Periprocedural results and 90-day quality of life outcomes following treatment of pulmonary embolism with a novel 16F catheter computer assisted vacuum thrombectomy system: a STRIKE-PE subanalysis

Abstract Background Early mortality in pulmonary embolism (PE) is a key outcome when studying new treatments. However, PE can also cause significant long-term impairment in quality of life (QOL). We therefore examined QOL outcomes within STRIKE-PE after treatment with a mechanical thrombectomy catheter that uses an algorithm to adjust aspiration to remove thrombus. Purpose The purpose of this study is to report on safety, effectiveness, and QOL outcomes after treatment of PE with computer assisted vacuum thrombectomy (CAVT) using the 16F catheter system, a recent technological development for CAVT that uses novel aspiration algorithms designed for procedural efficiency. Methods STRIKE-PE is a prospective, international, multicentre study evaluating safety, effectiveness, and long-term outcomes after CAVT for up to 1500 patients with acute PE symptoms of ≤14 days and a right ventricular/left ventricular (RV/LV) ratio of ≥0.9. The primary endpoints for this study are the change in RV/LV ratio and a composite of major adverse events (MAEs) from baseline to 48 hours postprocedure. Secondary endpoints include additional safety measures, functional outcomes, and QOL. This analysis reports periprocedural and QOL results from the first 164 patients in the STRIKE-PE study treated with CAVT with the 16F catheter system. Results Mean patient age was 61.6 years, and 53.7% were male. Pulmonary embolism risk classification was high in 4.9% of patients, intermediate-high in 86.6%, and intermediate-low in 8.5%. Median thrombectomy time was 25.5 minutes, and median procedure time was 59.0 minutes. Mean on-table systolic pulmonary artery pressure significantly decreased from 50.8 mm Hg before CAVT to 38.8 mm Hg after CAVT (∆ 23.4%, P < .001). Mean RV/LV ratio significantly decreased from 1.34 at baseline to 0.94 at 48 hours (∆ 27.8%, P < .001). One composite MAE (0.6%) occurred within 48 hours. No device-related serious adverse events occurred. Specifically, no cases of major bleeding required transfusion, and no device-related transfusions occurred. The 30-day all-cause mortality rate was 1.2%. From baseline to 90-day follow-up, the EQ visual analog scale (VAS) significantly improved by a mean of 24.9 (P < .001; Figure 1a) and the EQ-5D-5L index value significantly improved by a mean of 0.336 (P < .001; Figure 1b). Over the same time interval, the overall extent of daily life affected by PE, as measured by the Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL), significantly improved by a mean of 22.8 percentage points (P < .001); all individual PEmb-QoL dimensions also significantly improved (P < .001; Figure 2). Conclusion The first 164 patients of STRIKE-PE treated with CAVT using a 16F catheter system demonstrated a shortened thrombectomy time and improved right ventricular function with no major bleeding that required transfusion. Additionally, this patient population demonstrated significant improvements in their QOL.Figure 1 Figure 2