Clinical Policy Bulletin: AngioJet Rheolytic Thrombectomy System
Aetna considers the AngioJet Rheolytic Thrombectomy System, also known as the Possis AngioJet Rapid Thrombectomy System, medically necessary for removing fresh blood clots from any of the following vessels:
Arterio-venous fistulas for hemodialysis by direct anastomosis of artery to vein or by placement of a synthetic graft (e.g., Gortex); or
Coronary arteries or coronary bypass grafts greater than or equal to 2.0 mm in diameter prior to angioplasty or stent placement; or
Infra-inguinal peripheral arteries greater than or equal to 2.0 mm in diameter.
Aetna considers the AngioJet Rheolytic Thrombectomy System experimental and investigational for the treatment of the following indications and for all other indications because its clinical value for these indications has not been established (not an all inclusive list):
Acute renal artery thrombosis
Cerebral venous sinus thrombosis
Deep vein thrombosis
Thrombosis of the native aortic valve and of the left ventricular assist device in individuals with heart failure.
The AngioJet Rheolytic Thrombectomy System (Possis Medical, Minneapolis, MN) consists of a single-use catheter, single-use pump set, and multi-use drive unit. The same drive unit and pump set are compatible with various catheters with different design features. Thrombectomy is accomplished with the introduction of a pressurized saline jet stream through the directed orifices in the catheter distal tip. The jets generate a localized low pressure zone via the Bernoulli effect, which entrains and macerates thrombus. The saline and clot particles are then sucked back into the exhaust lumen of the catheter and out of the body for disposal. Treatment with the device takes about one minute.
United States marketing of the AngioJet System began in 1997 following the receipt of U.S. Food and Drug Administration (FDA) marketing clearance for clot removal in arterio-venous (A-V) fistulas used for dialysis access. In March 1999, the AngioJet System was approved by the FDA for use in native coronary vessels and coronary bypass grafts and in February 2000, an expansion of this indication was made to include the treatment of fresh thrombus from infra-inguinal peripheral arteries greater than or equal to 2.0 mm in diameter.
The AngioJet has been shown to be appropriate for removal of fresh blood clots from native coronary arteries or coronary bypass grafts prior to angioplasty or stent placement in patients sustaining acute myocardial injury. Studies show that the AngioJet is similar in effectiveness to urokinase in removing blood clots during a heart attack; therefore, the procedure can be used as an alternative to thrombolytic drugs.
Regarding future AngioJet System applications, a four-hospital FDA clinical study is underway to evaluate AngioJet System safety and effectiveness in treating stroke caused by blood clot blockage of the carotid arteries.
Suarez et al (2004) stated that catheter thrombectomy techniques (e.g., aspiration thrombectomy, fragmentation thrombectomy, and rheolytic thrombectomy) are being developed to provide an alternative treatment modality for severe cases of acute massive pulmonary embolism (PE) when thrombolytics are contraindicated. Catheter thrombectomy devices have undergone major advances over the last decade, but literature support of their success is limited.
Current evidence for the effectiveness of rheolytic thrombectomy in pulmonary embolism is limited to case reports and one small case series. Zeni and associates (2003) examined the effectiveness of thrombus removal using the rheolytic thrombectomy catheter (RTC) in 17 patients with acute massive PE. The RTC was successfully delivered and operated via a 0.035-inch guide wire in all attempted cases. Treatment resulted in immediate angiographic improvement and initial relief of PE symptoms (improvement in dyspnea and oxygen saturation) in 16 of 17 patients. One patient developed heart block during the procedure, and further treatment with the RTC was discontinued. Bradycardia occurred in 1 patient (managed with lidocaine). After thrombectomy, 10 patients received adjunctive reteplase thrombolysis for treatment of residual thrombus, and 12 received inferior vena cava filters. In the patient with renal cell carcinoma, histopathological analysis of the evacuated material confirmed tumor origin of the embolism. There were 2 deaths, both within 24 hours of treatment and secondary to PE. One death occurred in a patient who had only minimal thrombus removal after treatment with the RTC and no thrombolysis. The remaining 15 patients showed continued improvement in PE symptoms and were eventually discharged from the hospital with mean length of stay 10.3 +/- 6.5 days (range of 5 to 30 days). The authors concluded that rheolytic thrombectomy can be performed effectively in patients with massive PE. However, a large portion of the patients in this study underwent adjuvant overnight thrombolytic infusion. Further evaluation in a larger cohort of patients is warranted to assess whether this treatment may offer an alternative or complement to thrombolysis or surgical thrombectomy. The Centers for Medicare & Medicaid Services considers as experimental transvenous (catheter) pulmonary embolectomy procedure for removing pulmonary emboli by passing a catheter through the femoral vein.
The AngioJet is being evaluated for its potential use in the management of patients with deep vein thrombosis. However, there is insufficient evidence to support its use for this indication. Bush et al (2004) describe a new method of thrombus removal, with simultaneous percutaneous mechanical thrombectomy (PMT) by means of the AngioJet and thrombolysis in treating symptomatic lower extremity deep venous thrombosis. These investigators reported that complete thrombus removal was obtained in 15 procedures (65 %), and partial resolution in the remaining 8 procedures (35 %). The investigators concluded, however, that further outcome measures are needed to examine the effectiveness of this treatment method on preservation of valve function, reduction of chronic venous insufficiency, and improvement in quality of life.
There have been a number of case reports (Siablis et al, 2005; Greenberg et al, 2005; Sternbergh et al, 2000) of the use of the AngioJet thrombectomy catheter for the percutaneous treatment of acute renal-artery thrombosis. However, the effectiveness of Angiojet for this indication needs to be validated by prospective clinical trials.
Current risk of inadequate myocardial perfusion for thrombus embolization in primary coronary interventions is not negligible. Margheri et al (2006) evaluated the safety and effectiveness of the AngioJet coronary device in patients with acute myocardial infarction (AMI). The AngioJet device was used in 116 consecutive patients with AMI and angiographic evidence of extensive thrombosis in a vessel with a reference diameter of greater than 2.5 mm. Glycoprotein IIb/IIIa inhibitors and stents were used. Epicardial and myocardial re-perfusion angiographic parameters, and in-hospital major adverse cardiac events (MACE, i.e., cardiac death, myocardial infarction, target vessel re-vascularization) were assessed. The AngioJet was successfully used in all patients. Angiographic analysis showed that the AngioJet significantly improved epicardial coronary flow (p < 0.01), frame count (p < 0.01) and myocardial blush (p < 0.01), while stenting yielded significant improvements only in diameter stenosis, minimum lesion diameter and correlated vessel parameters (p < 0.01). In-hospital MACE were uncommon (9 [8 %]). When compared to an AMI population with similar thrombus burden but not undergoing thrombectomy, the AngioJet population showed significant improvement of re-perfusion parameters. Moreover, there was greater AngioJet benefit in the high versus moderate thrombus burden subset; laboratory and operator experience also correlated significantly with final angiographic results. The authors concluded that the findings of this study supports the favorable risk-benefit profile of AngioJet device use in selected patients with AMI when it is employed in experienced laboratories and by trained operators.
On the other hand, De Luca et al (2007) stated that the benefits of adjunctive mechanical devices to prevent distal embolization in patients with AMI are still a matter of debate. In a meta-analysis, these researchers combined data from all randomized studies conducted with adjunctive mechanical devices to prevent distal embolization in AMI. A total of 21 studies with 3721 patients were included (1,877 patients [50.4 %] in the adjunctive mechanical device group and 1,844 [49.6 %] in the control group); 1,502 patients (40.3 %) were randomized in trials with distal protection devices, and 2,219 patients (59.7 %) were randomized in trials with thrombectomy devices. Adjunctive mechanical devices were associated with a higher rate of post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow (89.4 % versus 87.1 %, p = 0.03), a significantly higher rate of post-procedural myocardial blush grade 3 (48.8 % versus 36.5 %, p < 0.0001), and less distal embolization (6.0 % versus 9.3 %, p = 0.008), without any benefit in terms of 30-day mortality (2.5 % versus 2.6 %, p = 0.88). No difference was observed in terms of coronary perforations (0.27 % versus 0.07 %, p = 0.24). The authors concluded that this meta-analysis demonstrates that, among patients with AMI treated with percutaneous coronary intervention, the use of adjunctive mechanical devices to prevent distal embolization is associated with better myocardial perfusion and less distal embolization, but without an apparent improvement in survival.
Chauhan and Kawamura (2007) noted that pulmonary embolism (PE) is a common cardiovascular disease with significant mortality. Some patients with large PE are not eligible for current treatment options such as thrombolysis or surgical embolectomy. These investigators reported their experience of percutaneous rheolytic thrombectomy (PRT) using the AngioJet system combined with adjunctive local thrombolytic therapy and inferior vena cava (IVC) filter placement to treat massive or sub-massive PE in patients ineligible for current treatment options. Of the 14 consecutive patients ineligible for thrombolysis or embolectomy treated with PRT, 10 patients had massive PE (6 patients were hypotensive and 4 patients had intractable hypoxemia) and 4 patients had sub-massive PE. Adjunctive local thrombolysis was performed in 5 patients. An IVC filter was placed in 11 patients. Angiographic success based on Miller score was achieved in 13 patients (92.9 %). Procedure success was seen in 12 patients (85.7 %). Procedural mortality occurred in 1 patient (7.1 %) who presented in cardiogenic shock and non-fatal hemoptysis occurred in 1 patient (7.1 %). Total in-hospital mortality occurred in 3 patients (21.4 %). On a mean follow-up of 9 months, all 11 survivors had noted significant improvement in symptoms without recurrence. The authors concluded that percutaneous rheolytic thrombectomy using the AngioJet may be a treatment option for patients with massive or sub-massive PE who may not be eligible for thrombolytic therapy or surgical embolectomy.
In a multi-center, randomized, 2-arm, prospective study, Migliorini et al (2010) examined if rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial re-perfusion and clinical outcome in patients with AMI. Eligible subjects were patients with AMI, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter greater than or equal to 2.5 mm. Co-primary end points were early ST-segment resolution and (99m)Tc-sestamibi infarct size. An α value = 0.05 achieved by both co-primary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were TIMI flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8 % and 78.8 %, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2 % in the thrombectomy arm and 19.4 % in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 +/- 2.3 % for the RT arm, and 75.0 +/- 3.1 % for the DS alone arm (p = 0.009). The authors concluded that although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with AMI and evidence of coronary thrombus.
Barbieri and colleagues (2011) stated that with the diffusion of implantable ventricular assist pumps in heart failure patients refractory to treatments or ineligible to transplantation, acute aortic valve and device thrombosis is an unusual but potentially increasing complication. These investigators reported a novel application of Angiojet rheolytic thrombectomy for acute and massive thrombosis of the native aortic valve and of the left ventricular assist device in a heart failure patient. The clinical value of this approach has yet to be determined.
Dashti et al (2011) noted that cerebral venous sinus thrombosis (CVT) is an uncommon cause of stroke that is usually treated medically with intravenous heparin therapy followed by long-term anti-coagulation therapy. These researchers presented a series of patients with CVT who underwent rheolytic thrombectomy with the AngioJet as a first-line adjunctive treatment in addition to standard anti-coagulation therapy. Prospectively maintained endovascular databases at 2 institutions were retrospectively reviewed. The available clinical and imaging data were compiled at each institution and combined for analysis. Over 18 months, 13 patients (6 men and 7 women; age range of 17 to 73 years, median age of 45 years) with CVT were treated with rheolytic thrombectomy. Immediate (partial or complete) re-canalization of the thrombosed intra-cranial sinuses was achieved in all patients. At a median radiographical follow-up of 7 months there was continued patency of all re-canalized sinuses. Clinical follow-up was available on 9 patients: modified Rankin score of 0 in 4 patients, 1 in 3 patients and 6 in 2 patients. The authors concluded that this series demonstrated the feasibility of performing mechanical thrombectomy as a first-line treatment for acute CVT. This technique facilitates the prompt restoration of intracranial venous outflow, which may result in rapid neurological and symptomatic improvement. The findings of this study need to be validated by well-designed studies.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
37211 - 37213
ICD-9 codes covered if selection criteria are met::
410.00 - 410.9
Acute myocardial infarction
414.00 - 414.9
Cardiovascular disease, unspecified
Atherosclerosis, of native arteries of the extremities
Atherosclerosis, of bypass graft of the extremities
Peripheral vascular disease, unspecified
Arterial embolism and thrombosis of iliac artery
Arterial embolism and thrombosis of arteries of lower extremity
Stricture of artery
Chronic renal failure
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
Phlebitis and thrombophlebitis of intracranial venous sinuses
415.11 - 415.19
Pulmonary embolism and infarction
Nonpyogenic thrombosis of intracranial venous sinus
Embolism and thrombosis of vena cava [deep vein thrombosis]
453.40 - 453.42
Venous embolism and thrombosis of deep vessels of lower extremity [deep vein thrombosis]
Venous embolism and thrombosis of other specified veins
Vascular disorders of kidney [acute renal artery thrombosis]
The above policy is based on the following references:
U.S. Food and Drug Administration (FDA). FDA approves new device to remove blood clots from coronary arteries. FDA Talk Paper. Rockville, MD: FDA; March 15, 1999. Available at: http://www.fda.gov/bbs/topics/ANSWERS/ANS00945.html. Accessed June 20, 2001.
Possis Medical, Inc. AngioJet system overview. Minneapolis, MN: Possis Medical; 2001. Available at: http://www.possis.com/products/angiojet.htm. Accessed June 20, 2001.
Hamburger JN, Serruys PW. Treatment of thrombus containing lesions in diseased native coronary arteries and saphenous vein bypass grafts using the AngioJet rapid thrombectomy system. Herz. 1997;22(6):318-321.
Nakagawa Y, Matsuo S, Yokoi H, et al. Stenting after thrombectomy with the AngioJet catheter for acute myocardial infarction. Cathet Cardiovasc Diagn. 1998;43(3):327-330.
Rodes J, Bilodeau L, Bonan R, et al. Angioscopic evaluation of thrombus removal by the POSSIS AngioJet thrombectomy catheter. Cathet Cardiovasc Diagn. 1998;43(3):338-343.
Silva JA, Ramee SR, Collins TJ, et al. Rheolytic thrombectomy in the treatment of acute limb-threatening ischemia: Immediate results and six-month follow-up of the multicenter AngioJet registry. Possis Peripheral AngioJet Study AngioJet Investigators. Cathet Cardiovasc Diagn. 1998;45(4):386-393.
Nakagawa Y, Matsuo S, Kimura T, et al. Thrombectomy with AngioJet catheter in native coronary arteries for patients with acute or recent myocardial infarction. Am J Cardiol. 1999;83(7):994-999.
Whisenant BK, Baim DS, Kuntz RE, et al. Rheolytic thrombectomy with the Possis AngioJet?: Technical considerations and initial clinical experience. J Invasive Cardiol. 1999;11(7):421-426.
Vesely TM, Hovsepian DM, Darcy MD, et al. Angioscopic observations after percutaneous thrombectomy of thrombosed hemodialysis grafts. J Vasc Interv Radiol. 2000;11(8):971-977.
Silva JA, Ramee SR. The emergence of mechanical thrombectomy; a clot burden reduction approach. Semin Interv Cardiol. 2000;5(3):137-147.
Ali A, Malik FS, Dinshaw H, et al. Reduction in QT dispersion with rheolytic thrombectomy in acute myocardial infarction: Evidence of electrical stability with reperfusion therapy. Catheter Cardiovasc Interv. 2001;52(1):56-58.
Silva JA, Ramee SR, Cohen DJ, et al. Rheolytic thrombectomy during percutaneous revascularization for acute myocardial infarction: Experience with the AngioJet catheter. Am Heart J. 2001;141(3):353-359.
Kasirajan K, Gray B, Ouriel K. Percutaneous AngioJet thrombectomy in the management of extensive deep venous thrombosis. J Vasc Interv Radiol. 2001;12(2):179-185.
Kasirajan K, Gray B, Beavers FP, et al. Rheolytic thrombectomy in the management of acute and subacute limb-threatening ischemia. J Vasc Interv Radiol. 2001;12(4):413-421.
Cohen DJ, Ramee S, Baim DS, et al. Economic assessment of rheolytic thrombectomy versus intracoronary urokinase for treatment of extensive intracoronary thrombus: Results from a randomized clinical trial. Am Heart J. 2001;142(4):648-656.
Singh M, Tiede DJ, Mathew V, et al. Rheolytic thrombectomy with Angiojet in thrombus-containing lesions. Catheter Cardiovasc Interv. 2002;56(1):1-7.
Ansel GM, George BS, Botti CF, et al. Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry. J Endovasc Ther. 2002;9(4):395-402.
Rinfret S, Katsiyiannis PT, Ho KK, et al. Effectiveness of rheolytic coronary thrombectomy with the AngioJet catheter. Am J Cardiol. 2002;90(5):470-476.
Koning R, Cribier A, Gerber L, A new treatment for severe pulmonary embolism: Percutaneous rheolytic thrombectomy. Circulation. 1997;96(8):2498-2500.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Transvenous (Catheter) Pulmonary Embolectomy (240.6). Medicare Coverage Database. Baltimore, MD: CMS; undated.
Schneider RJ, Ntimba FJ, Hourizadeh A, et al. Massive pulmonary embolism: A comparison of radiological and clinical characteristics and outcomes. Emerg Radiol. 2002;9(2):79-81.
Zeni PT Jr, Blank BG, Peeler DW. Use of rheolytic thrombectomy in treatment of acute massive pulmonary embolism. J Vasc Interv Radiol. 2003;14(12):1511-1515.
Suarez JA, Meyerrose GE, Phisitkul S, et al. Review of catheter thrombectomy devices. Cardiology. 2004;102(1):11-15.
Blaustein HS, Schur I, Shapiro JM. Acute massive pulmonary embolism in a Jehovah’s Witness: Successful treatment with catheter thrombectomy. Chest. 2000; 117:594-597.
Voigtlander T, Rupprecht H-J, Nowak B, et al. Clinical application of a new rheolytic thrombectomy catheter system for massive pulmonary embolism. Cathet Cardiovasc Intervent. 1999; 47:91-96.
Biederer J, Schoene A, Reuter M, et al. Suspected pulmonary artery disruption after transvenous pulmonary embolectomy using a hydrodynamic thrombectomy device: Clinical case and experimental study on porcine lung explants. J Endovasc Therapy. 2003; 10:99-110.
Sternbergh WC 3rd, Ramee SR, DeVun DA, Money SR. Endovascular treatment of multiple visceral artery paradoxical emboli with mechanical and pharmacological thrombolysis. J Endovasc Ther. 2000;7(2):155-160.
Margheri M, Falai M, Vittori G, et al. Safety and efficacy of the AngioJet in patients with acute myocardial infarction: Results from the Florence Appraisal Study of Rheolytic Thrombectomy (FAST). J Invasive Cardiol. 2006;18(10):481-486.
De Luca G, Suryapranata H, Stone GW, et al. Adjunctive mechanical devices to prevent distal embolization in patients undergoing mechanical revascularization for acute myocardial infarction: A meta-analysis of randomized trials. Am Heart J. 2007;153(3):343-353.
De Rosa S, Cirillo P, De Luca G, et al. Rheolytic thrombectomy during percutaneous coronary intervention improves long-term outcome in high-risk patients with acute myocardial infarction. J Interv Cardiol. 2007;20(4):292-298.
Chauhan MS, Kawamura A. Percutaneous rheolytic thrombectomy for large pulmonary embolism: A promising treatment option. Catheter Cardiovasc Interv. 2007;70(1):121-128.
Menon SC, Hagler DJ, Cetta F, Cabalka AK. Rheolytic mechanical thrombectomy for pulmonary artery thrombus in children with complex cyanotic congenital heart disease. Catheter Cardiovasc Interv. 2008;71(2):237-243.
Arzamendi D, Bilodeau L, Ibrahim R, et al. Role of rheolytic thrombectomy in massive pulmonary embolism with contraindication to systemic thrombolytic therapy. EuroIntervention. 2010;5(6):716-721.
Todoran TM, Sobieszczyk P. Catheter-based therapies for massive pulmonary embolism. Prog Cardiovasc Dis. 2010;52(5):429-437.
Migliorini A, Stabile A, Rodriguez AE, et al JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010;56(16):1298-1306.
Barbieri A, Bertelli L, Sangiorgi GM. Novel application of Angiojet rheolytic thrombectomy for massive thrombosis of the native aortic valve and Jarvick 2000 ventricular assist device in a patient with end-stage heart failure. Catheter Cardiovasc Interv. 2011;78(6):958-961.
Dashti SR, Hu YC, Yao T, et al. Mechanical thrombectomy as first-line treatment for venous sinus thrombosis: Technical considerations and preliminary results using the AngioJet device. J Neurointerv Surg. 2011 Dec 5. [Epub ahead of print].
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.