AngioJet Thrombectomy

Plaque rupture or fissure leading to the exposure of highly thrombogenic material to platelets and coagulation factors and subsequent thrombosis of the coronary artery is thought to be the principal mechanism associated with acute coronary syndromes including acute myocardial infarction (MI) and unstable angina/non-ST-elevation MI.^1-3 Percutaneous coronary intervention (PCI) on thrombus-containing lesions represents a clinical challenge to the interventional cardiologist, since thrombus has been identified as a predictor of adverse outcome.^4,5 In attempts to reestablish coronary perfusion, PCI of thrombus-laden native coronary arteries and bypass saphenous venous grafts (SVGs) can lead to distal embolization.⁶ Distal embolization of thrombus, fibrin content and other atherosclerotic plaque particulate matter can lead to a varying degree of consequences ranging from asymptomatic cardiac enzyme leak to flow-limiting microvascular obstruction, which may result in no reflow, abrupt occlusion, peri-procedural MI, emergent coronary artery bypass graft surgery and death,^7–10 as well as play an important role in late restenosis.¹¹ The optimal treatment for thrombus-containing lesions has yet to be defined. Pharmacotherapy with anticoagulants and antiplatelet agents like glycoprotein (GP) IIb/IIIa antagonists has proven to be ineffective in the presence of angiographically evident thrombus. In an angiographic subanalysis of the Platelet Receptor Inhibition for Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) study, angiographic evidence of thrombus, despite treatment with tirofiban, predicted 30-day mortality, MI, repeat revascularization and the composite endpoints.¹² Similarly, in a retrospective analysis of the Evaluation of IIb/IIIa Platelet Receptor Antagonist 7E3 in Preventing Ischemic Complications (EPIC) trial, there was less procedural success in patients with angiographic evidence of thrombus in both the abciximab and placebo groups.¹³ Singh et al.¹⁴ reported on the pooled data from 6 large trials which showed that PCI on lesions with angiographic evidence of thrombus predicted in-hospital and 6-month death and MI, and that GP IIb/IIIa antagonists did not affect outcomes on thrombus-containing lesions. GP IIb/IIIa antagonists also have been ineffective in PCI of SVGs with angiographic evidence of thrombus.^15,16 The lack of efficacy of GP IIb/IIIa antagonists to improve microvascular flow in the setting of angiographically visible thrombus may be due to the large clot volume that has the potential for distal embolization during PCI. Novel devices to treat thrombus-containing lesions include distal protection devices such as the fixed-wire filter devices and the balloon-tipped wire of the PercuSurge system (PercuSurge, Sunnyvale, California), the latter being approved for temporary occlusion and aspiration in SVGs. The Saphenous Vein Free of Emboli Randomized (SAFER) trial showed that the PercuSurge device decreased the incidence of ischemic complications by 42% within 30 days of PCI of SVGs.¹⁷ The transluminal extraction catheter (TEC) (Interventional Technologies, San Diego, Calif.) has the advantage of removing plaque and old thrombus as well as fresh thrombus, but the results have been disappointing thus far.¹⁸ Thrombectomy devices are also an appealing adjunctive therapy for thrombus-containing lesions, given their potential for decreasing the thrombus burden, decreasing embolism and improving clinical outcomes. The X-sizer thrombectomy system (EndiCOR Medical Inc.) implements an intracoronary helical cutter that is connected to an external passive vacuum source which allows the fragmentation and removal of intracoronary thrombus.^19–22 Another such device is the AngioJet rheolytic thrombectomy device (Possis Medical, Minneapolis, Minnesota), a catheter-based system for the removal of thrombus (Figure 1). AngioJet thrombectomy implements multiple high-velocity, high-pressure saline jets which are introduced through orifices in the distal tip of the catheter to create a localized low-pressure zone (Venturi-Bernoulli effect), resulting in a vacuum effect with the entrainment and dissociation of bulky thrombus. The jets break down thrombus into small particles and propel them proximally through the exhaust lumen, leading to the aspiration and removal of the thrombotic debris without embolization. However, AngioJet thrombectomy is ineffective in removing well organized thrombus and atheroembolic debris in degenerated SVGs. AngioJet Rheolytic Thrombectomy System. The AngioJet rheolytic thrombectomy system includes three units: disposable catheter, disposable pump set and reusable drive unit. 1. The single-use XMI catheter is 135 cm in length and has a 4 French diameter stainless steel over-the-wire catheter tip designed for use in coronary arteries greater than 2.0 mm. The XVG catheter is 140 cm in length and has a 5 French diameter designed for use in SVGs. The catheter contains a dual lumen: one lumen allows for the in-flow of high-velocity saline jets through the catheter tip and the other lumen allows for the evacuation of thrombotic debris and for the passage of a 0.014–0.018 in. guidewire. The catheter tip contains 3 orifices which allow the retrograde high-pressure saline jets to form toward the opening of the effluent lumen. 2. The disposable pump connects to a bag of heparinized saline. Thrombotic debris is directed proximally through the aperture of the catheter and collected in a non-sterile collection bag. 3. The drive unit pumps pressurized heparinized saline at 10,000 psi at the tip of the catheter, providing the pressurized pulsatile flow at a rate of 50–60 cc/min that macerates the thrombus. An electronic air detector, which is located in the pump unit, inactivates the system when it detects any leakage of air once the catheter is introduced into the guide catheter. The drive unit will also be inactivated if there is occlusion of the vacuum created at the tip of the catheter tip. The AngioJet catheter is initially “primed” by submerging the catheter in a container with sterilized saline and activating it to purge the remaining air out of the system. Low-pressure predilatation of the lesion with a small-sized balloon may facilitate delivery with minimal thrombus disruption and embolization. The AngioJet catheter is then activated starting either at the proximal or distal end of the thrombus. In the first method, the AngioJet catheter is advanced over a guidewire just until it is proximal to the thrombus. The system is activated by depressing the footswitch. The AngioJet catheter is advanced at 1–2 mm/sec to the distal end of the thrombus and then deactivated. The alternative technique is to advance the AngioJet catheter to the distal end of the thrombus and then pull back through the thrombus after activation until the proximal portion of the thrombus is reached. On average, 3 to 5 passes are made on the thrombotic lesion. Subsequent angioplasty or stenting is performed for definitive treatment of the lesion for optimal results, along with the administration of GP IIb/IIIa antagonists (Figures 2 A–C). The AngioJet catheter is bulky and somewhat stiffer than conventional angioplasty or stenting equipment. This requires the operator to make careful judgments concerning the likelihood of disruption of the artery in cases of severe tortuosity, especially in small vessels ~2.0 mm. This is especially important in the case of total occlusion where the degree of tortuosity distal to the occlusion cannot be ascertained prior to passing the lesion. In these cases, much information about the potential safety of the AngioJet approach may be gained by injecting dilute contrast into the artery distal to the occlusion through a super low-profile over-the-wire balloon [such as a 1.5 x 9 mm Maverick balloon (Boston Scientific, Maple Grove, Minn.)] passed through the occlusion before proceeding with thrombectomy. Similarly, because of the stiffness of the system, good guide and wire support are essential, especially in situations with severe proximal tortuosity such as a shepherd’s crook RCA. VeGAS 1. Thrombotic lesions in SVGs represent a technically difficult subset of lesions to treat. SVG atheroma has a high content of lipid and foam cells with a thin fibrous cap and tends to be more diffuse and thrombogenic than native vessel atheroma.²³ The optimal treatment in these patients has yet to be defined. Plain old balloon angioplasty of degenerated SVGs leads to a poor acute success rate and high complication rates, with long-term success rates less than 50% at 1 year.^24,25 The risk of adverse outcomes is even higher in older SVGs, especially when thrombus is present.26 Reoperation for degenerated SVGs is more technically challenging and leads to increased morbidity and mortality.²⁷ The Vein Graft AngioJet Study (VeGAS) 1 pilot study consisted of a multicenter registry of 87 lesions (52 SVGs, 35 native coronary arteries) with angiographic evidence of thrombus.²⁸ Acute MI was present in 32%, and cardiogenic shock was present in 7%. AngioJet thrombectomy prior to angioplasty or stenting reduced the thrombus area from 79 mm to 21 mm, increased the minimum lumen diameter from 0.81 mm to 1.70 mm, and improved the mean diameter stenosis from 77% ± 21% to 48% ± 25%. The overall procedural success rate (defined as a residual stenosis VeGAS 2. The VeGAS 2 trial was a multicenter study in which patients were randomized to either AngioJet thrombectomy (n = 179) or intracoronary infusion of urokinase (n = 167) prior to PCI for coronary arteries or SVGs with angiographic evidence of thrombus.²⁹ Initially intended to enroll 500 patients, the trial enrolled only 346 patients (54% SVGs) and was terminated early because of safety concerns in patients who received urokinase. The AngioJet catheter was delivered successfully in 98% of lesions. Although there was no difference in the predefined 30-day primary endpoint of death, Q-wave MI, emergency coronary artery bypass graft surgery, target lesion revascularization, stroke, stent thrombosis, or procedural failure, there was higher procedural success rate (defined as a residual stenosis 30 AngioJet thrombectomy appears to be safe and effective in patients with acute MI (Figure 3). Nakagawa et al.³¹ reported the use of AngioJet thrombectomy in 31 patients with acute MI and angiographic evidence of thrombus in native coronary arteries. AngioJet thrombectomy was planned in 28 patients, while the other 3 patients underwent AngioJet thrombectomy after balloon angioplasty and subsequent no-reflow. All 28 patients who underwent planned AngioJet thrombectomy achieved procedural success with no evidence of no-reflow, as opposed to only one of 3 patients who underwent “bailout” AngioJet thrombectomy. The TIMI grade flow increased from 0.70 ± 0.97 before AngioJet thrombectomy to 2.61 ± 0.88 after AngioJet thrombectomy. The overall procedural success rate was 94%. There was a restenosis rate of 21% (6 patients) at 145 ± 78 days angiographic follow-up. All 31 patients had TIMI 3 coronary flow at follow-up. There were no major adverse in-hospital events and no major adverse events at follow-up. Similarly, Silva et al.³² reported on 70 acute ST-elevation MI patients (16% with cardiogenic shock) treated with AngioJet thrombectomy. The mean thrombus area was reduced from 73.2 ± 64.6 mm to 15.5 ± 30.1 mm after treatment with AngioJet thrombectomy (p 2 after final treatment) was 93.8%. Final TIMI 3 flow was established in 88%. Clinical success (defined as procedural success without major adverse cardiac events) was achieved in 88%. There were 6 patients who had distal embolization, 2 patients with perforation and 5 in-hospital deaths. There were no further major adverse cardiac events at 30-day follow-up. Furthermore, successful reperfusion therapy with AngioJet thrombectomy appears to confer electrical stability to vulnerable myocardium by decreasing QT dispersion after acute MI.³³ In a single center study from the Mayo Clinic, Singh et al.³⁴ reported the use of AngioJet thrombectomy in 72 high-risk patients with angiographic evidence of thrombus (SVG 45%, acute coronary syndrome 87%, cardiogenic shock 8%). There was 60% TIMI grade 0/1 flow prior to PCI with the achievement of post-procedural TIMI grade 3 flow in 79% of the patients. AngioJet thrombectomy was associated with a 93% procedural success rate. There was 1 death, 3% Q-wave MI and 7% non-Q-wave MI during hospitalization. At 1-year follow-up of successful PCI with AngioJet thrombectomy, the mortality, death/Q-wave MI, and composite endpoint rate were 10%, 13.3%, and 35.5%, respectively. Taghizadeh et al.³⁵ reported the use of AngioJet thrombectomy and stenting in patients with acute MI complicated by cardiogenic shock. An intraaortic balloon pump was placed in all 19 patients. Adjunctive therapy with GP IIb/IIIa antagonists was used in 18 of 19 patients. Procedural success, defined by a final diameter stenosis 2, was achieved in 95%, with final TIMI 3 flow in 89%. Clinical success, defined by procedural success with major in-hospital cardiac event, was obtained in 68% (13/19 patients). There were 5 in-hospital deaths. No patients experienced stroke or needed emergent CABG. At 30-day follow-up, 2 patients required target vessel revascularization for subacute thrombosis, both of which occurred within 6 hours of the initial treatment. AngioJet thrombectomy may represent a useful treatment modality for patients who present with acute MI complicated by cardiogenic shock. AngioJet thrombectomy along with GP IIb/IIIa antagonism offers an effective treatment option for stent thrombosis.^36,37 AngioJet thrombectomy with adjunctive GP IIb/IIIa antagonism (41% tirofiban, abciximab 35% and 18% eptifibatide) resulted in the complete removal of filling defects in all 16 procedures, leading to significant improvement in lumen diameter and TIMI flow with reduction in the length of the thrombotic lesion.³⁷ Angiographic success, defined as less than 30% residual stenosis and TIMI 3 flow, was attained in all but 1 procedure with no in-hospital death, repeat PCI or emergency CABG. Distal embolization occurred in 3 cases. At 6 months follow-up, there were 4 patients (29%) who underwent repeat PCI but no deaths. The ongoing AngioJet Rheolytic Thrombectomy in Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction (AiMI) trial is a multicenter randomized prospective trial comparing AngioJet thrombectomy followed by immediate definitive treatment (PCI with stenting) with immediate definitive treatment in patients undergoing primary angioplasty. The primary endpoint is the final infarct size as assessed by SPECT imaging with 99 mTc Sestamibi at 14 days following the index procedure. The secondary endpoints include TIMI grade flow and frame count, TIMI myocardial perfusion blush grade, procedural complications, major adverse cardiac events and ST-segment resolution. Complications. Temporary cardiac rhythm disturbances such as bradycardia and heart block (high-grade atrioventricular block, complete heart block, asystole) requiring temporary pacing have been reported to occur in 20–26% of cases.²⁸ The right coronary artery is particularly susceptible to bradyarrhythmias. This phenomenon may be related to the release of adenosine from hemolyzed blood. Pre-treatment with aminophylline prevented heart block associated with AngioJet thrombectomy.³⁸ There are also reports of atropine decreasing the susceptibility of cardiac rhythm disturbances. However, our experiences have shown us that pre-treatment with intravenous aminophylline 250 mg given over 2 minutes and 3–5 minutes prior to the use of the AngioJet does not prevent temporary heart block, regardless of the culprit artery. Of the 11 patients who were pre-treated with aminophylline at our institution, bradyarrhythmias requiring transvenous pacing occurred in 8 patients. Therefore, the insertion of a temporary pacemaker catheter in the right ventricle is highly recommended prior to the activation of AngioJet thrombectomy, especially during PCI of the right coronary artery. Sustained ventricular tachyarrhythmias, which occurred in 1.1% of the patients in the VeGAS 2 trial, resolved without further sequelae after the completion of AngioJet thrombectomy. During AngioJet thrombectomy, abrupt and dramatic ST-segment elevation may occur secondary to hemolysis (producing localized hyperkalemia) rather than ischemia, as the concurrent pulmonary pressures are frequently documented to be low and thus not characteristic of ischemia.³⁹ Patients frequently experience chest discomfort during activation of AngioJet thrombectomy, which can be palliated by narcotics and limiting each thrombectomy pass to less than 30 seconds.⁴⁰ The chest discomfort usually resolves after cessation of AngioJet thrombectomy. AngioJet thrombectomy was associated with non-Q-wave MI, defined by elevation of CK-MB, in 27% of patients in the VeGAS 1 registry. The potential risk of cerebral and peripheral embolism with the use of AngioJet thrombectomy on ostial thrombosis exists since a potent vacuum effect is created at the tip of the AngioJet catheter.⁴¹ Distal embolization, which occurred in 1 patient in the VeGAS 1 registry, may occur as the catheter is activated proximal to the thrombus or if it is passed through the thrombus-containing lesion prior to activation. AngioJet thrombectomy is not selective for platelets. Prolonged operating use of AngioJet thrombectomy of more than 15 minutes can lead to significant hemolysis of erythrocytes and may therefore require monitoring serum hemolytic markers following lengthy complex cases to prevent renal injury. Although hemolysis occurred with a significant increase of free hemoglobin and a decrease of haptoglobin, there was only a transient and mild decrease in hemoglobin in an animal model.⁴² Perforation associated with the use of the AngioJet catheter has been documented in coronary arteries 28 AngioJet thrombectomy should therefore not be performed when it is occlusive in the reference vessel. Coronary dissection from a loose intimal flap being sucked into the jetstream of the AngioJet catheter, which occurred in 16.7% of patients in the VeGAS 1 registry, can also occur. Non-coronary applications. AngioJet catheter thrombectomy has also been used for non-coronary purposes. Early experiences in peripheral arteries43 and intrahepatic portosystemic shunts⁴⁴ have shown promising results. Silva et al.⁴⁵ demonstrated that AngioJet thrombectomy removed 70% of the thrombus in 21 patients with a thrombotic occlusion causing acute limb-threatening ischemia, allowing the restoration of antegrade flow and limb salvage in 95% of the patients and 6-month limb salvage in 89% of the patients. However, recurrent thrombosis occurred in 4 patients (18%), most likely due to dissection that was inadequately treated with plain balloon angioplasty. AngioJet thrombectomy is also FDA approved for removing thrombus from dialysis access grafts. AngioJet thrombectomy has been used to treat thrombosis of the sigmoid and transverse sinuses,⁴⁶ internal carotid artery thrombosis in the setting of acute ischemic stroke,⁴⁷ acute renal artery thrombosis,⁴⁸ pulmonary embolism⁴⁹ and acute mesenteric vein thrombosis.⁵⁰ Conclusion PCI performed on thrombus-containing lesions is associated with a higher rate of adverse outcomes than when performed on thrombus-free lesions and hence, represents a challenging clinical scenario to the interventionalist. The ongoing Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial, with the primary objective of demonstrating that facilitated angioplasty has superior efficacy compared to primary angioplasty, may provide evidence that GP IIb/IIIa inhibition in potential combination with thrombolytic therapy may lead to improved clinical outcomes in patients treated with primary angioplasty for acute MI. AngioJet thrombectomy in this setting represents an important adjunctive technique allowing rapid resolution of thrombus with quick reconstitution of flow and a decrease in the incidence of the no- or slow-reflow phenomenon. In addition to treating acute coronary and SVG lesions, AngioJet thrombectomy may have been used successfully for peripheral applications in vessels containing thrombus, including acute stroke, hemodialysis access thrombosis, thrombotic renal arteries and limb-threatening ischemia. The ongoing AiMI trial may provide evidence that AngioJet thrombectomy during primary angioplasty is superior to conventional primary angioplasty in acute MI.

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