Zias Elias, Phillips Katherine G, Gerdisch Marc, Johnson Scott, El-Eshmawi Ahmed, Saum Kenneth, Moront Michael, Kasten Michael, Singh Chanderdeep, Bhatia Gautam, Takayama Hiroo, Damiano Ralph
Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA.
Department of Cardiothoracic Surgery, Franciscan Alliance dba Franciscan Health Indianapolis, 8111 South Emerson Ave, Indianapolis, IN 46237, USA.
J Clin Med. 2025 Aug 4;14(15):5473. doi: 10.3390/jcm14155473.
: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. : This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients ≥18 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. : Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; < 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up.
患有术前或术后心房颤动的心脏手术患者发生血栓栓塞性中风的风险增加，这通常是由于左心耳（LAA）血栓所致。可以进行外科左心耳封堵术（LAAE），且必须彻底完成以避免血栓形成增加。 ：这项前瞻性、多中心、上市后研究（NCT05101993）评估了心外膜V形AtriClip装置的长期安全性和性能。年龄≥18岁且在非急诊心脏手术期间接受V形AtriClip装置的患者同意进行为期12个月的前瞻性随访和LAA成像。主要性能指标是在最后一次随访成像时评估无残留左心房-LAA连通的LAAE。主要安全性指标是30天内与装置或植入手术相关的严重不良事件（SAE）（死亡、大出血、手术部位感染、需要干预的心包积液、心肌梗死）。 ：在美国11个中心的155例患者中，151例患者有可评估的成像结果。所有患者均实现了完全LAAE。在意向性治疗人群中达到了主要性能指标，97%（95%CI 93.52%，99.29%；P=0.0001）实现了完全LAAE。达到了主要安全性指标，100%（95%CI 97.75%，100%；P<0.0001）的患者在30天内无预先定义的SAE。报告了1例与装置相关的SAE，该事件在手术过程中得到解决。结论：AtriClip V形夹子在12个月的随访中显示出安全且成功的LAAE。
