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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 3  |  Issue : 3  |  Page : 71-75

Clinical efficacy of AngioJet™ mechanical thrombectomy for the treatment of acute lower extremity arterial embolism and thrombosis


Department of Vascular Surgery, People's Hospital in Gansu Province, Gansu, China

Date of Submission28-May-2020
Date of Decision12-Jun-2020
Date of Acceptance20-Jun-2020
Date of Web Publication26-Aug-2020

Correspondence Address:
Dr. Quan Chen
Department of Vascular Surgery, People's Hospital in Gansu Province, Gansu 730000
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/VIT.VIT_15_20

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  Abstract 


PURPOSE: This study aimed to evaluate the clinical efficacy of mechanical thrombectomy using the AngioJet™ System for the treatment of lower extremity acute arterial embolism and thrombosis.
METHODS: A total of twenty patients who had acute arterial embolism and thrombosis of the lower extremity were recruited. All patients were treated using the AngioJet mechanical thrombectomy system. Clinical data of the patients were retrospectively collected. The clinical efficacy of thrombectomy was analyzed.
RESULTS: Eighteen (90%) of the twenty patients successfully completed the mechanical thrombectomy using the AngioJet system. The mean time for hospital stay and operation was 4.2 ± 1.4 days and 1.31 ± 0.41 h, respectively. The average doses of urokinase and heparin during operation were 358,000 ± 123,000 U and 45.10 ± 8.30 mg, respectively. Two patients received a complementary treatment of incision for removing the thrombus. Two patients received catheter-directed thrombolysis (CDT) after the mechanical thrombectomy. Five patients received bare-metal stent implantation after balloon expansion. According to the Cooley standard, ten patients were in excellent conditions, six in good conditions, two in fair conditions, and two in poor conditions. No severe bleeding or renal function impairment was observed.
CONCLUSION: The AngioJet mechanical thrombectomy system is safe and effective. Combined with the use of CDT and stent implantation, the AngioJet system could lead to quick recoveries of the perfusion of the lower extremity and improve the limb salvage rates, exhibiting excellent clinical values.

Keywords: Acute lower extremity artery embolism, AngioJet™ thrombectomy system, stent implantation, thrombosis


How to cite this article:
Niu Q, Chen Q, Wen S, Li A, Dong F, Shi H, Sun W. Clinical efficacy of AngioJet™ mechanical thrombectomy for the treatment of acute lower extremity arterial embolism and thrombosis. Vasc Invest Ther 2020;3:71-5

How to cite this URL:
Niu Q, Chen Q, Wen S, Li A, Dong F, Shi H, Sun W. Clinical efficacy of AngioJet™ mechanical thrombectomy for the treatment of acute lower extremity arterial embolism and thrombosis. Vasc Invest Ther [serial online] 2020 [cited 2020 Oct 22];3:71-5. Available from: https://www.vitonline.org/text.asp?2020/3/3/71/293522




  Introduction Top


Acute lower extremity arterial embolism and thrombosis refers to the sudden narrowing or occlusion of the lumen of the lower extremity due to various causes of the lumen within a short time. It causes limb insufficiency and circulatory disorders that endanger the limbs of patients. The amputation rate and mortality rate in these patients are reported to range approximately from 10% to 30% and from 15% to 20%, respectively. Embolism is usually derived from the detachment of the heart and aortic thrombus. Thrombosis is often secondary to arterial stenosis or surgical intervention. The current treatment mainly includes Fogarty balloon catheter embolectomy and catheter-directed thrombolysis (CDT). The complications of Fogarty balloon catheter embolectomy include surgical trauma to the vessel wall and severe ischemia–reperfusion injury. The CDT requires prolonged time for thrombolysis and bedtime for recovery, which may adversely affect the quality lives of patients.[1],[2],[3] The AngioJet™ thrombectomy system is a novel fluid mechanics-based vascular intervention therapy. This system has been increasingly recognized and used by clinicians due to its safety and high efficiency. In this study, twenty patients who had acute arterial embolism and thrombosis of the lower extremity were recruited in our hospital. All the participants were eligible to receive treatment using the AngioJet system and were willing to be followed after the procedure. The clinical efficacy of AngioJet mechanical thrombectomy was evaluated.


  Methods Top


Study subjects

We recruited twenty patients (12 males and 8 females) who visited the Department of Vascular Surgery of the People's Hospital in Gansu Province and were diagnosed as having acute arterial embolism and thrombosis of the lower extremity between September 2017 and March 2019. The average age of the patients was 63.6 ± 10.8 years (range: 45–83 years). Among them, 13 patients had left-sided disease. The onset of disease ranged from 6 h to 72 h. The diagnosis of each patient was confirmed by preoperation color Duplex ultrasonography or computed tomography (CT) angiography of the lower extremity artery. The symptoms of the patients included acute pain of lower extremity, paralysis, pallor, paresthesia, and pulselessness. The comorbidities included atrial fibrillation (three patients), rheumatic heart disease (one patient), coronary heart disease (five patients), hypertension (13 patients), and diabetes mellitus (ten patients). The ankle-brachial index (ABI) was 0 for 14 cases, 0.1 for 4 cases, and 0.2 for 2 cases.

Operation procedure

AngioJet mechanical thrombus aspiration was performed on all patients enrolled during this study. AngioJet machine equipment and its supporting catheter assembly manufactured by Boston Scientific were used as the main equipment for treatment. CT angiography was used for intraoperative monitoring. If the operation could not effectively remove the thrombus, the patients then received complementary treatments, such as incision for removing the thrombus, CDT, or bare-metal stent implantation.

Mechanical thrombectomy using the AngioJet system

After successful local anesthesia with 2% lidocaine in all patients, femoral artery retrograde puncture was performed. The pigtail catheter was placed on the abdominal aorta to confirm the patency of the abdominal aorta and the bilateral iliac and femoral arteries. In order to determine the area and extent of occlusions of the affected limb, a 6 Fr catheter in combination with a guidewire was introduced from the lower femoral aorta of the unaffected side into the affected side. The catheter crossed the occlusion and reached the extremity of vascular cavity, and then was exchanged with a guidewire for an AngioJet catheter for mechanical thrombectomy. Specially, the procedure of thrombectomy includes: (1) switch on the AngioJet device, connect the catheter with the system, and flush the catheter following instructions; (2) set the Jet mode, jet 100 ml saline containing 250,000 U urokinase, and then wait for 20 min; and (3) introduce the catheter along with the guidewire to the occlusion site. The aspiration starts when the catheter is approximately 1 cm close to the occlusion, and at a speed of 2 mm/s. If postthrombectomy angiogram demonstrated that there were residual thrombi, thrombectomy was performed repeatedly, but the duration of the whole procedure was normally <480 s.

Angioplasty

For some patients with a long history of arterial occlusions, it is possible that the mechanical thrombectomy can only partially remove the thrombi. In these cases, repeatedly performing mechanical thrombectomy may cause injury to the vessels of these patients and thus is not recommended. Therefore, we conducted complementary treatments in these patients by (1) incising the artery to remove the thrombi, which was performed in two (10%) of the twenty patients with an unfavorable imaging of the extremity of vessel and (2) performing CDT with 60,000 U urokinase for 1–2 days, which was conducted in two (10%) patients with residual thrombi. The effect of thrombolysis was evaluated again after all of these procedures were completed. If the results of angiogram showed that the remaining stenosis of the vessels was still >50% (unrelated to thrombi), balloon expansion and/or stent implantation was then conducted.

Complications

The most frequently observed complication after the use of the AngioJet device is impaired renal function due to hemolysis-induced red blood cell fragmentation. In our study, intraoperative or postoperative hemoglobinuria was detected in 16 (80%) patients. The color of urine returned to normal within 24 h post operation. When the duration of procedure was <480 s, alkalized urine and hemoglobinuria disappeared within 1–3 days after the operation. However, in patients with abnormal renal functions, renal function may further deteriorate and thus needs to be closely monitored.

Postoperative treatments

At the end of the operation, drug treatment was selected according to the patient's specific condition. For instance, patients with atrial fibrillation were treated with warfarin or rivaroxaban anticoagulation therapy. The international standardized ratio of oral warfarin patients was between 2 and 3; patients with rheumatic heart diseases were transferred to surgery departments for the treatment of primary heart diseases; and some patients took clopidogrel sulfate or bayaspirin orally for 3 months, and then continued to take bayaspirin for antiplatelet therapy.

Clinical efficiency

Successful mechanical thrombectomy was defined from both technical and clinical aspects. The technical success was defined as the complete revascularization of the acutely occluded vessel or restoration of >70% blood flow in the occluded arterial lumen, restoration of distal artery pulses, as well as relief/elimination of symptoms related to arterial ischemia.[4] The clinical success was defined as the relief of clinical symptoms such as limb pain, paralysis, pallor, paresthesia, pulselessness, and improvement of postoperation ABI (>0.6) in the lower extremity artery.

The Cooley standard was used for evaluating the outcomes of the treatment of arterial embolism. The outcome was rated excellent, good, fair, or poor as follows: excellent – the distal pulse recovered to normal without muscle or skin necrosis and dyskinesia; good – the symptoms disappeared but distal pulse recovery was relatively weaker than contralateral pulses; fair – distal limb blood supply partially restored and was able to compensate; and poor – distal limb arteries could not be compensated collaterally, and ischemia, amputation, and death were observed.[5]

Follow-up

The patients were followed in 1 month, 3 months, 6 months, and 12 months after operation. During each follow-up, the clinical symptoms and signs of the patients were evaluated and recorded, ABI was calculated, and Duplex ultrasonography of the lower extremity artery was performed.

Statistical analysis

SPSS version 18.0 (IBM Crop. Armonk, New York, US) was used for statistical analyses. The mean ± standard deviation was used to describe continuous variables and n (%) to describe categorical variables.


  Results Top


Thrombectomy and clinical efficacy

Mechanical thrombectomy with the AngioJet system was performed in the twenty enrolled patients. The mean time for hospital stay and operation was 4.2 ± 1.4 days and 1.31 ± 0.41 h, respectively. The average doses of urokinase and heparin during operation were 358,000 ± 123,000 U and 45.10 ± 8.30 mg, respectively. The operation was successfully completed in 18 (90%) patients. The other two (10%) patients received incision to remove the thrombus. Two (10%) patients received CDT (24 h and 48 h) because postthrombectomy angiogram demonstrated residual thrombi. Five (25%) patients received bare-metal stent implantation after balloon expansion because postoperation angiogram still showed a >50% stenosis in the iliac and femoral arteries. The clinical efficacy after the treatments was evaluated according to the Cooley standard: ten (50%) patients were in excellent conditions, six (30%) in good conditions, two (10%) in fair conditions, and two (10%) in poor conditions. During the operation, there were two (10%) patients with distal arterial embolization, two (10%) patients with bradycardia and precordial discomfort, and four (20%) patients with bleeding in the puncture site. No severe bleeding in the gastrointestinal tract or intracranial area was observed. Sixteen (80%) patients had hemoglobinuria during or after the operation. The color of urine returned to normal within 24 h after the operation. The decrease in hemoglobin was detected in all the patients, with the average level of 6.6 ± 2.3 g/L.

Patient follow-up

The average follow-up time for the twenty patients was 8.6 ± 3.8 m (range 6–12 m). During the follow-up, ultrasonography did not identify any occlusion in the arteries of 15 (75%) patients. One (5%) patient died from myocardial infarction (MI) in 9 months after the operation. Lower extremity ischemia re-occurred in two (10%) patients who then received endovascular intervention again. Two (10%) patients had lower extremity ulcer due to lower extremity ischemia. No lower extremity necrosis, amputation, or death was reported in other patients.


  Discussion Top


As the aging of China's population continues to increase, the incidence of acute arterial embolism and thrombosis continues to increase. Atherosclerosis-caused stenosis of luminal thrombosis, detachment of platelet thrombus attached to plaque, and detachment of thrombus from the ventricular wall after MI are among the common causes of arterial embolism in recent years. The disease is characterized by acute onset, rapid development, more complications, and poor prognosis. Patients exhibit the “6 Ps” symptoms including pain, pallor, pulselessness, paresthesia, paralysis, and poikilothermia.[1],[6] Therefore, once the diagnosis is clear, surgical treatment should be performed as soon as possible. It is generally considered that it is best to perform the surgery within 6–8 h of diagnosis. It is critical to restore the blood supply to the distal part of the ischemic limb as soon as possible.

The success rate of thrombectomy was significantly improved after Fogarty balloon catheter was introduced in 1963. However, Fogarty catheter has several disadvantages including impairment to arterial endothelium during operation and lack of effective intervention to potential lesions. The current use of Fogarty embolectomy focuses on treating occlusions at femoral–popliteal artery level or above, treating the thrombi from rheumatic heart disease and atrial fibrillation, as well as treating the arterial thrombi in patients without potential arterial diseases. In recent years, CDT has been increasingly used as an alternative endovascular treatment. CDT reduces damages to the arterial endothelium, dissolves thrombus in the trunk and branches of blood vessels, and detects and treats potential arterial stenotic lesions, thus leading to higher success rate of thrombectomy. Due to its efficacy and safety, CDT has been widely used in clinics, especially when the occlusions occur at popliteal artery level or below. Nevertheless, CDT also has limitations. For example, CDT is unable to improve limb salvage rate and restore circulation. If severe thrombi could not be removed in short time and the circulation could not be restored quickly, patients may develop limb ischemic necrosis, amputation, and even death.[2],[7],[8]

The AngioJet system was developed for mechanical thrombectomy and has been used in the clinics in recent years. The mechanism of the device is based on the so-called Bernoulli Effect, that is, pressurized saline jets travel backward to create a low pressure zone, causing a vacuum effect, and then the thrombus which has been loosen by the saline is drawn into the catheter where it is fragmented by the jets and evacuated from the body through the catheter. The procedure including saline jet and thrombus fragmentation is determined according to the patients' condition, in order to achieve the optimal efficacy of treatments.[9],[10] Mechanical thrombectomy with the AngioJet System shortens the time of hospital stay (the average time was 4.2 ± 1.4 days in our study), lowers the dosage of urokinase for thrombolysis, reduces complications, and costs less.

The results of our study showed that compared to traditional CDT, the AngioJet system delivered the medicine under a jet mode, which increased the area covered by the medicine, improved the efficacy, and reduced the dosage of urokinase (250,000–500,000 U in mechanical thrombectomy vs. 358,000 ± 123,000 U in CDT). Therefore, mechanical thrombectomy ensures local plasma drug concentration, but avoids the complications from systemic administration of thrombolytic drugs. In this study, the success rate of the AngioJet thrombectomy reached 90%. The average time for operation was 1.31 ± 0.41 h. The time for reperfusion in mechanical thrombectomy was significantly shorter than that in CDT. Moreover, the symptoms related to lower extremity ischemia were improved. The quick restoration of circulation and the increased limb salvage rate further demonstrated the clinical efficacy of this method.

If patients with lower extremity occlusion have relatively fresh thrombus, the AngioJet system could provide satisfactory treatment outcomes by quickly aspirating the thrombus from the vessel, improving the circulation of the affected limbs, and ameliorating the extent of limb ischemia. The majority of patients with arterial embolus have normal peripheral arteries. The AngioJet system could also be successfully applied in these patients; however, the emboli are hard to be fragmented and could only be partly evacuated. Therefore, the treatment efficacy is satisfactory in patients with fresh emboli, but not in those with old emboli. The Fogarty catheter embolectomy may be a better choice for patients with arterial embolus. Mechanical thrombectomy can be used when the stenosis is caused by fresh thrombus, and if it has no effect, CDT is used alternatively. If the stenosis is caused by atherosclerosis or old thrombi, balloon expansion and stent implantation can be used when the remaining stenosis after thrombolysis is >50% or the blood flow significantly slows down. In the current study, two (10%) patients received incision for removing the thrombi due to detection of neoplasm, two (10%) patients received CDT (24 h and 48 h) because postthrombectomy angiogram demonstrated residual thrombi, and five (25%) patients received balloon expansion and bare-metal stent implantation because postoperation angiogram showed a > 50% stenosis in the iliac and femoral arteries. If the patients had obliterating atherosclerosis, balloon expansion and stent implantation will also need to be performed after thrombolysis. Although the AngioJet system has advantages in the aspiration and lysis of thrombus, the clinical efficacy could be further improved if mechanical thrombectomy is used in combination of traditional CDT and stent placement.[11]

The AngioJet thrombectomy system also has inherent limitations. In our study, two patients had distal arterial embolization due to the fragments of thrombus. The patients' clinical symptoms improved after conducting CDT and administration of alprostadil. The specific complications of use of the AngioJet device include hemolysis due to high-speed jet flow and mechanical injury by the catheter. When the free hemoglobin levels exceeded renal threshold, hemoglobinuria was visible. In our study, hemoglobinuria was visible in 16 (80%) patients during or after mechanical thrombectomy. The color of urine returned to normal within 24 h after operation. Previous studies reported the case of renal failure after mechanical thrombectomy using the AngioJet device.[12] Therefore, it is of vital importance to enhance diuresis by drinking a large amount of water and alkalinize urine during the perioperative period.


  Conclusion Top


Collectively, mechanical thrombectomy using the AngioJet system is safe and effective for treating acute arterial embolism and thrombosis of the lower extremity. Compared to traditional CDT, it can quickly restore circulation, halt disease progression, and increase limb salvage rate, thus having the potential of large-scale clinical application. Although the short-term follow-up in the present study demonstrated satisfactory treatment efficacy, prospective studies with large sample sizes and longer follow-up are warranted to provide additional comparative data to validate our findings.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Galanakis N, Kontopodis N, Peteinarakis I, Kehagias E, Ioannou CV, Tsetis D. Direct stenting in patients with acute lower limb arterial occlusions: Immediate and long-term results. Cardiovasc Intervent Radiol 2017;40:192-201.  Back to cited text no. 1
    
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Zhang L, Lu QS, Pei YF, Wang HF, Yuan LX, Wei XL, et al. Experience of AngioJet mechanical thrombectomy treatment on acute arterial embolism. Chin J Vasc Surg (Electron Version) 2016,8:203-7.  Back to cited text no. 2
    
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Gerhard-Herman MD, Gornik HL, Barrett C, Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the management of patients with lower extremity peripheral artery disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Am Coll Cardiol 2017;69:e71-126.  Back to cited text no. 3
    
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Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, et al. Endovascular management of deep vein thrombosis with rheolytic thrombectomy(final report of the prospective multicenter PEARL (peripheral use of AngioJet rheolytic thrombectomy with a variety of catheter lengths) registry. J Vasc Interv Radiol 2015;26:777-85.  Back to cited text no. 11
    
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Dukkipati R, Yang EH, Adler S, Vintch J. Acute kidney injury caused by intravascular hemolysis after mechanical thrombectomy. Nat Clin Pract Nephrol 2009;5:112-6.  Back to cited text no. 12
    




 

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