Inoue K
Kyobu Geka. 1989 Jul;42(8 Suppl):596-602.
Inoue-Balloon was the first one developed for non-surgical mitral commissurotomy. The advantages of Inoue-Balloon are 1) large diameter (30mm-24mm) with low profile (4.5mm), 2) easy balloon placement, 3) non-slip during dilatation, 4) adjustability of diameter, 5) quick inflation and deflation. From 1982 to 1988, PTMC were performed in 512 pts by using Inoue-Balloon. Contra-indication for PTMC are Combined mitral regurgitation of 3/4 or more and fresh thrombus in the left atrium. No patients died during PTMC. Complication included 2 (0.4%) cerebral embolisms, 11 (2%) severe mitral regurgitations. PTMC resulted in increase of mitral valve area from 1.13 +/- 0.02 cm2 to 1.97 +/- 0.04 cm2. The statistic analysis using unpaired t test identified that the increased MVA is significantly larger in pliable valve than in non pliable valve (p less than 0.0001). The increased MVA is also significantly affected by the following conditions; subvalvular lesion (p less than 0.02), previous surgical mitral commissurotomy (0.0007), and atrial fibrillation (p less than 0.001). Incidence of resultant mitral regurgitation is significantly higher in thickened commissure than in non-thickened commissure (p less than 0.005). Similarly, this is also higher in the pre-MVA under 1 cm2 than in those over 1 cm2 (p less than 0.006). No correlation was found between balloon size and the incidence of mitral regurgitation. The optimal sizes of the balloon for the PTMC are 27 or 28 mm in diameter for an average Asian patient, and 28 to 30 mm for the European patients.(ABSTRACT TRUNCATED AT 250 WORDS)
Inoue球囊是首个为非手术二尖瓣交界切开术研发的球囊。Inoue球囊的优点包括:1)大直径(30毫米 - 24毫米)且外形低(4.5毫米);2)球囊放置容易;3)扩张时防滑;4)直径可调节;5)快速充盈和放气。1982年至1988年期间,使用Inoue球囊对512例患者进行了经皮球囊二尖瓣成形术(PTMC)。PTMC的禁忌症为中重度或以上二尖瓣反流以及左心房新鲜血栓。PTMC过程中无患者死亡。并发症包括2例(0.4%)脑栓塞、11例(2%)严重二尖瓣反流。PTMC使二尖瓣瓣口面积从1.13±0.02平方厘米增加至1.97±0.04平方厘米。使用非配对t检验的统计分析表明,柔韧性瓣膜中二尖瓣瓣口面积增加量显著大于非柔韧性瓣膜(p小于0.0001)。二尖瓣瓣口面积增加量还受以下因素显著影响:瓣下病变(p小于0.02)、既往二尖瓣交界切开手术(0.0007)以及心房颤动(p小于0.001)。增厚瓣叶交界处导致二尖瓣反流的发生率显著高于未增厚瓣叶交界处(p小于0.005)。同样,术前二尖瓣瓣口面积小于1平方厘米时的发生率高于大于1平方厘米时(p小于0.006)。未发现球囊大小与二尖瓣反流发生率之间存在相关性。对于亚洲患者,PTMC的最佳球囊直径为27或28毫米,欧洲患者为28至30毫米。(摘要截断于250字)