Hospital Clinic de Barcelona, Institut Clinic Cardiovascular, IDIBAPS, Barcelona, Spain.
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Catheter Cardiovasc Interv. 2022 Nov;100(5):801-809. doi: 10.1002/ccd.30406. Epub 2022 Sep 24.
The present article aims to compare a novel sizing chart based on both maximum and minimum diameters (novel MATRIX) with the current sizing recommendation instructions for use (IFU) based on the maximum diameter.
Current IFU with the Amulet device are still based on the maximum left atrial appendage (LAA) diameter, which might lead to inappropriate oversizing, especially in elliptic appendages.
This was a retrospective analysis of patients undergoing LAA occlusion in two high-volume centers. Two hundred patients were included (100 patients with baseline cardiac computed tomography angiography [CCTA] and 100 with baseline 2D and 3D-transesophageal echocardiography [TEE]). The degree of concordance between the predicted device size recommendation and the actual device selection was the primary outcome.
The novel MATRIX showed a higher level of concordance between the predicted and implanted device size, regardless of imaging modalities. CCTA showed the strongest, and 2D-TEE the weakest concordance between the predicted and implanted device for both MATRIX and IFU charts. The percentage of patients in whom the disagreement among the predicted and implanted device represented >1 size was higher when using the IFU chart. In elliptical LAA anatomies, the differences favoring the use of MATRIX compared to the IFU in terms of predicted/implanted agreement were higher. Finally, no significant differences in clinical or imaging endpoints were observed between the two different sizing charts.
Incorporating both the LAA maximum and minimum diameters, as opposed to just maximum diameter, appears to improve sizing accuracy. The proposed MATRIX sizing chart offered a higher level of concordance between predicted and implanted device compared to the current IFU.
本文旨在比较一种基于最大和最小直径的新型尺寸图（新型 MATRIX）与目前基于最大直径的使用说明（IFU）。
目前 Amulet 装置的 IFU 仍然基于左心耳（LAA）的最大直径，这可能导致不合适的过度尺寸选择，尤其是在椭圆形心耳中。
这是对两个大容量中心接受 LAA 闭塞治疗的患者进行的回顾性分析。共纳入 200 例患者（基线心脏计算机断层扫描血管造影术 [CCTA] 100 例，基线 2D 和 3D 经食管超声心动图 [TEE] 100 例）。主要结局是预测设备尺寸推荐与实际设备选择之间的一致性程度。
新型 MATRIX 无论采用何种成像方式，在预测和植入设备尺寸之间均显示出更高的一致性。CCTA 在预测和植入设备之间显示出最强的一致性，而 2D-TEE 则显示出最弱的一致性，无论是对于 MATRIX 还是 IFU 图表。使用 IFU 图表时，预测和植入设备之间的差异表示 >1 个尺寸的患者比例更高。在椭圆形 LAA 解剖结构中，与 IFU 相比，使用 MATRIX 的优势在于预测/植入的一致性更高。最后，两种不同的尺寸图表之间在临床或成像终点方面没有观察到显著差异。
与仅使用最大直径相比，同时考虑 LAA 的最大和最小直径似乎可以提高尺寸准确性。与当前 IFU 相比，提出的 MATRIX 尺寸图在预测和植入设备之间具有更高的一致性。
