Aims: The aim of this study was to evaluate the safety and efficacy of the EkoSonic Endovascular System (EKOS) in patients with acute pulmonary embolism (APE) at high or intermediate-high risk and contraindication to systemic fibrinolysis.
Methods: This is a retrospective study including consecutive patients admitted due to high-risk or intermediate-high-risk APE and treated by EKOS because of an absolute or relative contraindication to systemic fibrinolysis. The primary efficacy end-point was the change from baseline to 72 h in right to left ventricular dimension ratio [right ventricular/left ventricular (RV/LV) ratio]; pulmonary embolic burden using the Qanadli Index; and systolic pulmonary arterial pressure (SPAP). The primary safety end-point was the occurrence of bleeding (GUSTO classification) within 72 h.
Results: Eighteen patients (5 men, 13 women; mean age 74 ± 12.7 years) affected by high-risk APE (n = 5; 27.8%) or intermediate-high-risk APE (n = 13; 72.2%) were included. A significant reduction of mean RV/LV ratio (1.38 ± 0.3 vs. 0.97 ± 0.16; P < 0.0005); Qanadli Index [27.06 ± 2.6 vs. 18.8 ± 7.8 (P < 0.001) and SPAP (71.1 ± 12 vs. 45.2 ± 16 mmHg; P < 0.001)] was observed within 72 h after EKOS. Five bleeding events occurred: one fatal and four moderates; three out of them led to the access site hematoma, two due to pre-existing active bleeding.
Conclusion: EKOS is an effective tool to treat patients with APE at high or intermediate-high risk and contraindication to fibrinolysis. It is a relatively safe therapy considering the critical conditions and high bleeding risk of the receiving population.