OBJECTIVES: This study reports the long-term outcome of patients undergoing percutaneous balloon mitral commissurotomy who were enrolled in the National Heart, Lung, and Blood Institute (NHLBI) Balloon Valvuloplasty Registry. BACKGROUND: The NHLBI established the multicenter Balloon Valvuloplasty Registry in November 1987 to assess both short- and long-term safety and efficiency of percutaneous balloon mitral commissurotomy. METHODS: Between November 1987 and October 1989, 736 patients > or = 18 years old underwent percutaneous balloon mitral commissurotomy at 23 registry sites in North America. The maximal follow-up period was 5.2 years. RESULTS: The actuarial survival rate was 93 +/- 1% (mean +/- SD), 90 +/- 1.2%, 87 +/- 1.4% and 84 +/- 1.6% at 1, 2, 3 and 4 years, respectively. Eighty percent of the patients were alive and free of mitral surgery or repeat balloon mitral commissurotomy at 1 year. The event-free survival rate was 80 +/- 1.5% at 1 year, 71 +/- 1.7% at 2 years, 66 +/- 1.8% at 3 years and 60 +/- 2.0% at 4 years. Important univariable predictors of actuarial mortality at 4 years included age > 70 years (51% survival), New York Heart Association functional class IV (41% survival) and baseline echocardiographic score > 12 (24% survival). Multivariable predictors of mortality included functional class IV, higher echocardiographic score and higher postprocedural pulmonary artery systolic and left ventricular end-diastolic pressures (p < 0.01). CONCLUSIONS: Percutaneous balloon mitral commissurotomy has a favorable effect on the hemodynamic variables of mitral stenosis, and long-term follow-up data suggest that it is a viable alternative with respect to surgical commissurotomy in selected patients.
OBJECTIVES: This study reports the long-term outcome of patients undergoing percutaneous balloon mitral commissurotomy who were enrolled in the National Heart, Lung, and Blood Institute (NHLBI) Balloon Valvuloplasty Registry. BACKGROUND: The NHLBI established the multicenter Balloon Valvuloplasty Registry in November 1987 to assess both short- and long-term safety and efficiency of percutaneous balloon mitral commissurotomy. METHODS: Between November 1987 and October 1989, 736 patients > or = 18 years old underwent percutaneous balloon mitral commissurotomy at 23 registry sites in North America. The maximal follow-up period was 5.2 years. RESULTS: The actuarial survival rate was 93 +/- 1% (mean +/- SD), 90 +/- 1.2%, 87 +/- 1.4% and 84 +/- 1.6% at 1, 2, 3 and 4 years, respectively. Eighty percent of the patients were alive and free of mitral surgery or repeat balloon mitral commissurotomy at 1 year. The event-free survival rate was 80 +/- 1.5% at 1 year, 71 +/- 1.7% at 2 years, 66 +/- 1.8% at 3 years and 60 +/- 2.0% at 4 years. Important univariable predictors of actuarial mortality at 4 years included age > 70 years (51% survival), New York Heart Association functional class IV (41% survival) and baseline echocardiographic score > 12 (24% survival). Multivariable predictors of mortality included functional class IV, higher echocardiographic score and higher postprocedural pulmonary artery systolic and left ventricular end-diastolic pressures (p < 0.01). CONCLUSIONS: Percutaneous balloon mitral commissurotomy has a favorable effect on the hemodynamic variables of mitral stenosis, and long-term follow-up data suggest that it is a viable alternative with respect to surgical commissurotomy in selected patients.