The results of percutaneous mitral valvotomy by means of the Inoue single-balloon (N = 85, group 1) and the double-balloon (N = 322, group 2) techniques were compared in a nonrandomized study. The groups were not significantly different with regard to age, sex, calcification, or hemodynamic values before percutaneous mitral valvotomy. After percutaneous mitral valvotomy, patients in both groups had significant hemodynamic and clinical improvement. The increases in mitral valve area and cardiac output and the decreases in mitral valve gradient, mean pulmonary artery pressure, and mean left atrial pressure were greater in group 2. Mitral valve area determined by the Gorlin method increased 191% in group 2 and 106% in group 1; Doppler-determined mitral valve area increased 133% in group 2 and 98% in group 1. Optimal results were achieved in 93% of the patients in group 2 and 76% in group 1 (p less than or equal to 0.0001). In group 1, 6% of patients had a left-to-right shunt as shown by angiography versus 14% in group 2 (p less than or equal to 0.05). In group 2, 46% of patients had at least a 1+ increase in mitral regurgitation versus 52% in group 1. Among the patients who had an increase in mitral regurgitation, 36% of those in group 1 versus 9% in group 2 had a 2+ or more increase (p less than or equal to 0.001). The mean balloon diameter to anulus ratio was larger in group 2, and the larger the balloon diameter to anulus ratio, the greater the increase in mitral valve area.(ABSTRACT TRUNCATED AT 250 WORDS)