Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study

Feasibility and safety of left atrial appendage occlusion guided by procedural fluoroscopy only: A pilot study
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DOI:
10.1111/pace.14292
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发表时间:
2021-06-16
影响因子:
1.8
通讯作者:
Zhong, Jing-Quan
Zhong, Jing-Quan
中科院分区:
工程技术4区
文献类型:
--
作者:
Wang, Juntao;Rong, Bing;Zhong, Jing-Quan

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目的探讨单纯经食管超声心动图(TEE)引导下左心耳封堵术(LAAO)的可行性和安全性。仅在手术荧光透视下进行手术,未伴随GA;通过造影剂血管造影评估器械的位置、形状和泄漏。结果97例房颤患者分别行Watchman装置(n = 49)和LAmbre装置(n = 48)治疗,术后随访3个月,行TEE检查,观察血栓形成情况及装置渗漏情况。Watchman器械组的CHA(2)DS(2)-VASc和HAS-BLED评分低于LAmbre器械组(p < .05);两组的其他基线特征分布相似,(p > .05),包括手术成功率(98.0% vs. 97.9%)、平均手术时间、平均透视时间、总辐射剂量、造影剂剂量、器械周围泄漏百分比。Watchman组中有2例发生需要干预的心包积液。TEE随访未发现3个月时残余渗漏>= 5 mm的患者,也未发现器械相关血栓形成(DRT)。在22.0 ± 11.1个月的随访中,2例患者发生缺血性卒中。结论LAAO与透视的程序成像只显示了有希望的结果的有效性和安全性。需要一项前瞻性随机多中心研究来验证本研究中的观察结果。
Background Left atrial appendage occlusion (LAAO) is usually performed via the guidance of procedural transesophageal echocardiography (TEE) companied by general anesthesia (GA).Objective To investigate the feasibility and safety of LAAO guided by procedural fluoroscopy only.Methods The patients eligible for LAAO were enrolled into the current study and received implantation of either Watchman device or LAmbre device. The procedure was carried out with procedural fluoroscopy only and no companied GA; the position, shape, and leakage of the device were assessed by contrast angiography. TEE was performed after 3-month follow-up to evaluate the thrombosis, and leakage of device.Results Ninety-seven patients with atrial fibrillation (AF) with either Watchman device (n = 49) or LAmbre device (n = 48) were consecutively enrolled. Watchman device group was of lower CHA(2)DS(2)-VASc and HAS-BLED scores compared with LAmbre device groups (p < .05); the two groups had similar distributions of other baseline characteristics (p > .05), including procedural success rate (98.0% vs. 97.9%), mean procedure time, mean fluoroscopy time, total radiation dose, contrast medium dose, percentage of peri-device leakage. Pericardial effusions requiring intervention occurred in two of the Watchman group. TEE follow-up found no patient with residual leakage >= 5 mm at 3 months and no device related thrombosis (DRT). During the 22.0 +/- 11.1 months follow-up, two patients experienced ischemic stroke.Conclusions LAAO with the procedural imaging of fluoroscopy only exhibited the promising results of efficacy and safety. A prospective randomized multicenter study would be required to verify the observations in this study.