Comparison of Percutaneous Ultrasound-Accelerated Thrombolysis Versus Catheter-Directed Thrombolysis in Patients with Acute Massive Pulmonary Embolism

Abstract

Acute massive pulmonary embolism (PE) is a life-threatening condition that requires prompt and aggressive interventions, includinganticoagulation, catheter-directed thrombolysis (CDT), mechanical thrombectomy, or surgical thromboembolectomy. The aim of this study was to evaluate the treatment outcome in patients with massive PE who were treated with either ultrasound-accelerated thrombolysis using the EkoSonic Endovascular System (EKOS) or CDT intervention. During a recent 10-year period, the clinical records of all patients with massive PE undergoing catheter-directed interventions were evaluated. Patients were divided into two treatment groups: EKOS versus CDT interventions. Comparisons were made with regard to the treatment outcome between the two groups. Twenty-five patients underwent 33 catheter-directed interventions for massive PE during the study period. Among them, EKOS or CDT was performed in 15 (45%) and 18 (55%) procedures, respectively. In the EKOS group, complete thrombus removal was achieved in 100% cases. In the CDT cohort, complete or partial thrombus removal was accomplished in 7 (50%) and 2 (14%) cases, respectively. Comparing treatment success based on thrombus removal, EKOS treatment resulted in an improved treatment outcome compared with the CDT group (p < .02). The mean time of thrombolysis in EKOSand CDT group was 17.4 ± 5.23 and 25.3 ± 7.35 hours, respectively (p = .03). The mortality rate in the EKOS and CDT group was 9.1% and 14.2%, respectively (not significant). Treatment-related hemorrhagic complication rates in the EKOS and CDT group were 0% and 21.4%, respectively (p = .02). A significant reduction in Miller scores was noted in both groups following catheter-based interventions. No significant difference in relative Miller score improvement was observed between groups. Ultrasound-accelerated thrombolysis using the EkoSonic system is an effective treatment modality in patients with acute massive PE. When compared with CDT, this treatment modality provides similar treatment efficacy with reduced thrombolytic infusion time and treatment-related complications.

Safety and Efficacy of Endovascular Sonolysis Using the EkoSonic Endovascular System in Patients with Acute Stroke

“…Other studies showed the effect of endovascular sonolysis by the EkoSonic Endovascular System in patients with deep venous thrombosis of the lower extremities and in patients with pulmonary embolism. [30][31][32][33][34][35] Complete recanalization was achieved in 85.2%-96.0% of patients with arterial thrombosis 34,35 and in 83.0% patients with venous thrombosis. 31 Mahon et al 22 published the first experience with endovascular sonolysis by using the EkoSonic Endovascular System in patients with acute ischemic stroke.…”

Catheter-directed interventions for pulmonary embolism

“…One study showed an advantage of the EKOS system compared to catheter-directed thrombolysis alone in achieving thromboembolus removal in 100% of cases and reduction of removal time by approximately 8 hours (33). Moreover, the Ultrasound-Assisted Catheter Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism (ULTIMA) trial showed improvement in the right ventricular parameters without increased risk of death, major bleeding, or intracranial hemorrhage in submassive PE (9).…”

Catheter-Assisted Pulmonary Embolectomy

“…22 Even shorter treatments of 17 hours with mean tPA doses of 0.86 mg/h effectively reduce the Miller score and result in larger thrombus resolution in comparison with higher rates and longer infusions via traditional, passive infusion catheters. 23 In a retrospective series of 24 patients with massive and submassive PE, a 12-hour treatment with the EKOS catheter infusing as little as 20 mg of tPA resulted in a statistically significant reduction in the RV to left ventricle ratio. 24 Early clinical experience has led to the approval of this device for treatment of PE in Europe where the ongoing randomized ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA) trial (ClinicalTrials.gov Identifier: NCT01166997) will compare outcomes in patients with submassive PE who are treated with the EKOS system versus standard anticoagulation.…”