Liu Qian, You Ling, Yang Jing, Zhang Yan, Wu Jinglan, Yin Hongning, Zhang Yanan, Xie Ruiqin
Department of Cardiology, The Second Hospital of Hebei Medical University, 050000 Shijiazhuang, Hebei, China.
Department of Cardiac Ultrasound, The Second Hospital of Hebei Medical University, 050000 Shijiazhuang, Hebei, China.
Rev Cardiovasc Med. 2024 May 27;25(6):192. doi: 10.31083/j.rcm2506192. eCollection 2024 Jun.
The goal of this study was to compare the procedural safety and long-term outcome associated with a combined catheter ablation and left atrial appendage occlusion (LAAO) procedure utilizing intracardiac echocardiography (ICE) guidance versus transesophageal echocardiography (TEE) guidance. The study focuses on implementing LAmbre and Watchman devices in patients diagnosed with nonvalvular atrial fibrillation (AF).
A total of 363 patients diagnosed with nonvalvular AF and who underwent a combined procedure were prospectively enrolled between November 2017 and May 2022. Following 1:1 propensity score matching, the TEE group (n = 132) and ICE group (n = 132) were systematically compared in terms of the combined procedure, imaging parameters, events related to the procedure, and subsequent outcomes during follow-up, including mortality, stroke, bleeding, device-related thrombus (DRT), and peri-device leaks (PDLs).
The ICE group exhibited a significant reduction in total procedural duration (153.71 31.71 vs. 174.74 18.79 min), fluoroscopy radiation dosage (207.24 108.39 vs. 268.61 122.88 mGy), left atrial appendage occlusion procedure time (34.69 10.91 vs. 51.46 15.84 min), and contrast agent exposure (108.71 37.59 vs. 158.41 45.00 mL) compared to the TEE group. Angiography and ICE demonstrated a substantial correlation between the left atrial appendage (LAA) orifice and landing zone/LAA ostium (Pearson's correlation coefficient r = 0.808 and 0.536/0.697, two-tailed 0.001). No occurrences of device-related embolism, thromboembolism, significant bleeding, or unexpected fatalities were observed in either group. Comparable rates of all-cause death (0.76% vs. 0.76%), stroke or transient ischemic attack (2.27% vs. 1.52%), severe bleeding (1.52% vs. 0.76%), PDL (23.81% vs. 24.62%), and DRT (1.52% vs. 1.52%) were noted after an average follow-up of 18.46 7.70 months in both groups, with no discernible differences. Multivariate logistic regression analysis identified a correlation between LAA velocity and the risk of PDL.
The effectiveness and safety of ICE-guided combined treatment were demonstrated to be comparable to TEE guidance, accompanied by the additional advantages of decreased procedure time and fluoroscopy radiation exposure.
NCT04391504, https://register.clinicaltrials.gov.
本研究的目的是比较在心脏内超声心动图(ICE)引导与经食管超声心动图(TEE)引导下,联合导管消融和左心耳封堵(LAAO)手术的操作安全性和长期结果。该研究重点在于对诊断为非瓣膜性心房颤动(AF)的患者植入LAmbre和Watchman装置。
2017年11月至2022年5月期间,前瞻性纳入了总共363例诊断为非瓣膜性AF且接受联合手术的患者。经过1:1倾向评分匹配后,对TEE组(n = 132)和ICE组(n = 132)在联合手术、成像参数、手术相关事件以及随访期间的后续结果(包括死亡率、中风、出血、器械相关血栓(DRT)和器械周围渗漏(PDL))方面进行了系统比较。
与TEE组相比,ICE组在总手术时间(153.71 ± 31.71 vs. 174.74 ± 18.79分钟)、透视辐射剂量(207.24 ± 108.39 vs. 268.61 ± 122.88 mGy)、左心耳封堵手术时间(34.69 ± 10.91 vs. 51.46 ± 15.84分钟)和造影剂暴露量(108.71 ± 37.59 vs. 158.41 ± 45.00 mL)方面均有显著减少。血管造影和ICE显示左心耳(LAA)开口与着陆区/LAA口之间存在高度相关性(Pearson相关系数r = 0.808以及0.536/0.697,双侧P < 0.001)。两组均未观察到器械相关栓塞、血栓栓塞、严重出血或意外死亡。两组在平均随访18.46 ± 7.70个月后,全因死亡(0.76% vs. 0.76%)、中风或短暂性脑缺血发作(2.27% vs. 1.52%)、严重出血(1.52% vs. 0.76%)、PDL(23.81% vs. 24.62%)和DRT(1.52% vs. 1.52%)的发生率相当,无明显差异。多因素逻辑回归分析确定LAA速度与PDL风险之间存在相关性。
ICE引导下联合治疗的有效性和安全性被证明与TEE引导相当,同时还具有减少手术时间和透视辐射暴露的额外优势。
NCT04391504,https://register.clinicaltrials.gov 。