BACKGROUND: The Inoue balloon technique for mitral commissurotomy is well established and carried out worldwide. Metallic commissurotomy is reported to be a cheaper and effective alternative to balloon mitral commissurotomy. METHODS:One hundred patients were randomized into 2 groups to undergo percutaneous transmitral commissurotomy (PTMC) by means of the Inoue balloon technique (IBMC, n = 49) or metallic commissurotomy (PMMC, n = 51). Patients were crossed over to the other technique when the initial technique was a failure. Success of valvotomy, procedure-related complications, and follow-up events of the 2 techniques were compared. RESULTS:Basal echocardiographic and hemodynamic data were similar in both groups. Procedural success was similar in both groups: 45 of 49 procedures (91.8%) in the IBMC group, compared with 46 of 51 procedures (90.18%) in the PMMC group (P = 1.0). Crossover was also comparable, with 1 occurring in the IBMC group, compared with 3 in the PMMC group. Complications such as cardiac tamponade and mitral regurgitation (requiring or not requiring mitral valve replacement) were similar in both groups, with 3 complications in the IBMC group, compared with 4 complications in the PMMC group (P =.29). After a follow-up period of approximately 4 months, both groups had similar event rates and comparable hemodynamic parameters (P = not significant). CONCLUSIONS: Both IBMC and PMMC are successful means of providing relief from severe mitral stenosis with a gain in valve area and reduction in transmitral gradient. Both techniques have similar procedural success, complication rates, and follow-up events.
RCT Entities:
BACKGROUND: The Inoue balloon technique for mitral commissurotomy is well established and carried out worldwide. Metallic commissurotomy is reported to be a cheaper and effective alternative to balloon mitral commissurotomy. METHODS: One hundred patients were randomized into 2 groups to undergo percutaneous transmitral commissurotomy (PTMC) by means of the Inoue balloon technique (IBMC, n = 49) or metallic commissurotomy (PMMC, n = 51). Patients were crossed over to the other technique when the initial technique was a failure. Success of valvotomy, procedure-related complications, and follow-up events of the 2 techniques were compared. RESULTS: Basal echocardiographic and hemodynamic data were similar in both groups. Procedural success was similar in both groups: 45 of 49 procedures (91.8%) in the IBMC group, compared with 46 of 51 procedures (90.18%) in the PMMC group (P = 1.0). Crossover was also comparable, with 1 occurring in the IBMC group, compared with 3 in the PMMC group. Complications such as cardiac tamponade and mitral regurgitation (requiring or not requiring mitral valve replacement) were similar in both groups, with 3 complications in the IBMC group, compared with 4 complications in the PMMC group (P =.29). After a follow-up period of approximately 4 months, both groups had similar event rates and comparable hemodynamic parameters (P = not significant). CONCLUSIONS: Both IBMC and PMMC are successful means of providing relief from severe mitral stenosis with a gain in valve area and reduction in transmitral gradient. Both techniques have similar procedural success, complication rates, and follow-up events.