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

Cathet Cardiovasc Diagn. 1998 Jun;44(2):235-43. doi: 10.1002/(sici)1097-0304(199806)44:2<235::aid-ccd23>3.0.co;2-k.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / instrumentation
  • Angioplasty, Balloon, Laser-Assisted / methods*
  • Chronic Disease
  • Coronary Angiography
  • Coronary Disease / surgery*
  • Equipment Failure
  • Feasibility Studies
  • Female
  • Fiber Optic Technology
  • Follow-Up Studies
  • Humans
  • Intraoperative Complications
  • Male
  • Middle Aged
  • Optical Fibers
  • Postoperative Complications
  • Retrospective Studies
  • Safety
  • Treatment Outcome
  • Vereinigte Staaten