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Mynx股动脉闭合装置在真实世界队列中的成功率、安全性和有效性:单中心经验

Success, Safety, and Efficacy of the Mynx Femoral Closure Device in a Real-World Cohort: Single-Center Experience.

作者信息

Hutchings David, Hayat Afzal, Karunakaran Arun, Malik Nadim

机构信息

Stepping Hill Hospital, Stockport, Greater Manchester, United Kingdom.

出版信息

J Invasive Cardiol. 2016 Mar;28(3):104-8.

PMID:26945253
Abstract

BACKGROUND

Femoral artery closure device use following percutaneous cannulation allows earlier mobilization, reduced staff burden, and improved comfort for patients compared with manual compression. The Mynx device (Access Closure, Inc), a novel extravascular closure device, uses a water-soluble non-thrombogenic polyethylene glycol plug.

METHODS

We report retrospective analysis of success, complication rates, and associated factors in 432 consecutive patients undergoing elective outpatient coronary angiography in a single United Kingdom center.

RESULTS

Six Fr sheaths were used in 62.1% and 5 Fr sheaths were used in 37.8%, with 100% successful deployment using a Mynx device. A total of 57.5% of patients were male. In 79.4%, this was the first procedure requiring femoral arteriotomy, while 20.6% had a previous procedure. Overall, 3.2% required conversion to manual compression/ FemoStop (St. Jude Medical) due to impending hematoma. In all, 99.5% of patients were discharged on the same day. Confirmed hematoma >5 cm was noted in 0.7% patients, with only 2 patients (0.5%) reporting "any discomfort" during deployment and the same requiring overnight hospitalization. Use of a 6 Fr sheath (compared with 5 Fr) was associated with conversion to manual compression and complications (P<.05), as was valvular heart disease as the indication for angiography (P<.05). Hematoma formation was associated with higher diastolic and mean arterial pressure (107.4 mm Hg vs 99.6 mm Hg; P<.01). There was no increase in complications associated with use of antiplatelet/anticoagulants, previous stroke, myocardial infarction/ischemic heart disease, peripheral vascular disease, diabetes, high body mass index, or previous angiographic procedure.

CONCLUSIONS

Postangiography use of the Mynx closure device is highly successful, safe, and well-tolerated with a low complication rate, allowing safe same-day discharge.

摘要

背景

与手动压迫相比,经皮穿刺后使用股动脉闭合装置可使患者更早活动,减轻医护人员负担,并提高患者舒适度。Mynx装置(Access Closure公司)是一种新型血管外闭合装置,使用水溶性非血栓形成的聚乙二醇塞子。

方法

我们报告了对英国一家中心432例连续接受择期门诊冠状动脉造影患者的成功情况、并发症发生率及相关因素的回顾性分析。

结果

62.1%的患者使用6F鞘管,37.8%的患者使用5F鞘管,使用Mynx装置的成功率为100%。患者中男性占57.5%。79.4%的患者此次是首次需要股动脉切开的手术,20.6%的患者曾接受过此类手术。总体而言,3.2%的患者因即将出现血肿而需要转为手动压迫/FemoStop(圣犹达医疗公司)。所有患者中,99.5%在同一天出院。0.7%的患者确认血肿>5 cm,只有2例患者(0.5%)在装置置入过程中报告“有任何不适”,这2例患者需要过夜住院。使用6F鞘管(与5F鞘管相比)与转为手动压迫及并发症相关(P<0.05),以瓣膜性心脏病作为血管造影指征也与并发症相关(P<0.05)。血肿形成与较高的舒张压和平均动脉压相关(107.4 mmHg对99.6 mmHg;P<0.01)。使用抗血小板/抗凝药物、既往中风、心肌梗死/缺血性心脏病、外周血管疾病、糖尿病、高体重指数或既往血管造影手术与并发症增加无关。

结论

血管造影术后使用Mynx闭合装置非常成功、安全且耐受性良好,并发症发生率低,可实现安全的当日出院。

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