Background: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking.


Methods: This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE 14 days, systolic blood pressure 90 mm Hg, and right ventricular- to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post- procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval.


Results: A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced three major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7% and 0.8%, respectively.


Conclusions: In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]).


J Vasc Surg. 2021 Apr;73(4):1445-1455. doi: 10.1016/j.jvs.2020.10.026. Epub 2020 Oct 22.


Systematic review and meta-analysis of endovascular versus open repair for common femoral artery atherosclerosis treatment


Mourad Boufi, Meghan Ejargue, Magaye Gaye, Laurent Boyer, Yves Alimi, Anderson D Loundou


Background: Encouraging recent reports on endovascular treatment of common femoral artery (CFA) atherosclerotic disease has rendered the question regarding the place of this technique evermore pertinent and legitimizes the performance of randomized trials. The present comprehensive review focused on the early and midterm outcomes to help assess the benefit/risk balance of endovascular vs open repair for CFA treatment.


Methods: Embase and Medline searches were conducted according to the PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) standards to identify studies from 2000 to 2018 reporting on endovascular repair (ER), open surgery (OS) and comparisons of both techniques for CFA atherosclerosis treatment. The outcomes measured


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were 30-day mortality, morbidity, reintervention rates, midterm patency, late reintervention and restenosis rates.


Results: Twenty-eight studies were eligible: 14 OS (1920 patients), 12 ER (1900 patients) and 2 comparative randomized trials (197 patients). The meta-analysis of the comparative studies revealed no differences in 30-day mortality or reintervention rates but improved 30-day morbidity after ER. At 1 year, the primary patency rates did not differ between ER and OS, nor did the late reintervention rate. In the noncomparative studies, with a mean followup period of 23.8 months for ER and 66 months for OS, the restenosis rate was 14.4% and 4.7%, respectively. The reported stent fracture rate was 3.6%. In the ER cohort, the overall primary patency at 1, 2 and 3 years was 81.9%, 77.8% and 75.1%, respectively. For the OS cohort, the overall primary patency rate at 1, 2 and 3 years was 93.4%, 91.4% and 90.5%, respectively.


Conclusions: Despite expectations, our analysis of the reported data suggests that the perioperative mortality is not in favor of ER; however, the perioperative morbidity showed an advantage for ER compared with OS. Also, although comparable in the first year, the long-term primary patency rate was much greater after OS. At present, the place of ER for CFA treatment still requires further definition. Additional clarification of the indications and more research are both required to determine the optimal endovascular technology and femoral bifurcation reconstruction with stenting.


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