Objective: Several types of valves and valved conduits have been developed for right ventricular outflow tract reconstruction and yet no one has provided prolonged satisfactory hemodynamic performance. The RVOT Elan is a bioprosthetic heart valve conduit constructed from a vascular graft and a porcine stentless valve indicated specifically for right ventricular outflow tract reconstruction. The present study aimed to evaluate the early clinical and hemodynamic results following implantation of the RVOT Elan in adults and adolescents with congenitally corrected right ventricular outflow tract anomalies requiring reintervention.
Design: Nineteen consecutive patients underwent right ventricular outflow reconstruction with the RVOT Elan between June 2012 and May 2013 in a nationally centralized center for surgery of patients with congenital heart disease. Pulmonic transvalvular gradients were evaluated with echocardiograms at discharge. Postoperative data on adverse clinical events were obtained from patient records. Follow-up was performed in October 2013 and was 100% complete (mean 331 ± 102, median 315 days).
Results: There were no intraoperative deaths. Survival at 30 days was 100% and there were no late deaths. The mean gradients were 14, 15, 13 mm Hg for the 21, 23, and 25 mm valve size, respectively. There were no cases of endocarditis or valve thrombosis. Freedom from reoperation for any cause was 100%. Freedom from cardiovascular adverse events was 94.4% (data 90.5% complete).
Conclusions: The RVOT Elan demonstrates excellent early clinical and favorable hemodynamic results, with low transvalvular gradients, good flow characteristics, and a complete freedom from reoperation. Ease of implantation is evidenced by favorable ischemic times. Long-term results are awaited.
Keywords: Congenital-Cyanotic; Hemodynamics; Right Ventricular Outflow Tract; Valve Disease.
© 2014 Wiley Periodicals, Inc.