Magnum system for routine coronary angioplasty: a randomized study.
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.
Nukta
E D
ED
Cardiology Center, University Hospital, Geneva, Switzerland.
Meier
B
B
Urban
P
P
Muller
T
T
Dorsaz
P A
PA
Favre
J
J
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004562:Electrocardiography; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged