Nukta E D, Meier B, Urban P, Muller T, Dorsaz P A, Favre J
Cardiology Center, University Hospital, Geneva, Switzerland.
Cathet Cardiovasc Diagn. 1992 Apr;25(4):272-7. doi: 10.1002/ccd.1810250403.
The Magnum system, initially designed for coronary angioplasty (PTCA) of chronic total occlusion, consists of a balloon catheter and a solid steel 0.021 inch (0.53 mm) steerable and removable wire with a soft and moldable distal portion, tipped with a 1 mm olive. To evaluate its performance in routine PTCA, 200 unselected consecutive patients were randomized to two equal groups, i.e., group Magnum (100 patients, 115 vessels) and group Standard (100 patients, 118 vessels) including 18 and 21 patients with chronic total occlusions, respectively. Randomization was performed by the sealed envelope system in the catheterization laboratory and crossover of system was imposed if it was not possible to place a balloon correctly within 20 min of fluoroscopy time. There were no significant differences between groups concerning clinical and angiographic baseline characteristics, size of initial balloons (3.0 +/- 0.3 mm in both groups), fluoroscopy time to cross the lesion with the wire (Magnum: 4 +/- 5, Standard: 5 +/- 6 min), total fluoroscopy time (Magnum: 11 +/- 9, Standard: 12 +/- 12 min), and need for crossover (Magnum: 10%, Standard: 16%). Success rates per lesion were comparable with 90% in group Magnum and 84% in group Standard, as were the complications with one inhospital death in group Standard, occurring three weeks after PTCA and stent implantation. There was no emergency operation. Six patients per group had myocardial infarction of whom two in group Magnum and one in group Standard developed a Q-wave. The following variables were significantly in favor of the Magnum system compared with the Standard system: success rate in nontotal lesions (97% versus 90%) crossover success in total occlusions (0 vs. 33%), fluoroscopy time to cross the lesion with the balloon once the wire was in place (1 +/- 2 vs. 2 +/- 4 min), and use of a single versus 1.2 +/- 0.5 wires per lesion. The only advantage of the Standard systems was the more common use of 7 French guiding catheters (Magnum: 40%, Standard: 53%, p = 0.09). The Magnum system compares favorably with standard systems for routine PTCA. The robust design of the Magnum wire does not impair ease of placement and safety but saves material and facilitates balloon advancement across the lesion.
Magnum系统最初是为慢性完全闭塞病变的冠状动脉血管成形术（PTCA）设计的，它由一个球囊导管和一根直径0.021英寸（0.53毫米）的实心钢质可操控、可移除导丝组成，导丝远端柔软且可塑形，顶端有一个1毫米的橄榄头。为评估其在常规PTCA中的性能，200例未经选择的连续患者被随机分为两组，即Magnum组（100例患者，115处血管病变）和标准组（100例患者，118处血管病变），其中慢性完全闭塞病变患者分别为18例和21例。随机分组在导管室通过密封信封系统进行，如果在荧光透视时间20分钟内无法正确放置球囊，则实施系统交叉使用。两组在临床和血管造影基线特征、初始球囊大小（两组均为3.0±0.3毫米）、导丝通过病变的荧光透视时间（Magnum组：4±5分钟，标准组：5±6分钟）、总荧光透视时间（Magnum组：11±9分钟，标准组：12±12分钟）以及交叉使用的必要性（Magnum组：10%，标准组：16%）方面均无显著差异。每组病变的成功率相当，Magnum组为90%，标准组为84%，并发症方面标准组有1例住院死亡，发生在PTCA和支架植入后三周。无急诊手术。每组有6例患者发生心肌梗死，其中Magnum组2例、标准组1例出现Q波。与标准系统相比，以下变量明显有利于Magnum系统：非完全闭塞病变的成功率（97%对90%）、完全闭塞病变的交叉成功率（0对33%）、导丝到位后球囊通过病变的荧光透视时间（1±2分钟对2±4分钟）以及每组病变使用单根导丝与1.2±0.5根导丝的情况。标准系统的唯一优势是更常使用7F引导导管（Magnum组：40%，标准组：53%，p = 0.09）。Magnum系统在常规PTCA方面与标准系统相比具有优势。Magnum导丝的坚固设计不影响放置的简便性和安全性，反而节省材料并便于球囊通过病变。
