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血管内使用血栓消融术治疗深静脉血栓形成:前瞻性多中心PEARL(使用不同导管长度的AngioJet血栓消融术进行外周应用)注册研究的最终报告

Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry.

作者信息

Garcia Mark J, Lookstein Robert, Malhotra Rahul, Amin Ali, Blitz Lawrence R, Leung Daniel A, Simoni Eugene J, Soukas Peter A

机构信息

Vascular Interventional Radiology , Christiana Care Health Services, Suite 1E20, 4755 Ogletown-Stanton Rd., Newark, DE 1 3 x. ?9708.

Department of Interventional Radiology, Mount Sinai Medical Center, New York, New York.

出版信息

J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.

Abstract

PURPOSE

To report procedural and patient outcomes of endovascular treatment for lower-extremity deep vein thrombosis (DVT) with rheolytic thrombectomy (RT).

MATERIALS AND METHODS

A total of 32 sites in the United States and Europe enrolled patients with DVT in the Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths (PEARL) registry. Patient characteristics and outcomes data were collected from consenting patients who underwent rheolytic AngioJet thrombectomy at investigative sites from January 2007 through June 2013. Three hundred twenty-nine patients were enrolled, with 67% of patients undergoing an AngioJet procedure within 14 days of the onset of symptoms.

RESULTS

Four treatment approaches using AngioJet thrombectomy were identified: RT without lytic agent in 4% of patients (13 of 329), pharmacomechanical catheter-directed thrombolysis (PCDT) in 35% (115 of 329), PCDT and catheter-directed thrombolysis (CDT) in 52% (172 of 329), and RT in combination with CDT in 9% (29 of 329). Median procedure times for RT alone, PCDT, PCDT/CDT, and RT/CDT were 1.4, 2, 22, and 41 hours, respectively (P < .05, Kruskal-Wallis test). Procedures were completed in less than 24 hours for 73% of patients, with 36% of procedures completed within 6 hours; 86% of procedures required no more than 2 catheter laboratory sessions. The 3-, 6-, and 12-month freedom from rethrombosis rates were 94%, 87%, and 83%, respectively. Major bleeding events occurred in 12 patients (3.6%), but none were related to the AngioJet procedure.

CONCLUSIONS

PEARL registry data demonstrate that rheolytic PCDT treatment of DVT is safe and effective, and can potentially reduce the need for concomitant CDT and intensive care.

摘要

目的

报告采用机械性血栓消融术(RT)对下肢深静脉血栓形成(DVT)进行血管内治疗的手术过程及患者预后情况。

材料与方法

美国和欧洲的32个机构将患有DVT的患者纳入外周使用不同导管长度的AngioJet机械性血栓消融术(PEARL)登记研究。从2007年1月至2013年6月在研究机构接受AngioJet机械性血栓消融术的符合条件患者中收集患者特征和预后数据。共纳入329例患者,67%的患者在症状出现后14天内接受了AngioJet手术。

结果

确定了使用AngioJet血栓消融术的四种治疗方法:4%的患者(329例中的13例)采用无溶栓剂的RT,35%(329例中的115例)采用药物机械性导管定向溶栓(PCDT),52%(329例中的172例)采用PCDT和导管定向溶栓(CDT),9%(329例中的29例)采用RT联合CDT。单纯RT、PCDT、PCDT/CDT和RT/CDT的中位手术时间分别为1.4、2、22和41小时(P < 0.05,Kruskal-Wallis检验)。73%的患者手术在24小时内完成,36%的手术在6小时内完成;86%的手术不需要超过2次导管室操作。3个月、6个月和12个月无再血栓形成率分别为94%、87%和83%。12例患者(3.6%)发生了严重出血事件,但均与AngioJet手术无关。

结论

PEARL登记研究数据表明,机械性PCDT治疗DVT安全有效,并且有可能减少联合使用CDT和重症监护的需求。

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