LAUSR

Background Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double‐balloon techniques up to 25 years in a randomized trial. Methods Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double‐balloon technique (n = 150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3. Results During median follow‐up of 20.7 years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event‐free survival rates at 24 years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65–1.20; P = .423). On multivariate analysis, absence of post‐PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28–2.63; P = .001) and immediate post‐PMC mitral valve area (MVA) <1.8 cm2 (HR, 1.53; 95% CI, 1.04–2.25; P = .031) were independently correlated with clinical events after successful PMC. Conclusions The Inoue and double‐balloon methods showed similar good clinical outcomes up to 25 years, and the achievement of effective commissurotomy to develop post‐PMC commissural MR or immediate post‐PMC MVA ≥1.8 cm2 is important in optimizing the late results of PMC.