Evaluation of Long-Term Key Outcomes and Safety in Pulmonary Embolism: The EKOS-PE Study

Pulmonary embolism (PE) is a major cause of morbidity and mortality, particularly in massive and submassive cases that lead to right ventricular (RV) strain and long-term complications. The EkoSonic Endovascular System (EKOS) offers a catheter-directed thrombolytic treatment option for patients with contraindications to systemic thrombolysis, but data on long-term outcomes remain limited. We aimed to evaluate long-term mortality, RV function, and quality of life (QoL) in patients with massive or submassive PE who were treated with EKOS therapy.

The EKOS-PE is a retrospective cohort study of 137 patients with massive or submassive PE who underwent EKOS therapy within a single health care system from 2020 to 2024. The primary outcome was all-cause mortality; secondary outcomes included changes in the RV-to-left ventricular (LV) (RV/LV) ratio, residual RV dysfunction, and QoL as assessed using the Pulmonary Embolism Quality of Life questionnaire.

All-cause mortality was 7.2% at a mean follow-up of 26.5 ± 17.2 months. During the index hospitalization, 1 retroperitoneal bleed (0.7%) and 1 ischemic stroke (0.7%) were observed. The mean RV/LV ratio decreased from 1.13 ± 0.24 to 0.83 ± 0.19 (P < .01). No residual RV dysfunction was evident in 105 (75.5%) patients, whereas 16 (11.5%) exhibited moderate to severe residual dysfunction. Of 52 respondents who completed the QoL survey at a mean follow-up of 37.2 ± 12.1 months, minimal residual symptoms, limited functional interference, and improved perceived lung health were reported.

The EKOS therapy is associated with significant long-term improvement in RV function, low mortality, and favorable perceived QoL, supporting its use in massive and submassive PE, aligning with current guideline recommendations for high-risk patients.