Background
High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR PE treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population.
Methods
This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, US) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-hour after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the RV-to-left ventricular (RV/L) ratio assessed in the imaging 24-48 hours after the CDMT.
Results
71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 hours. CDMT was complicated by major bleeding in 1.8, pulmonary artery injury in 1.8%, and ischemic stroke in 0.9%. Immediate hemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (p < 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (p < 0.0001).
Conclusions
These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.