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EkoSonic Endovascular System for patients with acute pulmonary embolism and contraindication to systemic fibrinolysis

Visco, Emanuele; Adamo, Marianna; Locantore, Elisa; Fiorina, Claudia; Chizzola, Giuliano; Branca, Luca; Abbenante, Alessandro; Castiello, Assunta; Metra, Marco; Curello, Salvatore; Ettori, Federica

Journal of Cardiovascular Medicine: March 2019 - Volume 20 - Issue 3 - p 131–136
doi: 10.2459/JCM.0000000000000751
Research articles: Interventional cardiology
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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.

Civil Hospital and University of Brescia, Brescia, Italy

Correspondence to Dr. Marianna Adamo, Cardiac Catheterization Laboratory, Piazzale Spedali Civili 1, Brescia 25123, Italy Tel: +390303995564; fax: +390303995821; e-mail: mariannaadamo@hotmail.com

Received 2 September, 2018

Revised 4 October, 2018

Accepted 5 December, 2018

© 2019 Italian Federation of Cardiology. All rights reserved.