To evaluate the influence of intra-balloon pressure on the development of severe mitral regurgitation (> or = grade 3+), we measured intraballoon pressure during percutaneous transvenous mitral commissurotomy (PTMC) in 62 patients using the Inoue balloon catheter. The peak intraballoon pressure was 2.29 +/- 0.55 kg/cm2. Severe mitral regurgitation as a result of leaflet tear occurred in 7 patients (11%). Patients were divided into two groups those with (n = 7) and those without (n = 55) severe mitral regurgitation. Intraballoon pressure had been significantly higher in those with vs. those without severe mitral regurgitation (2.76 +/- 0.31 kg/cm2 vs. 2.23 +/- 0.55 kg/cm2, P < 0.01). Multiple logistic regression analysis revealed that the occurrence of severe mitral regurgitation was related to only the peak intraballoon pressure. These data suggest that a high intraballoon pressure is a risk factor for severe mitral regurgitation as a result of leaflet tear.