Early clinical and hemodynamic evaluation of the aortic intact porcine bioprosthesis.

Between October 1990 and June 1992, 89 patients underwent aortic valve replacement using the Intact porcine bioprosthesis. Their mean age (+/- SD) was 74.6 +/- 7.8 years (range 48 to 92). Seventy-five percent were in NYHA Class III-IV, 79 (89%) had AS or AS/AI, 10 (11%) had had previous cardiac surgery and 25 (32%) had an EF < 0.50. Associated procedures included CABG 45 (51%), septal myectomy 13 (15%), annular enlargement eight (9%), LV aneurysmectomy one, ascending aortic replacement one, and arch replacement one. Hospital mortality was four (4.5%). Hemodynamics were assessed with 2D echo with Doppler at seven days, six weeks and 12 months, and compared with 130 standard Carpentier-Edwards (C-E) porcine bioprostheses. At follow up, two patients have 2/4 perivalvular AI. The transvalvular gradients for the Intact valve were as follows: 21 mm-16.9 +/- 7.4 mmHg; 23 mm-18.9 +/- 6.2 mmHg; 25 mm-17.1 +/- 5.4 mmHg; 27 mm-15.0 +/- 3.7 mmHg; and 29 mm-15.0 +/- 2.1 mmHg. When compared to the standard Carpentier-Edwards porcine bioprostheses, the 21 mm Intact valve had the same gradient as the C-E prosthesis. However, the transvalvular gradients were slightly higher for the Intact valve for sizes 23-29 mm when compared to the corresponding C-E valve. The effective orifice area and effective orifice area index was no different between the two valves. Satisfactory hemodynamics are seen in the smaller prostheses when valves are matched for BSA and when aortic annular enlargement is performed when necessary.