Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure

• Published in: Heart (British Cardiac Society) Vol. 101; no. 11; pp. 877 - 883
• Main Authors: Mínguez, José Ramón López, Asensio, Juan Manuel Nogales, Gragera, Javier Elduayen, Costa, Marco, González, Ignacio Cruz, de Carlos, Federico Gimeno, Díaz, José Antonio Fernández, Yuste, Victoria Martín, González, Raúl Moreno, Domínguez-Franco, Antonio, Buendía, Amparo Benedicto, Garibi, Jesús Herrero, Hernández, Felipe Hernández, Ribeiro, Vasco Gama
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.06.2015
• Subjects: Aged; Anticoagulants; Atrial Appendage; Atrial Fibrillation - therapy; Blood clots; Cardiac arrhythmia; Clinical outcomes; Data analysis; Female; Gastrointestinal Diseases - etiology; Heart Atria; Hemorrhage - etiology; Humans; Hypertension; Male; Medical imaging; Prosthesis Design; Prosthesis Implantation - methods; Registries; Septal Occluder Device; Stroke; Stroke - etiology; Therapeutic Occlusion - adverse effects; Therapeutic Occlusion - methods; Thromboembolism; Thromboembolism - etiology; Treatment Outcome; Veins & arteries
• ISSN: 1355-6037; 1468-201X; 1468-201X
• DOI: 10.1136/heartjnl-2014-306332

Aims The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. Methods LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively). Conclusions LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.