title: Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial.
abstract: OBJECTIVE
  Atrial fibrillation (AF) is a significant risk factor for embolic stroke originating from the left atrial appendage (LAA). This is the first report of long-term safety and efficacy data on LAA closure using a novel epicardial LAA clip device in patients undergoing cardiac surgery.
  
  
  METHODS
  Forty patients with AF were enrolled in this prospective 'first-in-man' trial. The inclusion criterion was elective cardiac surgery in adult patients with AF for which a concomitant ablation procedure was planned. Intraoperative transoesophageal echocardiography (TEE) was used to exclude LAA thrombus at baseline and evaluate LAA perfusion after the procedure, while computed tomography (CT) was used for serial imagery workup at baseline, 3-, 12-, 24- and 36-month follow-up.
  
  
  RESULTS
  Early mortality was 10% due to non-device-related reasons, and thus 36 patients were included in the follow-up consisting of 1285 patient-days and mean duration of 3.5 ± 0.5 years. On CT, clips were found to be stable, showing no secondary dislocation 36 months after surgery. No intracardial thrombi were seen, none of the LAA was reperfused and in regard to LAA stump, none of the patients demonstrated a residual neck >1 cm. Apart from one unrelated transient ischaemic attack (TIA) that occurred 2 years after surgery in a patient with carotid plaque, no other strokes and/or neurological events demonstrated in any of the studied patients during follow-up.
  
  
  CONCLUSIONS
  This is the first prospective trial in which concomitant epicardial LAA occlusion using this novel epicardial LAA clip device is 100% effective, safe and durable in the long term. Closure of the LAA by epicardial clipping is applicable to all-comers regardless of LAA morphology. Minimal access epicardial LAA clip closure may become an interesting therapeutic option for patients in AF who are not amenable to anticoagulation and/or catheter closure. Further data are necessary to establish LAA occlusion as a true and viable therapy for stroke prevention.
  
  
  BACKGROUND
  The trial is registered at www.ClinicalTrials.gov, reference: NCT00567515.
authors: Clinic for Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland.
authors: Maximilian Y
authors: MY
authors: Emmert
authors: Gilbert
authors: G
authors: Puippe
authors: Stephan
authors: S
authors: Baumüller
authors: Hatem
authors: H
authors: Alkadhi
authors: Ulf
authors: U
authors: Landmesser
authors: Andre
authors: A
authors: Plass
authors: Dominique
authors: D
authors: Bettex
authors: Jacques
authors: J
authors: Scherman
authors: Jürg
authors: J
authors: Grünenfelder
authors: Michele
authors: M
authors: Genoni
authors: Volkmar
authors: V
authors: Falk
authors: Sacha P
authors: SP
authors: Salzberg
mesh_terms: D000368:Aged; D000925:Anticoagulants; D001281:Atrial Fibrillation / Q000453:epidemiology / Q000601:surgery*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D002546:Ischemic Attack, Transient / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D020521:Stroke / Q000453:epidemiology; D014057:Tomography, X-Ray Computed
chemical_list: D000925:Anticoagulants
keywords: Anticoagulation; Atrial fibrillation; Epicardial clip occlusion; Left atrial appendage; Stroke; TIA