Clinical status, exercise treadmill performance, and hemodynamics were determined in 24 patients with symptomatic mitral stenosis before catheter balloon valvuloplasty (CBV) and at 3 months follow-up. Hemodynamic determinations at rest showed that mitral CBV performed by the double-balloon technique resulted in significant immediate decreases in mean pulmonary arterial wedge pressure (28 + 7 to 16 ± 5 mm Hg, p < .01), mean pulmonary arterial pressure (41 ± 11 to 33 + 10 mm Hg, p < .05), and mitral valve gradient (16 ± 7 to 6 ± 3 mm Hg, p < .01), and significant increases in cardiac output (4.3 ± 1.1 to 5.0 ± 1.4 liters/min, p < .01). Mitral valve area increased from 1.0 + 0.3 to 2.2 ± 0.7 cm2 (p < .01). The mitral valve area was unchanged (2.0 ± 0.7 cm2, p = NS) at 3 months. The lower pulmonary arterial wedge pressure, pulmonary arterial pressure, and mitral valve gradient persisted at 3 month follow-up catheterization. Clinical examinations showed that before CBV, 21 of 24 patients were in New York Heart Association functional class III or IV; 3 months after CBV, 22 patients were in class I or II. Before CBV, the mean exercise treadmill time was 5.9 + 3.2 min and it had increased to 9.8 ± 2.9 min (p < .01) by the 3 month follow-up. Comparisons of hemodynamic determinations at the same exercise workload and duration before CBV and 3 months after CBV showed that despite similar heart rates and increased cardiac outputs (5.9 ± 1.7 vs 6.9 -1.5 liters/min, p < .01), there were significant decreases in the mean pulmonary arterial wedge pressure (42 ± 10 vs 28 ± 10 mm Hg, p < .01), mean pulmonary arterial pressure (61 ± 17 vs 42 + 12 mm Hg, p < .01), and mitral valve gradient (27 ± 8 vs 14 ± 7 mm Hg, p < .01). Comparisons of hemodynamic determinations at symptom-limited supine bicycle exercise before and 3 months after CBV showed that the exercise time (9.1 ± 3.2 vs 17.1 + 3.7 min, p < .01) and workload (43.0 + 18.7 vs 58.9 ± 18.2 W, p < .01) both increased. Despite significant increases in heart rate (116 + 23 vs 127 ± 20 beats/min, p < .01) and cardiac output (5.9 ± 1.7 vs 8.0 ± 1.5 liters/min, p < .01), the decreases in pulmonary arterial wedge pressure (41 ± 10 vs 29 ± 10 min Hg, p < .01), mean pulmonary arterial pressure (61 + 17 vs 42 + 11 mm Hg, p < .01), and mitral gradient (27 + 8 vs 16 ± 5 mm Hg, p < .01) were significant. Comparisons of hemodynamic determinations at the two exercise levels 3 months after CBV (Post-CBV:Exl vs Post-CBV: Ex2) also demonstrated significant increases in heart rate (119 + 25 vs 127 ± 20 beats/min, p < .01) and cardiac output (6.9 ± 1.5 vs 8.0 ± 1.5 liters/min, p < .01) associated with small changes in the pulmonary arterial wedge pressure (28 ± 10 vs 28 ± 9 mm Hg, p = NS) and pulmonary arterial pressure (42 + 12 vs 42 ± 11 mm Hg, p = NS). We conclude that mitral CBV by the double-balloon technique resulted in increased mitral valve areas that persisted at 3 month follow-up and were associated with reduced symptoms, increased exercise treadmill time, increased supine exer...