Abstract
BACKGROUND: We have developed a new hybrid warp-knit fabric for induction of in situ tissue regeneration that has shown appropriate antideterioration properties and expandability in preclinical studies. This study was performed to assess the clinical efficacy and safety of this fabric in the early postoperative period after congenital cardiac surgery. METHODS: The fabric comprises biodegradable (complete degradation period, 2-3 years) and nonbiodegradable yarns coated with cross-linked gelatin. A multicenter single-arm 3-year study was conducted. The primary end point for regulatory approval was the surgical success rate without death or reintervention related to fabric failure at 1 year after surgery. Secondary end points included the incidence of material-related secondary lesions. RESULTS: The fabric was implanted at 41 sites (pulmonary artery, n = 18; right ventricular outflow tract, n = 12; atrial septum, n = 7; and ventricular septum, n = 4) in 34 patients of median age 1 year 11 months (range, 4 months-58 years). The surgical success rate was 100%. There were no abnormal findings for the fabric on echocardiography and no serious adverse events in a median follow-up period of 40 months (range, 36-55 months), other than 3 stenotic lesions that were due to the surgical procedure. These results permitted regulatory approval for use of the fabric in Japan. CONCLUSIONS: The new fabric promoting tissue self-organization through a novel technology showed acceptable efficacy and safety in the early postoperative period after congenital cardiac surgery.