Ten-year follow up after prospectively randomized evaluation of stentless versus conventional xenograft aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: The aim of this prospectively randomized study was to analyze the long-term clinical results after stentless versus conventional aortic valve replacement (AVR).
METHODS: Between March 1996 and April 1998, a total of 225 patients was prospectively included into the study. Of these patients, 130 received a stentless aortic valve (SAV), and 95 a conventional stented bioprosthesis (CSB). In these patient groups, 95% and 96%, respectively, had an aortic stenosis, and the mean ages were 71 +/- 7 and 74 +/- 4 years, respectively. There were no significant inter-group differences in left ventricular function, preoperative pressure gradient, or NYHA functional status, and the aortic annulus diameter indices were comparable (13.5 mm in SAV patients versus 13.6 mm in CSB). Larger SAVs were implanted by using an oversizing technique.
RESULTS: The 10-year follow up was 98% complete (mean follow up 102 +/- 48.5 months). At follow up the mean NYHA class was 1.7 +/- 0.8 after SAV versus 1.9 +/- 0.7 after CSB, the left ventricular ejection fraction was 61 +/- 11% versus 60 +/- 8%, and the maximum aortic valve pressure gradient 19.4 +/- 8.7 mmHg versus 24.7 +/- 7.7 mmHg (p = 0.03). The 10-year survival was 54 +/- 4.4% (SAV) versus 46 +/- 5.1% (CSB) (p = NS). In a subanalysis to obtain age-matched patient samples, the 10-year survival was 64 +/- 4.9% after SAV versus 46 +/- 5.1% after CSB (p = 0.02). Among the surviving patients, 78% were satisfied with the procedure because of an improved ability to perform their daily activities, and an improved quality of life.
CONCLUSION: A good functional and hemodynamic outcome was observed at 10 years after xenograft AVR. Stentless AVR was associated with a trend to a better survival; however, a regression of left ventricular hypertrophy occurred in all patients after AVR.

RCT Entities:   Population Interventions Outcomes