五分位递增而逐渐增大（p < 0.001）。同样，对于 Evolut R 瓣膜，植入后 EOA 随基线瓣环周长的每五分位递增而显著增大（p < 0.001）。
按瓣膜类型和尺寸列出的预期经导管主动脉瓣血流动力学的表格对于评估这些经导管人工瓣膜的功能至关重要。根据固有瓣环解剖结构列出的预期 EOA 表格可能有助于植入前决策。提出了用于定义结构性瓣膜功能障碍的标准。
