Procedural and Functional Outcomes After Computer Assisted Vacuum Thrombectomy With the 16F Catheter System for Treatment of Pulmonary Embolism: A Subanalysis of the STRIKE-PE Study.
Publication/Presentation Date
9-26-2026
Abstract
PURPOSE: This subanalysis of the STRIKE-PE study evaluates use of computer assisted vacuum thrombectomy (CAVT), a form of endovascular therapy for acute pulmonary embolism (PE), with the 16F catheter system.
MATERIALS AND METHODS: This subanalysis from a prespecified interim analysis reports procedural outcomes and functional outcomes to 90 days from the first 244 patients treated using the 16F catheter system in STRIKE-PE, an ongoing single-arm, prospective, global study evaluating safety, effectiveness, and outcomes after CAVT in patients with acute PE. The primary end points of STRIKE-PE are change in right-to-left ventricular (RV/LV) ratio from baseline to 48-hour follow-up and composite major adverse event (MAE) rate within 48 hours.
RESULTS: Mean RV/LV ratio at baseline was 1.34, which decreased to 0.95 at 48 hours postprocedure (27.3% reduction; P < .001). The composite MAE rate within 48 hours was 0.8%. Procedural results included a reduction in mean on-table systolic pulmonary artery pressure (23.6% reduction; P < .001) and a median thrombectomy time of 25 minutes. The functional outcome assessments of Borg dyspnea scale (P < .001) and 6-minute walk test distance (P < .001) progressively improved to 90 days. New York Heart Association (NYHA) class I or none increased from 67.4% of patients at discharge to 82.9% at 90-day follow-up (P < .001).
CONCLUSIONS: Treatment of PE with CAVT using the 16F catheter system was associated with statistically significant improvement in right heart function, hemodynamics, dyspnea, and distance walked; additionally, NYHA class recovered. The device had a short procedure time and a low composite MAE rate.
First Page
109100
Last Page
109100
ISSN
1535-7732
Published In/Presented At
Moriarty, J. M., Schiro, B. J., Weinberg, I., Dohad, S. Y., Davis, H. C., Shavelle, D. M., Chrysant, G. S., Perkowski, P. E., Muck, P. E., Bishay, V. L., Holden, A., West, F. M., Scheidt, M. J., Sethi, S. S., Keeling, W. B., & Araszkiewicz, A. (2026). Procedural and Functional Outcomes After Computer Assisted Vacuum Thrombectomy With the 16F Catheter System for Treatment of Pulmonary Embolism: A Subanalysis of the STRIKE-PE Study. Journal of vascular and interventional radiology : JVIR, 109100. Advance online publication. https://doi.org/10.1016/j.jvir.2026.109100
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
42800582
Department(s)
Administration and Leadership
Document Type
Article