Seeger Julia, Birkemeyer Ralf, Rottbauer Wolfgang, Wöhrle Jochen
Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
Herzklinik Ulm, Ulm, Germany.
Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):512-516. doi: 10.1016/j.carrev.2017.04.018. Epub 2017 Apr 29.
We aimed to evaluate efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyze procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients.
Twelve consecutive non-valvular atrial fibrillation patients (age 76.6±7.8years) at high risk for stroke (CHADS-VASc-Score 5.5±0.9) and bleeding (HAS-BLED-Score 3.8±0.9), received LAA closure with the Watchman FLX. Bench testing demonstrated easy repositioning as well as optimized sealing and anchoring. Follow-up was done at 30days, and at 3 and 6months including transesophageal echocardiography after 3months. Compression was calculated as occluder size to diameter at shoulder in final position. The device was successfully implanted in all patients. Partial recapture was necessary in 6 (50%) of cases, and full recapture in one (8.3%). There were no procedure-related complications. In 83.3% of cases (N=10/12) compression was between 10 and 27%, and mean compression was 24.0±11.1%. Mean implantation depth was 4.0±4.4mm distal of LAA ostium. There was no residual flow. Proximal shift in device position was noticed in 2 patients. One device was embolized at 30day follow-up, and another device showed thrombus formation. There was no disabling or non-disabling stroke through 6months of follow-up with dual antiplatelet therapy for 3months.
LAA closure with the new Watchman FLX is associated with a good periprocedural safety, complete sealing of the LAA and simple repositioning.
We evaluated the efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyzed procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. This is a first observational study demonstrating procedural safety, complete sealing of the LAA and simple technique for repositioning. There was no stroke within a 6month follow-up.
我们旨在评估新型Watchman FLX封堵左心耳（LAA）的疗效和安全性，并分析一系列连续的高危非瓣膜性心房颤动患者的手术特征。
连续12例高危非瓣膜性心房颤动患者（年龄76.6±7.8岁），卒中风险高（CHADS-VASc评分5.5±0.9）且出血风险高（HAS-BLED评分3.8±0.9），接受了Watchman FLX封堵LAA治疗。体外测试显示易于重新定位以及优化的密封和锚定效果。在30天、3个月和6个月进行随访，3个月后进行经食管超声心动图检查。压缩率计算为封堵器尺寸与最终位置肩部直径之比。所有患者均成功植入该装置。6例（50%）需要部分回收，1例（8.3%）需要完全回收。无手术相关并发症。83.3%的病例（N=10/12）压缩率在10%至27%之间，平均压缩率为24.0±11.1%。平均植入深度为LAA开口远端4.0±4.4mm。无残余血流。2例患者出现封堵器位置近端移位。1例封堵器在30天随访时发生栓塞，另1例封堵器出现血栓形成。在3个月双联抗血小板治疗的6个月随访期内，无致残或非致残性卒中发生。
新型Watchman FLX封堵LAA具有良好的围手术期安全性、LAA完全密封和简单的重新定位效果。
我们评估了新型Watchman FLX封堵左心耳（LAA）的疗效和安全性，并分析了一系列连续的高危非瓣膜性心房颤动患者的手术特征。这是第一项观察性研究，证明了手术安全性、LAA完全密封和简单的重新定位技术。在6个月的随访期内无卒中发生。
