PERCUTANEOUS BALLOON VALVULOPLASTY COMPARED WITH OPEN SURGICAL COMMISSUROTOMY FOR MITRAL-STENOSIS

Background. Percutaneous balloon mitral valvuloplasty has been propose d as an alternative to open surgical commissurotomy for the treatment of rheumatic mitral-valve stenosis. Methods. We enrolled 60 patients w ith severe mitral stenosis and favorable valvular anatomy in a prospec tive, randomized trial comparing the two procedures. All patients unde rwent cardiac catheterization before the procedure and one week, six m onths, and three years thereafter. Hemodynamic data were analyzed by i nvestigators who were blinded to the patients' treatment assignments. Results. Mitral-valve areas improved initially in both groups, from a mean (+/-SD) of 0.9+/-0.3 cm(2) to 2.l+/-0.6 cm(2) in the balloon-valv uloplasty group (30 patients; P<0.01) and from 0.9+/-0.3 cm(2) to 2.0/-0.6 cm(2) in the surgical group (30 patients; P<0.001). Although imp rovement was maintained in both groups, mitral-valve areas were greate r in the patients in the balloon-valvuloplasty group at three years (2 .4+/-0.6 cm(2), vs. 1.8+/-0.4 cm(2) in the surgery group; P<0.001). Re stenosis occurred in three patients in the balloon-valvuloplasty group and four in the surgery group. One patient in the balloon-valvuloplas ty group died of an apparent stroke after 2.5 years; four patients in the balloon-valvuloplasty group had residual atrial septal defects, an d three patients (two in the balloon-valvuloplasty group and one in th e surgery group) were judged to have severe mitral regurgitation. Seve nty-two percent of the patients who underwent balloon valvuloplasty an d 57 percent of the surgically treated patients were in New York Heart Association functional class I (i.e., they had no cardiovascular symp toms) at three years. No patient was lost to follow-up. Conclusions. I n the treatment of mitral stenosis, balloon valvuloplasty and open sur gical commissurotomy have comparable initial results and low rates of restenosis, and both produce good functional capacity for at least thr ee years. The potential complications associated with balloon valvulop lasty should be noted. The better hemodynamic results at three years, lower cost, and elimination of the need for thoracotomy suggest that b alloon valvuloplasty should be considered for all patients with favora ble mitral-valve anatomy.