PERCUTANEOUS BALLOON VERSUS SURGICAL CLOSED AND OPEN MITRAL COMMISSUROTOMY - 7-YEAR FOLLOW-UP RESULTS OF A RANDOMIZED TRIAL

Background-Percutaneous balloon mitral commissurotomy (BMC) has been p roposed as an alternative to surgical closed mitral commissurotomy (CM C) and open mitral commissurotomy (OMC) for the management of rheumati c mitral valve stenosis (MS). Methods and Results-We conducted a prosp ective, randomized trial comparing the results of the 3 procedures in 90 patients (30 patients in each group) with severe pliable MS. Cardia c catheterization was performed in all patients before and at 6 months alter each procedure. All patients had clinical and echocardiographic evaluation initially and throughout the 7-year follow-up period, Gorl in mitral valve area (MVA) increased much more after BMC (from 0.9 +/- 0.16 to 2.2 +/- 0.4 cm(2)) and OMC (from 0.9 +/- 0.2 to 2.2 +/- 0.3 c m(2)) than after CMC (from 0.9 +/- 0.2 to 1.6 +/- 0.1 cm(2)), Residual MS (MVA < 1.5 cm(2)) was 0% after BMC or OMC and 27% after CMC. There was no early or late mortality or thromboembolism among the three gro ups. At 7-year follow-up, echocardiographic MVA was similar and greate r after BMC and OMC (1.8 +/- 0.4 cm(2) than after CMC (1.3 +/- 0.3 cm( 2); P < .001). Restenosis (MVA < 1.5 cm(2)) rate was 6.6% after BMC or OMC versus 37% after CMC. Residual atrial septal defect was present i n 2 patients and severe grade 3 mitral regurgitation was present in 1 patient in the BMC group, Eighty-seven percent of patients after BMC a nd 90% of patients after OMC were in New York Heart Association functi onal class I versus 33% (P < .0001) after CMC. Freedom from reinterven tion was 90% after BMC, 93% after OMC, and 50% after CMC, Conclusions- In contrast to surgical CMC, BMC and QMC produce excellent and compara ble early hemodynamic improvement and are associated with a lower rate of residual stenosis and restenosis and need for reintervention. Howe ver, the good results, lower cost, and elimination of drawbacks of tho racotomy and cardiopulmonary bypass indicate that BMC should be the tr eatment of choice for patients with tight pliable rheumatic MS.