Initial experience with the Toronto Root bioprosthesis

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess the safety and efficacy of the Toronto Root bioprosthesis for aortic root or valve replacement during the early postoperative stages. METHODS: Between November 2000 and December 2002, the Toronto Root was implanted in 191 patients in 17 institutions. The patients' mean age was 65 years (range: 25 to 87 years) and 70% were males. The bioprosthesis was implanted as a full aortic root in 76% of patients, as a root inclusion in 9%, and in the subcoronary position in 15%. The sizes used in decreasing frequency were 27, 29, 25, 23 and 21 mm. Coronary artery bypass was performed in 25% of patients. Echocardiography was performed before hospital discharge and at six months postoperatively. Serum aluminum levels were monitored pre- and postoperatively as this metal is used in anticalcification treatment of the arterial wall of the porcine root. For the purpose of this study, follow up was closed at six months in all patients, and was complete. RESULTS: Eight patients died, though none of the deaths was valve-related. Two patients required reoperation because of technical errors during implantation. Two patients developed endocarditis, one patient required surgical intervention, and two patients suffered cerebral transient ischemic attacks. All survivors experienced symptomatic improvement, and 97% were in NYHA functional classes I and II at six months postoperatively. Blood levels of aluminum were unchanged at follow up. The mean effective orifice area of all valves studied was 2.0 +/- 0.8 cm2, and the mean systolic gradient 7.0 +/- 3.9 mmHg at six months postoperatively. No patient had more than trace aortic insufficiency. CONCLUSION: Early experience with the Toronto Root bioprosthesis has shown it to be a safe and effective valve for aortic valve or aortic root replacement, with excellent hemodynamic characteristics, a low transvalvular gradient and a large effective orifice area.