Safety of the open-irrigated ablation catheter for radiofrequency ablation: safety analysis from six clinical studies.

ABSTRACT

BACKGROUND: The open-irrigated catheter is used most frequently for atrial and ventricular radiofrequency ablation (RFA), and is often considered as the standard by which new ablation systems are compared. But few data have been published concerning its safety. This report provides a comprehensive safety analysis of the use of an open-irrigated catheter for RFA of atrial flutter, ventricular tachycardia, and atrial fibrillation in 1,275 patients in six rigorously monitored, prospective, multicenter studies. METHODS: This analysis is of data from six studies conducted as part of both Food and Drug Administration-mandated investigational device exemption studies and postapproval studies. The six studies span a period of more than 10 years. All serious RFA complications and vascular access complications that occurred within seven days postprocedure were included. RESULTS: The number of patients who experienced any acute serious RFA complication in these studies combined was 4.9% (63/1,275). The two earliest studies were conducted when the open-irrigated catheter was first introduced, and accounted for 55.6% of the complications. In the first atrial flutter ablation study, RFA complications decreased by 60% (15.4%-6.2%) after a proctoring program was initiated during the study. For all studies, vascular access complications ranged between from 0.5%-4.7%, and no stroke or transient ischemic attack was reported within 7 days postprocedure. No significant pulmonary vein stenosis was reported from the atrial fibrillation studies. CONCLUSION: A proctoring program, careful fluid management, and absence of char and coagulum contributed to the safe use of the open-irrigated RFA catheter.