Follow-up of a modified Fontan randomized trial for intraatrial reentrant tachycardia prophylaxis.

OBJECTIVE: Atrial arrhythmias represent significant morbidity and risk for mortality in Fontan patients. In a randomized trial involving patients undergoing a lateral tunnel Fontan between 1999 and 2001, Collins et al. investigated the safety and efficacy of a surgical atrial incision aimed at decreasing the incidence of intraatrial reentrant tachycardia (IART). The purpose of this study was to report the late follow-up of the aforementioned trial.

DESIGN: All surviving patients previously enrolled in the randomized trial were eligible for this follow-up study. Patients' legal guardians were contacted for informed consent and data were obtained form a retrospective chart review.

RESULTS: Of the 39 eligible patients, 29 were recruited: 15 in the intervention and 14 in the control groups. The median follow was 9.0 (1.2) years for the intervention group and 9.3 (1.1) years for the control group (P= .86). At most recent follow-up, there was no statistically significant difference in the demographic, echocardiographic, and electrophysiological data between the two groups. There was no late incidence of the primary outcome, IART. There were nine cases of late-onset sinus node dysfunction (SND): 5/15 in the intervention and 4/14 in the control groups (P= .99). There was only one late pacemaker implantation for early post-op SND.

CONCLUSION: At late follow-up 9 years post-Fontan, IART had not occurred in either group. There was no evidence of late-onset complications related to the interventional atrial incision. Further follow-up is warranted for this cohort.