An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses

Abstract

Objectives: To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of mechanical wear, because mechanical stresses are distributed differently. Because long-term evidence for new prosthetic valves is lacking, this in vitro study compared hydrodynamic performance and durability among 3 currently available bioprosthetic valves with internally (IMLV) or externally mounted leaflets (EMLV).

Methods: Prostheses of the internally mounted Medtronic Avalus and Carpentier-Edwards Perimount Magna Ease valves were compared to prostheses of the externally mounted Abbott Trifecta valve. For each labelled size (e.g. 19, 21 and 23) of the 3 types, 3 valves underwent accelerated wear testing for up to 600 million cycles, corresponding to ∼15 years of simulated wear. The valves underwent hydrodynamic testing and visual inspection.

Results: EMLV had the largest effective orifice area and lowest pressure gradient for each labelled size at baseline and 600 million cycles; the effective orifice area and the pressure gradient were equivalent for the 2 types of IMLV. Five of 9 EMLVs had at least 1 hole or tear in the leaflet tissue around the stent posts, which resulted in severe regurgitation at 500 million cycles in 2 cases. All IMLVs were intact at 600 million cycles with minimal tissue wear.

Conclusions: EMLV showed superior hydrodynamic performance but inferior mechanical durability compared to IMLV after 600 million cycles of testing. The primary failures were because of significant mechanical abrasion in the commissural region, which may warrant close monitoring of EMLV during long-term follow-up.

Keywords: In vitro testing; Bioprosthetic valves; Durability.