TY - JOUR
T1 - A prospective, randomized comparison of 3 contemporary bioprosthetic aortic valves
T2 - Should hemodynamic performance influence device selection?
AU - Suri, Rakesh M.
AU - Michelena, Hector I.
AU - Burkhart, Harold M.
AU - Greason, Kevin L.
AU - Daly, Richard C.
AU - Dearani, Joseph A.
AU - Park, Soon J.
AU - Joyce, Lyle D.
AU - Stulak, John M.
AU - Sundt, Thoralf M.
AU - Li, Zhuo
AU - Schaff, Hartzell V.
PY - 2012/12
Y1 - 2012/12
N2 - Objective: Latest generation biologic aortic valve prostheses were designed to improve hemodynamic performance. We sought to determine whether there are clinically important early differences among these devices. Methods: Three hundred adults with severe aortic valve stenosis undergoing aortic valve replacement were randomized to receive the Edwards Magna, Sorin Mitroflow, or St. Jude Epic bioprostheses (n = 100, n = 101, n = 99, respectively). Early hemodynamic performance was studied by echocardiography. Results: Mean patient age was 76 ± 8 years and there were 203 men (68%). There were no significant differences in baseline characteristics among implant groups. Early mortality was 1.7%, and there were no differences in early adverse events. Postoperative echocardiography showed small but statistically significant differences overall between the Magna, Mitroflow, and Epic valves in mean gradient (14.2 mm Hg, 16.3 mm Hg, 16.5 mm Hg, respectively; P = .011), aortic valve area (2.05 cm2, 1.88 cm2, 1.86 cm2, respectively; P = .012), and indexed aortic valve area (1.05 cm 2/m2, 0.97 cm2/m2, 0.95 cm 2/m2, respectively; P = .012). Prosthetic performance was similar among all with a small (≤21 mm) aortic annulus. Patients who received the Magna device with a 23-mm annulus had slightly greater indexed aortic valve area; those with >23 mm had a slightly lower transprosthetic gradient. Analogous trends were found when data were stratified by either commercial implant size or echocardiography-determined aortic annulus size. Severe patient-prosthesis mismatch was infrequent overall and was similarly low among devices (P value not significant). Conclusions: This prospective, randomized comparison reveals that there are small but consistent early postoperative hemodynamic differences among current third-generation porcine and pericardial aortic valve prostheses. The 3 valves studied performed equally well in patients with a small (≤21 mm) aortic annulus. The Magna valve had a slightly lower mean gradient in those with larger annular size (>23 mm). Longitudinal follow-up of these randomized cohorts is essential to determine late clinical implications of these early postoperative findings.
AB - Objective: Latest generation biologic aortic valve prostheses were designed to improve hemodynamic performance. We sought to determine whether there are clinically important early differences among these devices. Methods: Three hundred adults with severe aortic valve stenosis undergoing aortic valve replacement were randomized to receive the Edwards Magna, Sorin Mitroflow, or St. Jude Epic bioprostheses (n = 100, n = 101, n = 99, respectively). Early hemodynamic performance was studied by echocardiography. Results: Mean patient age was 76 ± 8 years and there were 203 men (68%). There were no significant differences in baseline characteristics among implant groups. Early mortality was 1.7%, and there were no differences in early adverse events. Postoperative echocardiography showed small but statistically significant differences overall between the Magna, Mitroflow, and Epic valves in mean gradient (14.2 mm Hg, 16.3 mm Hg, 16.5 mm Hg, respectively; P = .011), aortic valve area (2.05 cm2, 1.88 cm2, 1.86 cm2, respectively; P = .012), and indexed aortic valve area (1.05 cm 2/m2, 0.97 cm2/m2, 0.95 cm 2/m2, respectively; P = .012). Prosthetic performance was similar among all with a small (≤21 mm) aortic annulus. Patients who received the Magna device with a 23-mm annulus had slightly greater indexed aortic valve area; those with >23 mm had a slightly lower transprosthetic gradient. Analogous trends were found when data were stratified by either commercial implant size or echocardiography-determined aortic annulus size. Severe patient-prosthesis mismatch was infrequent overall and was similarly low among devices (P value not significant). Conclusions: This prospective, randomized comparison reveals that there are small but consistent early postoperative hemodynamic differences among current third-generation porcine and pericardial aortic valve prostheses. The 3 valves studied performed equally well in patients with a small (≤21 mm) aortic annulus. The Magna valve had a slightly lower mean gradient in those with larger annular size (>23 mm). Longitudinal follow-up of these randomized cohorts is essential to determine late clinical implications of these early postoperative findings.
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U2 - 10.1016/j.jtcvs.2012.07.105
DO - 10.1016/j.jtcvs.2012.07.105
M3 - Article
C2 - 23140964
AN - SCOPUS:84869036701
SN - 0022-5223
VL - 144
SP - 1387
EP - 1398
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 6
ER -