BACKGROUND: A stentless valve is expected to be hemodynamically superior to a stented valve. The aim of this study was to compare early postoperative hemodynamic function and clinical events in a randomized, prospective series of 160 stentless and stented biological replacement aortic valves. METHODS: We randomized 160 consecutive patients on 1 surgeon's list to receive either aToronto stentless porcine valve (St Jude Medical, Inc, St Paul, Minn) or a Perimount stented bovine pericardial valve (Edwards Lifesciences, Irvine, Calif). Echocardiography was performed at discharge, between 3 and 6 months, and at 1 year after surgery. Statistical analysis was performed by both intention to treat and actual valves implanted. RESULTS: The mean labeled size of both designs of valve was 24.7. There were no statistically significant differences in results at any time interval or whether analysis was performed by actual valves implanted or intention 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 was 7.54 versus 7.42 mm Hg, and the peak velocity was 2.07 versus 2.0.1 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 through the valves was similar for Toronto (10%) and Perimount (13.8%) at 1 year, but mild paraprosthetic regurgitation was found in 5 patients with the Perimount valve and none with Toronto valves. CONCLUSIONS: There were no significant differences in hemodynamic function or clinical events between the stented and stentless biological valves chosen for comparison in the early postoperative period or in preliminary follow-up to 5 years.
RCT Entities:
BACKGROUND: A stentless valve is expected to be hemodynamically superior to a stented valve. The aim of this study was to compare early postoperative hemodynamic function and clinical events in a randomized, prospective series of 160 stentless and stented biological replacement aortic valves. METHODS: We randomized 160 consecutive patients on 1 surgeon's list to receive either a Toronto stentless porcine valve (St Jude Medical, Inc, St Paul, Minn) or a Perimount stented bovine pericardial valve (Edwards Lifesciences, Irvine, Calif). Echocardiography was performed at discharge, between 3 and 6 months, and at 1 year after surgery. Statistical analysis was performed by both intention to treat and actual valves implanted. RESULTS: The mean labeled size of both designs of valve was 24.7. There were no statistically significant differences in results at any time interval or whether analysis was performed by actual valves implanted or intention 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 was 7.54 versus 7.42 mm Hg, and the peak velocity was 2.07 versus 2.0.1 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 through the valves was similar for Toronto (10%) and Perimount (13.8%) at 1 year, but mild paraprosthetic regurgitation was found in 5 patients with the Perimount valve and none with Toronto valves. CONCLUSIONS: There were no significant differences in hemodynamic function or clinical events between the stented and stentless biological valves chosen for comparison in the early postoperative period or in preliminary follow-up to 5 years.