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.

Background: Postoperative patients are at risk of pulmonary embolism. They typically exhibit multiple contributing factors such as comorbidities, immobility, blood loss, increased hematocrit, dehydration, long hospital stays, and a higher bleeding risk. PE management in this vulnerable group is challenging. Although current guidelines provide differing recommendations, many clinical questions remain unanswered. Decisions regarding periprocedural anticoagulation management must balance the thromboembolic and procedural higher bleeding risks. In addition, a recent major surgery is an absolute contraindication to systemic thrombolysis. Small doses of local lytics or a mechanical percutaneous embolectomy in the era of catheter-based therapy may be a safer option. However, the safety and efficacy of CDT have not been evaluated in this particular PE-vulnerable population. Methods: We performed a retrospective study of 35 postoperative patients with intermediate–high-risk PE treated with the EkoSonic Endovascular System. Operative bleeding risk, different management modalities, and post-PE-therapy presumptive complications were assessed before PE treatment. Results: Procedural success was achieved in 100% of cases. We observed a marked improvement in clinical and PE hemodynamics. One major bleeding, defined as life-threatening, required surgical intervention; four moderate bleedings, defined as bleeding without hemodynamic compromise, required intervention such as drainage. Minor bleeding was managed conservatively. Conclusions: Catheter-directed therapies may be an alternative to systemic reperfusion therapies for selected postoperative intermediate–high-risk PE-vulnerable populations.