Periprocedural Results and Right Ventricular Outcomes of Computer Assisted Vacuum Thrombectomy Treatment of Acute Pulmonary Embolism: Interim Analysis of 300 Patients From the STRIKE-PE Study.

Background: Pulmonary embolism (PE) can be a life-threatening condition. Endovascular treatment is emerging as a promising treatment to restore hemodynamic stability and reverse right ventricular (RV) dysfunction in PE; however, more studies are needed to elucidate the effects on the right ventricle after endovascular treatment. This analysis reports the effects of computer assisted vacuum thrombectomy on RV function.

Methods: Eligible patients for the single-arm, prospective, international, multicenter STRIKE-PE (A Prospective, Multicenter Study of the Indigo Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism) cohort study are adults with acute PE with symptoms for ≤14 days and an RV/left ventricular ratio of ≥0.9 who are treated with computer assisted vacuum thrombectomy. Reported here are periprocedural and RV outcomes of the initial 300 patients of STRIKE-PE, to provide insights into effects on RV function after computer assisted vacuum thrombectomy.

Results: Patients were classified with high-risk (5.7%), intermediate-high-risk (84.7%), or intermediate-low-risk (9.7%) PE. Median thrombectomy time was 30 minutes. Mean on-table systolic pulmonary artery pressure decreased from 51.7 mm Hg to 41.3 mm Hg, a 19.1% reduction (<0.001). The change in mean RV/left ventricular ratio from baseline to 48 hours postprocedure (primary effectiveness end point) was a decrease from 1.40 to 0.99, a 26.8% reduction (<0.001). Clinical parameters and echocardiographic measures of right heart strain improved from baseline to 48 hours postprocedure (<0.001). The rate of composite major adverse events within 48 hours postprocedure (primary safety end point) was 2.0%. Median Borg dyspnea scale at rest decreased from 4.0 at baseline to 0.5 at discharge (<0.001).

Conclusions: This interim analysis demonstrates that computer assisted vacuum thrombectomy safely and expeditiously improves hemodynamic status, RV function, and perceived dyspnea.

Registration: Url: https://clinicaltrials.gov; Unique Identifier: NCT04798261.