Liuba Ioan, Younis Arwa, Vasandani Paresh, Sroubek Jakub, Higuchi Koji, Lee Justin, Saliba Walid, Krywanczyk Alison, Nakhla Shady, Bhargava Mandeep, Hussein Ayman, Kanj Mohamed, Kapadia Samir, Wazni Oussama, Santangeli Pasquale
Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Cleveland Clinic Innovations, Cleveland, Ohio.
Heart Rhythm. 2025 Jul;22(7):1728-1735. doi: 10.1016/j.hrthm.2025.03.1977. Epub 2025 Mar 25.
Trans-right atrial appendage (RAA) pericardial insufflation of carbon dioxide can improve safety of percutaneous epicardial access. Dedicated device solutions for safe, effective, and standardized microperforation are needed.
We evaluated the efficacy and safety of a novel radiofrequency (RF)-powered microcatheter specifically designed to facilitate trans-RAA exit to the pericardial space.
Four healthy swine underwent repeated RAA and left atrial appendage (LAA) perforations to access the pericardial space by a dedicated 1.8F microcatheter with an RF tip. Perforations were obtained by delivering short bursts of RF energy (20-25 W, <1 second, "cut" mode). Animals were sacrificed immediately after the experiment, and the hearts were assessed by gross pathologic and histologic examination.
A median number of 7 microperforations/animal (interquartile range, 7-9) were performed in the RAA and 3/animal (interquartile range, 2-3) in the LAA. In 1 animal, a posterolateral right atrial perforation was also performed. All perforations and microcatheter advancements in the pericardial space were successful (<5 seconds). There was no evidence of pericardial effusion by intracardiac echocardiography and no hemodynamic changes with any of the perforations. On pathologic examination, no pericardial effusion was noted, and the atrial perforations could be identified as punctate red areas (0.5-1 mm) in 28 of 31 targeted RAA sites and 5 of 8 targeted LAA sites. Histologic evaluation showed central full-thickness defects with associated acute thrombus formation and surrounded by a small rim of contraction band necrosis.
In this preclinical study, repeated trans-RAA/LAA perforations with pericardial space access were successfully obtained with a dedicated RF-tip 1.8F microcatheter with no evidence of significant pericardial bleeding.
经右心耳（RAA）心包内注入二氧化碳可提高经皮心外膜穿刺的安全性。需要专门的设备解决方案来实现安全、有效和标准化的微穿孔。
我们评估了一种专门设计用于促进经RAA进入心包腔的新型射频（RF）动力微导管的有效性和安全性。
对4只健康猪进行重复的RAA和左心耳（LAA）穿孔，通过带有RF尖端的专用1.8F微导管进入心包腔。通过输送短脉冲RF能量（20 - 25W，<1秒，“切割”模式）获得穿孔。实验结束后立即处死动物，通过大体病理和组织学检查评估心脏。
在RAA中，每只动物平均进行了7次微穿孔（四分位间距，7 - 9），在LAA中为每只动物3次（四分位间距，2 - 3）。在1只动物中，还进行了右心房后外侧穿孔。所有在心包腔内的穿孔和微导管推进均成功（<5秒）。经心内超声心动图检查未发现心包积液的证据，且任何穿孔均未引起血流动力学变化。病理检查未发现心包积液，在31个靶向RAA部位中的28个和8个靶向LAA部位中的5个，心房穿孔可被识别为点状红色区域（0.5 - 1mm）。组织学评估显示中央全层缺损，伴有急性血栓形成，并被一小圈收缩带坏死包围。
在这项临床前研究中，使用专用的带RF尖端的1.8F微导管成功实现了经RAA/LAA的重复穿孔并进入心包腔，未发现明显心包出血的证据。
