Background: Ultrasound-facilitated and catheter-directed low-dose fibrinolysis (EKOS) has shown favorable hemodynamic and safety outcomes in intermediate- to high-risk pulmonary embolism (PE) cases. Objectives: This prospective single-arm monocentric study assessed the effects of using a delivery catheter for fibrinolysis as a novel approach for acute intermediate- to high-risk patients on pulmonary artery hemodynamics PE. Methods: Forty-five patients (41 intermediate–high and 4 high risk) with computer tomography (CT)-confirmed PE underwent EKOS therapy. By protocol, a total of 6 mg of tissue-plasminogen activator (t-PA) was administered over 6 h in the pulmonary artery (unilateral 6 mg or bilateral 12 mg). Unfractionated heparin was provided periprocedurally. The primary safety outcome was death, as well as major and minor bleeding within 48 of procedure initiation and at 90 days. The primary effectiveness outcomes were: 1. to assess the difference in pulmonary artery pressure from baseline to 6 h post-treatment as a primary precise surrogate marker, and 2. to determine the echocardiographic RV/LV ratio from baseline to 48 h and at 90 days post-delivery. Results: Pulmonary artery pressure decreased by 15/6/10 mmHg (p < 0.001). The mean RV/LV ratio decreased from 1.2 ± 0.85 at baseline to 0.85 ± 0.12 at 48 and to 0.76 ± 0.13 at 90 days (p < 0.001). Five patients (11%) died within 90 days of therapy. Conclusions and Highlights: Pulmonary artery hemodynamics were assessed using a delivery catheter for fibrinolysis, which is reproducible for identifying PE at risk of adverse outcomes. The results matched the right heart catheter results in EKOS and Heparin arm of Ultima trial, thereby confirming the validity of this potential diagnostic tool to assess therapy effectiveness and thereby reduce additional procedure-related complications, hospital residency, and economics. These results stress the importance of having an interdisciplinary team involved in the management of PE to evaluate the quality of life of these patients and this protocol shortens ICU admission to 6 h.
25 June 2025 in The International Journal of Cardiovascular Imaging
Background: The use of interventional endovascular therapy for pulmonary embolism (PE) has become increasingly important over the last decade. In contrast to other cardiovascular interventions, these procedures carry a higher risk of access-related bleeding due to the acute clinical setting, elevated body mass index, and the frequent need for high-dose anticoagulation. However, there is still no clear consensus regarding the optimal vascular access site for endovascular PE therapy or the impact of ultrasound (US)-guided puncture on access-related complications. Methods: We treated 89 patients with intermediate- to high-risk PE using the Ekosonic endovascular system (EKOS). Group A (n = 39) underwent femoral venous puncture without US guidance, and Group B (n = 50) underwent US-guided femoral venous puncture. Results: Intraprocedural complications differed significantly between the two groups, with a higher incidence of vascular access complications in the non-US-guided group. Access-site pseudoaneurysms and retroperitoneal bleeding events occurred exclusively in the non-US-guided group (n = 6). Major (n = 3) and moderate (n = 5) bleeding events were also observed only in the non-US-guided group (p < 0.001). However, the total length of stay in the intermediate care unit and in the hospital did not differ between the groups. These findings are consistent with prior reports from other interventional settings that demonstrate fewer bleeding events among patients undergoing US-guided procedures. Conclusion: Widespread adoption of US-guided puncture in interventional PE therapy could reduce access-related complications, increase first-pass success, and reduce the number of puncture attempts, inadvertent arterial punctures, and unsuccessful access-site cannulations, particularly in patients with unfavorable access anatomy, obesity, or anatomical variations. Further education and implementation of US-guided access into training programs could improve the adoption of this technique.