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254 Cardiovascular Thrombus
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reasons for the lack of clinical improvement from aspiration thrombectomy might be that the current-generation aspiration catheter systems are not totally effective. The effectiveness of these catheters has been measured by improvement in surrogate markers of ischemia such as ST-segment elevat ion and myocardial blush grade. Based on these measurements, we know that the current aspiration catheters may lack precision, as they lead to improvement in reperfusion markers in only a minority of patients. This was supported by the fact that a visible thrombus was observed in only one-third of the cases in the aspirated blood from the coronary vasculature [6]. In addition, in their meta-analysis, Elgendy and colleagues showed that a myocardial blush grade of 2 was achieved in only roughly 60% of the patients undergoing aspiration thrombectomy, while resolution of ST-segment elevation was observed in approximately 70% of the patients [19]. These ndings clearly demonstrate that our current aspiration catheters are not 100% effective. This may be due to the fundamental design of these catheters or the fact that these catheter systems are best suited only to aspiration of soft thrombus debris, while attempted aspiration of rm or large thrombi contributes to the aforementioned failure rates. Last, with no additional benet of aspiration thrombectomy on clinical outcomes, one has to analyze if this adjunct therapy is really necessary. Adjunction of aspiration thrombectomy to PPCI may not be necessary, owing to modern advancements in the conventional PCI procedure itself. With the increased application of intravascular ultrasound (IVUS) technology, the sizing of stents during deployment into a thrombus has increased in accuracy. One could postulate that owing to IVUS-guided deployment, aspiration of thrombus debris prior to stenting may not be as necessary as once thought [28]. Another upcoming modality that may explain the minimal benet yield of aspiration catheters is the use of M-guard stents. M-guard stents are part of an experimental device that is intended to decrease distal embolization [29]. During stent implantation, these mesh-covered stents provide adequate capture of thrombus between the outer layer of the stent and the intima layer of the coronary artery, which reduces distal embolization. With the use of these new-generation stents along with potent ADP receptor antagonists, as well as the IVUS technology, one can propose that the current technique of PPCI has already been perfected to a great extent. With that being said, it is natural to then understand why the addition of aspiration catheters may not yield any further benets in cardiovascular or all-cause mortality.
EMBOLIC PROTECTION DEVICES
To prevent the well-known complications from manipulation of guidewires and catheters through atherosclerotic lesions and subsequent distal showering of plaque debri s, the use of EPDs during PCI has been well studied. In addition to the coronary vasculature, the use of these devices is being studied in renal vascular beds, during transcatheter aortic valve replacement, and during carotid artery stenting procedures. The introduction of these devices into the interventional cardiology community was thought to reduce the multitude of adverse clinical events resulting from microembolization of thrombus and plaque debris. Since the inception of this concept of embolic protection, although the designs have evolved, there continues to remain three broad categories of devices that are available on the market at the time of writing. It is hoped that all three of these EPDs will accomplish the same effect, but they employ slightly different mechanisms in doing so. These devices include proximal occlusion aspiration catheters, distal lters, and distal occlusion aspiration devices (Table 17.3).
Proximal Occlusion Aspiration Catheters
Proximal occlusion aspiration devices consist of a exible catheter with an inatable balloon at its tip. These devices occlude the antegrade ow and thus prevent distal embolization via balloon deployment proximal to the culprit lesion. This catheter system consists of a proximal end with a Y adaptor, which has the capability of allowing easy entry and exchange of guidewire as well as built-in Luer connections for aspiration and balloon ination. The distal end consists of a circumferential inatable balloon, which requires approximately 2e3 atm of pressure to sufciently seal the epicardial vessel. The ination system is operated via a carbon dioxide inatio n device, which uses a push-button technology. Although not currently in production in North America, the principle behind proximal occlusion devices is demonstrated by St. Judes 7-Fr compatible Proxis device [30]. After proper anticoagulation and engagement of the coronary ostium via the guidewire, the Proxis catheter system is advanced through the guidewire and positioned proximal to the target lesion, allowing at least a 10-mm landing zone proximally. With its balloon still deated, the position of the distal tip is visualized under uoroscopy, and only after satisfactory placement of the balloon is it fully deployed using the built-in ination system. The interventional wire is introduced into the catheter system and the lesion is carefully traversed. Using the Luer connection, aspiration is performed intermittently throughout the PCI. After satisfactory balloon angioplasty and stenting, the interventional wire is withdrawn and the stagnant column of blood containing debris is aspirated once more prior to deating the balloon and retracting the device.
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TABLE 17.3 Embolic Protection Devices
Device Type Device Name Manufacturer Guide Catheter (Fr)
Distal occlusion
Proximal occlusion Proxis catheter system St. Jude 7
Distal embolic filter
GuardWire (MDT-Percusurge) Medtronic 8
TriActiv balloon protected flush extraction system
FilterWire EX Boston Scientific 4
EV3 Spider Mednova
Interceptor PLUS coronary filter system Medtronic Vascular
Mednova MDT-Filter Medtronic 7
Mednova, Neuroshield Abbott 9
AngioGuard XP Cordis 8
Accunet Guidant
E-Trap/E-Sack Metamorphic 6
Kensey Nash Corp 3
Proximal occlusion catheter systems have an advantage over other EPDs in that they create a barrier proximal to the lesion and prior to any manipulation or crossing over of the lesion. Theoretically, this ensures a complete recovery of all debris material and minimal distal embolization due to negligible antegrade ow. Another advantage is that these devices do not require a distal landing zone and hence are ideal for very distal coronary lesions. There is also no limitation on the amount of debris trapped by this device mechanism. The disadvantage of these catheters is the limited lesion visualization due to suboptimal contrast opacication. Loss of antegrade ow not only limits visua lization but also poses a genuine concern regarding iatrogenic ischemia due to prolonged balloon ination.
Distal Embolic Filter Devices
The basic design of a distal embolic lter device includes a capture wire as well as a catheter. The capture wire, which can act as the guidewire, consists of a mesh lter bag at its dist al tip. The catheter itself is composed of a proximal recovery end and a distal delivery end. Prior to deployment of this device, the distal, lter-containing end is submerged and adequately ushed with heparinized saline to ensure removal of trapped air within the catheter. A standard guidewire is used to cross the lesion, at which point the catheter system is introduced. The delivery end of the catheter is loaded onto the proximal tip of the guidewire. This catheter is then slowly advanced over the primary guidewire and maneuvered until the delivery end of the catheter reaches the predened landing zone, usually 2.5e3 cm distal to the target lesion. The catheter along with the capture wire is xed in place while the primary guidewire is retracted. Subsequently, the capture wire is held in place and the catheter is gently withdrawn, which allows exposure and deployment of the lter bag. At this juncture, PCI is performed using the capture wire as the primary guidewire. After satisfactory completion of PCI, the recovery end of the catheter is advanced over the capture wire for lter removal. Under uoroscopic visualization and with the radiopaque markers acting as a guide, the distal end of the recovery catheter is engaged with the proximal end of the lter and slowly advanced over it to allow for complete capture of the lter. The catheter and the capture wire are then cautiously removed together to ensure minimal dislodgment of debris material from the lter. Some examples of these lter devices include the Spider from Mednova, the FilterWire from Boston Scientic, and the Interceptor Plus coronary lter system by Medtronic Vascular (Fig. 17.2).
The biggest advantage that this class of EPDs has over the other two classes is their ability to maintain antegrade ow and thus minimize the risk of iatrogenic ischemia due to perfusion being cut off. The antegrade perfusion also allows better visualization for the operator, with complete contrast opacication, compared with hindrance in this with the other two EPDs. Like other classes of EPDs, distal embolic lter devices have their own shortcomings. The potential risk of distal embolization exists with these devices during traversing of the lesion as well as while retrieving the lter through the catheter. The capacity of capture being limited by the size of the lter bag as well as the lter pore size is a potential disadvantage of this class of EPD. The pore size of the lter bags ranges from 100 to 110 mm, thereby being effective for
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FIGURE 17.2 FilterWire EZ embolic protection system. Image provided courtesy of Boston Scientic. © 2017 Boston Scientic Corporation or
its afliates. All rights reserved.
capturing only debris particles that are greater than this size. Although this is theoretically true, studies have shown that owing to the reduction in functional pore size from entrapment and clumping of debris, the size of the particles captured by distal lters is identical to what is captured by distal occlusion devices [31,32]. Last, another limitation of these devices includes the large diameter of the delivery catheter, which predisposes to higher risk of embolization, complex maneuverability, and longer procedural times.
Distal Occlusion Aspiration Devices
The concept of a distal occlusion catheter system paral lels that of the proximal occlusion aspiration catheter systems. The device apparatus contains a carbon dioxideelled ination system, an occlusion balloon, and a hypotube, which acts as an interventional guidewire. With the balloon deated, the catheter system is introduced into the coronary vessel and passed across the target lesion. Instead of placing the balloon proximal to the lesion, these systems are designed for the balloon to be placed several centimeters (landing zone) distal to the lesion. After proper placement is ensured, the occlusion balloon is carefully inated to the desired pressure. Antegrade blood ow is hence arrested and PCI is performed via the hypotube acting as the primary guidewire for balloon angioplasty and stenting purposes. Plaque debris liberated during PCI and vasoactive mediators are all captured in the stagnant pool of blood proximal to the occluded balloon. The pool of blood along with debris is then aspirated using an aspiration catheter. Subsequently, the balloon is deated, allowing restoration of blood ow and the hypotube is retracted. Some examples of this class of EPD include the PercuSurge GuardWire from Medtronic and the TriActiv system from Kensey Nash Corp. [30].
The primary selling point of distal occlusion aspiration devices is their capability to capture an unlimited amount of debris, including really minute particles (less than 100 mm), which are otherwise unable to be captured by other EPDs. As with proximal occlusion devices, the risks of causing ischemia during balloon occlusion, poor visualization due to limited contrast opacication, and distal embolization while wiring and crossing the lesion also exist with these devices. Moreover, the use of distal EPDs may jeopardize the ow in other coronary territories by shunting debris particles into proximal side branches.
Clinical Evidence Behind Embolic Protection Devices
Although the use of EPDs has been studied in several vascular beds, including renal, cerebral, and carotid arteries, we will primarily discuss their application and outcomes pertaining to coronary vasculature and saphenous vein grafts (SVGs). Patients with prior coronary artery bypass grafts (CABGs), in particular SVGs, are at higher risk of embolic complications while undergoing PPCI. With SVG intervention, several studies have estimated the incidence of MACE to be as high as 20%, largely due to complications from distal embolization [33e37]. It is postulated that such a high incidence is probably due to the type of plaque that builds up within the SVG. Vein grafts, such as those used during CABG, carry a higher propensity to accumulate more friable and lipid-rich plaque compared with native coronary vasculature. These diffuse plaques are characterized by an overlaying thrombus underneath a concent ric plaque with an absent brous cap [38,39]. The very thin, or lack of, brous cap poses a higher threat for distal embolization with even the slightest manipulation. One of the rst few trials on the use of EPDs in SVGs was the Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. This trial specically examined the use of distal occlusion balloon catheter systems and the authors demonstrated a 42% reduction in MACE rates in patients within the EPD arm compared with their non-EPD counterparts
[40]. After careful analysis of these results, the US FDA approved the use of distal occlusion devices in SVG interventions.
This was followed by several other trials that aimed to examine the use of newer-generation devices during SVG interventions. With the results of these trials also being positive and similar to those of SAFER, the ACC/AHA published
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their recommendation and gave a class I indication for the use of distal occlusion devices during SVG PCI [41]. The only instances in which this recommendation is not completely applicable are during PCI of aorto-ostial lesions or during cases with in-stent restenosis (ISR). This is predominantly due to the variation in plaque characteristics in these two scenarios compared with plaque buildup in regular SVG. Instead of the friable plaque with thin brous cap, the plaque buildup in aorto-ostial lesions or cases with ISR is composed of smooth muscle cells and is signicantly more brocalcic. This variation in plaque characteristics lends itself to reduced risk of distal embolization and subsequently lower rates of no-reow phenomenon and MACE [42].
In contrast to their use in SVG PCI, the use of EPDs in native coronary artery intervention has not yielded positive results. The majority of the studies that have examined the utility of EPDs during native coronary artery PCI were in patients presenting with a STEMI. As alluded to earlier in the chapter, intracoronary thrombus and subsequent distal embolization are negative prognostic indicators and lead to negative outcomes, in part due to the no-reow phenomenon seen in these patients. Numerous trials have assessed the use of EPDs in STEMI patients but have failed to demonstrate any signicant benet related to clinical outcomes or myocardial perfusion [10]. Haeck and colleagues conducted the Proximal Embolic Protection in Acute Myocardial Infarction and Resolution of ST-Elevation (PREPARE) trial, which randomized patients into either the PPCI arm or the PCI with EPD arm. The specic EPD used in this study was St. Jude Medicals Proxis system, a proximal occlusion aspiration catheter. The authors concluded that although the use of proximal embolic protection led to more frequent ST-segment resolution, there was no signicant difference in TIMI ow grade, myocardial blush grade, or angiographic evidence of distal embolization between the two cohorts [43]. The Drug Elution and Distal Protection in ST Elevation Myocardial Infarction (DEDICATION) trial and the Distal Protection Combined with PTCA (percutaneous transluminal coronary angioplasty) in AMI (acute myoca rdial infarction) Patients (DIPLOMAT) trial both examined the benets of distal embolic lter systems during PPCI. The AngioGuard lter device by Cordis Endovascular was utilized in the DIPLOMAT trial, in which the primary outcome was set to be absolute ST-segment resolution. The authors of the DED ICATION trial utilized Boston Scientics FilterWire device and their primary outcome included rate of complete ST-segment resolution, while secondary end points were inclusive of MACE, wall motion index, and maximal cardiac biomarkers. Both of these trials failed to show any positive benets of distal embolic lters in combination with PCI. Moreover, the long-term follow-up at 15 months showed that there was a higher incidence of statistically signicant stent thrombosis and target lesion revascularization in patients who underwent PCI with adjunctive embolic protection
[44]. The last class of EPDsddistal occlusion devicesdhave also been studied in the setting of native coronary
intervention during STEMI. Enhanced Myocardial Efcacy and Recovery by Aspiration of Liberated Debris (EMERALD) was a prospective randomized trial set out to dene the benets of microcirculatory protection via a distal embolic occlusion device. Primary end points included ST-segment resolution and left-ventricular infarct size (measured by technetium Tc99m sestamibi scan), whereas the secondary end point consisted of MACE. Unfortunately, distal embolic protection via the GuardWire Plus by Medtronic again failed to demonstrate any clinical advantage over just PPCI [45].In line with data from the aforementioned trials, the concept of distal embolic protection remains an attractive alternative but is not backed up by any clinical evidence and hence not encouraged for routine use during native coronary artery PCI (Table 17.4).
TABLE 17.4 Landmark Trials on Embolic Protection Devices
Study Device Patients (n) Primary Outcome Significance of Results
EMERALD GuardWire 501 Resolution of ST-segment
PROMISE FilterWire 200 Maximal flow velocity in
DIPLOMAT AngioGuard 60 Resolution of ST-segment elevation Nonsignificant
SAFER PercuSurge
PREPARE Proxis system 280 Resolution of ST-segment elevation Significant
DEDICATION FilterWire 626 Resolution of ST-segment elevation Nonsignificant
MACE, major adverse cardiac event; SVG, saphenous vein graft.
elevation; infarct size
Nonsignificant
Nonsignificant
infarct-related artery; infarct size
801 MACE in patients with SVG Significant
GuardWire
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SUMMARY
Based on the available data as of this writing, the routine use of aspiration thrombectomy catheters in patients with STEMI or NSTEMI is not recommended, although it is still useful in select cases. The use of EPDs in native coronary artery interventions is not recommended. However, based on the positive results of clinical trials and ACC/AHA recommendations, EPDs are recommended during SVG interventions because of the difference in their plaque characteristics. Distal embolization during coronary intervention and subsequent negative clinical manifestations are worrisome. Although the current generation of aspiration catheters and EPDs is not recommended for routine use, future studies to examine their selective use are warranted. Further clinical trials are necessary to examine the selective use of both of these modalities to prevent distal embolization in specic patient populations, for certain complex lesions, or after suboptimal success of balloon angioplasty.
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FURTHER READING
The following references correspond to clinical trials mentioned in tables 17.2, 17.3, and 17.4.
[1] Gick M, Jander N, Bestehorn HP, Kienzle RP, Ferenc M, Werner K, Comberg T, Peitz K, Zohlnhöfer D, Bassignana V, Buettner HJ, Neumann FJ.
Randomized evaluation of the effects of lter-based distal protection on myocardial perfusion and infarct size after primary percutaneous catheter
intervention in myocardial infarction with and without ST-segment elevation. Circulation 2005;112:1462e9. [2] Sangiorgi G, Colombo A. Embolic protection devices. Heart 2003;89(9):990e2. [3] Onuma Y, Thuesen L, van Geuns RJ, van der Ent M, Desch S, Fajadet J, et al. TROFI Investigators. Randomized study to assess the effect of
thrombus aspiration on ow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study e TROFI trial. Eur
Heart J 2013;34:1050e60. [4] De Carlo M, Aquaro GD, Palmieri C, Guerra E, Misuraca L, Giannini C, et al. A prospective randomized trial of thrombectomy versus no
thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in
Acute ST-Segment ELevation Acute Myocardial Infarction) trial. JACC Cardiovasc Interv 2012;5:1223e30. [5] Ciszewski M, Pregowski J, Teresinska A, Karcz M, Kalinczuk Ł, Pracon R, et al. Aspiration coronary thrombectomy for acute myocardial infarction
increases myocardial salvage: single center randomized study. Catheter Cardiovasc Interv 2011;78:523e31. [6] Dudek D, Mielecki W, Burzotta F, Gasior M, Witkowski A, Horvath IG, et al. Thrombus aspiration followed by direct stenting: a novel strategy of
primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized
ThrombEctomy Trial (PIHRATE Trial). Am Heart J 2010;160:966e72. [7] Liistro F, Grotti S, Angioli P, Falsini G, Ducci K, Baldassarre S, et al. Impact of thrombus aspiration on myocardial tissue reperfusion and left
ventricular functional recovery and remodeling after primary angioplasty. Circ Cardiovasc Interv 2009;2:376e83. [8] Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, et al. VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary
intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval)
trial. JACC Cardiovasc Interv 2008;1:424e31. [9] Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, et al. Systematic primary aspiration in acute myocardial percutaneous
intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention 2008;62:555e61.
[10] Chao CL, Hung CS, Lin YH, Lin MS, Lin LC, Ho YL, et al. Time-dependent benet of initial thrombosuction on myocardial reperfusion in primary
percutaneous coronary intervention. Int J Clin Pract 2008;62:555e61.
[11] Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, et al. Thrombus aspiration before primary angioplasty improves myocardial
reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll
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[12] De Luca L, Sardella G, Davidson CJ, De Persio G, Beraldi M, Tommasone T, et al. Impact of intracoronary aspiration thrombectomy during primary
angioplasty on left ventricular remodelling in patients with anterior ST elevation myocardial infarction. Heart 2006;92:951e7.
[13] Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, et al. Routine thrombectomy in percutaneous coronary intervention for
acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation 2006;114:40e7.
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Chapter 18
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Power-Sourced Mechanical Thrombectomy in the Management of Thrombus-Containing Atherosclerotic Lesions
On Topaz
1
Charles George Veterans Affairs Medical Center, Asheville, NC, United States;2Duke University School of Medicine, Durham, NC, United States;
3
Brooklyn Medical Center, Brooklyn, NY, United States
1,2
and Allyne Topaz
3
INTRODUCTION
Intracoronary thrombus is commonly found in patients with acute coronary syndromes (ACS) such as unstable angina or acute myocardial infarction (AMI) [1,2]. The histopathologic causes behind the formation and accumulation of thrombus are plaque erosion and subsequent rupture (Fig. 18.1A and B). The presence of thrombus is associated with an increased complication rate during and after percutaneous revascularization procedures [3e6]. In these acute clinical scenarios, the goal for primary and rescue PCI (percutaneous coronary intervention) is to provide expedient revascularization. These procedures aim at restoration of impaired antegrade coronary ow to a normal level, regaining of maximal patency of the ischemia/infarct-related vessel, enhancement of myocardial tissue perfusion, and achievement of maximal myocardial salvage. The utilization of manual aspiration catheters (i.e., non-power-sourced devices) has demonstrated a positive impact on myocardial perfusion and late clinical outcome [7]. Accordingly, the standard treatment approach to acute ischemic (thrombotic) syndromes is pharmacotherapy with aspirin, P2Y12 inhibitors, heparin, or glycoprotein IIb/IIIa receptor antagonists combined with manual aspiration [8,9]. Nevertheless, the reality of PCI in ACS is unsettling, as interventions quite frequently fall short of the desired outcome. The main cause of procedural failure is the underestimation of the volume of the underlying thrombus and insufcient removal. Consequently, a practical need to utilize a more powerful and capable technology for improved thrombus removal is highly recognized [10]. Hence, this chapter describes the challenges facing management of ACS associated with signicant thrombus burden and includes a detailed presen­tation of the utilization of the main power-based mechanical thrombus removal devices.
THROMBUS AS A DYNAMIC VASCULAR STRUCTURE
Active changes in the composite architecture of thrombus oc cur in ACS [11] and, in particular, among patients sustaining STEMI (ST-segment elevation myocardial infarction) [12,13]. Early AMI thrombi are white, platelet rich, and friable. In contrast, in those patients arriving late (dened as more than 6 h) for care after the onset of STEMI the thrombus is red, as it has already become brin/erythrocyte rich with almost no platelets and exhibits rigidity [14]. From a practical revascularization perspective, most patients who experience ACS/STEMI develop thrombus; thus, compromised antegrade coronary ow can be antic ipated and, in case the thrombus is angiographically recognized as the culprit mechanism, a corresponding pharmacologic and accommodating mechanical thrombus removal strategy should be incorporated [15,16].
Cardiovascular Thrombus. https://doi.org/10.1016/B978-0-12-812615-8.00018-1
Copyright © 2018 Elsevier Inc. All rights reserved.
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FIGURE 18.1 Histopathology of acute coronary syndrome. (A) High-power view of the right coronary artery demonstrating layering of acute thrombus
(T). (B) Red blood cells alternate between layers of brin (H&E, 20). P, plaque. Courtesy of Shannon Mackey-Bojack MD, The Jesse E. Edwards Registry of Cardiovascular Disease Collection, Nasseff Heart Center, United Hospitals, St. Paul, MN and the Department of Pathology, University of Minnesota School of Medicine, Minneapolis, MN.
The strategy calls for attention to the ischemic time from the onset of the event to the PCI; consideration of the thrombus composition, size, and anatomic location; and proper choice of thrombectomy tools [17]. Inevitably, as experience has repeatedly demonstrated, thrombus, whether visible by angiography or not, frequently presents as an unstable structure with dynamic morphologic features affecting its content, integrity, and rigidity. This makes thrombus a formidable obstacle to the attainment of the aforementioned revascularization goals during primary or rescue PCI.
POWER-SOURCED THROMBECTOMY TOOLS: RATIONALE FOR UTILIZATION
In the EXPIRA (Thrombectomy With Export Catheter in Infarct-Related Artery During PCI [18]) study investigators found that, as an adjunct therapy in PCI, manual thrombus aspiration prevents thrombus embolization, preserves microvascular integrity, enhances myocardial blush score and ST-segment resolution, and reduces the infarct size. Nevertheless, despite the recognition of the usefulness of the standard manual aspirati on catheters, this technology commonly encounters substantial limitations when the need arises to deal with a signicant thrombus burden and with a very aggressive thrombus accumulation, termed the angry clot phenomenon[19] or the hostile thrombus[20,21].
Accordingly, there is a strong conviction among many interventionalists that the larger the target thrombus volume, the greater the need for the extracting capability of power-sourced mechanical thrombectomy devices [22e24]. A landmark study by Sianos and colleagues incorporated a quantitative thrombus grading scale that demonstrated beyond any doubt that a baseline large thrombus burden predicts markedly increased risk of subsequent stent thrombosis and the potential for development of major coronary adverse events [25]. Treatment with rheolytic thrombectomy signicantly decreased these risks (Fig. 18.2A and B) and this lesson can be extrapolated toward other powerful mechanical thrombectomy tools as well.
The mainstay representatives of percutaneous power-sourced mechanical devices are the rheolytic thrombectomy, excimer laser, X-Sizer extraction tool, and ultrasonic catheter. The question as to whether power-sourced mechanical thrombectomy devices offer an advantage over standard aspiration catheters in the management of ACS and especially in cases of signicant thrombus burden carri es practical and cost-related implications [26]. In a detailed study from Japan, Shishikura and colleagues compared the excimer laser coronary atherectomy with manual aspiration treatment of ACS. The ndings showed that the power-sourced laser is superior to aspiration catheters regarding the ability to cross the target lesion, attaining TIMI (thrombolysis in myocardial infarction) 3 ow and myocardial blush score 3, rate of distal embolization, development of in-hospital major adverse cardiac events including myocardial infarction, target lesion revascularization, need for coronary artery bypass surgery, and death [27]. However, only a limited number of prospective studies offer direct comparison between the aforementioned two classes of devices. The TREAT-MI (Manual vs. Mechanical Thrombus Removal in the Treatment of ST-Segment Elevation Myocardial Infarction) trial prospectively randomized 201 STEMI patients to treatment of the infarct-related vessel with either the Export manual aspiration catheter (Medtronic, Minneapolis, MN, USA) or the power-sourced X-Sizer thrombectomy tool (ev3,Minneapolis, MN, USA) prior
Power-Sourced Mechanical Thrombectomy in the Management Chapter | 18 263
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FIGURE 18.2 (A) The presence of a large unresolved thrombus increases MACE. (B) Large unresolved thrombus increases stent thrombosis. MACE,
major adverse coronary event. From Sianos G, Papafakits M, Daemen J, Vaina S, van Milegherm C, van Domberg R, Michalis L, Serruys P. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol 2007;50:572e83.
to stent deployment [28]. Technical success in advancing to and across the lesion, improvement of ow, reduction of thrombus burden, and effect on ST-segment resolution were examined. The Export catheter was easier and more successful in maneuvering and deployment and was associated with shorter procedural time and fewer complications. Other pro­cedural parameters were similar, with the X-Sizer exhibiting a trend toward better ST-segment resolution (57% vs. 44%, P ¼ .06). Both surrogate points as well as 3-year clinical follow-up were similar with the use of the Export catheter compared with the X-Sizer system. In Italy, Parodi and colleagues enrolled 80 AMI patients to compare the AngioJet rheolytic thrombectomy system with manual thrombus aspiration catheter [29] using optical coherence tomography to assess the presence of postprocedure residual thrombus. Importantly, the investigation demonstrated that all but one patient had postintervention residual thrombus. This occurred whether they received mechanical rheolytic thrombectomy or manual aspiration catheter. The number of optical coherence tomography quadrants containing thrombus in the manual