Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy.
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.
Stone
Gregg W
GW
The Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, NY 10022, USA. gstone@crf.org
Rogers
Campbell
C
Ramee
Steve
S
White
Christopher
C
Kuntz
Richard E
RE
Popma
Jeffrey J
JJ
George
John
J
Almany
Steve
S
Bailey
Steve
S
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