Prospectively Randomized Evaluation of Stented Xenograft Hemodynamic Function in the Aortic Position

Abstract

Background-Standard stented aortic xenograft valves have not yet been compared regarding their hemodynamic function using a stratified intraoperative randomization protocol. Methods and Results-100 patients were prospectively included after intraoperative metric sizing of the decalcified aortic annulus. They received Mosaic (M) or Perimount (P) aortic valve replacement. Patient age was 73Ϯ5 years, 51 were female, and New York Heart Association (NYHA) functional class was 2.8Ϯ0.5. The 21-mm annulus group consisted of 5 (M)/7 (P) patients, the 23-mm annulus group of 20 (M)/20 (P), the 25-mm annulus group of 18 (M)/19 (P), and the 27-mm annulus group of 4 (M)/7 (P) patients, respectively. Hemodynamic function was evaluated using transthoracic echocardiography before discharge and at follow-up (438Ϯ352 days). Surgery was uncomplicated in all patients. Labeled valve sizes were 0.93 (M) and 1.05 (P) mm smaller than the annulus diameters (pϭNS). In-hospital mortality was 5%, all nonvalve-related. Transvalvular blood flow velocities and transvalvular pressure gradients were significantly lower in the 25 P versus the 25 M group at baseline and in the 23 P and 25 P groups at follow-up. There was a significant regression of left ventricular mass index in all patients at follow-up. However, left ventricular mass regression was more pronounced after P aortic valve replacement. Conclusion-Labeled sizes of prosthetic heart valves implanted are smaller than the true aortic annulus. Both standard aortic xenografts compared in this prospectively randomized trial provide a sufficient hemodynamic and functional outcome.

ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease

“…Stented pericardial heterografts have better hemodynamic performance than porcine heterografts, especially in smaller sizes (less than 21 mm) (863)(864)(865)(866). In a randomized trial comparing stented porcine xenografts and stented pericardial valves (866), the reduced pressure gradients with the pericardial valve translated into greater reduction in LV mass at a mean 1.2-year follow-up period after AVR.…”

2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease

“…Stented pericardial heterografts have better hemodynamic performance than porcine heterografts, especially in smaller sizes (less than 21 mm). [863][864][865][866] In a random-ized trial comparing stented porcine xenografts and stented pericardial valves, 866 the reduced pressure gradients with the pericardial valve translated into greater reduction in LV mass at a mean 1.2-year follow-up period after AVR.…”

Stentless valves for aortic valve replacement: where do we stand?

“…The difference in the results comparing stentless valves with porcine or pericardial valves can be explained by the hemodynamic difference that has been reported between the two stented valves [6,42,43] although this is not universally accepted [44].…”

“…For this reason and despite a more complex implantation technique, they are considered as an alternative in elderly patients. The development of better profiled stented valves, however, presents a constant challenge to stentless valves [6,7]. After almost 15 years of clinical experience with stentless valves, do they maintain hemodynamic superiority?…”