BACKGROUND: Immediate and intermediate term results of percutaneous mitral valvotomy (PMV) are comparable to closed surgical commissurotomy (CSC). We aimed at exploring this relation in the long term. METHODS: Previously, we randomized 40 consecutive patients with moderate to severe mitral stenosis [defined as mitral valve area (MVA) less than 1.5 cm²] to undergo eitherPMV (PMV group = 20 patients) or CSC (CSC group = 20 patients). For all patients, full echocardiographic assessment was performed before the procedure/operation. Patients assigned to PMV underwent the double balloon technique. Echocardiographic assessment was done following both procedures before discharge and repeated 1 and 6 months later. Echocardiographic follow-up was performed, thereafter, on a yearly basis for up to 15 years, with a mean follow-up period of 99 ± 12 months. RESULTS: Immediate echocardiographic results showed no statistically significant difference between the 2 groups regarding the final MVA or mean diastolic gradient across the mitral valve. Two patients dropped out from the CSC group and one from the PMV group. MVA was 1.8 ± 0.3 cm² versus 1.8 ± 0.4 cm² (p > 0.05) and mean diastolic pressure gradient across the mitral valve was 7 ± 4 mmHg versus 6.6 ± 4 mmHg (p > 0.05) in the PMV and CSC groups, respectively. Mitral restenosis occurred in 5 (26.3%) patients in the PMV group versus 5 (27.8%) patients in the CSC group (p > 0.05). Kaplan-Meier curves for restenosis-free survival showed no difference between the 2 groups. CONCLUSION:PMV achieves comparable results to CSC both in the short and long term.
RCT Entities:
BACKGROUND: Immediate and intermediate term results of percutaneous mitral valvotomy (PMV) are comparable to closed surgical commissurotomy (CSC). We aimed at exploring this relation in the long term. METHODS: Previously, we randomized 40 consecutive patients with moderate to severe mitral stenosis [defined as mitral valve area (MVA) less than 1.5 cm²] to undergo either PMV (PMV group = 20 patients) or CSC (CSC group = 20 patients). For all patients, full echocardiographic assessment was performed before the procedure/operation. Patients assigned to PMV underwent the double balloon technique. Echocardiographic assessment was done following both procedures before discharge and repeated 1 and 6 months later. Echocardiographic follow-up was performed, thereafter, on a yearly basis for up to 15 years, with a mean follow-up period of 99 ± 12 months. RESULTS: Immediate echocardiographic results showed no statistically significant difference between the 2 groups regarding the final MVA or mean diastolic gradient across the mitral valve. Two patients dropped out from the CSC group and one from the PMV group. MVA was 1.8 ± 0.3 cm² versus 1.8 ± 0.4 cm² (p > 0.05) and mean diastolic pressure gradient across the mitral valve was 7 ± 4 mmHg versus 6.6 ± 4 mmHg (p > 0.05) in the PMV and CSC groups, respectively. Mitral restenosis occurred in 5 (26.3%) patients in the PMV group versus 5 (27.8%) patients in the CSC group (p > 0.05). Kaplan-Meier curves for restenosis-free survival showed no difference between the 2 groups. CONCLUSION:PMV achieves comparable results to CSC both in the short and long term.