Lakhter Vladimir, Bichard Christian, Ouriel Kenneth, Firth Brian, Rali Parth, Bashir Riyaz
Division of Cardiovascular Diseases, Temple University Hospital, Philadelphia, Pennsylvania, USA.
Department of Internal Medicine, Temple University Hospital, Philadelphia, Pennsylvania, USA.
JACC Adv. 2025 May 19;4(6 Pt 1):101789. doi: 10.1016/j.jacadv.2025.101789.
Acute pulmonary embolism (PE) is a leading cause of morbidity and mortality. Pharmacomechanical lysis (PML) with the Bashir endovascular catheter has been shown to reduce the right ventricular/left ventricular (RV/LV) ratio in patients with intermediate-risk (IR) PE. Nevertheless, the original protocol required a 5-hour postprocedural infusion of recombinant tissue plasminogen activator (r-tPA) and intensive care unit monitoring.
The RESCUE-II (Safety and Feasibility of On-The-Table Pharmacomechanical Lysis for Acute Intermediate-Risk Pulmonary Embolism) study aimed to evaluate the safety and efficacy of on-the-table PML using bolus-only r-tPA, without postprocedural infusion, in patients with IR-PE.
In this single-center, prospective study, symptomatic patients with IR-PE (computed tomographic-derived RV/LV ratio ≥0.9) were treated with bolus-only r-tPA via the Bashir catheter (4 mg per lung, 8 mg total for bilateral PE). The primary efficacy endpoint was the change in RV/LV ratio at 48 hours, and the primary safety endpoint was major bleeding within 72 hours.
Nine patients were enrolled and successfully treated. The median procedure time was 39 ± 13.4 minutes. At 48 hours, the mean RV/LV ratio decreased from 1.66 ± 0.56 to 1.27 ± 0.41 (P = 0.0001), and pulmonary artery obstruction, measured by the Refined Modified Miller index, reduced by 29.2%. There were no major bleeding events. One patient had a minor access site hematoma, managed with manual compression.
On-the-table PML using the Bashir catheter effectively reduced RV/LV ratio and PA obstruction. The procedure was safe, with no major bleeding complications, and offers a rapid, cost-effective treatment option for patients with acute IR-PE.
急性肺栓塞（PE）是发病和死亡的主要原因。已证明使用巴希尔血管内导管进行药物机械溶栓（PML）可降低中度风险（IR）PE患者的右心室/左心室（RV/LV）比率。然而，原始方案要求术后输注重组组织型纤溶酶原激活剂（r-tPA）5小时并进行重症监护病房监测。
RESCUE-II（急性中度风险肺栓塞术中药物机械溶栓的安全性和可行性）研究旨在评估在IR-PE患者中使用仅推注r-tPA、术后不输注的术中PML的安全性和有效性。
在这项单中心前瞻性研究中，对有症状的IR-PE患者（计算机断层扫描得出的RV/LV比率≥0.9）通过巴希尔导管仅推注r-tPA进行治疗（每侧肺4mg，双侧PE共8mg）。主要疗效终点是48小时时RV/LV比率的变化，主要安全终点是72小时内的大出血。
9名患者入组并成功治疗。中位手术时间为39±13.4分钟。48小时时，平均RV/LV比率从1.66±0.56降至1.27±0.41（P = 0.0001），通过改良米勒指数测量的肺动脉阻塞减少了29.2%。没有大出血事件。1名患者出现轻微穿刺部位血肿，通过手动压迫处理。
使用巴希尔导管进行术中PML可有效降低RV/LV比率和肺动脉阻塞。该手术安全，无大出血并发症，为急性IR-PE患者提供了一种快速、经济有效的治疗选择。
