Efficacy
A total of 94 patients had at least one rhythm assessment at least 90 days post procedure and were included in analysis of efficacy outcomes. The follow-up duration ranged from 3.0 to 30.1 months with an average duration of 9.5 months. Rhythm assessments were made with CIEDs in 17% of patients, prescribed wearable monitors in 41.5%, and standard electrocardiography alone in 41.5% of patients. The overall recurrence rate was 14%. Only five (5%) patients experienced clinical failure, a subjective assessment by the authors conveying failure of arrhythmia control (on or off antiarrhythmic drugs) or a need for further procedures. The majority of the others were modest and detailed in a Supplemental Table 1. Survival probabilities are shown in Figure 3, estimating an 80% arrhythmia free survival at twelve months following the initial VOM infusion ablation. The respective arrhythmia freedom probabilities at twelve months were 80% when restricting analysis to initial procedures (N=65 procedures), and 79% when only analyzing persistent AF patients undergoing an initial procedure (N=54 procedures).
Four patients were taken for redo ablations after the VOM ethanol infusion procedure. Two of these patients experienced atypical flutter, both corresponding to circuits involving the posterior wall. The mitral isthmus required reablation in one of those patients though it was not mediating the recurrent arrhythmia. The other two patients each experienced recurrent paroxysmal AF. The first required early reablation for repeated cardioversions in emergency room settings with poorly controlled rates. In this case, the left veins, posterior wall, and mitral isthmus all required reablation. Unfortunately he continued to have poorly controlled rapid AF and underwent AV nodal ablation. The other patient had a completely intact initial lesion set (standard lesion set plus SVC isolation) but an additional right atrial trigger was noted with isoproterenol and successfully ablated. This was complicated by sinus nodal injury necessitating a pacemaker. Among these four patients, only the one requiring the AV nodal ablation has had documented recurrence following the redo ablation (Supplemental Table 1).