Background: A stentless valve is expected to be hemodynamically superior to a stented valve. The aim of this study was to compare early postoperative hemodyna mic function and clinical events in a randomized, prospective series of 160 sten tless and stented biological replacement aortic valves. Methods: We randomized 1 60 consecutive patients on 1 surgeon’s list to receive either a Toronto stentle ss porcine valve (St Jude Medical, Inc, St Paul, Minn) or a Perimount stented bo vine pericardial valve (Edwards Lifesciences, Irvine, Calif). Echocardiography w as performed at discharge, between 3 and 6 months, and at 1 year after surgery. Statistical analysis was performed by both intention to treat and act ual valves implanted. Results: The mean labeled size of both designs of valve wa s 24.7. There were no statistically significant differences in results at any ti me interval or whether analysis was performed by actual valves implanted or inte ntion to treat. At 3 to 6 months for the Toronto versus the Perimount valve, the effective orifice area was 1.58 versus 1.66 cm2, the mean pressure difference w as 7.54 versus 7.42 mm Hg, and the peak velocity was 2.07 versus 2.01 m/s. There was no difference in mortality, regression of left ventricular hypertrophy, or complications other than paraprosthetic regurgitation at 12 months or on follow -up for a proportion of the sample to 8 years. The incidence of regurgitation t hrough the valves was similar for Toronto (10%) and Perimount (13.8%) at 1 yea r, but mild paraprosthetic regurgitation was found in 5 patients with the Perimo unt valve and none with Toronto valves. Conclusions: There were no significant d ifferences in hemodynamic function or clinical events between the stented and st entless biological valves chosen for comparison in the early postoperative perio d or in preliminary follow-up to 5 years.
展开▼
