CLINICAL RESEARCH
`
`
`
`of the GuideLiner catheter to enhance
`sefulness and safety
`
`intubation and support of
`guide catheters: insights from
`the
`
`
`
`
` , MEP Martin G. Stoel!) ME} Hans V
`
`
`
` , ME, PRD
`4D. Martie ML Lowik’, Phd: Clemens von Bircele
`
`ie
`a
`vlemds: 2 ALLRA ~ In
`
`
`
`
`
`Abstract
`
`Aims: Optimalostial seating and adequate back-upofguide catheters are required for challenging percutane-
`ous coronary interventions (PCI). The GuideLimer™(GL)(Vascular Solutions Inc., Mimneapolis, MN, USA)
`is 4 guide catheter extension system that provides active back-up support by deep coronary intubation. We
`aimed to assess feasibility and safety of GL-use in routineclinical practice.
`
`Methods and results: We prospectively recorded patient and procedural details, technical success, and in-
`hospital outcome of 65 consecutive patients undergoing “5-in-6” Fr GL-facilitated PCI of 70 target vessels. The
`GL was mainly used for PCI of complex coronarylesions: 97% (68/70) had American Heart Association/Ameri-
`can College of Cardiology (AHA/ACC) lesion types B2/C, 53%(37/70) were distally located; and 23%(17/70)
`were heavily calcified. Indications were to increase back-up of the guide and facilitate stent delivery (59%,
`41/70), achievementof coaxial alignmentof the guide catheter (29%; 20/70), and selective contrast injections
`(13%; 9/70). Device success rate was 93%(65/70). There were no major complications and two minor compli-
`cations managed without clinical sequelae: one air embolism and one stent dislodgement.
`
`Conclusions: GL-use resulted in increased back-up and guide catheter alignmentfor stent delivery in unfa-
`vourable tortuous coronary anatomies and complex, heavily calctfied, and often distally located lesions,
`which otherwise may have been considered unsuitable for PCT. Procedural success rate was high and there
`
`were no major complications.
`
`Page 1
`
`Teleflex Ex. 2169
`Medtronicv. Teleflex
`
`VSIQXM_E00044491
`
`
`Page 1
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`Abbreviations
`ACS
`acute coronary syndrome
`CK
`creatine kinase
`cTo
`chronic total occlusion
`
`DES
`GEA
`GL
`
`LAD
`LOX
`LM
`
`drug-eluting stents
`gastroepiploic artery
`GuideLiner
`
`left anterior descending coronary artery
`left circumflex coronaryartery
`left main
`
`Twente Guideliner registry
`
`a.SS:
`
`BREDSe
`
`
`There are three systems available: the Heartrail® II catheter (Terumo
`Corp., Tokyo, Japan), the Proxis™ device (St Jude Medical, St Paul,
`MN, USA)and the GuideLiner™catheter (Vascular Solutions Inc.,
`Minneapolis, MN, USA). The Heartrail® I catheter and Proxis™device
`are 120 cmcatheters that are mtroducedinto the mother guide by remov-
`ing the Y-connector®’. The GuideLiner (GL) catheter (Figure 1) is
`anovel rapid exchange guide catheter extension system that provides
`active guide support byits 20 cm-long flexible tubular end, which canbe
`deeply advanced into target vessels!'®. Tis handling is particularlyeasy,
`as it is docs not require disconnection of the haemostatic valve at the
`proximal end of the guide catheter and is compatible with standard
`NSTEMI non-ST-elevation myocardial infarction
`PCI
`percutaneous coronary intervention
`180 em-long guidewires.Its soft distal tip promuses a low risk ofdissect-
`
`STEMI=ST-elevation myocardial infarction ing vessels comparedto the deep-seating ofregular guide catheters.
`RCA
`right coronary artery
`So far, onlya limited number of reports and case series have been
`UAP
`unstable angina pectoris
`published on the GL guide catheter extension'®'*. Mamas et al
`teported a case series of 13 complex coronary interventions, per-
`formed via the radial artery with the “5-in-6” Fr GL system!,
`Although their success rate was high, the main limitation encoun-
`tered was stent damage upon advancementofthe stent across the
`metallic collar of the GL (two out of 32 stents)!?. Recently, Lunaet
`al published their experience with the GL catheter in a series of
`21 patients!’. In their study, a transfemoral approach and 7 Fr guide
`catheters were used in the majority of the cases with a procedural
`success rate of 90%. Pressure dampening was seen in 57%oftheir
`patients, contributing to three out of four unsuccessful cases. There
`was one major complication in the series reported by Lunaetal,
`which was a flow-limiting dissection in the proximalleft anterior
`descending coronary artery (LAD) but they noted no case of stent
`damage!>. The purpose of the present Twente GuideLiner registry
`was to assess feasibility and safely of use of the “5-m-6° Fr GT.
`guide catheter extension system during routine, clinical PCT proce-
`dures as performed at Thoraxcentrum Twente, a high-volume PCI
`centre located in Enschede, ‘he Netherlands.
`
`introduction
`Despite the advancements made in percutaneous coronaryinterven-
`tions, the interventional cardiologist nowadays has to deal with an
`increasing complexity of procedures. A good back-up of the guide
`catheter is essential to advance guidewires and balloons, and to
`deliver stents. Support of the guide can be increased by use of extra
`back-up guides and larger guide dimensions.In addition, the stabil-
`ity of the guide can be improved by advancing a buddy wire, and
`use of stiffer guidewires or anchoring balloons’. Another way to
`imcrease back-up support is deep imtubationofthe guide**. There is,
`however, a considerable risk of dissecting the vessel. Introduction
`of guide catheter extension systems, in which a long guide catheter
`with a flexible tip is advanced through the mother guide, has further
`refined this concept*’. Besides the improvement in back-up sup-
`port, the use ofguide catheter extensions provides selective visuali-
`sation of the target vessel, improves the stability of the guide and
`allows coaxial alignment ofthe guide.
`
`
`
`
`
`
`
`
`
`Figure 1. Schenitic presentation ofthe Guidediner catheter
`
`Page 2
`
`337
`
`VSIQXM_E00044492
`
`Teleflex Ex. 2169
`
`Medtronic v. Teleflex
`
`
`Page 2
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`
`
`Methods
`STUDY POPULATION
`
`Between November 2010 and July 2011, we prospectively col-
`lected data from a consecutive series of 65 patients, in whomthe
`GL was applied to facilitate routine PCL. The patients had a back-
`ground of stable or unstable angina pectoris, or presented with an
`acute myocardialinfarction.
`
`INTERVENTIONAL PROCEDURES
`
`A team of five interventional cardiologists performed the PCT proce-
`dures, each of them had performed PCI for more thanfive years (250-
`500 PCI procedures per operator annually; total PC] experience of
`4,000 or more per operator). PCI procedures were performed accord-
`ing to standard clinical protocols via the femoralor radial routes, using
`6 Fr guide catheters as a standard. All patients received a bolus of
`unfractionated heparin (5,000 TE or 70-100 TF/kg). Prior to PCT,alll
`patients reccived adequate loading doses of aectylsalicylic acid
`(300 mg)and clopidogrel (300-600 mg), if not pretreated. During the
`procedure, an intracoronary bolus of nitrates was administered. The
`choice of interventional approaches, devices, and techniques wasleft at
`the operators’ discretion, considering current clinical protocols and
`guidelines. Following PCI, clopidogrel was prescribed for one year
`(75 mg once daily[o.d.] in addition to life-long treatment with acetyl-
`salicylic acid [at least 100 mg 0.d.]).
`
`THE GUIDELINER CATHETER AND ITS USE
`
`The GT. (Vascular Solutions, Minneapolis, MN, USA) consists of
`a flexible, 20 cm, straight, flexible, soft-tipped extension tubethat is
`connected via a metal collar to a thin 115 cm-longstainless steel shaft
`(Figure 1A and Figure 1B). The extension tube has a silicon coating for
`lubricity. The procedure starts by positioning the mother guide and
`advancing the guidewire across the target lesion. Then the GLis
`advanced over the guidewire through the haemostatic valve of the
`‘Y-adapter (handling comparable to regular balloons) to mlubate the
`target coronaryartery or bypass graft (Figure 10). The GL reduces the
`innerdiameter of the mother guide by approximately | Fr, but it does
`not lengthen the guide outside the patient. When the GL is inplace,
`balloons and stents can be delivered over the sameinitial guidewire.
`The GL is available in sizes of6 I'r, 7 Ir, and 8 I'r. In this study, only
`6 Fr GL were used (also called the “S-in-6° Fr system), which has an
`internal diameter of 0.056" (1.422 mm). Nolably, the use in vessels
`<2.5 mm is discouraged by the manufacturer. Bifurcation lesions in
`our study were treated as follows: two wires were advanced through
`the guide. ‘Then, the GL was advanced over both wires simultane-
`ously. Provisional stenting was the strategyof choice. In cases where
`a kissing balloon technique was demanded, a wire exchange wasper-
`formed followed by balloon dilation of the side branch through the
`stent struts. Before the final kissing balloon inflation could be per-
`formed, the GLhad to be removed.
`
`STUDY PARAMETERS AND DATA ACQUISITION
`
`To assess the usefiulness (feasibility and safety) of the GLin clinical
`practice, we prospectively recorded various procedural data and clinical
`
`details on the in-hospital outcome of a consecutive series of 65
`patients, who underwent PCI with the use of the GL. Patient demo-
`graphics, indication for GL use, angiographic and procedural details
`including technical success, and all complications were recorded.
`Quantitative coronary angiography (QCA) was used to determine the
`intubation depth of the GL catheter. Procedural success was defined as
`the achievement of <20%diameter stenosis with TIMI 3 flow in the
`
`target vessel. Routine peri-interventional assessment of cardiac bio-
`markers was performed to screen for PCT-induced myocardial necro-
`sis up to 24 hoursafter PCI or until the highest value of creatine kinase
`(CK) was measured. Peri-PCI myocardial infarction was defined as
`two times the upper reference limit of CK, confirmed bysignificant
`elevation ofother specific biomarkers (MB-fraction of CK or troponin).
`
`STATISTICAL ANALYSIS
`
`
`
`Values are expressed as mean+tSD. Comparison of contimious varia-
`bics was performed with the Student's t-test. Categorical variables
`are presented as numbers or
`percentages and were tested with the
`chi-square test or Fisher's exacttest. A p-value <0.05 was considered
`statistically significant. Statistical analysis was performed with SPSS
`version 15.0 for Windows(SPSSInc., Chicago, IL, USA).
`
`Results
`PATIENT POPULATION AND LESION CHARACTERISTICS
`
`The demographic characteristics of the study population are pre-
`sented in Table 1. ‘he majority ofpatients were male (74°), and the
`
`mean age was 67413 years. Target lesions were relatively complex as
`is shown in Table 2. Most lesions (97%) had American Heart Asso-
`ciation/American College of Cardiology (AHA/ACC)lesion types
`B2 or C, with more than half of them being located in distal vessel
`segments. A total of 90%of lesions wasclassified as being calcified:
`AO%
`67% mild to moderately and 23%heavily calcified. Mean lesion
`
`length was 38426 mm, whichis indicative of long lesions.
`
`Table 1. Demographic characteristics of study population.
`
`
`74% (48/65)
`Male gender
`
`
`Hypertension 6/% (BH61
`Hypercholesierolaemia
`
`
`Current smoking
`
`Family history of CAD
`
`
`
`
`Prior myocardial infarction
`26% (17/65)
`26% (17/65)
`Prior CABG
`Indication for PCI
`
`SEelevation M|
`12% (8/65)
`
`Non-S T-elevation Ml
`20% (13/65)
`6% (4/65)
`Unstable angina
`62% (40/55)
`Stable angina
`CAD: coronary artery disease; PCI: percutaneous coronary intervention;
`| CABG: coronary ariery bypass graft; MI: myocardial infarction
`
`
`
`:
`
`Page 3
`
`VSIQXM_E00044493
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`
`Page 3
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`Twerte Guidelineregistry
`
`Sa
`ue‘ee
`S
`
`Table 2. Target vessels and lesion characteristics.
`Table 3. Procedural details, success,failures, and complications.
`
`5
`i
`:
`:
`
`2 Left anterior descending artery
`|
`17/70 (24%)
`Radial access
`22/65 (34%)
`:
`oe
`i
`| Lett circumflex artery
`|
`20/70 29%)
`|
`—
`:
`Multivessel procedure
`19/65 (29%)
`23/70 (33%)
`| Right coronary artery
`
`79243
`Lovo 14%)
`|
`:
`Proceduraltime (min)
`
`Volume:of contrast (11) 2204118
`
`
`
`
`[eeeneereer eleeepe
`(70
`(97%
`
`
`Type B2IC lesion
`BRITO (97%)
`Total length of stents implanted (mm)
`41+29
`=S(asé‘(i‘<CS*é‘(C;‘«‘;«‘;é‘«STBH)!‘|
`Distallocation
`Number-of stents implanted
`1,841.2
`
`| Severe calcification 33421 16/70. (23%) Depth of GuideLiner intubation (mm)
`
`
`
`
` | Chronic total occlusion
`12/70 (17%)
`Reference vessel diameter (mm)
`3.020,5
`Improvement of back-up and facilitated
`i
`41/70 (59%)
`
`| Diameter stenosis (%)
`89413
`stent delivery
`Lesion length (mm)
`S156
`More Selective contrast injection
`970 S%)
`20/70 (29%)
`|
`Improvement of alignment of the guide
`
`
`Success, failures, end complications
`!
`:
`
`Device success
`|
`65/70 (93%)
`
`64/70 (91%)
`t
`0/70
`
`
`
`M aor complications
`370 (3%)
`Air embolism
`
`1/70 (1%)
`
`eeees
`
`1/70 (1%)
`Stent dislodgement
`
`INDICATION FOR GL USE AND PROCEDURALDETAILS
`All procedures were carried outwiththe “S-in-6” F'r GL device. As shown
`in Figure 3, the primary indications for GL use were to increase back-up
`of the guide catheter, in general to facilitate stent delivery (59%), andto
`improve alignmentofthe guide catheter (29%) (Table 3). In a fewpatients
`(13%), the GL was used for selective contrast injection, predominantly
`because of dommantleft coronary arlery (TCA) and/orrenal impairment.
`.
`°
`There were differences between the application in right coronary artery
`
`
`
`
`
`
`
`Figure 2. dagiographyofa cheonicaily occluded RE
`gor-oid female patieer (Ap. Wie craasiis wis achieved using a pilat 30 wire.
`Ajter subsequens pissage and diation with low profile balloons, gueflowis partially restored cul a long dissection can be noled theé extends
`
`into the postero-laweeal becach (13). Passage of a stent was unsuce
`ful dus to marked resistance ia the distal segment of ihe vessel, Wits the
`
`fe
`
`
`
`deepiy intubated over the guidewire (Ci, Then, several drug-eluting
`stenis were
`help ofan anchoring balloon, the Guidelmer catheter was
`successfiellydelivered and pastdiiated, with a good Anal angiographic resudt (EH.
`
`Page 4
`
`VSIQXM_E00044494
`
`Teleflex Ex. 2169
`Medtronicv. Teleflex
`
`
`Page 4
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`
`
`
`
`
`
`elds fhefest case was a 7P-yearold qude pations wih an acute inferiee Ad The
`Figure 3. dagiograplie overviewaf the devicefaibmes: Cas
`
`
`
`
`forget lesron was located ina chtfusely diseased, heavily calcifiedRCA, The GL
`ould not be advanced through the guide catheter
`because of
`
`
`
`2
`severe diag torausaty (4), dud piv
`af success was accoagilished bt
`Mand LOCKthat
`
`
`
`#2) The second case was a long andcal
`balioan. Case
`ed proximal LCX lesion, located belund a sharp angle between the.
`
`
`
` sot who mulenwent cut elecky
`
`
`
`
`prevented OF. matuhaton 3). Case #3) The th
`af cree was G 36-year-old sulife
`CY ofa diffssely diseased RCA,
`
`
`Hh catheter could not be intubatedin the vessel diez to a prexiraal lexicn|
`3@ procedure wasjauished successtuliy with an ALi guide.
`
` BA? In thefo
`
`“4 lesion iD). The
`fh patient, the 1ereet lesion was a heavily ciate
`ocnma ROA segment we,
`taney
`
`ji
`
` gen was sotvedt ly
`Hp
`diseased, whic
`vevented dey
`DL intubation ja depth ofonly 3 may and resuliedin insufficient support: hawever this pral
`
`
`ILUEF
`se was a vital 874
`
`
`potablation af the ostium. Case #3) The Bahr ca
`ddfonuile wilt stable angina due toa severely 2
`
`inet é-vear-dd saphenous veer
`j
`
`wes advanced ac
`
`
`
`udewire cenud natpass ie ostium either We chscussed die patient with our thoracn:
`(EB), ond the PCT panicedure was terminated as a second gt
`
`
`Surgeons, whto then performed an elective repeat lane.
`susgery welt an uneventfid climcal conse.
`
`(RCA) and LCA interventions. In the LCA, the GL catheter was used
`regularly to improve the alignment ofthe guide or enhanceselective con-
`trast mjections, whereas its use in RCA interventions was maimly to
`increase catheter back-up (p=0.024). An example is shown in Figure 2.
`AG Fr guide catheter was used inall subjects, while radial access was
`chosen in one third of cases. Multivessel procedures were performed in
`almost one third of the patients, and there were 17%of chronic total
`occlusions. Ofall 126 stents implanted, 123 (98%) were third-generation
`
`drug-eluting stents (DES). In this registry, we noted a single stent that
`was damaged upon advancement across the metallic collar of the GL;
`damageto the (secondary) guidewire tip when passing the metallic collar
`of the GLoccurred slightly more often (4/70; 6%).
`
`DEVICE SUCCESS AND DEVICE FAILURE
`
`The overall success rate of the GL was 93%. The average depth to
`which the GL was intubated in the proximal target vessels was
`
`33422 mm(range: 0 lo 106 mm), however, these generally deepmtu-
`bations did not cause any coronary dissections. The rate of procedural
`success ofthe transradial and transfemoral access routes was 95.5%
`
`and 88.4%(p=0.35), respectively, but the power ofthe study was insuf-
`ficient to draw sound conclusions from this comparison. There were
`five device failures (5/70; 7%), which are illustrated in Figure 3.
`
`COMPLICATIONS
`
`We noted no major complications or coronary dissections. There
`were two minor complications, which are outlined below. In the
`first case, during PCI of a diffusely diseased RCA in a 53-year-old
`male, the GL was deeply advanced (61 mmintubation depth) to
`increase back-up support and to pass a balloon catheter across the
`heavily calcified distal RCA stenosis. During this manoeuvre, some
`air embolism was noted as a result of insufficient venting of the
`wedged GL, which caused a brief phase of stasis of coronary flow
`that was rapidly resolved. The second minor complication occurred
`during PCI of a long mid lesion in an RCA with “shepherd’s crook”
`anatomy. After predilatation and stenting of the mid RCA, an
`attempt to advance a second stent through the first one was made,
`which turned out to be extremely difficult. To increase support, the
`GL was advanced over both guidewires and the second stent balloon
`
`340
`
`Page 5
`
`VSIQXM_E00044495
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`
`Page 5
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`
`
`&i
`
`e&oe
`
`= aa“E
`
`sxa
`
`S
`
`system(stent still undeployed), whichled to dislodgement ofthe
`stent from the balloon. Eventually the dislodged stent was crushed
`behind a third stent and was postdilated with high balloon pres-
`sures, leading to a goodfinal angiographic result with an uneventful
`clinical course until the eight-month follow-up.
`
`Discussion
`Good back-up ofthe guide catheter 1s crucial for both wiring and
`equipment delivery. The development of guide catheter extension
`systems has further expanded the therapeutic arsenal of the inter-
`ventional cardiologist**. Intubation of the guide catheter extension
`system into the target vessel provides enhancement of equipment
`delivery in challenging coronary lesions, and facilitates cngage-
`ment in case ofdifficult takeoff of the coronary osttum. Takahashi
`et al demonstrated that a guide catheter extension system provides
`a substantial improvement in back-up support’. The support was
`directlyrelated to the depth of intubation. For example, insertion of
`a5 Fr guide catheter 15 mminto a 6 Fr catheter doubled the back-
`up support. The guide catheter extension system may be used as
`atool for deeper intubation of the guide, referred to as “rail-road-
`ing”, as was described in detail by Farooq et al!*. Its use in graft
`mlerventions is well recognised as aiding gralt camnulation and
`enhancing the stability of the guide in the graft ostium. Further
`back-up may be achieved by advancing the extension catheter,
`thereby allowing the guide to back out and downuntilit rests on the
`aorlic valve or contralateral aortic wall (Swan-neck manoeuvte)®.
`And finally, guide catheter extension systems can be used as an
`aspiration device'’.
`The ‘Twente GuideLinerregistry reports on a consecutive series of
`GL applications in 65 patients, treating 70 target vessels with implan-
`tation of 126 stents (98%being third-generation DES). Sofar, this is
`the largest registry on the use of the GL in routine daily practice.
`Demographics and clinical characteristics of the study population are
`similar to previous all-comersstent studies and our gencral PCI pop-
`19-25
`ulation’, However, lesion characteristics differed a lot from the
`general patient populationas the majority of target lesions were long
`
`and complex: all but two target lesions (97%) were classified as
`lesion type B2 or C with more than half of them being located dis-
`tally, and the vast majority being at least moderately calcified.
`During the first months, the GL was used as a bailout device in
`challenging cases, whenthe “old familiar tricks” (e.g., deep-seat-
`ing manoeuvres or use of buddy wires) had failed. However, after
`becoming more familiar with the device, we switched to a more
`uptront use in difficult anatomical situations. In ourpresentseries,
`the main indication for GL use was to improve guide support to
`facilitate stent delivery (59%). An illustration is shown in
`Figure 2. However, in one third of the cases the GL was used to
`improve coaxial alignmentof the guide catheter in anatomicalsit-
`uations with an abnormal takeoff of the target vessel (c.g., shep-
`herd’s crook-shaped proximal RCA)or a vertical takeoff of either
`RCAorleft main stem. Inparticular, a vertical offspring of the left
`main stem, as may be sccn in young Ican paticnts or patients with
`pulmonary emphysema, bears an increased risk of dissecting the
`eft main stem with a guide catheter. Gentle intubation of the GL
`substantially
`facilitated the
`intervention
`im
`such patients
`(Figure 4). In a small numberof paticnts, the GL was used to per-
`form selective contrast injections for a better visualisation of the
`vessel of interest with smaller amounts of contrast; this mdication
`for GL use maybe considered in patients with large calibre ves-
`sels, such as a dominant left coronary artery, and an impaired
`renal function, or if an adequate visualisation cannot be achieved
`y other means”®.
`The GL mayalso be useful to facilitate demanding diagnostic cor-
`onary angiographies, which has not been described so far and was
`beyond the scope of our registry of GL use in PCI patients.
`
`group also used the GL in several demanding cases of diagnostic
`angiographic visualisation of bypass grafis. Figure 5 shows an example
`of a gastroepiploic artery (GEA) graft, visualised both with and
`without use of a GL. It should be emphasised that in case of coronary
`angiography, the operator should refrain from the use of intracoro-
`nary wires and devices as much as possible. However, there are
`
` Nevertheless, we would not like to withhold the information that our
`
`
` ofthe leftmaia (Aand 8). The GoidelLiner catheter was usedfor
`prin
`Figure 4. dugiographic overviewof a subject wiih«vertical off.
` flexion,
`cowaal alignnent oftre guiding catheter providiag eenile intubarion in Bre LAL and wood supmort to teat the LAD
`
`
`
`Page 6
`
`VSIQXM_E00044496
`
`Teleflex Ex. 2169
`
`Medtronic v. Teleflex
`
`
`Page 6
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

`
`
`
`} enaftia a 86-year-old male patient.Pomel A shows vague images ofthe GHA graft,
`Figure 8. Mevelsetion ofa gastroepiploic arte
`i
`
`
`abioined during route angiography Bevo years earlier Pane: 2
`trates the difference in wnage quality, obtained recentip withthe ese a
`Guideliner (Gt) catheter Tre arrowin Panel ©is pointed at the up ofihe GL catheter.
`
`circumstances in which a graft cannot be properly visualised. Instead
`of accepting a poor visualisation, the use of a guide catheter exten-
`sion system can be considered in order to achieve conclusive angio-
`graphic maging. It should be used by an mterventional cardiologist
`with great care, and maximumeffort should be taken to ensure that
`such manoeuvres do not give rise to a coronarydissection.
`
`SUCCESS RATE, SHORTCOMINGS, AND POTENTIAL
`PROCEDURAL RISK
`
`The success rate of the GL was 93% in our study, which is in agree-
`ment with previously reported smaller case series!**"!5, Stent dam-
`age at the site of the metallic collar of the GL occurred in one out of
`126 stents implanted, which was a drug-eluting stent with a nominal
`diameter of 3.5 mm. Others have reported a higher rate of stent dam-
`age (6%) due to the collar of the GT, catheter’? Therefore, we dis-
`courage the use of stents with a nominal diameter of 4 mm or more
`through a “5-in-6” 'r GL catheter. Murphy et al recently reported an
`uncommoncase of balloon damageatthe site of the metallic collar'®.
`In addition, secondary (buddy) guidewires can be damaged upon
`advancement when the GL is in place, as reported in our present
`study. The “S-in-6” Fr GL catheter permits the passage of virtually all
`regular balloon catheters, contemporary optical coherence tomogra-
`phy (OCT)catheters, and coronary stents up to a nominal diameter of
`3.5 mm. Ilowever,it does notallowthe use of larger devices such as
`thrombectomy catheters, some intravascular ultrasound ((VUS)
`probes, and simultaneous kissing balloon inflations.
`Although the GL turned out to be generally beneficial with
`a relatively lowrate of device failure, we identified some scenar-
`
`in which the usefulness of the GI. may be questionable.
`ios,
`Firstly, a difficult access due to iliac tortuosity mav impede the
`advancement of the GL through the mother guide, as was seen in
`one ofour patients. Secondly, the proximalpart ofthe target ves-
`sel should be suitable for intubation of the GL catheter, therefore,
`ostial/very proximal lesions or sharp angles of coronary arteries
`maylead to device failure, as was noted in the majority of our
`cases with device lailure.
`
`In general, use of the GL tumedoutto be safe. No major compli-
`cations were noted, but there were two minor complications with
`tavourable outcomes and an otherwise uneventtul clinical course.
`
`There was one case of air embolism due to insufficient venting. In
`the secondcase, a stent was dislodged from the balloon by thetip of
`the GL when advancing the GL over a stent balloon system. Both
`complications could have been avoided, if more care had been
`taken and the instructions of the manufacturer had been followed.
`
`Luna et al‘ reported a substantially higher numberof cases with
`pressure dampening (57%) during engagement ofthe GL catheter,
`however, dissimilar to our study, they used a “6-in-7” Fr system in
`the majority of cases.
`
`HOW TO USE THE GUIDELINER AND HOW TO AVOID
`COMPLICATIONS
`Several considerations can be mentioned in order to chooseor refrain
`
`from the use of a guide catheter extension. If more back-up of the
`guide catheter is required, the first step can be the use of buddy wires,
`extra stiff wires, or buddy balloons. However, if these measures fail,
`aGLcatheter may be considered, which allows the mother guide and
`
`VSIQXM_E00044497
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`e >g
`
`paaren
`
`
`BE
`
`Page 7
`
`
`Page 7
`
`Teleflex Ex. 2169
`Medtronic v. Teleflex
`
`

`

` &i
`
`e&oe
`=ieee
` S
`aa
`“Es
`S
`
`xa
`
`Twente Guigeliner:
`
`
`LIMITATIONS
`
`The present registry of a consecutive series of PCT patients treated
`with the use ofthe “5-in-6” Ir GL provides some “real-life” insight
`into efficacy,
`limitations, and the potential msk of this device.
`Although our patient population is larger than that of all previously
`reported cases and patient series altogether'™"* the population is still
`relatively small. In addition, due to well-known limitations inherent
`o registries, this smgle centre registry cannot provide the scientific
`evel of insight that might be obtained from a randomised study. Dur-
`ing the course of this registry, use of highly deliverable third-genera-
`29
`
`ion DES in most patients was our standard of care”, which could
`ave affected our results. We cannot exclude that in cases with
`
`upfront use of the GL, a standard guide catheter or other manocuvres
`and tricks (e.g., deep intubations or buddy wires) could also have led
`o procedural SLICCESS.
`
` eavily calcified, and often distally located lesions, which other
`
`CONCLUSIONS
`
`Jse of the GuideLiner catheter resulted in an increased back-up
`support and guide catheter alignmentfor slent delivery in the pres-
`enec of unfavourable tortuous coronary anatomics and in complex,
`
`wise may have been considered unsuitable lor PCI. The procedural
`success rate of the GL was high without major complications.
`
`FUNDING
`
`This investigator-imiliated study was performed without specific
`funding. The research department reecived educational and/or
`research grants in the past and has participated in clinical studies
`funded by Abbott Vascular, Biosensors, Biotronik, Boston Scien-
`tific, Cordis, and Medtronic.
`
`Contict of interest statement
`C. von Birgelen is a consultant to and has received lecture fees or
`travel expenses from Abbott, Medtronic, and Boston Scientific and
`has received a speaker’s honorariumfrom Merck Sharp & Dohme.
`All ofthe other authors have no conflict ofinterest to declare.
`
`References
`1. Burzotta F, Trani C,Mazzari MA, Mongiardo R, Rebuzzi AG,
`Buffon A, Niccoli G, Biondi-Zoccai G, Romagnoli FE, Ramazzotti V,
`Schiavoni G, Crea F. Use of a second buddywire during percutane-
`ous coronaryinterventions: A simple solution for some challenging
`situations. J Invasive Cardiol. 2005,17:171-174.
`2. Hirokami M, Saito S, MutoH. Anchoring technique to
`improve guiding catheter support in coronary angioplasty of chronic
`total occlusions. Catheter Cardiovasc Interv. 2006,67:306-371.
`3. Peels HO, van Boven AJ, den HeijerP, Tio RA, Lie KT,
`Crijns HJ. Deep Scating of six French guiding catheters for deliv-
`ery of new Palmaz-Schatz stents. Catheter Cardiovasc Interv.
`1996;38:210-213.
`4. von Sohsten R, O7 R, Marone G, McCormick DJ. Deep intu-
`bation of 6F guiding catheters for transradial coronary interven-
`tions. J lnvasive Cardiol. 1998,10-198-202.
`
`wires to be left mmplace. ‘The operator should, however, be convinced
`that the proximalpart ofthe target vessel is suitable for intubation. If
`the lesion extendsto the proximal segmentor if there 1s sharp angula-
`tion, the use of a guide catheter extension system is generally not
`recommended. Alternatively, the proximal segment may be stented
`first, followed by gentle intubation of the GL catheter and treatment
`of the distal segment (so-called proximal-to-distal stenting). How-
`ever, care should be takento avoid deformationorlongitudinal com-
`27,2
`pression of a proximally implanted stent?’ If there is a problem
`with coaxial alignmentof the available guide catheters, the operator
`should estimate the risk of performing the procedure with a subopti-
`mal position of the tip of the guide (in case of a simple proximal
`lesion one maycontinuc). However, if substantial back-up is required,
`it appears wise to use a guide catheter extension. This decreases the
`tisk of guide-induced dissections and improves the back-up of the
`mother guide. If the patient has an impaired renal function and the
`operator expects to use large amounts of contrast (e.g., in a dominant
`left coronary artery system), a guide catheter extension system may
`be considered as a valuable firsi choice. And finally, if the operator
`intendsto treat a bifurcation lesion, it should be realised that a “5-in-
`6” T'r system does not allowthe simultaneous use of two balloons.
`Therefore, a choice should be made to use a larger guide catheter
`extension system (“6-in 7” Fr system or Proxis™ device), remove the
`guide catheter extension system before the kissing procedure, or
`refrain fromits use and adhere to usual practice.
`
`A WORD OF CAUTION
`
`Intubation ofthe GL bears the risk of causing a dissection in a prox-
`mal coronary artery and should be performed carefully. Iresist-
`ance is encountered when advancing the device, the GL can be
`retrieved into the mother guide and then re-advanced over a balloon
`catheter (to improve alignment) into the target vessel!’. After
`advancing the GL into the vessel, the operator should check the
`coronary pressure waves and verify the presence of adequate, pre-
`served antegrade coronary flow. Since use of the GL reduces the
`size of the working lumen, there is an increased risk of air embo-
`lism, which can be diminished by slow advancement and with-
`drawal of the equipment; time should then be taken to carefully
`vent the system. A limitation of the GL device is the metallic collar
`located at the entrance ofthe extension tube. In case ofresistance
`
`while advancing the stent, the location of the stent in relation to the
`metallic collar of the GL should be checked and the stent should be
`
`inspected for damage. If the collaris located at a bend in the cath-
`eter, the GL should beretrieved gently into a straight section of the
`mother guide in order to allow more coaxial alignment of the
`collar’. The use of more th