BACKGROUND:Percutaneous balloon mitral commissurotomy (BMC) has been proposed as an alternative to surgical closed mitral commissurotomy (CMC) and open mitral commissurotomy (OMC) for the management of rheumatic mitral valve stenosis (MS). METHODS AND RESULTS: We conducted a prospective, randomized trial comparing the results of the 3 procedures in 90 patients (30 patients in each group) with severe pliable MS. Cardiac catheterization was performed in all patients before and at 6 months after each procedure. All patients had clinical and echocardiographic evaluation initially and throughout the 7-year follow-up period. Gorlin mitral valve area (MVA) increased much more after BMC (from 0.9+/-0.16 to 2.2+/-0.4 cm2) and OMC (from 0.9+/-0.2 to 2.2+/-0.4 cm2) than after CMC (from 0.9+/-0.2 to 1.6+/-0.4 cm2). Residual MS (MVA <1.5 cm2) was 0% after BMC or OMC and 27% after CMC. There was no early or late mortality or thromboembolism among the three groups. At 7-year follow-up, echocardiographic MVA was similar and greater after BMC and OMC (1.8+/-0.4 cm2) than after CMC (1.3+/-0.3 cm2; P<.00l). Restenosis (MVA <1.5 cm2) rate was 6.6% after BMC or OMC versus 37% after CMC. Residual atrial septal defect was present in 2 patients and severe grade 3 mitral regurgitation was present in 1 patient in the BMC group. Eighty-seven percent of patients after BMC and 90% of patients after OMC were in New York Heart Association functional class I versus 33% (P<.0001) after CMC. Freedom from reintervention was 90% after BMC, 93% after OMC, and 50% after CMC. CONCLUSIONS: In contrast to surgical CMC, BMC and OMC produce excellent and comparable early hemodynamic improvement and are associated with a lower rate of residual stenosis and restenosis and need for reintervention. However, the good results, lower cost, and elimination of drawbacks of thoracotomy and cardiopulmonary bypass indicate that BMC should be the treatment of choice for patients with tight pliable rheumatic MS.
RCT Entities:
BACKGROUND: Percutaneous balloon mitral commissurotomy (BMC) has been proposed as an alternative to surgical closed mitral commissurotomy (CMC) and open mitral commissurotomy (OMC) for the management of rheumatic mitral valve stenosis (MS). METHODS AND RESULTS: We conducted a prospective, randomized trial comparing the results of the 3 procedures in 90 patients (30 patients in each group) with severe pliable MS. Cardiac catheterization was performed in all patients before and at 6 months after each procedure. All patients had clinical and echocardiographic evaluation initially and throughout the 7-year follow-up period. Gorlin mitral valve area (MVA) increased much more after BMC (from 0.9+/-0.16 to 2.2+/-0.4 cm2) and OMC (from 0.9+/-0.2 to 2.2+/-0.4 cm2) than after CMC (from 0.9+/-0.2 to 1.6+/-0.4 cm2). Residual MS (MVA <1.5 cm2) was 0% after BMC or OMC and 27% after CMC. There was no early or late mortality or thromboembolism among the three groups. At 7-year follow-up, echocardiographic MVA was similar and greater after BMC and OMC (1.8+/-0.4 cm2) than after CMC (1.3+/-0.3 cm2; P<.00l). Restenosis (MVA <1.5 cm2) rate was 6.6% after BMC or OMC versus 37% after CMC. Residual atrial septal defect was present in 2 patients and severe grade 3 mitral regurgitation was present in 1 patient in the BMC group. Eighty-seven percent of patients after BMC and 90% of patients after OMC were in New York Heart Association functional class I versus 33% (P<.0001) after CMC. Freedom from reintervention was 90% after BMC, 93% after OMC, and 50% after CMC. CONCLUSIONS: In contrast to surgical CMC, BMC and OMC produce excellent and comparable early hemodynamic improvement and are associated with a lower rate of residual stenosis and restenosis and need for reintervention. However, the good results, lower cost, and elimination of drawbacks of thoracotomy and cardiopulmonary bypass indicate that BMC should be the treatment of choice for patients with tight pliable rheumatic MS.