ABSTRACT
PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.
ABSTRACT
The purpose of this study was to determine whether retention of a post-pyloric Dobhoff tube (DHT) in position to serve as a visual guide through the pylorus during gastrojejunostomy (GJ) tube placement results in a reduction in fluoroscopy time, procedure time, and estimated radiation dose. A retrospective study evaluated patients who underwent GJ tube placement or gastric to GJ conversion from January 1, 2017, to April 1, 2021. Demographic and procedural data were collected, and results were evaluated using descriptive statistics and hypothesis testing through an unpaired Student's t-test. Of the 71 GJ tube placements included for analysis, 12 patients underwent placement with a post-pyloric DHT in position, and 59 patients underwent placement without a post-pyloric DHT in position. The mean fluoroscopy time and estimated radiation dose were significantly reduced in patients who underwent GJ tube placement with a post-pyloric DHT in position compared with those without (7.08 min vs. 11.02 min, P = 0.004; 123.12 mGy vs. 255.19 mGy, P = 0.015, respectively). The mean total procedure time was also reduced in patients who underwent GJ tube placement with a post-pyloric DHT in position compared with those who had no post-pyloric DHT, but this finding lacked statistical significance (18.55 min vs. 23.15 min; P = 0.09). Post-pyloric DHT retention can be utilized during GJ tube placement to reduce radiation exposure to both the patient and interventionalist.
