C(cid:2)2011, Wiley Periodicals, Inc.
`DOI: 10.1111/j.1540-8183.2011.00671.x
`
`The GuidelinerTM Catheter for Stent Delivery in Difficult Cases:
`Tips and Tricks
`
`CLARISSA COLA, M.D.,1,2 FAUSTINO MIRANDA, M.D.,1 BEATRIZ VAQUERIZO, M.D.,1
`ANDRES FANTUZZI, M.D.,1 and JORDI BRUGUERA, M.D.1
`
`From the 1Interventional Cardiology Unit, Department of Cardiology, Hospital Del Mar, Barcelona, Spain; 2Internal Medicin Department,
`Universidad Autonoma de Barcelona
`
`Introduction: Stent delivery in complex coronary anatomy with severe calcification and tortuosity is still a common
`cause of percutaneous coronary interventions (PCI) failure. Recently, a new support rapid exchange catheter, the
`Guideliner, has been designed specifically for device delivery.
`Methods: From June 2010 to December 2010, we performed 10 cases using the Guideliner catheter to improve
`backup support and facilitate stent delivery: 2 emergent PCI for ST elevation myocardial infarction, and 8 stable
`elective PCI. In 3 cases the operator chose the femoral access, in 2 cases crossover from radial to femoral
`access was needed, and the other cases were performed radially. In 2 cases PTCA with drug-eluting balloon was
`performed; in the other cases second-generation drug-eluting stent was implanted.
`Results: One case, the first one, failed, as stent could not be delivered to the target lesion. The other 9 cases were
`performed successfully. Three proximal dissections were detected and sealed with stent implantation. In 2 cases, we
`had stent damage due to the passage of the stent through the Guideliner metal collar. Another stent had to be used.
`Conclusions: In our experience, the Guideliner catheter is safe to use and helps device delivery in difficult
`settings. We describe here our experience with the Guideliner catheter for stent delivery and backup support;
`we discuss its utility and drawbacks in acute and stable clinical settings. Moreover, the aim of this article is to
`help interventional cardiologists using the device in difficult lesions to avoid potential complications. (J Interven
`Cardiol 2011;24:450–461)
`
`Introduction
`
`Over the last decade, numerous advancements in
`percutaneous coronary interventions (PCI) have been
`achieved. However, the interventional cardiologist of-
`ten deals with difficult scenarios, like complex coro-
`nary anatomy with severe calcification and tortuosity,
`where the operator may still be unable to deliver a
`stent to the target lesion. Several new devices and tech-
`niques have been developed to overcome this problem,
`including more supporting guiding catheters, newer
`stents with lower profile and better delivery systems,
`the “buddy” wire to improve guiding catheter coax-
`iality, or buddy balloon techniques,1 and the anchor
`
`Address for reprints: Clarissa Cola, M.D., Interventional Cardiology
`Unit, Department of Cardiology, Hospital Del Mar, Paseo Mar´ıtimo
`25–29, 08003 Barcelona, Spain. Fax: +34 932483398; e-mail:
`clarissacola@gmail.com
`
`technique, as examples. In particular, for the tran-
`sradial approach, stent delivery is improved with 5
`or 6 French guiding catheter deep-intubation.2 More
`recently sheathless catheters have been commercial-
`ized, with an outer diameter approximately 1.5 F sizes
`smaller than the corresponding radial sheathes to over-
`come the limitations due to radial smaller diameter
`(6.5 or 7.5 French, Asahi, Intecs, Aichi, Japan). From
`the methodological point of view in some situations,
`especially in elderly hypertensive patients, the choice
`of transradial left despite right approach is associated
`with higher procedural success.3 Mamas et al.4 de-
`scribed the 5F Heartrail II catheter (Terumo, Tokyo,
`Japan) within a standard 6F guiding catheter (so called
`‘‘five-in-six’’ system, or “mother and child”) which
`was initially developed for use in chronic total oc-
`clusion PCI.5 Recently a new support catheter, the
`Guideliner catheter (Vascular Solutions, Minneapolis,
`MN, USA) has been developed specifically for device
`
`450
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 1
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`delivery. The Guideliner catheter consists of a short
`guiding catheter extension connected to an introducer
`rod; it is essentially a rapid exchange equivalent of
`the “five in six” Heartrail II catheter, being poten-
`tially easier to use. The device received CE marking in
`September 2009. First-in-human experience with this
`device was described by Mamas et al.,5 the same group
`then extended its series performing transradial cases
`for coronary bypass graft interventions.6 We describe
`here our initial experience with the Guideliner catheter
`for stent delivery and backup support, and we discuss
`its utility and drawbacks in acute and stable clinical
`settings (Table 1).
`
`Device Details
`
`The Guideliner catheter is a coaxial guide exten-
`sion with the advantage of rapid exchange. In difficult
`and challenging interventions, guiding catheters have
`a tendency to back out of the artery whereas the Guide-
`liner allows guiding catheter extension into the vessel
`for deep seating. The catheter has been described else-
`where.7 Briefly, it is composed of a flexible 20-cm soft
`tipped catheter connected via a metal “collar” with a
`115-cm stainless steel shaft to a proximal positioning
`tab (Fig. 1). It is currently available in three sizes: 5-in-
`6 (0.056’’ internal diameter (ID)), 6-in-7 (0.062’’ID)
`and 7-in-8 (0.071” ID). The extension is 20-cm long
`(although a maximum intubation of 10 cm is recom-
`mended, in order to place the collar in a straighter
`portion of the catheter) and has silicon coating for lu-
`bricity. The extension section is a component built tube,
`with good flexibility and adequate radial strength; the
`external layer is made of the same material as a guid-
`ing catheter. There is a radio-opaque marker located
`at 2.66 mm from the tip. Two positioning white mark-
`ers on the push tube, at 95 cm (single) and 105 cm
`(double), assist catheter placement through the guide.
`At any time, following placement of the mother
`guide catheter and coronary guidewire in the target
`vessel, the Guideliner catheter can be advanced over
`the wire through the hemostatic valve without the
`need to disconnect the valve from the mother guide.
`The catheter tip is then advanced beyond the tip of
`the mother guide into the coronary vessel by pushing
`on the proximal tab. The interventional procedure is
`performed in the usual manner through the hemostatic
`valve.
`The Guideliner has two indications for use: deep
`seating for added back-up guiding catheter support
`in challenging cases to facilitate device delivery, and
`
`coaxial alignment when a difficult coronary ostium
`takeoff prevents guiding catheter placement. It is con-
`traindicated in vessels with less than 2.5- mm diame-
`ter. Herein follows a description of some cases illus-
`trating the advantages and potential drawbacks of this
`new device. Case 1 was the only failure in our series,
`the Guideliner catheter being extremely helpful in the
`other cases; cases 3 and 6 illustrate the advantages of
`the Guideliner catheter; case 4 is a case of stent dam-
`age while being advanced into the Guideliner catheter;
`and finally, cases 5 and 10 show coronary dissections
`related to the device.
`
`Case 1
`
`An 80-year-old female patient with unstable angina
`and transient ST segment elevation in inferior leads
`was admitted to our center. She was on chronic an-
`ticoagulation treatment because of chronic atrial fib-
`rillation (INR 1.2). Coronary angiography showed a
`dominant right coronary artery (RCA) with severe
`calcification all along the vessel, with a 90% prox-
`imal stenosis as the culprit lesion; and a small di-
`ameter (1.8 mm) posterior descendent artery (PDA),
`with a severe proximal stenosis (90%) (Fig. 2). PCI
`was programmed 7 days after the diagnostic coro-
`nary angiography. Oral anticoagulation was discon-
`tinued, and femoral access PCI was chosen because
`of negative bilateral Allen test and small radial pulses.
`Access for PCI was through right femoral artery. A
`6F Judkins Right guiding catheter was chosen. A
`0.014’’ Balance Middle Weight Universal guidewire
`(Abbott Vascular, Abbott Laboratories, Abbott Park,
`IL, USA) was positioned in the distal PDA. Proxi-
`mal lesion was predilated using a 3.0 × 10 mm Flex-
`tome Cutting Balloon (Boston Scientific, Natick, MA,
`USA). Afterward, different balloons were used to try
`to dilate the PDA lesion (1.25 × 15 mm Nimbus
`Pico PTCA balloon catheter, ClearStream Technolo-
`gies Ltd, Wexford, Ireland; 1.25 × 15 mm Ryujin
`Plus—RX PTCA Balloon Catheter, Terumo Europe
`N.V., Leuven, Belgium) but none could cross the le-
`sion, which was tight and hard. The operator then intro-
`duced the Guideliner, carefully across the hemostatic
`valve, deeply down to the acute marginal angle of the
`RCA, with particular attention to device friction in-
`side the coronary artery. At this point device coaxiality
`is very important to decrease risk of dissection. Dila-
`tion with several small balloons was attempted again,
`but none of them could cross the lesion. The opera-
`tor decided to conclude the procedure, as the PDA, a
`
`Vol. 24, No. 5, 2011
`
`Journal of Interventional Cardiology
`
`451
`
`
`Page 2
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`COLA, ET AL.
`
`N/A
`
`N/A
`
`N/A
`
`dissection
`
`Proximal
`
`Link8
`
`2.5×5mmMulti
`
`N/A
`
`N/A
`
`N/A
`
`Failure
`
`Complication
`
`Resolute
`Endeavor
`2.25×18
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`40mm
`
`Balloonand
`
`Failure
`
`StentDamage/
`
`StentDeployed
`
`Depth
`
`Intubation
`
`GL
`
`Indicationfor
`
`Continued
`
`Resolute
`
`3×38mmEndeavor
`3×30mmEndeavor
`EndeavorResolute
`2.5×30mm
`3.5×13mm
`3.0×28mmMulti
`2.75×18mmMulti
`2.5×23mmMulti
`EndeavorResolute
`3.5×30mm
`2.75×24mm
`2.25×14mm
`
`Resolute
`
`HexacathTitan2
`
`Link8
`
`Link8
`
`Link8
`
`EndeavorResolute
`
`EndeavorResolute
`
`catheter
`DIORPTCA
`elutingballoon
`2.0×25-mmdrug
`Drugelutingballoon
`
`DIOR
`
`delivery
`Stent
`
`100mm
`
`Balloonand
`
`delivery
`stent
`
`25mm
`
`Balloonand
`
`40mm
`
`20mm
`
`Stentdelivery
`
`30mm
`
`60mm
`
`delivery
`
`delivery
`stent
`
`calcification
`distal,severe
`
`Longlesion,
`TypeC
`
`distallesion
`calcification,
`
`RCA/DP/PL
`
`Severe
`
`RCA-CTO
`
`R
`
`R
`
`52
`
`Case7
`
`81
`
`Case6
`
`Stentdelivery
`
`TypeC
`Extremetortuosity
`
`LAD
`
`R
`
`80
`
`Case5
`
`Stentdelivery
`
`Balloon
`
`TypeC
`
`ity/angulation
`Extremetortuos-
`
`TypeC
`Severetortuosity
`
`TypeC
`TypeB
`
`calcification
`
`Severe
`
`LMS-Circ
`
`F
`
`68
`
`Case4
`
`RCA
`
`Circ-DPA
`
`R/F
`
`F
`
`79
`
`75
`
`Case3
`
`Case2
`
`RCA
`
`R/F
`
`80
`
`Case1
`
`LesionType
`
`Vessel
`
`Access
`
`Age
`
`Case
`
`Table1.CaseDetailswithPatient’sAge,ArterialAccess,GuidelinerCatheterIndication,DepthofIntubation,KindofStentImplanted,andComplications
`
`452
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 3
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`Dissection
`
`LM-LAD
`
`N/A
`
`dissection
`
`Proximal
`
`N/A
`
`N/A
`
`N/A
`
`Complication
`
`Failure
`StentDamage/
`
`PL=posterior-lateral;Circ=circumflex;LMS=leftmainstem;LAD=leftanteriordescendingartery;lesiontype=ACC/AHAclassification.
`R=radial;F=femoral;R/F=switchfromradialtofemoral;GL=guidelinercatheter;N/A=notapplicable;RCA=rightcoronaryartery;DP=descendingposteriorartery;
`
`Prime
`
`2.25×28mmXience
`2.25×20mm
`2.5×20mmPromus
`2.25×24mm
`2.5×24mm
`3.0×30mm
`3.0×15mm
`3.0×12mm
`2.25×18mm
`2.5×14mm
`3.5×38mm
`StentDeployed
`
`PromusElement
`
`EndeavorResolute
`
`EndeavorResolute
`
`EndeavorResolute
`
`EndeavorResolute
`
`EndeavorResolute
`
`EndeavorResolute
`
`EndeavorResolute
`
`PromusElement
`
`Element
`
`TypeC
`
`30mm
`
`Stentdelivery
`
`Extremetortuosity
`
`CircCTO
`
`20mm
`
`Stentdelivery
`
`AngulatedCirc
`
`Circ-OM2
`
`TypeC
`origin
`
`F
`
`R
`
`72
`
`Case10
`
`61
`
`Case9
`
`Stentdelivery
`
`Verytortuousand
`
`RCA
`
`R
`
`60
`
`Case8
`
`TypeC
`
`calcified
`
`depth
`Intubation
`
`GL
`Indicationfor
`
`Table1.Continued.
`
`TypeC
`
`LesionType
`
`Vessel
`
`Access
`
`Age
`
`Case
`
`Vol. 24, No. 5, 2011
`
`Journal of Interventional Cardiology
`
`453
`
`
`Page 4
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`COLA, ET AL.
`
`Figure 1. The 5F Guideliner catheter.
`(A) Guideliner flexible 20-cm distal seg-
`ment,
`the guide extension, made of an
`inner polytetrafluoroethylene liner, a mid-
`dle stainless steel coil, providing maximum
`flexibility while retaining radial strength,
`and an outer polyether block amide (Pebax)
`polymer extrusion, same material as a guide
`catheter. (B) The Guideliner metal collar (ar-
`row) connecting the flexible catheter exten-
`sion with a 115-cm stainless steel shaft to a
`proximal positioning tab. (C) The proximal
`end of the Guideliner while used inside the
`catheter through the hemostatic valve, like a
`regular balloon.
`
`small diameter vessel, was not suitable to rotablation.
`The proximal lesion was then treated with a 2.75 ×
`30-mm drug-eluting Dior PTCA catheter balloon (Eu-
`rocor GmbH, Bonn, Germany), avoiding stent place-
`ment since the patient was on chronic anticoagulation
`treatment.
`
`Case 3
`
`A 79-year-old female patient with Killip I infe-
`rior ST elevation myocardial infarction (STEMI) was
`admitted to our center for primary PCI. Initially the
`
`right radial access was attempted, and left radial pulse
`was absent, but due to severe subclavian artery tortu-
`osity the operator shifted to right femoral access. The
`coronary angiography showed RCA proximal occlu-
`sion (Fig. 3). With a 6F Judkins Right guiding catheter
`a Balance Middle Weight Universal guidewire (Ab-
`bott Vascular, Abbott Laboratories) was placed dis-
`tally. Manual thrombectomy was attempted with the
`Pronto thrombectomy catheter (Vascular Solutions) but
`it could not cross the lesion. A Pronto LP extrac-
`tion catheter (Vascular Solutions) was then used al-
`lowing recanalization of the artery. A long, severely
`
`Figure 2. Case 1. (A) Baseline angiography. (B) Guideliner catheter deep intubation. (C) Final result. This case was failed.
`
`454
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 5
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`Figure 3. Case 3. (A) RCA baseline angiography. (B) RCA angiography after manual thrombus aspiration; a long, severely calcified and
`tortuous lesion is visualized. (C) The Guideliner catheter deployed beyond the guide into the RCA and subsequent passage of the stent. (D) final
`result without complication, TIMI III flow.
`
`calcified and tortuous lesion could then be visualized
`(Fig. 3B), affecting proximal and mid RCA. With dif-
`ficulties, due to a low guide catheter support, multiple
`predilations were performed (2.0 × 6.0 mm Flextome
`Cutting Balloon; 2.0 × 15 mm and 2.5 × 15 mm
`Maverick balloon, Boston Scientific). However, no
`stent could be delivered: 2.5 × 23 mm and 2.5 × 12
`mm Multi-Link stents (Abbott Vascular, Abbott Labo-
`ratories) could not cross the lesion. The operator used
`the Guideliner 5F catheter and deployed it 3 cm be-
`yond the guide into the RCA. At this time a small
`profile short balloon is useful to preserve device coax-
`iality in the coronary artery: the balloon is advanced
`before and inside the Guideliner; once the Guideliner
`is in position deeply seated inside the coronary artery,
`the balloon is retrieved to advance the desired mate-
`rial. Subsequent passage of the stent was achieved: 2
`
`overlapped 2.5 × 23 mm and 2.5 × 12 mm Multi-Link
`stents were successfully implanted. Final angiographic
`control showed good result with TIMI III flow without
`complications.
`
`Case 4
`
`A 68-year-old male patient was admitted to our
`center to perform protected left main stem (LM)–left
`circumflex (LCX) coronary artery PCI due to stable
`angina. The patient had previous coronary artery by-
`pass graft surgery, but with no graft supply to the LCX
`territory. Coronary angiography showed a severely tor-
`tuous and calcified LCX, with ostial and proximal 50%
`◦
`, and a second
`stenosis, with a take-off angle of 90
`curve proximal to a big trifurcated 1st obtuse marginal
`
`Vol. 24, No. 5, 2011
`
`Journal of Interventional Cardiology
`
`455
`
`
`Page 6
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`COLA, ET AL.
`
`Figure 4. Case 4. (A) Coronary angiography showing a very tortuous and calcified LCX, with proximal 50% stenosis, 90
`angle at the
`origin, and a second curve before the big trifurcated 1st OM brunch. The latter showed a severe proximal stenosis and a second one
`after the trifurcation. (B) Stent passage was difficult at the metal collar, where the operator felt resistance and pulled the stent back:
`stent distal struts were deformed and lifted up (C) Guideliner deployed beyond the guide tip while the stent is crossing the first very
`angulated curve. (D) Guideliner deployed beyond the guide tip, and the stent crossing the 2nd very angulated curve. (E) Guideliner de-
`ployed beyond the guide tip and the stent (2.25 × 14-mm Endeavor Resolute) at implantation site. (F) Final result, without complication,
`TIMI III flow.
`
`◦
`
`(1st OM) branch. The latter showed a severe proxi-
`mal stenosis and a second one after the trifurcation
`(Fig. 4). Through the right femoral artery with a 6F
`Extra Back-up 4.0 Launcher guiding catheter we ad-
`vanced an extra-support hydrophilic Whisper guide-
`wire (Abbott Vascular, Abbott Laboratories) into the
`distal 1st OM and a Balance Heavy Weight guide wire
`(Abbott Vascular, Abbott Laboratories) into the LAD
`to protect it and optimize support. Predilations with
`3.0 × 6.0 and 3.5 × 6.0 mm Flextome Cutting Balloon
`(Boston Scientific) were performed in proximal LCX.
`A 2.25× 18 mm Endeavor Resolute drug-eluting stent
`(Medtronic Cardiovascular) could not cross the curve
`at proximal LCX. The operator introduced a Guideliner
`
`catheter after retrieving LAD and distal LCX guide-
`wires to make room inside the guiding catheter. When
`inserting the stent through the Guideliner catheter, dif-
`ficulties were encountered at the collar level, where
`the stent could not be advanced. The operator pulled it
`back and checked it for damage: stent distal struts were
`deformed and lifted up (Fig. 5). A new 2.25 × 14 mm
`Endeavor Resolute drug eluting stent (Medtronic
`Cardiovascular) could then be cautiously advanced
`after slight withdrawal of
`the Guideliner, so as
`to place the collar in a straighter portion of the
`catheter, and then successfully implanted.The final an-
`giogram showed a good result, TIMI III flow, without
`complications.
`
`456
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 7
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`Figure 5. A damaged stent (2.25 × 18-mm
`Endeavor Resolute drug-eluting stent, Med-
`tronic Cardiovascular). Difficulties were en-
`countered at the collar level where the stent
`could not be advanced. We pulled it back
`and checked it for damage: stent distal struts
`were deformed and lifted up.
`
`Case 5
`
`Case 6
`
`An 80-year-old female was admitted to our center
`for primary PCI with a Killip II anterior STEMI. The
`coronary angiography showed thrombotic occlusion of
`the mid LAD, with a tortuous and calcified proximal
`segment. The operator chose the right radial artery
`access and a 6F extra-back-up 4.0 Launcher guiding
`catheter. An hydrophilic Whisper guidewire (Abbott
`Vascular, Abbott Laboratories) was deployed distally
`in the artery and thrombectomy was performed using a
`Pronto R(cid:2)
`LP extraction catheter (Vascular Solutions).
`A severely angulated lesion was then detected (Fig. 6).
`Multiple predilations were performed with a 2.5 ×
`6 mm Flextome Cutting Balloon (Boston Scientific)
`and type B dissection of mid LAD was visualized,
`with TIMI III flow. The operator tried to pass a 2.5 ×
`15 mm Multi-Link bare metal stent (Abbott Vascular,
`Abbott Laboratories) but it could not cross the proximal
`curve, so a Guideliner catheter was used. The device
`was advanced through the proximal tortuous segment
`allowing a deep seating into proximal LAD, which
`added back-up support. The same 2.5 × 15-mm Multi-
`Link stent was advanced through the Guideliner and it
`could not proceed further because of the next mid seg-
`ment curve. It was impossible to pull the stent back into
`the tip of the Guideliner, so all the system (Guideliner
`catheter and stent together) had to be retrieved; the stent
`distal struts were lifted up and deformed, while Guide-
`liner tip appeared in good condition. We cut the stent
`delivery system to recover the Guideliner. A deeper
`seating was then reached with the same Guideliner
`catheter, crossing the second curve as well, and a new
`2.5 × 23-mm Multi-Link stent was implanted followed
`by a proximal and overlapped 2.75 × 18-mm Multi-
`Link stent. Hence a proximal LAD type B dissection
`was detected, which was suspected to be caused while
`advancing the Guideliner. Two new 3 × 28 and 3.5 ×
`13-mm stents were implanted in proximal LAD to seal
`the all dissected segment.
`
`An 80-year-old male patient with known coronary
`artery disease was admitted to our center because of
`effort angina. Coronary angiography showed chronic
`total occlusion (CTO) of RCA (Fig. 7) with severe cal-
`cification, and PCI was programmed with rotational
`atherectomy. Right femoral artery access was chosen
`with a 6F extra back up right coronary artery guid-
`ing catheter (Cordis, Johnson & Johnson Corpora-
`tion). The operator crossed the occlusion with a Fielder
`XT guidewire (Abbott Vascular, Abbott Laboratories)
`and predilated with a 1.2 × 15 mm Ryujin balloon
`(Terumo Corp., Tokyo, Japan) without successful re-
`canalization. A 2.6 Tornus catheter (Abbott Vascular
`Devices, Redwood City, CA) was then advanced to
`the distal segment and TIMI III flow was achieved, al-
`lowing visualization of diffuse and severe disease all
`along proximal and mid-RCA. Rotational atherectomy
`was then performed with a 1.25 burr (Rotablator Ro-
`tational Atherectomy System, Boston Scientific, Nat-
`ick, MA, USA). The operator tried to dilate with a
`2.0 × 6.0 mm Flextome Cutting Balloon (Boston Sci-
`entific) which could not reach the most distal part of the
`lesion. Hence a Guideliner catheter was used, which
`allowed distal cutting balloon dilatation followed by
`implantation of 2.5 × 30 mm and 3.0 × 30 mm En-
`deavor Resolute drug-eluting stents (Medtronic Car-
`diovascular). After stent implantation, the Guideliner
`was again advanced into the stents to allow for stent
`redilatation with a noncompliant balloon. Final an-
`giography showed a good result without complications
`(Fig. 7F).
`
`Case 10
`
`A 72-year-old female patient was admitted to our
`center with stable angina functional class II and a pos-
`itive stress test with lateral ischemia. The angiogram
`
`Vol. 24, No. 5, 2011
`
`Journal of Interventional Cardiology
`
`457
`
`
`Page 8
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`COLA, ET AL.
`
`Figure 6. Case 5. (A) Coronary angiography showed a thrombotic occlusion of the mid LAD, with a very tortuous and calcified proximal
`segment. (B) Guideliner deployed beyond the guide tip and the 2.5 × 23-mm Multi-Link stent distally to the lesion across the proximal severe
`tortuosity. (C) Angiography showing Guideliner catheter deeply seated and stent position in mid LAD (arrowhead). (D) Stent deployment in
`mid LAD thanks to Guideliner deep seating, crossing the severe tortuosity. (E) LAD proximal segment type B dissection was detected and a
`third 3 × 28 and 3.5 × 13-mm stent was implanted to seal the all dissected segment. (F) Final result.
`
`showed a 30% stenosis of proximal LAD, and a chronic
`total occlusion of proximal left circumflex in bifur-
`cation with the 2nd OM branch, with severe tortu-
`osity (Fig. 8). PCI was performed from the right
`radial artery with a 6F extra-backup 4.0 Launcher
`guiding catheter (Cordis, Johnson & Johnson Corpora-
`tion). The occlusion was crossed with an Asahi Fielder
`XT coronary guidewire (Abbott Vascular, Abbott Lab-
`oratories). This guidewire was then exchanged to a
`0.014’’ Balance Middle Weight Universal guidewire
`(Abbot Vascular, Abbott Laboratories) which was po-
`sitioned distally in the 2nd OM. A hydrophilic Whisper
`guidewire (Abbot Vascular, Abbott Laboratories), was
`introduced distally into the LCX and proximal LCX
`dilated with a 2.0 × 15 Trek balloon catheter (Abbott
`Vascular, Abbott Laboratories). As a 2.25 × 20 mm
`Promus Element drug eluting stent (Boston Scientific)
`
`did not cross the proximal LCX, a Guideliner catheter
`was used to advance it through the proximal LCX- 2nd
`OM severe tortuosity. We implanted 2.25 × 20 mm
`Promus Element drug eluting stent (Boston Scien-
`tific) and an overlapped 2.25 × 28 mm Xience Prime
`drug eluting stent (Abbott Vascular, Abbott Labora-
`tories). During stent placement and implantation, LM
`and proximal to mid LAD type B dissection was de-
`tected (Fig. 8D). The Guideliner was occlusive, and
`this dissection was possibly due to the direct injec-
`tion in the diseased proximal LCX. We implanted
`2.75 × 33 mm and 3.5 × 18 mm Xience Prime
`drug eluting stents (Abbot Vascular, Abbott Labora-
`tories) to heal the dissected segment, from mid-LAD
`up to the ostium of LM. The final angiogram showed
`a good result with TIMI III flow and no residual
`dissection.
`
`458
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 9
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`Figure 7. Case 6. (A) Baseline angiography showing RCA chronic total occlusion. (B) Rotational atherectomy with a 1.25 burr
`(Rotablator Rotational Atherectomy System, Boston Scientific, Natick, MA, USA). (C) Postrotational atherectomy angiography showing a
`severely calcified long lesion. (D) Deep intubation of the Guideliner allowing distal balloon dilation. (E) Deep intubation of the Guideliner and
`distal stent implantation (2.5 × 30 mm and 3.0 × 30 mm Endeavor Resolute drug eluting stent, Medtronic Cardiovascular). (F) Final result.
`TIMI III flow.
`
`Discussion
`
`Coronary artery tortuosity is associated with in-
`creased technical difficulty, increased use of contrast
`and fluoroscopy, and reduced PCI success rates. Ves-
`sel calcification is an additional anatomical factor as-
`sociated with procedural failure and complications.8,9
`The combination of coronary tortuosity and calcifi-
`cation could impede stent delivery and significantly
`increase the risk for stent loss or stent damage. Several
`strategies to increase PCI success in difficult scenarios
`have been described. Good guiding catheter support is
`crucial for both wiring and equipment delivery. The
`rapid exchange Guideliner catheter has been designed
`as a guiding catheter extension to ease stent delivery
`when guiding catheter support is poor. Mamas et al.6
`described their experience in a series of 13 challeng-
`ing cases treated with the Guideliner catheter. They
`
`concluded that the catheter can cross points of prox-
`imal obstruction where a stent gets stuck due to the
`greater flexibility and smoother surface of the catheter
`than the stent. Therefore, it increases backup support
`in the setting of difficult disease. Moreover, these cases
`were performed transradially, when an extra-backup is
`needed, especially facing complex anatomy, demon-
`strating safety and feasibility of the use of this catheter
`extension in this setting. Furthermore, the same group
`extended the series successfully performing transradial
`coronary bypass graft PCI with guide catheter exten-
`sions.7,10 Our purpose with this case review is to ex-
`pand the description of how to use this device and warn
`of some complications that may be associated. We per-
`formed 10 cases with the Guideliner catheter: 9 suc-
`cessful cases and 1 failure, 2 primary PCIs and 2 CTOs.
`In 3 cases we had a proximal dissection as a complica-
`tion and, in 2 cases, stent damage. In our experience,
`
`Vol. 24, No. 5, 2011
`
`Journal of Interventional Cardiology
`
`459
`
`
`Page 10
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`COLA, ET AL.
`
`Figure 8. Case 10. (A) Baseline angiography showing 30% stenosis of proximal LAD, chronic total occlusion of proximal circumflex in
`bifurcation with the 2nd OM with severe tortuosity. (B) Asahi Fielder XT coronary guidewire (Abbott Vascular, Abbott Laboratories, Abbott
`Park, IL, USA) inside the 2nd OM showing its severe tortuosity. (C) Guideliner catheter introduced into the diseased segment (arrow), then
`contrast has been injected selectively into the proximal LCX, straight to the plaque in the disease segment. and retrograde dissection was
`detected, involving LAD and LM (arrow). (D) After selective intracoronary injection retrograde dissection was detected, involving proximal
`LCX, proximal LAD and LM (arrows). (E) Guideliner intubation and stent implantation across the severely tortuous segment. (F) Final result,
`the dissection is sealed. TIMI III flow.
`
`the Guideliner catheter increased back-up support and
`allowed to cross proximal points of obstruction where
`no stent could pass and helped crossing tortuous seg-
`ments. These cases could not have been completed
`successfully if the Guideliner catheter would not have
`been used, as other techniques (buddy wire, anchor-
`ing, incremental dilatations) failed. In every case the
`Guideliner was easy to deploy and retrieve, like a con-
`ventional balloon.
`Typically, stenting is performed from distal to prox-
`imal because of potential difficulty of crossing a
`deployed stent in the setting of vessel tortuosity. As
`reported by Mamas et al.,5 in some cases proximal
`segments are stented first; once proximal disease is
`treated, deep intubation of the device is safe and al-
`lows stenting of distal lesions. Use of the Guideliner
`catheter overcomes this restriction: the device easily
`
`passes through even very tortuous stented segments.
`This strategy was used in our 6th case, to allow for stent
`redilatation. Our first case was a failure. In the attempt
`to treat a proximal PDA with a 6F Judkins Right guid-
`ing catheter, we could advance the Guideliner over the
`wire into the acute margin of the right coronary artery,
`but support was not enough to cross the lesion with a
`balloon. A deeper intubation could have been achieved
`if we had advanced and dilated a balloon distally, us-
`ing it as an anchor to further advance the Guideliner.
`We had 2 cases of proximal dissection (as exempli-
`fied in case 5 and 10) after Guideliner deep seating.
`In particular in case 5 a retrograde large type D dis-
`section involving the mid-proximal segment of LAD
`was visualized once the operator retrieved the Guide-
`liner. This complication, which can add considerable
`risk to the procedure, was probably caused during the
`
`460
`
`Journal of Interventional Cardiology
`
`Vol. 24, No. 5, 2011
`
`
`Page 11
`
`Teleflex Ex. 2176
`Medtronic v. Teleflex
`
`

`

`THE GUIDELINER CATHETER FOR STENT DELIVERY IN DIFFICULT CASES
`
`device advancement directly over the wire. In our first
`case, the device was advanced alone over a wire into
`the distal vessel. In later cases, we always advanced
`a balloon before, which made the Guideliner passage
`more coaxial, decreasing dissection risk. Besides, this
`balloon can be inflated distally, creating an anchor that
`helps advancing the Guideliner catheter. This strategy
`has avoided new cases of dissection. In case 10, a large
`retrograde type C dissection involving left main stem
`and LAD proximal segment originated at the tip of the
`Guideliner while injecting; the device was occlusive in
`a diseased segment, and then the dissection extended
`backward into the left main. Again a severe compli-
`cation added important risk to the procedure. Extreme
`caution has to be exerted when injecting in these kinds
`of risky situations; the injection must be avoided un-
`less strictly necessary and, if needed, should be gentle.
`Using the Guideliner, few but important tips have to
`be known: a useful tool can be dangerous, as it often
`happens during interventional procedures.
`One limitation Mamas et al. described6 is a small
`risk that large/bulky stents can get damaged entering
`the collar; they recommend the use of low profile stents
`with this system, avoiding >4-mm diameter stents. We
`report 2 cases of stent damage: In case 4 the opera-
`tor felt resistance crossing the device steel collar with
`the stent (2.25×18 Endeavor Resolute, Medtronic Car-
`diovascular) and retrieved it. In case 5, stent damage
`probably was due to the severe tortuosity and calcifica-
`tion of the mid-LAD segment. Problems at the collar
`level have been described by other operators as well.6
`In case of resistance while inserting a stent through
`the Guideliner catheter, the location of the device in
`relation to the metal collar should be checked and the
`stent checked for damage. In our experience, even a
`low profile stent with 2.25-mm diameter got damaged.
`Instead, coaxiality is probably more important, as the
`stent may get stuck at the metallic collar if it coincides
`to be in a bend of the catheter. In this case, gentle re-
`trieval of the Guideliner so as to place the collar in a
`more straight segment of the guide helps getting the
`stent into the catheter extension.
`
`Conclusions
`
`The Guideliner c