Comparison of Results of Percutaneous Mitral Balloon Valvotomy Using Single(Inoue) and Double Balloon Techniques(Randomized Trial) ; Mechanism of Dilation, Immediate Results and Follow Up

To assess the efficacy of 2 different mitral balloon valvotomy (PMV) techniques, PMV was performed using Inoue balloon (I) in 35 pts and double balloon (D) in 33 pts with mitral stenosis (male 27, female 41, mean age 42±12 years). The success rate of PMV was 89%(31/35 pts) in I group and 97%(33/33 pts) in D group. Mitral valve area after dilation increased equally effectively in both groups (I and D) from 0.9±0.2 and 0.8±0.2 to 1.9±0.2 and 1.9±0.3cm² respectively (p<0.0001). There were no differences in degree of improvement of cardiac output, mitral gradient, left atrial pressure, pulmonary artery pressure and various doppler echocardiographic findings in both groups, but EF slope was more improved from 13±7 to 48±16 mm/sec in D group than those (from 15±6 to 39±15mm/sec) of I group. Increments of long and short diameters of mitral valve orifice by 2D-echocardiogram were 1.1±0.6 and 0.3±0.3cm in D group and 0.9±0.5, 0.4±0.3cm in I group. The ratio of long and short diameter increase was significantly larger in D than that of I group (long/short 2.8±0.7 vs 2.4±0.7, p<0.05) and short diameter of orifice after dilation was more improved in I than that of D group (1.1±0.2 vs 1.0±0.2cm p<0.05). Complications included deflation failure of Inoue balloon in 2, and cerebral embolic episode in 1 (D). Incidence of increased mitral regurgitation was 50% in D and 45% in I, development of ASD (Qp/Qs>1.2) was 20% in D, 13% in I group respectively and mean amount of left to right shunt (Qp/Qs) was 1.7±0.3 in D and 1.5±0.1 in I group. Total procedure and fluoroscopic time were 84±24 and 25±11 min. in D and 56±20 and 16±6 min. In I, which had statistically significant differences (p<0.002). Thus we concluded PMV using Inoue or double balloons was equally effective in selected patients. Total procedure and fluoroscopic time of Inoue balloon technique were significantly shorter than those of double balloons. Double balloon technique had more tendency of longitudinal splitting of the commissures.