The new St. Jude Medical regent mechanical heart valve: laboratory measurements of hydrodynamic performance.
OBJECTIVE
The St. Jude Medical (SJM) mechanical heart valve was the first bileaflet valve with leaflets and orifice all fabricated from pyrolytic carbon. In 1992, a supra-annular cuff configuration, the SJM mechanical heart valve Hemodynamic Plus Series (HP), was introduced, which gave a one-size gain in orifice area over the standard valve. In a continuing effort to improve hydrodynamic performance, a new enhanced configuration of the mechanical valve - the SJM Regent valve - has been developed. The blood-contacting components of the SJM Regent valve have the same design features as those of the standard or HP valve, but the orifice lumen area has been increased, without compromising structural integrity, by a shift in the cuff-retaining orifice rims.


METHODS
Valve performance has been measured using a laboratory simulation of the left heart system. Three samples of both valve types (SJM Regent, HP) for sizes 17 mm to 27 mm, were tested at a cardiac output of 5 l/min. Supplementary steady-flow measurements were made at flow rates between 5 and 30 l/min. Pressure and flow signals were recorded and several performance parameters, including pressure gradient, effective orifice area (EOA), insufficiency (regurgitant volume as a percent of forward flow volume) and energy loss, were computed.


RESULTS
All sizes of the SJM Regent valve showed improved hydrodynamic performance compared with the HP valve. For the small sizes (17, 19, 21 mm), the pressure gradient of the SJM Regent decreased by 37%, 36% and 39%, respectively; the EOA increased by 22%, 22% and 21%; and the total transaortic energy loss decreased by 33%, 31% and 31% compared with the HP valve. The regurgitation for both valves ranged between 4% and 8% of forward flow volume over the 17-27 mm size range.


CONCLUSIONS
Hydrodynamic measurements confirm the gain of the SJM Regent valve over the HP valve that is expected based on the increased geometric orifice area. Given its basic similarity of design, but with an increased EOA as demonstrated in vitro, the SJM Regent valve is anticipated to provide an increased level of clinical benefit.
Walker
D K
DK
Cardiac Development Laboratory, Victoria, BC, Canada.
Brendzel
A M
AM
Scotten
L N
LN
D001672:Biocompatible Materials; D006350:Heart Valve Prosthesis / Q000592:standards; D006439:Hemodynamics; D006801:Humans; D066298:In Vitro Techniques; D019563:Mechanics; D011474:Prosthesis Design
D001672:Biocompatible Materials