© 2013, Wiley Periodicals, Inc.
`DOI: 10.]111/joic.12040
`
`CORONARY ARTERY DISEASE
`
`GuideLiner Mother-and-Child Guide Catheter Extension: A Simple
`
`Adjunctive Tool in PCI for Balloon Uncrossable Chronic Total Occlusions
`
`JASON C. KOVACIC, M.D., PH.D., AMIT B. SHARMA, M.D., SWATHI ROY, M.B.B.S.,
`
`JENNIFER R. LI, B.A., RAJEEV NARAYAN, M.D., DONG-BIN KIM, M.D., PH.D.,
`
`SAMIN K. SHARMA, M.D., and ANNAPOORNA S. KINI, MD.
`
`From the Cardiac Catheterization Laboratory, Cardiovascular Institute, Mount Sinai Hospital, New York, New York
`
`
`
`Objectives: To investigate the use ofthe GuideLiner “mother-and—child ” guide catheter extension system as a simple
`solution to facilitate initial device delivery in balloon uncrossable chronic total occlusions (CTOs) undergoing
`percutaneous coronary intervention (PCI).
`Background: During PCls for CT0 lesions, an important reason for proceduralfailure is the inability to deliver a
`balloon or microcatheter across the lesion.
`
`Methods: We retrospectively accessed our interventional registryfor 07/01/2010 to 03/21/2012 and extracted data
`on all CT0 lesions involving GuideLiner catheter use. Cine review was performed to identifi) cases where a
`guidewire had crossed the CT0 and the use of a GuideLiner catheter facilitated initial device delivery.
`Results: We identified 28 patients that underwent PCIfor CT0 with a GuideLiner catheter used to assist initial
`balloon or microcatheter advancement across the culprit lesion. Mean overall CTO length was 26.3 :1: 18.] mm. The
`GuideLiner catheter was successful in delivering a small balloon to the CT0 lesion in 85.7% of cases (24/28). A
`single CT0 PCI resulted in a distal guidewire perforation, but there was no hemodynamic compromise or
`pericardial effusion and thepatient was discharged the next day. Overallprocedural success in these selected cases
`(where a guidewire had already crossed the CT0) was 89.3% (25/28).
`Conclusions: The GuideLiner mother-and—child catheter is a simple, safe and efficacious adjunctive device for
`difiicult CT0 PCIs where despite standard measures it is not possible to deliver an initial balloon or microcatheter
`across the occluded segment. (J Interven Cardiol 2013 ;26:343—350)
`
`Introduction
`
`There is growing interest in percutaneous coronary
`intervention (PCI) for chronic total occlusions (CTOs),
`particularly in patients with myocardial ischemia of the
`CTO territory despite optimal medical therapy. CTO
`lesions present numerous challenges that may reduce
`procedural success. However, several important tech-
`nical and device advances have recently been made that
`appear to have positively impacted the likelihood of
`
`No specific funding or grant was used to fund this study. Jason
`Kovacic is supported by National
`Institutes of Health Grant
`K08HL111330.
`Address for reprints: Dr. Annapooma S. Kini, M.D., Mount Sinai
`Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029.
`Fax: +1—212-534—2845; e—mail: annapooma.kini@mountsinai.org
`
`procedural success, including newer generation and
`novel guidewires, retrograde techniques, novel cathe-
`ters,
`and smaller profile balloons and stents."2
`Nevertheless, perhaps due to increasingly challenging
`patient and lesion selection, in contemporary series the
`overall procedural success rate for CTOs has remained
`stable at only 65e70%.3 Continued advancement in
`relevant techniques and equipment will be required if
`the success rate of PCI for CTO is to improve.
`Importantly, once a CTO lesion has been successfully
`wired, a key reason for procedural failure is the inability
`to deliver a balloon, microcatheter and/or stents to the
`target lesion. Interventionalists often colloquially refer
`to this situation as “the wire has crossed but nothing will
`go.” Several options are available in this scenario of a
`balloon uncrossable CTO lesion during PCI. Standard
`initial maneuvers
`in this
`situation include deep
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`KOVACIC, ET AL.
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`inspiration by the patient, use of a second (buddy) wire,
`using a lower profile balloon, deep seating or changing
`the guide catheter to a more supportive configuration or
`attempting to rewire the lesion with a stiffer guidewire.l
`If these actions fail, some of the more technically
`complex options include anchor balloon techniques,
`changing to a retrograde approach, or attempting to
`rewire the lesion with a rotawire and performing
`rotational atherectomy with a small burr (Rotablator®;
`Boston Scientific, Natick, MA, USA).1 However, not
`all operators are familiar with these latter techniques,
`and the unsuccessful termination of a failed CTO PCI is
`a not uncommon outcome if standard maneuvers have
`
`failed to deliver an initial device to the target lesion.
`Recently, “mother-and-child” guide catheter extension
`systems have been introduced into the interventional
`armamentarium. These catheters may be extended
`beyond the angioplasty guide catheter, and enable deep
`culprit vessel intubation to achieve extra support and
`improve alignment.4‘5 Currently available mother-and-
`child catheters
`include the Heartrail® (Terumo,
`Somerset, NJ, USA) and GuideLiner® (Vascular
`Solutions, Minneapolis, MN, USA).“’5 Here, we report
`our initial experience using the GuideLiner catheter as
`an adjunct device in CTO cases where despite standard
`measures it was not possible to deliver an initial balloon
`or microcatheter to the target lesion and to perform a
`first balloon dilation.
`
`Methods
`
`The purpose of this study was to describe the
`procedural and clinical outcomes in CTO PCI patients
`where a guidewire had been successfully navigated into
`the distal vessel, but neither microcatheter nor balloon
`could be advanced across the lesion. The study was
`performed using our
`single center
`interventional
`registry. Details of this registry have been published
`previously.6 In brief, all PCI procedures are entered into
`a prospectively collected, institutional review board
`approved registry. Data collected includes baseline
`clinical characteristics, procedural details (including
`CTO vs. non-CTO PCI, equipment use, and procedural
`success), details of events occurring immediately post-
`procedurc, in—hospital clinical course, laboratory data,
`and other test results associated with the procedure.
`Afier discharge, subjects are routinely contacted and
`undergo 30-day and 12-month follow-up. We retro-
`spectively accessed our interventional registry for the
`
`period of July 1, 2010 to March 31, 2012 (inclusive)
`and extracted data on every PCI performed (n = 8,306)
`that included the use of the GuideLiner catheter (204
`GuideLiner cases; 2.4% overall GuideLiner use). All
`unstable patients including those with myocardial
`infarction (ST-segment elevation or non-ST-segment
`elevation) were then excluded. There were 372 CTOs
`that underwent PCI during this period (successful and
`unsuccessful), indicating a CTO PCI rate of4.5% (372/
`8306). Initially, 66 patients were identified that fulfilled
`our screening criteria of having CTO PCI with
`GuideLiner use. Next, because the Gui deLiner catheter
`may also be used to deliver stents through tortuous or
`calcified vessels, or for other reasons unrelated to initial
`device delivery, cineangiographic review was per-
`formed to identify CTO cases with documented
`GuideLiner use (GuideLiner advanced beyond vessel
`ostium) to deliver an initial balloon or microcatheter, or
`at first balloon inflation (28 cases identified). Cin-
`eangiographic review was performed by 2 experienced
`interventional cardiologists, blinded to the procedural
`and clinical outcomes. Cases were discarded from this
`
`analysis if the GuideLiner was not visible in the first
`angiographic image showing a balloon inflation or
`microcatheter delivery across
`the
`culprit
`lesion.
`Cineangiographic review also included angiographic
`quantitative coronary analysis (QCA) to determine: (1)
`Shepherd’s Crook right coronary artery (RCA) mor-
`phology (as defined by Gossman et al.7) in all cases; (2)
`CTO length (all cases), and; (3) estimated distance of
`GuideLiner intubation into the target vessel (performed
`in 26/28 cases—in two cases technical difficulties
`
`prevented QCA assessment of intubation distance).
`QCA was performed using the Cardiovascular Angio-
`graphic Analysis System (CAAS) Version 5.7 (Pie
`Medical Imaging B.V., Maastricht, The Netherlands).
`Additional lesion and procedural details were obtained
`from the PCI registry, but were also verified during
`cineangio graphic review. For in-hospital and long-term
`clinical outcomes, the following definitions were used:
`myocardial
`infarction was defined according to the
`Universal definitions of Thygesen et al.8; bleeding was
`defined using BARC criteriag; vascular access com-
`plications were defined according to ACUITY
`criteria.10
`Revascularization Procedure. All patients pre-
`senting to the catheterization laboratory routinely
`received 325 mg aspirin > 90 minutes prior to angiog-
`raphy and were reloaded with clopidogrel (300 mg)
`(n:21) or prasugrel
`(30mg)
`(n24) “on-table”
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`GUIDELINER IN CTO PCI
`
`immediately prior to CTO PCI. Patients naive to these
`latter medications
`received a 600 mg “on-table”
`loading dose of clopidogrel (n = 3). No patient reported
`here received ticagrelor. As an institutional protocol we
`use a 45 cm long sheath for improved guide catheter
`support
`in all CTOs attempted via a transfemoral
`approach. All patients were anticoagulated using
`bivalirudin with loading bolus followed by a weight-
`adjusted infusion to maintain an activated clotting time
`of 2300 seconds. Although the GuideLiner V2 catheter
`was approved for use in the US in December 2011, all
`cases in this study were performed with the GuideLiner
`V1 device. Other technical decisions regarding the PCI
`and CTO procedure were at the operator’s discretion.
`Statistical Analysis. This was not a comparative
`study as the number of patients was too small to permit
`meaningfiil statistical analyses. Data are presented as
`meanzl: SD, or as % (II).
`
`Results
`
`During the study period there were 372 CTOs that
`underwent PCI, with the GuideLiner catheter used in
`17.8% (66/372) of these cases. After exclusion of PC15
`in which the GuideLiner was used for other reasons
`
`(e.g., advancement of a stent), we identified 28 patients
`that underwent PCI for CTO with a GuideLiner catheter
`used to assist advancement of an initial balloon or
`
`In 22/28
`microcatheter to the culprit CTO lesion.
`(78.6%) of these cases the GuideLiner was first used for
`the specific purpose of initial balloon or microcatheter
`advancement
`to the culprit
`lesion after successfill
`wiring of the vessel. Alternatively, in 6/28 (21.4%)
`cases the GuideLiner was first used during wiring of the
`lesion and then further utilized to assist balloon or
`
`microcatheter advancement. Baseline patient charac-
`teristics are presented in Table l. The majority of
`patients had undergone prior PCI (85.7%), 50% had
`suffered a prior myocardial infarction, and 42.9% were
`diabetic. Among the 24 patients (85.7%) that had not
`previously undergone coronary artery bypass graft
`surgery, the mean SYNTAX score at the time of CTO
`PCI was 18.2:1: 11.6. CTO lesion characteristics are
`
`presented according to SYNTAX criteria in Table 2.
`The RCA was the most common culprit vessel (75%),
`and mean overall CTO length was 26.3 d: 18.1 mm. In
`four cases (14.3%) the CTO lesion was due to occlusive
`in-stent restenosis. Heavy calcification was judged to
`be present in only 4 CTO lesions (14.3%). All CTOs
`
`Table 1. Baseline Patient Characteristics
`
`Variable
`
`Male/female
`Age (years)
`Hypertension
`Hyperlipidemia
`Diabetes mellitus
`Current smoking
`Peripheral vascular disease
`Prior myocardial infarction
`Prior CABG
`Prior PCI
`Baseline serum creatinine (mg/d1)
`CKD
`LVEF
`Medication use
`
`Aspirin
`Clopidogrel
`Prasugrel
`Beta blocker
`ACE inhibitor/ARE
`Calcium channel blocker
`Statin
`Diuretic
`Nitrates
`Ranolazine
`
`
`% (n) or Mean :: SD
`
`82/18% (23/5)
`64.1 i 10.0
`100% (28)
`100% (28)
`42.9% (12)
`25% (7)
`3.6% (1)
`50% (14)
`14.2% (4)
`85.7% (24)
`0.97 i019
`14.2% (4)
`45.5 :t 17.4
`
`93% (26)
`75% (21)
`14% (4)
`86% (24)
`54% (15)
`57% (16)
`82% (23)
`29% (8)
`32% (9)
`14% (4)
`
`ACE, angiotcnsin converting enzyme; ARB, angiotcnsin II receptor
`blocker; CABG, coronary artery bypass grafi surgery; CKD, chronic
`kidney disease (eGFR < 60 ml/min/l .73 m2); LVEF, lefi ventricular
`ejection fraction.
`
`except 1 were performed using an antegrade approach,
`with a single CTO initially attempted via retrograde
`approach that was then converted to antegrade. In this
`case,
`the GuideLiner was used only during the
`antegrade attempt. Contralateral
`injection was per-
`
`formed in 13 cases (46.4%). A mean of 5.1 :: 2.1
`guidewires were used per CTO (Table 3). By entry
`criteria, a GuideLiner catheter was used in every case.
`In 27 cases (96.4%)
`this was a 6 Fr—compatible
`GuideLiner within a 6 Fr guide catheter, while in 1 case
`(3.6%) a 7 Fr—compatible GuideLiner was used in a 7 Fr
`guide catheter. The mean estimated distance of
`GuideLiner intubation into the culprit vessel was
`26.0 d: 20.0 mm, while intubation distance was >10 cm
`in only a single case (3.6%). The mean diameter of the
`smallest dilation balloon used in association with the
`
`GuideLiner was 1.39 i 0.21 mm, with a 1.25 mm
`diameter balloon being the most frequent (used in 15
`cases). Although technically possible, in no case was
`the GuideLiner successfully used to facilitate delivery
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`Table 2. Baseline CTO Lesion Characteristics
`
`Table 3. Procedural Details
`
`KOVACIC, ET AL.
`
`% (n) or
`Mean i SD
`
`% (n) or
`Mean :: SD
`Procedural/Technical Details
`
`CTO and Vessel Characteristics
`
`Vessel
`Right coronary artery
`Shepherd’s Crook right coronary
`morphology
`Left circumflex artery
`Left anterior descending artery
`Most proximal occluded segment
`Proximal vessel
`Mid vessel
`Distal vessel
`Branch (marginal, postero-lateral,
`and posterior-descending, diagonal)
`Number of occluded segments
`1
`2
`3
`Blunt stump
`Side branch involvement
`None
`<1.5 mm diameter side branch only
`>1 .5 mm diameter side branch only
`Both <15 and >l.5 mm side branches
`Age of CTO
`Unknown
`<3 months
`>3 months
`Antegrade bridging collateral vessels
`Length of CTO (mm)
`Heavy calcification (angiographic assessment)
`ln—stent restenosis of CTO lesion
`
`75% (21)
`52.4% (11/21)
`
`17.9% (5)
`7.1 % (2)
`
`35.7% (10)
`35.7% (10)
`10.7% (3)
`17.9% (5)
`
`57.1% (16)
`39.3% (11)
`3.6% (l)
`25% (7)
`
`7.1% (2)
`67.9% (19)
`0% (0)
`25% (7)
`
`7.1% (2)
`0 (0%)
`92.9% (26)
`67.9% (19)
`
`26.3 :: 18.1
`14.3% (4)
`14.3% (4)
`
`92.9% (26)
`7.1 % (2)
`46.4% (13)
`96.4% (27)
`3.5% (1)
`
`92.9% (26)
`5.1 :l: 2.1
`28.6% (8/28)
`3.1 :: 1.4
`
`1.39 :: 0.21
`7.1% (2)
`100% (28)
`32.1% (9)
`0% (0)
`7.1% (2)
`
`Approach
`Femoral access site for primary guide catheter
`Radial access for primary guide catheter
`Contralateral injection
`Antegrade CTO approach
`Retrograde CTO approach‘
`Supporting equipment and maneuvers
`Long sheath (45 cm)§
`Number of guidewires
`Parallel or buddy wire technique
`Number of balloons
`Mean smallest diameter balloon (mm)
`Anchor balloon technique
`Finecross micro-catheterT
`Corsair micro-catheter;
`Tomus micro-cathetert
`Rotational atherectomy“|
`Stent use in CTO segment (excluding
`non-CTO lesions in culprit vessel)
`Number of stents deployed in CTO
`Total stent length in CTO (mm)
`Maximum stent diameter in CTO (mm)
`Total stent use per culprit vessel (including
`CTO segment and other lesions)
`Number of stents deployed in culprit vessel
`Total stent length in culprit vessel (mm)
`Maximum stent diameter in culprit vessel (mm)
`Fluoroscopy time/contrast use
`45.4i22.0
`Total fluoroscopy time (minute)
`
`Contrast use (ml) 206.9 3; 84.4
`
`1.2 i 0.7
`40.421: 13.4
`
`3.0 :: 0.36
`
`2.0 :: 1.0
`62.7 :: 22.9
`3.15 :: 0.35
`
`
`
`of a microcatheter or any other device (other than a
`balloon) across the CTO lesion. Example images
`(Fig. 1) are provided showing a case where it was
`initially not possible to deliver any device, but then a
`small balloon was able to be passed using a GuideLiner
`catheter.
`
`Overall procedural success in these selected cases
`(where a guidewire had already crossed the CTO
`lesion) was 89.3% (25 CTO PCIs). The GuideLiner
`catheter was successful in delivering a small balloon to
`the CTO lesion in 85.7% of cases (24 CTO PCIs)
`(Fig. 2). Of the failed cases,
`in 2 CTO PCIs the
`operators were entirely unsuccessful at delivering any
`device to the lesion (despite GuideLiner use) and the
`PCI was abandoned. In 2 cases the GuideLiner failed to
`
`the
`permit balloon or other device delivery, but
`operators were able to rewire the CTO with a rotafloppy
`wire
`(Boston Scientific)
`and perform rotational
`
`‘Later converted to antegrade—the GuideLiner was used during the
`antegradc attempt; lTerumo lnterventional Systems, Somerset, NJ,
`USA;
`iAsahi
`Intecc Co., Ltd., Aichi, Japan; §100% use for
`transfcmoral cases (not used in 2 radial cases); lBoth cases were
`failed use of GuideLiner to deliver balloon/microcatheter.
`
`atherectomy with a 1.25 mm burr. A final CTO PCI
`resulted in a distal guidewire perforation. In this case,
`the GuideLiner was successfully used to deliver a
`balloon across the CTO and although balloon dilation
`was performed, a stent was not placed to avoid opening
`flow to the perforation. However, it was unclear if the
`perforation was related to GuideLiner use, or if this
`occurred during earlier attempts to deliver a balloon
`and/or microcatheter. There was no hemodynamic
`compromise and transthoracic echocardiography did
`not demonstrate any pericardial effusion. The patient
`was discharged home the next day. Apart from this wire
`perforation there were no other in-hospital complica-
`tions including periprocedural myocardial infarction,
`
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`GUIDELINER TN CTO PCI
`
`
`
`Figure l. A: Right coronary artery CTO prior to revascularization. B: Guidewire successfully placed distal to the lesion using a FineCross
`microcatheter (Terumo). A second guidewire is seen to be coiled up at the site of the occlusion (arrow). Even after removing the second (redundant)
`wire, file FineCross catheter was not able to be advanced across the lesion. C: The operators then attempted to pass several different balloons and
`devices across the lesion, including a 1.25 mm X 6.0 mm balloon and a Corsair microcatheler (Asahi lntecc Co., Ltd.). Here the guide catheter is
`seen to be “kicking out” in an attempt to pass a device (arrow) across the CTO lesion. D: A 6 Fr GuideLiner catheter is advanced to the lesion (upper
`arrow), and a Rapid Exchange Apex 2.0 mm X 20 mm balloon (Boston Scientific) was able to be passed across the occluded segment (lower arrow
`marks distal edge of balloon). E: The Apex 2.0 mm x 20 mm balloon was inflated to 16 atm. F: Final angiographic result after deployment of a
`3.5 mm x 38 mm (proximal), 3.0 mm x 28 mm (mid) and 2.5 mm x 23 mm (distal) Xience V stents (Abbott, Abbott Park, IL, USA) with TIMI 111
`final flow.
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`KOVACIC, ET AL.
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`28 patients: GuideLiner used to assist
`
`advancing initial device to CT0 lesion
`
`24 patients: GuideLiner permitted
`balloon delivery to CT0 lesion
`
`4 patients: device or balloon unable to
`
`be advanced to lesion using GuideLiner
`
`23 patients:
`PC! successful
`
`2 patients:
`conversion to
`rotational
`atherectomy.
`
`PCI successful
`
`1 patient: wire
`perforation; PC!-
`ehemdn’tml mar
`
`PEI-um"ma:a:
`
`Figure 2. Acute procedural outcomes.
`
`vascular access complications, bleeding, worsening
`renal function or progression to dialysis, stroke or
`death. Therefore, excluding the cases that required
`rewiring and rotational atherectomy, the technique of
`GuideLiner-facilitated initial small balloon delivery to
`an already wired but otherwise uncrossable lesion was
`associated with procedural success in 82.1% (23/28) of
`CTO PCIs (Fig. 2). Of the 28 patients, one was
`discharged home the same day, 25 the next day, one
`stayed in hospital for 2 nights (due to nonspecific
`nausea in an 84-year-old patient), while one patient
`who was wheelchair-bound with multiple sclerosis and
`baseline left ventricular ejection fraction of 15%
`remained in hospital for 7 days for medical optimiza-
`tion. At 30-day follow up all patients were alive and
`there were no episodes of myocardial infarction, stroke
`or target vessel revascularization.
`
`Discussion
`
`CTO lesions remain a major challenge for percuta-
`neous
`revascularization strategies,
`and are often
`referred to as the “final frontier” of interventional
`
`cardiology. Due to progressive device evolution, in the
`current era a simple, short CTO presents little technical
`challenge. However,
`the high-level complexity and
`long procedural
`times are a major barrier for the
`widespread use of many advanced CTO techniques,
`such as a retrograde approach. Nevertheless, the recent
`reports that successful recanalization of CTO lesions by
`
`PC] is associated with improved long-term survival is
`strong incentive to seek improved success rates for
`these procedures.3’ll Here, we
`report
`a
`simple
`technique that can be easily used in any catheterization
`laboratory to increase procedural
`success
`for a
`challenging sub-set of CTO procedures were a guide-
`wire has crossed the lesion, but no device can be
`tracked over the wire. As our core finding reported
`here, we identified that the GuideLiner mother-and—
`child guide catheter extension facilitated the successful
`delivery of a small balloon to 24 of 28 CTO lesions
`(85.7%). These data suggest the GuideLiner catheter
`may be a useful adjunctive device to aid in the
`successful percutaneous revascularization of chroni-
`cally occluded coronary vessels. Furthermore, the fact
`that only 1/28 (3.6%) cases resulted in a procedural
`complication (with unclear association to GuideLiner
`use) suggests that the GuideLiner catheter is a safe
`technique in this technically challenging interventional
`setting]2 Previous studies have defined that the most
`common reason for an unsuccessful CTO PCI attempt
`is failure to cross (wire) the lesion.13 However, an
`interesting question to arise from our study is, how
`common is the scenario described here of a balloon
`
`uncrossable CTO? Despite an extensive literature
`search, we were unable to find a satisfactory answer.
`It is also a challenging situation to define, as it is also
`likely to be dependent on operator experience and the
`number of alternative strategies that are attempted
`(deep inspiration, buddy wire, anchor balloon, wire
`trapping, etc.). However, at
`least anecdotally, we
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`GUIDELINER IN CTO PCI
`
`suggest that this situation is not uncommon and that it
`may also occur in tightly stenotic non-CTO cases.
`Therefore,
`the technique described here may have
`significant applicability in everyday clinical practice.
`What type of CTO lesions might be well suited to
`facilitated initial balloon delivery using a GuideLiner
`catheter? First, all cases presented here were attempted
`with an antegrade approach (a single initial retrograde
`attempt was converted to antegrade, which is when the
`GuideLiner was used). Other common features of the
`patients reported here are a CTO of the RCA, and the
`level of occlusion being in the proximal or mid vessel.
`Specifically, while in our series 75% (21) of CTOs with
`GuideLiner use involved the RCA, other contemporary
`series typically report that RCA CTOs represent 40—
`50% of cases.3’1l We speculate that the anatomical “C”
`or even “Shepherd’s Crook” curve of the RCA is
`particularly unfavorable from the mechanical perspec-
`tive of device delivery (compared to the left coronary
`vessels), which potentially resulted in the high number
`of RCA cases in this series, including 52.4% of these
`with a Shepherd’s Crook morphology.
`Importantly for those attempting this technique,
`caution needs to be exercised if the metal collar of the
`
`GuideLiner extends beyond the guiding catheter. When
`this occurs,
`it may prove difficult or impossible to
`withdraw the GuideLiner back onto the guide catheter.
`This was the basis for the proprietary recommendation
`of limiting the extension ofVersion 1 ofthe GuideLiner
`(used in this study) to <10 cm beyond the tip of the
`guide. In our study the mean length of GuideLiner
`intubation into the culprit vessel was 26.0 d: 20.0 mm.
`However, we successfully used the GuideLiner without
`issue in a single case with extension >10 cm beyond
`the guide catheter, and others have also reported that
`these long intubation depths in rare cases.14 The guide
`catheter section of the newly released GuideLiner V2
`has been extended from 20 to 25 cm to allow deeper
`intubation, and the proprietary recommendation now
`suggests not
`to advance the GuideLiner catheter
`>15 cm beyond the tip of the guide catheter. Another
`relevant aspect of the GuideLiner catheter use is the
`possibility of causing vessel dissection; a feared
`complication of all deep intubation techniques. While
`operators should remain vigilant for this possibility, we
`have not
`found this to be a practical problem.
`Furthermore, our concern for vessel dissection in the
`setting of CTO for PCI is reduced, as often much of the
`culprit vessel will be stented during a CTO PCI.
`Finally, additional
`limitations of the GuideLiner
`
`include equipment entanglement and deformation
`when advancing devices through the metal collar of
`the guide catheter section of the device.
`While our manuscript is intended to highlight that the
`GuideLiner catheter can be easily and successfully used
`in the situation where a lesion has been antegradely
`wired but a balloon cannot be delivered to the lesion, it
`
`is important to note that the GuideLiner can also be
`used in several other situations. Most commonly, the
`GuideLiner can be used to deliver a coronary stent to a
`lesion that has been dilated but still the stent will not
`
`easily pass. In addition, the GuideLiner may have niche
`roles for specialized techniques such as acting as a
`guide catheter extension during internal mammary
`grafi
`interventions, or
`facilitating entry into the
`proximal
`(antegrade)
`true lumen with the reverse
`CART technique during retrograde CTO PCIs. How—
`ever, there is no role at the current time for using the
`GuideLiner for enhancing the retrograde course of a
`CTO PCI, as this may cause channel perforation.
`It is important to note that there are many other
`techniques for facilitating the delivery of an initial
`device to a balloon uncrossable lesion. Several of these
`
`were also utilized in the patients presented here
`(Table 3). These include: (a) advancing a small balloon
`into the lesion and inflating at high pressures slowly
`progressing into the CTO;
`(b) use of the Tornus
`catheter (Asahi Intecc Co., Ltd., Aichi, Japan); (0) use
`of the Corsair or other alternative microcatheter
`
`for
`(which may aid in creating a small channel
`subsequent balloon delivery);
`((1) anchor balloon
`techniques;
`(e)
`laser;
`(f)
`rotational
`atherectomy
`(although this requires rewiring of the lesion with a
`specialized guidewire); (g) rewiring the lesion with a
`different wire course; (h) the use of a parallel (buddy)
`wire, and (i) the use of a more supportive (e.g., 8 Fr)
`guide catheter.l Furthermore, combinations of these
`techniques may be used (e.g., anchor-Tornus). Never-
`theless, we believe that its ease and simplicity augur
`well for the use of the GuideLiner catheter to permit a
`small (1 25—15 mm) balloon to cross a difficult lesion
`and that this technique should be added to the above
`armamentarium.
`
`Limitations. Our data were retrospectively ob-
`tained from a single center. In addition, because cases
`were included in this series only if the cineangiogram
`demonstrated GuideLiner use in association with the
`
`first balloon inflation, unknown case selection bias may
`have occurred. While the GuideLiner permitted
`successful CTO PCI in 82.1% (23/28) cases,
`it
`is
`
`Vol. 26, No. 4, 2013
`
`Joumal of Interventional Cardiology
`
`349
`
`Page 7
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`Teleflex EX. 2168
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`Medtronic v. Teleflex
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`

`KOVACIC, ET AL.
`
`likely that an unknown number of these cases could
`have been completed using other techniques and it is
`I
`.
`I
`.
`unknown 1f the Gu1deL1ner Increased overall CTO PCI
`success rates. Also, cases were selected because the
`-
`-
`-
`guidew1re had already crossed the CTO les1on (qut the
`lesron was balloon uncrossable). Thls pre-selectlon of
`cases likely accounts for the high overall procedural
`success (89 3%) Heavy calcification (which is the
`.
`'
`.
`'
`I
`I
`mam factor hlndermg balloon/microcatheter advance-
`ment through a CTO) was only present in four cases
`(14 3%)_hem:e these lesions might not be the most
`'
`_
`I
`challengrng leSIOns to cross. In 27/28 (96.4%) cases 6
`Fr guiding catheters were utilized which provide less
`backup support than 7 or 8 Fr guides (which are most
`I
`commonly “33d for CTO PCB—that IS, the need for
`GuideLiner may have been less if larger guide catheters
`were utilized. Finally, although supported by the
`literature,15‘17 our practice of using bivalirudin anti-
`coagulation during PC} for CTO lesions differs from
`t
`[h 1‘
`t
`mos 0 6 Gen ers.
`
`Conclusion
`
`The GuideLiner mother-and-child catheter
`is a
`simple, safe and efficacious niche device for difficult
`CTO PCIS Where desplte Standard measures 1t 15 net
`possible to deliver an initial balloon or microcatheter to
`-
`-
`-
`-
`the target leslon. QperatorsIshould cons1der mcludlng
`the use Of thlS deVICe 1n the“ llSt 0f srmple maneuvers
`for balloon uncrossable CTOs,
`
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