Low Rates Of Thromboembolic Events Associated With Epicardial Ablation Of The Left Atrium During Cardiac Surgical Ablation
Andy Kiser1, Gansvoort Dunnington2, Claudio Muneretto3, Ivar Friedrich4.
1ECHI, Greenville, NC, USA, 2Adventist Heart Institute, St. Helena, CA, USA, 3University of Brescia Medical School, Brescia, Italy, 4Krankenhaus der Barmherzigen Brueder Trier, Trier, Germany.
Objective The Society of Thoracic Surgeons has given surgical ablation of AF, in a concomitant or a stand-alone setting, a class I or II indication, with benefits outweighing risks. A known major complication associated with AF ablation, however, is thromboembolic events (TE) (e.g. stroke/ CVA/TIA). We performed a post market trending to determine the TE rates associated with the epicardial ablation of the left atrium during cardiac surgical ablation using bipolar and monopolar radiofrequency (RF) ablation system. The ablation system delivers temperature-controlled RF energy sequentially in bipolar mode followed by a monopolar mode. It incorporates a unique suction design to engage tissue on a beating heart, which eliminates the heat sink effect during ablation.
Methods The worldwide post market data reported on the ablation system over 4 years (2013- Oct 2017) was analyzed to determine the rate of TE. For comparison, the rates associated with cardiac surgical procedures and endocardial RF ablation were reviewed in the literature (Jan 1990- Mar 2017), using the following data sources: Society of Thoracic Surgeons' National Adult Cardiac Surgery and Duke Clinical Research Institute databases, PubMed Medline and the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
Results For the ablation device, the reported rate of TE is 0.34% (24/ 7076) worldwide and 0.68% (19/2798) in the US. The internal sales records obtained from the company were used as denominator to calculate these rates. In comparison, the TE rates associated with isolated endocardial RF catheter ablation are 0.43-1.20% and those with cardiac surgical procedures are 0.59 - 5.10%
Conclusion The thromboembolic event rate associated with left atrial epicardial ablation using bipolar and monopoly RF energy during cardiac surgical ablation is low and well within the range of endocardial RF catheters and cardiac surgical procedures reported in the published literature.
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