Percutaneous mitral balloon valvuloplasty. Single versus Inoue balloon. long term follow-up

Abstract Introduction The single balloon (SB) is the less expensive technique to perform mitral balloon valvuloplasty (MBV). Objectives: This study aimed to demonstrate that MBV with the Balt single (BSB) and Inoue ballon, the wordwire accepted technique, had similar outcome and long-term follow-up (FU). Methods From 1987 to 2013, 526 procedures were performed, being 312 with a FU, 56 (17,9%) with Inoue balloon (IB) and 256 (82,1%) with BSB. The mean FU 156±144 months, p<0.0001. Univariate analysis (UA) and multivariate Cox analysis (MCA) to determine independent predict variables of survival and event free survival (EFS) of death, cardiac surgery and new MBV, in both techniques groups. Results In IB and BSB groups there were, respectively: female 42 (75.0%) and 222 (86.7%); mean age 37.3±10.0 (19 to 63) and 38.0±12.6 (13 to 83) years, p=0.7138; sinus rhythm 51 (91.1%) and 215 (84.0%), p=0.1754; echo score (ES) 7.6±1.3 (5 to 10) and 7.2±1.5 (4 to 14) points, p=0.0528; echo mitral valve area (MVA) pre-MBV 0.96±0.18 and 0.93±0.21 cm2, p=0.2265; post-MBV mean MVA (Gorlin) were 2.00±0.52 and 2.02±0.37 cm2, p=0.9554; MBV dilatation área 6,09±0,27 and 7,02±0,30, p<0,0001. At the end of the FU, there were in IB and BSB groups, respectively: echo MVA 1.71±0.41 and 1.54±0.51 cm2, p=0.0552; new severe mitral regurgitation in 5 (8.9%) and 17 (6.6%) patients, p=0.5633; new MBV in 1 (1.8%) and 13 (5.1%), p=0.4779; mitral valve surgery in 3 (5.4%) and 27 (10.4%), p=0.3456; deaths 2 (3.6%) and 11 (4.3%), p=1.000; cardiac deaths 1 (1.8%) and 9 (3.5%), p=1.000; ME 5 (8.9%) and 46 (18.0%), p=0.1449. In UA and MCA the BSB or IB technique do not predict survival or EFS. The independent risk factors to survival were: age <50 years (p=0.016, HR=0.233, 95% IC 0.071- 0.764), ES ≤8 (p<0.001, HR=0.105, 95% IC 0.34–0.327), MBV dilatation area (p<0.001, HR 16.838, 95% IC 3.353–84.580) and no mitral valve surgery in the FU (p=0.001, HR0.152, 95% IC 0.050–0.459). Independent risk factors to EFS: no prior commissurotomy (p=0.012, HR=0.390, 95% IC 0.187–0.813) and post-MBV MVA ≥1.50 cm2 (p=0.001, HR=7.969, 95% IC 3.413–18.608). Conclusion In 25 years, survival and EFS were similar in BSB and IB technique. Independent predictors of surviva: age <50 years, ES≤8 points, MBV dilatation area >7 mm2 and no mitral valve surgery in the FU. Independent predictors of EFS: no prior commissurotomy and post-MBV MVA≥1.50 cm2 Funding Acknowledgement Type of funding source: None