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

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

The Amplatzer cardiac plug (ACP) is a self-expanding device designed to close the orifice of the left atrial appendage (LAA) to prevent clot formation. Reda Ibrahim, MD, University of Montreal, Montreal, Quebec, Canada, presented data from trials and registries of ACP implantation in patients with atrial fibrillation (AF).

A European retrospective, multicenter data analysis of 143 patients scheduled for transcatheter ACP implantation focused on periprocedural technical and safety issues [Park JW et al. Catheter Cardiovasc Interv 2011]. ACP implantation was attempted in 137 of the patients and was successful in 132 patients (96.4%). Ten procedural safety events (7%) were reported: stroke (n=3; 2.1%), serious pericardial effusion (n=5; 3.5%), and device embolization (n=2; 1.4%).

An EU prospective observational study with 6-month follow-up enrolled 204 patients with a history of AF [Walsh K et al. EuroPCR 2012]. The ACP was successfully implanted in 197 of the patients (96.6%). The closure rate was 99.5% at implant and 98.9% at 6 months. Residual flow >3 mm was observed in 0.5% of patients at implant and 1.1% at 6 months. At 6 months, the stroke rate was 1.98%, a 65% reduction from the expected stroke rate (based on the CHADS₂ score) of 5.6%. Six safety events (2.9%) were reported: serious pericardial effusion (n=3; 1.5%) and device embolization (n=3; 1.5%).

The Canadian registry implanted 52 patients and had a 98.1% procedural success rate. Complications included one embolization, one pericardial effusion, and one in-hospital transient ischemic attack [Urena M et al. J Am Coll Cardiol 2013]. At a mean follow-up of 20±5 months, there was a 65% reduction in the expected stroke rate from 8.6% to 1.1% (p<0.001). Thromboembolic events (3.4%) and major bleeding (3.4%) were significantly reduced from expected rates (p<0.001 for both).

A prospective Italian registry reported that in 134 patients with nonvalvular AF at high risk of stroke and bleeding, ACP implantation was successful in 118 patients (88.1%), with major complications in 1.5% [Stolcova M et al. J Am Coll Cardiol 2013 (abstr TCT-97)]. At a median follow-up of 22.8 months, stroke was reduced by 82% (p<0.01) and bleeding by 35% from the expected rates.

A multicenter study attempted ACP implantation in 1047 patients [Tzikas A et al. TCT 2013 (abstr)]. The device was successfully implanted in 1019 patients (97.3%).

Major periprocedural complications were death (n=8; 0.76%), pericardial tamponade (n=13; 1.24%), major bleeding (n=13; 1.24%), stroke (n=9; 0.86%), device embolization (n=1; 0.10%), and myocardial infarction (n=1; 0.10%). At 1349 patient-years, stroke was reduced 59% from the expected rate of 5.62% to 2.30%; bleeding was reduced 61% from the expected 5.34% to 2.08%.

A single-center prospective trial of 80 patients with AF compared the Watchman (n=40) and ACP (n=40) devices [Chun KRJ et al. Heart Rhythm 2013]. Watchman implantation was successful in 38 patients (95%) compared with successful ACP implantation in all 40 patients (100%). Procedural complications included delayed tamponade in 2.5% of patients in both groups and air embolism in 2.5% of both groups. At 6 weeks, thrombus occurred in 3 Watchman patients (7.9%) and 1 ACP patient (2.5%). The device was dislodged in 1 ACP patient (Table 1).

Prof. Ibrahim concluded that the ACP can be implanted successfully in a large proportion of patients. Randomized trials comparing the ACP with other devices and with oral medical therapy are needed to determine if the devices are efficacious and can improve outcomes for patients with atrial fibrillation.

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