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.

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.