GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple Applications
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`GuideLiner Catheter Facilitated PCI – A Novel Device
`with Multiple Applications
`
`By hmpeditor
`Created 10/26/2011 - 11:37
`November 2011 [1]
`GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple
`Applications
`
`• Wed, 10/26/11 - 11:37am
`• 0 Comments
`•
`
`Section:
`Online Exclusive
`Issue Number: Volume 23 - Issue 11 - November 2011 [2]
`Author(s):
`
`Ashish Pershad, MD, Victor Sein, MD, Nathan Laufer, MD
`
`[3]ABSTRACT: Objective. The GuideLiner catheter (Vascular Solutions, Inc.) is a monorail guiding
`catheter extension that serves to facilitate stent delivery and is approved for providing extra support
`and coaxial guide engagement. The objective of this manuscript is to familiarize interventionalists
`with this new device, describe its versatile uses, and its limitations with case-based examples.
`Background. Failure of stent delivery is responsible for 5% of procedural failures in coronary
`interventions in the current era. Different techniques to enhance guiding catheter support and facilitate device
`delivery have been described. These include use of buddy wires, anchoring balloons at different locations for
`extra support for device delivery, and even rotational atherectomy in the most calcified lesions. Methods. The
`database of coronary interventions at Banner Good Samaritan Medical Center was queried for use of the
`GuideLiner catheter and stents. The angiograms of all those cases were reviewed and selections of cases
`highlighting different uses of the catheter were chosen for inclusion in this manuscript. Results. All potential uses
`of the GuideLiner catheter are described in this manuscript. Nuances about use and tips and tricks related to the
`device are also discussed in the case examples. Conclusions. The manuscript provides a complete summary of
`the different uses and limitations of the catheter and its contemporary role in modern day coronary intervention.
`
`J INVASIVE CARDIOL 2011;23(11):E254-E259
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`__________________________________
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`[4]PCI has been simplified greatly over the last decade. Lower profile balloons and versatile
`guidewires have made coronary device delivery and interventions relatively simple as compared to
`a few decades ago. However in about 5% of cases, stent delivery is unsuccessful and is one of the
`main causes of procedural failure.1 Drug-eluting stents have a higher profile as compared to bare
`metal stents and are more difficult to deliver, but they provide a remarkable benefit with respect to
`reduction in target lesion revascularization. Use of multiple shorter drug-eluting stents is not economical. Longer
`drug-eluting stents are not easy to deliver to the lesion site especially in tortuous and calcified coronary vessels.
`This poses new dilemmas to operators and presents a new challenge in coronary stenting. This may have added
`significance when more and more interventional procedures are being done using smaller guiding catheters via
`the radial approach.
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`http://www.invasivecardiology.com/print/3022
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`GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple Applications
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`[5]The GuideLiner catheter (Vascular Solutions, Inc.) is a novel device that is FDA
`approved and CE marked for assistance with device delivery during coronary
`interventional procedures. It is an extension of the mother-and-child guide concept,
`but the advantage over the Heartrail mother-and-child guiding catheter is that the
`entire procedure can be completed using the same guide catheter with the
`convenience of a rapid exchange format.2 In this article, all the different applications of the GuideLiner catheter
`will be presented with case examples. A brief discussion of the limitations as well as some tips related to its use
`will be highlighted.
`
`[6]Case 1. A 63-year-old African American female presented with chest pain, bradycardia, and ECG
`evidence of a STEMI. The culprit vessel was the right coronary artery (RCA). The RCA was noted to
`have a complete occlusion at the bifurcation of the posterior descending artery (PDA) and
`posterolateral branches (Figure 1). The proximal RCA had a huge aneurysm measuring 1.0–1.2 cm
`with swirling of contrast in the aneurysmal segment and no visualization of the distal vessel even
`with injections of 20cc of contrast through an automated injection [7] system (ACIST CVi). PCI of the
`RCA was planned urgently. A 7 Fr JR4 (Medtronic) guiding catheter was used to engage the RCA.
`A 2 mm over the wire Sprinter balloon (Medtronic) was advanced into the distal RCA over a
`Prowater Flex 0.014 coronary guidewire (Abbott Vascular). The wire was unable to cross the
`occlusion and attempts to visualize the distal vessel were futile because of the proximal aneurysm
`and the swirling of contrast in the proximal RCA. At this point it was decided to place a GuideLiner catheter
`beyond the aneurysm in the distal RCA to facilitate subselective injection into the distal RCA. This was effectively
`achieved over the same wire (Figure 2). Once it was possible to see the distal vessel better, a hydrophilic 0.014-
`inch guidewire was advanced into the posterolateral and then the PDA respectively; PCI of both vessels was
`performed successfully using 24 mm Vision (Abbott Vascular) bare metal stents (Figure 3).
`
`[8]This case highlights another niche role of the GuideLiner catheter. In addition to providing support
`for facilitating stent delivery and enhanced backup for coronary interventions, this device allows safe
`subselective injections for better visualization of the distal vessel and decreasing contrast load. This
`particular application of the GuideLiner catheter has not been described in the literature thus far.
`
`Case 2. A 50-year-old male with known occlusion of his RCA and inferior wall ischemia was
`referred for angiography. Bilateral femoral access with 8 Fr sheaths was obtained and simultaneous injections of
`the RCA and left coronary were performed (Figure 4) with a JR4 guiding catheter in the RCA. The CTO was
`successfully crossed using the antegrade approach and the GuideLiner catheter was then used to deliver long
`DES successfully (Figure 5). The final angiogram demonstrated the RCA successfully recanalized and a diffuse
`negatively modeled distal vessel (Figure 6).
`
`[9]Case 3. A 65-year-old male presented with unstable angina. Diagnostic angiography
`demonstrated triple vessel coronary disease and normal ventricular function (Figure 7). After
`intervention on the RCA was performed, attention was turned to the circumflex artery (Figure 8). A 7
`Fr EBU (Medtronic Vascular) guiding catheter was used for the intervention on the circumflex artery.
`A BMW (Abbott Vascular) guidewire was used to cross the lesion in the circumflex artery and
`angioplasty performed with a 3mm Voyager (Abbott Vascular) balloon. After [10]predilatation, there
`was difficulty advancing the stents through the calcified proximal vessel (Figure 8). A GuideLiner
`catheter was then advanced into the circumflex artery and this facilitated delivery of long drug-
`eluting stents to treat the stenosis successfully without need for a different wire or a different guiding
`catheter (Figure 9).
`
`The GuideLiner catheter allowed a second vessel (circumflex) to be treated ad hoc by greatly simplifying a
`complex procedure and minimizing contrast load and radiation exposure to the patient. The patient was then
`brought back for treatment of the LAD chronic total occlusion. This enabled complete revascularization for this
`patient.
`
`[11]Case 4. In this case, another potential advantage of the GuideLiner is highlighted. A 66-year-old
`male presented with stable angina and a history of prior CABG and inferior ischemia on noninvasive
`perfusion imaging. The culprit lesion was identified in the PDA. The proximal and mid RCA were
`previously stented, the ostium of the RCA was anterior, and the vessel was very tortuous proximally
`(Figures 10 and 11). A 7 Fr AL 0.75 guiding catheter engaged the RCA ostium coaxially. After a
`BMW wire was used to cross the lesion, [12]predilatation of the lesion was performed with a 2.75 mm
`balloon and then the GuideLiner catheter was advanced past the previously placed stents (Figure
`12). This permitted placement of a 2.75 mm x 23 mm Promus (Boston Scientific) DES with relative
`ease (Figure 13). The GuideLiner allows delivery of stents distally past previously placed stents,
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`GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple Applications
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`which is an advantage in cases like this when there is a new de novo lesion beyond previously
`placed stents or even in difficult cases in stenting a distal dissection after placement of freshly placed stents. This
`challenges the well-established dictum of stenting from distally in the vessel to proximally in the vessel because
`the atraumatic soft tip of the GuideLiner catheter can easily be placed past freshly placed stents for extra support
`to deliver a stent distally in the vessel.
`
`[13]Case 5. A distal lesion in a small posterolateral vessel was successfully treated after very deep
`engagement of the GuideLiner catheter (Figures 14–16). In the past, this lesion would either be
`treated medically or with balloon angioplasty, but with the availability of drug-eluting stents in
`smaller diameters (2.25 mm) and low late loss of 0.1 mm, these patients can be offered relief of
`their angina as was demonstrated in this case. Caution needs to be exercised with such maneuvers
`with the catheter.
`
`[14]Case 6. This case demonstrates the utility of the GuideLiner catheter in coaxial alignment for
`delivering stents even in very proximal coronary segments because of difficulties related to extreme
`proximal vessel tortuosity. An extremely angulated take off of the left circumflex artery off the left
`main coronary artery was dealt with by placing a GuideLiner catheter into the distal left main. Even
`though the GuideLiner did not actually enter the circumflex artery, it provided enough support for the
`delivery of a drug-eluting stent to treat the entire proximal stenosis successfully with one stent (Figures 17–19).
`
`[15]Discussion. The GuideLiner catheter is a coaxial guiding catheter extension delivered through a
`standard guiding catheter on a monorail. It is comprised of a 20 cm yellow straight extension whose
`inner diameter is 1 Fr size smaller than the guiding catheter.3 This extension is tri-layered. The inner
`most layer is PTFE; the second layer is a stainless steel coil, which imparts flexibility and strength;
`and the outer lining is that of pebax polymer with silicone coating. The silicone coating imparts
`lubricity. This is connected to a stainless steel push tube and a metal collar that can be deployed through the “Y”
`adapter. There is a radiopaque marker 2.6 mm from the tip of the extension and 2 white positioning markers at 95
`cm and 105 cm on the push tube. This construction and design does not lengthen the guiding catheter. By not
`adding length to the guiding catheter it does not reduce working length of balloons and stents. This may confer an
`advantage when treating distal lesions. Also, this does not require a separate hemostatic valve. These are
`significant advantages over the Heartrail mother-and-child catheter.
`
`[16]After guide catheter and wire placement, the GuideLiner catheter can be advanced over the wire
`through the hemostatic valve as an extension to the guide catheter for extra back up and deep
`guide engagement. The rest of the interventional procedure is completed as usual through the same
`hemostatic valve and guide catheter without need for disconnection and reattachment. The
`interventional equipment tracks over the wire and through the GuideLiner collar with exit at the distal
`tip of the catheter at the desired vascular location. On completion of the case, the GuideLiner catheter can be
`removed in a similar fashion to removal of a monorail balloon. In the first case, the use of the GuideLiner catheter
`as a tool for distal vessel visualization and subselective injection of contrast is showcased. This has never been
`described previously in the literature. Without the GuideLiner catheter, due to the presence of a coronary
`aneurysm the distal vessel was unable to be opacified. This was in spite of injecting 20 cc of contrast (10 cc/sec
`for 2 sec) via the ACIST CVi automatic injection system. Once advanced past the aneurysm, the GuideLiner
`allowed for subselective injection, providing complete distal vessel opacification utilizing <8 cc of contrast. This
`can be used to our advantage in coronary intervention on patients with compromised renal function minimizing
`contrast load and thereby potentially reducing the incidence of contrast associated nephropathy. This is especially
`important given the knowledge about adverse outcomes in patients with CIN following PCI.4 In this particular case,
`an unusual problem was elegantly solved with the assistance of the GuideLiner catheter.
`
`[17]Chronic total occlusions represent a unique challenge with respect to the diffuse nature of the
`disease even proximal to the occluded segment of the vessel and the small negatively remodeled
`distal target vessel. The GuideLiner catheter lends itself to use in this lesion subset because of the
`ability for deep engagement of the guiding catheter atraumatically and providing the support
`necessary for delivery of long drug-eluting stents for definitive treatment. The safety of the
`GuideLiner when used for deep intubation relies on the absence of a primary curve for the extension. It provides a
`safer alternative to using aggressive guiding catheters like the Amplatz left curves for the RCA. This is amply
`demonstrated in the second case in which the RCA chronic total occlusion was successfully treated with deep
`atraumatic engagement of the RCA ostium and subsequent delivery of long relatively inflexible first generation
`drug-eluting stents. The device allows for robust support for secure delivery of equipment to distal segments of the
`coronary tree. During in vitro testing, when extended 15 cm into the vessel, the 6 Fr GuideLiner catheter provides
`greater back up support than even an 8 Fr guiding catheter.
`
`http://www.invasivecardiology.com/print/3022
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`5/15/2012
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`Medtronic v. Teleflex
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`GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple Applications
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`[18]In the third, fourth, and fifth cases, the reason for the development of this device,
`facilitating distal stent delivery, is demonstrated. Commonly used methods to
`overcome difficulty with stent delivery include straightening of the vessel with a buddy
`wire, use of an anchor balloon, and using large diameter guiding catheters with more
`supportive curves. The GuideLiner facilitates delivery of stents to distal segments of
`the coronary vessel (Figures 4 and 5) by allowing safe deep vessel intubation. This provides the necessary extra
`back-up support needed for stent delivery. In an era when radial artery intervention is making a comeback into the
`mainstream, this may have added significance because the vast majority of cases via the radial artery are
`performed with 6 Fr guiding catheters. Also because of the angle of entry from the radial approach into the aortic
`sinus, coaxial guide placement is difficult. The GuideLiner catheter may allow for maintaining coaxial guide
`orientation. In case 3, a long circumflex artery stenosis was treated with deep engagement of the GuideLiner
`catheter to deliver 2 long DES as opposed to several shorter length drug-eluting stents. This may have
`incremental value in an era of cost containment by treating long lesions with fewer drug-eluting stents, thus
`lowering the cost per case.
`
`[19]With this technique, use an inflated low profile balloon or a microcatheter on the wire while the
`catheter is advanced into the coronary artery. This reduces the dead space between the GuideLiner
`catheter and guidewire, providing a tapered, atraumatic leading edge. It also stiffens the rail over
`which the device can be advanced. This decreases the incidence of coronary dissections in the
`proximal vessel. An extension of this concept involves using the GuideLiner catheter even with
`aggressive guiding catheters, especially when there is a need for delivery of long stents to distal portions of the
`vessel. This is amply illustrated in cases 4 and 5 of this series. When delivering stents to distal parts of the vessel,
`caution needs to be exercised when the metal collar of the GuideLiner extends past the secondary curve of the
`guiding catheter. This is the basis for the recommended deep seating distance of 10 cm from the tip of the guide.
`If necessary, deeper engagement (>10 cm) can be performed without risk to the vessel or the patient.
`
`[20]Another situation where the GuideLiner finds utility in coronary intervention is in the setting of
`proximal vessel tortuosity illustrated in case 6. In this case, the extreme angulation of the origin of
`the circumflex artery from the left main artery made it impossible to advance the stent past the
`proximal vessel even after straightening out the proximal vessel with stiff coronary guidewires and
`with deep engagement of the guiding catheter. The soft atraumatic tip of the GuideLiner catheter
`allowed delivery of stents relatively easily after negotiating the proximal bend of the vessel. This can greatly
`shorten the case and fluoroscopy times and minimize contrast load to the patient.
`
`[21]Limitations. Every time a catheter is used for deep intubation of a coronary vessel, regardless of
`how soft the tip is, there remains a risk of dissection of the ostium and/or the proximal aspect of the
`vessel. It is no different with the GuideLiner catheter with reported dissection rates of 0.5%–1%.
`One of the techniques described in this manuscript involves using a low-profile balloon to eliminate
`the dead space between the catheter tip and wire, which greatly reduces the risk of dissection.
`Particular caution needs to be exercised in the setting of an anomalous origin of a vessel and in the setting of a
`diffusely diseased proximal segment. The GuideLiner is less likely to dissect the coronary ostia than a guiding
`catheter because of the lack of a primary curve in the GuideLiner catheter and the inner coating of the GuideLiner
`tip provides atraumatic support. Another drawback of this device is the potential for stents especially larger profile
`stents to get caught on the metal collar of the device. This can damage the stent and may even cause it to shear
`off, if this is not readily recognized. The cause of this complication is wire wrap around the metal collar. If any
`resistance is encountered during advancement of the stent through the GuideLiner catheter, the stent should not
`be pushed but instead withdrawn and inspected for damage to its integrity.
`
`Wire wrap is another important consideration while using this device. When two wires are used in a coronary
`intervention, the GuideLiner catheter should be advanced only over the primary wire as the secondary wires may
`wrap around the GuideLiner catheter and prevent advancement of devices. When inserting the GuideLiner into
`the guiding catheter, the flat push tube should be oriented laterally and be advanced without rotation to avoid
`wrapping of even the primary guidewire.
`
`Conclusion. The GuideLiner catheter has greatly simplified coronary intervention and broadened the lesion
`subsets that can be safely treated with 6 Fr guiding catheters and via the radial approach. The catheter could be
`used upfront or if difficulty is encountered delivering stents or devices as a bailout option. Like all new devices
`there are certain precautions and limitations that operators need to be aware of prior to using this device.
`
`Future iterations of the device may aim to provide modifications at the steel collar to minimize risk of damage to
`larger profile stents and find ways to avoid wire wrap.
`
`http://www.invasivecardiology.com/print/3022
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`5/15/2012
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`Medtronic v. Teleflex
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`GuideLiner Catheter Facilitated PCI – A Novel Device with Multiple Applications
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`References
`
`1. Nikolsky E, Gruberg L, Pechersky L, et al. Stent deployment failure: Reasons, implications and short- and
`long-term outcomes. Catheter Cardiovasc Interv. 2003;59(3):324-328.
`2. Mamas MA, Eichhöfer J, Hendry C, et al. Use of the HeartRail II catheter as a distal stent delivery device: An
`extended case series. EuroIntervention. 2009;5(2):265-271.
`3. Kumar S, Gorog DA, Secco GG, Di Mario C, Kukreja N. The GuideLiner “child” catheter for percutaneous
`coronary intervention-early clinical experience. J Invasive Cardiol. 2010;22(10):495-498.
`4. McCullough P. Outcomes of contrast-induced nephropathy: Experience in patients undergoing
`cardiovascular intervention. Catheter Cardiovasc Interv. 2006;67(3):335-343.
`5. Takahashi S, Saito S, Tanaka S, et al. New method to increase a backup support of a 6 French guiding
`coronary catheter. Catheter Cardiovasc Interv. 2004;63(4):452–456.
`6. Nakamura M, Shiba M, Wada M. A novel method for deploying a stent into a highly angulated position
`through use of a stent strut: Application of a five-in-seven system. J Invasive Cardiol. 2006;18(3):E105-107.
`
`__________________________________
`
`From Banner Good Samaritan Medical Center Interventional CV Program, Phoenix, Arizona.
`Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of
`Interest. The authors report no conflicts of interest regarding the content herein.
`Manuscript submitted March 14, 2011, provisional acceptance given April 11, 2011, final version accepted April
`28, 2011.
`Address for correspondence: Ashish Pershad MD, Heart and Vascular Center of AZ, 1331 N. 7th Street; #375
`Phoenix, AZ 85006. Email: asper1971@cox.net [22]
`
`[23]
`
`[24]
`
`Source URL: http://www.invasivecardiology.com/articles/guideliner-catheter-facilitated-pci-%E2%80%93-novel-device-multiple-
`applications
`
`Online Exclusive
`
`Links:
`[1] http://www.invasivecardiology.com/issue/3006
`[2] http://www.invasivecardiology.com/content/volume-23-issue-11-november-2011
`[3] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%201.png
`[4] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%202.png
`[5] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%203.png
`[6] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%204.png
`[7] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%205.png
`[8] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%206.png
`[9] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%207.png
`[10] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%208.png
`[11] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%209.png
`[12] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2010.png
`[13] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2011.png
`[14] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2012.png
`[15] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2013.png
`[16] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2014.png
`[17] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2015.png
`[18] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2016.png
`[19] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2017.png
`[20] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2018.png
`[21] http://www.invasivecardiology.com/files/9%20OE_E249_Fig%2019.png
`[22] mailto:asper1971@cox.net
`[23] http://www.invasivecardiology.com/printmail/3022
`[24] http://www.invasivecardiology.com/print/3022
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`http://www.invasivecardiology.com/print/3022
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`5/15/2012
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`Page 5
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`Teleflex Ex. 2175
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