title: Laser wire for crossing chronic total occlusions: "learning phase" results from the U.S. TOTAL trial. Total Occlusion Trial With Angioplasty by Using a Laser Wire.
abstract: The Prima laser guidewire system (Spectranectics Corp., Colorado Springs, CO) consists of an 0.018" hypotube containing a bundle of 45-microm optical fibers coupled to a pulsed excimer laser operating at a tip fluence of 60 ml/mm2 and a repetition rate ranging from 25-40 Hz. This laser guidewire was specifically designed to cross total occlusions refractory to passage with conventional wires. The Prima wire was evaluated in a feasibility study at 15 U.S. centers. Following failure to cross a total occlusion with approved guidewires, the Prima wire was utilized in 179 patients. Average age of subjects was 61 yr. Lesion locations included left anterior descending (36%), right (45%), and circumflex (19%) coronary arteries. Mean angiographic age of total occlusions was 70 wk (range, 2-1,020 wk, median, 14 wk). The use of the Prima wire either solely or in combination with conventional guidewires resulted in successful crossing in 61% of these previously impenetrable occlusions. Failure of the device was commonly related to length of the occlusion and tortuosity along the occluded pathway. Major complications included myocardial infarction in 7 patients (3.9%), tamponade in 3 (1.7%), and death in 2 (1.1%). This "learning phase" pilot study confirmed the feasibility of a laser guidewire in chronic total occlusions that are resistant to passage of conventional guidewires. An extended registry at these investigative sites is planned.
authors.affiliation: Department of Medicine, Stanford University Medical Center, California 94305, USA. steve_oesterle@cvmed.stanford.edu
authors.forename: S N
authors.initials: SN
authors.lastname: Oesterle
authors.forename: J A
authors.initials: JA
authors.lastname: Bittl
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
authors.forename: J
authors.initials: J
authors.lastname: Hamburger
authors.forename: J E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: F
authors.initials: F
authors.lastname: Litvack
authors.forename: J
authors.initials: J
authors.lastname: Margolis
authors.forename: P
authors.initials: P
authors.lastname: Gilmore
authors.forename: R
authors.initials: R
authors.lastname: Madsen
authors.forename: D
authors.initials: D
authors.lastname: Holmes
authors.forename: J
authors.initials: J
authors.lastname: Moses
authors.forename: H
authors.initials: H
authors.lastname: Cohen
authors.forename: S
authors.initials: S
authors.lastname: King
authors.forename: J
authors.initials: J
authors.lastname: Brinker
authors.forename: T
authors.initials: T
authors.lastname: Hale
authors.forename: D J
authors.initials: DJ
authors.lastname: Geraci
authors.forename: W J
authors.initials: WJ
authors.lastname: Kerker
authors.forename: J
authors.initials: J
authors.lastname: Popma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D017222:Angioplasty, Balloon, Laser-Assisted / Q000379:methods*; D002908:Chronic Disease; D017023:Coronary Angiography; D003327:Coronary Disease / Q000601:surgery*; D004868:Equipment Failure; D005240:Feasibility Studies; D005260:Female; D005336:Fiber Optic Technology; D005500:Follow-Up Studies; D006801:Humans; D007431:Intraoperative Complications; D008297:Male; D008875:Middle Aged; D055100:Optical Fibers; D011183:Postoperative Complications; D012189:Retrospective Studies; D012449:Safety; D016896:Treatment Outcome; D014481:United States