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Embolic Protection Devices in Saphenous Vein Graft Intervention.

One of the major challenges in the field of interventional cardiology is the treatment of saphenous vein graft (SVG) disease. Approximately 15% of SVGs are occluded during the first year after bypass surgery, and within 10 years of surgery, nearly half of all SVGs have either failed or are failing.1 Although some have advocated preferential treatment of native coronary artery disease in this setting, this is frequently challenging owing to the presence of heavy calcification or chronic total occlusion; as a result, SVG percutaneous coronary intervention (PCI) remains a common initial revascularization strategy.2 Although advances in PCI devices, adjunct pharmacology, and technique have led to substantial improvement in the acute success and safety of native vessel PCI, SVG-PCI remains a high-risk procedure with 5to 20-fold higher risk of periprocedural complications compared with native coronary PCI.3 The high-risk nature of SVG-PCI relates mainly to the degenerative nature of SVG disease, which is characterized by bulky, friable lesions that frequently incorporate thrombotic elements, dramatically increasing their embolic potential with subsequent higher risk of the no-reflow phenomenon and periprocedural myocardial infarction (MI). Given these inherent risks of SVG-PCI, one of the most important technical advances has been the development of embolic protection devices (EPDs). The first such device was the Percusurge Guardwire system, which consisted of a compliant balloon inflated distal to the SVG lesion to occlude flow during PCI and an aspiration catheter to remove the resulting debris.4 This device was formally evaluated in the pivotal SAFER trial (Saphenous Vein Graft Angioplasty Free of Emboli Randomized),4 where it led to a 42% reduction in the primary end point of death, MI, emergency coronary artery bypass graft surgery, or target vessel revascularization at 30 days, driven mainly by a 46% reduction in the occurrence of periprocedural MI (defined as peak creatine kinase-muscle brain enzyme >3× upper limit of normal). These striking benefits led to approval of the device in August 2001, and use of an EPD soon became the standard of care for anatomically suitable patients undergoing SVG-PCI. Novel devices followed shortly after and were prospectively tested mostly in non-inferiority trials against the Guardwire, as unprotected SVGPCI raised ethical concerns. Ultimately, several additional EPDs including distal filters and proximal occlusion devices were approved,5 and in 2010/2011—largely on the strength of the original SAFER trial—use of an EPD for all SVG-PCI procedures where technically feasible was given a Class I recommendation by both the European Society of Cardiology and American College of Cardiology Foundation/ American Heart Association PCI guidelines.6,7 Notwithstanding these guidelines, uptake of EPD in SVG-PCI has been modest at best. For example, data from >49 000 patients undergoing SVG-PCI who were Francesco Costa, MD, PhD David J. Cohen, MD, MSc EDITORIAL