Safety of ultrasound-assisted catheter-directed thrombolysis for central pulmonary embolism in intermediate–high-risk patients with increased bleeding risk in a rural hospital setting

BACKGROUND: The EkoSonic Endovascular System (EKOS™) is an ultrasound-assisted catheter-directed thrombolysis (UACDT) device, which is becoming more popular for treatment of pulmonary embolism (PE) in patients with intermediate-high and high risk. Ultrasound waves help clot fragmentation and dissolution, therefore requiring less thrombolytic agent. With lower doses of thrombolysis, the bleeding risk is reduced but not eliminated. We aimed to evaluate the safety of this therapy in intermediate-high-risk central PE with intermediate and high bleeding risk. METHODS: We retrospectively analyzed the database of a rural hospital between March 2021 and July 2024 for UACDT with EKOS™ in patients with intermediate-high-risk central PE and Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) score ≥ 1. We evaluated procedure-related complications, bleeding events within the first 7 days, the need for further intervention, and all-cause in-hospital mortality. RESULTS: Thirty patients underwent UACDT with EKOS™. Their mean age was 68 ± 15.6 years (30% ≥ 80 years). Deep vein thrombosis was present in 16 patients (53.3%). Access was via the brachial vein (23.3%) or the common femoral vein (76.7%). One patient had major bleeding from the access site. There were no other procedure-related major complications. Two patients had minor bleeding events. All bleeding events were managed conservatively without the need for blood transfusion. One patient (3.3%) died in-hospital due to multiple organ failure, and 86% of the patients (26/30) had no complications. CONCLUSIONS: Our analysis suggests that UACDT with EKOS™ is safe for the management of intermediate-high-risk central PE in patients with intermediate and high bleeding risk even in a rural hospital setting.