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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3829_Библиотеки_им_академика_М_И_Перельмана

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a comprehensive review of the PMT catheters and descrip-
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tions of more common treatment techniques.
TECHNIQUE
In order to successfully perform PMT, several general premises must be considered.  ese include whether to place a temporary vena cava  lter, determining optimal site for venous access, and how to traverse the thrombosis. Although the technique unique to each PMT catheter is highly variable, these general principles apply to most clini­cal scenarios in treating DVT. Following thrombus removal, subsequent interventions such as balloon angioplasty and/ or stenting can be performed if necessary.
TEMPORARY INFERIOR VENA CAVA IVC
FILTER PLACEMENT
 e risk of fatal PE during thrombolytic therapy of iliac
24
vein thrombus has been reported as high as 6%.
All PMT devices, including those that aspirate during treatment, generate small particles that can migrate to the pulmonary circulation.  e placement of a retrievable IVC  lter has become a valuable adjunct to PMT.  ere are many types of temporary IVC  lters available with di erent time periods for retrieval (see Table47.1). Additionally, each  lter varies in the approach to deployment and retrieval.  ese impor­tant issues must be considered prior toPMT.
An in vitro model of early large-volume DVT demon­strated that in placing an IVC  lter prior to PMT, 99% of particles larger than 500µm were either macerated by the
25
device or captured by the  lter.
Trerotola etal. demon­strated a signi cant number of clinically signi cant segmen­tal and subsegmental pulmonary emboli while evaluating the Arrow-Trerotola Percutaneous  rombectomy Device (Arrow International, Reading, PA) in a canine model.
26
Further investigations determined that use of a temporary IVC  lter reduced the number of pulmonary emboli as
27
diagnosed by pulmonary angiography.
In the majority of patients, placement of a retriev­able IVC  lter should be performed just prior to PMT. Generally, access to the deployment site should be void of
thrombus, and guide wire traversal should be observed with  uoroscopy for any deviation or di culty that may indicate the presence of thrombus. Avenogram should be obtained prior to deployment of the IVC  lter to identify the renal veins and to further ensure the proposed deployment loca­tion is devoid of any thrombus. Alow threshold to perform venography by selective catheterization should be consid­ered if nonselective venography fails to show important
28
venous tributaries.
Depending on the results of PMT, the  lter can be removed immediately or remain in place 1 to 3 weeks during the healing process.  e IVC  lter should remain in place if contraindications to anticoagulation arise, development of recurrent DVT, or increases in DVT riskoccur.
V E N O U S  A C C E S S
If possible, the same venous access for IVC  lter placement should be used when selecting an access site to perform PMT.  e ipsilateral common femoral vein is the optimal access site for thrombus con ned to the iliocaval segments. In this clinical scenario, the IVC  lter should be placed via the contralateral femoral vein. If the thrombosis is con ned to a single lower extremity, possible access sites include either common femoral vein or the ipsilateral popliteal vein.  e internal jugular vein can also be used to access DVT in the lower extremities.
Generally, access to lower extremity DVT from the external iliac vein to the super cial femoral vein is from the contralateral common femoral vein. Selective catheteriza­tion comes over the iliac vein bifurcation and the involved contralateral venous segments are accessed in a retrograde direction. If the thrombus burden is high or there is antici­pated di culty in performing a retrograde cannulation, antegrade access through the ipsilateral popliteal vein is preferred.
 e antegrade approach through the ipsilateral popliteal vein to treat iliofemoral DVT remains the most common alternative to the contralateral approach. With the patient in the prone position, duplex ultrasound is required for needle guidance. Amicropuncture kit that uses a 22-gauge needle and a 0.014-inch wire aids in providing a nontrau­matic, safe access. Advantages of antegrade access through
Table47.1 RETRIEVABLE IVC FILTERS
ALN (ALN Implants Chirurgicaux, Ghisonaccia,
France)
Recovery (Bard Peripheral Vascular, Tempe, AZ) X X X X X X
Günther Tulip (Cook Medical, Bloomington, IN) X X X X X
OptEase (Cordis Endovascular, Warren, NJ) X X X
SafeFlo (Rafael Medical, Caesarea, Israel) X X
F I LT E R INSERTION SITES RETRIEVAL SITES
F E M O R A L J U G U L A R A N T E C U B I T A L F E M O R A L J U G U L A R A N T E C U B I T A L
X X X X
398 • VENOUS THROMBOEMBOLISM
the popliteal vein include ease of traversing valves and mini-
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mal need for selective catheterization.
Other more remote sites such as the jugular and subcla­vian veins have been used to gain access to DV T. More com­monly these access sites may be required for direct access to the con uence of the common iliac veins. Occasionally, common iliac vein stenosis in combination with thrombo­sis can be negotiated only via a retrograde approach from the brachiocephalic veins. Treating iliofemoral DVT may require dual access with the use of a snare to pull the wire from one access site to another, thereby providing for more stable access to treat with PMT. In the case of upper extrem­ity DVT treatment, venous access generally is obtained at the ipsilateral basilic vein.  is also requires ultrasound guidance and use of a micropuncturekit.
TRAVERSING THE THROMBUS
A er de ning the venous segment by venography as an entry point to the thrombus, stable access with a sheath or guiding catheter usually is required. A sti hydrophilic guide wire (Boston Scienti c; Natick, MA) allows optimal manipulation and guidance in gaining access into throm­bus. As the wire is advanced, a catheter is advanced over the wire to maintain crossing and increase stability. Usually a straight catheter such as a 4-Fr. glidecath (Boston Scienti c, Natick, MA) is used in combination with a sti angled guide wire (Boston Scienti c, Natick, MA). Alternatively, an angled catheter such as a Kumpe catheter (Cook; Bloomington, IN) can be used with a straight guide wire (Boston Scienti c; Natick, MA).  ese combinations are particularly useful when traversing thrombus in a retro­grade direction. Valve lea ets can be negotiated with slow directed movements under magni ed  uoroscopy.
Another technique that can facilitate crossing thrombs is forming the guide wire into a long “J” con guration.  is maneuver takes advantage of the sti portion of the guide-wire while preventing trauma to the vein wall because the  oppy tip is in a “J” shape. When pushing antegrade through older thrombus, this technique may prove useful. Emphasis should be placed on not forcing wires, catheters, and PMT systems into position. Careful continuous  uoro­scopic imaging is mandatory when moving wires and cath­eters and observing their tracking path is vital to avoiding injury. Amanifold hand injection system with the ability to withdraw contrast and dilute with saline is helpful in facilitating quick, periodic views to assure correct catheter position.
D E V I C E S
PMT catheters can be categorized a variety of ways. One important distinction is whether the catheter has com­plete or incomplete wall contact. Advantages of complete
wall contact include more thorough thrombus dissolution. Potential disadvantages include endothelial and valvular damage. PMT catheters also can be categorized by their method of thrombus dissolution.  ese mechanical meth­ods include rheolytic aspiration, rotational thrombectomy, and ultrasonic fragmentation. Rheolytic devices remove thrombus based on the Venturi e ect.  is adaptation of the Bernoulli e ect states that  uid moving at high speeds generates low pressure zones.  ese low pressure zones cre­ate a partial vacuum, termed the Venturi e ect. In rheolytic thrombectomy devices, high speed saline jets are directed into the thrombus creating low pressure zones near the cath­eter where the fragments are aspirated through the device via the vacuum e ect.  eoretic advantages of rheolytic aspiration include less valvular damage and decreased endo­thelia damage.
 e rotational devices are designed to spin at varying speeds within the thrombus causing fragmentation.  is mechanism also can result in increased endothelial dam­age. Ultrasonic fragmentation occurs through the delivery of high-frequency, low-energy ultrasound.  e ultrasound waves cause the aggregated  brin strands to dissociate, resulting in both increased permeability of the thrombus and exposure of new plasminogen activator sites on the  brin strands.  rombolytic drugs are forced into the thrombus by the radial pressure generated by the ultrasoundwaves.
Finally, PMT catheters are designed to either aspi­rate fragmented thrombus or create a near liquefaction of thrombus that migrates into the venous circulation. Ultimately, the microemboli are propelled to the pulmo­nary circulation, where endogenous lysis takes place.  e aspiration catheters can increase blood loss associated with the procedure, and, therefore, the operator must be vigilant in monitoring the aspirated volume. Clinically signi cant sequelae of pulmonary emboli from the nonaspiration catheters have not been reported a er treatment for DVT. Table47.2 includes the commercially available devices sub­sequently discussed in this chapter.
ANGIOJET
THROMBECTOMYSYSTEM
Indications for use approved by the US Food and Drug Administration (FDA) of the AngioJet thrombectomy system (ATS; Possis Medical, Minneapolis, MN) include treatment of peripheral arterial occlusions, thrombosed hemodialysis gra s, and DVT.  is dual lumen catheter (see Figure 47.1) operates on the Bernoulli-Venturi prin­ciples. Saline or a thrombolytic drug are infused by the drive unit to generate approximately 10,000 psi of pressure within the catheter.  e infusate is ejected from the catheter in retrograde-directed, pulsatile jets.  e jets generate low pressure zones that allow for thrombus maceration and aspi­ration. An exhaust port near the tip of the catheter allows for aspiration thereby avoiding the potential for localized
PERCUTANEOUS MECHANICAL THROMBECTOMY IN THE TREATMENT OF DVT • 399
Table47.2 PMT DEVICES
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DEVICE METHOD OF
AKonya Eliminator Arrow-Trerotola AngioJet XMI XVG Xpeedior 120 AVX XMI-RX+ DVX Castaneda Over-the-Wire Brush Helix Clot Buster  rombectomy
Device (Amplatz Device)
Lysus Infusion System
Oasis  rombectomy System ProLumen  rombex PMT Trellis Infusion System X-Sizer Catheter System
THROMBUS
REMOVAL
Mechanical Mechanical
Rheolytic Rheolytic Rheolytic Rheolytic Rheolytic Rheolytic Mechanical Mechanical
Ultrasonic
Rheolytic Mechanical Mechanical Mechanical Mechanical
WA L L
CONTACT
Mechanical Complete
Incomplete Incomplete Incomplete Incomplete Incomplete Incomplete Complete Incomplete
Incomplete
Complete Incomplete Incomplete Incomplete
endothelial damage from a more eccentrically placed vor­tex. Ninety-nine percent of the particulate matter generated
29
by the ATS is 0 to 12µm in diameter.
Aseparate pump drive unit is necessary for the catheter to function with dual lumen tubing that delivers the infusate and collects the e u­ent.  e system functions in an isovolumetric manner with
30
60 cc/min being infused and aspirated simultaneously.
Multiple catheters have been designed for use in vessels of varying diameters and locations (see Table47.3). Additionally, di erent types of tubing are available to allow for saline infu­sion or power pulsation. Power pulsation is designed to force standard pharmacologic thrombolytics into the thrombus. In contrast, traditional CDT uses lacing , whereby the drug seeps from the multiple side holes of an infusion catheter.
Sharafuddin et al. evaluated endothelial damage incurred a er use of the ATS compared to the Fogarty bal­loon embolectomy in a canine model.  e ATS-treated ves­sels had signi cantly more endothelial coverage than vessels
ASPIRATION
CATHETER
No Yes
Yes Yes Yes Yes Yes Yes N o N o
N o
Ye s
Yes Yes
treated with the Fogarty balloon.
FDA APPROVED INDICATION
 rombosed AVF and dialysis gra s  rombosed AVF and dialysis gra s
Coronary or vein gra lesions >2mm  rombosed infrainguinal arteries >3mm  rombosed infrainguinal arteries >3mm  rombosed dialysis gra s  rombosed infrainguinal arteries >2mm  rombosed infrainguinal arteries >3mm  rombosed dialysis gra s  rombosed AVF and dialysis gra s
Selective infusion of medication into
peripheral vessels  rombosed dialysis gra s  rombosed dialysis gra s  rombosed dialysis gra s
 rombosed dialysis gra s
31
Segments treated with the ATS showed no di erence in endothelial coverage or valvular damage when histologically compared to untreated control segments.
 rombus extraction rates using the ATS range from 52
22
to 95%. to the adjunctive use of pharmacologic thrombolysis.
 is wide range of variability appears to be related
32
 e ATS has been used in the treatment of symptomatic lower extremity DVT with success. Bush etal. reported the use of the ATS in the treatment of twenty-three limbs in twenty patients. Technical success was achieved in   een of the twenty-three treated limbs.  e remaining limbs dem­onstrated varying degrees of thrombus removal. Seven of twelve patients being treated for iliofemoral DVT had pro­phylactic IVC  lters placed. Marked clinical improvement within 24 h of therapy was noted in 74% of patients. Only three minor bleeding complications were noted, and no one
33
required a blood transfusion.
Figure47.1 (A) Demonstration of the Bernoulli-Venturi e ect as used by the Angiojet thrombectomy system. (B) e free-standing pump drive unit
for the Angiojet thrombectomy system.
B
A
400 • VENOUS THROMBOEMBOLISM
Table47.3 ANGIOJET THROMBECTOMY SYSTEM CATHETERS
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C AT H E T E R M I N . V E S S E L
XMI-OTW XMI-RX+ XVG Xpeedior D V X
DIAMETER
>2mm >2mm >3mm >3mm >3mm
W O R K I N G
LENGTH
135cm 135cm 140cm 120cm 90cm
Kasirajan et al. reported similar results in seventeen patients treated with the ATS.  rombus extraction rates were lower with only 24% having >90% thrombus removal. Adjunctive thrombolytic therapy was used in nine of thir­teen that demonstrated less than 90% thrombus extrac­tion. Eighty-two percent of patients had signi cant clinical
34
improvement, and no complications were reported.
 e ATS also has been successfully used in the manage­ment of Paget-Schroetter’s syndrome, PE, and mesenteric
35–37
venous thrombosis.
AKONYA ELIMINATOR
 e Eliminator catheter (IDev Technologies, Houston, TX) is a nonmotor-driven thrombectomy device approved by the FDA for thrombectomy of dialysis gra s.  e device uses a 6-Fr. adjustable basket that can accommodate vessels from 2 to 10mm in diameter.  e catheter has directional control that allows easy navigation of tortuous vessels.  e catheter has no drive unit, and through manipulation in an axial direction or manual rotation, the thrombus can be stripped from the veinwall.
A R R O W  T R E R O T O L A
PERCUTANEOUS
THROMBECTOMYDEVICE
 e Arrow-Trerotola Percutaneous  rombectomy Device (ATPTD) fragments thrombus using a self-expanding 9-mm fragmentation cage.  e device comes as either an over-the-wire con guration or the original design whereby the cage is constrained by a sheath.  e latter device must be positioned across the thrombus before withdrawing the sheath and releasing the fragmentation cage. In both devices, the cage rotates at 3,000 rpm and is pulled through the thrombus.  e rotating cage strips and macerates throm­bus from the vein wall creating a slurry that can be aspirated through the sheath. Two passes of the device usually provide
38
optimal clot fragmentation.
Damage to the veins a er thrombectomy with the ATPTD was assessed in an experimental canine model.  e device was passed  ve times in the antegrade direction through thrombosed lateral saphenous veins.  e venous segments were assessed for endothelial loss, the presence of thrombus, and valvular damage. Compared to valves desig­nated as controls in untreated thrombosed lateral saphenous
GUIDEWIRE
COMPATIBILITY
0.014″
0.014″
0.014″
0.035″
0.035″
S H E A T H
COMPATIBILITY
4 Fr. 4 Fr. 5 Fr. 6 Fr. 6 Fr.
veins, valves in the experimental group treated with ATPTD
39
had signi cantly less in ammatory cell in ltrates.
Technical success rates are reported between 92 and
100% when treating thrombosed dialysis gra s.
38,40,41
Procedure times are markedly shortened when compared to
38
pulse-spray thrombolysis. from 39 to 70%.
38,41
Ninety-day patency rates range
Preliminary work has begun to evalu­ate the ATPTD for treating DVT. Animal studies indicate promising local success rates, but segmental and subsegmen­tal pulmonary emboli were demonstrated with concomitant increases in mean and systolic pulmonary arterial pressure. Increasing pCO
and acidosis were also observed. 42  e
2
thrombus fragments produced by the device range in size
42
from <1mm to as high as 3mm.
Truong etal. reported successful PMT using the ATPTD in a patient that pre­sented with a subacute iliocaval thrombosis. Atemporary Günther basket  lter was placed prior to intervention. At 3 months, magnetic resonance imaging (MRI) demon-
43
strated no recurrent thrombosis in the treated vessels.
HELIX CLOTBUSTER
Previously marketed as the Amplatz  rombectomy Device, the HELIX Clot Buster (ev3, Plymouth, MN) was the  rst device approved by the FDA for percutaneous treatment of thrombosed dialysis gra s. Basic components include an impeller mounted on a drive sha that is pow­ered by a compressed air turbine. Rotation of the impeller at 150,000 rpm creates a vortex at the distal tip of the catheter that draws in the thrombus and recirculates the particulate matter. Particles from this PMT catheter are less than 1,000
44
microns. thrombosed dialysis gra s range from 79 to 93%.
Success rates of the HELIX for treatment of
45,46
 e blunt tip design of the HELIX make it di cult to navigate tortuous vessels.
Successful treatment of venous thrombosis has been reported in multiple vascular segments using the HELIX. U acker reported treatment of nine acute and subacute venous thromboses in the IVC and iliac veins (n = 3), SVC and subclavian veins (n = 3), portal vein and tran­sjugular intrahepatic portosystemic shunt (TIPS) (n=2), and an IVC to pulmonary artery Fontan conduit (n=1).  romboses had been present from 2 d to four weeks.  ree patients had failed prior CDT with urokinase. PMT was successful in all CDT failures, but each required an adjunc­tive measure to ensure long-term patency. One patient being
PERCUTANEOUS MECHANICAL THROMBECTOMY IN THE TREATMENT OF DVT • 401
treated for an iliocaval thrombosis developed intraproce-
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dural shortness of breath attributed to pulmonary embo-
47
lism despite placement of an IVC  lter.
Similarly, Smith etal. reported using the HELIX in patients with DVT who had relative or absolute contraindications to pharmacologic thrombolysis. Treatment of DVT was performed in the superior mesenteric vein, bilateral femoral veins, and the
48
SVC and brachiocephalic veins. has been used to treat major and minor pulmonary emboli.
HYDROLYSER
Additionally, the HELIX
49
 is multilumen catheter (Cordis, Warren, NJ) is designed for over-the-wire use. It utilizes the Venturi e ect to frag­ment thrombus (see Figure47.2). Simultaneous infusion of thrombolytic drugs or saline is possible through an injec­tion port. Aspiration takes place through a 6-mm elliptical exhaust port that is located 4mm proximal to the distal tip of the catheter.
Disadvantages of the Hydrolyser (see Figure47.3) can include possible  uid overload and hemolysis. Additionally, the guide wire may obstruct the exhaust port and decrease the amount of thrombus extracted.  e eccentrically located exhaust port creates an imbalanced vortex.  is may result in tenting of the vessel toward the low pressure region and
22
increase the endothelial damage.
 e Hydrolyser was compared to the ATS in an in
50
vitro model to determine the degree of embolization.
 e
catheters were also compared with and without the guide wires in place, as previous data has indicated decreased e ectiveness when the guide wire remained.  e Hydrolyser demonstrated greater thrombus resolution and less dis­tal embolization when compared to the ATS.  rombus destruction was improved for both catheters when the
51
guide wire remained in the catheter.
Successful cases of PMT using the Hydrolyser for the treatment of acute DVT and pulmonary embolism have been reported.
52–54
Henry et al. reported 83% technical
success in a variety of patients with arterial, bypass gra ,
53
and venous thrombosis.
 rombus less than 10 d old provided the optimal therapeutic window when using the Hydrolyser, and segments treated took less than 4 min on
53
average.
Poon et al. reported on three women that had IVC thromboses treated with the Hydrolyser. None of these patients could receive heparin or thrombolytics due to neurosurgical problems. All patients were successfully treated with the Hydrolyser and had complete resolution of their lower extremity edema. Each patient had an IVC  lter placed, and one patient required a second treatment with
54
the Hydrolyser.
LYSUS INFUSION CATHETERSYSTEM
 e Lysus Infusion Catheter System (EKOS Corporation, Bothell, WA) uses high-frequency, low-powered ultrasound to lyse thrombus. A er traversal of the thrombus with guide wire, a multiholed drug delivery catheter is advanced over the guide wire.  e guide wire is removed and the ultra­sound core is placed within the catheter.  e ultrasound core contains many ultrasound transducers along its length, and a separate control system regulates the ultrasound out­put and temperature.  e core is actively cooled by a saline infusion that exits the distal tip of the catheter during treat­ment.  rombolytic drugs are infused via the multiholed delivery catheter and the radial force generated by the ultra­sound propels the drug away from the catheter and deeper into the more permeable thrombus.
Figure47.2  e Venturi e ect as used in the Hydrolyser Catheter (Cordis
Endovascular, Warren,NJ).
EXHAUST LUMEN
INJECTION LUMEN
402 • VENOUS THROMBOEMBOLISM
O A S I S
 e Oasis catheter (Boston Scienti c, Natick, MA), originally marketed as the Shredding Embolectomy  rombectomy catheter, is a triple-lumen catheter placed over a guide wire 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.  e 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
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SALINE INJECTION (MAD. 750 PSI)
HIGH PRESSURE CATHETER EXTENSION3-WAY STOPCOCK
INJECTION LUMEN
CUIDE WIRE
CLIP
100 200 300 400 500 600 700 800 900 1000
CLIP
Figure47.3  e Hydrolyser set-up.
1000 900 800 700 600 500 400 300 200 100
3-WAY STOPCOCK
EXHAUST LUMAN
HEMOSTASIS DEVICE
INJECTION BY HAND ONLY
COLLECTION BAG
internal elastic lamina, while no injury extended to the media .
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55
Signi cant pulmonary embolization was not observed.
Technical success in the treatment of thrombosed dialy­sis gra s approaches 90%, and clinical success, de ned as the ability to access the gra s 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 supe-
58
rior mesenteric veins.
extremity venous thrombosis. Arko etal. reported use of the TTS to treat two patients with axillosubclavian vein throm-
59
Ramaiah etal. used the TTS to treat an iliofemo-
bosis. ral thrombosis. In both reports, use of the TTS resulted in shorter treatment times when compared with 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 compli-
59,60
cation or PE reported.
P R O L U M E N
Approved for use in hemodialysis access, the ProLumen (Datascope, Montvale, NJ) is a self-contained thrombec­tomy catheter that requires no additional equipment.  e device contains a 0.035-inch 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 4,000 rpm.  e S-wire maintains contact with the gra wall to release adherent thrombus. No reports are published to date using the ProLumen for treatment ofDVT.
TRELLIS8 THROMBECTOMYSYSTEM
 e Trellis-8  rombectomy System (Bacchus Vascular, Santa Clara, CA) combines CDT and PMT by isolating the thrombosed venous segment between proximal and distal occlusion balloons. A er a thrombolytic drug is infused into this closed system, a sinusoidal wire mixes the lytic agent into the thrombus together.  e balloon occlusion limits systemic exposure to the lytic agent and prevents pulmonary emboli.  e slurry created in the treated segment is then aspirated to remove lysed clot and the residual activedrug.
 e Trellis-8  rombectomy System (see Figure47.4)
has been successful in treating both upper and lower
8Fr Multi-
Lumen
Catheter
Figure47.4  e Trellis-8  rombectomy System.
Isolated Treatment Zone
Ination/Infusion
Ports
Oscillation
Drive
Unit
X  S I Z E R
 e X-Sizer helical thrombectomy catheter (ev3, Plymouth, MN) is composed of a rotating helical cutter that is housed in an outer sheath.  e device is attached to a vacuum source for the aspiration of particulate matter created during the procedure.  e device has been evaluated in the coronary arterial circulation, but to date treatment of hemodialysis gra s, the peripheral arterial tree, and the venous system has not been reported.
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  rombectomy System and the ATS lytic power pulse system are approved by the FDA for treatment of acuteDVT.
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.  e 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  rombectomy System with Alteplase (Genentech, South San Francisco, CA) for upper extremity DVT.  ese two patients were treated at a single
59
setting and received 5 mg of Alteplase over 10min.
When evaluating these devices in the treatment of thrombosed hemodialysis access, the ATS, ATPTD, and Oasis were found to have equivalent technical success rates
28,56,61
when compared to pulse-spray thrombolysis.
 e
procedure times were signi cantly shorter in the groups
38,56
that underwent PMT.
Complications such as bleeding requiring transfusion, PE, and arterial embolization were less in the PMT arm, but statistical signi cance was not
38
reached due to the small number of patients.
PMT most o en 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
404 • VENOUS THROMBOEMBOLISM
that developed increased thrombus burden while on hepa-
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rin. A er failure following 36 h of CDT with reteplase (Centocor, Horsham, PA), PMT using the Trellis-8  rombectomy System was successful with complete clot
60
lysis in 45 minutes.
Similar results have been reported
in the treatment of upper extremity DVT when using the
59
Trellis-8  rombectomy System.
Bleeding complications may be less when compared to CDT. In seventeen patients treated with PMT for lower extremity DVT, Kasirajan etal. observed no hemorrhagic
34
or access site complications.
Bush et al. reported two patients that developed access site hematomas and one that developed a retroperitoneal hematoma out of twenty patients treated for DVT with the ATS. None required sur-
33
gical intervention or transfusion.
 e discovery of an underlying venous stenosis can occur a er PMT.  irty-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 out ow obstruction. Reducing out 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 guide wire, with a 0.016-inch guide wire, and with a 0.035-inch guide wire to the Hydrolyser, Oasis, and Amplatz  rombectomy. Interestingly, the ATS had sig­ni cantly less thrombus removal using the 0.016-inch guide wire compared to other con gurations. No signi cant dif­ference was found among the other catheters.  e highest
50
percentage of embolism was noted with theATS.
Delomez etal. reported use of the Amplatz  rombec­tomy Device in eighteen patients with symptomatic lower extremity DVT. Successful recanalization was reported in 83% of patients. Apermanent IVC  lter was placed in one patient and a temporary  lter placed in another. No pulmo-
62
nary emboli were reported.
 e time thrombus was pres­ent prior to treatment ranged from 4 to 240 d. e age of DVT that can still be optimally treated with PMT has not been determined. Generally 2 weeks represents a common
47,62–64
window used by many practicioners.
 rombi older than this begin to have a denser  brin network and are more resistant to PMT. Moreover, older thrombi are associated
63
with an increased incidence of distal embolization.
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
23
compared to using either independently.
 is retrospective review analyzed twenty patients who underwent twenty-two 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  ndings, he concluded that PMT has an important role in the endolumi-
23
nal therapy for DVT.
Siablis etal. compared the ATS with CDT for the treatment of massive pulmonary embolism. He found signi cant decrease in the mean urokinase dose and
36
duration of therapy in the ATS group.
Many clinical scenarios exist in daily practice in which pharmacologic therapy with either thrombolytic agents or anticoagulation are contraindicated. Although an IVC  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,
33,34,48
pain, and disability with the use of PMT alone.
Other advantages include minimizing bleeding complications and shorter hospital stays.  e bene 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 bene t. More prospective stud­ies are needed to help determine who will bene t most. As technology continues to change rapidly, past studies can be di 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 e ect is the potential for  uid overload resulting in congestive heart failure and pulmonary edema.  e ATS, Hydrolyser, Oasis, and ATD are all designed to function in an isovolumetric manner. Müller-Hülsbeck etal. evaluated all four PMT devices in an in vitro model, and found that none functioned isovolumetrically.  e ratio of infused saline to aspirated  uid improved for the ATS when the guide wire was le in place.  e Oasis was noted to have the greatest
50
discrepancy between infused saline and aspirated  uid.
Another potential disadvantage of all PMT catheters is hemolysis. Qian et al. found no signi cant di erences regarding the hemolytic e ect when comparing the Helix
65
thrombectomy catheter and the ATD.
Gandini etal. eval­uated plasma free hemoglobin (PFH) levels and hematocrit in eight patients treated for iliocaval thrombosis with the ATD, and found no signi cant abnormality in either param-
66
eter in any patient a er treatment.
U acker reported a sig-
ni cant increase in PFH in thirteen patients treated with the
47
ATD.  e PFH levels returned to normal within 24 h.
In preclinical evaluations, treatment with the ATS resultedin a transient increase in PFH and a concomitant decrease in
31
the hematocrit.
In eighteen patients treated with the ATS for DVT, Delomez etal. reported no postoperative anemia. One patient developed a transient increase in haptoglobin
PERCUTANEOUS MECHANICAL THROMBECTOMY IN THE TREATMENT OF DVT • 405
without clinical sequelae. 62 However, Danetz etal. reported
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two patients with chronic renal insu ciency who developed
67
pancreatitis a er using the ATS.
 e degree of hemolysis is directly proportional to the length of PMT. In patients with chronic renal insu ciency, minimizing the treatment time and careful attention to the hydration status may ame­liorate the occurrence of posttreatment pancreatitis. Use of the ATPTD has not resulted in clinically signi cant eleva­tion of the PFH a er treatment of thrombosed hemodialy-
38
sis gra s.
Based on these observations, patients with renal and hepatic insu ciency should proceed with caution when considering PMT.  e increased PFH can result in intra­nephronal cast formation resulting in acute renal failure.  e increased PFH also increases heme catabolism, which enhances the formation of tetrapyrrol unconjugated bili­rubin.  e unconjugated bilirubin is metabolized and excreted by the liver.  ose with abnormal liver function
47
may not tolerate the increased PFH.
Although these con­siderations are paramount, no case of renal failure or fulmi­nant hepatic failure has been reported a erPMT.
C O N C L U S I O N
PMT o ers many bene 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 e 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  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 e ective patientcare.
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5 : 24–31 .
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