Aortic valve replacement: Is the stentless xenograft an alternative to the homograft? early results of a randomized study

From November 1992 to October 1993 we randomized 101 patients over 60 years of age undergoing elective aortic valve replacement, with or without concomitant coronary artery bypass grafting, to receive either a cryopreserved aortic or pulmonary homograft (n = 38) or a stentless porcine aortic valve xenograft (Edwards Prima 2500) (n = 63). The majority of all valves (92%) were inserted freehand in the subcoronary position. Six homografts (16%) were implanted as a free-root replacement and two xenografts (3%) were used as a mini root. There were four in-hospital deaths (4%), three in the homograft group and one in the xenograft group (homograft, 7.9% versus xenograft, 1.6%; p = not significant). Forty-one patients were followed at 3- to 6-month intervals for 9 ± 2 months (3 to 14 months) and valve pathology was assessed routinely by means of color flow Doppler echocardiography. Two patients in the homograft group developed new aortic insufficiency grade II; all others remained with trivial or no valve incompetence. The mean gradient remained unchanged to immediate postoperative measurements (homograft, 5 ± 1 mm Hg versus xenograft, 11 ± 4 mm Hg; p < 0.001). Despite a slightly higher transvalvular gradient, xenografts achieved excellent initial results when compared to homografts. Ease of implantation and freedom from thromboembolism indicate that xenografts can be an acceptable alternative to homografts, particularly in older patients with small aortic annuli. Long-term studies assessing the durability of the xenograft are necessary for final evaluation.