PDF(Pubmed)
Abstract：
UNASSIGNED: We aim to establish the degree of agreement related to gradient measurement during transcatheter aortic valve replacement (TAVR) between the OpSens OptoWire III and its new proprietary TAVR algorithm and hemodynamic value derived by catheterization and echocardiogram (transthoracic echocardiogram and transesophageal echocardiogram).
UNASSIGNED: The current study was a prospective, single-arm, single-center study. All subjects underwent hemodynamic assessment before and after TAVR using standard hemodynamic assessment using 2 pigtails, transthoracic echocardiogram, transesophageal echocardiogram, and the OpSens OptoWire III. The primary end point was the final post-TAVR mean gradient correlation between OpSens OptoWire III and hemodynamic values derived by catheterization.
UNASSIGNED: Between July 2021 and September 2021, 20 patients were enrolled. The median age was 79 [6.5] years, and 9 (45%) patients were female. The mean gradient before TAVR derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (35 ± 14 mm Hg vs 35 ± 14 mm Hg, P = 1.00), with an absolute mean difference of 2.2 ± 3.5 mm Hg and a strong correlation (r = 0.96, P < .0001). After TAVR, the mean gradient derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (2.2 ± 3.5 vs 2.8 ± 2.7, P = .16), with an absolute mean difference of 1.2 ± 1.3 mm Hg and a strong correlation (r = 0.89, P < .0001).
UNASSIGNED: Hemodynamic assessment derived by the OpSens OptoWire III wire and its new TAVR algorithm demonstrated excellent correlation with measurements derived by 2 pigtails both before and after TAVR. Integration of this new technology within a dedicated TAVR wire with live hemodynamic assessment could bring meaningful value to TAVR operators.
UNASSIGNED: The current study was a prospective, single-arm, single-center study. All subjects underwent hemodynamic assessment before and after TAVR using standard hemodynamic assessment using 2 pigtails, transthoracic echocardiogram, transesophageal echocardiogram, and the OpSens OptoWire III. The primary end point was the final post-TAVR mean gradient correlation between OpSens OptoWire III and hemodynamic values derived by catheterization.
UNASSIGNED: Between July 2021 and September 2021, 20 patients were enrolled. The median age was 79 [6.5] years, and 9 (45%) patients were female. The mean gradient before TAVR derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (35 ± 14 mm Hg vs 35 ± 14 mm Hg, P = 1.00), with an absolute mean difference of 2.2 ± 3.5 mm Hg and a strong correlation (r = 0.96, P < .0001). After TAVR, the mean gradient derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (2.2 ± 3.5 vs 2.8 ± 2.7, P = .16), with an absolute mean difference of 1.2 ± 1.3 mm Hg and a strong correlation (r = 0.89, P < .0001).
UNASSIGNED: Hemodynamic assessment derived by the OpSens OptoWire III wire and its new TAVR algorithm demonstrated excellent correlation with measurements derived by 2 pigtails both before and after TAVR. Integration of this new technology within a dedicated TAVR wire with live hemodynamic assessment could bring meaningful value to TAVR operators.
摘要：
■我们的目标是在OpSensOptoWireIII及其新的专有TAVR算法与导管插入术和超声心动图（经胸超声心动图和经食道超声心动图）得出的血液动力学值之间建立与经导管主动脉瓣置换术（TAVR）期间梯度测量相关的一致性程度。
■当前的研究是前瞻性的，单臂,单中心研究。所有受试者在TAVR之前和之后都进行了血液动力学评估，使用标准的血液动力学评估，使用2根辫子，经胸超声心动图,经食管超声心动图,和OpSensOptoWireIII。主要终点是OpSensOptoWireIII与导管插入术得出的血液动力学值之间的最终TAVR后平均梯度相关性。
■在2021年7月至2021年9月之间，招募了20名患者。中位年龄为79[6.5]岁,9（45％）患者为女性。通过2-pigtail技术得出的TAVR之前的平均梯度与使用OpSensOptoWireIII的平均梯度相似（35±14mmHgvs35±14mmHg，P=1.00),绝对平均差为2.2±3.5mmHg，具有很强的相关性(r=0.96，P<.0001)。在TAVR之后，2-pigtail技术得出的平均梯度和使用OpSensOptoWireIII的平均梯度相似（2.2±3.5vs2.8±2.7，P=.16），绝对平均差为1.2±1.3mmHg，具有很强的相关性（r=0.89，P<.0001）。
■由OpSensOptoWireIII导线及其新的TAVR算法得出的血液动力学评估与TAVR之前和之后的2根光纤得出的测量值具有极好的相关性。将这项新技术集成到具有实时血液动力学评估的专用TAVR线中，可以为TAVR操作员带来有意义的价值。
■当前的研究是前瞻性的，单臂,单中心研究。所有受试者在TAVR之前和之后都进行了血液动力学评估，使用标准的血液动力学评估，使用2根辫子，经胸超声心动图,经食管超声心动图,和OpSensOptoWireIII。主要终点是OpSensOptoWireIII与导管插入术得出的血液动力学值之间的最终TAVR后平均梯度相关性。
■在2021年7月至2021年9月之间，招募了20名患者。中位年龄为79[6.5]岁,9（45％）患者为女性。通过2-pigtail技术得出的TAVR之前的平均梯度与使用OpSensOptoWireIII的平均梯度相似（35±14mmHgvs35±14mmHg，P=1.00),绝对平均差为2.2±3.5mmHg，具有很强的相关性(r=0.96，P<.0001)。在TAVR之后，2-pigtail技术得出的平均梯度和使用OpSensOptoWireIII的平均梯度相似（2.2±3.5vs2.8±2.7，P=.16），绝对平均差为1.2±1.3mmHg，具有很强的相关性（r=0.89，P<.0001）。
■由OpSensOptoWireIII导线及其新的TAVR算法得出的血液动力学评估与TAVR之前和之后的2根光纤得出的测量值具有极好的相关性。将这项新技术集成到具有实时血液动力学评估的专用TAVR线中，可以为TAVR操作员带来有意义的价值。
