title: Incidence, predictors, and outcomes of device failure of X-sizer thrombectomy: real-world experience of 200 cases in 5 years.
abstract: BACKGROUND
  Clinical studies have evaluated the safety and efficacy of adjunctive X-sizer (EndiCOR Inc, San Clemente, CA) in percutaneous coronary intervention (PCI). However, patient and lesion subsets were highly selected, and extrapolation of the results to daily practice is problematic.
  
  
  METHODS
  X-sizer thrombectomy was performed in 200 procedures from August 2000 to July 2005. The indications for the procedures were primary PCI in 71%. Device failure was defined as the occurrence of 1 or more of the following conditions: (a) failure of the X-sizer to reach the target segment, (b) failure to achieve final thrombolysis in myocardial infarction 3 flow, (c) slow flow or no-reflow, (d) distal embolization, and (e) coronary perforation.
  
  
  RESULTS
  Device failure occurred in 48 procedures, giving a device failure rate of 24%. Logistic regression analysis showed that ostial lesion was the only independent predictor of device failure (OR 4.89, 95% CI 1.23-19.51, P = .024). A total of 19 patients had developed 22 adverse events, giving a 30-day adverse event rate of 9.5%. Among these, there were 13 deaths, 4 strokes, 2 reinfarctions, 2 repeat PCIs, and 1 coronary artery bypass grafting. Logistic regression analysis showed that X-sizer device failure was independently associated with 30-day adverse events (OR 3.42, 95% CI 1.04-11.25, P = .043).
  
  
  CONCLUSIONS
  The incidence of device failure of X-sizer thrombectomy was 24%. Ostial lesion was an independent predictor of device failure. Notably, X-sizer device failure was independently associated with 30-day adverse event. These highlight the importance of case selection and the problem with its use in ostial lesions.
authors.affiliation: The Heart Institute, Singapore, Singapore. leerch@hotmail.com
authors.forename: Chi-Hang
authors.initials: CH
authors.lastname: Lee
authors.forename: Huay-Cheem
authors.initials: HC
authors.lastname: Tan
authors.forename: Hwee-Bee
authors.initials: HB
authors.lastname: Wong
authors.forename: Xiao-Ling
authors.initials: XL
authors.lastname: Zhang
authors.forename: Shermaine
authors.initials: S
authors.lastname: Fun
authors.forename: Mae
authors.initials: M
authors.lastname: Gay
authors.forename: Lucy
authors.initials: L
authors.lastname: Qu
authors.forename: Jimmy
authors.initials: J
authors.lastname: Lim
authors.forename: Adrian
authors.initials: A
authors.lastname: Low
authors.forename: Yean-Teng
authors.initials: YT
authors.lastname: Lim
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000295:instrumentation; D017023:Coronary Angiography; D004562:Electrocardiography; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy*; D012039:Regional Blood Flow; D016019:Survival Analysis; D017131:Thrombectomy / Q000295:instrumentation*