Search Results (3)

Introduction: Due to the aging population, the number of elderly patients with atrial fibrillation and contraindications for anticoagulation due to bleeding complications is growing. After the epicardial ligation of the left atrial appendage (LAA), anticoagulation can be omitted. We present the single-center procedure data and long-term data of octogenarians being treated with LARIAT^®. Method: Out of 145 patients eligible for the epicardial ligation of the LAA, 45 were older than 80 y and included in this analysis. After successful ligation, patients were screened at 6 weeks of follow-up (FUP), at 12 weeks and after 12 months for transesophageal echocardiography (TOE) and clinical events. During long-term FUP, TOE sessions and clinical events for embolic events and death were documented. Results: The procedure was successful in 93% of patients, with a mean CHA₂DS₂VASC score of 4.6 and HASBLED score of 3.7 and a mean age of 82 y. One major complication occurred, with the laceration of the LAA and surgical closure of the LAA with an Atriclip. The 6-week FUP data were available in 39 patients, with the detection of four leaks (1–3 mm, median 2 mm) and three thrombi; one thrombus occurred at the site of a leak. The 12-week FUP (in 26 patients) showed that three leaks were closed, one leak persisted and one new thrombus developed at the site of the leak. All thrombi were resolved. The 12-month FUP showed the persistent resolution of three thrombi; one thrombus recurred after the withdrawal of the anticoagulant, and no new gap or thrombus could be detected. The long-term FUP (mean 38 months) was documented in 30 patients, with no new gaps and no new thrombi; one patient suffered from a stroke, with a good long-term result of LAA closure in TOE (stroke rate 1%/y, absolute risk reduction of 4.4% to a stroke rate of 5.4% related to the score, relative CHA₂DS₂VASC risk reduction of 88%). Eleven patients died: four in the first year of ligation and seven during long-term FUP. Conclusions: The epicardial ligation of the LAA for stroke prevention in octogenarians is highly safe and effective. Early TOE FUP is crucial for the detection of thrombi and establishing an optimal anticoagulation regime. No late development of thrombi or gaps can be observed at up to 5 years. Full article

Background: In patients with atrial fibrillation and contraindications for oral anticoagulation, in which an increased risk of stroke remains, a left atrial appendage exclusion should be considered for elimination, because the left atrial appendage is the most common site of thrombus. The aim of this study is to present the first-in-human study results of the Sierra Aegis Left Atrial Appendage Ligation System, a new epicardial-only left atrial appendage closure system. Methods: This study was a prospective, first-in-human, single-center study evaluating the effectiveness and safety of the Sierra Aegis Left Atrial Appendage Ligation System device for epicardial left atrial appendage closure. Seven patients (mean age: 57.3 ± 10.6 years, 71.4% male) were qualified for a left atrial appendage closure because of an increased risk of bleeding with the need for lifelong anticoagulation pharmacology due to an increased risk of stroke. The patients’ preoperative and intraoperative characteristics were collected. Patients were observed during their 1-month, 3-month, 6-month, and 1-year follow-up. Results: The mean procedure time was 21.2 ± 8.2 min. All patients spent 3 days in the hospital including monitoring, the performance of preoperative CT scans, and anatomical evaluation. No tamponade, bleeding, thrombus, or left atrial appendage leakage were observed during the procedure or in-hospital stay. During the 1-month, 3-month, 6-month, and 1-year follow-up visits, none of the patients reported any complications. No tamponade, leakage, or left atrial appendage thrombus were observed. Conclusions: This first-in-human study regarding Sierra use for left atrial appendage closure shows promising results regarding the effectiveness and safety of the Sierra device for use in humans. Full article

Background: Recent data suggest that epicardial left atrial appendage closure (LAAC) is associated with several short-term neurohormonal effects. However, the long-term effects are currently unknown. Objective: To investigate the effects of percutaneous epicardial left atial appendage (LAA) exclusion using LARIAT on neurohormonal profiles at long-term follow-up. Methods: In a prospective single centre study, 60 patients with long-standing, persistent atrial fibrillation (AF) LARIAT were treated. The major hormones of the adrenergic system, renin-angiotensin-aldosterone system (RAAS), and natriuretic peptides were assessed before the intervention and at regular intervals during the following two years. Results: In patients with epicardial LAAC, atrial natriuretic peptide (ANP) levels were significantly increased from baseline at 24 h and decreased at 7 days, 1 month, and 3 months, while remaining unchanged at 12 and 24 months. Noradrenaline levels were significantly lower at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months, while epinephrine levels decreased significantly at 1 month, 6 months, 12 months, and 24 months. Plasma renin activity significantly decreased at 7 days, 1 month, 6 months, 12 months, and 24 months, while aldosterone levels significantly decreased at 6 months, 12 months, and 24 months. Endothelin-1 and vasopressin showed a significant increase and decrease, respectively, at 24 h, 7 days, 1 month, 6 months, 12 months, and 24 months. There was also a significant decrease in systolic and diastolic blood pressure at 3 months, 6 months, 1 year, and 2 years after the intervention. Conclusions: Epicardial LAAC in AF patients is associated with persistent neurohormonal changes favouring blood pressure reduction. Full article