• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Arrhythmias

• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Cardiology & Cardiovascular Medicine
• Arrhythmias

James R. Edgerton, MD, The Heart Hospital, Baylor Plano, Plano, Texas, USA, discussed trials of the AtriClip nonpiercing, parallel-closure, left atrial appendage (LAA) surgical closure device for patients with atrial fibrillation (AF). The goal of surgical closure of the LAA is to eliminate the entire trabeculated portion of the left atrium to decrease thromboembolic risk.

The AtriClip was first tested in humans in 2009 [Salzberg SP et al. J Thorac Cardiovasc Surg 2010] when 34 patients underwent successful open clip deployment. At 3 months, the clip was stable with appendage occlusion in all patients. There were no device complications. In the Exclusion of Left Atrial Appendage With AtriClip Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery trial [EXCLUDE; Ailawadi G et al. J Thorac Cardiovasc Surg 2011], the AtriClip was placed in 71 patients undergoing heart surgery. The successful exclusion rate was 95.7% perioperatively and 98.4% at 3 months. No device or clip procedure-related adverse events were reported.

The LAA AtriClip occlusion also provides electrical isolation of the LAA, as demonstrated in a case study of a patient with refractory atrial tachycardia [Benussi S et al. Circulation 2011] and in a study of 10 patients with paroxysmal AF [Starck CT et al. Interact Cardiovasc Thorac Surg 2012]. In the first long-term study of the AtriClip [Emmert MY et al. Eur J Cardiothorac Surg 2014], 40 patients who had AtriClip placement during concomitant Maze surgery were followed with computed tomography (CT) at 3, 12, 24, and 36 months. Non-device-related mortality was 10%. At 36 months, all clips were stable with no displacement, intracardiac thrombi, perfused LAA, residual neck >1 cm, or strokes or other neurological events.

Implantation of the AtriClip can occur through thorascopic, right mini-thoracotomy, robotic, or posterior thoracotomy approaches. According to Dr. Edgerton, earlier surgical trials led to the conclusion that excision of the LAA is necessary; however, the AtriClip does not excise the appendage. Dr. Edgerton speculated that success with the AtriClip is due to the closing pressure of the clip, which induces ischemic necrosis.

Many devastating strokes originate in the LAA for patients with A F. Minimally invasive new technologies like the AtriClip are used to occlude the LAA, with the goal of reducing the stroke rate. Dr. Edgerton felt that AtriClip placement could be a treatment option for patients who are not candidates for anticoagulant medications. Ongoing stroke trials are, however, needed to define the efficacy and safety of AtriClip for patients with AF.

One such trial, the prospective AtriCure Stroke Feasibility study [NCT01997905], is currently recruiting. The objective is to evaluate the initial procedural safety and efficacy of the AtriClip for stroke prevention for patients with nonvalvular AF and medical contraindications to long-term anticoagulation therapy. A maximum of 30 patients will be enrolled for a duration of ∼3.5 years. The AtriClip will be implanted using the totally thorascopic approach. The primary efficacy endpoint is successful implantation of the AtriClip device and complete exclusion of the LAA, intraprocedurally and at 30 days post implantation. The secondary end points are the 3- and 6-month stroke rates.

Dr. Edgerton noted that the procedure costs substantially less than do transcatheter closures, takes only 30 to 45 minutes, and does not require anticoagulation. The minimally invasive nature of the procedure allows either same-day or next-day discharge.

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