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264 Cardiovascular Thrombus
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TABLE 18.1 Rationale for Application of Power-Sourced Mechanical Thrombus Removal Devices
Usefulness of Thrombectomy Devices
Benefits
1. Shortening of the door-to-thrombus clearance time
2. Direct thrombus engagement for targeted thrombus removal
3. Synergism with thrombolytic agents
4. Removal of prothrombotic procoagulants
5. Removal of vasoactive reactants and platelet aggregation promoters
6. Reduction of distal embolization and “no-reflow” phenomenon
7. Restoration of antegrade flow, improvement of myocardial blush score, and lowering of corrected TIMI flow counts
8. Enabling of proper assessment of the underlying plaque morphology and degree of stenosis
9. Facilitation of stenting
10. Improved post-MI 6 months and 1 year MACE and survival rates
Limitations
1. Requires specific operator training and expertise
2. May prolong the PCI procedure time
3. Distal embolization due to device manipulations
4. Possible “no-reflow” phenomenon
5. May not achieve complete thrombus clearance
6. Need for adjunct stenting remains in most cases
7. Increased cost of intervention
MACE, major adverse coronary event; MI, myocardial infarction; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardial infarction.
aspiration arm was higher (i.e., residual thrombus) than in the rheolytic arm but the difference did not reach statistical difference. Large residual thrombus was more frequently identied in the manual aspiration group (P ¼ .039) and all markers of reperfusion were better in the rheolytic thrombectomy arm. At 6 months the percentage of malapposed stent struts in the manual aspiration arm was higher than in the rheolytic thrombectomy arm (2.7% 4.5% and 0.81% 1.6%, respectively; P ¼ .02). The investigators concluded that both technologies were associated with incomplete removal of thrombus in patients with AMI; however, the rheolytic thrombectomy seemed more effective in actual thrombus removal and in gaining improved myocardial reperfusion.
A 2013 meta-analysis of 24 randomized trials involving 4927 STEMI patients encompassed 21 studies with indirect comparison and 3 with direct comparison between these thrombus removal modalities [30]. The authors concluded that the meta-analysis lent support to the benets of mechanical thrombectomy, but only when used in patients with high thrombus burden. Indeed, some authorities opine that any randomized prospective comparison between manual aspiration and power-based mechanical thrombectomy is essentially unethical among those patients who exhibit large thrombus burden, because these patients should be assigned exclusively to treatment with the mechanical, power-sourced thrombectomy devices [31]. Moreover, in instances of late stent thrombosis the usefulness of thrombus removal with the rheolytic thrombectomy device becomes apparent and many share the opinion that this tool can be considered the preferred tech­nology for this purpose [32]. Table 18.1 depicts the rationale, benets, and limitations of application of power-sourced mechanical thrombus removal devices.
LASERS
Lasers have been used in cardiovascular medicine since the 1980s owing to the recognition of avid absorption and potential for recanalization in atherosclerotic diseased peripheral and coronar y arteries [33e35]. Following a promising initial experience with powerful vaporization of atherosclerotic plaques and associated thrombus by various laser wavelengths
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[36,37], several large-scale successful clinical trials [38,39] indicated that a potential role had been found for laser
applications in interventional cardiology. Specically, the strong interaction between laser and thrombus drew attention. Thrombus appeared to favorlaser emission serving as a thermal sink with resultant thrombolysis. Furthermore, analyses demonstrated that in laser procedures the presence of thrombus had a positive effect on the PCI success. This nding stands in sharp contrast to other devices [39,40]. In reality, however, during the 1980s lasers encountered considerable technical difculties in both peripheral arterial and coronary vasculature alike [41]. The rst generation of cardiovascular lasers were built with very large generators requiring lengthy warmup and calibration time. Typically, these continuous-wave-mode lasers produced low output and generated considerable heat at the distal end of the catheters, which was deposited onto the irradiated plaque. These catheters were also rigid and cumbersome to handle. Moreover, the old lasing technique involved too-rapid advancement of the catheters across target lesions with disregard to the unique physics of laserebiotissue interactions. Consequently, this lasing technique did not enable adequate debulking of the irradiated plaques and created unnecessary heat within the treated vessels and lesions. Laser-associated complications such as spasm, thrombosis, dis­sections, and perforations became then an issue of signicant concern [42e44]. The solution emerged with the introduction of the second-generation, powerful coldpulsed-wave lasers, such as the ultraviolet excimer and the midinfrared holmium:YAG. Smaller laser generators, renements in catheter designs [45e47], and incorporation of safer and more efcient lasing techniques were useful developments [48]. The core concept behind the new lasing techniques was reliance on sound principles of the physics of laser absorption within plaque and thrombus and strong emphasis on slow catheter advancement pace (0.5e1 mm/s) during laser emission and debulking of the targeted plaques [49]. Crucially, concomitant saline injections during laser activation were incorporated [50] for heat reduct ion and elimination of the contrast-induced potentiation effect of the lasers acoustic shock waves on plaque and vessel. These substantial changes exerted a positive impact on the laser procedures resulting in signicant improvement in safety, efcacy, and clinical outcomes [51,52]. Indeed, once a realistic understanding of the lasers capabilities and limitations developed, numerous appropriate indications for utilization were established [53]. Globally, the dominant and most commonly used cardiovascular laser is the US FDA-approved ultraviolet pulsed-wave excimer (xenon chloride) laser (Spectranetics, Colorado Springs, CO, USA). It operates at 308-nm wavelength with a pulse duration of 135 ns and output of 200 mJ/pulse. The laser energy is delivered via either over-the-wire or rapid-exchange catheters containing exible optic bers. The modern laser catheters have a unique ber array with a concentric or eccentric tip conguration [45e47]. A laser generator and a cross section of the structure of a laser catheter are shown in Figs. 18.3 and 18.4, respectively. Overall, the current use of the excimer laser
FIGURE 18.3 The computerized console containing the generator of the US FDA-approved ultraviolet pulsed-wave excimer laser (Spectranetics,
Colorado Springs, CO, USA). This laser operates at 308-nm wavelength, delivering laser energy through dedicated percutaneous catheters. This laseris used in a variety of cardiovascular applications.
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FIGURE 18.4 A cross-sectional prole of a dedicated percutaneous excimer laser catheter.
is for plaque debulking of complex coronary [54,55] and peripheral atherosclerotic vascular lesions [56,57], which are deemed unsuitable or at high risk of complications for standard percutaneous coronary [58e60] and peripheral arterial interventions [61]. A major and unique role for the laser technology is revascularization of thrombus-containing lesions, for which the advantage of the dual capability of the laser power, i.e., concomitant plaque vaporization and thrombus dissolution, is especially useful [3,62,63]. In a comprehensive study Nishino and coauthors analyzed the performance of the excimer laser in thrombotic lesions and conrmed that excimer laser coronary atherectomy can provide a safe and effective treatment for thrombus-rich lesions [64]. A considerable advantage of various wavelength lasers (e.g., ultraviolet, midinfrared) is safe and effective utilization in hemodynamically unstable ACS patients, including those in cardiogenic shock, whereas for most devices the presence of depressed left-ventricular function constitutes a restriction or contrain­dication for use [65,66]. A new role for the excimer laser coronary technology as a unique tool when an urgent need arises to rapidly expand a stent resisting deployment has emerged. In such cases the nonexpandable stent severely obstructs coronary ow, causing marked ischemia and chest pain. The application of a high-pressure noncompliant balloon for stent dilatation usually fails to expand the metal structure. The mechanism behind the success of excimer laser in this critical scenario is attributed to the radial distribution and penetration of contrast-enhanced laser energy into the constricting calcications that surround the stent. As the emission ablates and weakens the calcium deposits the underdeployed stent readily yields to the postlaser balloon dilatations and expands properly [67]. Another important clinical role has been established for excimer laser as the preferred technology to replace the traditional, high-risk open heart surgery for extraction of abandoned, dysfun ctional, dislodged, broken, or infected pacemaker/automatic implantable cardiac de­brillator leads [68]. Finally, lasers are applied in select patients for direct myocardial revascularization by means of either percutaneous or surgical transmyocardial revascularization [69,70].
LasereTissue Interactions and Effects Pertinent to Thrombus Removal
Table 18.2 describes the ph y sica l phenomena that occur during laser activation and their corresponding effects on the
biotissue target. Absorption within atheromatous plaques and thrombotic material results in initiation of photoacoustic , photomechanical, and photothermal processes that lead to vaporization [71]. The unique optical properties of key thrombus constituents favor laser absorption. Among these are red blood cells with their oxyhemoglobin, platelets,
TABLE 18.2 Biotissue Laser Interactions and Effects
Target and Process Laser Effect References
Atherosclerotic plaque Debulking without injury to vessel or plaque [1]
Absorption in a plaque Vaporization of atherosclerotic material [2]
Creation of acoustic shock waves
Thrombolysis Enhancement of thrombolytics in old, resistant thrombus [5,6]
Absorption in platelets Platelet aggregation inhibition (“stunned” platelets effect) [7]
References:1Cardiovasc Pathol 2001; 10:223e228;2Laser Surg Med 1996; 19:299e310;3J Thrombosis Thrombolysis 1996; 3:327e330;
7
Thromb Haemost 2001; 86:1087e1093.
4
Cardiology 1996; 87:384e391;5J Thrombosis Thrombolysis 1996; 3:209e214;6Lasers Med Sci 1999; 14:123e112;
Mechanical disruption of the thrombus constituents [3,4]
Fibrinolytic effect on the thrombus fibrin mash
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FIGURE 18.5 (A and B) The in vitro effect of excimer laser on aggregation and suppression of platelets resulting in the stunned platelets
phenomenon. Based on Topaz O, Minisi AJ, Bernardo NL, McPherson RA, Martin E, Carr SL, Carr Jr ME. Alterations of platelet aggregation kinetics with ultraviolet laser emission: the stunned plateletphenomenon. Thromb Haemost 2001;86:1087e93. With permission of the authors and Schattauer Publishers, Stuttgart, Germany.
brin, and water [72]. As absorption can occur with several wavelengths, such as ultraviolet light (excimer [308 nm]), visible light (dye [420, 540, 577 nm], Nd:YAG [1064 nm]), and midinfrared (holmium:YAG [2010 nm], erbium:YAG [2940 nm]), all can ablate and vaporize thrombus [73,74]. The in vitro effect of laser on human thrombus was originally investigated by Lee and associates in the early 1980s [75], with examination of the continuous-wave argon laser at 454 and 514 nm. At the same time Crea and colleagues ad van ced the application o f laser for thrombol ysi s and r e porte d recanalization of thrombosed arteries in dogs [76].
Importantly, the excimer laser alters the aggregation kinetics of platelets by reduction of the platelet force development and inhibition of the platelet activity. This unique phenomenon, which is termed the platelet stunningeffect, is dose dependent and most pronounced at high levels of laser emission such as 60 mJ/mm
2
[77] (Fig. 18.5). Moreover, the laser
can potentiate thrombus-directed pharmacotherapy. In a series of in vitro experiments the effect of laser emission on the function of thrombolytic agents was studied. The experiments provided strong evidence that laser energy signicantly augments brinolysis in brin clots initially exposed to tissue plasminogen activator (tPA) treatment. Furthermore, despite a signicant decline in the rate of tPA-induced brinolysis with old clot age, once laser energy is applied it reverses this decline, resulting in signicant brinolysis [78] (Figs. 18.6, 18.7, and 18.8). This capability offers an important benet for
FIGURE 18.6 Laser effect on tissue plasminogen activator (tPA)-induced thrombolysis. Normally, tPA-induced thrombolysis signicantly declines with
increased clot age. Laser energy reverses this decline in clots older than 1 h. The reversal is emphasized in 4- and 8-h-old clots as manifested by signicant increase in brin degredation products (FDPs). From Topaz O, Morris C, Minisi AJ, Mohanty PK, Carr Jr M. Enhancement of t-PA induced brinolysis
with laser energy: in-vitro observations. Lasers Med Sci 1999;14:123e8. With permission of the authors and Springer Verlag, London, UK.
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FIGURE 18.7 The extent of tissue plasminogen activator (tPA)-induced brinolysis is directly related to exposure time. Delivery of 75 J of energy from
a holmium:YAG midinfrared laser does not enhance release of FDPs in a 1-h-old clot. However, in clots exposed to tPA for longer durations, such as 6 and 12 h, the laser energy signicantly increases the release of FDPs. Of note, in 12-h-old clots the laser energy completely dissolves the targeted clot.
From Topaz O, Morris C, Minisi AJ, Mohanty PK, Carr Jr M. Enhancement of t-PA induced brinolysis with laser energy: in-vitro observations. Lasers Med Sci 1999;14:123e8. With permission of the authors and Springer Verlag, London, UK.
FIGURE 18.8 Comparison of clot dissolution by two levels of laser (holmium:YAG, 2.1-mm wavelength) energy. The rise in FDPs is a hallmark of
thrombolysis. This rise is signicantly greater with 75 J produced by holmium:YAG laser energy compared with a level of 25 J. Note that in energy levels greater than 75 J a plateau phenomenonin the doseeresponse relationship is observed. From Topaz O, Morris C, Minisi AJ, Mohanty PK, Carr Jr M.
Enhancement of t-PA induced brinolysis with laser energy: in-vitro observations. Lasers Med Sci 1999;14:123e8. With permission of the authors and Springer Verlag, London, UK.
select patients with ACS and AMI who fail to respond to the initial treatment with thrombolytic agents. The excimer laser emission interacts mainly with the brin and platelets in the thrombus through acoustic shock waves, which propagate along the irradiated vessel in a dynamic pressure front. The process disrupts and mechanically breaks the brin bers resulting in brinolysis and decreased thrombus size [79,80]. Thus, the application of various wavelength lasers for thrombus-containing atherosclerotic lesions carri es considerable clinical advantages such as absence of systemic lytic states, time-efcient delivery of energy, targeted removal of occlusive clots with resultant rapid restoration of antegrade ow, vaporization of procoagulant reactants, enhancement of tPA effect [78], and facilitation of adjunct balloon angio- plasty and stent deployment [49]. Table 18.3 displays the selection, at the time of writing, of coronary excimer laser catheters that can be used in PCI for revascularization of thrombus-containing lesions.
Laser catheter diameter
RAPID EXCHANGE (RX)
0.9mm
0.9mm X 80
1.4mm
1.7mm
1.7mm E
2.0mm
Vessel Size
1.5mm
2.0mm
2.2mm
2.5mm
2.5mm
3.0m
Guide wire size
0.014”
0.014”
0.014”
0.014”
0.014”
0.014”
Guide catheter compatibility
6F6F6F / 7F
7F7F8F
Max. tip diameter
0.038”
0.038”
0.057”
0.069”
0.066”
0.080”
Max. shaft outer diameter
0.049”
0.049”
0.062”
0.072”
0.072”
0.084”
Working catheter’s length
130cm
130cm
130cm
130cm
130cm
130cm
Fluence (mJ/mm2)
30-60
30-80
30-60
30-60
30-60
30-60
Repetition rate[Hz]
25-40
25-80
25-40
25-40
25-40
25-40
Laser on/off time (sec)
5/10
10/5
5/10
5/10
5/10
5/10
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TABLE 18.3 Excimer Laser Coronary Catheters for Percutaneous Coronary Intervention
2.0mm E
≥≥ ≥≥≥≥
3.0mm
0.014”/0.018”
8F
0.079”
0.084”
130cm 30-60 25-40 5/10
Laser in Acute Myocardial Infarction
Clinically, the excimer laser is a useful interventional tool for targeted thrombus removal strategy [60,80]. Patients who sustain AMI and continue to experience chest pain with unrelieved ischemia are frequently in unsta ble hemodynamic condition. These patients commonly present following initial failure to respond to throm bolytic pharmacotherapy (dened as continuous chest pain and/or no resolution of the abnormal ST segment on the ECG) or have contraindications to these medications. The initial experience with laser application in AMI was gained by utilization of the holmium:YAG solid state, pulsed-wave midinfrared laser [81]. Then interest in treating these patients shifted to the ultraviolet, pulsed-wave excimer laser. This stems from recognition of this lasers ability to simultaneously treat plaque and accompanying thrombus [82e84]. Figs. 18.9, and 18.10 demonstrate the excimer laser application in atherosclerotic/thrombotic lesions in the context of AMI and unstable angina. The thrombus dissolution extent and impact of the excimer laser was thoroughly studied in the CARMEL international multicenter study [23]. This trial enrolled 151 real-world AMI patients with continuous chest pain and ischemia in the presence of either STEMI or non-STEMI, including late presentation, cardio­genic shock (13%), and failed thrombolytic therapy (11%) and those with contraindications for the pharmacotherapy (17%). The target vessel was a native coronary vessel in 79% and an old saphenous vein bypass graft in 21%. The entire cohort underwent quantitative and statistical analyses by independent core laboratories and the results proved that despite the presence of compromised hemodynamics and a heavy thrombus burden in as many as 65% of the patients, laser success was achieved in 95%, angiographic success in 97% and procedural success in 91%. A baseline TIMI 0 ow of 1.2 1.1 increased to 2.8 0.5 with the laser energy and was followed by nal a TIMI ow of 3.0 0.2 (P < .001 vs. baseline) with adjunct stenting. Distal embolization occurred in only 2%, no reow in 3%, device-induced small dissection was observed in 4%, and a small perforation in 0.6%. Total major adverse coronary event (MACE) was relatively low at 13%. The two most important ndings of the CARMEL study were the following: (1) Maximal laser thrombus removal effect was directly proportional to the basel ine thrombus burden, i.e., the larger the initial thrombus burden at the target lesion, the more effective and the higher gain for the laser-induced dissolution (Fig. 18.11). Intriguingly, multivariable regression analysis of the CARMEL study did not identify thrombus as a predictor of PCI failure, while the opposite holds true with any other interventional device. (2) A subgroup analysis identied very specic laser gain in patients with late presentation, who typically carry a heavy thrombus burden and unstable hemodynamic condition [85]. Altogether, the CARMEL study provided the rst quantitative evidence of the considerable benet of a dedicated power-sourced mechanical thrombectomy device in a thrombus removal strategy and, in particular, in patients sustaining AMI (Fig. 18.12). Thus, the role of the excimer laser in revascularization of thrombus-containing lesions has been established with the growing recognition of the debulking ability to create favorable vessel lumen morphology which, in turn, facilitates stent deployment and long-term results [86].
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(A) (B)
(C) (D)
FIGURE 18.9 Excimer laser in acute myocardial infarction AMI. (A) The anterior descending artery is the infarct-related vessel. It is occluded in the
middle segment with a heavy thrombus burden and no antegrade ow (TIMI 0) (arrow). (B) Arrow denotes the tip of a 1.4-mm excimer laser catheter, which was positioned into the total occlusion of the vessel and then activated. (C) An angiogram immediately following laser thrombolysis and debulking of the artery. Restoration of antegrade ow and removal of most of the thrombus burden were achieved. (D)Final angiogram after stenting. TIMI 3 ow was gained, the patients chest pain subsided and hemodynamic stability observed. TIMI, thrombolysis in myocardial infarction.
Unique Thrombotic Lesions Treated With Laser
Stent Thrombosis
Nowadays with the common use of poststenting dual antiplatelet therapy with aspirin and thienopyridines, incidents of acute, late, and very late stent thrombosis are infrequent; however, when they occur they are commonly associated with poor clinical outcome (see Chapter 15). The need to remove a large-volume thrombus from within a stent frequently requires application of mechanical, power-sourced thrombectomy device. The excimer laser carries a particular value for this task as it does not interact with the stent metallic struts, unlike other mechanical debulking devices (e.g., rotational atherectomy) [87].
Stent Restenosis
This histopathologic process with its clinical characteristics and angiographic features is attributed to localized or diffuse endovascular tissue growth [88]. Laser debulking of stent restenosis is a preferred treatment modality over the traditional
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(A) (B)
(C) (D)
FIGURE 18.10 Excimer laser in unstable angina. (A) The target lesion accounting for the severe chest pain is a critical 99% eccentric lesion (arrow)in
the body of an old saphenous vein graft. (B) The arrow denotes the tip of a 0.9-mm X-80 excimer laser catheter, which was used for debulking. (C) An angiogram immediately following debulking. (D) Final angiogram after adjunct stenting. The angina resolved.
limited technique of tissue displacement by balloon angioplasty [89]. Mehran and colleagues compared excimer laser and adjunct balloon dilations to balloon treatment alone, nding that the laser caused no complications, ablated more intimal hyperplasia, created greater cross-sectional lumen gain, and was associated with a tendency toward decreased frequency of subsequent target-vessel revascularization [90].
Saphenous Vein Bypass Graft Lesions
Atherosclerotic old saphenous vein bypass grafts frequently exhibit diffuse or multifocal plaques and occlusive thrombi
[91,92] (Fig. 18.13). These degenerative vascular conduits contain multilayered thrombi of varying ages prone to distal
embolization even without intervention. In cases of stented bypass grafts, the development of stent restenosis can be successfully managed by laser, which provides adequate debulking and removal of the obstructive regrowth tissue and its accompanying thrombus. With this activity the laser facilitates adjunct balloon angioplasty and stenting. A considerable success rate of 94% was reported both with ultraviolet excimer laser and with midinfrared holmium:YAG laser despite the presence of a large clot burden and friable atherosclerotic content within these vascular conduits [40,93]. Moreover, the
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FIGURE 18.11 Maximal thrombus dissolution and thrombectomy device gain were obtained in the group of patients with extensive thrombus. DS,
diameter stenosis; MLD, minimal luminal diameter; QCA, quantitative coronary arteriography; TIMI, thrombolysis in myocardial infarction. Adapted from Topaz O, Ebersole D, Das T, et al. Excimer laser angioplasty in acute myocardial infarctiondthe CARMEL multicenter study. Am J Cardiol 2004;93:694e701.With permission of the authors and Elsevier.
laser ability to provide effective and safe debulking within these grafts, even in the setting of AMI and a heavy thrombus load, has been documented [94,95] (Fig. 18.14). The remarkable low rate of distal embolization (1%e5%) suggests no need for an adjunct protection system in most cases.
RHEOLYTIC THROMBECTOMY
The mechanical power-based rheolytic thrombectomy system (AngioJet, Boston Scientic, Boston, MA, USA) (Fig. 18.15 ), is a US FDA-approved device for targeted mechanical extraction of thrombus from coronary and peripheral vasculature [96]. The concept of powerful mechanical thrombus extraction was rst promoted by the introduction of the rst-generation power-sou rced thrombectomy transluminal extraction catheter device, which was used for treatment of signicant thrombus burden [97,98]. The principle of activation for the rheolytic thrombectomy is based on the creation of saline jets inside the catheter, which travel backward from the tip at very high speed, creating a negative-pressure zone by the Venturi effect. Side holes along the catheters tip optimize uid ow and draw the thrombus into the catheter for fragmentation and removal by suction into a collecting bag (Fig. 18.16). A second-generation AngioJet, the ULTRA, was introduced several years ago, featuring automated, rapid setup and support for a wide range of catheters. Multiple rapid­exchange 4- or 5-Fr exible catheters (Fig. 18.17) are available for various target vessels, including native coronary arteries, old saphenous vein grafts (SVGs), and peripheral arter ies. Fig. 18.18 demonstrates the gradual steps taken along a unique revascularization technique aimed at recanalization and revascularization of totally occluded SVGs, which cause ischemic myocardium. We intr oduced this technique and termed it SVG sculpturing.Other power-based thrombus removal technologies can be incorporated with the rheolytic thrombectomy along with SVG sculpturing. Another advantage of utilization of the rheolytic thrombectomy is a unique device function termed power spray,which infuses tPA or other thrombolytic agents intraluminally directly onto the thrombus during revascularization. This offers a com­bined pharmacologic thrombolytic effect with powerful mechanical extraction, a synergistic strategy aptly termed power thrombectomy[10]. Proper thrombectomy technique incorporating slow antegrade advancement of the AngioJet catheter eliminates in most cases the need for a temporary pacemaker protection against device-induced bradycardia. However, some interventionalists still recommend standby or even active pacing for patients requiring thrombectomy of a major epicardial coronary vessel and in those with limited myocardial reserve.
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(A) (B)
(C)
FIGURE 18.12 Laser in inferiorelateral acute myocardial infarction. (A) The circle encompasses ruptured plaque and thrombosis of the proximal right
coronary artery. (B) Tip of the arrow points to the excimer laser catheter as it debulks while crossing the target plaque. (C) Angiogram demonstrating plaque and thrombus removal. Residual plaque and thrombus were managed with adjunct stenting. (D) Final angiogram depicting complete patency of the infarct-related vessel. Marked clinical improvement was observed.
(D)
The AngioJets ability to treat large thrombus burden in STEMI patients and provide more effective myocardial perfusion than that obtained with standard balloon and adjunct stenting has been well documented [99,100]. In the FAST (Florence Appraisal Study of Rheolytic Thrombectomy) study, the AngioJet was used to treat 116 AMI patients with extensive thrombus load, leading to signicant improvements in perfusion compared with a control group with similar thrombus burden who received standard PCI [101]. The in-hospital MACE rate for the AngioJet was relatively low at 8%. Further evidence of the excellent safety prole of the AngioJet has been repeatedly reported [102,103]. Then the Thor­axcenter group elegantly demonstrated that AngioJet thrombectomy is a signicant, independent predictor of reduced risk for stent thrombosis and MACE specically when applied for removal of large thrombus burden in STEMI patients [25]. However, the concept of thrombus extraction suffered a signicant setback when negative results from the AIMI (AngioJet in Myocardial Infarction) multicenter study were published [104]. In perspective, the unfavorable ndings could have been predicted because of the poor study design that did not require the angiographic presence of a thrombus for enrollment. Moreover, the studys rigid protocol mandated passive advancement of the AngioJet catheter across the thrombus and the entire length of the target vessel before activation at the distal end of the vessel with retrograde thrombectomy, neces­sitating recrossing of the thrombus. Later on, with the intention to address questions and reservations concerning the AIMI