Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier–Edwards pericardial valve with the Toronto Stentless Porcine Valve

摘要: Objective The benefit of stentless valves remains in question. In 1999, a randomized trial comparing and stented was unable to demonstrate any hemodynamic or clinical benefits at 1 year after implantation. This study reviews long-term outcomes patients the aforementioned trial. Methods Between 1996 99 undergoing aortic valve replacement were receive either Carpentier–Edwards pericardial (CE) (Edwards Lifesciences, Irvine, Calif) Toronto Stentless Porcine Valve (SPV) (St Jude Medical, Minneapolis, Minn). Among these, 38 available for late echocardiographic follow-up (CE, n = 17; SPV, 21). Echocardiographic analysis undertaken both rest with dobutamine stress, functional status (Duke Activity Status Index) compared mean 9.3 years postoperatively (range, 7.5–11.1 years). Clinical 82% complete 10.3 7.5–12.2 Results Preoperative characteristics similar between groups. Effective orifice areas increased groups over time. Although there no differences effective year, 9 years, significantly greater SPV group 1.49 ± 0.59 cm 2 ; 2.00 0.53 P .011). Similarly, peak gradients decreased time; however, lower (mean: CE, 10.8 3.8 mm Hg; 7.8 4.8 .011; peak: 20.4 6.5 14.6 7.1 .022). Such magnified stress 22.7 6.1 15.3 8.4 .008; 48.1 11.8 30.8 17.7 .001). Ventricular mass regression occurred groups; demonstrated on echocardiographic, magnetic resonance imaging, biochemical (plasma B-type [brain] natriuretic peptide) assessment ( .74). Duke Index scores improved noted 27.5 19.1; 19.9 12.0; .69). Freedom from reoperation 12 92% 5% CEs 75% SPVs .65). valve-related morbidity 7% 55%  = .05). Finally, 12-year actuarial survival 35% 52% .37). Conclusion offering outcomes, did not afford superior up after implantation.