A reusable metallic valvotomy device has been developed with the goals
of improving the results of percutaneous mitral valvotomy and increas
ing the cost-effectiveness of the procedure. The device consists of a
detachable and reusable metallic dilator with two articulated bars scr
ewed at the distal end of a catheter. Using transseptal catheterizatio
n, the device is placed across the valve over a traction guidewire and
then opened gradually by means of pliers up to a maximum of 40 mm. To
date, the device was used in 168 patients with a broad spectrum of mi
tral valve disease. The procedure was successful in 95% of cases and r
esulted in an increase in mitral valve area from 1.01 +/- 0.8 to 2.20
+/- 0.7 cm(2). No increase in mitral regurgitation was noted in 87% of
cases. Bilateral splitting of the commissures was observed in 89%. Co
mplications included the following: 2 severe mitral regularization (on
e requiring surgery), 1 pericardial tamponade, 1 transient cerebrovasc
ular embolic event. The maximum number of consecutive patients treated
with the same device was 35. The results obtained are at least compar
able to those of current balloon techniques and confirm the possibilit
y of safe multiple reuses of the device after sterilization.