Left atrial appendage closure with the Ultraseal device: Initial experience and mid‐term follow‐up

• Published in: Journal of interventional cardiology Vol. 31; no. 6; pp. 932 - 938
• Main Authors: Pagnotta, Paolo A., Chiarito, Mauro, Pllaha, Elton, Zavalloni Parenti, Dennis, Rossi, Marco L., Mantovani, Riccardo, Pisano, Francesco, Stefanini, Giulio G., Reimers, Bernhard
• Format: Journal Article
• Language: English
• Published: United States Hindawi Limited 01.12.2018
• Subjects: Aged; Angiography; Atrial Appendage - diagnostic imaging; Atrial Appendage - surgery; Atrial Fibrillation - surgery; bleeding; Cardiac Surgical Procedures - adverse effects; Cardiac Surgical Procedures - instrumentation; Cardiac Surgical Procedures - methods; Computed tomography; Computed Tomography Angiography - methods; Echocardiography; Echocardiography, Transesophageal - methods; Equipment Design - adverse effects; Equipment Design - methods; Equipment Failure - statistics & numerical data; Female; Fibrillation; Follow-Up Studies; Humans; left atrial appendage closure; Male; Middle Aged; Myocardial infarction; Occlusion; Postoperative Complications - epidemiology; Prospective Studies; Registries; Stroke; Treatment Outcome; stroke; bleeding; left atrial appendage closure
• ISSN: 0896-4327; 1540-8183
• DOI: 10.1111/joic.12541

Aims Left atrial appendage (LAA) closure is considered an effective option in patients with non‐valvular atrial fibrillation (NVAF) and contraindications to long‐term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long‐term OAC therapy. Methods Twenty‐three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure. Results Procedural success was achieved in all patients except two who experienced incorrect device deployment with incomplete LAA closure. Procedure duration halved from first to last procedure performed. The only periprocedural adverse events observed were a myocardial infarction and an in‐hospital death due pneumonia. At mean follow‐up (166 ± 80 days) all other patients were alive and free from major bleedings and ischaemic strokes. Conclusions Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.