To determine the rate of mitral restenosis and mitral regurgitation increase 1 year after mitral valvotomy using the Inoue balloon catheter, 66 consecutive patients with severe, pliable mitral stenosis had their mitral valve area (MVA) calculated by two-dimensional echocardiography (2DE) and Doppler before, immediately after balloon valvotomy, and at 1-year follow-up. Color Doppler studies were also done to detect small atrial septal defects (ASDs) and mitral regurgitation. The mean age of the patients was 31 +/- 12 years. Three patients were in New York Heart Association (NYHA) class II and 63 patients were in NYHA class III to IV. Sixty-two of the 66 patients had an echo score (Boston) of < or = 8. After Inoue balloon valvotomy (IBV), the MVA (2DE) increased from 0.8 +/- 0.2 to 1.9 +/- 0.3 cm2 (p < 0.001), and the Doppler MVA increased from 0.8 +/- 0.2 to 1.8 +/- 0.3 cm2 (p < 0.001). We detected 4 of 66 cases (6%) with significant residual mitral stenosis (MVA < 1.5 cm2). Mitral regurgitation increased in 14 of 66 patients (21%), but no patient developed severe mitral regurgitation. Fourteen out of 66 patients (20%) had ASDs that were detected on color Doppler. At 1-year follow-up the mean Doppler MVA was maintained at 1.8 +/- 0.4 cm2, with 6 of 66 patients (9%) exhibiting significant mitral valve restenosis. Residual significant mitral stenosis must be differentiated from mitral restenosis.(ABSTRACT TRUNCATED AT 250 WORDS)