Fenestration improves clinical outcome of the fontan procedure: a prospective, randomized study.

BACKGROUND The Fontan procedure is the definitive operation for palliation of complex congenital heart disease with single-ventricle physiology. Fenestration of the Fontan circuit allows for shunting of deoxygenated blood to the systemic circulation. This procedure improved the clinical outcomes of patients who are at high risk for poor Fontan results. However, it is controversial whether fenestration is beneficial for standard-risk patients. METHODS AND RESULTS This prospective, randomized trial evaluated the clinical utility of fenestration in patients with standard preoperative risk profiles for Fontan surgery. Forty-nine consecutive patients were assigned to undergo either a fenestrated (25 patients) or nonfenestrated (24 patients) Fontan procedure. The fenestrated and nonfenestrated groups were comparable with respect to age (P=0.944), body surface area (P=0.250), number of preoperative risk factors for poor outcome (P=0.681), cardiopulmonary bypass time (P=0.302), number of patients who required aortic cross-clamping (P=0.240), preoperative oxygen saturation (P=0.101), and number of patients with dominant left ventricular morphology (P=0.534). Patients in the fenestrated group had 55% less total chest tube drainage (P=0.036), 41% shorter total hospitalization (P=0.018), and 67% fewer additional procedures in the postoperative period (P=0.006) than those in the nonfenestrated group. CONCLUSIONS Baffle fenestration performed at the time of Fontan surgery improves short-term outcome in standard-risk patients by decreasing pleural drainage, hospital length of stay, and need for additional postoperative procedures.