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250 Medical treatment of acute deep venous thrombosis and pulmonary embolism
https://t.me/med1917
 ●
31. Gabriel F, Portolés O, Labiós M etal. Usefulness of thrombophilia testing in venous thromboembolic disease: Findings from the RIETE Registry. Clin Appl Thromb Hemost 2013;19(1) :42–7.
 ●
32. Palareti G, Cosmi B, Legnani C etal. D-dimer test­ing to determine the duration of anticoagulation therapy. N Engl J Med 20 06;355(17):1780–9.
33. Crowther MA and Warkentin TE. Bleeding risk and the management of bleeding complications in patients undergoing anticoagulant therapy: Focus on new anticoagulant agents. Blood 2008;111(10 ):4871–9.
34. Yeh CH, Gross PL, and Weitz JI. Evolving use of new oral anticoagulants for treatment of venous throm­boembolism. Blood 2014;124(7):1020–8.
35. Greinacher A, Michels I, and Mueller-Eckhardt C. Heparin-associated thrombocytopenia: The anti­body is not heparin specific. Thromb Haemost 1992;67(5):545–9.
36. Martel N, Lee J, and Wells PS. Risk for hep­arin-induced thrombocytopenia with unfrac­tionated and low-molecular-weight heparin thromboprophylaxis: Ameta-analysis. Blood 2005;106(8):2710–5.
37. Alving BM. How I treat heparin-induced thrombocy­topenia and thrombosis. Blood 2003;101(1):31–7.
38. Prandoni P, Lensing AW, Prins MH etal. Below-knee elastic compression stockings to prevent the post­thrombotic syndrome: A randomized, controlled trial. Ann Intern Med 2004;141(4):249–56.
39. Aschwanden M, Labs KH, Engel H etal. Acute deep vein thrombosis: Early mobilization does not increase the frequency of pulmonary embolism. Thromb Haemost 2001;85(1):42–6.
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40. Kahn SR, Shapiro S, Wells PS etal. Compression stockings to prevent post-thrombotic syndrome: A randomised placebo-controlled trial. Lancet 2014;383(9920):880–8.
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41. Prandoni P, Lensing AW, Cogo A etal. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med 1996;125(1):1–7.
42. Wakefield TW, Myers DD, and Henke PK. Mechanisms of venous thrombosis and resolution. Arterioscler Thromb Vasc Biol 2008;28(3):387–91.
 ●
43. Meissner MH, Manzo RA, Bergelin RO, Markel A, and Strandness DE Jr. Deep venous insufficiency: The relationship between lysis and subsequent reflux. J Vasc Surg 1993;18(4):596–605; discussion 606–8.
44. Juhan CM, Alimi YS, Barthelemy PJ, Fabre DF, and Riviere CS. Late results of iliofemoral venous throm­bectomy. J Vasc Surg 1997;25(3):417–22.
 ●
45. Enden T HY, Kløw NE, Slagsvold CE etal.; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): A randomised controlled trial. Lancet 2012;379:31–8.
46. Baekgaard NBR, Just S, Jørgensen M, and Jensen LP. Long-term results using catheter-directed thrombolysis in 103 lower limbs with acute iliofemo­ral venous thrombosis. Eur J Vasc Endovasc Surg 2010;39(1):112–7.
47. Raju S, Darcey R, and Neglén P. Unexpected major role for venous stenting in deep reflux disease. J Vasc Surg 2010;51(2):401–8.
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48. Kearon C, Akl EA, Ornelas J etal.; Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest 2016;149(2):315–52.
49. Marti C, John G, Konstantinides S etal. Systemic thrombolytic therapy for acute pulmonary embo­lism:A systematic review and meta-analysis. Eur Heart J 2014;2015;36(10):605–14.
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50. Meyer G, Vicaut E, Danays T etal. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med 2014;370(15):1402–11.
51. Rodger M. Evidence base for the manage­ment of venous thromboembolism in pregnancy. HematologyAm Soc Hematol Educ Program 2010;2010:173–80.
 ●
52. Goldhaber SZ. Risk factors for venous thromboem­bolism. J Am Coll Cardiol 2010;56(1):1 – 7.
53. Hirsh J and Lee AY. How we diagnose and treat deep vein thrombosis. Blood 2002;99(9):3102–10.
54. Greenfield LJ and Proctor MC. Current sta­tus of inferiorvena cava filters. Ann Vasc Surg 2000;14(5):525–8.
 ●
55. PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism The PREPIC (Prévention du Risque d’Embolie Pulmonaire par Interruption Cave) randomized study. Circulation 2005;112(3):416–22.
56. Meissner MH, Gloviczki P, Comerota AJ etal. Early thrombus removal strategies for acute deep venous thrombosis: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2012;55:1449– 62.
20
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Catheter-directed thrombolysis, mechanical thrombectomy, and surgery for the treatment of acute iliofemoral deep venous thrombosis
ARTHUR DELOS REYES AND ANTHONY J. COMEROTA
20.1 Introduction 251
20.2 Rationale for removal ofthrombus 251
20.3 Published guidelines andevidence 251
20.4 Pre-treatment evaluation 253
20.5 Intrathrombus CDT 254
20.1 INTRODUCTION
Venous thromboembolic disease aects over 900,000 indi­viduals annually in the United States,1 and remains a major source of morbidity and mortality throughout the world. Current therapy focuses on preventing the embolization of deep venous thrombosis (DVT), for which anticoagula­tion remains the cornerstone of treatment. Anticoagulation alone has been shown to reduce the incidence of pulmo­nary embolism (PE) and death in multiple randomized tri­als,2 thus reducing the early complications associated with DVT. However, anticoagulation does not prevent or treat the development of post-thrombotic syndrome (PTS), most signicant late complication of venous thromboem­bolic disease.
PTS is dened as a constellation of signs and symptoms in the aected extremity that occur aer acute DVT; PTS is generally evident within the rst few months aer the diag­nosis (and treatment) of DVT.6 Clinical manifestations prog­ress over time and include chronic pain, edema, varicosities, pigmentation, eczema, and ulceration in severe cases, which have a signicant impact on quality of life. incidence of PTS varies, due in part to the variability and precision of the follow-up of patients aer their acute DVT. In the United States, PTS is estimated to aect up to half of all people who have a DVT. PTS aects up to 6 million indi­viduals, and ulceration exists in 400,000–500,000 patients who have suered a DVT.
10
A large body of evidence reveals
7–9
e reported
3–5
the
20.6 Pharmacomechanical thrombolysis 256
20.7 Operative venous thrombectomy 257
20.8 Post-operative care 260 References 261
that PTS is more prevalent and severe following iliofemoral DVT if treatment involves anticoagulation alone.
4,6
20.2 RATIONALE FOR REMOVAL OFTHROMBUS
Ambulatory venous hypertension is the underlying patho­physiology of chronic venous disease. tence and venous obstruction—consequences of iliofemoral DVT—are associated with the most severe post-thrombotic morbidity.12 us, the underlying rationale for thrombus removal in patients with iliofemoral DVT is that eliminating the acute clot avoids or reduces chronic venous obstruction (Figure 20.1), resulting in marked reduction of the PTS.
5,11
Valvular incompe-
4,12,13
20.3 PUBLISHED GUIDELINES
ANDEVIDENCE
In 2012, the Society for Vascular Surgery published guide­lines titled Early rombus Removal Strategies for Acute Deep
Venous rombosis: Clinical Practice Guidelines of the Society for Vascular Surgery and the American Venous Forum.
2.1 We suggest a strategy of early thrombus removal in selected patients meeting the fol­lowing criteria: (a) first episode of acute iliofem­oral deep venous thrombosis, (b) symptoms <14
14
251
252 Catheter-directed thrombolysis, mechanical thrombectomy, and surgery
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(a)
(b)
Figure 20.1 (a and b) Post-thrombotic venous disease
illustrating the inability to identify obstruction as part of the pathophysiology of chronic venous disease. This patient had suffered from iliofemoral deep venous throm­bosis 10 years earlier and was treated with anticoagula­tion alone. Severe post-thrombotic syndrome developed, and the patient underwent multiple hospitalizations for venous ulceration. An ascending phlebogram showed recanalization of the iliofemoral venous system; however, the radiologist’s interpretation was that there was “no obstruction” of the deep venous system, and a 3-second maximal venous outflow test was “normal.” A classic Linton procedure was performed and showed (insert) the cross-section of the femoral vein at the correspond­ing location on the phlebogram, just below the profunda femoris vein.
days, (c) a low risk of bleeding, and (d) ambu­latory with good functional capacity and an acceptable life expectancy (Grade 2C).
In 2014, the American Heart Association (AHA)
released a consensus statement entitled e Postthrombotic
Syndrome: Evidence-Based Prevention, Diagnosis, and Treatment Strategies. eir recommendations for throm-
bolysis and endovascular approaches to acute DVT for the
6
prevention of PTS state the following
:
[Catheter-directed thrombolysis] and [pharma­comechanical catheter-directed thrombolysis] in experienced centers, may be considered in select patients with acute (<14 days) symptom­atic, extensive proximal DVT who have good functional capacity, >1 year life expectancy, and low expected bleeding risk (Class IIb, Level of Evidence B).
Controversies surrounding the use of thrombolytic therapy to prevent the development of PTS persist. Most notably, the American College of Chest Physicians (ACCP) Consensus Committee has wavered on its recommendation regarding the use of thrombolysis for treatment of proxi­mal DVT. In the Antithrombotic erapy for VTE Disease,
published in 2012, the ninth ACCP guideline recommenda-
15
tion states the following
:
2.9 In patients with acute proximal DVT of the leg, we suggest anticoagulation therapy alone over catheter-directed thrombolysis (CDT) (Grade 2C).
is redacts the eighth ACCP Consensus Committee recommendation published in 2008 for thrombus removal in patients with proximal DVT. At the time, prevailing evi­dence suggested that operative venous thrombectomy or CDT was recommended for patients with acute iliofemoral DVT to reduce acute symptoms and post-thrombotic mor­bidity (grade 2B).2 e eighth ACCP consensus committee recognized that iliofemoral DVT was an important subset of patients deserving of added attention for a treatment strategy of thrombus removal.
Both the AHA and ACCP base their recommendations on the available published research. In this case, the strict method to include “evidence” used by the ACCP in 2012 compared to 2008 excluded all non-randomized controlled trials and did not include other evidence. Despite the avail­able evidence, the use of the decided-upon criteria resulted in no study or treatment meeting the ACCP 2012 criteria for a grade 1A recommendation for any treatment of acute venous thromboembolic disease. Unfortunately, the ninth ACCP edition reverted to the generic “proximal DVT” clas­sication and did not recognize iliofemoral deep venous thrombosis (IFDVT) as an important subset of patients fac­ing more frequent and severe post-thrombotic morbidity.
Much of the evidence supporting thrombolysis for the treatment of iliofemoral DVT to prevent PTS is from single-center, non-randomized studies, although a more recent multicenter trial showed benets of CDT. In the Catheter-Directed rombolysis in Acute Iliofemoral Vein rombosis (CaVenT) trial, 209 patients were randomized to CDT plus anticoagulation or anticoagulation alone.4 e addition of CDT resulted in a signicant reduction in PTS compared to anticoagulation alone. In the rombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial, pharmacomechanical catheter directed thrombolysis (PCDT) plus anticoagulation was tested against anticoag­ulation alone in 183 patients with DVT. Once again, PCDT plus anticoagulation showed a signicant reduction in risk of PTS in the treatment group. e use of a non-standard measure of PTS and non-blinding of the clinical observers limits the strength of these results.
6
e National Institutes of Health (NIH) has sponsored the Acute Venous rombosis: rombosis Removal with Adjunctive Catheter-directed rombolysis (ATTRACT) trial. is is a multicenter, randomized, open-label, asses-
16,17
sor-blinded, parallel, two-arm, controlled clinical trial. ATTRACT met its recruitment goal of randomizing 692 patients in December of 2014. Patients were strati­ed at entry to iliofemoral DVT or femoropopliteal DVT
Symptomatic proximal DVT
The ATTRACT Trial
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Stratify
20.4 Pre-treatment evaluation 253
Femoral-popliteal DVTIlio-femoral DVT
RandomizeRandomize
Catheter based
thrombus removal
-plus-
anticoagulation
Villalta score CEAP classication QOL evaluation
Figure 20.2 Algorithm of the protocol of the ATTRACT trial. DVT: deep venous thrombosis; QOL: quality of life.
Anticoagulation
alone
Postthrombotic syndrome during 24-month follow-up
Venous clinical severity score Venous duplex -patency
(Figure20.2). A total of 692 patients have been randomized. e ATTRACT trial is now into its 2-year follow-up phase for assessing its primary ecacy endpoint of PTS. Results are anticipated in early 2017.
Based upon all of the available evidence to date, and based upon the increased safety of CDT infusing low doses of a plasminogen activation in high volumes of saline (1 mg in 50–100 cc/hour), which improves ecacy, we would suggest that CDT for iliofemoral DVT be given a strong recommendation (level 1) supported by grade B evidence.
Catheter based
thrombus removal
-plus-
anticoagulation
-valve function
complication of either lytic therapy or venous thrombec­tomy, rather than a delayed manifestation of a pre-existing PE. Additionally, the CT scan oen identies other tho­racic, abdominal, or pelvic pathologies (see Figure 20.3b). Martinez and colleagues reviewed the results of CT scan evaluations for 47patients with iliofemoral DVT and found PE in 48% and other unexpected thoracic, abdominal, or pelvic pathologies in 23%. tumors, retroperitoneal lymphoma, pulmonary adeno­carcinoma, hepatic metastases, iliac vein aneurysms, and vena caval atresias were identied on CT as unanticipated
Anticoagulation
alone
22
Renal cell carcinoma, adrenal
sources and risk factors for iliofemoral DVT. Whether by
20.4 PRE-TREATMENT EVALUATION
Aer the diagnosis of acute DVT is established, all patients should be placed on anticoagulation therapy immediately, followed by leg elevation and leg compression. anticoagulation and compression, ambulation is encour­aged. Patients with iliofemoral DVT who are eligible for anticoagulation and are ambulatory should be consid­ered for thrombus removal. In patients with normal renal function, a contrast-enhanced computed tomography (CT) scan of the head, chest, abdomen, and pelvis is per­formed. Approximately 50% of these patients will have an asymptomatic pulmonary embolus. Although such emboli may not change the treatment plan, the value of establish­ing the diagnosis is oen not appreciated until 3–5 days later when pleuritic chest pain develops in up to 25% of asymptomatic PE patients. of PE, physicians might suspect that the result of pleuritic chest pain represents a “treatment failure” or an embolic
21
Without a previous diagnosis
18–20
Aer
CT or by duplex scan, imaging of the vena cava is impor­tant for assessing the degree of vena caval involvement with thrombus. If oering catheter-based techniques, a vena caval lter is recommended for patients with free-oating, non-occlusive vena caval thrombus. If operating, either proximal balloon occlusion of the inferior vena cava (IVC) or caval ltration is appropriate in those patients with free­oating thrombus. e majority of patients with iliofemo­ral DVT do not require an IVC lter.
Patients with extensive venous thrombosis frequently have a clinically obvious etiology (trauma), a known throm­bophilia, or perhaps an occult cancer. However, those with an unprovoked VTE frequently undergo a full hereditary thrombophilia evaluation. Although we routinely per­formed a full battery of hereditary thrombophilia testing earlier in our experience, we now know t hat it is unnecessary, as the patient’s extensive DVT imparts such substantial risk for future venous thromboembolic events that the risk con­ferred by the acute thrombotic event oen exceeds the risk
254 Catheter-directed thrombolysis, mechanical thrombectomy, and surgery
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of any identied hereditary thrombophilia.23 However, test­ing for an acquired thrombophilia is warranted. A serious consequence of a negative thrombophilia evaluation is phy­sician underestimation of future thrombotic risk. However, thrombophilia testing is important in rst-degree female relatives of childbearing potential, especially for factor V Leiden, prothrombin, 20210 mutation, and antithrombin, as these test results may impact future care during pregnancy. Additionally, testing for an acquired thrombophilia, such as antiphospholipid antibodies, is warranted.
Aer the extent of the disease has been established, contraindications to either surgical or catheter-based techniques should be objectively reviewed. In general, the majority of patients with iliofemoral DVT should be oered a strategy of thrombus removal. Individuals with occlu­sive thrombus of the common femoral vein have eectively obliterated venous drainage from the lower extremity and are subject to severe post-thrombotic morbidity. Although most patients with acute DVT are treated as outpatients, those with occlusion of the common femoral vein and/or iliac vein should be hospitalized for an appropriate proce­dure designed to restore patency and provide unobstructed venous drainage from their common femoral vein into their vena cava. Our algorithm for the management of iliofemo­ral DVT is outlined in Figure 20.4.
20.5 INTRATHROMBUS CDT
e technique of CDT has evolved over the past several years. Our preferred approach is generally through an ultrasound-guided popliteal vein puncture with antegrade passage of the infusion catheter. Patients who have distal popliteal and tibial vein thrombosis are now approached through ultrasound-guided posterior tibial vein access. Adjunctive mechanical techniques are routinely used to shorten the duration of lysis and speed clot resolution. e dose and volume of the plasminogen activator that is delivered has also evolved. Since the activation of brin­bound plasminogen is not dose dependent, its exposure to the plasminogen activator appears to be the most impor­tant factor. e volume of lytic solution has increased over the years, with a decrease in the concentration (dose) of the plasminogen activator. It is now our preference to increase the volume of lytic infusion to 80–100 mL/hour. e larger volume is intended to saturate the thrombus, exposing more brin-bound plasminogen to the plasminogen activator. One milligram of recombinant tissue plasminogen activa­tor (rtPA) is delivered in 100 mL of saline. Phlebograms are generally repeated at 12-hour intervals and are used to monitor the success of lysis, reposition catheters, and per­form other mechanical interventions. Following successful
(a)
(b)
(d)
(c)
(e) (f) (g)
Figure 20.3 A 65-year-old white man was referred with phlegmasia cerulea dolens of his left leg (a) 36 hours after major
abdominal laparotomy. Venous duplex demonstrated a clot in the posterior tibial veins extending to the external iliac vein. A contrast-enhanced computed tomography scan of the chest, abdomen, and pelvis was performed and demonstrated asymptomatic pulmonary emboli (b) and mediastinal (c), retroperitoneal (c, arrows), and pelvic lymphadenopathy (d, arrows). The extensive thrombus is demonstrated by a catheter phlebogram of the femoral vein (e and f) and the silhou­ette of the calf thrombus (g) by the catheter in the posterior tibial vein at the ankle. (Continued)
20.5 Intrathrombus CDT 255
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(h)
(i)
Isolated segment between balloons
(k) (l)
(j)
Ultrasound transducers
(m) (n)
(o) (p)
(q)
Figure 20.3 (Continued) The bulk of the thrombus from the proximal popliteal vein to the common iliac vein was treated
with the Trellis catheter via an ultrasound-guided popliteal vein approach
(h). The clot in the posterior tibial and popliteal
veins was treated with the EKOS EndoWave system (i). Liquefied and fragmented thrombus resulting from isolated seg­mental pharmacomechanical thrombolysis was aspirated via the Trellis catheter (j). Segmental phlebography is performed to check the results of treatment before moving to an adjacent thrombosed segment (k and l). Residual thrombus is removed by rheolytic thrombectomy with the AngioJet, and the iliac vein compression is treated with a stent. A comple­tion phlebogram shows patency of the calf, popliteal, femoral, and iliac veins, as well as supple valve cusps, thus suggest­ing that valve function persists (m –p). When catheter-based techniques are completed, a catheter is left in the popliteal vein (or posterior tibial vein if distal access is used) for infusion of unfractionated heparin for 24 hours. The concept is that the high concentration of heparin being infused into the target vein will increase its binding to residual thrombus, endothelium, and subendothelial collagen, thereby reducing the risk of thrombosis. The patient was treated with systemic chemotherapy for his underlying lymphoma. At 16 months
(q), the patient was asymptomatic, had no post-thrombotic
symptoms, maintained lower extremity venous patency with normal valve function, and fortunately had no evidence of lymphoma recurrence.
256 Catheter-directed thrombolysis, mechanical thrombectomy, and surgery
Management of iliofemoral DVT
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Immediate anticoagulationRapid CT Scan with contrast
Leg elevation Long leg compression Ambulation permitted
Head
Chest
Abdomen
Pelvis
Patient physically active
Strategy of thrombus removalEvaluate vena cava
No Ye s
Pharmacomechanical
thrombolysis and/or
Catheter-directed
Anticoagulation
plus
compression
Figure 20.4 Suggested management protocol for patients with iliofemoral deep venous thrombosis. CT: computed
tomography; DVT: deep venous thrombosis.
Contraindication to thrombolysis
thrombolysis
Correct underlying venous lesion
Correct iliac vein stenosis
Arteriovenous fistula
Catheter-directed anticoagulation
thrombolysis, the venous system is examined with comple­tion phlebography. If an underlying stenosis exists, which is frequently observed in the le common iliac vein where it is compressed by the right common iliac artery, the vein is balloon dilated and stented. e addition of intravascular ultrasonography has improved the evaluation of iliac com­pression and the precision of stent deployment. Residual areas of stenosis must be corrected to achieve long-term success; otherwise, the patient faces a high risk of re-throm­bosis. If a stent is used, it should be sized appropriately to the projected normal diameter of the recipient vein.
20.6 PHARMACOMECHANICAL
THROMBOLYSIS
YesNo
Filter for free-
floating thrombus
Venous thrombectomy
treating thrombosed veins larger than the 6-mm hemodi­alysis gra. In an experimental model, Greenberg and asso-
25
ciates
evaluated mechanical, pharmacomechanical, and pharmacologic thrombolysis. eir ndings are consistent with anecdotal clinical observations as well as the results reported by Kinney etal.24 ey reported that pulse-spray mechanical thrombectomy was associated with the largest number and greatest size of distal emboli. When urokinase was added to the solution, the embolic particles diminished in number and size and increased the speed of lysis and reperfusion.
Vedantham etal.26 evaluated the eectiveness of mechani­cal thrombectomy alone and in combination with pharma­cologic thrombolysis in 28 limbs of patients with acute DVT. ey evaluated multiple devices, including the Amplatz
e adjunctive use of mechanical techniques is rapidly becoming the standard for catheter-based management of extensive venous thrombosis.
24–30
Percutaneous mechani­cal thrombectomy alone is less successful than CDT, and is associated with unacceptably high pulmonary embolic com­plications. A prospective evaluation of pulse-spray pharma­comechanical thrombolysis of thrombosed hemodialysis gras found that PE occurred in 18% of patients treated with a plasminogen activator pulse-spray solution versus 64% of patients treated with a heparinized saline pulse­spray solution (P = 0.04).
24
Since thrombosed hemodialysis gras are in direct communication with the venous circula­tion, they can be considered similar to proximal veins with acute DVT. Observations would likely be magnied when
(ev3, Inc.), AngioJet (Possis Medical), Trerotola (Arrow International), and Oasis (Boston Scientic/Medi-tech) catheters. Venography was performed at each step of the procedure. A total of 26% of the thrombus was removed by mechanical thrombectomy alone, whereas adding a plasmin­ogen activator solution to the mechanical technique (phar­macomechanical) removed 82% of the thrombus.
27
Lin et al.
reported their 8-year experience with phar­macomechanical thrombolysis using a rheolytic thrombec­tomy catheter. Of their 98 patients, 46 received CDT alone and 52 underwent pharmacomechanical thrombolysis. Pharmacomechanical thrombolysis with the AngioJet cath­eter (Boston Scientic) was associated with signicantly fewer phlebograms, shorter intensive care unit stays, shorter
20.7 Operative venous thrombectomy 257
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hospital stays, and fewer blood transfusions. Bleeding com­plications were not dierent between the two groups. A smaller patient group treated by rheolytic thrombectomy was reported by Kasirajan et al.,28 who demonstrated that mechanical thrombectomy alone was less eective than combined pharmacomechanical thrombolysis.
CDT alone was associated with the slowest reperfusion but the fewest distal emboli. In general, mechanical throm­bectomy alone most oen is inadequate. Although rheolytic pharmacomechanical techniques have been helpful in many patients for clearing a dicult lesion, hemolytic complica­tions are common, and occasionally result in anemia and renal dysfunction. A device designed for isolated segmen­tal and controlled pharmacomechanical thrombolysis is the Trellis catheter (Covidien). is hybrid catheter isolates the thrombosed vein segment between two occluding bal­loons aer the introduction of a dispersion wire. A lytic agent is infused into the thrombus between the occluding balloons. e intervening catheter sha assumes a spiral conguration, which is then motor-activated to rotate at 3500 rpm. Aer 15–20 minutes, the liqueed thrombus and remaining fragments can be aspirated through the sheath. Phlebographic evaluation was performed before mov­ing on to treat additional thrombosed vein segments. e advantages of such a device include its ability to incorpo­rate mechanical and pharmacological therapies, and to treat patients who have traditional contraindications to higher doses of thrombolytic agents, as much of the lytic infusate can be aspirated. e clot is more rapidly lysed and treat­ment times are signicantly shortened. Martinez-Trabal showed that patients treated with isolated segmental phar­macomechanical thrombolysis had a signicantly more rapid lysis time, with a reduction in the dose of plasminogen activator.
29,30
Unfortunately, the Trellis catheter is no longer
available.
An adjunct to CDT is the incorporation of ultrasound transducers into the infusion catheter. Ultrasound waves generated during infusion of the plasminogen activator increase the surface area of brin and speed lysis. Several reports have emerged indicating that an infusion catheter with ultrasound transducers built into the infusion end of the catheter can be used to accelerate thrombolysis.
31–33
In vitro studies have demonstrated that ultrasound enhances the brinolytic activity of tissue plasminogen activators
32,34,35
(t-PA).
e potential mechanism for augmented clot lysis has been extrapolated from in vitro studies show­ing that ultrasound produces clot fragmentation in the presence of t-PA and, consequently, more t-PA binds to brin binding sites because of the larger available surface
36,37
area.
e concept of a transducer tip catheter that deliv­ers a brinolytic drug in combination with high-frequency, low-intensity ultrasound has been studied by Engelberger etal.38 In a single-center randomized and controlled trial
38
of patients with PE, Engelberger etal.
showed that xed­dose, low-intensity ultrasound-assisted thrombolysis was a safe and eective treatment for PE. ey reported that their experience with ultrasound-accelerated thrombolysis for
iliofemoral DVT followed by routine stenting of residual stenosis resulted in low bleeding rates, high patency rates, and a low rate of PTS.
39
e same authors investigated the added benet of ultrasound to CDT in patients with iliofemoral DVT. ey randomized 48 patients with acute iliofemoral DVT to receive CDT or ultrasound-accelerated thrombolysis.40 All patients had the ultrasound infusion catheter inserted into the thrombosed iliac veins. Only those randomized to the ultrasound-accelerated group had the ultrasound activated. Aer their target of 15 hours of treatment, the authors found that patients had 54% and 55% thrombus load reduc­tions with CDT and ultrasound-accelerated thrombolysis, respectively. ere were no dierences between treatment groups in any of the other outcomes evaluated.
e patient with phlegmasia cerulea dolens described in
Figure 20.3 illustrates the advantage of using isolated seg-
mental pharmacomechanical thrombolysis to potentially shorten treatment duration and limit exposure to the throm­bolytic agent, thereby maximizing the chance of a safe and successful outcome. As this patient was treated before the study published by Engelberger etal.,40 we cannot conclude that ultrasound assisted thrombolysis (USAT) achieved bet­ter results than would have been achieved with CDT by the drip technique. As technology continues to improve, lytic infusion times will shorten, more patients will be oered a treatment strategy that includes thrombus removal (Figure
20.4), and many more patients will be spared their other-
wise certain post-thrombotic morbidity.
20.7 OPERATIVE VENOUS
THROMBECTOMY
Although operative venous thrombectomy is infrequently required because of the increased safety and eectiveness of CDT for IFDVT, it remains a valuable treatment option in selected patients. Such patients include those with multiple trauma, and active bleeding in those at high risk for bleed­ing into a critical site (intracranial and intraocular). What follows is a description of our current technique.
General anesthesia is usually recommended for patients undergoing operative venous thrombectomy. A longitudi­nal inguinal incision exposes the common femoral, femo­ral, saphenofemoral junction, and profunda femoris vein or veins (Figure 20.5a). A longitudinal venotomy of the com­mon femoral vein is recommended to ensure access to the origin of the saphenous and profunda femoris branches. If infrainguinal thrombus is present, the leg is elevated and compressed with a tightly wrapped rubber bandage, the foot is dorsiexed, and the calf and thigh are squeezed. If all infrainguinal thrombus is removed, which is clinically evident when it occurs, balloon thrombectomy of the ilio­femoral venous system is performed.
If the infrainguinal thrombus persists and a guidewire can be advanced distally, an infrainguinal thrombectomy can be performed using an over-the-wire balloon throm­bectomy catheter. If a guidewire cannot be passed through
258 Catheter-directed thrombolysis, mechanical thrombectomy, and surgery
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the infraingual valves, a cut-down is performed to expose the distal posterior tibial vein. A No. 3 Fogarty catheter is advanced from the distal posterior tibial vein to and through the common femoral venotomy. e Silastic stem of an intravenous catheter (12–14 gauge) is amputated from its hub and slid halfway onto the balloon catheter. Another bal­loon catheter (No. 4 Fogarty) is placed in the opposite end of the Silastic sheath (Figure 20.5a). Pressure is applied to the two balloons by a single operating surgeon to ensure that the catheters remain secure inside the sheath. e No. 4 balloon catheter is guided distally through the thrombosed venous valves and clotted veins (Figure 20.5b) to the level of the posterior tibial venotomy (Figure 20.5c). Alternatively, if an over-the-wire balloon thrombectomy catheter is available, a guidewire can be passed proximally from the distal posterior tibial vein and the infrainguinal thrombectomy performed, with passage repeated as necessary (Figures 20.5d and e).
Aer infrainguinal balloon catheter thrombectomy, the infrainguinal venous system is ushed by placing a large red rubber catheter into the proximal posterior tibial vein and
(a)
Tip of balloon catheter
Silastic sheath
vigorously ushing with a heparin–saline solution, using a bulb syringe to hydraulically force residual thrombus from the deep venous system (Figure 20.5f). Frequently, an impressive amount of additional thrombus will be retrieved with this maneuver. Once the infrainguinal venous system is adequately cleared, a vascular clamp is applied below the femoral venotomy and the infrainguinal venous system is lled with dilute plasminogen activator solution consisting of approximately 4–6 mg of rtPA in 200 mL of saline. e plasminogen activator solution remains in the infraingui­nal veins for the remainder of the procedure. is amount of local rtPA will bind to brin-bound plasminogen in the residual thrombus and promote further clot dissolution; however, this dose will not cause a systemic lytic response due to circulating plasminogen activator and plasmin inhibitors. If the infrainguinal venous thrombectomy is not successful because of older thrombus or chronic disease, the femoral vein is ligated and divided below the profunda femoris vein. Patency of the profunda is ensured by direct thrombectomy if necessary.
(c)
(b)
(e)
(d)
Figure 20.5 Surgical repair of venous thrombosis. (a) Longitudinal inguinal incision to expose the common femo-
ral vein, femoral vein, saphenofemoral junction, and profunda femoris vein. (b and c) The balloon catheter is guided distally through the thrombosed venous valves and clotted veins to the level of the posterior tibial venotomy. (d and
e) Performance of infrainguinal venous thrombectomy, with passage of the balloon catheter repeated as necessary.
(Continued)
(f) (g)
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20.7 Operative venous thrombectomy 259
(h)
(i)
Figure 20.5 (Continued) (f) After infrainguinal balloon catheter thrombectomy, flushing of the infrainguinal venous system
with a heparin–saline solution is performed by placing a large red rubber catheter into the proximal posterior tibial vein and flushing vigorously with a bulb syringe. After flushing is complete, 250–300 cc of saline with 3–4 mg rtPA is infused into the deep venous system after the clamp is reapplied to the distal common femoral vein (CFV). The proximal throm­bectomy is then performed. (g) Ilio-caval thrombectomy can be performed with a protective balloon catheter inflated above the caval thrombus, if it exists, as an alternative to vena caval filtration. A large venous thrombectomy catheter is used, with an 8–10-Fr balloon. (h) Placement of a piece of polytetrafluoroethylene or Silastic wrap around the saphenous arteriovenous fistula. A large, permanent monofilament suture is looped and clipped with approximately 2 cm left in the subcutaneous tissue. This serves to limit dilation of the arteriovenous fistula and is also a guide for dissection should surgical disconnection of the arteriovenous fistula become necessary.
(i) Placement of a small infusion catheter (pediatric
feeding tube) into the wound via a separate stab incision in the skin. It is inserted and fixed in the proximal posterior tibial vein for infusion of unfractionated heparin directly into the thombectomized vein.