Division of Cardiology, Sparrow Hospital and College of Human Medicine, Michigan State University, Lansing, Michigan, USA.
Division of Cardiology, Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan, USA.
Catheter Cardiovasc Interv. 2022 Oct;100(4):628-635. doi: 10.1002/ccd.30345. Epub 2022 Jul 28.
To study the safety and efficacy of AngioVac for left-sided transcatheter vacuum-assisted mass extraction (TVME).
The AngioVac system is approved for right-sided TVME and has emerged as an effective and safe alternative for open surgical treatment. The use of the AngioVac device for aspiration of left-sided TVME has been limited.
Consecutive patients from two Michigan centers who underwent left-sided TVME were included. Data on patient demographics, procedural information, in-hospital and follow-up events were collected through electronic medical records review. Technical success was defined as aspirating of 70%-100% of the material.
Ten patients (mean age 58.3 [±17.3] years, 50% male) were included. Indications for TMVE were in large for recurrent embolic events. All patients underwent bilateral cerebro-embolic protection using the Sentinel device. The total mean procedure time was 192.5 (±47.5) min of which the meantime for active aspiration (bypass time) was 9.3 (±4.2) min. The circuit configuration was: arteriovenous (AV) in four cases and arterioarterial (AA) in six cases. Successful aspiration was achieved in 80% of cases. No complications were reported (range follow-up 1-16 months).
Our small case series demonstrates the feasibility and safety of the AngioVac system in left-sided mass extraction. Larger trials are needed to further demonstrate its effectiveness and safety and potentially apply for on-label use.
研究 AngioVac 用于左侧经导管真空辅助血栓切除术(TVME)的安全性和有效性。
AngioVac 系统已获准用于右侧 TVME,已成为开放式手术治疗的有效且安全的替代方法。但该设备用于抽吸左侧 TVME 的应用受到限制。
纳入来自密歇根州两个中心的连续接受左侧 TVME 的患者。通过电子病历回顾收集患者人口统计学、手术信息、住院和随访事件的数据。技术成功定义为抽吸 70%-100%的物质。
共纳入 10 名患者(平均年龄 58.3[±17.3]岁,50%为男性)。TMVE 的适应证为大的复发性栓塞事件。所有患者均使用 Sentinel 装置进行双侧脑保护。总平均手术时间为 192.5(±47.5)分钟,其中主动抽吸(旁路时间)的平均时间为 9.3(±4.2)分钟。血管配置为:4 例动静脉(AV),6 例动动脉(AA)。80%的病例成功抽吸。未报告任何并发症(随访时间 1-16 个月)。
我们的小病例系列表明 AngioVac 系统在左侧血栓抽吸中的可行性和安全性。需要更大的试验来进一步证明其有效性和安全性,并可能申请标签使用。