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).