Purpose: To compare immediate and late (12 months) follow-up of clinical and Doppler echocardiographic results between percutaneous mitral balloon valvuloplasty and open commissurotomy in a prospective and randomized trial.
Methods: Eighty eight symptomatic patients with severe mitral stenosis and favorable anatomy were randomized in a prospective trial comparing the two procedures. All patients were submitted to clinical and Doppler echocardiographic evaluation before the procedures and immediate and twelve months thereafter.
Results: Mean mitral gradient (mmHg) decreased from 12.2 +/- 5.8 to 5.80 +/- 2.7 (p < 0.001) in commissurotomy group (CG) and from 11.7 +/- 6.1 to 5.0 +/- 2.4 (p < 0.001) in the balloon valvuloplasty group (VG). Mitral valve are (cm2) increased from 0.98 +/- 0.21 to 2.52 +/- 0.46 in CG and from 1.05 +/- 0.25 to 2.18 +/- 0.40 in VG (p < 0.001). In both groups there was a slight decrease in mitral valve area at 12 month follow-up. There was no death in either group. One patient in the VG had moderate mitral regurgitation and underwent surgery. At the 12 month follow-up, all patients in CG and 97.7% of patients in VG were in New York Heart Association functional class I or II.
Conclusion: Both procedures were safe and showed similar immediate improvement in mitral gradient and functional class. Mitral valve area had a greater increase immediately after commissurotomy, however, there was a significantly greater reduction in the CG after 12 months of follow-up, when compared to balloon valvuloplasty. In both groups, mitral gradient remained reduced and most patients did not change functional class during the follow-up.