y[ Plaque Composition and Dynamics
`Novel Use of a Guide Extension Mother-and-Child Catheter for
`Adjunctive Thrombectomy During Percutaneous Coronary
`Intervention for Acute Coronary Syndromes
`
`Anil J. Mani, MBBS
`
`Medtronic
`ex 7/2 7
`Date G'3o-ZI
`
`Debby J. Campeau
`Stirewalt & Associates
`
`ABSTRACT: Background. The use o f adjunctive thrombectomy
`during primary percutaneous coronary intervention (PCI) has steadily
`increased with recent trials demonstrating an improved clinical and
`mortality benefit for manual aspiration thrombectomy. The use o f an
`in-dwelling guide extension mother-and-child catheter allows direct
`aspiration o f thrombus from the vessel with its larger extraction area.
`Methods. Between December 2011 and September 2013, a total o f 17
`patients who presented with acute coronary syndromes (ACS) in whom
`a guide extension catheter was utilized specifically for manual thrombus
`aspiration were identified and studied. Results. The guide extension
`catheter was utilized specifically for thrombus aspiration in 18 vessels
`involving 17 patients presenting with A C S where severe thrombus bur­
`den was noted. The cases involved 4 saphenous vein grafts and 14 native
`coronaiy arteries, with 4 cases involving vessels with late stent throm­
`bosis. Successful outcomes with thrombus aspiration and T1M I-3 flow
`were achieved in 17/18 vessels treated, with no adverse outcomes ot ves­
`sel trauma or strokes noted. Conclusions. Adjunctive manual aspiration
`thrombectomy utilizing a guide extension mother-and-child catheter af­
`fords a novel method o f thrombus aspiration, offering a larger extraction
`area within the conventional 6 Fr system, with demonstrated efficacy for
`vessel lesions with a large thrombus burden.
`
`J IN V A SIV E C A R D IO L 2 0 l4 ;2 6 (6 ):2 4 9 -2 5 4
`
`K e y w o rd s: throm bus, adjunctive m anual aspiration throm bectom y
`
`The use o f adjunctive throm bectom y during prim ary per­
`cutaneous coronary intervention (PCI) has steadily increased,
`largely from increased utilization o f m anual aspiration throm bec­
`tom y.1 Distal em bolization with subsequent microvascular dys­
`function during prim ary P C I is associated with worse outcom es,
`including larger infarct sizes and reduced survival.2*4 Reduction
`o f throm bus burden during prim ary PCI by manual throm bec­
`tom y has in som e recent trials dem onstrated an improved 30-day
`and 1-year survival com pared with conventional P C I.5'7
`M anual throm bectom y involves an in-dwelling coronary aspi­
`ration catheter with vacuum aspiration performed with syringes.
`Devices such as the Export (Medtronic, Inc), the Diver C E (In-
`vatec), Pronto (Vascular Solutions), Fetch catheter (M edrad), and
`
`From the Division o f Cardiovascular Diseases, Department of Medicine, Stony
`Brook University Medical Center, Stony Brook, New York.
`Disclosure: The authors have completed and returned the ICM JE Form for Dis­
`closure of Potential Conflicts o f Interest. The authors report no conflicts o f interest
`regarding the content herein.
`Manuscript submitted July 8, 2013, provisional acceptance given August 27, 2013,
`final version accepted December 3, 2013.
`Address for correspondence: Anil J. Mani, MBBS, Division of Cardiology, HSC-
`T-16-80, Stony Brook University Hospital, Stony Brook, NY 11794. Email: Anil.
`Mani@stonybrookmedicine.edu
`
`PriorityOne A C (Terumo Interventional Systems) are a partial list
`o f the numerous manual thrombectomy devices currently avail­
`able on the market (Table 1). The success o f m anual aspiration is
`limited by multiple factors including catheter tip extraction area,
`vacuum generation, deliverability, and w orking length, as well as
`vessel and thrombus characteristics. The large m ajority o f prim ary
`PC Is are performed utilizing 6 Fr guide systems. The average tip
`extraction area o f these devices ranges from 0.80-1.24 m m 2 on a
`6 Fr system. We hypothesized that the use o f a larger tip extrac­
`tion area afforded by a guide extension mother-and-child catheter
`would serve a greater aspiration potential with improved outcom es
`during prim ary PCI. The 6 Fr GuideLiner V 2 catheter (Vascular
`Solutions) provides a tip extraction area o f 1.58 m m 2, with a work­
`ing length o f 150 cm in com bination with the 6 Fr guide utilized.
`
`Methods
`T h e 6 Fr G uideLiner V 2 catheter (outer tip diameter, 1.7018
`m m ) was first tested under water utilizing a 6 Fr Launcher (inner
`diameter, 1.80 m m ) guide catheter (M edtronic, Inc) to ensure
`a fairly acceptable seal between the proxim al end o f the extrac­
`tion catheter (lying within the guide) and the distal extraction
`dp, with m inim al air leak dem onstrated. A m axim um o f 20 cm
`o f the total 25 cm throm bectom y catheter length was allowed
`out o f the distal guide tip during extraction. Extraction with a
`30 cc vacuum syringe on a stopcock release m echanism ensured
`excellent aspiration potential o f fine particulate sand, utilizing
`the device with the distal guide tip and catheter tip placed un­
`der water in this manner. T h e extraction was com pared with a 6
`Fr Pronto V 4 throm bectom y catheter sim ilarly positioned and
`was noted to be com parable or better in perform ance in terms
`o f both extraction tim e and quantity. N o visually apparent as­
`piration o f particulate m atter was noted in the syringe when the
`G uideLiner exit point from the guide was positioned to extract
`particulate sand, with the distal G uideLiner end occluded. The
`continuous aspiration revealed no apparent rem nant particulate
`m atter w ithin the guide after com pletion o f aspiration.
`Between D ecem ber 2011 and Septem ber 2013, patients
`w ho presented with acute coronary syndrom es (A C S) at a single
`university hospital during which the G uideLin er catheter was
`utilized specifically for direct m anual throm bus extraction in
`vessels deem ed to have a very large throm bus burden undergo­
`ing PC I were identified. T h is is an observational study o f this
`series o f patients with retrospective analysis o f patient data. N o
`com parators with alternate m ethods o f throm bectom y were per­
`form ed except in individual cases. A single reader as part of the
`
`Vol. 26, No. 6, June 2014
`
`249
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`

`

`M ANI
`
`B
`
`C
`
`Figure 1. A 50'jear'old male with inferior ST-elevation myocardial infarction. (A ) Right coronary artery preintervention. (B ) After thrombectomy
`with GuideLiner catheter. (C ) After direct stenting.
`
`All angiographic data were reviewed
`and clinical data were obtained from
`retrospective chart review. Troponin I
`testing was perform ed post procedur-
`ally every 6 hours for the first 48 hours
`o f adm ission. Electrocardiogram (E C G )
`w as perform ed daily until discharge or if
`sym ptom s o f ischem ia or instability oc­
`curred in hospital.
`
`Figure 2. A 69-year'old male with non-ST elevation myocardial infarction. (A ) Saphenous vein
`graft to obtuse marginal preintervention. (B ) After thrombectomy and direct stenting.
`
`Results
`Between Decem ber 2011 and M ay
`20 1 3 , a total o f 17 patients presenting
`with A C S (12 ST-elevation myocardial
`infarction [ST E M I] and 5 n on-ST eleva­
`tion myocardial infarction [N S T E M I]) in­
`volving 18 culprit vessels were treated spe­
`cifically for manual throm bus aspiration
`utilizing the guide extension catheter, wherein severe throm bus
`burden was identified (Table 2). T h is included 9 right coro­
`nary artery (RCA ) interventions (Figure 1), 4 saphenous vein
`graft (SV G ) interventions (Figure 2), 2 left anterior descending
`(LA D ) artery interventions, 2 left circumflex (L C X ) coronary
`artery interventions, and 1 ram us interm edius (RI) artery in­
`tervention. Four culprit native vessel lesions were the result o f
`late throm bosis within previously placed stents. A 6 Fr Launcher
`guide catheter was utilized in all cases o f m anual aspiration with
`the G uideLiner V 2 catheter as the m other-and-child aspiration
`system. D rug-eluting stents were deployed in all but 1 case post
`aspiration, using the direct stenting technique.
`Successful outcom es as judged by sym ptom resolution, im ­
`provement in ST-segm ents, and obtaining brisk Throm bolysis
`in M yocardial Infarction (T IM IJ-3 flow occurred in 17/18 ves­
`sels treated. M yocardial blush grade (M B G ) o f 2 or greater was
`achieved in 9 4 .4 % o f patients undergoing PC I with manual
`aspiration (Table 3). A single case o f an acutely occluded SV G
`that was throm bus laden proxim al to distal had an unsuccessful
`outcom e. Initial aspiration with the Pronto catheter in 3 cases
`and the Export catheter in 1 case was unsuccessful (Figure 3B).
`Subsequent use o f the guide extension catheter provided a suc­
`cessful outcom e with throm bus aspiration (Figures 3 C and 3D ).
`In 1 case involving the L C X artery, delivery o f the G uideLiner to
`
`observational series perform ed review o f films retrospectively.
`T h e PC I m ethods utilized for throm bectom y were as follows.
`A 6 Fr guide catheter was utilized in all cases. T h e vessels were
`wired utilizing a suitable guidew ire after anticoagulation with
`either heparin or bivalirudin at the operator’s discretion. N o gly­
`coprotein Ilb /lla inhibitors were used in this series o f patients
`evaluated. All patients received a thienopyridine drug load either
`prior to or at the tim e o f intervention. T h e G uideLiner cath­
`eter was introduced directly to the throm bus-laden lesion. The
`w orking length o f the catheter allows 25 cm o f usable length
`with radiopaque markers dem arcating these crucial boundaries,
`although the extraction length was lim ited to 20 cm. A locked
`30 cc vacuum aspiration syringe attached to the m anifold as­
`sem bly by a three-way stopcock afforded aspiration once the
`catheter was delivered to the throm botic lesion. D urin g aspira­
`tion, the distal tip o f the G uideLiner was gradually advanced
`from the proximal edge o f the throm botic lesion, positioning it
`in gradual increments further distally. C are was taken to avoid
`any back and forth m ovem ent during actual throm bus aspira­
`tion in order to avoid clot dislodgm ent and distal em bolization.
`T h e guide was aspirated prior to further contrast injection or
`device delivery with the guide extension catheter left w ithin the
`coronary vessel. Lesions were then direct stented post aspiration
`with the avoidance o f balloon dilation before or after stenting.
`
`250
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`

`Novel Adjunctive Thrombectomy in Percutaneous Coronary Intervention
`
`to date have centered on either reduc­
`tion in throm bus burden with throm ­
`bus extraction or in protection against
`distal em bolization utilizing proxim al
`and distal em bolic protection devices.
`Th e use o f distal protection devices has
`failed to date to show a benefit in pri­
`m ary p c i .s-'°
`in­
`T h ro m bu s reduction devices
`clude the previously nam ed vacuum -
`assisted m anual aspiration devices and
`m echanical aspiration devices such as
`the A ngiojet Rheolytic T h ro m b ec­
`tom y device (Possis M edical, Inc) and
`the X -Sizer device (ev3, Inc). M anual
`aspiration devices have seen
`larger
`grow th and utilization during prim ary
`PC I than m echanical devices. Recent
`analysis o f data from the C ath P C I
`registry o f prim ary P C I indicates that
`between 2 0 0 9 and 20 1 0 , aspiration
`throm bectom y was utilized in 18.9%
`o f prim ary interventions, with m anual
`aspiration accounting for 18.3% o f
`all prim ary P C ls, and with rheolytic
`throm bectom y used in 0 .6% . T h e use
`o f m anual aspiration throm bectom y
`appeared to steadily increase over the
`tim e period stu d ied .1
`T h e Angiojet in Acute M yocardial
`Infarction (AiM I) random ized m ulti­
`center trial utilizing the Angiojet rheolytic throm bectom y device
`in prim ary PC I studied 481 patients with acute M I and found
`a paradoxically larger infarct size and higher m ortality occurring
`with throm bectom y com pared with conventional P C I.11 T h e
`findings o f the A iM I trial run contrary to other random ized trials
`utilizing the A ngiojet device. In the JE T S T E N T (Angiojet R heo­
`lytic Throm bectom y Before D irect Infarct Artery W ith D irect
`Stenting Alone in Patients W ith Acute M yocardial Infarction)
`trial, a total o f 501 acute myocardial infarction patients with an­
`giographic evidence o f throm bus benefited from rheolytic throm ­
`bectom y with a higher early ST-segm ent resolution (85.8% vs
`78 .8 % ; P =.04) and freedom from m ajor adverse cardiac events
`(M A C E) at 1 year (85 .2 % vs 7 5 .0 % ; / ><.01). T h is appeared pri­
`marily driven by lower death and target vessel revascularization
`in the throm bectom y arm .12 T h e V eG AS-2 (Vein G raft A ngiojet
`Study) com paring rheolytic throm bectom y with intracoronary
`urokinase for coronary and vein graft throm bus dem onstrated a
`higher procedural success rate with rheolytic throm bectom y, but
`no significant difference in im m ediate M A C E rates. One-year
`follow-up did show a significantly reduced M A C E rate in those
`receiving rheolytic throm bectom y.13 Lim iting factors o f this de­
`vice included a learning curve in set-up and use, tim e constraints
`involved during prim ary P C I, and possible paradoxical device­
`induced distal em bolization.
`M anual aspiration
`throm bectom y has fo u n d favor for
`its rapidity o f utilization, ease o f set-up, low er cost, an d the
`
`Figure 3. A 46-year-old male with inferior ST-elevadon myocardial infarction. (A ) Right coronary
`artery before intervention. (B ) After manual thrombectomy with Pronto V4 6 Fr catheter. (C ) After
`thrombectomy with GuideLiner catheter. (D ) Right coronary artery post direct stenting.
`
`the lesion was unsuccessful and aspiration was perform ed proxi­
`mal to the lesion with direct stenting o f the lesion with a successful
`outcom e noted both clinically and by angiography.
`N o cases o f adverse clinical outcom e related to guide exten­
`sion catheter utilization were noted and no mortalities occurred
`at hospital discharge. N o vessel traum a related to the guide exten­
`sion catheter requiring additional stenting occurred. N o subse­
`quent strokes occurred at procedure term ination or in hospital.
`
`Discussion
`D urin g P C I, the avoidance o f distal em bolization and mi-
`crovascular injury is param ount to an optim al outcom e. T h e
`occurrence o f distal em bolization is especially concerning d u r­
`ing P C I for A C S with the presence o f throm bus w ithin vessel
`lesions. Vessels with lim ited or no branches lend them selves
`to the developm ent o f large throm bi with the occurrence o f a
`flow -lim iting occlusive lesion. T h e throm bus usually extends
`proxim ally and distally to the nearest outflow branch or vessel.
`This is especially true in an SV G and in the body o f the RCA.
`In-stent throm bosis is also characterized by severe throm bus
`burden, likely due to the presence o f exposed m etal stent struts.
`Further injury and possible infarct expansion associated with
`distal em bolization occur to the jeopardized m yocardium with
`device introduction, m anipulation, an d during perform ance o f
`P C I to lesions with large throm bus burden.
`Various m ethods o f reducing distal em bolization developed
`
`Vol. 26, No. 6, June 2014
`
`251
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`

`

`M A N I
`
`Device
`
`Table 1. Com parison of manual thrombectomy devices and their respective features.
`Tip Extraction
`Lum en A rea'
`
`Required
`Guide
`
`Device Internal
`Diam eter
`
`Rapid Exchange
`Length
`
`W orking
`Length
`
`5.5 Fr GuideLiner
`
`6 Fr
`
`6 Fr GuideLiner
`
`7 Fr GuideLiner
`
`8 Fr GuideLiner
`
`Pronto V 4 5.5 Fr
`
`Pronto V 4 6 Fr
`
`Pronto V4 7 Fr
`
`Diver C E
`
`PriorityOne
`
`Export X T 7 Fr
`
`Q uickCat 6 Fr
`
`6 Fr (>1.78 mm)
`
`7 Fr
`
`8 Fr
`
`6 Fr
`
`6 Fr (>1.78 mm)
`
`7 Fr
`
`6 Fr
`
`6 Fr
`
`7 Fr
`
`6 Fr
`
`1.30 mm
`
`1.42 mm
`
`1.57 mm
`
`1.80 mm
`
`—
`
`—
`
`—
`
`1.2 mm
`
`1.08 mm
`
`—
`
`—
`
`Data obtained from respective company information online.
`
`1.326 mm2
`
`1.58 mm2
`
`1.93 mm2
`
`2.54 mm2
`1.01 mm2
`
`1.24 mm2
`
`1.54 mm2
`
`1.13 mm2
`
`0.80 mm2
`
`1.12 mm2
`
`0.86 mm2
`
`25 cm
`
`25 cm
`
`25 cm
`
`25 cm
`
`—
`
`—
`
`—
`
`—
`
`—
`
`—
`
`—
`
`150 cm
`
`150 cm
`
`150 cm
`
`150 cm
`
`138 cm
`
`138 cm
`
`138 cm
`
`145 cm
`
`140 cm
`
`140 cm
`
`145 cm
`
`Table 2. Patient clinical data and outcomes.
`Patient Age
`Presentation
`C ulprit Vessel
`(years) / Sex
`
`Peak T n l
`(ng/mL)
`
`Symptom O nset to
`Peak T n l for ST E M I
`
`Ejection
`Fraction
`
`4 8 / M
`
`4 6 / M
`
`6 9 / M
`
`STEM I
`
`STEM I
`
`N STEM I
`
`SV G 'diagonal
`
`Distal R C A
`
`SV G -O M
`
`47.2
`
`551.9
`
`10.6
`
`24 hours
`
`3 hours
`
`—
`
`54%
`40%
`
`70%
`
`Outcom e
`of P C I
`
`Unsuccessful
`
`Successful
`
`Successful
`
`52 /M
`
`6 0 / M
`
`5 0 / M
`
`58 /M
`
`4 4 / M
`
`8 3 / F
`
`6 8 / M
`
`52 /M
`
`7 7 / M
`
`6 3 / M
`
`52 /M
`
`6 2 / M
`
`61 / M
`
`STEM I
`
`N STEM I
`
`STEM I
`
`STEM I
`
`STEM I
`
`STEM I
`
`NSTEM I
`
`STEM I
`
`STEM I
`
`N STEM I
`
`STEM I
`
`STEM I
`
`STEM I
`
`Proximal LA D
`
`Distal R C A
`
`Proximal R C A
`
`Proximal R C A
`
`Distal LC X in-stent
`RI in-stent
`
`Mid-distal R C A in-stent
`
`SV G -O M 1
`
`Proximal LA D
`
`SV G -LA D
`
`Proximal R C A
`
`Proximal-distal R C A
`
`Proximal R C A
`
`Mid R C A in-stent
`
`123.9
`
`9.3
`
`101.02
`
`153.42
`
`211.93
`
`75.11
`
`110.23
`
`196.79
`
`542.40
`
`86
`
`208.69
`
`238.58
`
`23
`
`10 hours
`
`—
`
`14 hours
`
`15 hours
`
`6 hours
`
`14 hours
`
`—
`
`10 hours
`
`12 hours
`
`—
`
`24 hours
`
`15 hours
`
`14 hours
`
`35%
`
`45%
`
`45%
`
`56%
`
`45%
`
`69%
`
`55%
`
`30%
`
`35%
`
`50%
`
`40%
`
`45%
`
`70%
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`Successful
`
`65%
`48.42
`24 hours
`Proximal LC X
`N STEM I
`4 2 / M
`M = male; F = female; STEM ! = ST-elevation myocardial infarction; N STEM I = non-ST elevation myocardial infarction; SVG = saphenous vein graft; RCA
`= right coronary artery; OM = obtuse marginal; LAD = left anterior descending coronary artery ; Tnl = troponin I; PCI = percutaneous coronary intervention.
`
`Successful
`
`lack o f need for associated bulky extraction m achinery. T h e
`TA PA S trial utilizing the 6 Fr E xport catheter in a total o f
`1071 patients dem onstrated a better M B G , im proved ST-
`segm ent resolution, lower persistent ST -deviation, as well as
`a trend to low er 30-day m ortality in the th rom bectom y arm
`versus conventional P C I. A lower 1-year cardiac m ortality at
`3 .6 % in the throm bectom y group com pared w ith 6 .7 % in
`the conventional P C I group was also noted. Interestingly, the
`
`m ajority o f the patients in both groups were treated with d i­
`rect sten tin g.’
`T h e R andom ized evaluation o f the effect o f M echanical re­
`duction o f D istal em bolization by throm bus aspiration in pri­
`m ary and rescue A ngioplasty (R E M E D IA ) trial evaluated 100
`patients with S T E M I utilizing the D iver C E device and dem ­
`onstrated im proved M B G and better ST -segm en t resolution
`w ithout a significant difference in clinical o u tco m es.14
`
`252
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`The Journal of Invasive Cardiology®
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`

`

`Table 3. Procedural results.
`
`Culprit Vessel
`
`Pre-PCI
`T IM I
`Flow
`
`Post-PCI
`T IM I
`Flow
`
`Post-PC I
`M B G
`G rade
`
`SV G-diagonal
`
`Distal R C A
`
`SV G -O M
`
`Proximal LAD
`
`Distal R C A
`
`Proximal R C A
`
`Proximal R C A
`
`Distal LC X in-stent
`
`RI in-stent
`
`Mid-distal R C A in-stent
`
`SV G -O M 1
`
`Proximal LA D
`
`SV G -LA D
`
`Proximal R C A
`
`Proximal to distal R C A
`
`Proximal R C A
`
`Mid R C A
`
`Proximal LC X
`
`0
`
`0
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`1
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`1
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`2
`
`2
`
`3
`
`2
`
`3
`
`3
`
`3
`
`3
`
`3
`
`3
`
`2
`
`0.22*
`2.94*
`TIMI = Thrombolysis in Myocardial Infarction; MBG = myocardial blush
`grade. 'Mean scores.
`
`2.66*
`
`In the D E A R M I (D ethrom bosis to Enhance A cute R eper­
`fusion in M yocardial Infarction) study, the Pronto extraction
`catheter was stud ied in 148 A M I patients random ized to m an­
`ual aspiration routinely prior to P C I, com pared to no routine
`aspiration. Im proved rates o f ST-segm ent resolution (6 8 % vs
`50% ; P < .05), better M B G scores, less no-reflow, an d less C P K
`release were noted, w ithout a significant benefit in clinical out­
`com es being d em on strated.15
`A m eta-an alysis o f 9 ran dom ized trials w ith a total o f
`2 4 1 7 p atien ts w ith S T E M I, co m p arin g ad ju n ctiv e m anu al
`throm b ectom y w ith routin e P C I, again d em o n strated sig ­
`nificantly im p ro v ed p o stp ro ced u ral T IM I-3 flow (8 7 .1 %
`vs 8 1 .2 % ; P c .0 0 1 ), p o stp ro ced u ral M B G 3 scores (5 2 .1 %
`vs 3 1 .7 % ; P c .0 0 1 ), an d less distal em bolization (7 .9 % vs
`1 9 .5 % ; P c .0 0 1 ), b u t w ith im proved 30-day m ortality (1 .7 %
`vs 3 .1 % ; P = .0 4 ).16 In the recent m ulticenter, prospective,
`ran dom ized open -label T h ro m b u s A sp iration in ST -E leva-
`tion M yocardial In farction in Scan d in avia ( T A ST E ) trial,
`co m p arin g ro u tin e th rom bu s asp iratio n and P C I w ith PC I
`only in 7 2 2 4 p atien ts w ith S T E M I failed to d em o n strate a
`benefit in the b ro ad p rim ary en d poin t o f all-cause m ortality
`at 30 d a y s.17 Trends tow ard redu ction in recurrent h o sp i­
`talization an d sten t th rom b osis w ith routine asp iratio n did
`not reach statistical significance. T h is calls in to q u estio n the
`routine use of th ro m b ecto m y as o p p o sed to a m ore selective
`ap pro ach in A C S .
`
`Novel Adjunctive Thrombectomy in Percutaneous Coronary Intervention
`
`in their
`lim ited
`Current m anual aspiration devices are
`tip extraction area through a 6 Fr delivery guide to between
`0.8 0 -1 .2 4 m m : (Table 1). T h e 6 Fr G uideL in er V 2 m other-
`and-child guide extension catheter allows a larger tip extrac­
`tion area o f 1.58 m m 2. T h e extraction area increases to the
`inner diam eter o f the guide (extraction area o f 2 .55 m m 2 for
`a 6 Fr Launcher gu iding catheter) after the initial 25 cm o f
`G uideLin er catheter length. T h e 6 Fr G uideL in er V 2 catheter
`is com patible with guide catheters with inner diam eters > 1 .7 8
`m m (> 0 .0 7 0 "). T h e extraction potential and safety o f the 6 Fr
`G uideLin er in guide catheters with inner diam eters > 1 .8 m m
`is not tested and not assured by this approach. T h e all-polym er
`collar provides flexibility and is less traum atic to the vessel com ­
`pared with standard guide tips. T h e catheter offers trackability,
`allow ing distal positioning w ithin the vessel for throm bus aspi­
`ration. T h e seal provided by the 6 Fr m other-and-child catheter
`within the guide allows effective aspiration through its rapid ex­
`change length. T h e radiopaque m arker w ithin the usable length
`o f the catheter allows m aintenance o f the proxim al open end of
`the catheter w ithin the guide at all tim es. C on tin u o u s aspira­
`tion directly from the guide, with the ability for direct arterial
`pressure m easurem ent, helps prevent rem nant clot fragm ents
`being present within the guide after com pletion o f aspiration.
`Standard throm bectom y catheters require the operator to en­
`sure no dislodged clot rem ains in the guide follow ing catheter
`removal by adequate guide aspiration. T h e vacuum extraction
`force generated by the 6 Fr G uideL in er V 2 catheter w ithin a 6
`Fr guide (with an inner diam eter 1.78-1.80 m m ) utilizing a 30
`cc syringe locked in vacuum m ode appears in vivo to provide
`greater aspiration potential com pared w ith a 6 Fr Pronto V 4
`device and the 6 Fr Export catheter in this lim ited observational
`patient series. O nce in position w ithin the vessel, the G u id e­
`Liner catheter further allows ease o f stent delivery in tortuous
`or difficult anatom y post aspiration.
`C are was taken to prevent distal and proxim al em bolization
`periprocedurally that w ould be detrim ental to a successful ou t­
`com e. C on tin uo us aspiration during w ithdraw al o f the G u id e­
`Liner catheter is o f utm ost im portance, as the ability to aspirate
`larger throm bus fragm ents does lend to a higher risk o f signifi­
`cant em bolic events with throm bus dislodgm ent. T h e stoppage
`o f aspiration during continuous vacuum suction w ould im ply
`the presence o f throm bus fragm ent occludin g at the distal tip
`or in the body o f the catheter, and utm ost care needs to be
`taken at this point to avoid throm bus dislodgm ent. Avoidance
`o f additional balloon dilatation either before or after stenting
`was utilized to avoid shearing clot w ith resultant distal em boli­
`zation. N o cases o f stroke occurred in this case series. A recent
`m eta-analysis o f random ized trials o f throm bectom y in prim ary
`PC I did show a trend to a higher stroke rate, with no tim e to
`event occurrence reported.18
`Study limitations. T h is is an observational case series with
`no com parison group to dem onstrate the feasibility o f utiliza­
`tion o f the guide extension catheter for throm bus aspiration
`during PC I involving vessels with severe throm bus burden.
`Larger random ized trials w ould afford greater evidence o f bene­
`fit for this novel approach and allow w ider utilization. It w ould
`take a larger series o f patients to dem onstrate w ith confidence
`
`Vol. 26, No. 6, June 2014
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`253
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`IPR2020-01343
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`Page 5 of 6
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`

`MANI
`
`the safety o f this approach, despite the lack o f adverse events
`noted in this observational series.
`T h e G uideLin er extraction is also potentially lim ited by
`reduced distal deliverability and a lim ited w orking length for
`distal vessel throm bus extraction.
`
`Conclusion
`T h e use o f m anual aspiration throm bectom y for prim ary
`PC I is steadily increasing in use with recent data to suggest im ­
`proved outcom es. T h e G uideLin er guide extension m other-and
`child catheter affords a novel m ethod o f throm bus aspiration
`with a larger extraction area w ithin a conventional 6 Fr sys­
`tem . T h is observational series o f patients studied retrospectively
`dem onstrates the feasibility for throm bus aspiration o f this ap­
`proach, especially in vessels with a large throm bus burden.
`
`References
`1. Owan TE, Roc MT, Messenger JC , Dai D, Michaels AD. Contemporary use of
`adjunctive thrombectomy during primary percutaneous coronary intervention for
`ST-elevarion myocardial infarction in rhe United States. Catheter Cardiovasc Interv.
`2012;80(7):1173-1180.
`2. Morishima I, Sone T, Okumura K, et al. Angiographic no-reflow phenomenon as a
`predictor of adverse long-term outcome in patients treated with percutaneous trans­
`luminal coronary angioplasty for first acute myocardial infarction. J Am Coll Cardiol.
`2000;36(4): 1202-1209.
`3. Henriques JP, Zijlstra F, Ottervanger JP, et al. Incidence and clinical significance o f
`distal embolization during primary angioplasty for acute myocardial infarction. Eur
`Heart J. 2002;23(14):1112-1117.
`Saber RS, Edwards WD, Bailey KR, McGovern TW, Schwartz RS, Holmes DR Jr.
`Coronary embolization after balloon angioplasty or thrombolytic therapy: an autopsy
`study o f 32 cases. J Am Coll Cardiol. 1993;22 (5): 1283-1288.
`5. Svilaas T, Vlaar PJ, van der Horst IC, et al. Thrombus aspiration during primary
`percutaneous coronary intervention. N Engl J Med. 2008;358(6):557-567.
`6. Burzotra F, Trani C , Romagnoli E, et al. Manual thrombus-aspiration improves myo­
`cardial reperfusion: the randomized evaluation of the effect o f mechanical reduction
`o f distal embolization by thrombus-aspiration in primary and rescue angioplasty (RE­
`MEDIA) trial. J Ant Coll Cardiol. 2005;46(2):371-376.
`
`4.
`
`7. De Luca L, Sardella G, Davidson C J, et al. Impact of intracoronary aspiration throm­
`bectomy during primary angioplasty on left ventricular remodelling in patients with
`anterior ST elevation myocardial infarction. Heart. 2006;92(7):951-957.
`8. Stone GW, Webb J, Cox DA, et al. Distal microcirculatory protection during percu­
`taneous coronary intervention in acute ST-se^ment elevation myocardial infarction: a
`randomized controlled trial. JAM A. 2005;293(9): 1063-1072.
`9- Gick M, Jander N, Bestehorn HP, et al. Randomized evaluation o f the effects o f filter-
`based distal protection on myocardial perfusion and infarct size after primary percu­
`taneous catheter intervention in myocardial infarction with and without ST-segment
`elevation. Circulation. 2005; 112(10): 1462-1469-
`10. Cura FA, Escudero AG, Berrocal D, et al. Protection o f distal embolization in high-
`risk patients with acute ST-segment elevation myocardial infarction (PREMIAR). Am
`J Cardiol 2007;99(3):357-363.
`11. Ali A, Cox D, Dib N, et al. Rheolytic thrombectomy with percutaneous coronary
`intervention for infarct size reduction in acute myocardial infarction: 30-day results
`from a multicenter randomized study. J Am Coll Cardiol. 2006;48(2):244-252.
`12. Antoniucci D, Valenti R, iViigliorini A, et al. Comparison o f rheolytic thrombectomy
`before direct infarct artery stenring versus direct stenting alone in patients undergoing
`percutaneous coronary' intervention for acute myocardial infarction. Am ] Cardiol.
`2004;93(8): 1033-1035.
`13. Kuntz RE, Baim DS, Cohen DJ, et al. A trial comparing rheolytic thrombectomy
`with intracoronary urokinase for coronary and vein graft thrombus (the Vein Graft
`Angiojet Study |VeGAS 2]). Am J Cardiol. 2002;89(3):326-330.
`14. Burzotra F, Trani C, Romagnoli E, et al. Manual thrombus-aspiration improves myo­
`cardial reperfusion: the randomized evaluation o f the effect o f mechanical reduction
`of distal embolization by thrombus-aspiration in primary and rescue angioplasty (RE­
`MEDIA) trial. J Am Coll Cardiol. 2005;46(2):371-376.
`15- Silva-Orrego P, Colombo P, Bigi R, et al. Thrombus aspiration before primary angio­
`plasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI
`(Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am
`Coll Cardiol. 2006;48(8): 1552-1559.
`16. De Luca G , Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunc­
`tive manual thrombectomy improves myocardial perfusion and mortality in
`patients undergoing primary percutaneous coronary intervention for ST-eleva-
`tion myocardial infarction: a meta-analysis of randomized trials. Eur H eart J.
`2008;29(24):3002-3010.
`17. Frobert O, Lagerqvist B, Olivecrona GK, et al. Thrombus aspiration during ST-seg-
`ment elevation myocardial infarction. N Engl J Med. 2013;369( 17): 1587-1597.
`18. Tamhane UU, Chetcuti S, Hameed I, Grossman PM, Moscucci M, Gurm HS. Safety
`and efficacy o f thrombectomy in patients undergoing primary percutaneous coronary
`intervention for acute ST elevation MI: a meta-analysis o f randomized controlled tri­
`als. BM C Cardiovasc Disord. 2010; 10:10.
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