Mitral valvuloplasty with an Inoue balloon catheter was performed at our institution in 15 patients affected by mitral stenosis. All were severely symptomatic (class NYHA III or IV). Transthoracic and transesophageal echocardiography showed a mitral score less than 10 (Wilkins criteria). Patients with thrombi in the left atrium and those with important mitral regurgitation were excluded. The mitral valve area increased from 0.98 +/- 0.2 to 1.89 +/- 0.4 cm2 and the transvalvular gradient decreased from 18.2 +/- 7.5 to 6.7 +/- 3.7 mmHg. There was a small increase of the mitral regurgitation. Two complications occurred during the procedure: the first was a haemopericardium, which was percutaneously drained, and the other a rupture of the anterior mitral leaflet with acute, severe mitral regurgitation necessitating urgent surgical correction. Applying the criteria of Herrmann, the results were optimal in 11 and suboptimal in 3 cases.