Device Failure and Acute Vessel Thrombosis with PercuSurge

Author Affiliations: From the Long Island Jewish Medical Center/Schneider Children’s Hospital, New Hyde Park, New York, and the *Bradenton Heart Center, Bradenton, Florida. The authors report no conflicts of interest regarding the content herein. Manuscript submitted January 14, 2008, provisional acceptance given April 18, 2008, and accepted April 22, 2008. Address for correspondence: Shailendra Upadhyay, MD, Long Island Jewish Medical Center/Schneider Children’s Hospital, 269-01 76th Avenue, New Hyde Park, NY 11040. E-mail: drsdu@yahoo.com

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J INVASIVE CARDIOL 2008;20:E256-E257 Percutaneous intervention in saphenous vein bypass grafts (SVGs) is associated with a high level of major adverse clinical events (MACE).7 Work with the PercuSurge GuardWire® (Medtronic, Inc., Minneapolis, Minnesota), a distal protection device, has shown a significant reduction in MACE.9 This device employs a low-pressure distal balloon to trap embolic material which can be aspirated after stent deployment. Every new device has associated limitations and complications reported as its use becomes more mainstream. Here we report a case of failure to deflate the distal balloon after stent deployment associated with acute thrombosis. Case Report. A 50-year-old male with a history of 4-vessel coronary artery bypass grafting (CABG) in 1994 and a previous myocardial infarction (MI) in 1997 was admitted to the hospital with unstable angina. He subsequently underwent left-heart catheterization which revealed 3-vessel native coronary disease manifested by 100% stenosis of the mid-left anterior descending coronary artery (LAD), 80% stenosis of the distal left circumflex and third obtuse marginal (OM), respectively, and total occlusion of the mid-right coronary artery. The left internal mammary artery graft to the LAD was patent, but the SVGs to the OM and diagonal were occluded. The SVG to the posterior descending coronary artery (PDA) had a 90% mid stenosis in mid shaft. The decision was made to proceed with stenting of the SVG to the PDA employing the PercuSurge GuardWire distal protection device. The method of PercuSurge GuardWire use is described in detail below. Coronary Intervention. Prior to the procedure, the patient received 5,000 U of intravenous (IV) heparin and two 19.5 mg IV boluses of eptifibatide followed by an eptifibatide drip (13 cc/minute). A Multipurpose Cordis J&J 8 Fr guide catheter (Cordis J&J, Miami Lakes, FLorida) was used to engage the SVG to the PDA. Guiding shots were obtained. The 0.014 inch hollow core GuardWire was advanced beyond the culprit lesion. The protection device’s distal balloon was inflated with diluted radiocontrast using a proximal adaptor. This was progressively dilated until flow of contrast within the graft was halted. The stent size was determined by visual comparison of the vessel with the guide catheter. The GuardWire is used as a conventional guidewire for angioplasty. A 5 x 13 mm ACS Multi-Link stent (Abbott Vascular, Abbott Park, Illinois) was deployed across the lesion. After successful stent deployment, the Export® aspiration catheter (Medtronic) was used to aspirate the stagnant blood and embolic debris. No significant embolic debris was visualized after aspiration. Following aspiration, the GuardWire was attached to the proximal adaptor for deflation of the distal balloon. To our surprise, the balloon failed to deflate. After multiple attempts with the adaptor, a visual inspection was made to locate kinks in the hollow wire. As no kinks were observed, we proceeded to cut the wire at the distal most visible point. This led to slow deflation of the distal balloon. Repeat angiography revealed a thrombus at the balloon inflation site. Multiple attempts to aspirate this thrombus with the Export aspiration catheter failed. At this time, a decision was made to proceed with direct stenting of the graft, thus covering the thrombus. A 5 x 18 mm Multi-Link Ultra stent (Cordis) was deployed at 14 atm for 30 seconds, with excellent angiographic results. Following the procedure, the patient received aspirin and clopidogrel and an 18-hour infusion of eptifibatide. There was no significant elevation in postprocedure cardiac markers. Discussion. More than 1 million patients have undergone CABG in the United States alone.11 Long-term results of saphenous vein grafting are not extremely satisfactory. 50–75% of SVGs become occluded within 10 years after surgery.1,6 Graft failure results in return of symptoms9 and the realization of the stigmata of coronary heart disease such as MI, heart failure and sudden cardiac death. SVGs fail due to thrombosis, fibro-intimal hyperplasia and atherosclerosis. Vein graft atherosclerosis is different from native coronary atherosclerosis. SVG atherosclerosis is diffuse and concentric, with an excess of foam cells and lipid debris.6 The fibrous cap in SVGs is either absent or very thin.6 This provides a significant source of distal embolization and subsequent MACE. Due to the high risk of repeat CABG, relatively low-risk percutaneous catheter-based interventions are utilized where lesions appear amenable. Recent studies have noted MIs in up to 20% of the individuals undergoing percutaneous interventions to SVGs.7 Distal embolization has been suspected as the most likely culprit leading to MACE, primarily MIs.8 Significantly elevated cardiac markers representing these MI are associated with a higher mortality rate.10 The PercuSurge GuardWire has been recently approved by the U.S. Food and Drug Administration (FDA). A reduction in MI from 14.7% to 8.6% has been noted with this device.9 Residual MACE of 9.6% was noted, even with the use of this device. Consequently, further technical innovation is needed to decrease and, ideally, eliminate, the MACE noted, despite the use of a distal protection device. Inherent limitations with this device include high procedural complexity, inability of patients to tolerate prolonged ischemia and failure of the aspiration catheter to remove all the trapped particles.8 Despite its limitations, as with any other devices, the PercuSurge GuardWire is presently the only FDA-approved device available for distal protection. Since this device is associated with a significant reduction in MACE, its use will become more mainstream. Widespread use will lead to observational and potential complications not previously noted with this device. The present observations may be advantageous in early recognition of this complication. Nonionic contrast media is known to be thrombogenic.12 The PercuSurge device requires the operator to maintain a stagnant column of contrast from the time the distal balloon is deployed to the time the stent is deployed. This would leave a stagnant thrombogenic mixture of blood and contrast at the site incurring the risk of thrombus formation, as noted in the case described here. Using a mixture of heparinized saline with contrast for the final injection at the time of distal balloon deployment might be beneficial, however, evidence-based data to support this are not available. Considering the nature of the disease, this complication may not be entirely preventable, but awareness as to its occurrence and the potential technique of cutting the wire and the use of heparinized saline and contrast mixture can be potentially life-saving.

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