Preliminary Experience With the Use of an Extracellular Matrix to Augment the Native Pulmonary Valve During Repair of Tetralogy of Fallot.

BACKGROUND: During repair of tetralogy of Fallot (TOF), when a transannular patch is needed in case of a small annulus and dysplastic pulmonary valve, we chose to reconstruct the right ventricular outflow tract by augmenting the divided anterior leaflet with an extracellular matrix (ECM) patch to produce a competent valve. In this study, we present our preliminary experience and early outcomes.

METHODS: From March 2013 to December 2015, of the 206 patients who underwent primary repair of TOF, 52 required a transannular incision. The median age was 18 months and the median weight was 8.2 kg. The native hinge mechanism of the valve was preserved by dividing only the anterior leaflet at the time of the transannular incision and augmenting it with an ECM patch that was sutured to the endocardium and to the divided leaflet.

RESULTS: Two patients died due to reasons not related to the use of the patch. Intraoperative evaluation showed a competent pulmonary valve without significant outflow gradient. During early follow-up (median 20 months), all patients were doing well without any decongestive therapy. Valve regurgitation was assessed as severe in 2, moderate in 26, and mild in 22 patients. In the majority of patients, the valve appeared thin and pliable in spite of mild to moderate regurgitation.

CONCLUSIONS: Early experience with the use of ECM in repair of TOF shows satisfactory outcomes. It does not show obvious growth of the material. Long-term follow-up will be required in order to assess whether the valve function is durable without acquisition of significant regurgitation.