Background: Between December 1988 and December 1992, 235 patients (pts) underwent percutaneous balloon mitral valvuloplasty (PBMV).
Methods and results: There were 55 men (23%) aged 49 +/- 13 years and 180 women (77%) aged 51 +/- 13 years. Previous surgical commissurotomy (PSC) had been performed in 22 pts. Procedure was successful (area > 1.5 cm2 or area increase > or = 50% without mitral regurgitation > 2+) in 91.9% of pts, with increase in mitral valve area from 1.05 +/- 0.2 to 2.26 +/- 0.6 cm2, decrease of transvalvular mean pressure gradient from 14.4 +/- 5.5 to 6.05 +/- 4.91 mm Hg and increase of cardiac index from 2.79 +/- 0.75 to 3.17 +/- 0.9 l/m'/m2 (p < 0.001). Insufficient increase in valve area occurred in 3.8% of pts. Major complications included 5 pts with 3+ mitral regulation (MR) requiring mitral valve replacement (MVR), 2 TIA's (0.85%) and 1 pericardiocentesis (0.42%). At follow-up (mean 18.9 months) clinical improvement was achieved in 93.8% of pts (NYHA class from 2.4 to 1.3); mitral valve area was 1.9 +/- 0.4 cm2 and mean mitral valve gradient 5.3 +/- 2.3 mm Hg. Restenosis (area < 1.5 cm2 or > or = 50% loss of initial gain) occurred in 24 pts (10.16%). Six pts required MVR; 1 pt underwent a second successful PBMV. Multivariate study (logistic regression) identified as independent factors of severe MR NYHA class and PSC; echo score, age and basal mean mitral valve gradient were independent factors for restenosis.
Conclusions: In conclusion, PBMV is a safe technique and stable clinical improvement can be obtained in the majority of pts.