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Percutaneous Thrombectomy with the JETi8 Peripheral Thrombectomy System for the Treatment of Deep Vein Thrombosis
CLINICAL STUDY
Percutaneous Thrombectomy with the JETi8 Peripheral Thrombectomy System for the Treatment of Deep Vein Thrombosis Jean Cournoyer-Rodrigue, MD, The-Bao Bui, MD, Patrick Gilbert, MD, Gilles Soulez, MD, MSc, Pierre Perreault, MD, Louis Bouchard, MD, Vincent L. Oliva, MD, Marie-France Giroux, MD, and Eric Therasse, MD ABSTRACT Purpose: This study evaluated the safety and efficacy of the JETi8 peripheral thrombectomy system in treating acute deep vein thrombosis (DVT). Materials and Methods: A retrospective study was conducted in 18 consecutive patients (mean age, 41 years old [range, 15-74 years old]; 5 men and 13 women). There were 21 instances of DVTs (9 iliofemoral, 10 axillosubclavian, and 2 portal), which were treated using the JETi8 thrombectomy device between November 2016 and July 2018. Thrombus was laced with recombinant tissue plasminogen activator (r-TPA) (9.3 mg, on average; range, 2–12 mg) in 17 procedures (81%) prior to thrombectomy. Technical success was defined as restoration of antegrade flow using the JETi8 with or without additional treatment of an underlying obstructive lesion. Procedural success was defined as technical success with or without the addition of overnight catheter-directed thrombolysis (CDT) Results: Mean procedure time was 83 minutes (range, 30–160 minutes), and mean thrombus reduction with the JETi8 alone was 92% (range, 60%–100%). Stent placement was required in 6 procedures (29%). Technical success using the JETi8 system alone was 76% (16 of 21 procedures), whereas 5 procedures (24%) required subsequent overnight CDT in the intensive care unit. Procedural success rate was 100% (20 of 20 procedures). Mean aspirated volume was 531 mL (range, 250–1,230 mL). The only adverse event was a subsegmental pulmonary embolism. Seven patients (33%) were discharged the same day. Recurrent thrombosis was observed in 5 patients (24%), of whom 3 were successfully treated with the JETi8 system. Conclusions: The JETi8 system may be a safe and effective option for thrombectomy of acute DVT.
ABBREVIATIONS CDT ¼ catheter-directed thrombolysis, DVT ¼ deep vein thrombosis, r-TPA ¼ recombinant tissue plasminogen activator
Endovascular DVT treatments such as catheter-directed thrombolysis (CDT), mechanical thrombectomy, and pharmacomechanical thrombectomy have gained significant From the Department of Radiology (J.C-R., P.G., G.S., P.P. L.B., V.L.O., M-F.G., de Montre al, Montreal, Quebec, E.T.), Centre Hospitalier de l’Universite Canada; Department of Radiology (T-B.B.), Centre Hospitalier de l’Universite ^pital Fleurimont (CHUS), Sherbrooke, Que bec, Canada; and de Sherbrooke, Ho Centre de recherche (G.S., E.T.), CHUM, Pavillon R, 900 rue Saint-Denis, al, Que bec, Canada, H2X 0A9. Received June 16, 2019; final revision Montre received October 12, 2019; accepted October 15, 2019. Address correspondence to E.T.; E-mail: [email protected] None of the authors have identified a conflict of interest. Figures E1 and E2 can be found by accessing the online version of this article on www.jvir.org and clicking on the Supplemental Material tab. © SIR, 2019 J Vasc Interv Radiol 2019; ▪:1–10 https://doi.org/10.1016/j.jvir.2019.10.022
interest as the treatment of choice for DVT in the last decade (1–5). Many studies have highlighted the benefits of clot removal in long-term outcomes in specific clinical settings compared to anticoagulation alone. Among these studies, the recent prospective multicenter PEARLII (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths; NCT01086215) study demonstrated the potential of reducing concomitant CDT and the intensive care unit stay by using a thrombectomy device (2–4,6–10). In comparison with CDT, mechanical and pharmacomechanical thrombectomy devices can accelerate thrombus removal, which may lead to same-day patient discharge, making overnight observation in the intensive care unit obsolete, thus resulting in important cost savings (5,11–13). The JETi8 thrombectomy system (Walk Vascular, Irvine, California), a thrombectomy device that combines clot fragmentation with catheter aspiration, received US Food and Drug Administration (FDA) 510K clearance in October
2 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Cournoyer-Rodrigue et al ▪ JVIR
2016 as a device intended to remove or aspirate fluid and break up soft emboli and thrombi from coronary and peripheral systems. This device does not have any specific FDA approvals for the treatment of iliofemoral, axillosubclavian, or portal vein thrombosis. Experience with the JETi8 system is sparse; only a single study has been published so far. Furthermore, that study described the use of a smaller version of the JETi8 device (the ClearLumen II peripheral thrombectomy system; Walk Vascular) as adjunctive therapy in a case of primary percutaneous coronary intervention (14). There is no hemolysis reported with the use of the JETi8 system, which could lead to no time restriction for the use of this device, in contrast to other rheolytic catheters (15). The purpose of this study was to evaluate the safety and efficacy of the JETi8 thrombectomy system in treating acute DVT.
MATERIALS AND METHODS Study Design This retrospective study was approved by the institutional review board of 2 general university medical centers, which waived informed consent from the patients. Inclusion criteria consisted of all consecutive patients who were treated with the JETi8 system for acute venous thrombosis (11 patients from Centre Hospitalier de l’Universite de Montreal and 7 patients from Centre Hospitalier de l’Universite de Sherbrooke) between November 2016 and July 2018. Exclusion criteria were patients with chronic DVT and those with acute DVT treated with another mechanical thrombectomy device. Patients with chronic DVT were excluded based on their clinical history and thrombus appearance on Doppler ultrasonography. One case of pulmonary artery embolism and 1 case of acute chronic iliofemoral thrombus treated with the JETi8 system were excluded. Of the 146 thrombolysis and thrombectomy procedures performed since JETi8 was made available in the participating centers in October 2016, 21 percutaneous venous catheter thrombectomies were undertaken using the JETi8 system in 18 patients (Fig 1). Procedures included 10 axillosubclavian, 9 iliofemoral, and 2 portal vein thromboses. Selection of the JETi8 system or other thrombectomy devices for venous thrombectomy was based mostly on the radiologist’s individual preference and experience with the device. Axillosubclavian and iliofemoral vein thromboses were diagnosed using Doppler ultrasonography, whereas portal vein thrombosis was diagnosed using Doppler ultrasonography and contrast-enhanced computed tomography (CT).
Thrombectomy Technique All cases were performed or supervised by interventional radiologists with 10–28 years of endovascular practice who had no prior experience with the JETi8 system and used techniques they had learned by using other thrombectomy catheters.
Figure 1. Flow chart demonstrating inclusion and exclusion of patients.
The JETi8 system is a single-lumen open-end catheter with a pressurized saline jet located inside the tip of the catheter. The jet fragments the thrombus to help clot aspiration through the catheter. This device does not maintain an isovolumetric balance between the amount of injected saline and the aspirated volume. All procedures were performed with the patient under conscious sedation and local anesthesia. Venous accesses were achieved under ultrasonographic guidance using micropuncture sets. For iliofemoral vein thrombectomy, the lesser saphenous vein or the popliteal vein was accessed while the patient was in a prone position. For axillosubclavian vein thrombectomy, the brachial or a basilic vein was punctured at the junction between the middle and distal thirds of the arm. The portal vein was accessed through a right transhepatic percutaneous puncture. In all cases, venography was obtained by hand injection, given the slow flow associated with venous thrombosis. Following vascular access and venography, in 11 cases, an angled catheter, often a 5-F DAV catheter (Cook Medical Inc., Bloomington, Indiana) was introduced, without the use of a sheath, and thrombus lacing with recombinant tissue plasminogen activator (r-TPA) (most often 10-mg in 10 mL of sterile water) was performed manually. Use and dosage of r-TPA was applied at the interventionist’s discretion and was generally proportional to the amount of
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thrombus to be removed. Thrombus lacing was performed because interventional radiologists participating in this study had good experience with this technique in association with other thrombectomy devices, despite nonuniform rTPA dispersion throughout the entire clot. After thrombus lacing with r-TPA, the JETi8 catheter was inserted percutaneously into an 8-F introducer, most often through a curved guiding sheath (Adelante Breezeway, Oscor, Palm Harbor, Florida), which allowed the JETi8 to be directed during the thrombectomy procedure. Negative pressure was applied concomitantly in the system using either a Gomco pump (Allied Healthcare Product, St. Louis, Missouri) or, more frequently, a 60-mL locking syringe. The thrombectomy technique was the same for iliofemoral, axillosubclavian, and portal vein thromboses. The first thrombectomy pass was performed using the JETi8 activated while retrieving and rotating both the introducer and the JETi8 together with the tip of the JETi8 protruding 1 or 2 cm beyond the tip of the curved guiding sheath. The next passes were performed while the JETi8 was activated while pushing the device forward with the introducer, while rotating them together. Although the JETi8 was used over a 0.035-inch Bentson wire (Cook Medical) in the first few cases, thrombectomy was performed without any guidewire thereafter. After the occluded segment was crossed once or twice with the JETi8, completion venography was performed, and thrombectomy was repeated at sites of residual thrombus, as required, until either the thrombus was fully removed or only a negligible amount remained. In instances where the thrombectomy catheter was occluded, it was either retrieved to remove the obstructing clot or flushed in situ with saline before resuming thrombectomy. In all cases, once clot removal was considered satisfactory, balloon angioplasty of residual stenoses was performed. If the result remained unsatisfactory, stents were placed for iliofemoral and portal vein thromboses (self-expanding stents were used in all but 1 case). Stents were never placed in cases of axillosubclavian vein thrombosis. No inferior vena cava filter was placed during any of the procedures. Criteria for the use of overnight CDT in the intensive care unit included a persistent, hemodynamically significant obstructive thrombus after the thrombectomy attempt. Overnight CDT was performed with 1 mg/h of r-TPA for 24 hours followed by venography to assess patency and residual thrombus. The use of the JETi8 system was not constrained by time limits. Throughout the procedure, vital signs were monitored, and the amount of aspirated volume was recorded.
Variables Collected and Patient Follow-up Data were collected mainly from the Radiology Information System (RIS) and the Electronic Medical Record of the patients. Baseline demographics and patient information are presented in Table 1. Patients presented with typical symptoms of acute deep vein thrombosis, and no patient had limb-threatening deep venous
3
Table 1. Patients Baseline Characteristics Characteristic Mean age, y (range) Males (%) Females (%)
Value 41 (15–74) 5 (28) 13 (72)
Site of venous thrombosis (%) Iliofemoral vein Axillosubclavian vein Portal vein Underlying cause (%) Paget-Schrotter syndrome
9 (43) 10 (48) 2 (10) 9 (43)
Unknown
7 (33)
May-Thurner syndrome
3 (14)
Stent placement
1 (5)
Hepatic transplant
1 (5)
Risk factors (%) Previous DVT
2 (10)
Previous tobacco use Hypercoagulability
0 (0) 0 (0)
Oral contraceptive use
2 (10)
Immobilization
1 (5)
Current malignancy
0 (0)
Clinical presentation (%) Iliofemoral vein Edema
9 (100)
Pain Cramps
7 (78) 3 (33)
Discoloration
2 (22)
Axillosubclavian vein (%) Edema Pain
10 (100) 9 (90)
Portal vein (%) Ascites Duration of symptoms, d (range) Iliofemoral vein
2 (100) 3.6 (1–7)
Axillosubclavian vein
3.6 (1–7)
Portal vein
4.5 (2–7)
Overall
3.7 (1–7)
DVT ¼ deep vein thrombosis.
thrombosis. All patients were treated with anticoagulation following thrombectomy. Most patients were referred from other medical centers and were followed by their referring physicians. Therefore, the anticoagulation protocol was not standardized. Follow-up imaging information was retrieved from a centralized electronic databank. Clinical follow-up data were retrieved from the electronic medical record, and a telephone survey was also undertaken in September 2019 that included specific questions about clinical symptoms.
Variables Defined Technical success was defined as restoration of antegrade flow using the JETi8 system with or without additional
Case
Side
r-TPA (mg)
Procedure Time (min)
Aspirated Volume (mL)
PTA
Stent (Type, Size)
CDT
1
Left
10
160
No data
No
No
Yes
2
Left
10
65
1,230
Yes
No
No
3
Left
10
79
300
No
No
Yes
4
Right
2
95
No data
Yes
S.M.A.R.T. stent 12 mm 8 cm
5
Left
No dose
95
No data
Yes
No
6
Right
10
118
780
Yes
7
Left
10
160
No data
Yes
8
Left
0
60
700
No
9
Bilateral
0
90
800
No
6.5 (0–10)
102 (60–160)
762 (300–1,230)
5/9 (56)
Clot Reduction Using JETi8 Alone (%)
Technical Success (%)
Clot Reduction Using JETi8 D CDT (%)
Procedural Success (%)
60
No
No data*
NA*
100
Yes
No CDT
Yes
70
No
100
Yes
No
80
Yes
No CDT
Yes
Yes
60
No
90
Yes
Two S.M.A.R.T. stents 14 80 mm
No
100
Yes
No CDT
Yes
Two S.M.A.R.T. stents 14 60 mm No
No
100
Yes
No CDT
Yes
Yes
80
No
100
Yes
Yes
80
No
95
Yes
81 (60–100)
4/9 (44)
96 (80–100)
9/9 (100) *
Iliofemoral vein
Mean result (range) or yes proportion (%)
Epic stent 14 mm and Palmaz stent 20 mm 4/9 (44)
5/9 (56)
4 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Table 2. Procedure-Related Information
Axillosubclavian vein 1
Left
10
60
360
Yes
No
No
100
Yes
No CDT
Yes
2
Left
No dose
70
380
Yes
No
No
100
Yes
No CDT
Yes
Left
2
50
420
Yes
No
No
100
Yes
No CDT
Yes
4
Right
10
58
350
Yes
No
No
100
Yes
No CDT
Yes
5
Right
10
30
250
Yes
No
No
100
Yes
No CDT
Yes
6
Left
12
60
500
Yes
No
No
100
Yes
No CDT
Yes
7 8
Left Right
10 10
90 90
500 400
Yes No
No No
No No
100 100
Yes Yes
No CDT No CDT
Yes Yes
9
Right
10
60
400
Yes
No
No
100
Yes
No CDT
Yes
10
Right
12
45
600
Yes
No
No
100
Yes
No CDT
Yes
9.6 (2–12)
61 (30–90)
426 (250–600)
9/10 (90)
0/10 (0)
0/10 (0)
100
10/10 (100)
100
10/10 (100)
Mean result (range) or yes proportion (%)
continued
Cournoyer-Rodrigue et al ▪ JVIR
3
2/2 (100%) 530 0 Mean result (range) or yes proportion (%)
101 (90–111)
No No data 111 0 NA 2
5
CDT ¼ catheter-directed thrombolysis; Epic ¼ stent (Boston Scientific, Maple Grove, Minnesota); JETi8 ¼ thrombectomy system (Walk Vascular, Irvine, California); NA ¼ nonapplicable; Palmaz-Schatz ¼ balloon expandable stent (Cordis); PTA ¼ percutaneous transluminal angioplasty; r-TPA ¼ recombinant tissue plasminogen activator; S.M.A.R.T. ¼ stent (Cordis, Miami Lakes, Florida). *This case was excluded from the successful procedures because the control venogram was cancelled.
2/2 (100%) 100 0/2 (0%)
100
2/2 (100%)
Yes No CDT No
100
Yes
Yes No CDT Yes 0 NA 1
90
530
Yes
Portal vein S.M.A.R.T. stent 10 30 mm Two S.M.A.R.T. stents 12 40 mm and 12 30 mm 2/2 (100%)
No
100
Clot Reduction Using JETi8 D CDT (%) Aspirated Volume (mL) Procedure Time (min) r-TPA (mg) Side Case
Table 2. Procedure-Related Information (continued)
PTA
Stent (Type, Size)
CDT
Clot Reduction Using JETi8 Alone (%)
Technical Success (%)
Procedural Success (%)
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treatment of an underlying obstructive lesion. Procedural success was defined as technical success with or without the addition of overnight CDT. Device success was defined as technical success with the absence of any major adverse event related to it. Minor and major complications were classified according to Journal standards and guidelines (16). Two interventional radiologists estimated the percentage of thrombus removal by subjective visual observation in comparison with initial thrombus load on completion venography at the end of the intervention and after CDT, for cases requiring overnight CDT. The duration of the procedure was defined as the time between venous access and the end of the thrombectomy session. Continuous variables were displayed by using means and ranges, whereas categorical variables were tabulated using frequency distributions.
RESULTS Procedural data for each patient can be found in Table 2, and clinical and follow-up outcome data are listed in Table 3. The mean time between the onset of symptoms and intervention was 3.7 days (range, 1–7 days). All patients included in this study had symptoms for less than 14 days. Thrombus lacing was performed in 17 procedures (81%) prior to thrombectomy, with an average of 9.3 mg of r-TPA (range, 0–12 mg). No thrombus lacing was done in either of the portal vein cases because of the higher risk of bleeding complication and, in 2 cases of iliofemoral vein thrombosis, because the thrombus load was considered limited. Balloon angioplasty was required in 15 procedures (71%) for residual stenosis at the thrombus site, whereas 6 procedures (29%) required stent placement for persistent stenosis. Mean aspiration volume using the JETi8 system was 531 mL (range, 250–1,230 mL), including blood diluted with saline as well as aspirated fragmented thrombi collected in the suction container. The amount of saline injected was not recorded, and it is impossible to know the proportion of blood and saline in the aspirated volume. Despite this, no patients experienced hypotension during the procedure, and no transfusions were required. Mean procedure time for all patients was 83 minutes (range, 30–160 minutes), including the prethrombectomy lacing of the thrombus with r-TPA and a 20- to 30-minute delay before thrombectomy due to the JETi8 system. Overall mean thrombus removal was 92% (range, 60%– 100%) with the use of the JETi8 system only. Technical success was obtained in 76% (16 of 21 procedures) (Fig 2, Fig E1 [available online on the article’s Supplemental Material page at www.jvir.org]). In 5 procedures (24%) thrombi removal was considered insufficient using the JETi8 alone. Insufficient thrombectomy occurred essentially in iliofemoral vein thrombosis cases. These 5 procedures were all subsequently followed by overnight CDT in the intensive care unit. Mean thrombus removal after overnight CDT was 98% (range, 80%–100%). Four of the 5 technical failures after thrombectomy alone were considered
Case
Hospitalization
Recurrence (d)
Length (d)
Same-Day Discharge
1
1
No
No
2
1
No
No
3
1
No
4
0
5
1
Additional Intervention
Imaging Follow-up
Clinical Follow-up
Duration, Modality, Results
Duration
Symptoms
No
No data
No data
No data
No
No data
31 mo
VS ¼ 0
No
No
No data
30 mo
VS ¼ 0
Yes
No
No
No data
No data
No data
No
Yes (5 d)
No
21 mo
VS ¼ 6
5 d, CT, common iliac vein thrombosis 1 mo, Doppler, no lesion
6
0
Yes
No
No
1 mo
VS ¼ 0
7
0
Yes
No
No
No data
13 mo
VS ¼ 0
8
3
No
No
No
No data
14 mo
VS ¼ 0
9
7
No
No
No
2 mo, CT, no lesion
No data
No data
1.6 (0–7)
3/9 (33)
1 (11)
1/9 (11)
NA
18 mo (1–31)
NA
1
0
Yes
No
FRR and subclavian PTA
3.5 mo, phlebography, no lesion
30 mo
Mild pain during exercise
2
0
Yes
Yes (10 d)
JETi8 thrombectomy
10 d, phlebography, axillosubclavian thrombosis
10 d
Upper extremity pain and edema
3
0
Yes
Yes (2 d)
No
11 mo, phlebography, chronic axillary vein thrombosis with collaterals
25 mo
Persistent pain, upper extremity edema and discoloration
4
0
Yes
No
FRR
3 mo, phlebography, no lesion
18 mo
Mild pain during exercise
5
3
No
No
No
11 mo, MR imaging, mild stenosis
31 mo
6
2
7
7
No
No
FRR
12 mo, phlebography, no lesion
27 mo
8
3
No
No
No
No data
23 mo
No symptom
9
5
No
No
No
22 mo
No symptom
2 2.2 (0–7)
No 4/10 (40)
No 3/10 (30)
FRR 6/9 (67)
No data NA
19 mo 20 mo (0–31)
No symptom NA
21
No
Yes (47 d)
No
1.5 mo, CT, complete portal vein thrombus occlusion
1.5 mo
Dyspnea, ascites, mild lower extremity edema
10 16 (10–21)
No 0/2 (0)
No 1/2 (50)
No 0/2 (0)
29 mo 15 mo (1.5–29)
No symptom NA
Mean results, % (range)
1 2 Mean results, % (range)
JETi8 thrombectomy
2 d, phlebography, axillosubclavian vein thrombosis
5 mo, MR imaging, no lesion
29 mo, CT, no lesion NA
FRR ¼ first rib resection; JETi8 ¼ thrombectomy system (Walk Vascular, Irvine, California); NA ¼ not applicable; VS ¼ Villalta score.
2d
No symptom Upper extremity pain and edema No symptom
Cournoyer-Rodrigue et al ▪ JVIR
10 Mean results, % (range)
Yes (2 d)
6 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Table 3. Clinical and Follow-up Outcomes
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Figure 2. Left iliofemoral vein thrombectomy with the JETi8. A 57-year-old female with a left leg plaster cast after Achilles tendon rupture presented with left leg swelling and calf induration over the previous 7 days. The venogram obtained in a prone position demonstrated an acute left (a) femoral and (b) iliac vein thrombosis. Venous access was performed through the gastrocnemius muscle vein, and the thrombus was laced with 10 mg of r-TPA. Thrombectomy was performed using the JETi8 20 minutes later through an 8-F introducer. Venogram of the (c) femoral and (d) iliac veins after thrombectomy and angioplasty of the femoral vein using a 10-mm angioplasty balloon show complete thrombus removal. Because there was no iliac vein compression, no stent was placed. The duration of the procedure was 65 minutes. The patient was placed on anticoagulation therapy with apixaban for 6 months. Doppler ultrasonography showed no thrombus recurrence 51 days later. At 30 months’ follow-up, the patient had mild superficial varicose veins but no symptoms.
successful after subsequent overnight CDT. In the fifth case, the patient developed an important headache in the intensive care unit, and CDT was stopped prematurely for suspicion of intracranial hemorrhage; however, no hemorrhage was found on the head CT. Lumbar puncture was negative for subarachnoid hemorrhage, and the headache resolved within 24 hours. Completion venography was cancelled in this patient, and venous patency could not be confirmed. Therefore, procedural success was 100% (20 of 20 procedures). Six patients (29%) had pre- and post-thrombectomy hemoglobin dosages (normal value, 12–16 g/dL), which showed an average decrease of 1.6 g/dL (range, 0.1–3.4 g/dL). No patient presented with macroscopic hemoglobinuria. Bilateral subsegmental pulmonary embolism was diagnosed in 1 patient on the day after the procedure, as demonstrated by pulmonary CT angiography following the onset of hypotension. The patient experienced dyspnea for the next 2 days and she was subsequently transferred to her referring center. There were no other major adverse events related to the use of the JETi8 system,; hence, device success was 76% (16 of 21 procedures). Mean length of hospitalization after thrombectomy was 3.0 days (range, 0–21 days), with 7 patients (33%) discharged the same day as the intervention. Recurrent thromboses were observed in 5 cases (24%), 3 of which were subsequently treated successfully by using the JETi8 system and were included in this study. One of these thromboses recurred again 2 days
after the second thrombectomy. Portal vein thrombus recurrence, diagnosed by CT angiography, occurred in a young cirrhotic patient who was receiving a therapeutic intravenous heparin regimen despite good angiographic results after stent placement (Fig 3). Three other recurrent thromboses, diagnosed by venography, occurred in a patient with Paget-Schroetter syndrome despite good angiographic results after thrombectomy (Fig 4, Fig E2 [available online on the article’s Supplemental Material page at www.jvir.org]). The fifth case was diagnosed by venography 5 days after thrombectomy for May-Thurner syndrome. Thirteen cases (62%) underwent imaging follow-up with a mean imaging follow-up duration of 6.6 months (2 days–29 months). Eight cases (62%) showed good patency at long-term follow-up; 4 cases (31%) had short-term thrombosis recurrence; and 1 case (8%) showed chronic thrombosis. Imaging follow-up data were not available in 8 cases (38%). Eighteen cases (86%) had clinical follow-up with a mean duration of 19.7 months (2 days–31 months). At long-term clinical followup, 11 of 18 cases (61%) were asymptomatic, whereas 7 of 18 cases (39%) cases experienced mild or moderate symptoms. No patient mentioned having severe symptoms.
DISCUSSION This study demonstrates that JETi8 can achieve successful venous thrombectomy without overnight CDT in most
8 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
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Figure 3. Thrombectomy of a portal vein thrombosis using the JETi8. A 20-year-old male with cystic fibrosis and cirrhosis presented with abdominal pain, ascites, and leukocytosis 5 days after receiving a liver transplant. A 9-F introducer was placed through a transhepatic right portal vein. No thrombus lacing or heparin perfusion was performed. (a) The venogram showed a thrombus limited to the main portal vein. Thrombectomy using the JETi8 was then performed, and (b) the venogram obtained after placement of a 10-mm selfexpandable stent (solid arrow) shows no remaining thrombus. (c) One week later, follow-up CT angiography demonstrated good patency of the main portal vein. Six weeks after thrombectomy (d), the venogram showed recurrent main portal vein thrombosis. (e) The venogram obtained after thrombectomy using the JETi8 (using the same technique described above) and placement of an additional 12mm self-expanding stent more distally (arrowheads) demonstrated complete recanalization of the main portal vein. At 29 months, CT imaging showed continued main portal vein patency (not shown).
patients. The present report evaluated the performance of the JETi8 thrombectomy system for the treatment of acute DVT and included the results of the first patients treated with this device in the authors’ centers. Thrombus removal was complete in axillosubclavian and portal vein thrombosis, whereas all cases of partial thrombectomy occurred in cases of iliofemoral vein thrombosis. This might have been due to the greater amount of thrombus and larger vein diameters in iliofemoral vein thromboses in comparison with the other thrombectomy sites, explaining why all cases of CDT following thrombectomy were also present in iliofemoral cases. For all venous thrombectomy sites, only a minority of patients were discharged the same day as the thrombectomy was performed. This was due not only to the need for CDT in cases of partial iliofemoral thrombectomies but also due to other medical reasons associated with the DVT. In comparison to CDT, thrombectomy with the JETi8 system allowed for lesser hospitalization needs and decreased use of the intensive care unit, with important cost savings. However, larger prospective studies will be
required to assess whether these results could be replicated and how they compare with those using other thrombectomy devices. Despite complete thrombectomy in the axillosubclavian veins, thrombosis recurrences were more frequent than in iliofemoral vein thrombosis. This may be due to the underlying vein compression in Paget-Schroetter syndrome, which is generally not treated with stenting following thrombectomy, whereas in iliofemoral vein thrombosis, extrinsic compression is generally treated with stent insertion. Treatment of iliofemoral venous thrombosis with CDT can reduce early leg symptoms as well as the proportion of patients who develop moderate or severe post-thrombotic syndrome (17). CDT carries a significant risk of major bleeding (5), and there is a need for thrombectomy devices that could reduce the duration and the amount of pharmacological thrombolysis required to remove the thrombus. This study suggests that the JETi8 thrombectomy system has a technical success rate and thrombus reduction similar to those of the Angiojet rheolytic system (Boston Scientific, Maple Grove, Minnesota) (5,7,8,10,18,19). In the PEARLII
Volume ▪ ▪ Number ▪ ▪ Month ▪ 2019
9
Figure 4. Left iliofemoral vein thrombectomy using the JETi8 required overnight catheter-directed thrombolysis. A 17-year-old female presented with severe left leg swelling, skin discoloration, and pain that had started 4 days previously. (a) The venogram performed with the patient in a prone position using a 4-F catheter inserted through the popliteal vein demonstrated an acute left iliofemoral vein thrombosis. Thrombus was laced with 10 mg of r-TPA, and thrombectomy was performed 20 minutes later using the JETi8 catheter inserted through an 8-F introducer. (b) The venogram obtained after thrombectomy showed an important reduction in thrombus burden in the iliofemoral vein. A short, eccentric thrombus with 80% luminal narrowing of the distal inferior vena cava (solid arrow) and a 60% stenosis of the left common iliac vein remained after thrombectomy (arrowhead). (c) Distal inferior vena cava stenosis was dilated by using a 16-mm angioplasty balloon catheter. (d) The venogram after balloon angioplasty showed a 40% residual thrombus at the end of this 95-minute procedure. Given that good blood flow was present, no intravascular ultrasonography was performed, and no stent was placed at the iliocaval junction. The patient received anticoagulation therapy using enoxaparin for 6 months, but iliofemoral vein thrombosis recurred 5 days later. At 21 months’ follow-up, the patient presented with a mild post-thrombotic syndrome characterized mainly by moderate pain, cramps, and heaviness in the leg (Villalta score ¼ 6).
registry, 69% of patients had 100% clot retrieval in the group treated only with the Angiojet system, whereas 31% of them had a 50%–99% clot reduction (10). In the present study, the JETi8 thrombectomy system was able to remove an average of 92% of the thrombus, with a technical success rate of 86%. Procedural time range with the JETi8 was identical to those reported in other studies using other pharmacomechanical thrombectomy devices with the reported procedure time varying between 36 and 145 minutes with the Angiojet system (8,10,18,20). One of the main advantages of the JETi8 system is the absence of reported hemolysis associated with its use (19). This is important in patients with renal failure, and it also allows for thrombectomy procedures without activation time limitations. Although precautions can be undertaken to minimize the adverse effects of hemolysis, hemoglobinuria can potentially lead to acute renal failure and remains a concern with the use of the Angiojet system (10,15,21,22). Despite important blood volume aspirated using the JETi8 system in some of the present study patients, vital signs remained stable, and no patient required a blood transfusion. This may be partly explained by the fact that the aspirated volume is a mixture of fragmented clot, blood, and saline from the highly pressurized saline jet used for clot
fragmentation. Another possible explanation is the use of some volume replacement with saline during the procedure through a peripheral intravenous access and the side port of the guiding sheath. JETi8 is not an isovolumetric device and could potentially lead to significant blood loss, which may limit its use, especially in anemic patients. The aspiration volume should be monitored during every procedure to avoid hemodynamic complications. Small sample size and the retrospective nature of this report are the main limitations of this study. Despite these limitations, data from this study strongly suggest that JETi8 is effective for thrombectomy of acute DVT with large thrombus load. Lack of systematic and standardized patient follow-up due to referrals from peripheral centers is another limitation of this study, limiting long-term clinical assessment. Whether good immediate technical results will translate into beneficial longterm clinical results remains to be demonstrated. Larger prospective studies with long-term follow-up are necessary to determine the efficacy and safety profiles of the JETi8 for DVT thrombectomy more accurately. In conclusion, the JETi8 peripheral thrombectomy system may be a safe and effective treatment option for thrombectomy of acute deep venous thrombosis and could allow for performing thrombectomy on an outpatient basis in some patients.
10 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
REFERENCES 1. Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Klow NE. Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis. J Vasc Interv Radiol 2013; 24: 17–24. 2. Kohi MP, Kohlbrenner R, Kolli KP, Lehrman E, Taylor AG, Fidelman N. Catheter directed interventions for acute deep vein thrombosis. Cardiovasc Diagn Ther 2016; 6:599–611. 3. Dasari TW, Pappy R, Hennebry TA. Pharmacomechanical thrombolysis of acute and chronic symptomatic deep vein thrombosis: a systematic review of literature. Angiology 2012; 63:138–145. 4. Kwon SH, Oh JH, Seo TS, Ahn HJ, Park HC. Percutaneous aspiration thrombectomy for the treatment of acute lower extremity deep vein thrombosis: is thrombolysis needed? Clin Radiol 2009; 64:484–490. 5. Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med 2017; 377:2240–2252. 6. Streiff MB, Agnelli G, Connors JM, et al. Guidance for the treatment of deep vein thrombosis and pulmonary embolism. J Thromb Thrombolysis 2016; 41:32–67. 7. Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Catheter-directed thrombolysis with percutaneous rheolytic thrombectomy versus thrombolysis alone in upper and lower extremity deep vein thrombosis. Cardiovasc Intervent Radiol 2006; 29:1003–1007. 8. Lin PH, Zhou W, Dardik A, et al. Catheter-direct thrombolysis versus pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis. Am J Surg 2006; 192: 782–788. 9. Rao AS, Konig G, Leers SA, et al. Pharmacomechanical thrombectomy for iliofemoral deep vein thrombosis: an alternative in patients with contraindications to thrombolysis. J Vasc Surg 2009; 50:1092–1098. 10. Garcia MJ, Lookstein R, Malhotra R, 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; 26:777–785.
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11. Fleck D, Albadawi H, Shamoun F, Knuttinen G, Naidu S, Oklu R. Catheterdirected thrombolysis of deep vein thrombosis: literature review and practice considerations. Cardiovasc Diagn Ther 2017; 7(Suppl 3): S228–S237. 12. Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Adjunctive percutaneous mechanical thrombectomy for lower-extremity deep vein thrombosis: clinical and economic outcomes. J Vasc Interv Radiol 2006; 17:1099–1104. 13. Vedantham S, Vesely TM, Parti N, Darcy M, Hovsepian DM, Picus D. Lower extremity venous thrombolysis with adjunctive mechanical thrombectomy. J Vasc Interv Radiol 2002; 13:1001–1008. 14. Biasco L, Gotberg M, Harnek J, et al. First-in-man experience with the ClearLumen thrombectomy system as an adjunctive therapy in primary percutaneous coronary interventions. J Interv Cardiol 2016; 29:155–161. 15. Abate MR, Burks D, Ali A, Smeds MR, Escobar GA. Effects on renal function after percutaneous mechanical thrombectomy using AngioJet. J Vasc Surg 2015; 61:576. 16. Vedantham S, Grassi CJ, Ferral H, et al. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol 2006; 17:417–434. 17. Comerota AJ, Kearon C, Gu CS, et al. Endovascular thrombus removal for acute iliofemoral deep vein thrombosis. Circulation 2019; 139:1162–1173. 18. Dumantepe M, Uyar I. The effect of Angiojet rheolytic thrombectomy in the endovascular treatment of lower extremity deep venous thrombosis. Phlebology 2017, 268355517711792. 19. Kasirajan K, Gray B, Ouriel K. Percutaneous AngioJet thrombectomy in the management of extensive deep venous thrombosis. J Vasc Interv Radiol 2001; 12:179–185. 20. Arko FR, Davis CM 3rd, Murphy EH, et al. Aggressive percutaneous mechanical thrombectomy of deep venous thrombosis: early clinical results. Arch Surg 2007; 142:513–518. 21. Morrow KL, Kim AH, Plato SA, et al. Increased risk of renal dysfunction with percutaneous mechanical thrombectomy compared with catheterdirected thrombolysis. J Vasc Surg 2017; 65:1460–1466. 22. Karthikesalingam A, Young EL, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ. A systematic review of percutaneous mechanical thrombectomy in the treatment of deep venous thrombosis. Eur J Vasc Endovasc Surg 2011; 41:554–565.
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10.e1
Figure E1. Paget-Schroetter syndrome treated with thrombus removal using the JETi8 and followed by surgical correction of the thoracic outlet compression. A 36-year-old female presented with swelling of her left arm over the last 4 days. (a) The venogram demonstrated an acute left axillosubclavian vein thrombosis with few collateral veins. The left basilic vein was punctured at mid-arm and thrombus was laced with 4 mg of r-TPA. Twenty minutes later, thrombectomy was performed with the JETi8 through an 8-F introducer. (b) The venogram after thrombectomy and dilation of the subclavian vein with a 14mm angioplasty balloon catheter showed complete thrombus removal and persistent subclavian vein stenosis (solid arrow). The duration of the procedure was 58 minutes. The patient was anticoagulated with apixaban until surgery. Sixteen weeks after thrombectomy, the venogram performed in (c) adduction and (d) abduction following first rib resection showed persistent subclavian vein stenosis, without modification related to arm positioning. (e) Digital radiography showed a waist on the 10 mm angioplasty balloon catheter at the beginning of dilation. The subclavian vein stenosis was subsequently dilated with a 12mm angioplasty balloon catheter and then (f) the venogram showed an important reduction of the stenosis. After 17 months, the patient has no symptoms, except for some pain during exercise.
10.e2 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Cournoyer-Rodrigue et al ▪ JVIR
Figure E2. Recurrent thrombosis after left axillosubclavian vein thrombectomy with the JETi8. A 37 year-old female presented 7 days after the onset of left arm pain and swelling. (a) The venogram demonstrated an acute left axillosubclavian vein thrombosis. After left distal basilic vein access, thrombus was laced with 10 mg of r-TPA and thrombectomy was performed 20 minutes later with JETi8 thrombectomy system through an 8-F introducer. Persistent subclavian vein stenosis was dilated with a 9mm angioplasty balloon catheter and the duration of the procedure was 70 minutes. (b) The venogram at the end of the procedure showed complete thrombus removal and non-hemodynamically significant stenosis in the axillary vein that was not dilated (solid arrow). No provocative maneuver was done after the thrombectomy. The patient was on intravenous heparin while waiting for surgery. (c) The venogram performed 10 days later, because of recurrent symptoms, demonstrated axillosubclavian vein thrombosis. After thrombectomy with the JETi8 using the same technique described above, (d) the venogram with the arm in abduction showed complete thrombus removal, without subclavian vein stenosis. Two days later, the patient had a second recurrence and the patient was treated with apixaban for 6 months. At 24 months clinical follow-up, the patient still experienced upper extremity swelling and pain during exercise.
Percutaneous Thrombectomy with the JETi8 Peripheral Thrombectomy System for the Treatment of Deep Vein Thrombosis Jean Cournoyer-Rodrigue, MD, The-Bao Bui, MD, Patrick Gilbert, MD, Gilles Soulez, MD, MSc, Pierre Perreault, MD, Louis Bouchard, MD, Vincent L. Oliva, MD, Marie-France Giroux, MD, and Eric Therasse, MD ABSTRACT Purpose: This study evaluated the safety and efficacy of the JETi8 peripheral thrombectomy system in treating acute deep vein thrombosis (DVT). Materials and Methods: A retrospective study was conducted in 18 consecutive patients (mean age, 41 years old [range, 15-74 years old]; 5 men and 13 women). There were 21 instances of DVTs (9 iliofemoral, 10 axillosubclavian, and 2 portal), which were treated using the JETi8 thrombectomy device between November 2016 and July 2018. Thrombus was laced with recombinant tissue plasminogen activator (r-TPA) (9.3 mg, on average; range, 2–12 mg) in 17 procedures (81%) prior to thrombectomy. Technical success was defined as restoration of antegrade flow using the JETi8 with or without additional treatment of an underlying obstructive lesion. Procedural success was defined as technical success with or without the addition of overnight catheter-directed thrombolysis (CDT) Results: Mean procedure time was 83 minutes (range, 30–160 minutes), and mean thrombus reduction with the JETi8 alone was 92% (range, 60%–100%). Stent placement was required in 6 procedures (29%). Technical success using the JETi8 system alone was 76% (16 of 21 procedures), whereas 5 procedures (24%) required subsequent overnight CDT in the intensive care unit. Procedural success rate was 100% (20 of 20 procedures). Mean aspirated volume was 531 mL (range, 250–1,230 mL). The only adverse event was a subsegmental pulmonary embolism. Seven patients (33%) were discharged the same day. Recurrent thrombosis was observed in 5 patients (24%), of whom 3 were successfully treated with the JETi8 system. Conclusions: The JETi8 system may be a safe and effective option for thrombectomy of acute DVT.
ABBREVIATIONS CDT ¼ catheter-directed thrombolysis, DVT ¼ deep vein thrombosis, r-TPA ¼ recombinant tissue plasminogen activator
Endovascular DVT treatments such as catheter-directed thrombolysis (CDT), mechanical thrombectomy, and pharmacomechanical thrombectomy have gained significant From the Department of Radiology (J.C-R., P.G., G.S., P.P. L.B., V.L.O., M-F.G., de Montre al, Montreal, Quebec, E.T.), Centre Hospitalier de l’Universite Canada; Department of Radiology (T-B.B.), Centre Hospitalier de l’Universite ^pital Fleurimont (CHUS), Sherbrooke, Que bec, Canada; and de Sherbrooke, Ho Centre de recherche (G.S., E.T.), CHUM, Pavillon R, 900 rue Saint-Denis, al, Que bec, Canada, H2X 0A9. Received June 16, 2019; final revision Montre received October 12, 2019; accepted October 15, 2019. Address correspondence to E.T.; E-mail: [email protected] None of the authors have identified a conflict of interest. Figures E1 and E2 can be found by accessing the online version of this article on www.jvir.org and clicking on the Supplemental Material tab. © SIR, 2019 J Vasc Interv Radiol 2019; ▪:1–10 https://doi.org/10.1016/j.jvir.2019.10.022
interest as the treatment of choice for DVT in the last decade (1–5). Many studies have highlighted the benefits of clot removal in long-term outcomes in specific clinical settings compared to anticoagulation alone. Among these studies, the recent prospective multicenter PEARLII (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths; NCT01086215) study demonstrated the potential of reducing concomitant CDT and the intensive care unit stay by using a thrombectomy device (2–4,6–10). In comparison with CDT, mechanical and pharmacomechanical thrombectomy devices can accelerate thrombus removal, which may lead to same-day patient discharge, making overnight observation in the intensive care unit obsolete, thus resulting in important cost savings (5,11–13). The JETi8 thrombectomy system (Walk Vascular, Irvine, California), a thrombectomy device that combines clot fragmentation with catheter aspiration, received US Food and Drug Administration (FDA) 510K clearance in October
2 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Cournoyer-Rodrigue et al ▪ JVIR
2016 as a device intended to remove or aspirate fluid and break up soft emboli and thrombi from coronary and peripheral systems. This device does not have any specific FDA approvals for the treatment of iliofemoral, axillosubclavian, or portal vein thrombosis. Experience with the JETi8 system is sparse; only a single study has been published so far. Furthermore, that study described the use of a smaller version of the JETi8 device (the ClearLumen II peripheral thrombectomy system; Walk Vascular) as adjunctive therapy in a case of primary percutaneous coronary intervention (14). There is no hemolysis reported with the use of the JETi8 system, which could lead to no time restriction for the use of this device, in contrast to other rheolytic catheters (15). The purpose of this study was to evaluate the safety and efficacy of the JETi8 thrombectomy system in treating acute DVT.
MATERIALS AND METHODS Study Design This retrospective study was approved by the institutional review board of 2 general university medical centers, which waived informed consent from the patients. Inclusion criteria consisted of all consecutive patients who were treated with the JETi8 system for acute venous thrombosis (11 patients from Centre Hospitalier de l’Universite de Montreal and 7 patients from Centre Hospitalier de l’Universite de Sherbrooke) between November 2016 and July 2018. Exclusion criteria were patients with chronic DVT and those with acute DVT treated with another mechanical thrombectomy device. Patients with chronic DVT were excluded based on their clinical history and thrombus appearance on Doppler ultrasonography. One case of pulmonary artery embolism and 1 case of acute chronic iliofemoral thrombus treated with the JETi8 system were excluded. Of the 146 thrombolysis and thrombectomy procedures performed since JETi8 was made available in the participating centers in October 2016, 21 percutaneous venous catheter thrombectomies were undertaken using the JETi8 system in 18 patients (Fig 1). Procedures included 10 axillosubclavian, 9 iliofemoral, and 2 portal vein thromboses. Selection of the JETi8 system or other thrombectomy devices for venous thrombectomy was based mostly on the radiologist’s individual preference and experience with the device. Axillosubclavian and iliofemoral vein thromboses were diagnosed using Doppler ultrasonography, whereas portal vein thrombosis was diagnosed using Doppler ultrasonography and contrast-enhanced computed tomography (CT).
Thrombectomy Technique All cases were performed or supervised by interventional radiologists with 10–28 years of endovascular practice who had no prior experience with the JETi8 system and used techniques they had learned by using other thrombectomy catheters.
Figure 1. Flow chart demonstrating inclusion and exclusion of patients.
The JETi8 system is a single-lumen open-end catheter with a pressurized saline jet located inside the tip of the catheter. The jet fragments the thrombus to help clot aspiration through the catheter. This device does not maintain an isovolumetric balance between the amount of injected saline and the aspirated volume. All procedures were performed with the patient under conscious sedation and local anesthesia. Venous accesses were achieved under ultrasonographic guidance using micropuncture sets. For iliofemoral vein thrombectomy, the lesser saphenous vein or the popliteal vein was accessed while the patient was in a prone position. For axillosubclavian vein thrombectomy, the brachial or a basilic vein was punctured at the junction between the middle and distal thirds of the arm. The portal vein was accessed through a right transhepatic percutaneous puncture. In all cases, venography was obtained by hand injection, given the slow flow associated with venous thrombosis. Following vascular access and venography, in 11 cases, an angled catheter, often a 5-F DAV catheter (Cook Medical Inc., Bloomington, Indiana) was introduced, without the use of a sheath, and thrombus lacing with recombinant tissue plasminogen activator (r-TPA) (most often 10-mg in 10 mL of sterile water) was performed manually. Use and dosage of r-TPA was applied at the interventionist’s discretion and was generally proportional to the amount of
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thrombus to be removed. Thrombus lacing was performed because interventional radiologists participating in this study had good experience with this technique in association with other thrombectomy devices, despite nonuniform rTPA dispersion throughout the entire clot. After thrombus lacing with r-TPA, the JETi8 catheter was inserted percutaneously into an 8-F introducer, most often through a curved guiding sheath (Adelante Breezeway, Oscor, Palm Harbor, Florida), which allowed the JETi8 to be directed during the thrombectomy procedure. Negative pressure was applied concomitantly in the system using either a Gomco pump (Allied Healthcare Product, St. Louis, Missouri) or, more frequently, a 60-mL locking syringe. The thrombectomy technique was the same for iliofemoral, axillosubclavian, and portal vein thromboses. The first thrombectomy pass was performed using the JETi8 activated while retrieving and rotating both the introducer and the JETi8 together with the tip of the JETi8 protruding 1 or 2 cm beyond the tip of the curved guiding sheath. The next passes were performed while the JETi8 was activated while pushing the device forward with the introducer, while rotating them together. Although the JETi8 was used over a 0.035-inch Bentson wire (Cook Medical) in the first few cases, thrombectomy was performed without any guidewire thereafter. After the occluded segment was crossed once or twice with the JETi8, completion venography was performed, and thrombectomy was repeated at sites of residual thrombus, as required, until either the thrombus was fully removed or only a negligible amount remained. In instances where the thrombectomy catheter was occluded, it was either retrieved to remove the obstructing clot or flushed in situ with saline before resuming thrombectomy. In all cases, once clot removal was considered satisfactory, balloon angioplasty of residual stenoses was performed. If the result remained unsatisfactory, stents were placed for iliofemoral and portal vein thromboses (self-expanding stents were used in all but 1 case). Stents were never placed in cases of axillosubclavian vein thrombosis. No inferior vena cava filter was placed during any of the procedures. Criteria for the use of overnight CDT in the intensive care unit included a persistent, hemodynamically significant obstructive thrombus after the thrombectomy attempt. Overnight CDT was performed with 1 mg/h of r-TPA for 24 hours followed by venography to assess patency and residual thrombus. The use of the JETi8 system was not constrained by time limits. Throughout the procedure, vital signs were monitored, and the amount of aspirated volume was recorded.
Variables Collected and Patient Follow-up Data were collected mainly from the Radiology Information System (RIS) and the Electronic Medical Record of the patients. Baseline demographics and patient information are presented in Table 1. Patients presented with typical symptoms of acute deep vein thrombosis, and no patient had limb-threatening deep venous
3
Table 1. Patients Baseline Characteristics Characteristic Mean age, y (range) Males (%) Females (%)
Value 41 (15–74) 5 (28) 13 (72)
Site of venous thrombosis (%) Iliofemoral vein Axillosubclavian vein Portal vein Underlying cause (%) Paget-Schrotter syndrome
9 (43) 10 (48) 2 (10) 9 (43)
Unknown
7 (33)
May-Thurner syndrome
3 (14)
Stent placement
1 (5)
Hepatic transplant
1 (5)
Risk factors (%) Previous DVT
2 (10)
Previous tobacco use Hypercoagulability
0 (0) 0 (0)
Oral contraceptive use
2 (10)
Immobilization
1 (5)
Current malignancy
0 (0)
Clinical presentation (%) Iliofemoral vein Edema
9 (100)
Pain Cramps
7 (78) 3 (33)
Discoloration
2 (22)
Axillosubclavian vein (%) Edema Pain
10 (100) 9 (90)
Portal vein (%) Ascites Duration of symptoms, d (range) Iliofemoral vein
2 (100) 3.6 (1–7)
Axillosubclavian vein
3.6 (1–7)
Portal vein
4.5 (2–7)
Overall
3.7 (1–7)
DVT ¼ deep vein thrombosis.
thrombosis. All patients were treated with anticoagulation following thrombectomy. Most patients were referred from other medical centers and were followed by their referring physicians. Therefore, the anticoagulation protocol was not standardized. Follow-up imaging information was retrieved from a centralized electronic databank. Clinical follow-up data were retrieved from the electronic medical record, and a telephone survey was also undertaken in September 2019 that included specific questions about clinical symptoms.
Variables Defined Technical success was defined as restoration of antegrade flow using the JETi8 system with or without additional
Case
Side
r-TPA (mg)
Procedure Time (min)
Aspirated Volume (mL)
PTA
Stent (Type, Size)
CDT
1
Left
10
160
No data
No
No
Yes
2
Left
10
65
1,230
Yes
No
No
3
Left
10
79
300
No
No
Yes
4
Right
2
95
No data
Yes
S.M.A.R.T. stent 12 mm 8 cm
5
Left
No dose
95
No data
Yes
No
6
Right
10
118
780
Yes
7
Left
10
160
No data
Yes
8
Left
0
60
700
No
9
Bilateral
0
90
800
No
6.5 (0–10)
102 (60–160)
762 (300–1,230)
5/9 (56)
Clot Reduction Using JETi8 Alone (%)
Technical Success (%)
Clot Reduction Using JETi8 D CDT (%)
Procedural Success (%)
60
No
No data*
NA*
100
Yes
No CDT
Yes
70
No
100
Yes
No
80
Yes
No CDT
Yes
Yes
60
No
90
Yes
Two S.M.A.R.T. stents 14 80 mm
No
100
Yes
No CDT
Yes
Two S.M.A.R.T. stents 14 60 mm No
No
100
Yes
No CDT
Yes
Yes
80
No
100
Yes
Yes
80
No
95
Yes
81 (60–100)
4/9 (44)
96 (80–100)
9/9 (100) *
Iliofemoral vein
Mean result (range) or yes proportion (%)
Epic stent 14 mm and Palmaz stent 20 mm 4/9 (44)
5/9 (56)
4 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Table 2. Procedure-Related Information
Axillosubclavian vein 1
Left
10
60
360
Yes
No
No
100
Yes
No CDT
Yes
2
Left
No dose
70
380
Yes
No
No
100
Yes
No CDT
Yes
Left
2
50
420
Yes
No
No
100
Yes
No CDT
Yes
4
Right
10
58
350
Yes
No
No
100
Yes
No CDT
Yes
5
Right
10
30
250
Yes
No
No
100
Yes
No CDT
Yes
6
Left
12
60
500
Yes
No
No
100
Yes
No CDT
Yes
7 8
Left Right
10 10
90 90
500 400
Yes No
No No
No No
100 100
Yes Yes
No CDT No CDT
Yes Yes
9
Right
10
60
400
Yes
No
No
100
Yes
No CDT
Yes
10
Right
12
45
600
Yes
No
No
100
Yes
No CDT
Yes
9.6 (2–12)
61 (30–90)
426 (250–600)
9/10 (90)
0/10 (0)
0/10 (0)
100
10/10 (100)
100
10/10 (100)
Mean result (range) or yes proportion (%)
continued
Cournoyer-Rodrigue et al ▪ JVIR
3
2/2 (100%) 530 0 Mean result (range) or yes proportion (%)
101 (90–111)
No No data 111 0 NA 2
5
CDT ¼ catheter-directed thrombolysis; Epic ¼ stent (Boston Scientific, Maple Grove, Minnesota); JETi8 ¼ thrombectomy system (Walk Vascular, Irvine, California); NA ¼ nonapplicable; Palmaz-Schatz ¼ balloon expandable stent (Cordis); PTA ¼ percutaneous transluminal angioplasty; r-TPA ¼ recombinant tissue plasminogen activator; S.M.A.R.T. ¼ stent (Cordis, Miami Lakes, Florida). *This case was excluded from the successful procedures because the control venogram was cancelled.
2/2 (100%) 100 0/2 (0%)
100
2/2 (100%)
Yes No CDT No
100
Yes
Yes No CDT Yes 0 NA 1
90
530
Yes
Portal vein S.M.A.R.T. stent 10 30 mm Two S.M.A.R.T. stents 12 40 mm and 12 30 mm 2/2 (100%)
No
100
Clot Reduction Using JETi8 D CDT (%) Aspirated Volume (mL) Procedure Time (min) r-TPA (mg) Side Case
Table 2. Procedure-Related Information (continued)
PTA
Stent (Type, Size)
CDT
Clot Reduction Using JETi8 Alone (%)
Technical Success (%)
Procedural Success (%)
Volume ▪ ▪ Number ▪ ▪ Month ▪ 2019
treatment of an underlying obstructive lesion. Procedural success was defined as technical success with or without the addition of overnight CDT. Device success was defined as technical success with the absence of any major adverse event related to it. Minor and major complications were classified according to Journal standards and guidelines (16). Two interventional radiologists estimated the percentage of thrombus removal by subjective visual observation in comparison with initial thrombus load on completion venography at the end of the intervention and after CDT, for cases requiring overnight CDT. The duration of the procedure was defined as the time between venous access and the end of the thrombectomy session. Continuous variables were displayed by using means and ranges, whereas categorical variables were tabulated using frequency distributions.
RESULTS Procedural data for each patient can be found in Table 2, and clinical and follow-up outcome data are listed in Table 3. The mean time between the onset of symptoms and intervention was 3.7 days (range, 1–7 days). All patients included in this study had symptoms for less than 14 days. Thrombus lacing was performed in 17 procedures (81%) prior to thrombectomy, with an average of 9.3 mg of r-TPA (range, 0–12 mg). No thrombus lacing was done in either of the portal vein cases because of the higher risk of bleeding complication and, in 2 cases of iliofemoral vein thrombosis, because the thrombus load was considered limited. Balloon angioplasty was required in 15 procedures (71%) for residual stenosis at the thrombus site, whereas 6 procedures (29%) required stent placement for persistent stenosis. Mean aspiration volume using the JETi8 system was 531 mL (range, 250–1,230 mL), including blood diluted with saline as well as aspirated fragmented thrombi collected in the suction container. The amount of saline injected was not recorded, and it is impossible to know the proportion of blood and saline in the aspirated volume. Despite this, no patients experienced hypotension during the procedure, and no transfusions were required. Mean procedure time for all patients was 83 minutes (range, 30–160 minutes), including the prethrombectomy lacing of the thrombus with r-TPA and a 20- to 30-minute delay before thrombectomy due to the JETi8 system. Overall mean thrombus removal was 92% (range, 60%– 100%) with the use of the JETi8 system only. Technical success was obtained in 76% (16 of 21 procedures) (Fig 2, Fig E1 [available online on the article’s Supplemental Material page at www.jvir.org]). In 5 procedures (24%) thrombi removal was considered insufficient using the JETi8 alone. Insufficient thrombectomy occurred essentially in iliofemoral vein thrombosis cases. These 5 procedures were all subsequently followed by overnight CDT in the intensive care unit. Mean thrombus removal after overnight CDT was 98% (range, 80%–100%). Four of the 5 technical failures after thrombectomy alone were considered
Case
Hospitalization
Recurrence (d)
Length (d)
Same-Day Discharge
1
1
No
No
2
1
No
No
3
1
No
4
0
5
1
Additional Intervention
Imaging Follow-up
Clinical Follow-up
Duration, Modality, Results
Duration
Symptoms
No
No data
No data
No data
No
No data
31 mo
VS ¼ 0
No
No
No data
30 mo
VS ¼ 0
Yes
No
No
No data
No data
No data
No
Yes (5 d)
No
21 mo
VS ¼ 6
5 d, CT, common iliac vein thrombosis 1 mo, Doppler, no lesion
6
0
Yes
No
No
1 mo
VS ¼ 0
7
0
Yes
No
No
No data
13 mo
VS ¼ 0
8
3
No
No
No
No data
14 mo
VS ¼ 0
9
7
No
No
No
2 mo, CT, no lesion
No data
No data
1.6 (0–7)
3/9 (33)
1 (11)
1/9 (11)
NA
18 mo (1–31)
NA
1
0
Yes
No
FRR and subclavian PTA
3.5 mo, phlebography, no lesion
30 mo
Mild pain during exercise
2
0
Yes
Yes (10 d)
JETi8 thrombectomy
10 d, phlebography, axillosubclavian thrombosis
10 d
Upper extremity pain and edema
3
0
Yes
Yes (2 d)
No
11 mo, phlebography, chronic axillary vein thrombosis with collaterals
25 mo
Persistent pain, upper extremity edema and discoloration
4
0
Yes
No
FRR
3 mo, phlebography, no lesion
18 mo
Mild pain during exercise
5
3
No
No
No
11 mo, MR imaging, mild stenosis
31 mo
6
2
7
7
No
No
FRR
12 mo, phlebography, no lesion
27 mo
8
3
No
No
No
No data
23 mo
No symptom
9
5
No
No
No
22 mo
No symptom
2 2.2 (0–7)
No 4/10 (40)
No 3/10 (30)
FRR 6/9 (67)
No data NA
19 mo 20 mo (0–31)
No symptom NA
21
No
Yes (47 d)
No
1.5 mo, CT, complete portal vein thrombus occlusion
1.5 mo
Dyspnea, ascites, mild lower extremity edema
10 16 (10–21)
No 0/2 (0)
No 1/2 (50)
No 0/2 (0)
29 mo 15 mo (1.5–29)
No symptom NA
Mean results, % (range)
1 2 Mean results, % (range)
JETi8 thrombectomy
2 d, phlebography, axillosubclavian vein thrombosis
5 mo, MR imaging, no lesion
29 mo, CT, no lesion NA
FRR ¼ first rib resection; JETi8 ¼ thrombectomy system (Walk Vascular, Irvine, California); NA ¼ not applicable; VS ¼ Villalta score.
2d
No symptom Upper extremity pain and edema No symptom
Cournoyer-Rodrigue et al ▪ JVIR
10 Mean results, % (range)
Yes (2 d)
6 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Table 3. Clinical and Follow-up Outcomes
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7
Figure 2. Left iliofemoral vein thrombectomy with the JETi8. A 57-year-old female with a left leg plaster cast after Achilles tendon rupture presented with left leg swelling and calf induration over the previous 7 days. The venogram obtained in a prone position demonstrated an acute left (a) femoral and (b) iliac vein thrombosis. Venous access was performed through the gastrocnemius muscle vein, and the thrombus was laced with 10 mg of r-TPA. Thrombectomy was performed using the JETi8 20 minutes later through an 8-F introducer. Venogram of the (c) femoral and (d) iliac veins after thrombectomy and angioplasty of the femoral vein using a 10-mm angioplasty balloon show complete thrombus removal. Because there was no iliac vein compression, no stent was placed. The duration of the procedure was 65 minutes. The patient was placed on anticoagulation therapy with apixaban for 6 months. Doppler ultrasonography showed no thrombus recurrence 51 days later. At 30 months’ follow-up, the patient had mild superficial varicose veins but no symptoms.
successful after subsequent overnight CDT. In the fifth case, the patient developed an important headache in the intensive care unit, and CDT was stopped prematurely for suspicion of intracranial hemorrhage; however, no hemorrhage was found on the head CT. Lumbar puncture was negative for subarachnoid hemorrhage, and the headache resolved within 24 hours. Completion venography was cancelled in this patient, and venous patency could not be confirmed. Therefore, procedural success was 100% (20 of 20 procedures). Six patients (29%) had pre- and post-thrombectomy hemoglobin dosages (normal value, 12–16 g/dL), which showed an average decrease of 1.6 g/dL (range, 0.1–3.4 g/dL). No patient presented with macroscopic hemoglobinuria. Bilateral subsegmental pulmonary embolism was diagnosed in 1 patient on the day after the procedure, as demonstrated by pulmonary CT angiography following the onset of hypotension. The patient experienced dyspnea for the next 2 days and she was subsequently transferred to her referring center. There were no other major adverse events related to the use of the JETi8 system,; hence, device success was 76% (16 of 21 procedures). Mean length of hospitalization after thrombectomy was 3.0 days (range, 0–21 days), with 7 patients (33%) discharged the same day as the intervention. Recurrent thromboses were observed in 5 cases (24%), 3 of which were subsequently treated successfully by using the JETi8 system and were included in this study. One of these thromboses recurred again 2 days
after the second thrombectomy. Portal vein thrombus recurrence, diagnosed by CT angiography, occurred in a young cirrhotic patient who was receiving a therapeutic intravenous heparin regimen despite good angiographic results after stent placement (Fig 3). Three other recurrent thromboses, diagnosed by venography, occurred in a patient with Paget-Schroetter syndrome despite good angiographic results after thrombectomy (Fig 4, Fig E2 [available online on the article’s Supplemental Material page at www.jvir.org]). The fifth case was diagnosed by venography 5 days after thrombectomy for May-Thurner syndrome. Thirteen cases (62%) underwent imaging follow-up with a mean imaging follow-up duration of 6.6 months (2 days–29 months). Eight cases (62%) showed good patency at long-term follow-up; 4 cases (31%) had short-term thrombosis recurrence; and 1 case (8%) showed chronic thrombosis. Imaging follow-up data were not available in 8 cases (38%). Eighteen cases (86%) had clinical follow-up with a mean duration of 19.7 months (2 days–31 months). At long-term clinical followup, 11 of 18 cases (61%) were asymptomatic, whereas 7 of 18 cases (39%) cases experienced mild or moderate symptoms. No patient mentioned having severe symptoms.
DISCUSSION This study demonstrates that JETi8 can achieve successful venous thrombectomy without overnight CDT in most
8 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Cournoyer-Rodrigue et al ▪ JVIR
Figure 3. Thrombectomy of a portal vein thrombosis using the JETi8. A 20-year-old male with cystic fibrosis and cirrhosis presented with abdominal pain, ascites, and leukocytosis 5 days after receiving a liver transplant. A 9-F introducer was placed through a transhepatic right portal vein. No thrombus lacing or heparin perfusion was performed. (a) The venogram showed a thrombus limited to the main portal vein. Thrombectomy using the JETi8 was then performed, and (b) the venogram obtained after placement of a 10-mm selfexpandable stent (solid arrow) shows no remaining thrombus. (c) One week later, follow-up CT angiography demonstrated good patency of the main portal vein. Six weeks after thrombectomy (d), the venogram showed recurrent main portal vein thrombosis. (e) The venogram obtained after thrombectomy using the JETi8 (using the same technique described above) and placement of an additional 12mm self-expanding stent more distally (arrowheads) demonstrated complete recanalization of the main portal vein. At 29 months, CT imaging showed continued main portal vein patency (not shown).
patients. The present report evaluated the performance of the JETi8 thrombectomy system for the treatment of acute DVT and included the results of the first patients treated with this device in the authors’ centers. Thrombus removal was complete in axillosubclavian and portal vein thrombosis, whereas all cases of partial thrombectomy occurred in cases of iliofemoral vein thrombosis. This might have been due to the greater amount of thrombus and larger vein diameters in iliofemoral vein thromboses in comparison with the other thrombectomy sites, explaining why all cases of CDT following thrombectomy were also present in iliofemoral cases. For all venous thrombectomy sites, only a minority of patients were discharged the same day as the thrombectomy was performed. This was due not only to the need for CDT in cases of partial iliofemoral thrombectomies but also due to other medical reasons associated with the DVT. In comparison to CDT, thrombectomy with the JETi8 system allowed for lesser hospitalization needs and decreased use of the intensive care unit, with important cost savings. However, larger prospective studies will be
required to assess whether these results could be replicated and how they compare with those using other thrombectomy devices. Despite complete thrombectomy in the axillosubclavian veins, thrombosis recurrences were more frequent than in iliofemoral vein thrombosis. This may be due to the underlying vein compression in Paget-Schroetter syndrome, which is generally not treated with stenting following thrombectomy, whereas in iliofemoral vein thrombosis, extrinsic compression is generally treated with stent insertion. Treatment of iliofemoral venous thrombosis with CDT can reduce early leg symptoms as well as the proportion of patients who develop moderate or severe post-thrombotic syndrome (17). CDT carries a significant risk of major bleeding (5), and there is a need for thrombectomy devices that could reduce the duration and the amount of pharmacological thrombolysis required to remove the thrombus. This study suggests that the JETi8 thrombectomy system has a technical success rate and thrombus reduction similar to those of the Angiojet rheolytic system (Boston Scientific, Maple Grove, Minnesota) (5,7,8,10,18,19). In the PEARLII
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9
Figure 4. Left iliofemoral vein thrombectomy using the JETi8 required overnight catheter-directed thrombolysis. A 17-year-old female presented with severe left leg swelling, skin discoloration, and pain that had started 4 days previously. (a) The venogram performed with the patient in a prone position using a 4-F catheter inserted through the popliteal vein demonstrated an acute left iliofemoral vein thrombosis. Thrombus was laced with 10 mg of r-TPA, and thrombectomy was performed 20 minutes later using the JETi8 catheter inserted through an 8-F introducer. (b) The venogram obtained after thrombectomy showed an important reduction in thrombus burden in the iliofemoral vein. A short, eccentric thrombus with 80% luminal narrowing of the distal inferior vena cava (solid arrow) and a 60% stenosis of the left common iliac vein remained after thrombectomy (arrowhead). (c) Distal inferior vena cava stenosis was dilated by using a 16-mm angioplasty balloon catheter. (d) The venogram after balloon angioplasty showed a 40% residual thrombus at the end of this 95-minute procedure. Given that good blood flow was present, no intravascular ultrasonography was performed, and no stent was placed at the iliocaval junction. The patient received anticoagulation therapy using enoxaparin for 6 months, but iliofemoral vein thrombosis recurred 5 days later. At 21 months’ follow-up, the patient presented with a mild post-thrombotic syndrome characterized mainly by moderate pain, cramps, and heaviness in the leg (Villalta score ¼ 6).
registry, 69% of patients had 100% clot retrieval in the group treated only with the Angiojet system, whereas 31% of them had a 50%–99% clot reduction (10). In the present study, the JETi8 thrombectomy system was able to remove an average of 92% of the thrombus, with a technical success rate of 86%. Procedural time range with the JETi8 was identical to those reported in other studies using other pharmacomechanical thrombectomy devices with the reported procedure time varying between 36 and 145 minutes with the Angiojet system (8,10,18,20). One of the main advantages of the JETi8 system is the absence of reported hemolysis associated with its use (19). This is important in patients with renal failure, and it also allows for thrombectomy procedures without activation time limitations. Although precautions can be undertaken to minimize the adverse effects of hemolysis, hemoglobinuria can potentially lead to acute renal failure and remains a concern with the use of the Angiojet system (10,15,21,22). Despite important blood volume aspirated using the JETi8 system in some of the present study patients, vital signs remained stable, and no patient required a blood transfusion. This may be partly explained by the fact that the aspirated volume is a mixture of fragmented clot, blood, and saline from the highly pressurized saline jet used for clot
fragmentation. Another possible explanation is the use of some volume replacement with saline during the procedure through a peripheral intravenous access and the side port of the guiding sheath. JETi8 is not an isovolumetric device and could potentially lead to significant blood loss, which may limit its use, especially in anemic patients. The aspiration volume should be monitored during every procedure to avoid hemodynamic complications. Small sample size and the retrospective nature of this report are the main limitations of this study. Despite these limitations, data from this study strongly suggest that JETi8 is effective for thrombectomy of acute DVT with large thrombus load. Lack of systematic and standardized patient follow-up due to referrals from peripheral centers is another limitation of this study, limiting long-term clinical assessment. Whether good immediate technical results will translate into beneficial longterm clinical results remains to be demonstrated. Larger prospective studies with long-term follow-up are necessary to determine the efficacy and safety profiles of the JETi8 for DVT thrombectomy more accurately. In conclusion, the JETi8 peripheral thrombectomy system may be a safe and effective treatment option for thrombectomy of acute deep venous thrombosis and could allow for performing thrombectomy on an outpatient basis in some patients.
10 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
REFERENCES 1. Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Klow NE. Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis. J Vasc Interv Radiol 2013; 24: 17–24. 2. Kohi MP, Kohlbrenner R, Kolli KP, Lehrman E, Taylor AG, Fidelman N. Catheter directed interventions for acute deep vein thrombosis. Cardiovasc Diagn Ther 2016; 6:599–611. 3. Dasari TW, Pappy R, Hennebry TA. Pharmacomechanical thrombolysis of acute and chronic symptomatic deep vein thrombosis: a systematic review of literature. Angiology 2012; 63:138–145. 4. Kwon SH, Oh JH, Seo TS, Ahn HJ, Park HC. Percutaneous aspiration thrombectomy for the treatment of acute lower extremity deep vein thrombosis: is thrombolysis needed? Clin Radiol 2009; 64:484–490. 5. Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med 2017; 377:2240–2252. 6. Streiff MB, Agnelli G, Connors JM, et al. Guidance for the treatment of deep vein thrombosis and pulmonary embolism. J Thromb Thrombolysis 2016; 41:32–67. 7. Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Catheter-directed thrombolysis with percutaneous rheolytic thrombectomy versus thrombolysis alone in upper and lower extremity deep vein thrombosis. Cardiovasc Intervent Radiol 2006; 29:1003–1007. 8. Lin PH, Zhou W, Dardik A, et al. Catheter-direct thrombolysis versus pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis. Am J Surg 2006; 192: 782–788. 9. Rao AS, Konig G, Leers SA, et al. Pharmacomechanical thrombectomy for iliofemoral deep vein thrombosis: an alternative in patients with contraindications to thrombolysis. J Vasc Surg 2009; 50:1092–1098. 10. Garcia MJ, Lookstein R, Malhotra R, 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; 26:777–785.
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11. Fleck D, Albadawi H, Shamoun F, Knuttinen G, Naidu S, Oklu R. Catheterdirected thrombolysis of deep vein thrombosis: literature review and practice considerations. Cardiovasc Diagn Ther 2017; 7(Suppl 3): S228–S237. 12. Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Adjunctive percutaneous mechanical thrombectomy for lower-extremity deep vein thrombosis: clinical and economic outcomes. J Vasc Interv Radiol 2006; 17:1099–1104. 13. Vedantham S, Vesely TM, Parti N, Darcy M, Hovsepian DM, Picus D. Lower extremity venous thrombolysis with adjunctive mechanical thrombectomy. J Vasc Interv Radiol 2002; 13:1001–1008. 14. Biasco L, Gotberg M, Harnek J, et al. First-in-man experience with the ClearLumen thrombectomy system as an adjunctive therapy in primary percutaneous coronary interventions. J Interv Cardiol 2016; 29:155–161. 15. Abate MR, Burks D, Ali A, Smeds MR, Escobar GA. Effects on renal function after percutaneous mechanical thrombectomy using AngioJet. J Vasc Surg 2015; 61:576. 16. Vedantham S, Grassi CJ, Ferral H, et al. Reporting standards for endovascular treatment of lower extremity deep vein thrombosis. J Vasc Interv Radiol 2006; 17:417–434. 17. Comerota AJ, Kearon C, Gu CS, et al. Endovascular thrombus removal for acute iliofemoral deep vein thrombosis. Circulation 2019; 139:1162–1173. 18. Dumantepe M, Uyar I. The effect of Angiojet rheolytic thrombectomy in the endovascular treatment of lower extremity deep venous thrombosis. Phlebology 2017, 268355517711792. 19. Kasirajan K, Gray B, Ouriel K. Percutaneous AngioJet thrombectomy in the management of extensive deep venous thrombosis. J Vasc Interv Radiol 2001; 12:179–185. 20. Arko FR, Davis CM 3rd, Murphy EH, et al. Aggressive percutaneous mechanical thrombectomy of deep venous thrombosis: early clinical results. Arch Surg 2007; 142:513–518. 21. Morrow KL, Kim AH, Plato SA, et al. Increased risk of renal dysfunction with percutaneous mechanical thrombectomy compared with catheterdirected thrombolysis. J Vasc Surg 2017; 65:1460–1466. 22. Karthikesalingam A, Young EL, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ. A systematic review of percutaneous mechanical thrombectomy in the treatment of deep venous thrombosis. Eur J Vasc Endovasc Surg 2011; 41:554–565.
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10.e1
Figure E1. Paget-Schroetter syndrome treated with thrombus removal using the JETi8 and followed by surgical correction of the thoracic outlet compression. A 36-year-old female presented with swelling of her left arm over the last 4 days. (a) The venogram demonstrated an acute left axillosubclavian vein thrombosis with few collateral veins. The left basilic vein was punctured at mid-arm and thrombus was laced with 4 mg of r-TPA. Twenty minutes later, thrombectomy was performed with the JETi8 through an 8-F introducer. (b) The venogram after thrombectomy and dilation of the subclavian vein with a 14mm angioplasty balloon catheter showed complete thrombus removal and persistent subclavian vein stenosis (solid arrow). The duration of the procedure was 58 minutes. The patient was anticoagulated with apixaban until surgery. Sixteen weeks after thrombectomy, the venogram performed in (c) adduction and (d) abduction following first rib resection showed persistent subclavian vein stenosis, without modification related to arm positioning. (e) Digital radiography showed a waist on the 10 mm angioplasty balloon catheter at the beginning of dilation. The subclavian vein stenosis was subsequently dilated with a 12mm angioplasty balloon catheter and then (f) the venogram showed an important reduction of the stenosis. After 17 months, the patient has no symptoms, except for some pain during exercise.
10.e2 ▪ Percutaneous Thrombectomy with the JETi8 System for DVT
Cournoyer-Rodrigue et al ▪ JVIR
Figure E2. Recurrent thrombosis after left axillosubclavian vein thrombectomy with the JETi8. A 37 year-old female presented 7 days after the onset of left arm pain and swelling. (a) The venogram demonstrated an acute left axillosubclavian vein thrombosis. After left distal basilic vein access, thrombus was laced with 10 mg of r-TPA and thrombectomy was performed 20 minutes later with JETi8 thrombectomy system through an 8-F introducer. Persistent subclavian vein stenosis was dilated with a 9mm angioplasty balloon catheter and the duration of the procedure was 70 minutes. (b) The venogram at the end of the procedure showed complete thrombus removal and non-hemodynamically significant stenosis in the axillary vein that was not dilated (solid arrow). No provocative maneuver was done after the thrombectomy. The patient was on intravenous heparin while waiting for surgery. (c) The venogram performed 10 days later, because of recurrent symptoms, demonstrated axillosubclavian vein thrombosis. After thrombectomy with the JETi8 using the same technique described above, (d) the venogram with the arm in abduction showed complete thrombus removal, without subclavian vein stenosis. Two days later, the patient had a second recurrence and the patient was treated with apixaban for 6 months. At 24 months clinical follow-up, the patient still experienced upper extremity swelling and pain during exercise.