title: Initial experience with a dedicated coronary re-entry device for revascularization of chronic total occlusions.
abstract: OBJECTIVE
  The aim of this registry was to evaluate a new device designed to facilitate antegrade guidewire re-entry into the true lumen of a chronic total coronary occlusion (CTO) from the adjacent subintimal space.
  
  
  BACKGROUND
  Successful recanalization of CTOs results in clinical improvement in appropriately selected patients. CTO intervention is time- and resource-consuming, and a simplified approach enabling antegrade guidewire re-entry into the distal true lumen might improve success.
  
  
  METHODS
  Patients with CTO and ischemia were entered into a prospective registry regardless of lesion characteristics. If wire manipulation resulted in subintimal wire entrapment, a new re-entry tool (a 2.5-mm flat subintimal balloon with two exit ports offset by 180°) was used as a platform to attempt guidewire penetration into the distal true lumen. The primary endpoint assessed was successful device-guided re-entry. Standard techniques were then utilized to open the CTO.
  
  
  RESULTS
  In 40 consecutive CTO lesions attempted, 19 resulted in subintimal wire entrapment (mean occlusion length 44 mm). Sixteen of these 19 were successfully crossed with an antegrade guidewire into the distal true lumen using the new device (84%). One patient with unsuccessful re-entry was subsequently recanalized with a retrograde technique. All crossed lesions were stented (17/17), resulting in TIMI 3 flow without major complications. Two cases were unsuccessful. One patient had a grade I coronary perforation requiring no treatment.
  
  
  CONCLUSIONS
  A new device to recanalize CTOs complicated by subintimal wire entrapment can be used successfully by experienced operators. Further study of this coronary re-entry device is ongoing.
authors: Cleveland Clinic, Cleveland, Ohio 44195, USA. whitlop@ccf.org
authors: Patrick L
authors: PL
authors: Whitlow
authors: William L
authors: WL
authors: Lombardi
authors: Mario
authors: M
authors: Araya
authors: R
authors: R
authors: Michael Wyman
authors: Humberto
authors: H
authors: Torres
authors: Christian
authors: C
authors: Dauvergne
authors: Etsuo
authors: E
authors: Tsuchikane
authors: Alexandra
authors: A
authors: Lansky
authors: Craig A
authors: CA
authors: Thompson
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002677:Chile; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000293:injuries; D004867:Equipment Design; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome; D057772:Vascular System Injuries / Q000209:etiology