Device Evaluations - Interventional Cardiology (2013) Volume 5, Issue 4

1. Guideliner Wire
2. Guidelines.org
3. Guidelines

The GuideLiner ® catheter (Vascular Solutions Inc., Minneapolis, Minnesota, United States) is a coaxial “mother and child” catheter, mounted on a monorail system, that extends the angioplasty guiding catheter and enables deep intubation of the coronary artery to achieve extra.

Corresponding Author:

Peter O’Kane
Dorset Heart Centre, Royal Bournemouth Hospital
Bournemouth, BH7 7DX, UK
Tel: +44 120 270 4333
E-mail: peter.o'[email protected]

AccessGUDID - GuideLiner® V3 catheter (M20655690)- No description. GMDN Preferred Term Name GMDN Definition; Vascular guide-catheter, single-use. The GuideLiner catheter is a soft-tipped, coaxial guide catheter extension that is specifically designed to be deeply intubated into the target coronary artery to permit safe and effective delivery of balloons and/or stents within challenging coronary anatomy where conventional techniques have failed. Successful endovascular treatment with GuideLiner catheter of chronic aortic occlusion with severe calcification. Cardiovasc Interv Ther. 2017; 32: 137-141. Urata R, Nomura T, Hori Y, Yoshioka K, Kubota H, Miyawaki D, Sugimoto T, Kikai M, Keira N, Tatsumi T.

Abstract

The past two decades have witnessed significant advances in interventional cardiology. Development of new devices, adjunctive techniques and pharmacotheraputics have been necessary to meet the demand of increasingly complex cases that are now routinely referred and accepted for percutaneous coronary intervention (PCI). Chronically occluded vessels, excessively tortuous coronary anatomy and severe calcific coronary disease typically encountered in the elderly population and/or those deemed unsuitable for surgical revascularization present as daily challenges. A contemporary interventional cardiologist must be equipped with the necessary tools and expertise to safely and effectively tackle these demanding cases.

Keywords

coronary artery disease, coronary stents, GuideLiner^® catheter, percutaneous coronary intervention

The past two decades have witnessed significantadvances in interventional cardiology. Developmentof new devices, adjunctive techniques andpharmacotheraputics have been necessary tomeet the demand of increasingly complex casesthat are now routinely referred and acceptedfor percutaneous coronary intervention (PCI).Chronically occluded vessels, excessively tortuouscoronary anatomy and severe calcific coronarydisease typically encountered in the elderlypopulation and/or those deemed unsuitable forsurgical revascularization present as daily challenges.A contemporary interventional cardiologistmust be equipped with the necessary toolsand expertise to safely and effectively tacklethese demanding cases.

A frequently occurring dilemma encounteredin patients with complex coronary anatomyundergoing PCI is failure to deliver balloonsand/or stents to the distal target lesion. Varioustechniques have been adopted to overcome thisproblem including the use of: more supportiveand aggressive guide catheters to facilitate deepintubation of the target vessel; an additionalsupportive guidewire (‘buddy wire’) to assistwith the straightening out of tortuous vesselsand improving guide catheter coaxiality [1,2];the anchor balloon technique to steady theguide catheter and provide more pushability[3]; rotational or laser atherectomy to effectivelydebulk calcific lesions prior to stent delivery;and newer, improved stent designs with betteroverall deliverability. Nonetheless, despite theseuseful adjunctive techniques and devices, stentdelivery failure is still encountered in approximately5% of cases, leading to proceduralfailure, incomplete revascularization and poorclinical outcomes [4].

Of the above techniques, deep seating of theguide catheter is often tempting when resistanceto device delivery is encountered, but cautionmust be applied in view of the significant risk ofproximal vessel dissection. This is the main catalystthat led to the development of guide catheterextensions whereby a smaller lumen ‘inner’ cathetercan be advanced within the guide catheterto take up a distal position in the vessel, thusproviding extra backup support without traumatizingthe proximal vessel. There are a numberof systems available including the GuideLiner^® catheter (Vascular Solutions, MN, USA) [5-12],the Heartrail^® II catheter (Terumo Corporation,Tokyo, Japan) [13,14] and the Proxis™ device(St Jude Medical, MN, USA) [15,16].

The GuideLiner catheter is a soft-tipped, coaxialguide catheter extension that is specifically designed to be deeply intubated into the targetcoronary artery to permit safe and effective deliveryof balloons and/or stents within challengingcoronary anatomy where conventional techniqueshave failed. The major advantage of thisdevice over its competitors is that it can be passedthrough the proximal guide catheter hemostaticvalve without disconnection, resulting in relativelysimple manipulation and rapid exchange.

Until recently, the only published literature onthe GuideLiner catheter was relatively small caseseries. However, de Man et al. have just reported their experience of 65 consecutive cases in theTwente GuideLiner registry performed by fiveinterventional cardiologists over an 8-monthperiod in a high-volume PCI center. A third ofthe cases in this series were transradial and theauthors concluded that the GuideLiner catheterwas associated with high procedural success(93%) and no major complications [12].

The purpose of this article is to report theexperience of the GuideLiner catheter in 50 complexPCI cases undertaken and/or supervised by asingle interventional cardiologist resident withinthe highest-volume nonsurgical PCI center inthe UK. Between October 2010 and June 2012,consecutive PCI cases where the GuideLinercatheter was utilized are included. The primaryinterventional operator has performed over 2200PCI procedures in the last 5 years and is a supervisorto interventional fellows within the center.In this 20-month period, the operator performedand/or supervised 897 interventional cases, 83% of which were performed transradially.Thecase mix included rotational atherectomy in 65(7%) patients and laser atherectomy on 29 (3%)patients.

We present: a step-by-step description of theGuideLiner catheter delivery technique; its variousclinical indications in our specific case series,including practical ‘tips and tricks’ and an outlineof the learning curve; device limitations andspecific complications encountered in this series;and modifications of the new and improvedGuideLiner catheter. To our knowledge, this isthe first published device evaluation of its kindthat includes a large series of patients in a singleinstitution treated by one consultant interventionalcardiologist, unlike previous publishedwork on this subject that included the collectiveexperience of multiple operators.

Device characteristics

The GuideLiner catheter is a coaxial guide catheterextension that received CE marking for assistancewith device delivery during PCI in September2009. It is composed of a flexible 20-cm guideextension connected via a metal collar to a 125-cm stainless steel shaft (Figure 1).The soft-tippedextension is coated with silicone for lubricity andcomprises an inner polytetrafluoroethylene liningsurrounded by a stainless steel coil for flexibilityand strength.

Figure 1:The GuideLiner^® catheter (Vascular Solutions, MN, USA) rapidexchange system.
Reproduced with permission from Vascular Solutions Inc., MN, USA.

The GuideLiner is delivered on its monorail systemthrough a standard guide catheter by advancementover the primary guidewire (0.014 inches).It travels through the Y-adaptor hemostasis valvewithout the need to disconnect the valve from theguide catheter, thereby providing the advantage ofrapid exchange. Delivery of the GuideLiner intothe target vessel is aided by a radiopaque markerlocated 0.105 inches (2.667 mm) from the distaltip and two positioning markers located 95 cm(single mark) and 105 cm (double mark) from thedistal tip, respectively.

The internal diameter of the GuideLinerextension is approximately 1 Fr size smallerthan the guide catheter and is currently availablein three sizes: 5-in-6 (0.056-inch internaldiameter), 6-in-7 (0.062-inch internal diameter)and 7-in-8 (0.071-inch internal diameter). Themanufacturer does not generally recommend theGuideLiner for use in target vessels of less than2.5 mm in diameter.

GuideLiner technique: step-by-stepguide

The GuideLiner catheter permits very deepintubation of the target vessel, thus providingbackup support to facilitate stent delivery acrossheavily calcified lesions and/or tortuous vessels.The deeply-engaged extension is always alignedcoaxial to the target vessel, and this is particularlyuseful if the take-off of the coronary ostiumimpedes coaxial engagement of the guiding catheter.The following is a step-by-step outline of theGuideLiner catheter delivery technique (Figure 2):

Figure 2:Transfemoral GuideLiner^® catheter (Vascular Solutions, MN, USA) delivery technique in a 70-year-old maleadmitted with unstable angina. (A) Subtotally occluded calcific proximal circumflex artery in a markedly tortuous vessel. (B) Thecircumflex artery was engaged with an Extra backup 3.5 GC (Medtronic, MN, USA) and the calcified lesion was crossed using a BalanceMiddleweight™ Wire (Abbott Laboratories, IL, USA) and the support of a 2.0 × 12 mm balloon. Following predilatation, stent deliveryfailure was encountered due to severe tortuousity. (C) Deep vessel intubation and effective backup support was achieved by deliveringthe GL catheter into the vessel over a balloon shaft, thus negating the effect of the proximal tortuosity. (D) The stent (3.5 × 16 mmPromus Element™ [Boston Scientific, MA, USA]) was advanced through the metal collar of the GL. (E) It was successfully delivered anddeployed in the circumflex artery. (F) The final angiographic result.GC: Guide catheter; GL: GuideLiner^®.

▪ Flush the lumen of the GuideLiner catheterwith heparinized saline solution;

▪Backload the distal tip of the GuideLiner ontothe primary guidewire and advance theGuideLiner on its monorail system throughthe Y-adaptor hemostasis valve;

▪ Under fluoroscopic guidance, advance andposition the GuideLiner at the desired locationwithin the vessel (up to a maximum of10 cm beyond the distal end of the guidingcatheter to prevent the metal collar fromexiting the guiding catheter). Our experiencehas been that coaxial deep vessel intubationwith the GuideLiner is more easilyachieved by first delivering an uninflatedballoon over the primary guidewire into the distal vessel, followed by advancement of theGuideLiner;

▪ With the GuideLiner fixed in the optimal positionwithin the vessel, backload the requiredcoronary stent over the primary guidewire;

▪ Under f luoroscopic guidance, carefullyadvance the stent into the guiding catheterthrough the metal collar of the GuideLiner,but be wary of resistance to stent advancementat this point (please refer to the ‘Tips andtricks’ section for further details);

▪ The stent should exit the distal end of theGuideLiner with ease and be delivered to thedesired location within the vessel;

▪ If further overlapping stents are required proximally,the GuideLiner can either be retractedto a more proximal position, left at the inflowof the delivered stent or advanced carefullyinto the delivered stent to facilitate overlap ofthe proximal stent;

▪ On completion of the interventional procedure,gently pull the GuideLiner out under fluroscopicguidance prior to removing the guidecatheter from the vessel.

Clinical indications and applications

In all 50 PCI cases where the GuideLiner catheterwas used, patients received preloading withaspirin (300 mg) and clopidogrel (300–600 mg)or prasugrel (60 mg). Unfractionated heparin(70 IU/kg), bivalirudin and/or abciximab wereused during PCI, dependent on clinical presentation.A summary of procedural details for the50 patients is outlined in Box 1.

Box 1: Case characteristics.

We employed the GuideLiner to overcomeunfavorable coronary anatomy and/or complexcoronary lesions during PCI. In the early caseswhere the GuideLiner was used, this followedmore established techniques for stent delivery incomplex lesions, such as the use of an additionalsupportive ‘buddy’ wire, more aggressive guidecatheters and adjunctive devices such as laser orrotational atherectomy. However, as experiencedwas gained, the GuideLiner was used more as afirst-line tool when difficulty was encountered.It should also be highlighted that some of theexcellent supportive and deliverable guidewirescurrently marketed were not available duringthis case series.

Without the use of the GuideLiner, somecases may not have been successfully completedand others would have entailed unacceptablyprolonged procedural times, inadvertentlyexposing the patient to increased risks associatedwith high contrast load and radiation dose.The specific procedural indications for usingthe GuideLiner catheter during PCI can becategorized as follows:

▪ Distal stent delivery within a tortuous vesseland/or calcified vessel: this was the indicationfor 27 out of 50 cases (Table 1). When conventionaltechniques fail to deliver a stent distallywithin a tortuous vessel, the GuideLiner isadvanced distally over the guidewire or balloonshaft providing more effective backupsupport to enable successful delivery of thedevice (Figure 3);

Figure 3:Deep vessel intubation to facilitate distal balloon and stent delivery in an 85-year-old male on peritoneal dialysisundergoing primary percutaneous coronary intervention for an ST-elevation myocardial infarction. (A) Heavily calcified andtortuous right coronary artery that was occluded distally. (B) The right coronary artery was engaged transfemorally with an Amplatz 0.75GC (Boston Scientific, MA, USA) and the lesion crossed with a PT Graphix™ Wire (Boston Scientific). Balloon delivery failure wasencountered due to marked vessel calcification and tortuosity particularly at the mid vessel U-bend. Proximal balloon dilatation wasrequired in order to deliver the GL (Vascular Solutions, MN, USA) distally as the proximal lesion was obstructive. (C) The GL was thendeeply intubated to permit distal lesion predilatation and stent delivery (Tsunami^® 3 × 15 mm and 3.5 × 10 mm [Terumo Corporation,Tokyo, Japan]). (D) The final angiographic result with thrombolysis in myocardial infarction grade III flow.GC: Guide catheter; GL: GuideLiner^®.

Table 1: Use of the GuideLiner^® (Vascular Solutions, MN, USA) for distal stent delivery within a tortuous and/or calcified vessel (n = 27).

▪ Distal stent delivery within a tortuous vesseland/or calcified vessel after rotational or laseratherectomy: this was the indication for 13 out of 50 cases (Table 2). The GuideLiner can beutilized to facilitate stent delivery in heavilycalcified vessels after debulking the lesion withrotational or laser atherectomy (Figure 4);

Figure 4:Stent delivery within a tortuous and/or calcified vessel after rotational or laser atherectomy. (A) Stent delivery in acalcified vessel after laser atherectomy in a 66-year-old male admitted with unstable angina. (i) Severe distal RCA lesion and a severelesion in the PDA branch extending back to the ostium. (ii) The RCA was engaged transradially with an Amplatz 1.0 GC (BostonScientific, MA, USA) and the lesion crossed with a Balance Middleweight™ Wire (Abbott Laboratories, IL, USA). Distal balloon deliveryfailure was encountered due to suboptimal GC support and the GL (Vascular Solutions, MN, USA) was therefore required to facilitatedeep vessel intubation and provide effective backup support. The lowest profile balloon (1.2 × 12 mm) would not cross the posteriordescending artery lesion despite an advanced GL position. (iii) With the GL deeply intubated, a 0.9-mm laser catheter was delivereddistally in order to effectively debulk the lesion. Following laser atherectomy, sequential balloon dilatation of the lesion was performedand four Promus Element™ stents (2.25 × 12; 2.75 × 20; 3.5 × 20; and 3.5 × 24 mm [Boston Scientific]) were successfully delivered anddeployed from distal to mid vessel. (iv) The final angiographic result. (B) Stent delivery in a calcified and tortuous vessel after rotationalatherectomy in a 61-year-old male with stable angina. (i) Heavily calcified, severe RCA disease. (ii) The RCA was engaged transfemorallywith an Amplatz 0.75 GC and the lesion initially crossed with a Balance Middleweight Wire. This was then exchanged for a rota wireusing a Fine Cross™ microcatheter (Terumo Corporation, Tokyo, Japan). After two burr rotational atherectomy, a 3.5 × 20 mmnoncompliant balloon expanded fully. However, stents could not be delivered. (iii) The GL was, therefore, advanced to mid vessel andthree Promus Element stents (3.5 × 24; 4 × 28; and 4 × 28 mm) were succsessfully delivered and deployed. (iv) The final angiographicresult.
GC: Guide catheter; GL: GuideLiner^®; PDA: Posterior descending artery; RCA: Right coronary artery.

Table 2: Use of the GuideLiner^® (Vascular Solutions, MN, USA) for distal stent delivery within a tortuous and/or calcified vessel after rotational or laser atherectomy (n = 13).

▪ Failure to cross a calcified lesion with a balloonand/or stent without atherectomy: this was theindication for six out of 50 cases (Table 3). Inthe context of a heavily calcified lesion that isuncrossable with a balloon or stent, the GuideLineris utilized to facilitate stent deliverywhen atherectomy is either not feasible ordesirable (Figure 5);

Figure 5:Stent delivery within a calcified lesion in a 70-year-old male admitted with an acute coronary syndrome.
(A) Severe calcific disease in a tortuous LAD artery. (B) The LAD artery was engaged transradially with an Extra backup 3.5 GC(Medtronic, MN, USA) and the lesion crossed with a Balance Middleweight™ Wire (Boston Scientific, MA, USA). Rotational atherectomywas not undertaken in this case due to the degree of tortuousity. The lesion was successfully predilated but stent delivery failure (despitea supportive ‘buddy wire’) was encountered due to severe calcification and tortuosity. Therefore, the GL (Vascular Solutions, MN, USA)was used to deliver four overlapping Promus Element™ stents (2.5 × 20; 2.5 × 24; 3 × 20; and 3.5 × 8 mm [Boston Scientific]) from thedistal vessel back to the ostium of the LAD artery. (C) The final angiographic result.GC: Guide catheter; GL: GuideLiner^®; LAD: Left anterior descending.

Table 3: Use of the GuideLiner^® (Vascular Solutions, MN, USA) following failure to cross a calcified lesion with a balloon and/or stent without atherectomy (n = 6).

▪ Inability to properly engage the guide catheter:this was the indication for three out of50 cases (Table 4). In some cases, difficultcoronary ostium take-off prevents coaxial engagement of the guiding catheter. TheGuideLineris useful in this situation, particularlywhen intubating arterial or vein graftostia (Figure 6);

Figure 6:The GuideLiner^® (Vascular Solutions, MN, USA) was used to engage the left internal mammary artery grafttransfemorally in order to treat the distal left anterior descending artery lesion in a 79-year-old male with stable angina.(A and B) The internal mammary artery GC (Boston Scientific, MA, USA) did not adequately engage the LIMA graft due to significantsubclavian tortuousity resulting in a 90° bend in the GC. The GL was required to properly intubate the LIMA graft and achieve successfulballoon delivery through the 90° bend in the guide catheter. Furthermore, the LIMA graft was tortuous with a distal U-bend. (C) The GLwas used to facilitate delivery of three overlapping Promus Element™ stents (2.25 × 20; 2.25 × 20; and 2.25 × 20 mm [Boston Scientific])to the severe distal LAD lesion via the tortuous LIMA graft. (D) The final angiographic result.GC: Guide catheter; GL: GuideLiner^®; LAD: Left anterior descending; LIMA: Left internal mammary artery.

Table 4: Use of the GuideLiner^® (Vascular Solutions, MN, USA) when unable to properly engage the guidecatheter (n = 3).

▪ Distal stent delivery without injuring theproximal vessel: this was the indication for oneout of 50 cases (Table 5). In some situations, thetarget lesion is in the distal segment of thevessel and may require a relatively large-diameterstent delivered across a very tortuous andmoderately diseased proximal vessel. In thissituation, in order to avoid injuring the proximalvessel during stent delivery, the GuideLineris gently advanced across the tortuousproximal segment resulting in safe and effectivedelivery of the bulky stent distally(Figure 7);

Figure 7:GuideLiner^® (Vascular Solutions, MN, USA) used for transradial distal stent delivery in a tortuous calcified vesselwithout injuring the diseased proximal segment in a 72-year-old female admitted with an acute coronary syndrome.
(A) Severe distal RCA stenosis and moderate calcific proximal disease within a tortuous vessel. (B) The RCA was engaged with a Judkinsright 4 GC (Medtronic, MN, USA) and the lesion crossed with a Balance Middleweight™ Wire (Abbott Laboratories, IL, USA). The distallesion was succesfully predilated but stent delivery failure was encountered due to vessel tortusity and calcification. The GL wasadvanced over a balloon shaft into the distal vessel and the bulky Tsunami^® 4 × 15 mm stent (Terumo Corporation, Tokyo, Japan) wassuccessfully delivered to the distal lesion, avoiding injury to the calcified and tortuous proximal vessel segment. (C) The finalangiographic result.
GC: Guide catheter; GL: GuideLiner^®; RCA: Right coronary artery.

Table 5: Use of the GuideLiner^® (Vascular Solutions, MN, USA) for distal stent delivery without injuring theproximal vessel (n = 1).

▪ Proximal to distal vessel stenting: although theconventionalapproach to stenting a long segmentof disease is to deliver overlapping stentsfrom distal to proximal vessel, this may not befeasible in certain situations. For example,when a stent is trapped within a proximal lesionand has to be deployed at this position, theGuideLiner can then be used to deliver furtherstents distally through the proximally deployedstent, allowing for proximal-to-distal vesselstenting. An example of such a case is describedin Figure 8. Caution needs to be applied to avoidlongitudinal stent compression and this techniqueis best performed by advancing theGuideLiner over the initial proximal stentballoon.

Figure 8:Advancement of the GuideLiner^® (Vascular Solutions, MN, USA) through a proximally deployed stent allowing themore distal lesion to be subsequently treated. (A) Severe diffuse disease in the RCA of a 79-year-old male with unstable angina. (B and C) The RCA was engaged transfemorally with an All Right 4 GC (Boston Scientific, MA, USA) and the lesion is crossed with a Luge™wire (Boston Scientific). After predilatation with full balloon expansion, an attempt was made to deliver a 3.5 × 33 mm Cypher (CordisCorporation, NJ, USA) stent to the distal lesion, but it would not cross the proximal lesion and could not be retracted into the GC. Therefore,the stent was deployed in this proximal position. The GL was then advanced through the proximally deployed stent (over the balloon shaft) inorder to effectively deliver the 3 × 23 mm distal Cypher stent. (D) The final angiographic result. In this case, the risk of longitudinal stentcompression was low since the Cypher stent has a high number of connectors between stent rings with a closed-cell design. Morecontemporary stents may be more prone to longitudinal stent compression and, therefore, more caution should be applied when using theGL in this situation.
GC: Guide catheter; GL: GuideLiner^®; RCA: Right coronary artery.

Other clinical applications

Other very useful clinical applications of theGuideLiner that have not been used in our caseseries but have been previously reported includethe following:

▪ Treatment of chronic total occlusions usingthe retrograde technique: the GuideLiner canbe used through the anterograde guide positionedat the proximal occlusion to aid externalizationof the retrograde wire. This techniquecan be used routinely or when difficultyis encountered in advancing the retrogradewire all the way into the anterograde guidecatheter;

▪ Retrieval of a trapped rotablation burr: in arecently reported case of an entrapped rotablatorburr [17], the rotawire and burr were cutproximally to permit advancement of theGuideLiner. Subsequent traction on the burrwith counter traction of the GuideLiner at thelesion allowed the burr to be successfullyretrieved.

Tips and tricks

When using the GuideLiner catheter, the following‘tips and tricks’ should be incorporatedin order to ensure optimal performance of thedevice:

▪ To facilitate coaxial and safe delivery of theGuideLiner within the distal vessel, theGuideLiner is usually best advanced over aballoon so that it runs on the shaft withoutinjuring the vessel and minimizes the risk ofproximal vessel dissection. Resistance toadvancement can be overcome by inflating theballoon within the distal target lesion followed by gentle traction on the balloon during theadvancement of the GuideLiner to create ananchor effect. Alternatively, sequential andprogressively increased distal balloon inflationsat the outflow of the GuideLiner permitmovement to a distal position (Figure 9);

Figure 9:Sequential and progressive balloon dilatations at the outflow of the GuideLiner^® (Vascular Solutions, MN, USA)facilitates distal to proximal stent delivery. (A) A diffusely diseased, ectatic and calcified RCA in a 58-year-old male with stableangina. (B) The RCA was engaged transradially with a Judkins right 4 GC (Medtronic, MN, USA) and the lesion crossed with a BalanceMiddleweight™ Wire (Abbott Laboratories, IL, USA). Deep vessel intubation was achieved with the GL. The diseased vessel wasreconstructed with sequential balloon predilatations and step-wise delivery of five Promus Element™ stents (3 × 8; 3.5 × 28; 4 × 32;4 × 32; and 4 × 28 mm [Boston Scientific, MA, USA]) at the outflow of the GL. (C) The final angiographic result.GC: Guide catheter; GL: GuideLiner^®; RCA: Right coronary artery.

▪ Occasionally, when attempting to deliver a distalstent, the stent can become wedged in theproximal lesion and can neither be advanced norretracted to facilitate deploymentin an adequateposition. In this situation, the stent has to bedeployed in this proximal position. The GuideLinercan then be advanced through the proximallydeployed stent allowing the more distallesion to be subsequently treated. Thus, withthe GuideLiner, access to the distal vessel canbe achieved safely. However, this must be performed very carefully, without much forceand, preferably, over a balloon shaft so as notto cause longitudinal stent compression(Figure 8);

▪ Large-diameter bulky stents can be damagedor stripped off on entering the metal collar ofthe GuideLiner, particularly when the metalcollar is situated within a bend in the guidingcatheter. In this situation, gentle retraction ofthe GuideLiner so as to place the metal collarin a straighter segment of the guiding catheteris required. Alternatively, this problem canpotentially be avoided by introducing thestent into the GuideLiner outside of the guidecatheter and subsequently advancing bothsystems together. However, this maneuvermay be difficult when an anchor balloon isrequired for deep-vessel intubation of theGuideLiner. Extreme caution must be exercisedwhen using large-diameter stents andthe use of lower profile, less bulky stentsshould always be consideredin the firstinstance (Figure 10);

Figure 10:GuideLiner^® (Vascular Solutions, MN, USA) complications. (A) Stent loss on enteringthe metal collar of the GuideLiner (transradial approach). (B) A damaged stent that was stripped offin the GuideLiner.

▪ When dealing with calcific lesions that requiredebulking, it is important to bear in mindwhen planning the intervention strategy thatrotational atherectomy cannot be performedthrough the GuideLiner catheter since eventhe smallest rotablator burr is too bulky adevice. Alternatively, a small-diameter cuttingballoon, for example a 2.5 × 10 mm balloon(Boston Scientific, MA, USA), can travelthrough the 6-in-7 GuideLiner if required,although a 3.0 × 10 mm cannot.

Device limitations and complications

The GuideLiner has few but important limitations.First, the requirement for deep vesselintubation, typically within tortuous or calcificarteries, means there is the potential risk ofproximal vessel dissection. In the authors experience,this occurred in two (4%) cases. This complication can be minimized by systematicallyadvancing the GuideLiner over the balloonshaft, as previously described, or using the dedicatedGuideLiner Navigation™ catheter (VascularSolutions). The Navigation catheter is adilator-like delivery catheter designed to protectthe arterial wall during guide deep seating usingrapid exchange delivery over a 0.014-inch guidewire.It is not yet distributed in the UK and theauthors have, therefore, not experienced its use.

Second, there is the risk of damage to larger,bulkier stents during their passage through themetal collar, particularly when the collar is situatedat a bend in the guiding catheter [18,19].In our series, we encountered two incidences(in one patient) of stent loss in the metal collar,which occurred in a 7 Fr GuideLiner using5-mm diameter stents. Fortunately, both stentswere easily retrieved. As such, caution mustbe exercised during stent passage through themetal collar and, if significant resistance isencountered, the stent should be immediatelywithdrawn and carefully examined for damageprior to proceeding with the case. Recent design modifications of the GuideLiner catheter,as described below, will address this particularlimitation.

Third, there is the potential for ‘guidewirewrap’ particularly if two or more wires are used.To avoid this complication, the GuideLiner shouldbe advanced without rotation and should only beadvanced over the primary guidewire as secondarywires may wrap around the GuideLiner, thuspreventing advancement of the balloon or stent.

New device components

In view of the above limitations, the GuideLinercatheter has been redesigned with the followingchanges incorporated into the new GuideLinerversion 2.0 in order to ensure an improved safetyand efficacy profile (Figure 11):

Figure 11:The new version of the GuideLiner^® catheter (Vascular Solutions, MN, USA)illustrating some of its modifications. This includes a longer rapid exchange section (25 cm), anall-polymer collar and additional proximal and distal marker bands.Reproduced with permission from Vascular Solutions Inc., MN, USA.

▪ Length of rapid exchange section increased from20 to 25 cm to allow deeper vessel intubation;

▪ Additional 5.5 Fr size for compatibility for all6 Fr guiding catheters;

▪ Metal collar changed to an all-polymer collarfor improved flexibility, which helps reduce therisk of stent damage or dislodgement;

▪ Added proximal and distal marker bands.

Center-based discussion of theexperiences encountered

We have described our experience with theGuideLiner version 1.0 catheter in 50 complexPCI cases undertaken and/or supervised by asingle operator at a high-volume center. In ourexperience, the GuideLiner was successful in96% of cases and device-related proceduralcomplications were encountered in 4% of cases.Specifically, proximal vessel dissection occurredin two out of 50 patients. As discussed, therisk of this complication occurring can beminimized by very careful advancement of theGuideLiner over a balloon shaft or by using thededicated GuideLiner Navigation catheter.

Furthermore, in our series, we encounteredtwo incidences of stent loss, both of which occurred during the passage of a 5-mm diameterstent within the metal collar of a 7 Fr GuideLiner.This problem can be attenuated by verycareful advancement of the stent through themetal collar and, if any resistance is encountered,the location of the stent in relation to the metalliccollar should be established and the stentthen withdrawn immediately and inspected fordamage. With the new and improved GuideLinerversion 2.0, which is now widely availableand currently in use at our center, the metalcollar has been replaced by an all-polymer collarin order to reduce the risk of stent damageor dislodgement. This has avoided any furtherincidences of stents being stripped off; however,as with version 1.0, it is important to have thecollar in a straight section of the guide catheterto permit easier passage of the device throughthe collar itself.

The majority of PCI cases undertaken at ourcenter are performed transradially and, in thisparticular series, 76% of cases were performedvia this route. Although the transradial approachis preferable to the transfemoral route owing tothe significantly lower risks of bleeding complications,the likelihood of suboptimal guidecatheter support is sometimes encountered morefrequently with the transradial approach, particularlyin the context of brachiocephalic tortuosity[20-22]. Therefore, the GuideLiner catheteris a particularly expedient device in centers, suchas ours, that perform the majority of procedurestransradially.

Since collecting the cases for this series, thecenter has used an additional 120 GuideLinercatheters over a 10-month period, which representsapproximately 7% of all PCI proceduresperformed at our center over this time period.

Conclusion

This device evaluation effectively illustrateshow the GuideLiner catheter can be successfullyused to treat patients with challengingand complex coronary disease/anatomy in a safeand timely manner, either as a ‘bailout’ whenconventional techniques have failed or at thestart of the case when device delivery failureis anticipated. With the increasing age of thePCI population and the higher complexity ofcases undertaken in many interventional centers,balloon and/or stent delivery failure will beencountered more frequently. Thus, the GuideLineris an essential tool that can be utilizedin standard PCI practice to effectively treatcoronary lesions that may have previously beenconsidered ‘untreatable’. The new modificationsof the device have addressed some of its currentlimitations.

Future perspective

The GuideLiner has clearly established its positionin the armory of the modern PCI operator.

The ease of use accompanied with the safetyand efficacy profile have permitted widespreaduptake across the world. The indications foruse have also expanded and we have attemptedto capture the majority in this article but, nodoubt, further clinical scenarios will be documentedin the future. The utilization of GuideLinerin the setting of retrograde chronicallyoccluded vessels technique is a good exampleof this, whereby the externalization of the retrogradewire through the anterograde wire canbe greatly facilitated.

The GuideLiner catheter is an importantdevelopment that has certainly played a role inshaping the future of interventional cardiology.

Executive summary

Device characteristics

▪ The GuideLiner^® (Vascular Solutions, MN, USA) catheter is a coaxial guide catheter extension, specifically designed for deep intubationof the target coronary artery, thereby permitting safe and effective device delivery during percutaneous coronary intervention.

▪ The soft-tipped extension is silicone coated for lubricity and comprises an inner polytetrafluoroethylene lining surrounded by a stainlesssteel coil for flexibility and strength.

▪ The GuideLiner travels through the Y-adaptor hemostasis valve without the need to disconnect the valve from the guide catheter,thereby providing the advantage of rapid exchange.

GuideLiner technique: step-by-step guide

▪ Advance the GuideLiner over its monorail system to the desired location within the vessel. Coaxial deep vessel intubation can beachieved by advancement over an uninflated balloon.

▪ Advance the coronary stent(s) into the guide catheter through the GuideLiner but be wary of resistance as the stent travels through themetal collar of the GuideLiner.

▪ Overlapping stents can be deployed from the distal to the proximal or from the proximal to the distal vessel using the GuideLiner.

▪ On completion of the procedure, gently pull the GuideLiner out under fluoroscopic guidance.

Clinical indications and applications

▪ Clinical indications and applications include the following:

– Distal stent delivery within a tortuous and/or calcified vessel.

– Distal stent delivery within a tortuous and/or calcified vessel after rotational or laser atherectomy.

– Failure to cross a calcified lesion with a balloon and/or stent without atherectomy.

– Inability to properly engage the guide catheter.

– Distal stent delivery without injuring the proximal vessel.

– Proximal to distal vessel stenting.

– Treatment of chronic total occlusions using the retrograde technique.

– Retrieval of a trapped rotablation burr.

Tips and tricks

▪ To facilitate coaxial and safe delivery of the GuideLiner within the distal vessel, the GuideLiner is usually best advanced over a balloon(uninflated or inflated).

▪ If a stent cannot advance to a distal position within the vessel and has to be deployed proximally, the GuideLiner can be advancedthrough the proximally deployed stent allowing the more distal lesion to subsequently be treated.

To avoid bulky stents being damaged or stripped off upon entering the metal collar of the GuideLiner, ensure that the metal collar is notpositioned within a bend in the guide catheter.

▪ When dealing with calcific lesions that require debulking, small-diameter cutting balloons can be delivered through the GuideLiner.A rotablator cannot travel through the GuideLiner.

Device limitations and complications

▪ There is risk of:

– Proximal vessel dissection.

– Damage to larger, bulkier stents during their passage through the metal collar.

– Guidewire wrap.

New device components

▪ New device components include the following:

– An increased length of the rapid exchange section to allow deeper vessel intubation.

– An additional 5.5 Fr size.

– The metal collar changed to an all-polymer collar for improved flexibility.

– Additional proximal and distal marker bands.

Center-based discussion of the experiences encountered

▪ The GuideLiner was successful in 96% of cases and device-related procedural complications were encountered in 4% of cases.

Guideliner Wire

▪ Two incidences of stent loss were encountered, both of which occurred during the passage of a 5-mm diameter stent within the metalcollar of a 7 Fr GuideLiner.

Conclusion

▪ The GuideLiner catheter is an essential tool that can be successfully used to treat patients with challenging and complex coronarydiseases/anatomies, either as a ‘bailout’ when conventional techniques have failed, or at the start of the case when device deliveryfailure is anticipated.

▪ The new modifications of the device have addressed some of its current limitations.

Future perspective

▪ The ease of use of the GuideLiner catheter, accompanied with its safety and efficacy profile, have permitted widespread uptake globally.

▪ The clinical indications for the GuideLiner are likely to expand in the future.

Financial and competing interests disclosure

P O’Kane is a European Proctor for Spectranetics. The authorshave no other relevant affiliations or financial involvementwith any organization or entity with a financial interest in orfinancial conflict with the subject matter or materials discussedin the manuscript apart from those disclosed.

No writing assistance was utilized in the production ofthis manuscript.

References

Papers of special note have been highlighted as:

▪ of interest
▪▪ of considerable interest

1. Jafary FH. When one won’t do it, use two-double ‘buddy’ wiring to facilitate stent advancement across a highly calcified artery. Catheter Cardiovasc. Interv. 67, 721–723 (2006).
2. Burzotta F, Trani C, Mazzari MA et al.Use of a second buddy wire during percutaneous coronary interventions: a simple solution for some challenging situations. J. InvasiveCardiol. 17, 171–174 (2005).
3. Hirokami M, Saito S, Muto H. Anchoring technique to improve guiding catheter support in coronary angioplasty of chronic total occlusions. Catheter Cardiovasc. Interv. 67, 366–371 (2006).
4. Nikolsky E, Gruberg L, Pechersky S et al. Stent deployment failure: reasons, implications, and short- and long-term outcomes. Catheter Cardiovasc. Interv. 59, 324–328 (2003).
5. Mamas MA, Fath-Ordoubadi F, Fraser DG. Distal stent delivery with Guideliner catheter: first in man experience. Catheter Cardiovasc.Interv. 76, 102–111 (2010).
6. Pershad A, Sein V, Laufer N. GuideLiner catheter facilitated PCI – a novel device with multiple applications. J. Invasive Cardiol. 23, E254–E259 (2011).
7. Rao U, Gorog D, Syzgula J, Kumar S, Stone C, Kukreja N. The GuideLiner ‘child’ catheter. EuroIntervention 6, 277–279 (2010).
8. 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. 22, 495–498 (2010).
9. Hanna EB, Dasari TW, Hennebry TA. Use of the GuideLiner catheter for the treatment of a bifurcational total occlusion of the native left anterior descending artery through a tortuous composite venous graft. J. Invasive Cardiol. 23, e40–e42 (2011).
10. Wiper A, Mamas M, El-Omar M. Use of the GuideLiner catheter in facilitating coronary and graft intervention. Cardiovasc. Revasc.Med. 1(68), e5–e7 (2011).
11. Luna M, Papayannis A, Holper EM, Banerjee S, Brilakis ES. Transfemoral use of the GuideLiner catheter in complex coronary and bypass graft interventions. Catheter Cardiovasc. Interv. 80, 437–446 (2012).
12. de Man FH, Tandjung K, Hartmann M et al. Usefulness and safety of the GuideLiner catheter to enhance intubation and support of guide catheters: insights from the Twente GuideLiner registry. EuroIntervention 8, 336–344 (2012).

▪▪ Largest Guideliner^® (Vascular Solutions,MN, USA) registry providing insights intothe feasibility and safety of the device.

13. Mamas MA, Fath-Ordoubadi F, Fraser D. Successful use of the Heartrail III catheter as a stent delivery catheter following failure of conventional techniques. Catheter Cardiovasc.Interv. 71, 358–363 (2008).
14. Mamas MA, Eichhofer J, Hendry C et al. Use of the Heartrail II catheter as a distal stent delivery device; an extended case series. EuroIntervention 5, 265–271 (2009).

▪ First-in-man experience of the Guidelinercatheter.

15. Brilakis ES, Banerjee S. Novel uses of the Proxis embolic protection catheter. CatheterCardiovasc. Interv. 74, 438–445 (2009).
16. Banerjee S, Brilakis ES. Use of the Proxis embolic protection device for guide anchoring and stent delivery during complex saphenous vein graft interventions. Cardiovasc. Revasc.Med. 10, 183–187 (2009).
17. Cunnington M, Egred M. GuideLiner, a child-in-a-mother catheter for successful retrieval of an entrapped rotablator burr. Catheter Cardiovasc. Interv. 79, 271–273 (2012).
18. Cola C, Miranda F, Vaquerizo B, Fantuzzi A, Bruguera J. The Guideliner™ catheter for stent delivery in difficult cases: tips and tricks. J. Interv. Cardiol. 24, 450–461 (2011).

▪ Small GuideLiner case series incorporatingtips and tricks for use of the device.

19. Murphy JC, Spence MS. Guideliner catheter – friend or foe? Catheter Cardiovasc. Interv. 80, 447–450 (2012).
20. Mamas MA, Ratib K, Routledge H et al. Influence of access site selection on PCI-related adverse events in patients with STEMI: meta-analysis of randomised controlled trials. Heart 98, 303–311 (2012).
21. Jolly SS, Yusuf S, Cairns J et al.Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet 377, 1409–1420 (2011).
22. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am. Heart J. 157, 132–140 (2009).

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Guide extension catheter with half-pipe technology

In 2009, the GuideLiner Catheter revolutionised the concept of guide extension, creating new possibilities in interventional cardiology. Now in its third generation, the GuideLiner V3 Catheter continues to build on a history of innovation and performance—one that's been demonstrated with more than half a million catheters in cath labs around the world.¹

Designed to perform

It's not just the proprietary half-pipe technology that sets the GuideLiner V3 Catheter apart. The coil-reinforced extension is specifically designed to enable dependable deep-seating for the delivery of interventional devices to distal locations.

Half-pipe technology

The half‑pipe channel is designed to minimise device/collar interaction by directing and aligning devices through the collar transition, facilitating smooth device entry and seamless delivery.

Tortuosity tested

From challenging lesions to impossibly acute angles, percutaneous coronary interventions have grown more complex. Since being introduced, GuideLiner Catheters have been recognised by interventionalists as essential tools for addressing difficult anatomies.

Guidelines.org

Available in five sizes: 5, 5.5, 6, 7 and 8 Fr.

This is about the engineering solutions presented by the GuideLiner V3 Catheter….

• Guide Extension Catheters (GECs) are a vital part of modern PCI practice.
• It works, in partnerships with other devices to overcome anatomical challenges.
• What features affect your ability to optimize your case?

GuideLiner Tips and Tricks

Tips and tricks to eliminate common handling errors during preparation and deployment of GuideLiner V3 and TrapLiner

We suggest best practice is to always use a balloon when you deliver a Guide Extension Catheter to “Rail” and centre the device away from the vessel wall and potential vessel damage. There are several techniques to delivering a Guide Extension Catheter, these are the ones we would recommend.

Guidelines

Delivering GuideLiner V3

Using these techniques reduces the need to push harder or have a slippier coating. If done correctly, they will facilitate predictable and safe delivery of the GuideLiner V3.

We suggest best practice is to always use a balloon when you deliver a Guide Extension Catheter to “Rail” and centre the device away from the vessel wall and any potential vessel damage. There are several techniques to delivering a Guide Extension Catheter, these are the ones we would recommend.

Inch worm Technique

Technique involves positioning small balloon at distal tip of the GuideLiner V3 during delivery.

Anchor Technique

Technique involves inflating balloon in target lesion to assist in GuideLiner V3 advancement. Balloon acts as an anchor that is used to pull GuideLiner V3 down the vessel, you will need 2 people.

Balloon assisted tracking (BAT)

We suggest good practice is to use a balloon or other device when you deliver a Guide Extension Catheter to “rail” and centre the device away from the vessel wall and any potential vessel damage.

Technique involves positioning small balloon at distal tip of the GuideLiner V3 during delivery.