The safety and in vitro effectiveness of applying silver to polyethyle
ne terephthalate fabric mechanical heart valve (MHV) sewing cuffs for
the prevention of prosthetic valve endocarditis (PVE) were evaluated.
PVE is an infrequent but grave complication of cardiac surgery associa
ted with mortality rates potentially exceeding 50%. A poor response to
antibiotic therapy is partly responsible for the high mortality rates
. Silver is a well known antimicrobial agent with broad effectiveness.
Preliminary in vitro microbial challenge studies of the coated fabric
using the New York State 63 bacteriostatic test and Dow Coming Shake
Flask test showed a greater than or equal to 97% reduction for most or
ganisms tested. Sheep mitral valve replacement studies suggest compara
ble tissue ingrowth of uncoated and coated fabric with a more organize
d, thinner pannus formed on silver coated fabric. Low levels of silver
were present in the serum at all time periods. These results indicate
MHVs with silver coated cuffs may provide additional protection again
st PVE.