Clinical and Economic Outcomes of Embolic Complications and Strategies for Distal Embolic Protection during Percutaneous Corona
- Volume 18 - Issue 2 - February, 2006
- Posted on: 8/1/08
- 0 Comments
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Over 500,000 coronary artery bypass grafts in 314,000 cases were performed in the United States in 2000, however, over half of all vein grafts develop significant stenosis within 10 years.1,2 Percutaneous coronary intervention in saphenous vein grafts is consequently an increasingly common therapeutic modality utilized in the treatment of vein graft stenosis. In contemporary practice, vein grafts develop bulky lesions composed of loose atheroma and thrombotic material, and are often degenerated.3 This poses a significant risk for distal embolization and no-reflow, resulting in a major adverse event in up to 20% of procedures.4
Since management of the no-reflow phenomenon is frequently unsuccessful and its outcome unpredictable,5 prevention is a more effective strategy. Distal embolic protection devices have been shown to reduce the frequency of distal embolization and sequelae. The SAFER trial was first to demonstrate that distal embolic protection provided a 42% relative risk reduction (16.5% versus 9.6%; p < 0.004) in major adverse events.6 The Food and Drug Administration (FDA) approved the PercuSurge Guardwire™ system (Medtronic, Inc., Minneapolis, Minnesota) utilized in SAFER, as well as the FilterWireEX™ (Boston Scientific Corp., Natick, Massachusetts), a second device with similar effectiveness. Cost analysis from SAFER shows increased initial procedure costs (median $1,547; p < 0.001) and slightly increased total hospital costs (median $582; p < 0.001).7
Despite the medical utility of distal embolic protection for vein graft interventions, the incremental cost is not reimbursed by the Centers for Medicare and Medicaid Services. In a cost-conscious era of medicine, strategies for the most cost-effective use of resources are imperative. Distal embolic protection could be routinely used in all patients, but the substantial costs may be prohibitive. However, not utilizing distal embolic protection would result in a significant number of otherwise preventable embolic complications and sequelae, including death. A better strategy may be to balance these competing alternatives to maximize clinical benefit and minimize the economic impact by selectively using distal embolic protection in patients at high risk for embolic complications.
Numerous investigators have consistently identified similar clinical and angiographic variables predictive of embolic complication.8–17 These factors could potentially identify patients at higher risk for embolic complications to receive distal embolic protection. To assess the optimal strategy, we analyzed data from patients undergoing percutaneous coronary intervention in saphenous vein grafts without distal embolic protection to determine the incidence and cost of embolic complications. We then analyzed the effect routine and selective distal embolic protection strategies might have on clinical outcome and resource utilization in comparison to the referent strategy of no distal embolic protection.