Early Midterm Results After Valve Replacement With Contemporary Pericardial Prostheses for Severe Aortic Stenosis.

ABSTRACT

BACKGROUND: Clinical studies have demonstrated improved gradients after aortic valve replacement with the Trifecta (TR) valve (Abbott Cardiovascular, St Paul, MN) as compared with the Carpentier-Edwards Magna Ease (ME) valve (Edwards Lifesciences, Irvine, CA). Clinical benefits of this strategy have not been demonstrated. METHODS: Patients undergoing aortic valve replacement for severe aortic stenosis with either valve were included. Patients were excluded if they underwent concomitant procedures other than coronary artery bypass grafting. Inverse proportion treatment weighting was used in the analysis. The primary outcome was a composite of cardiac mortality, need for reintervention, and freedom from first congestive heart failure (CHF). Secondary outcomes were all-cause mortality, the composite components, and cumulative CHF admission. Follow-up echocardiograms were assessed in a cohort of patients to assess structural valve degeneration. RESULTS: There were 331 patients in the TR group and 360 patients in the ME group. The TR group had more women (48% vs 32%, P < .001) with smaller roots (left ventricular outflow tract diameter TR, 2.11 cm; ME, 2.17 cm; P < .001). After weighting there was no significant difference in the composite measure between groups (P > .05). There was no difference in all-cause mortality (hazard ratio, 0.82; 95% confidence interval, 0.42-1.59; P = .56), and 5-year survival was 91.9% in the ME group and 93.4% in the TR group. There was no difference in cardiac death, reintervention, or first onset of CHF or incidence of structural valve degeneration between groups. There was no difference in the rate of admissions for CHF per 100 patients between the 2 valve types (P = .19). CONCLUSIONS: Early hemodynamic benefits have not translated into differences in medium-term clinical outcomes between these 2 valves. Long-term follow-up is necessary.