Bleeding Risk Profile in Patients With Symptomatic Peripheral Artery Disease

PURPOSE To assess the bleeding risk profile using the HAS-BLED score in patients with symptomatic peripheral artery disease (PAD). METHODS A post hoc analysis was performed using data from a series of 115 consecutive patients (mean age 72.4±11.4 years; 68 men) with symptomatic PAD undergoing endovascular revascularization. The endpoint of the study was to assess bleeding risk using the 9-point HAS-BLED score, which was previously validated in cohorts of patients with and without atrial fibrillation. For the purpose of this study, the low (0-1), intermediate (2), and high-risk (≥3) scores were stratified as low/intermediate risk (HAS-BLED <3) vs high risk (HAS-BLED ≥3). RESULTS The mean HAS-BLED score was 2.76±1.16; 64 (56%) patients had a HAS-BLED score ≥3.0. Patients with PAD Rutherford category 5/6 ischemia had an even higher mean HAS-BLED score (3.20±1.12). Logistic regression analysis revealed aortoiliac or femoropopliteal segment involvement, chronic kidney disease, as well as Rutherford category 5/6, to be independent risk factors associated with a HAS-BLED score ≥3. CONCLUSION Patients with PAD, especially those presenting with Rutherford category 5/6 ischemic symptoms, have high HAS-BLED scores, suggesting increased risk for major bleeding. Prospective clinical validation of the HAS-BLED score in patients with PAD may help with the risk-benefit assessment when prescribing antithrombotic therapy

Technical results of vacuum-assisted thrombectomy for arterial clot removal in patients with acute limb ischemia

PURPOSE To assess the efficacy and safety of a vacuum-assisted thrombectomy (VAT) catheter system for treating patients with acute limb ischemia (ALI). MATERIALS AND METHODS A retrospective study evaluated VAT systems (Penumbra, Alameda, California) in a consecutive series of 30 patients with ALI. ALI was defined as clinical symptoms within 2 weeks of presentation. The primary endpoint was improvement in blood flow across a lesion by improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures. Target lesions were grouped anatomically into above-the-knee (ATK) or below-the-knee (BTK) lesions. RESULTS In 30 patients, 33 lesions (ATK, n = 13; BTK, n = 20) were treated. No complications were attributed to the VAT systems. The primary endpoint was obtained in 24/33 (72.7%) lesions (BTK, 17/20 [85.0%]; ATK, 7/13 [53.9%]; P = .050 by χ(2) test). TIMI scores were similar at baseline but differed after VAT between the ATK and BTK groups (P < .025 by t test). ATK lesions required more concomitant angioplasty or stent placement, or both (P < .015 by χ(2) test). CONCLUSIONS VAT is a safe, technically successful short-term therapeutic option for thrombus removal in patients with ALI

Endovascular treatment of popliteal artery aneurysms: a single-center experience

PURPOSE: To evaluate the use of covered stent-grafts in the endovascular treatment (ET) of popliteal artery aneurysms (PAAs). MATERIALS AND METHODS: A retrospective analysis was conducted over a period of 52 months in 18 consecutive patients (17 men; mean age +/- SD, 70 years +/- 11) undergoing ET of PAAs with the Viabahn endograft in a single center. Patient symptoms, aneurysm characteristics, technical outcomes, complications, and follow-up were assessed. RESULTS: Aneurysm diameters ranged from 12 to 51 mm with a mean of 30 mm (+/-11). Thirteen aneurysms (72.2%) were partially thrombosed and 12 patients (66.6%) had symptoms of lower limb ischemia at presentation (11 chronic and one acute). The technical success rate was 94%. Intraprocedural emboli and endoleak occurred in one and two patients, respectively. Fourteen patients were available for follow-up after successful treatment, with a mean follow-up time of 15 months (range, 7-37 months). All stent-grafts were patent after 1 month, with no mortality or limb loss. The primary patency rate with complete exclusion of the aneurysm at 6 months was 86%. Pre- and postprocedural noninvasive arterial studies were available in 10 patients, demonstrating improvement of the ankle-brachial index from 0.96 +/- 0.41 to 1.17 +/- 0.18, respectively (P = .06). CONCLUSIONS: Endovascular stent-graft repair of PAAs is a feasible treatment option. However, further follow-up studies regarding the durability of results are required

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

OBJECTIVES: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). 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 \u3e0.9. 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 \u3c 0.0001). Two (1.7%) patients experienced 3 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]; NCT03218566)