EXPEDITED REVIEW
Distal filter protection during saphenous vein graft stenting
Technical and clinical correlates of efficacy
Gregg W. Stone, MD, FACC*,*,1,
Campbell Rogers, MD, FACC ,1,
Steve Ramee, MD, FACC ,
Christopher White, MD, FACC,
Richard E. Kuntz, MD, FACC,
Jeffrey J. Popma, MD, FACC,
John George, MD, FACC ,
Steve Almany, MD, FACC|| and
Steve Bailey, MD, FACC¶
* The Cardiovascular Research Foundation and Lenox Hill Hospital, New York, New York, USA
Brigham & Women’s Hospital, Boston, Massachusetts, USA
Ochsner Clinic, New Orleans, Louisiana, USA
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, USA
|| William Beaumont Hospital, Royal Oak, Michigan, USA
¶ University of Texas San Antonio, San Antonio, Texas, USA
Manuscript received August 25, 2002;
revised manuscript received September 2, 2002,
accepted September 10, 2002.
* Reprint requests and correspondence: Dr. Gregg W. Stone, The Cardiovascular Research Foundation, 55 E. 59th Street, 6th Floor, New York, New York 10022, USA.
gstone{at}crf.org
OBJECTIVES: 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.
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Abbreviations and Acronyms
| | GP | | glycoprotein | | LVEF | | left ventricular ejection fraction | | MACE | | major adverse cardiac events | | MI | | myocardial infarction | | PCI | | percutaneous coronary intervention | | SVG | | saphenous vein graft | | TIMI | | Thrombolysis In Myocardial Infarction | | TLR | | target lesion revascularization |
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