Fuller Timothy J, Paprzycki Christopher M, Zubair Muhammad H, Hussain Lala R, Kuhn Brian A, Recht Matthew H, Muck Patrick E
Division of Vascular Surgery, TriHealth, Cincinnati, OH.
Division of Vascular Surgery, TriHealth, Cincinnati, OH.
Ann Vasc Surg. 2017 Jan;38:158-163. doi: 10.1016/j.avsg.2016.09.002. Epub 2016 Sep 22.
Interventional strategies for massive and submassive pulmonary embolism (smPE) have historically included either systematic intravenous thrombolytic alteplase or surgical embolectomy, both of which are associated with significant morbidity and mortality. However, with the advent of endovascular techniques, recent studies have suggested that an endovascular approach to the treatment of acute smPE may be both safe and effective with excellent outcomes. The purpose of this study was to evaluate the outcomes of patients who have undergone catheter-directed thrombolysis (CDT) for smPE at our institution in an effort to determine the safety of the procedure.
A retrospective review was conducted from December 2012 to June 2015 to identify patients whom underwent CDT in the treatment of a smPE at our institution. Primary measure was safety of the procedure. Outcome variables were classified as serious or minor adverse events. Serious events included death, stroke, myocardial infarction, and bleeding complications requiring surgical intervention or transfusion. Minor events included groin hematoma, development of arteriovenous fistula, and bleeding requiring interruption or cessation of CDT. In addition, a secondary measure included effectiveness of CDT based on preinterventional and postinterventional clinical examination and radiographic findings.
A total of 27 patients undergoing CDT for smPE at our institution were evaluated. The standard procedure included access via bilateral femoral veins and placement of bilateral EKOS catheters for ultrasound-assisted thrombolysis (USAT), with Activase (alteplase) at 1 mg per hour in each catheter for a total of 12 hr. There were no serious adverse events and only 4 patients (14.8%) had minor events, of which only 1 patient required premature termination of therapy due to bleeding resulting in a 3.7% clinically relevant bleeding rate. In addition, a reduction in a right-to-left ventricular end-diastolic diameter ratio (RV/LV ratio) on follow-up imaging was observed in each of the 18 patients where preinterventional and postinterventional imaging was available. Likewise, via chart review, all patients reported significant cessation of shortness-of-breath and resolution of chest pain with associated decrease in supplemental oxygen requirement.
Current evidence, the majority of which has been industry funded, suggests that CDT should be considered as the first-line therapy for smPE. Our experience, in this single-institution retrospective review, demonstrates that CDT with USAT in the treatment of smPE is safe, while providing immediate resolution of both RV strain and clinical symptoms such as shortness-of-breath and chest pain. We hope that these data will allow other institutions to consider CDT as a plausible option in the treatment of smPE.
既往对于大面积和次大面积肺栓塞（smPE）的介入治疗策略包括系统性静脉溶栓使用阿替普酶或外科血栓切除术，这两种方法都伴有显著的发病率和死亡率。然而，随着血管内技术的出现，最近的研究表明，采用血管内方法治疗急性smPE可能既安全又有效，且预后良好。本研究的目的是评估在我们机构接受导管直接溶栓（CDT）治疗smPE患者的预后，以确定该手术的安全性。
对2012年12月至2015年6月期间在我们机构接受CDT治疗smPE的患者进行回顾性分析。主要评估指标是手术的安全性。结局变量分为严重或轻微不良事件。严重事件包括死亡、中风、心肌梗死以及需要手术干预或输血的出血并发症。轻微事件包括腹股沟血肿、动静脉瘘形成以及需要中断或停止CDT的出血。此外，次要评估指标包括基于介入前和介入后临床检查及影像学检查结果评估CDT的有效性。
我们机构共评估了27例接受CDT治疗smPE的患者。标准操作包括经双侧股静脉穿刺并置入双侧EKOS导管进行超声辅助溶栓（USAT），每个导管以每小时1mg的剂量注入阿替普酶（Activase），共持续12小时。未发生严重不良事件，仅有4例患者（14.8%）出现轻微事件，其中仅1例患者因出血需要提前终止治疗，临床相关出血率为3.7%。此外，在18例有介入前和介入后影像学资料的患者中，随访影像学检查均显示右心室与左心室舒张末期内径比值（RV/LV比值）降低。同样，通过病历审查发现，所有患者均报告呼吸急促明显缓解，胸痛消失，且吸氧需求相应减少。
目前的证据大多由行业资助，表明CDT应被视为smPE的一线治疗方法。我们在这项单机构回顾性研究中的经验表明，采用USAT的CDT治疗smPE是安全的，同时能立即缓解右心室负荷以及呼吸急促和胸痛等临床症状。我们希望这些数据能让其他机构将CDT视为治疗smPE的一种可行选择。
