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472 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
https://t.me/med1917
Oasis
The Oasis catheter (Boston Scientifi c, Natick, MA), orig­inally marketed as the Shredding Embolectomy Thrombec­tomy catheter, is a triple-lumen catheter placed over a guidewire that allows for the infusion of saline and simul­taneous aspiration of thrombus. In contrast to the ATS system, which requires a separate drive unit, the Oasis can be powered by a standard power injector. The presence of the dedicated wire lumen also avoids a reduction in suction through the exhaust lumen that can be observed with the ATS device.
In a canine DVT model, the Oasis catheter has an 80% procedural success rate. All vessels exhibited endothelial denudation that occasionally extended into the internal elastic lamina while no injury extended to the media. Sig­nifi cant pulmonary embolization was not observed.
55
Technical success in the treatment of thrombosed dialysis grafts approaches 90%, and clinical success, defi ned as the ability to access the grafts for dialysis, ranges from 76 to
56,57
81%.
Takahashi et al. reported a single case of successful use of the Oasis thrombectomy device to treat a symptom­atic mesenteric venous thrombosis in the portal and superior mesenteric veins.
58
ProLumen
Approved for use in hemodialysis access, the ProLumen (Datascope, Montvale, NJ) is a self-contained thrombec­tomy catheter that requires no additional equipment. The device contains a 0.035 stainless steel S-wire with a radi­opaque tip. With a 5.8-Fr outer diameter, the catheter has a handheld battery operated drive unit that rotates the sigmoid shaped S-wire at approximately 4000. The S-wire maintains contact with the graft wall to release adherent thrombus. No reports are published to date using the ProLumen for treat­ment of DVT.
8Fr Multi-
Lumen
Catheter
Isolated Treatment Zone
FIGURE 50.4 The Trellis-8 Thrombectomy System.
Inflation/Infusion
Ports
Oscillation
Drive
Unit
bosis. In both reports, use of the TTS resulted in shorter treatment times when compared to CDT alone, and decreased doses of the thrombolytic agent used. No bleeding complica­tions were reported in any of the patients described. Neither patient described had a bleeding complication or pulmonary embolism reported.
59,60
X-Sizer
The X-Sizer helical thrombectomy catheter (ev3, Plym­outh, MN) is comprised of a rotating helical cutter that is housed in an outer sheath. The device is attached to a vacuum source for the aspiration of particulate matter created during the procedure. The device has been evaluated in the coro­nary arterial circulation, but to date treatment of hemodialy­sis grafts, the peripheral arterial tree, and the venous system has not been reported.
Trellis-8 Thrombectomy System
The Trellis-8 Thrombectomy System (Bacchus Vascular, Santa Clara, CA) combines CDT and PMT by isolating the thrombosed venous segment between proximal and distal occlusion balloons. After a thrombolytic drug is infused into this closed system, a sinusoidal wire mixes the lytic agent into the thrombus together. The balloon occlusion limits systemic exposure to the lytic agent and prevents pulmonary emboli. The slurry created in the treated segment is then aspirated to remove lysed clot and the residual active drug.
The Trellis-8 Thrombectomy System (see Figure 50.4) has been successful in treating both upper and lower extrem­ity venous thrombosis. Arko et al. reported use of the TTS to treat two patients with axillosubclavian vein thrombosis. Ramaiah et al. used the TTS to treat an iliofemoral throm-
DISCUSSION
An increasing number of patients with acute DVT are undergoing treatment with PMT. Advantages of PMT include immediate improvement of symptoms, decreased treatment times and complications when compared to CDT alone, and a possible reduction in the incidence and severity of PTS. Although many PMT catheters are commercially available, only the Trellis-8 Thrombectomy System and the ATS lytic power pulse system are approved by the FDA for treatment of acute DVT.
59
Some PMT catheters, such as those just mentioned, are designed to allow for the concomitant infusion of thrombo­lytic agents in order to more thoroughly remove thrombus.
Discussion 473
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The combination of PMT and pharmacologic thrombolysis can drastically reduce the treatment times compared to CDT alone. Arko et al. reported complete thrombus removal in two patients using the Trellis-8 Thrombectomy System with Alteplase (Genentech, South San Fransisco, CA) for UE DVT. These two patients were treated at a single setting and received 5 mg of Alteplase over 10 minutes.
59
When evaluating these devices in the treatment of throm­bosed hemodialysis access, the ATS, ATPTD, and Oasis were found to have equivalent technical success rates when compared to pulse-spray thrombolysis.
28,56,61
The procedure
times were signifi cantly shorter in the groups that underwent
38,56
PMT.
Complications such as bleeding requiring transfu­sion, pulmonary embolization, and arterial embolization were less in the PMT arm, but statistical signifi cance was not reached due to the small number of patients.
38
PMT most often allows patients to be treated in a single setting, thereby avoiding multiple trips to the angiography suite. Ramaiah et al. reported a single case of a patient that developed increased thrombus burden while on heparin. After failure following 36 hours of CDT with reteplase (Centocor, Horsham, PA), PMT using the Trellis-8 Throm­bectomy System was successful with complete clot lysis in 45 minutes.60 Similar results have been reported in the treat­ment of upper extremity DVT when using the Trellis-8 Thrombectomy System.
59
Bleeding complications may be less when compared to CDT. In 17 patients treated with PMT for LE DVT, Kasirajan et al. observed no hemorrhagic or access site com­plications.34 Bush et al. reported two patients that developed access site hematomas and one developed a retroperitoneal hematoma out of 20 patients treated for DVT with the ATS. None required surgical intervention or transfusion.
33
The discovery of an underlying venous stenosis can occur after PMT. Thirty-eight to 95% of patients have been shown to have a lesion that is treated with percutaneous angioplasty or primary stenting. Importance should be placed on opening these stenoses so as to avoid outfl ow obstruction. Reducing outfl ow obstruction helps prevent recurrent DVT and further reduces the severity of PTS.
Many authors have described the use of various PMT catheters in the treatment of DVT. To date no prospective randomized in vivo trial has been performed comparing PMT to other various methods of DVT treatment. In an in vitro model, Müller-Hülsbeck et al. compared the ATS without a guidewire, with a 0.016 guidewire, and with a
0.035 guidewire to the Hydrolyser, Oasis, and Amplatz Thrombectomy. Interestingly, the ATS had signifi cantly less thrombus removal using the 0.016 guidewire compared to other confi gurations. No signifi cant difference was found among the other catheters. The highest percentage of embo­lism was noted with the ATS.
50
Delomez et al. reported use of the Amplatz Thrombec­tomy Device in 18 patients with symptomatic LE DVT.
Successful recanalization was reported in 83% of patients. A permanent IVC fi lter was placed in one patient and a temporary fi lter placed in another. No pulmonary emboli
62
were reported.
The time thrombus was present prior to treatment ranged from four to 240 days. The age of DVT that can still be optimally treated with PMT has not been determined. Generally two weeks represents a common window used by many practicioners.
47,62–64
Thrombus older than this begin to have a denser fi brin network and are more resistant to PMT. Moreover, older thrombi are associated with an increased incidence of distal embolization.
63
PMT can also be used alone or in conjunction with thrombolytic therapy. In one study comparing multiple thrombectomy devices and lytic agents, Vendatham et al. reported improved results when coupling the two modalities compared to using either independently.23 This retrospective review analyzed 20 patients who underwent 22 procedures. Due to the retrospective nature of the study, the methods of CDT and the timing and use of PMT could not be controlled. Vendatham reported an 82% procedural success when both modalities were combined. Major bleeding requiring trans­fusion occurred in three patients. Reduced doses and throm­bolytic infusion times were observed in those undergoing adjunctive PMT. Based on his fi ndings, he concluded that PMT has an important role in the endoluminal therapy for DVT.23 Siablis et al. compared the ATS to CDT for the treatment of massive pulmonary embolism. He found sig­nifi cant decrease in the mean urokinase dose and duration of therapy in the ATS group.
36
Many clinical scenarios exist in daily practice in which pharmacologic therapy with either thrombolytic agents or anticoagulation are contraindicated. Although an IVC fi lter can be placed for prophylaxis against PE, serious short- and long-term sequelae can still threaten the limb. Aside from the short-term decrease in quality of life from edema and pain, the long-term sequelae of PTS are devastating. Multi­ple reports illustrate resolution of edema, pain, and disability with the use of PMT alone.
33,34,48
Other advantages include minimizing bleeding complications and shorter hospital stays. The benefi ts of immediate improvement of leg edema following the use of PMT are underestimated. Although PMT is not indicated in some scenarios (e.g., patients with very poor prognosis and DVT), a majority of patients may prove to benefi t. More prospective studies are needed to help determine who will benefi t most. As technology continues to change rapidly, past studies can be diffi cult to interpret. Future research must also take into account quality of life measures in the short and long term.
Potential disadvantages of PMT are related to the indi­vidual catheter designs. Common to the catheters that utilize the Venturi effect is the potential for fl uid overload resulting in congestive heart failure and pulmonary edema. The ATS, Hydrolyser, Oasis, and ATD are all designed to func­tion in an isovolumetric manner. Müller-Hülsbeck et al.
474 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
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evaluated all four PMT devices in an in vitro model, and found that none functioned isovolumetrically. The ratio of infused saline to aspirated fl uid improved for the ATS when the guidewire was left in place. The Oasis was noted to have the greatest discrepancy between infused saline and aspi­rated fl uid.
50
Another potential disadvantage of all PMT catheters is hemolysis. Qian et al. found no signifi cant differences regarding the hemolytic effect when comparing the Helix thrombectomy catheter and the ATD.65 Gandini et al. evalu­ated plasma free hemoglobin (PFH) levels and hematocrit in eight patients treated for iliocaval thrombosis with the ATD, and found no signifi cant abnormality in either param­eter in any patient after treatement.66 Ufl acker reported a signifi cant increase in PFH in 13 patients treated with the ATD. The PFH levels returned to normal within 24 hours.47 In preclinical evaluations, treatement with the ATS resulted in a transient increase in PFH and a concomitant decrease in the hematocrit.31 In 18 patients treated with the ATS for DVT, Delomez et al. reported no postoperative anemia. One patient developed a transient increase in haptoglobin without clinical sequelae.62 However, Danetz et al. reported two patients with chronic renal insuffi ency who developed pan­creatitis after using the ATS.67 The degree of hemolysis is directly proportional to the length of PMT. In patients with chronic renal insuffi ciency, minimizing the treatment time and careful attention to the hydration status may ameliorate the occurrence of post-treatment pancreatitis. Use of the ATPTD has not resulted in clinically signifi cant elevation of the PFH after treatment of thrombosed hemodialysis
38
grafts.
Based on these observations, patients with renal and hepatic insuffi ency should proceed with caution when con­sidering PMT. The increased PFH can result in intraneph­ronal cast formation resulting in acute renal failure. The increased PFH also increases heme catabolism, which enhances the formation of tetrapyrrol unconjugated biliru­bin. The unconjugated bilirubin is metabolized and excreted by the liver. Those with abnormal liver function may not tolerate the increased PFH.47 Although these considerations are paramount, no case of renal failure or fulminant hepatic failure has been reported after PMT.
CONCLUSION
PMT offers many benefi ts in short-term therapy for DVT. Faster thrombus removal, smaller doses of thrombo­lytic agents, and shorter treatment times translate into improved symptom relief, decreased complications, and more effi cient patient care. Additionally, more rapid throm­bus resolution potentially can preserve valvular function and decrease the incidence and severity of PTS. PMT should be considered as fi rst line therapy for patients presenting with
DVT. Advanced endovascular skills, as well as being well versed in possible complications of PMT, are required to provide safe and effective patient care.
References
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18. Castaneda F, Li R, Young K et al. Catheter-directed thrombolysis in deep venous thrombosis with use of reteplase: Immediate results and complications from a pilot study, J Vasc Interv Radiol. 2002. 13: 577–580.
19. Meissner MH. Thrombolytic therapy for acute deep vein thrombosis and the venous registry, Rev Cardiovasc Med. 2002. 3(suppl): S53–S60.
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21. Comerota AJ. Quality-of-life improvement using thrombolytic therapy for iliofemoral deep vein thrombosis, Rev Cardiovasc Med. 2002. 3: S61–S67.
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23. Vendantham S, Vesely TM, Parti N et al. Lower extremity venous thrombolysis with adjunctive mechanical thrombectomy, J Vasc Interv Radiol. 2002. 13: 1001–1008.
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25. Wildberger JE, Haage P, Bovelander J et al. Percutaneous venous thrombectomy using the Arrow-Trerotola percutaneous thrombolytic device (PTD) with temporary caval fi ltration: In vitro investigations, Cardiovasc Intervent Radiol. 2005. 28: 221–227.
26. Trerotola SO, McLennan G, Davidson D et al. Preclinical in vivo testing of the Arrow-Trerotola percutaneous thrombolytic device for venous thrombosis, J Vasc Interv Radiol. 2001. 12: 95–103.
27. Trerotola SO, McLennan G, Eclavea AC et al. Mechanical thromboly­sis of venous thrombosis in an animal model with use of temporary caval fi ltration, J Vasc Interv Radiol. 2001. 12: 1075–1085.
28. Danetz JS, McLafferty RB, Ayerdi J et al. Selective venography versus nonselective venography before vena cava fi lter placement: Evidence for more, not less, J Vasc Surg. 2003. 28: 928–934.
29. Stahr P, Rupprecht HJ, Voigtlander T et al. A new thrombectomy catheter device (AngoJet) for the disruption of thrombi: An in vitro study, Catheter Cardiovasc Interv. 1999. 47: 381–389.
30. Bush RL, Lin PH, Lumsden AB. Mechanical thrombectomy in deep venous thrombosis, J Invas Cardiol. 2004. 16: 16S–22S.
31. Sharafuddin MJ, Hicks ME, Jennson ML et al. Rheolytic thrombec­tomy with the Angioget F-105 catheter: Preclinical evaluation of safety, J Vasc Interv Radiol. 1997. 8: 939–945.
32. Silva JA, Ramee SR, Collins TJ et al. Rheolytic thrombectomy in the treatment of acute limb-threatening ischemia: Immediate results and six-month follow-up of the multicenter AngioJet registry, Cathet Car­dovasc Diagn. 1998. 45: 386–393.
33. Bush RL, Lin PH, Bates JT et al. Pharmacomechanical thrombectomy for treatment of symptomatic lower extremity deep venous thrombosis: Safety and feasibility study, J Vasc Surg. 2004. 40: 965–970.
34. 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.
35. Schneider DB, Curry TK, Eichler CM et al. Percutaneous mechanical thrombectomy for the management of venous thoracic outlet syn­drome, J Endovasc Ther. 2003. 10: 336–340.
36. Siablis D, Karnabatidis D, Katsanos K et al. AngioJet rheolytic throm­bectomy versus local intrapulmonary thrombolysis in massive pulmo­nary embolism: A retrospective data analysis, J Endovasc Ther. 2005. 12: 206–214.
37. Ruy R, Lin TC, Kumpe D et al. Percuatneous mesenteric venous thrombecomty and thrombolysis: Successful treatment followed by liver transplantation, Liver Transpl Surg. 1998. 4: 222–225.
38. Trerotola SO, Vesely TM, Lund GB et al. Treatment of thrombosed hemodialysis access grafts: Arrow-Trerotola percutaneous thrombo­lytic device versus pulse-spray thrombolysis, Radiology. 1998. 206: 403–414.
39. McLennan G, Trerotola SO, Davidson D et al. The effects of a mechan­ical thrombolytic device on normal canine vein valves, J Vasc Interv Radiol. 2001. 12: 89–94.
40. Lazzaro CR, Treretola SO, Shah H et al. Modifi ed use of the Arrow-Trerotola percutaneous thrombolytic device for the treatment of thrombosed hemodialysis access grafts, JVIR. 1999. 10: 1025–
1031.
41. Rocˇek M, Peregrin JH, Lasˇtovicˇká J et al. Mechanical thrombolysis of thrombosed hemodialysis native fi stulas with use of the Arrow­Trerotola percutaneous thromblytic device: Our preliminary experi­ence, JVIR. 2000. 11: 1153–1158.
42. Trerotola SO, McLennan G, Davidson D et al. Preclinical in vivo testing of the Arrow-Trerotola percutaneous thrombolytic device for venous thrombosis, J Vasc Interv Radiol. 2001. 12-95–103.
43. Truong TH, Spuentrup E, Staatz G et al. Mechanical thrombectomy of iliocaval thrombosis using a protective expandable sheath, Cardiovasc Intervent Radiol. 2004. 27: 254–258.
44. Yasui K, Qian Z, Nazarian GK et al. Recirculation-type Amplatz clot macerator: Determination of particle size and distribution, JVIR. 1993. 4: 275–278.
45. Sofocleous CT, Cooper SG, Schur I et al. Retrospective comparison of the Amplatz thrombectomy device with modifi ed pulse-spray pharma­comechanical thrombolysis in the treatment of thrombosed hemodialy­sis access grafts, Radiology. 1999. 213: 561–567.
46. Ufl acker R, Rajagopalan PR, Selby JB et al. Thrombosed dialysis access grafts: Randomized comparison of the Amplatz thrombectomy device and surgical thromboembolectomy, Eur Radiol. 2004. 14: 2009–2014.
47. Ufl acker R. Mechanical thrombectomy in acute and subacute throm­bosis with use of the Amplatz device: Arterial and venous applications, J Vasc Interv Radiol. 1997. 8: 923–932.
48. Smith GJ, Molan MP, Brooks DM. Mechanical thrombectomy in acute venous thrombosis using an Amplatz thrombectomy device, Austral­asian Radiology. 1999. 43: 456–460.
49. Müller-Hülsbeck S, Brossmann J, Jahnke T et al. Mechanical throm­bectomy of major and massive pulmonary embolism with use of the Amplatz thrombectomy device, Invest Radiol. 2001. 36: 317–322.
50. Müller-Hülsbeck S, Grimm J, Leidt J et al. Comparison of in vitro effectiveness of mechanical thrombectomy devices, J Vasc Interv Radiol. 2001. 12: 1185–1191.
51. Bucker A, Schmitz-Rode T, Vorwerk D et al. Comparative in vitro study of two percutaneous hydrodynamic thrombectomy systems, J Vasc Interv Radiol. 1996. 7: 445–449.
52. Fava M, Loyola S, Huete I. Massive pulmonary embolism: Treatment with the hydrolyser thrombectomy catheter, J Vasc Interv Radiol.
2000. 11: 1159–1164.
53. Henry M, Amor M, Henry I et al. The hydrolyser thrombectomy cath­eter: A single-center experience, J Endovasc Surg. 1998. 5: 24–31.
54. Poon WL, Luk SH, Yam KY et al. Mechanical thrombectomy in infe­rior vena cava thrombosis after caval fi lter placement: A report of three cases, Cardiovasc Intervent Radiol. 2002. 25: 440–443.
55. Qian Z, Wholey M, Ferral H et al. Recanalization of thrombosed superfi cial femoral arteries with a hydraulic thrombectomy catheter in a canine model, AJR. 1999. 173: 1557–1563.
56. Barth KH, Gosnell MR, Palestrant AM et al. Hydrodynamic thrombec­tomy system versus pulse-spray thrombolysis for thrombosed hemodi­alysis grafts: A multicenter prospective randomized comparison, Radiology. 2000. 217: 678–684.
57. Sahni V, Kaniyur S, Malhotra A et al. Mechanical thrombectomy of occluded hemodialysis native fi stulas and grafts using a hydrodynamic
476 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
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thrombectomy catheter: Preliminary experience, Cardiovasc Intervent Radiol. 2005. Jul 28; [Epub ahead of print].
58. Takahashi N, Kuroki K, Yanaga K. Percutaneous transhepatic mechan­ical thrombectomy for acute mesenteric venous thrombosis, J Endo­vasc Ther. 2005. 12: 508–511.
59. Arko FR, Cipriano P, Lee E et al. Treatment of axillosubclavian vein thrombosis: A novel technique for rapid removal of clot using low-dose thrombolysis, J Endovasc Ther. 2003. 10: 733–738.
60. Ramaiah V, Del Santo PB, Rodriguez-Lopez JA et al. Trellis throm­bectomy system for the treatment of iliofemoral deep venous throm­bosis, J Endovasc Ther. 2003. 10: 585–589.
61. Sofocleous CT, Cooper SG, Schur I et al. Retrospective comparison of the Amplatz thrombectomy device with modifi ed pulse-spray pharma­comechanical thrombolysis in the treatment of thrombosed hemodialy­sis access grafts, Radiology. 1999. 213: 561–567.
62. Delomez M, Beregi JP, Willoteaux S et al. Mechanical thrombectomy in patients with deep venous thrombosis, Cardiovasc Interv Radiol.
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CHAPTER
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51
Mechanical Thrombectomy and Thrombolysis for
Acute Deep Venous Thrombosis
WEI ZHOU, PETER H. LIN, RUTH L. BUSH, ERIC K. PEDEN, and ALAN B. LUMSDEN
INTRODUCTION
Deep venous thrombosis (DVT) is estimated to affect 20 to 30% of all major surgical patients, and, as a result of pulmonary embolism, is responsible for more than 60,000 deaths annually in the United States. strategy for acute DVT largely remains systemic anticoagu­lation to prevent worsening of acute symptoms, pulmonary embolism, and recurrent thromboembolic events. However, conservative therapy with anticoagulation alone is rarely effi cient or suffi cient in reducing clot burden to prevent post­thrombotic syndrome, particularly in iliofemoral systems. Endovascular interventions, on the other hand, provide the capability of rapidly reestablishing patency of the affected veins, potentially preventing post-thrombotic complications, and timely revealing an inciting venous defect in patients with acute DVT. This chapter emphasizes on the rationale, various methods, and results of thrombolysis for acute DVT.
1,2
The current treatment
EPIDEMIOLOGY
Deep venous thrombosis has been recognized as a major health problem in the western culture. Incidence of DVT has been estimated at over one per 1000 per year in the United States.3 Similarly, the annual incidence in a British popula­tion studied was measured at 3.5 per 1000 per year.4 In Sweden, the incidence has been estimated at 1.6 per 1000 per year.5 Markel and colleagues followed a series of patients with DVT for a period of fi ve years and discovered that most involved veins had recanalized by six months and over 80% were recanalized at one year. By three years, all veins had recanalized, but residual thrombus was present in 50%.
6
Additionally, they noted that symptomatic DVTs involved the proximal segments in 95% of patients.7 The venous registry had similar fi ndings of iliofemoral involvement in 71% and the femoro-popliteal segment in 25%.
DVT is also a signifi cant marker for mortality. The one­year mortality rate of DVT has been found to be 16 to 30% with most deaths occurring within the fi rst month; this is at least three times as high as age-matched controls without
3,8
DVT.
CLINICAL PRESENTATION
AND DIAGNOSIS
The classic presentations of DVT are swelling and ten­derness, elevated temperature, and a positive Homans’ sign (calf pain on dorsifl exion of the foot) (see Figure 51.1). In an extreme scenario, phlegmasia cerulea dolens, as evi­dent by the painful blue appearance of the leg, can occur due to massive thrombosis involving the iliac veins and extending into the most distal venules in the leg. Phlegmasia cerulea dolens is a condition frequently associated with a hypercoagulable state or external obstruction, such as an underlying intraabdominal malignancy or May-Thurner syndrome.
Clinical diagnosis of DVT alone is unreliable due to only 50% of patients with evidence of DVT on venography having clinical symptoms. Venous duplex ultrasound, as the primary imaging technique, is extremely useful. Spectral Doppler can detect the presence of thrombus by determining normal or abnormal fl ow in the vessels. Normal Doppler will be unidirectional and spontaneous with respiratory phasicity. Flow should cease with Valsalva maneuver, and demonstrate augmentation by distal compression. The
8
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Controversies still exist over the pathophysiology of post thrombotic syndrome. Some authors believe that the primary mechanism is refl ux, whereas others think that it is the com­bination of refl ux and obstruction that leads to the most severe symptoms. Johnson studied the natural history of DVT by utilizing duplex ultrasound and demonstrated that the combination of refl ux and obstruction were three and a half times more likely in the legs with evidence of post­thrombotic syndrome than in those legs that appeared normal.11 Their fi ndings are also supported by Mohr and his colleagues, who demonstrated a progressive increase in post-thrombotic syndrome over 20 years.9 The highest risk group in their study were those patients under 40 with proxi­mal DVT, who were three times more likely to develop
FIGURE 51.1 A painful left lower extremity with severe swelling and
erythema due to acute deep venous thrombosis.
post-thrombotic symptoms than other groups.
Longer duration of venous occlusion has been shown to increase the likelihood of secondary refl ux, and thus post-
6,12
Additionally, the extent of the Doppler will appear abnormal when there is substantial occlusion of the vein. Flow augmentation and Valsalva will be diminished or absent. The most reliable method for detecting thrombus is compression. Compressions are done in gray scale in a transverse plane. The thrombus can only be ruled out when vessel walls completely collapse. Partial thrombosis may be present if the entire vein does not collapse.
thrombotic syndrome. original DVT, particularly multilevel disease and recurrent thrombosis, has been associated with an increased incidence of post-thrombotic syndrome.13 Techniques aimed at valve preservation and restoration of venous patency theoretically should decrease venous hypertension, thus reducing the inci­dence and degree of post-thrombotic symptoms. Improve­ments in venous hemodynamics also should lead to overall improvement in clinical symptoms. In fact, studies have shown that earlier clearance of the clot burden led to pre­served valvular function and less symptoms.
COMPLICATIONS AND POST-
THROMBOTIC SYNDROME
8,14
The potential complications of acute DVT include venous gangrene, pulmonary embolism, recurrent thromboembolic events, and the development of chronic venous insuffi ciency or post-thrombotic syndrome. Anticoagulation therapy, the current standard of care for acute DVT, may inhibit further clot propagation and prevent pulmonary embolism. However, it does not in itself prevent chronic post-thrombotic compli­cations. The consequences of chronic venous insuffi ciency and post-thrombotic syndrome are a major medical problem and often results in a signifi cant lifestyle compromise for the patient. DVT can render the venous valves incompetent, resulting in a spectrum of clinical presentations ranging from telengectasias and varicose veins through chronic lower extremity pain and edema to venous skin changes with lipodermatosclerosis and ulceration. The incidence of post­thrombotic syndrome following proximal venous thrombo­sis has been measured at 16 to 82%.
3,9
The incidence of ulceration has been estimated at 3 to 8% following DVT. Following extensive lower extremity deep venous throm­bosis, the post-thrombotic syndrome may manifest im­mediately or take several months or years to full patient debilitation.
10
SURGICAL THROMBECTOMY
Surgical thrombectomy with distal arteriovenous fi stula creation for acute DVT is mainly of historical interest because of its associated operative morbidity primarily related to blood loss and poor clinical outcomes. However, surgical thrombectomy may still be used in the clinical setting of venous gangrene with impending limb loss. The best reported results are from a 1999 study by Juhan et al. These authors demonstrated an improvement in long-term results following surgical venous thrombectomy for acute iliofemoral DVT in their personal series.15 In a review of 77 patients, principally young trauma victims, valvular compe­tency was preserved at fi ve years in 80%, and 90% of limbs had either mild symptoms of chronic venous insuffi ciency or no symptoms at all. Additionally, Meissner and col­leagues reported their results of venous thrombectomy with arteriovenous fi stula in 30 patients.16 In all but three patients, patency of the iliofemoral segment was maintained 12 months after clot extraction. However, other series have demonstrated only average results for this all but abandoned technique.
15
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THROMBOLYSIS
In light of the morbidity of post-thrombotic syndrome, more aggressive treatment regimens for acute DVTs have been proposed. The early reports of surgical thrombectomy and its impact on post-thrombotic syndrome encouraged development of nonsurgical methods to remove clots and achieve the same goals with minimally invasive means. Thrombolysis of DVTs offers potential rapid clearance of thrombus from the obstructed segments and reduction of subsequent obstruction and refl ux. A review done by Com­erota of 13 studies comparing thrombolysis versus antico­agulation confi rmed the effi cacy of thrombolysis.14 Their review also confi rmed that successful thrombolysis was associated with a lower incidence of post-thrombotic syn­drome and improved venous function during long-term follow-up.
There are various means of achieving thrombolysis of occluded venous segments. The basic options are chemical thrombolysis given either systemically or catheter-directed into the thrombus, percutaneous mechanical thrombectomy (PMT), or the combination of the two, termed pharmaco­mechanical thrombectomy.
thrombolysis due in part to more complete clot lysis com­bined with a lower rate of bleeding complications. By using one of the many commercially available multiple sidehole infusion catheters, higher drug concentrations are delivered directly to the location of the thrombus. An analysis of multiple studies by Comerota and Aldridge demonstrated increased success in treating patients with iliofemoral DVT by utilizing catheter-directed thrombolysis.
Catheter-directed thrombolysis has been advocated because of its theoretical advantage of complete and rapid clot dissolution. Multiple studies have documented the effi ­cacy of several lytic agents in the treatment of acute DVT, with total infusion times needed for thrombus removal
19–23
ranging from hours to days.
An association between time to lysis and the development of venous refl ux was evaluated in patients using serial duplex scans following a DVT episode.24 With the exception of the posterior tibial vein, early lysis and rapid venous recanalization appears to protect valve integrity in the lower extremity. Although catheter­directed thrombolysis results in early thrombus clearance and thus, potential lower incidence of post-thrombotic syn­drome by preservation of valvular function,19 the compli­cated profi le of the lytic agent and the infusion times may limit its widespread use.
Systemic Thrombolysis
Early reports documented success in treating phlegmasia with streptokinase, with enthusiastic reports of excellent results “beyond expectation.” Since then, several investiga­tors have found benefi ts of systemic thrombolysis.
8,14
Com­erota and Aldridge reviewed data from 13 studies comparing anticoagulant therapy with thrombolytic therapy for DVT in 591 patients.14 They found that complete lysis was observed in 45% of patients who received lytic therapy vesus 4% of patients treated with heparin alone. In addition, patients with successful lysis had a lower incidence of post-thrombotic syndrome and improved long-term venous function during long-term follow-up.
Not all reports of systemic thrombolysis had favorable results. In a report of 250 patients with received systemic or local therapy with rt-PA, streptokinase, or urokinase, Sch­weizer found signifi cantly greater patency and reduced inci­dence of post thrombotic syndrome in the group with lysis.
17
However, when taking into account a 5% major bleeding complication rate and an apparent increase in pulmonary embolism, they recommended selective use of systemic thrombolysis for limb-threatening situations only. Other studies also echo this observation.
18
Catheter-Directed Thrombolysis
The delivery of a pharmacologic lytic agent directly into an existing venous thrombosis has overtaken systemic
Technique for Catheter-
Directed Thrombolysis
All procedures are performed in a fully equipped operat­ing room with endovascular capabilities. Local anesthesia with light sedation is administered in most patients, whereas general anesthesia is used for patients not tolerating local anesthesia with sedation. For acute lower extremity DVT, the popliteal vein is cannulated using ultrasound-guided venous puncture techniques with the patient in the prone position (see Figure 51.2). Brachial vein is commonly accessed for acute upper extremity DVT. Following punc­ture of the vessel with a 21-gauge needle, a 0.014 guidewire is inserted and subsequently exchanged for a 0.035 guide­wire. A 6 French guiding sheath next is advanced into the vessel. Hand injection of 10–15 cc contrast is performed to confi rm the diagnosis as well as defi ne the anatomy and extent of the thrombus (see Figure 51.3). A 0.035 angled guidewire (Boston Scientifi c, MA) frequently is used to navigate through the occluded vein with relative ease in the setting of acute DVT. Next, the lysis catheter (Mewissen, Boston Scientifi c) with appropriate infusion length is advanced over the guidewire.
We typically start infusion by injecting 1- to 2-mg tissue plasminogen activator (tPA) through the catheter. Note that the Mewissen catheter must have a guidewire inserted to block the end hole and force the lytic agent through the side-holes. The tPA then is infused at the rate of 0.5 to
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FIGURE 51.2 Cannulation of the popliteal vein using ultrasound-guided
venous puncture techniques with the patient in the prone position.
FIGURE 51.4 Angioplasty being performed to macerate the residual
thrombus and achieve a patent venous lumen.
FIGURE 51.3 Ascending venogram being performed following cannula-
tion of the popliteal vein to confirm the diagnosis as well as define the anatomy and extent of the thrombus.
1 mg/hour through the catheter, and heparin at 500 units/ hour is infused concurrently through side port of sheath.
The patient subsequently is returned to the endovascular
suite after 12 to 24 hours thrombolysis. A 0.035 guidewire is inserted and the infusion catheter is removed. A repeat venogram is next performed by using hand injection of the contrast. A new catheter may be placed and repositioned to continue infusion if necessary. Once maximal thrombus removal has been achieved, angioplasty often is performed to macerate the residual thrombus (see Figure 51.4). Addi­tional stents may be used for stenotic areas. The most common location of extrinsic venous compression is at the junction of the left common iliac vein with the inferior vena cava. However, stenting of all areas with residual stenosis is performed, even if it necessitates crossing the hip joint. Wallstents are our stent of choice for venous angioplasty,
because of the large diameters and lengths. Failure to ade­quately resolve stenosis will result in rethrombosis.
PERCUTANEOUS MECHANICAL
THROMBECTOMY (PMT)
Although thrombolysis, both systemic and catheter­directed, is effective in relieving clot burden early and potentially decreasing post-thrombotic complication, the bleeding risks due to lytic agents have limited its usage. Therefore, PMT has emerged as an advantageous option for the treatment of acute DVT. There are several commercially available thrombectomy catheters (see Table 51.1). However, a full discussion of each of the catheters is beyond the scope of this article. The catheters fall into one of two categories for clot extraction mechanism: microfragmentation or thrombo-aspiration (so-called Venturi effect). Several PMT catheters may be used in combination with adjunctive thrombolytic agents for more complete and rapid thrombus removal with lower lytic infusion doses and durations. Reducing the dosage and/or time for complete thrombolysis should translate into cost savings and lower bleeding com­plications. Furthermore, inciting lesions leading to thrombo­sis may be unmasked with PMT with or without adjunctive lysis. Venous stenoses could be treated following PMT and/ or thrombolysis in the same operative setting. Our experi­ence is with the AngioJet® thrombectomy system (Possis Medical Inc., Minneapolis, MN), which will be described in this chapter.
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TABLE 51.1 Commercially Available and Investigational
Thrombectomy Devices
Mechanism of clot Clot suctioning Catheter name extraction capability
AngioJet (Possis, Inc.) Venturi Yes Hydrolyser (Cordis, Inc.) Venturi Yes Oasis (Boston Scientifi c/ Venturi Yes Meditech) Amplatz (Microvena) Microfragmentation No Helix (EV3) Microfragmentation No Treretola (Arrow Microfragmentation No International) Casteñeda and Cragg Microfragmentation No Brush (Micro Therapeutics) Trellis infusion catheter Microfragmentation Yes (Bacchus Vascular)
FIGURE 51.5 A three-way stopcock is placed on the AngioJet Rheolytic
catheter outflow lumen between the catheter and the aspiration tubing. The stopcock is in the off position converting the catheter into a lytic infusion system.
directed jets. These high-velocity jets create a localized low-
Several authors have evaluated multiple PMT catheters in the treatment of DVT. However, to date, there is no pro­spective, randomized trial data available. In one review, Vedantham et al. used percutaneous mechanical thrombec­tomy (several devices tested including Amplatz Thrombec­tomy Device, Microvena, White Bear Lake, MN; AngioJet; Trerotola Percutaneous Thrombectomy Device, Arrow International, Reading, PA; Oasis, Boston Scientifi c/ Meditech, Natick, MA) with catheter-directed thrombolysis for the treatment of lower extremity DVT.25 Procedural success was achieved in 82% of the patients with underlying culprit stenoses uncovered and stented in 15 patients (18 limbs). These authors reported substantial thrombus removal with the two techniques combined compared to either alone. Another group, using only the Amplatz Thrombectomy Device, reported successful recanalization of the throm­bosed segment in 83% of patients with proximal DVT.26 At
29.6 months follow-up, 10 patients had no or minimal symp­toms relating to the episode and only one patient had devel­oped post-thrombotic sequelae.
pressure zone (Bernoulli effect) for thrombus aspiration and maceration. The jets also provide the driving force for evac­uation of thrombus particulate debris through the catheter. The Xpeedior catheter design also has a means for radially directed low-velocity fl uid recirculation to assist with dis­lodgment from the vessel wall and direction to the catheter
®
tip for evacuation. The AngioJet
system works in an iso­volumetric manner: the saline infusion fl ow rate (60 cc/min) is in balance with the evacuation rate of thrombus particulate debris.
The infusion solution of saline may be replaced with saline mixed with a thrombolytic agent (1000 L saline com­bined with 250,000 u urokinase). A three-way stopcock is placed on the catheter outfl ow lumen between the catheter and the aspiration tubing. The stopcock can be positioned in the off setting, thus converting the thrombectomy catheter into a high pressure infusion—labeled “power pulse spray” by interventionalists who use this technique (see Figure
51.5). After lacing the thrombus with the pharmological agent and waiting an appropriate period of time (average 20 minutes), the stopcock is resumed in the open position and
Angiojet® Rheolytic Thrombectomy
System Description
The AngioJet® rheolytic thrombectomy system consists
aspiration performed (see Figure 51.6). If concern exists for pulmonary embolism during this procedure, a dual-purpose removable/permanent vena caval fi lter may be placed at the beginning prior to PMT.
of three components: a single-use catheter, a single-use pump set, and a pump drive unit. The 6 Fr Xpeedior catheter has a working length of 60, 100, or 120 cm, is introduced via a percutaneous approach (6 Fr sheath) and operates over a 0.035 guidewire. The dual lumen catheter design consists of one lumen supplying pressurized saline to the distal cath­eter tip, and a second lumen incorporating the fi rst lumen, guidewire, and thrombus particulate debris. The drive unit/ pump generates high pressure (10,000 psi) pulsatile saline fl ow that exits the catheter tip through multiple retrograde-
Technique of PMT for the Treatment of DVT
The AngioJet® rheolytic thrombectomy system is approved by the FDA for clot removal, particularly coronary arteries and hemodialysis grafts. The techniques described herein represent preferences of the authors based on experi­ence, not recommendations from a manufacturer. Subse­quent interventions such as endovascular stenting depend upon the judgment of the treating physician.