Mechanical Thrombectomy in Acute Thrombosis of ...

CLINICAL STUDY

Mechanical Thrombectomy in Acute Thrombosis of Dialysis Arteriovenous Fistulae and Grafts Using a VacuumAssisted Thrombectomy Catheter: A Multicenter Study ment Marcelin, MD, Stephen D’Souza, MD, Yann Le Bras, MD, Cle Francois Petitpierre, MD, Nicolas Grenier, MD, PhD, Jos C. van den Berg, MD, PhD, and Bella Huasen, MD

ABSTRACT Purpose: To prospectively analyze technical and clinical outcome of percutaneous thrombectomy aspiration using a vacuum-assisted thrombectomy catheter in acutely thrombosed dialysis arteriovenous fistula (AVF) and/or arteriovenous graft (AVG). Materials and Methods: From June 2016 to April 2017, 35 patients (average age, 61.8 y; range, 33–81 y) presenting with acute thrombosis of dialysis AVF and/or AVG were prospectively evaluated for mechanical thrombectomy using the Indigo System. Adjunctive therapies and procedure-related complications were noted. Technical success, clinical success, primary patency, primary assisted patency, and secondary patency of the dialysis fistula were assessed. Results: Mean follow-up time was 8.5 months (range, 3–12 months). Technical success was 97.1% (34/35 patients). Clinical success was 91.4% (32/35 patients). Complications included hematoma (n ¼ 1), thrombosis < 24 hours (n ¼ 1), and perforation (n ¼ 1). Other mechanical/aspiration thrombectomy devices were used in 1 site to clear the thrombus burden (Arrow-Trerotola [2.8%; 1/35 patients] and Fogarty [5.7%; 2/35 patients]). Average procedure time was 38.1 minutes (range, 15–140 min). Average blood loss during the procedure was 122.5 mL (range, 50–300 mL). The 6-month primary patency, primary assisted patency, and secondary patency were 71%, 80%, and 88.5%. No risk factors for early dialysis fistula occlusion were identified. There was no 30-day mortality. Conclusions: Percutaneous mechanical thrombectomy aspiration of thrombosed dialysis AVF and/or AVG with a vacuum-assisted thrombectomy catheter is a safe procedure with a low complication rate and effective method for restoring patency before hemodialysis.

ABBREVIATIONS AVF ¼ arteriovenous fistula, AVG ¼ arteriovenous graft

Thrombosis is a cause of failure of autologous arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) owing to an underlying stenosis in the venous anastomosis segment or along the venous limb (1,2). Delaying treatment can lead to the loss of AVF access and unnecessary temporary catheter placement (3). Percutaneous intervention

has become widespread and is now universally included in the management of thrombosed AVF/AVG with good efficacy (76%–100%) (4–8). Different kinds of devices have been described in a limited number of cases (4–8). Fistula salvage (native or graft) is a long procedure (5,8), as it involves a number of intraoperative management steps

From Interventional Radiology (C.M., Y.L.B., F.P., N.G.), Service d’Imagerie rapeutique de l’Adulte, Ho ^pital Pellegrin, Place Ame lieDiagnostique et The on, Bordeaux 33076, France; Endovascular Unit (S.D., B.H.), Royal Raba-Le Preston Hospital, Lancashire University Teaching Health Trust, Preston, United Kingdom; and Interventional Radiology (J.C.v.d.B.), Centro Vascolare Ticino, Lugano, Inselspital, Universit€atsspital Bern Universit€atsinstitut für Diagnostische, Interventionelle und P€adiatrische Radiologie, Bern, Switzerland. Received October 31, 2017; final revision received and accepted

February 26, 2018. Address correspondence to C.M.; E-mail: clement. [email protected] None of the authors have identified a conflict of interest. © SIR, 2018 J Vasc Interv Radiol 2018; ▪:1–5 https://doi.org/10.1016/j.jvir.2018.02.030

FLA 5.5.0 DTD JVIR4674_proof 24 May 2018 11:03 pm ce

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(gaining access, removal of clot, management of the underlying cause with balloon angioplasty and/or stent placement, and restoring flow). Despite the excellent published results, this treatment has important disadvantages, including bleeding complications with systemic therapy (9,10), hemolytic complications secondary to the AngioJet device (Boston Scientific, Marlborough, Massachusetts) (5), and long procedure time (5,8). The original Penumbra System (Penumbra, Inc, Alameda, California) was developed for thrombectomy in patients with stroke, demonstrated efficacy and safety (11–12), and was further developed with the Indigo Mechanical Thrombectomy System (Penumbra, Inc) for peripheral vascular indications, such as acute limb ischemia (13,14). The Indigo System consists of vacuum-assisted thrombectomy, which enables continuous thrombus aspiration. The catheter is available in 4 different sizes (3, 5, 6 and 8 F), which allows it to be used in fistulae of various sizes (immature to large aneurysmal). This article reports use of the Indigo System for management of dialysis fistula thrombosis and salvage. This study evaluated the technical and the clinical efficacy of thrombosed dialysis AVF and/or AVG with the use of the Penumbra Indigo device.

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Table. Patient and Fistula Characteristics Characteristics

Mean (range) or Number (%)

Average age, y

61.8 (33–81)

Sex Male

19

Female

16

Graft fistula Autologous fistula Fistula location Forearm

22

Upper arm

13

Cause of renal failure Diabetes

16

Sarcoidosis

1

Reflux Vascular

1 2

Genetics

5

PCKD

5

Cryoglobulinemia

1

FSG

1

Undetermined

3

History of renal graft

MATERIALS AND METHODS Study Design All patients who presented with acute thrombosis of dialysis AVF and/or AVG were prospectively followed over a 6-month period. Exclusion criteria were AVF and/or AVG infection or sepsis. No patients were excluded during the study period. The institutional review board approved the waiver of obtaining informed consent. All patients provided signed inform consent. Data were updated and analyzed in a prospective manner acquired through review of medical records and imaging reports.

Patients Between June 2016 and April 2017, 35 patients with acutely thrombosed dialysis fistulae were treated. Patient and fistula characteristics are summarized in the Table. Clinical examination by the attending nephrologist or dialysis physician or failed dialysis demonstrated by the absence of thrill and Duplex ultrasound confirmed the presence of thrombosis and stenosis of the vein or anastomosis. All procedures were performed within 48 hours of the occurrence of thrombosis. Patients (N ¼ 35; average age, 61.8 y; age range, 33–81 y; 19 men and 16 women) were treated with the Indigo System. The mean age of the dialysis fistula was 4.1 years (range, 1–7 y). Three patency outcomes were used in accordance with the Society of Interventional Radiology (SIR) reporting standards (15). Primary patency after intervention was defined as the interval after percutaneous transluminal angioplasty (PTA) until repeated percutaneous intervention or fistula thrombosis. Assisted primary patency after

19 16

3 (8%)

Age of fistula at intervention, y History of AVF/AVG thrombosis

4.1 (1–7) 15 (42%)

Previous angioplasty for AVF/AVG stenosis

26 (74%)

Previous AVG stent placement

6 (20%)

Concomitant diseases Arterial hypertension

18 (51%)

Diabetes

19 (54%)

Insulin-dependent Non–insulin-dependent Coagulopathy

2 17 4* (11%)

Smoking

12 (34%)

Long-term antithrombotic therapy with ASA

19 (54.3%)

Anticoagulation therapy with warfarin for atrial fibrillation and lupus

8 (26.6%)

ASA ¼ acetylsalicyclic acid; AVF ¼ arteriovenous fistula; AVG ¼ arteriovenous graft; FSG ¼ focal segmental glomerulosclerosis; PCKD ¼ polycystic kidney disease. *One patient had lupus treated with anti-DNA antibodies, 1 patient had a lupus anticoagulant, and 2 patients had myelodysplasia. No other patient had acquired or hereditary thrombophilia (protein C, protein S, antithrombin, factor VII, factor V mutation, factor II mutation, plasminogen activator inhibitor, lipoprotein (a), lupus anticoagulant, IgG or IgM anticardiolipin antibodies).

intervention was defined as the interval after PTA until fistula thrombosis or surgical intervention that excluded the treated lesion from the access circuit. Secondary patency after intervention was defined as the interval after PTA until the fistula was surgically declotted, revised, or abandoned. Clinical success, defined as successful dialysis session after procedure; safety, defined as the absence of complications classified according to the ClavienDindo grading system (16) and the SIR classification


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(17); blood loss; and procedure time from sheath insertion to completion fistulogram were also recorded. Major complications included vessel rupture, thrombus migration, infection, local bleeding requiring transfusion, hematoma requiring surgery, pseudoaneurysms, and fluid overload. All procedures were performed on 2 different angiographic units (Philips Medical Systems, Best, Netherlands, and Siemens AG, Forchheim, Germany). The working sheath access site was the venous side of the fistula (for all fistula types). Local anesthesia with 1% lidocaine subcutaneously was used for the venous access, and sedation (midazolam and fentanyl) was used only when required. Systemic heparinization with 30 IU/kg heparin was initiated before the procedure. The overall required heparin range was 1,500–5,000 units for all procedures. Both anterograde and retrograde vascular access to the venous segment of the dialysis fistula was performed using an 8-F sheath under ultrasound guidance. Clinical and ultrasound examination guided the optimum position of the initial fistula puncture. Injection of contrast material via the initial puncture sheath under fluoroscopy confirmed the location and the extent of the thrombosis. First, anterograde aspiration was performed, followed by retrograde aspiration (Fig a–e). Then angioplasty of the venous or arteriovenous stenosis was performed with a balloon (Extreme or Saber; Cordis, Fremont, California, or Dorado; Bard Peripheral Vascular, Inc, Tempe, Arizona) to treat the underlying primary stenosis. Stent grafts were inserted in case of persistent stenosis after balloon angioplasty in venous segments in patients known to have a persistent unresponsive stenosis. Two adjunctive thrombectomy devices were used: a Fogarty 4-F catheter (Edwards Lifesciences, Irvine, California) was used in case of thrombosis in arteriovenous anastomosis, whereas the Arrow-Trerotola device (Teleflex Inc, Wayne, Pennsylvania) was used to clear the clots in AVF aneurysms. The procedure was successful when a clinical thrill over the efferent vein was associated with an angiogram without residual clot. Vascular sheaths were removed, and hemostasis was achieved after a purse-string suture or manual compression/pressure dressings. In 17 cases, the sheaths were left in place as dialysis access sites to avoid repeat punctures when dialysis was performed immediately after the procedure. After declotting, patients were admitted to the nephrology department for dialysis. Patients were discharged from the hospital after dialysis if no complications arose during this time. Prospective clinical and imaging follow-up was performed until July 2017 with clinical examination during dialysis and Transonic ultrasound dilution (Transonic Systems Inc, Ithaca, New York) and Doppler ultrasound every 3 months. Statistical analysis was carried out for analysis of the effect of prognostic factors on dialysis AVF and/or AVG with the Fisher exact test, and P < .05 was considered significant.

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Figure. An acutely occluded brachiocephalic graft fistula in the right arm of a 42-year-old woman. The patient had a history of stent placement on the fistula owing to persistent venous stenosis. (a) Fistulogram obtained on anterograde puncture through an 8-F catheter (arrow) reveals clot (arrowhead) over the graft fistula. (b) Fistulogram obtained after aspiration with the Indigo device over the graft fistula shows no residual clot but reveals a graft stenosis after the stent graft (arrow). (c) Fistulogram obtained after balloon angioplasty with an 8-mm balloon demonstrates technical success with no residual stenosis (arrowhead). (d) Fistulogram obtained on retrograde puncture reveals clot over the graft fistula (arrowhead). (e) After aspiration with the Indigo device over the graft fistula, fistulogram obtained through a 5-F catheter (arrow) shows a completely patent graft, with no residual clot.

RESULTS Technical success was 97.1% (34 of 35 patients); 1 patient had a perforation of the vein, without declotting. Clinical success was 91.4% (32 of 35 patients); 1 patient developed a hematoma around the fistula during dialysis, 1 patient had a thrombosed dialysis fistula 24 hours after declotting (the patient has a renal transplant, so no new declotting procedure was planned), and 1 patient had a perforation of the


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vein without declotting. No technical or device-related complications were reported. The 3 complications were considered clinical complications, not related to use of the Indigo System. Adjunctive procedures included balloon angioplasty (93.3%), used at all sites, and stent graft deployment (57.%; 2 of 35 patients), using Arrow-Trerotola (2.8%; 1 of 35 patients) and Fogarty (5.7%; 2 of 35 patients) devices. Balloon angioplasty was performed in all procedures except 2, where no underlying cause other than dehydration was identified. High-pressure balloons (EXTREME 6–8 mm diameter or Dorado 4–10 mm diameter) were used on vein anastomoses, and smaller balloons (Saber 4 mm diameter) were used on the arterial anastomoses. Stents (Covera 8 4 mm; Bard Peripheral Vascular, Inc) were used in 2 patients because of immediate recoil at the level of the venous anastomosis of AVG. Fogarty thrombectomy was performed because of persistent adherent clot at the level of the arteriovenous anastomosis in 2 patients after aspiration with the Indigo device, with success. The ArrowTrerotola device was used after the Indigo device to declot an AVF aneurysm in 1 patient, with success. The Indigo System alone was used as a thrombectomy system in all other cases (n ¼ 32). Average procedure time was 38.1 minutes (range, 15–140 min). Average blood loss during the procedure was 122.5 mL (range, 50–300 mL). No devicerelated or procedure-related death was reported. No deaths 30 days or 6 months after the procedure were reported. All patients were followed until July 2017. Mean followup time was 8.5 months (range, 3–12 months). Five patients had a second aspiration for recurrent thrombosis of the dialysis fistula (mean, 2 months; range, 1 day to 7 months). Two patients had a restenosis during follow-up, which was treated with balloon angioplasty (mean, 2 months; range, 1–4 months). The 6-month primary patency, primary assisted patency, and secondary patency were 71%, 80%, and 88.5%. No statistically significant risk factors for early dialysis fistula occlusion were found, including sex (P ¼ .2), previous angioplasty, previous stent placement (P ¼ .4), hypertension (P ¼ .7), diabetes (P ¼ .8), coagulation disorder (P ¼ .5), anticoagulation (P ¼ .5), antithrombotic (P ¼ .2), and smoking (P ¼ .2).

DISCUSSION This study demonstrates technical success of clot removal of AVF and/or AVG using the Indigo System in 97.1% of cases. This technical success is similar to other studies (range, 76%–100%) (4–6,18–28). Vascular guidelines (29,30) report a clinical success rate of > 85% and a primary patency rate at 3 months > 40%. Clinical success was 91%, and the 6-month primary patency was 71%. This is comparable to other studies, in which clinical success and 6-month primary patency were 20%–62% and 54%–87%, respectively (4,6,7,22). The procedural time in this patient cohort compared favorably with studies reporting on other devices: AngioJet device (78 ± 31 min; range, 25–160) (5), mechanical thrombolysis (126 min; range, 105–160 min)

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(18), double angioplasty procedure (92 min; range, 35–165 min) (24), and pharmacomechanical thrombectomy (99 min; range, 49–261 min) (6). The avoidance of urokinase or other thrombolytic infusion is an advantage from a safety point of view (reduction of bleeding complications). Various systems for management of thrombosed vascular access are used for AVF and/or AVG, and most studies evaluated devices on both AVF and AVG. Systemic thrombolysis procedures were used, with medium efficacy of 33%–80% (9,10). Mechanical thrombectomy with devices such as the Arrow-Trerotola is effective in 90% (18,23), with a risk of migration of clot into the lungs (that remains asymptomatic most of the time); however, trackability and speed are less reliable. The AngioJet device (5) is effective in 62.4%, 69.9%, and 94.9% at 6 months and 56.1%, 61.6%, and 86.2% at 12 months; however, this device is unsafe in anastomosis sites where trauma and vasospasm are likely. Aspirex (Vascular Perspectives Ltd, Huddersfield, United Kingdom) (25) is effective with 81.5% clinical success and 100% technical success, without complications. Manual thromboaspiration (without continuous aspiration) is effective in 76%–93% in long segment clots (20,26). There was 1 major complication during the procedure, perforation of the vein, which was treated with surgical assistance (21,28,31). No symptomatic signs of embolization of thrombus fragments into the peripheral arterial system or into the pulmonary circulation were noted. This complication has been reported in the literature to range from 0% to 7% with other systems, including AngioJet and percutaneous thrombolytic device (5,31). No hemolytic complications are expected with the Indigo system (14), in contrast to the AngioJet device (5,27), and therefore it was safely used in all patients. In 17 patients, hemoglobin levels were measured before the Indigo procedure, as part of routine checks, and hemoglobin levels checked in these patients after the procedure (before dialysis) with initial Indigo cases were noted to be 70–90 g/dL. None of the patients demonstrated a change in hemoglobin level, even allowing for the short duration of time between the procedure and hemoglobin being checked. No patient presented clinically with symptoms secondary to blood loss after clot removal, and no blood transfusions were necessary. This study’s main limitations are the small number of patients, the short follow-up, and the lack of data regarding procedure cost. Further studies could compare costs of thrombectomy procedures with several devices. In conclusion, percutaneous mechanical thrombectomy aspiration of thrombosed dialysis fistulae with a vacuumassisted thrombectomy catheter is a safe procedure with a low complication rate and an effective method for restoring patency before hemodialysis.

ACKNOWLEDGMENTS The authors thank Pippa McKelvie-Sebileau for medical editorial services.


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