Safety and outcomes with use of FlowTriever for mechanical thrombectomy i n acute pulmonary embolism

Abstract

Objectives: Mortality in the pulmonary embolism (PE) risk categories has historically been reported between 30% and 40% in high-risk and <15% in intermediate-risk group. In those who survive, there is a high rate of morbidity with dyspnea and exercise intolerance. Advanced therapies with a favorable safety profile have the potential to improve outcomes. We present the largest single-center data set studied to-date for safety, mortality, and outcomes post-mechanical thrombectomy including functional assessment 3 months post-discharge. Material and Methods: We analyzed retrospective database of patients with PE undergoing catheter directed mechanical thrombectomy (CDMT). We report clinical characteristics and outcomes stratified by PE risk categories. Comparison in the groups has been made using analysis of variance method. Results: A total of 365 patients were evaluated in the CDMT group. Among these 81 (22%) presented with high-risk and 261 (71%) with intermediate-risk PE. The average age at diagnosis was 61 ± 17 years with male-to-female distribution ratio of 1.2. Most common risk factors being reduced mobility (18%), malignancy (15%), recent surgery (13%), and hormonal therapy (12%). Mortality within 30 days of PE diagnosis was 8.6% (7/81) in high-risk, 1.7% (4/230) in intermediate-high-risk groups. There were no deaths in intermediate-low and low-risk group post-CDMT. Before thrombectomy, 349 (95%) patients had right heart strain, 307 (84%) had elevated troponin, and 197 (54%) had elevated B-type natriuretic peptide. Post-procedure echocardiogram at 3 month revealed improvement in the right ventricular (RV) fractional area change (27.53 ± 10.38% to 39.73 ± 8.3%, P < 0.01), tricuspid annular plane systolic excursion (10.9 ± 8.3 mm to 21.81 ± 4.75 mm), and RV systolic pressure (43.96 ± 14.48 mmHg to 28.47 ± 7.88 mmHg, P < 0.01). At 3 months post-thrombectomy, the majority (74%) of the patients fell into non-to-negligible functional limitation. Conclusion: We present a descriptive analysis of outcomes including improved mortality, and functional assessment of patients undergoing CDMT.