Early hemodynamic evaluation of Trifecta and Freestyle bioprostheses in patients with a small aortic root: preliminary results from a prospective randomized study.

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement (AVR) in patients with a small aortic root is often associated with some degree of obstruction and residual gradients. Stentless valves display better hemodynamic performance than stented valves, and might be ideal in patients with a small aortic annulus. A new stented bioprosthesis, the Trifecta valve, has recently become available and has yielded interesting early results. The study aim was to compare the hemodynamic performance of the Trifecta valve with that of the Freestyle valve in patients with an aortic annulus ≤ 2.3 cm.

METHODS: Between September 2011 and September 2013, a total of 40 patients with pure aortic stenosis and native aortic annulus diameter ≤ 2.3 cm was randomized to receive either a St. Jude Medical Trifecta stented prosthesis (n = 20) or a Medtronic Freestyle stentless prosthesis (n = 20). Hemodynamics results were compared between the two groups on discharge from hospital.

RESULTS: The Trifecta valve showed slightly better hemodynamics, with peak gradients of 11 ± 5 mmHg and 17 ± 9 mmHg (p = 0.009), and mean gradients of 5.5 ± 3 mmHg and 7.5 ± 4 mmHg (p = 0.06) for the Trifecta and Freestyle valves, respectively. The average indexed effective orifice area (EOAi) was 1.14 ± 0.23 cm2/m2 and 1.09 ± 0.20 cm2/m2 (p = 0.520) for the Trifecta and Freestyle, respectively. Patient-prosthesis mismatch (PPM) occurred in two patients of the Freestyle group, and in three patients of the Trifecta group.

CONCLUSION: In the present study, the stentless and stented prostheses each yielded comparable and excellent early hemodynamics results. The data obtained suggest that Trifecta valve implantation is a valid means of avoiding PPM after AVR in patients with a small native aortic annulus.