Author + information
- Paolo Pagnotta1,
- Mauro Chiarito2,
- Elton Pllaha3,
- Riccardo Mantovani1,
- Giulio Stefanini4 and
- Bernhard Reimers5
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 safety and efficacy of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy.
Twelve consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and March 2017 were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure and a transthoracic echocardiography before discharge.
Procedural success was achieved in all patients except one who experienced incorrect device deployment but with complete LAA closure. Procedure duration halved from first to last procedure performed. No adverse events, including pericardial effusion, were observed during index hospitalization. At mean follow-up (168±84 days) all patients were alive and free from major bleedings and ischaemic strokes.
Our results suggest that the Ultraseal device is a safe and feasible option for LAA occlusion. Notably, the learning curve in this single-center experience was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.
STRUCTURAL: Left Atrial Appendage Exclusion