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.