Since the coronary stent was introduced, the complication rate after percutaneous coronary intervention (PCI) has been reduced.1 However, lesions with large thrombus burden are still associated with high morbidity and mortality rates after PCI.2 Recently, devices to prevent distal embolization have been introduced and the results in saphenous vein grafts are encouraging.3–9 This case report describes the successful treatment of a lesion with a large thrombus burden in a native coronary artery with an embolization containment device.
Case Report. An 84-year-old female who had been admitted due to acute non-Q wave myocardial infarction was transferred to our hospital. Coronary angiography was performed 4 days after the onset of myocardial infarction. It revealed a 99% stenosis with a large thrombus burden in the proximal and mid-right coronary artery (RCA) (Figure 1A). Contralateral collaterals from the left circumflex artery (LCX) to the RCA were observed. There was no significant stenosis in the left anterior descending coronary artery or the LCX. Left ventriculography demonstrated hypokinesis of the inferior wall. The patient was referred for coronary angioplasty.
An 8 French (Fr) JR4 guiding catheter (Cordis Corporation, Miami, Florida) was positioned at the RCA ostium. A 0.014´´ PercuSurge GuardWire Plus (Medtronic AVE, Sunnyvale, California) was prepped and advanced into the distal RCA. The GuardWire Plus occlusion balloon was positioned in the distal RCA and inflated up to 4 mm in diameter (Figure 1B). A 2.5 mm Adante balloon catheter (Boston Scientific/Scimed, Inc., Maple Grove, Minnesota) was passed through the lesion and balloon inflations at 6 atmospheres (atm) were performed. A 28 mm ULTRA stent (Guidant Corporation, Temecula, California) that was pre-mounted on a 4.0 mm balloon catheter was advanced to the lesion. Contrast was injected to confirm the appropriate position of the stent (Figure 2), which was then deployed in the proximal RCA using an inflation pressure of 12 atm. An 18 mm ULTRA stent that was pre-mounted on the 4.0 mm balloon catheter was then deployed in the mid-RCA using an inflation pressure of 12 atm. After the balloon catheter was removed, the Export catheter, which is the aspiration catheter of the PercuSurge GuardWire Plus system, was advanced over the GuardWire Plus to the distal occlusion balloon. Suction by aspiration syringe was performed and thrombus-like material was retrieved. The occlusion balloon was then deflated. There was no chest pain or significant change in the electrocardiogram during inflation of the occlusion balloon for 15 minutes. Angiography demonstrated Thrombosis in Myocardial Infarction (TIMI) grade 3 flow with no evidence of distal embolism or residual thrombus (Figure 1C). A 13 mm TETRA stent that was pre-mounted on the 3.5 mm balloon catheter was deployed in the distal RCA using an inflation pressure of 16 atm. The final angiogram demonstrated a good result (Figure 1D). The patient’s course after the procedure was uncomplicated. There was neither electrocardiographic nor enzymatic evidence of myocardial infarction related to the procedure.
Discussion. No reflow phenomenon is frequently observed during PCI in lesions with a large thrombus burden.2 This may be attributed mainly to distal embolization of thrombus in such lesions, although there are other possible mechanisms for this phenomenon, such as microvascular damage and spasm.10,11 Patients with distal embolization and no reflow have significantly higher rates of myocardial infarction and death (approaching 20%) compared to patients without these complications.12,13 In a series of patients who were treated with transluminal extraction catheter atherectomy (Interventional Technologies, Bellevue, Washington), 18.5% of patients with distal embolization died in the hospital.14
Vasodilators have been the primary pharmacological treatment of no reflow.15–17 Intracoronary verapamil, nitroprusside and adenosine have been shown to be effective in the treatment of no reflow. The mechanism of action may be improvement in microvascular circulation and may be unrelated to embolic phenomena. Thus, these agents may not be enough to prevent or relieve no reflow and distal embolization when treating a lesion with a large amount of embolization source, such as large bulky thrombus.
Previous studies18,19 demonstrated that thrombolytic agents and glycoprotein IIb/IIIa inhibitors dissolved coronary thrombus and improved TIMI flow grade. Furthermore, the efficacy of glycoprotein IIb/IIIa inhibitor as an adjunctive therapy for primary angioplasty was demonstrated.20,21 However, it may not be possible to dissolve all thrombus with thrombolytic agents or glycoprotein IIb/IIIa inhibitors in lesions with large thrombus burden. Thus, the risk of no reflow and distal embolization might remain when treating such lesions.20
Covered stents with suitable length and compatible covering have the potential to entrap thrombus, which would otherwise embolize during deployment.22 However, embolization may occur in a lesion with a large thrombus burden while delivering the stent to the lesion through thrombus.
The AngioJet Rapid Thrombectomy System (Possis Medical, Minneapolis, Minnesota) uses the Bernoulli effect to aspirate friable pathology such as poorly organized thrombus.23 This device has demonstrable success in extracting thrombus from both diseased vein grafts and native coronary arteries. However, in a pilot study of the AngioJet,24 no reflow was observed in 13% of the lesions while attempting thrombectomy.
Recently, devices to trap embolic material have been introduced.3–8 These devices fall into two general types. One is the filter-type device that traps debris during intervention and is then collapsed and withdrawn from the artery with the trapped debris.8 However, in lesions with large thrombus burden, no reflow and distal embolization may occur while delivering the filter-type device through thrombus.
The other embolization containment device consists of a distal balloon, which occludes the artery during intervention, and a small catheter for aspiration of debris.3–8 Stein et al.25 demonstrated the concept of balloon occlusion and transluminal aspiration to prevent distal embolization. A balloon catheter was inflated at the segment distal to the lesion in a saphenous vein graft to prevent distal embolization while PCI was performed with another balloon catheter. The particulate debris was aspirated with a Dorros Infusion/Probing Catheter (USCI, Billerica, Massachusetts). The balloon catheter at the distal segment was then deflated. However, this technique does not allow the deployment of stents.
The PercuSurge containment system is an advanced system that uses this concept.3–8 The PercuSurge GuardWire Plus is constructed of 0.014´´ nitinol hypotube with a 35 mm radio-opaque, shapeable, steerable tip. Incorporated in the distal wire is a 5.5-mm long elastomeric balloon with a 0.041–0.043´´ crossing profile and available inflated diameters of 3.0–6.0 mm.4 Thus, the low profile of the PercuSurge GuardWire Plus minimizes the risk of distal embolization and no reflow while delivering it through thrombus, although meticulous guidewire manipulation is essential. A detachable inflation adapter accesses the hypotube lumen by displacing a small seal, allowing inflation of the balloon. This system allows stenting while the distal occlusion balloon is inflated. After PCI, an aspiration catheter (Export catheter) with an internal lumen diameter of 0.040´´ is advanced over the PercuSurge GuardWire Plus and allows removal of particulate debris using a 20 ml locking syringe before deflation of the occlusion balloon. Following manual aspiration, the aspiration catheter is removed and the distal occlusive balloon is deflated.4
The efficacy of the PercuSurge containment system for the treatment of diseased saphenous vein grafts has been demonstrated with encouraging results of a decreased incidence of distal embolization.3,4 Carlino et al.3 performed stenting with the PercuSurge GuardWire in 15 degenerated saphenous vein grafts. There were no distal embolizations or major in-hospital complications, including Q-wave and non-Q wave myocardial infarctions. In 10 of 15 patients, macro- or microscopic debris was observed. Webb et al.4 demonstrated no procedural complications except for 3 post-procedure non-Q wave myocardial infarctions (11.1%) in 27 saphenous vein grafts. Particulate material was identified after 21 of 23 procedures suitable for analysis. Recently, the randomized Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial9 demonstrated a lower in-hospital major adverse cardiac event rate (8.8% versus 17.3%; p < 0.001), which was mainly due to a lower procedural myocardial infarction rate (8.4% versus 16.5%; p < 0.001) after PCI with the PercuSurge GuardWire Plus system in saphenous vein grafts compared to PCI without distal protection devices.
In another study,5 the PercuSurge GuardWire system was used when PCI in a native coronary artery was performed in 8 patients with acute myocardial infarction. Thrombus was aspirated in 7 of the 8 patients; in 1 patient, the system could not negotiate the angulated take-off of the LCX. Final TIMI grade 3 flow was observed in 5 of the 7 patients (71%). Because there are other possible mechanisms of slow or no reflow phenomenon, such as microvascular damage and spasm, it may be difficult to evaluate the efficacy of this device in patients with acute myocardial infarction without a randomized trial. To evaluate the efficacy of the PercuSurge GuardWire Plus system in acute myocardial infarction patients, the randomized Enhanced Myocardial Efficacy and Removal by Aspiration of Liberalized Debris (EMERALD) trial is now ongoing.
A case report by De Biase et al. showed successful treatment of a lesion with large thrombus burden using the PercuSurge GuardWire system.6 In this case, a glycoprotein IIb/IIIa inhibitor was used as adjunctive therapy. This drug may be useful as an adjunct to PCI with the embolization containment device in thrombotic lesions. In the present case, because decrease in hemoglobin had been observed before intervention, a glycoprotein IIb/IIIa inhibitor was not used. Thus, prevention of distal embolism and no reflow might be solely due to the embolization containment device, because thrombus-like material was retrieved through the aspiration catheter, which would have otherwise caused distal embolism and no reflow. However, if there is no contraindication, it may be recommended to use glycoprotein IIb/IIIa inhibitor as an adjunctive therapy.20,21
Angiography cannot be performed while inflating the distal occlusion balloon in a lesion of a saphenous vein graft, making assessment of the lesion and stent placement more difficult. However, contrast may be injected to confirm the appropriate position of the balloon catheter or stent when treating a lesion in a native coronary artery, because there is coronary flow into side branches (Figure 2). However, it means that this system does not prevent distal embolization into the branches proximal to the distal occlusion balloon. Thus, when there is a sidebranch, it is important to position the distal occlusion balloon at the segment proximal to the branch.
This device has some limitations. First, the distal occlusion balloon causes ischemia that may not be tolerated by some patients,3 although the present case did not have chest pain or electrocardiographic change during long inflation of the occlusion balloon, probably because of collateral circulation. Second, the distal occlusion balloon may cause vessel injury,7 although it is inflated at low pressure. Third, the aspiration catheter might not remove all particles trapped in the artery.
The PercuSurge GuardWire Plus temporary occlusion and aspiration system may be useful in lesions with large thrombus burden. Further large-scale studies, such as the EMERALD trial, are required to confirm the usefulness of this system.
1. Fischman D, Leon MB, Baim DS, et al. A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496–501.
2. Cura FA, L'Allier PL, Kapadia SR, et al. Predictors and prognosis of suboptimal coronary blood flow after primary coronary angioplasty in patients with acute myocardial infarction. Am J Cardiol 2001;88:124–128.
3. Carlino M, De Gregorio J, Di Mario C, et al. Prevention of distal embolization during saphenous vein graft lesion angioplasty. Experience with a new temporary occlusion and aspiration system. Circulation 1999;99:3221–3223.
4. Webb JG, Carere RG, Virmani R, et al. Retrieval and analysis of particulate debris after saphenous vein graft intervention. J Am Coll Cardiol 1999;34:468–475.
5. Belli G, Pezzano A, De Biase AM, et al. Adjunctive thrombus aspiration and mechanical protection from distal embolization in primary percutaneous intervention for acute myocardial infarction. Cathet Cardiovasc Intervent 2000;50:362–370.
6. De Biase AM, Belli G, Fouladvand F, Klugmann S. Treatment of a native right coronary artery with the PercuSurge Guardwire protection system during PTCA and stenting. G Ital Cardiol 1999;29:1503–1507.
7. Oesterle SN, Hayase M, Baim DS, et al. An embolization containment device. Cathet Cardiovasc Intervent 1999;47:243–250.
8. Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation 2000;101:570–580.
9. Webb JG, Khatri S. Distal embolization and no-reflow in the setting of saphenous vein graft in-stent restenosis. J Invas Cardiol 2001;13:451–452.
10. Michaels AD, Gibson CM, Barron HV. Microvascular dysfunction in acute myocardial infarction: Focus on the roles of platelet and inflammatory mediators in the no-reflow phenomenon. Am J Cardiol 2000;85:50B–60B.
11. Piana RN, Paik GY, Moscucci M, et al. Incidence and treatment of “no-reflow” after percutaneous coronary intervention. Circulation 1994;89:2514–2518.
12. Wilson RF, Laxson DD, Lesser JR, White CW. Intense microvascular constriction after angioplasty of acute thrombotic arterial lesions. Lancet 1989;1:807–811.
13. Feld H, Schulhoff N, Lichstein E, et al. Direct angioplasty as primary treatment for acute myocardial infarction resulting in the “no reflow” phenomenon predicts a high mortality rate. Circulation 1992;86:135A.
14. Moses JW, Moussa I, Popma JJ, et al. Risk of distal embolization and infarction with transluminal extraction atherectomy in saphenous vein grafts and native coronary arteries. Cathet Cardiovasc Intervent 1999;47:149–154.
15. Dillon WC, Hadian D, Ritchie ME. Refractory no-reflow successfully treated with local infusion of high-dose adenosine and verapamil. Angiology 2001;52:137–141.
16. Hillegass WB, Dean NA, Liao L, et al. Treatment of no-reflow and impaired flow with the nitric oxide donor nitroprusside following percutaneous coronary interventions: Initial human clinical experience. J Am Coll Cardiol 2001;37:1335–1343.
17. Assali AR, Sdringola S, Ghani M, et al. Intracoronary adenosine administered during percutaneous intervention in acute myocardial infarction and reduction in the incidence of “no reflow” phenomenon. Cathet Cardiovasc Intervent 2000;51:27–31.
18. Gersh BJ. Optimal management of acute myocardial infarction at the dawn of the next millennium. Am Heart J 1999;138:S188–S202.
19. Muhlestein JB, Karagounis LA, Treehan S, Anderson JL. “Rescue” utilization of abciximab for the dissolution of coronary thrombus developing as a complication of coronary angioplasty. J Am Coll Cardiol 1997;30:1729–1734.
20. Montalescot G, Barragan P, Wittenberg O, et al. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med 2001;344:1895–1903.
21. Mak KH, Challapalli R, Eisenberg MJ, et al. Effect of platelet glycoprotein IIb/IIIa receptor inhibition on distal embolization during percutaneous revascularization of aortocoronary saphenous vein grafts. EPIC Investigators. Evaluation of IIb/IIIa platelet receptor antagonist 7E3 in Preventing Ischemic Complications. Am J Cardiol 1997;80:985–988.
22. Briguori C, De Gregorio J, Nishida T, et al. Polytetrafluoroethylene-covered stent for the treatment of narrowings in aorticocoronary saphenous vein grafts. Am J Cardiol 2000;86:343–346.
23. Drasler WJ, Jenson ML, Wilson GJ, et al. Rheolytic catheter for percutaneous removal of thrombus. Radiology 1992;182:263–267.
24. Ramee SR, Kuntz RE, Schatz RA, et al. Preliminary experience with the POSSIS coronary AngioJet rheolytic thrombectomy catheter in the VeGAS 1 Pilot Study. J Am Coll Cardiol 1996;27:69A.
25. Stein BC, Moses J, Teirstein PS. Balloon occlusion and transluminal aspiration of saphenous vein grafts to prevent distal embolization. Cathet Cardiovasc Intervent 2000;51:69–73.