Sommer Robert J, Kim Jamie H, Szerlip Molly, Chandhok Sheetal, Sugeng Lissa, Cain Christopher, Kaplan Aaron V, Gray William A
Columbia University Medical Center, NY, New York, USA.
Catholic Medical Center, Manchester, New Hampshire, USA.
JACC Cardiovasc Interv. 2021 Nov 8;14(21):2368-2374. doi: 10.1016/j.jcin.2021.08.060.
The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.
The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.
Patients with atrial fibrillation at high stroke risk (CHADS-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year.
Twenty-two patients (63.7% with CHADS-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization.
This first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.
作者报告了使用保形左心耳封堵（CLAAS）装置的首例临床经验。
CLAAS装置旨在解决第一代左心耳封堵（LAAC）装置的局限性，提供一种微创植入物，可采用非同轴方式部署，且术后无需口服抗凝药。
采用标准选择标准招募高卒中风险（CHADS-VASc评分≥2）的房颤患者。LAAC手术在全身麻醉下由经食管超声心动图引导进行。CLAAS装置由一个泡沫杯组成，带有镍钛诺内骨骼和膨体聚四氟乙烯覆盖层，通过标准输送系统使用系绳进行完全回收输送。所有患者接受6个月的双联抗血小板治疗，随后单独服用阿司匹林。计划在45天和1年时进行经食管超声心动图随访。
共纳入22例患者（63.7%的CHADS-VASc评分≥3，76.2%的HAS-BLED评分≥3）。该装置成功植入18例患者，4例植入失败。无严重手术并发症。在45天时进行的经食管超声心动图检查中，发现1处严重渗漏（≥5毫米），这是由于植入时未发现的一个大的后叶所致，还发现1例与装置相关的血栓，经口服抗凝治疗后消失。无围手术期卒中、大量心包积液或全身性或装置性栓塞。
这项首次人体研究证明了CLAAS装置用于LAAC的临床可行性。
