We studied the first 202 patients with rheumatic mitral stenosis (MS) who underwent percutaneous balloon mitral valvuloplasty (PBMV) with the Inoue balloon catheter for a follow-up (FU) period of 5-11 years. Pre- and post-PBMV and at FU, the mean left atrial pressure was 21.3+/-7.4, 10.2+/-5.6, and 11.2+/-4.1 mm Hg; mean diastolic mitral gradient was 18.4+/-7.3, 2.9+/-3.2, and 5.1+/-4.3 mm Hg; and mitral valve area was 1.0+/-0.3, 2.1+/-0.6, and 1.7+/-0.5 cm2. Functional status improved from New York Heart Association (NYHA) class IV in 3, class III in 119, and class II in 80 pre-PBMV to class I in 163, class II in 37, and class III in 2 post-PBMV, and was class I in 146, class II in 39, and class III in 17 patients at FU. In the 17 patients with NYHA class III at FU, mitral restenosis was the culprit; 4 underwent repeat PBMV, 12 had mitral valve replacement for severe mitral calcification and subvalvular fusion, and 1 refused further intervention. Thus PBMV using the Inoue balloon catheter is an effective method of relieving MS with excellent long-term results in patients without severe mitral calcification and subvalvular fusion.