title: Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy.
abstract: OBJECTIVE
  The aim of this study was to evaluate the clinical, angiographic, and technical factors related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based distal protection device.
  
  
  BACKGROUND
  Protection of the distal microvasculature with a balloon occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The safety, efficacy, and technical factors relating to procedural success with filter-based distal protection devices are unknown.
  
  
  METHODS
  Percutaneous coronary intervention was performed in 60 lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230 SVGs at 65 U.S. centers.
  
  
  RESULTS
  Cumulative adverse events to 30 days occurred in 21.3% of patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-related contributors to these adverse events were identified, resulting in significant changes to the protocol and instructions for use. Subsequently, despite similar clinical and angiographic characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to 11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non-Q-wave MI.
  
  
  CONCLUSIONS
  Distal protection during SVG PCI with the FilterWire EX is associated with a low rate of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical, and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness.
authors.affiliation: The Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, NY 10022, USA. gstone@crf.org
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.forename: Steve
authors.initials: S
authors.lastname: Ramee
authors.forename: Christopher
authors.initials: C
authors.lastname: White
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: John
authors.initials: J
authors.lastname: George
authors.forename: Steve
authors.initials: S
authors.lastname: Almany
authors.forename: Steve
authors.initials: S
authors.lastname: Bailey
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D020878:Device Removal; D004867:Equipment Design; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery; D011446:Prospective Studies; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D016896:Treatment Outcome; D014481:United States