Radial approach for percutaneous coronary interventions on chronic total occlusions: technical...

Interventional Rounds

Radial Approach for Percutaneous CoronaryInterventions on Chronic Total Occlusions:

Technical Issues and Data Review

Francesco Burzotta,1* MD, PHD, Maria De Vita,2 MD, PHD, Thierry Lefevre,3 MD,Antonella Tommasino,1 MD, Yves Louvard,3 MD, and Carlo Trani,1 MD

Objective: To overview the scientific data and the technical details regarding percutane-ous coronary interventions (PCI) on chronic total occlusions (CTO) by radial approach.Background: Trans-femoral approach is commonly regarded as the standard for PCI onCTO. Methods: A systematic search in Medline and in the main international websiteswas realized. Key data were extracted and analyzed using standard meta-analytictechniques. Bench test assessment of compatibility between different combinations ofinterventional devices (required for CTO recanalization techniques) and the followingguiding catheters was performed: 5 Fr, Sheathless 6.5 Fr, 6 Fr, Sheathless 7.5 Fr and 8Fr. Results: No prospective randomized study was found, whereas 13 observationalstudies on 3,501 CTOs treated by radial approach were identified. Overall, the crossoverto femoral access rate ranged between 0 and 5.8%. Access site complications werenoted in <1% of cases and in-hospital major adverse events were reported in 0–3.8% ofpatients. PCI success was significantly influenced by the learning curve: In the five stud-ies comparing the success rates between a first and a later period of practice, a signifi-cant improvement was observed (OR, 95% CI: 0.30, 0.39–0.51; P < 0.001). The technicaldetails relevant to approach a CTO by transradial access are discussed, and the originalresults of bench tests provide details regarding the compatibility of various CTO recana-lization techniques with specific guiding catheter sizes. Conclusions: The transradialaccess represents a promising alternative to trans-femoral access to treat patientsundergoing CTO PCI in high-volume transradial centres. The presented data may beuseful to plan transradial PCI attempts on CTO lesions. VC 2013 Wiley Periodicals, Inc.

Key words: transradial approach; chronic total occlusion; percutaneous coronary inter-vention; vascular complications

INTRODUCTION

Chronic total occlusion (CTO) percutaneous coro-nary intervention (PCI) represents an evolving field ofinterventional cardiology [1–8]. According to the

standard practice of the majority of CTO-dedicated

centres and operators, PCI on CTO are attempted using

large guiding catheters and trans-femoral approach

(TFA). Yet, transradial approach (TRA) is a valuable

1Institute of Cardiology, , Catholic University of Sacred Heart,Rome, Italy2Interventional Cardiology, Morgagni-Pierantoni Hospital, Forl�ı,Italy3Interventional Cardiology, Istitut Cardiovasculaire Paris Sud,Massy, France

Conflict of interest: Nothing to report.

*Correspondence to: Francesco Burzotta, MD, PhD; Institute of Car-

diology, Catholic University of Sacred Heart, L.go Gemelli 1,

00168 Rome, Italy. E-mail: [email protected]

Revised 23 June 2013; Revision accepted 27 June 2013

DOI: 10.1002/ccd.25118

Published online 5 July 2013 in Wiley Online Library

(wileyonlinelibrary.com).

VC 2013 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 83:47–57 (2014)

alternative to TFA, which has been shown to reducevascular complications [9,10] and possibly be associ-ated to a better clinical outcome [11–13]. For such rea-sons, radial access is going to widespread not only inroutine coronary procedures, but also, thank to recenttechnological advances, in fields like complex PCIsand peripheral interventions [14–18]. As a conse-quence, radial approach may nowadays be successfullyused for the most complex CTO PCI like retrograde re-canalization of left main [19].

In the current study, we aimed at providing a com-prehensive overview of the scientific data and the tech-nical details that may be relevant for interventionalistsapproaching CTO by TRA. Moreover, because theissue of technique compatibility with different guidingcatheters may be pivotal, original bench tests were per-formed and reported.

SCIENTIFIC DATA ON THE FEASIBILITY ANDSAFETY OF TRA FOR CTO PCI

Study Search Strategy, Data Extraction, andStatistical Analysis

Studies published in extenso within November 2012on TRA for CTO were identified by Medline search(http://www.ncbi.nlm.nih.gov) entering the words“chronic total occlusion” or “CTO” and “radialapproach” or “transradial”. Furthermore, the TCT(http://www.tctmd.com), EuroPCR (www.europcr.com),ESC (www.escardio.org), SCAI (www.scai.org) andAHA (www.americanheart.org) websites were searchedfor pertinent abstracts and expert slides presentations

[20–32]. Case reports and case series with less than 10CTO lesions were excluded.

The study search algorithm is reported in Fig. 1. Noprospective randomized trial was found, whereas 13observational studies provided data regarding 3,501PCI for CTOs by TRA [20–31]. Of these, seven studies[20,21,24,26,27,31,32] were published as full papers,whereas six studies were available as abstract [28–30]or expert slide presentation [22,23,25]. One study,firstly published as an abstract, has been recentlyaccepted for publication as a full paper [29]. The fol-lowing data were abstracted from each study: Studydesign, number of CTO lesions, CTO technique (ante-grade or retrograde), size of guiding catheters used, rateof crossover to trans-femoral access, access site compli-cations, in-hospital major adverse coronary events(MACE: Cardiac death, myocardial infarction, target-vessel revascularization).

We also searched for the studies in which there wasa comparison of procedural success rate between trans-radial and transfemoral access groups and for studiesin which there was a comparison of procedural successrate between a first and a second period of TRA PCIon CTO lesions practice. After extracting the data onthese two issues, we performed a meta-analysis usingComprehensive Meta-Analysis 2.2 (Bio-Stat Solutions,Englewood, New Jersey).

Characteristics of Observational Studies onTransradial PCI for CTO

The main characteristics of the studies are reportedin Table I.

Fig. 1. Flowchart of the systematic search process.

48 Burzotta et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

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Transradial Approach for CTO 49


Of note, all studies [20–32] were single centre [20–32] and were conducted by operators reporting to havea specific experience in TRA PCI. The majority ofthe studies adopted mainly the antegrade technique(Table I), whereas two registries [31,32] reportedrespectively a single centre and a single operator expe-rience with retrograde bi-radial technique (Table I).

An important issue reflecting the feasibility of TRAfor CTO lesions is represented by the specific criteriaadopted to select patients in which TRA procedures isattempted. Of note, five studies [21–23,27,29] for a totalof 550 CTO lesions were retrospective registries report-ing the data on CTO lesions treated by radial accesswithout mentioning the rate of CTO lesions treatedusing the femoral (or others) route in the same period.Three studies only [21,29,32] reported the criteria usedto exclude patients from TRA and these were: NegativeAllen’s (and or Barbeau) test for both wrists and chronicrenal failure requiring dialysis. Eight studies [22,24–26,28,30–32] reported the rate of femoral access [22,24–26,28,30,32] or brachial access [31] use during the studyperiod and this ranged between 4.5 and 42%. The rea-sons for exclusion from radial artery access reported infour (out of such eight) studies were: Discretion of theindividual operator [24,26], radial artery too small for a6-Fr introducer, negative Allen’s test, absent or weak ra-dial pulse, haemodialysis [20,31]. Interestingly, threestudies [20,29,30] reported a selective choice of radialartery access in the first period of the study and a rou-tine radial artery access use in a second study period.These data suggest that (sometimes unclear) patients’selections were performed in the available studies onTRA CTO PCI and that with increased experience therelevance of patient’s selection may be reduced.

Another important issue reflecting the feasibility ofTRA CTO PCI is represented by the need of crossoverto another access after having attempted firstly the ra-dial artery approach. The crossover to TFA rate hasbeen reported in six studies [20,22,23,27,29] andresulted to be highly variable ranging between 0 and5.8% (Table I). According to the results reported in thetwo articles providing details regarding this issue[20,24], crossovers were mainly due to anatomical var-iants of radial and subclavian arteries affecting the ra-dial artery cannulation, the coronary ostia engagementand the guiding catheters support.

Procedural Efficacy and Clinical Results ofTransradial PCI for CTO

The clinical efficacy of vascular access selection inCTO PCI procedures may be evaluated by means ofprocedural success rates, by the rate of vascular com-plications and by the postprocedural MACE.

Of note, the definition of procedural success was notavailable in some studies [20,22,23,25,27,28,30,32] anddiffered significantly across studies providing it.Indeed, procedural success was defined as either:

1. PCI completion by TRA with a residual stenosis<30% and no major cardiovascular complications [21];

2. Final TIMI flow 3 and no major cardiovascularcomplications [26];

3. Residual stenosis< 20% and final TIMI flow 3[29];

4. Residual stenosis< 30% and final TIMI flow 3 [31];5. Successful lesion crossing with wire and balloon

with a residual stenosis <70% [24].

Besides such heterogeneity in its definition, thereported TRA CTO procedural success rate was highlyvariable among the studies in which mainly an ante-grade approach is used, ranging between 65% [22] and84% [30] (Table I). Such variability seems to be simi-lar to that encountered across studies on TFA CTOPCI [5,8,33–36] and is probably related to differentdefinitions of procedural success, different complexityof attempted lesions and different study periods.

Two studies provided statistical analysis on the pre-dictors of TRA PCI failure [20,21]. In such studies,nontapered stump, longer and older lesions [20,21]were associated to the inability to cross the occlusionwith a guidewire or a balloon [20,21], thus suggestingthat the procedural complexity markers are not differ-ent compared to TFA-CTO studies [5,8,33–37].

Five studies [20–22,29,32] provided data regardingthe comparison of success rates between a first and alater period of the study. As shown in Fig. 2, the suc-cess rate significantly improved in all the studies sothat an overall increased success has been observedwith increased experience (overall OR,95% CI:0.30,0.39–0.51; P< 0.001).

Finally, the overall clinical safety of TRA CTO PCIseems to be supported by the rarity of vascular compli-cations as well as by the overall clinical outcomereported in the available studies. Indeed, as shown inTable I, access-site complications were rarely reported(being constantly below 1% rate), whereas the rates ofin-hospital MACE ranged between 0 and 3.8% (TableI). Such results seems in line with the in-hospitalMACE observed in the major studies on CTO PCI per-formed by TFA [5,8,33–36].

Results of Observational Studies ComparingTransradial and Trans-Femoral PCI for CTO

Five studies reported a direct comparison betweenTRA and TFA for PCI on CTO [20,24,26,28,30]. As

50 Burzotta et al.


shown in Fig. 3, the results obtained by TRA comparedfavourably with that obtained by TFA (OR: 0.82; 95%CI: 0.68–0.99: P¼ 0.046). Such finding may be relatedwith a selection of patients with lower complexity forTRA PCI. This hypothesis is supported by the study byFerrante et al. [28] who reported a significantly lowerprevalence of difficult CTO lesions in the TRA groupas compared to the TFA group (39.4 vs. 48.4%;P¼ 0.001).

Regarding resource consumption, the contrast vol-ume [24,30], the procedure time [24] and the radiation

dose [30] were all found to be similar in TRAand TFA groups in the (few) studies reporting theseparameters.

The rate of entry site complications, reported byRathore et al. [24], was significantly higher in TFAgroup as compared to TRA group (3.5% TRA groupversus 11.3% TFA group; P< 0.001). Similar findingswere reported by Asgedom et al. [30].

Finally, in two studies who provided such data[24,30], early MACE resulted to be similar betweenTRA group and TFA group. However, it should

Fig. 2. Forrest plot of odds ratio (ORs) of procedural success of PCI in CTO lesions bytransradial in the comparison between first and second period of time. Statistical analysisperformed using Comprehensive Meta-Analysis 2.2 (Bio-Stat Solutions, Englewood, New Jer-sey).

Fig. 3. Forrest plot of odds ratio (ORs) of procedural success of PCI in CTO lesions in thecomparison between radial and femoral approach. Statistical analysis performed using Com-prehensive Meta-Analysis 2.2 (Bio-Stat Solutions, Englewood, New Jersey).



emphasized that such studies were clearly underpoweredto compare clinical outcomes.

TECHNICAL ISSUES OF TRA FOR CTO PCI

The radial approach is associated with some specifictechnical characteristics which may render the PCI pro-cedure quite different from that performed by the fem-oral approach.

Guiding Catheter Size

First of all, although large sized guiding catheters(GC) may safely be inserted in the radial arteries ofselected patients [38,39], only 5 and 6 Fr GC may rou-tinely be used in transradial PCI. As summarized inTable I, radial operators often select 6 Fr GC for CTOPCI to avoid excessive injury to the small sized radialartery. This attitude differs from that of many femoraloperators who like to have a large GC size (7 and 8Fr) allowing for free CTO technique selection in thecourse of CTO PCI procedure. Indeed, various techni-ques requiring the manipulation of various combina-tions of devices have been developed to improve thesuccess of CTO interventions [1–3]. Thus, in the set-ting of CTO interventions operators adopting the TRAshould focus their attention on materials’ compatibilitymuch more compared with those using systematicallylarge GC by TFA. This issue is complicated by the factthat same materials (for example same size balloons) ofdifferent manufactures may have different width thusinfluencing their possibility to be inserted in GC togetherwith other devices. As a consequence, the knowledge ofthe combination of materials that can fit into each GCtype may come from the direct or indirect experienceonly. Recently, the border between larger (7 and 8 Fr)and smaller (5 and 6 Fr) GC has been challenged by anew family of GC not requiring the insertion of asheath, commonly called “Sheathless” GC (first avail-able type: Eucath, Asahi, Japan). Again, no exhaustiveinformation regarding the compatibility of different de-vice combinations with the Sheathless GC is available.

To try clarify which are the techniques that can beapplied using different GC, we tested in the bench thecompatibility of different CTO techniques (requiringdifferent combinations of devices) with 5, 6, 7, and 8Fr GC and with 6.5 and 7.5 Fr sheathless GC. Theresults of these tests are reported in the Table II. Over-all, it is evident that the selection of 6 Fr GC may pro-foundly limit the freedom to select some CTOtechniques, so that 7 Fr are required when some com-plex, specific techniques are needed. Of note, the feasi-bility of standard large GC use in selected patientsundergoing TRA complex procedures [39] has been

previously reported. Thus, radial approach by itselfcannot be considered an absolute exclusion criteria forthe selection of 7 or 8 Fr GC and individual patientevaluation is needed (a large sheath TRA PCI on CTOis shown in Fig. 4). Moreover, as shown in Table II,the 7.5 Fr Sheathless GC technology seems to poten-tially offer a major advance which may overcomealmost completely the drawback of using a small arteryaccess like the radial. It should be underlined thatsheathless GC are still not available in some countrieslike United States of America and that the use ofsheathless GC requires specific experience because ofthe highly hydrophilic coating which may increasecatheter instability.

A further important issue specifically associated withbi-radial retrograde techniques is represented by theGC length. Indeed, the use of the 150 cm devices (likeCorsair catheter or long-shaft over the wire balloons)for retrograde access may need GC shorter than 100cm, especially when the patient is taller than 175 cm[31,32]. Actually, short 90 cm GC, but not sheathlessGC, are available in different curvature and size[31,32]. An alternative possibility to overcome theproblem of shorter GC need is to cut the standard GCand different effective techniques to cut standard GChave been described [31,32]. Finally, the last possibleoption is to perform an high radial stick (puncture site10 cm proximal to styloid process) for the retrograderadial artery access [31]. Yet, it should be emphasizedthat at that level radial artery travels deep so thathemostasis can be difficult and deserves meticulousattention to minimise the local bleeding risks.

Guiding Catheter Support

Another relevant issue related with the TRA forCTO intervention is represented by the need of GCback up to push wires, microcatheters and balloonsacross the occlusive lesion. The “passive” back up isthe support offered by the GC itself and is increasedwith increasing GC size. Of difference compared tofemoral operators, TRA interventional cardiologists useto gain the maximal “active” backup from the usuallysmaller GC. A series of specific points may optimizethe “active” support. Firstly, when dealing with aCTO, it may be important to achieve a stable coronarycannulation with the guiding catheter. Because of thewide spectrum of anatomical variations encounteredbetween the forearm and the aortic root [40], multiplepoints of contact can affect the guiding catheter torquetransmission from a radial access. Accordingly, thelearning curve of individual radial operators is charac-terized by the development of an appropriate selectionof guiding catheter shape and radial approach side

52 Burzotta et al.


(right or left) to achieve the best cannulation in thevarious clinical conditions. Beside these considerations,for CTOs located in the left coronary, the right radialapproach may be considered a valuable option as this“opposite” radial entry site warrants, especially withextra backup GC shapes, a strong support (see Fig. 4for example). Of difference, when dealing with theright coronary artery (RCA) CTOs, the right radialapproach is sometimes suboptimal as Ikary et al.showed increased back up force with left vs right ra-dial approach for RCA cannulation [41]. Thus, whenthe need of high support from the GC is anticipated,we consider the possibility to electively select the“opposite” left radial access for CTO on the RCA(Fig. 5).

It is important to recognize that the “passive back-up” offered by the same GC when inserted by radial orfemoral approach is strongly influenced by the GCshape. For example, when dealing with a RCA CTO,some GC shapes (Judkins) have wider and others have

smaller (Ikary and Amplatz Left) back up force differ-ence comparing their radial or femoral insertion [41].

Another important issue which may potentiallyreduce the drawback of using small sized GC is relatedwith the possibility to perform the “deep intubationtechnique” in the case of CTO with distal location[20,21]. This technique is more easily and efficientlyperformed with GC without complex curves (for exam-ple, Judkins, Hockey stick for the RCA) and is facili-tated by 5 or 6 Fr GC (Fig. 5).

Finally, it should be emphasized that specific devi-ces have been designed to improve the support ofsmall sized GC. Among these, the “five in sixtechnique” (or “mother and child technique”) has beenreported to be effective in the setting of CTO interven-tions [42–44]. This technique is facilitated by the avail-ability of specifically designed 5 Fr GC compatiblewith 6 Fr GC (Heartrail Terumo) or by a novel 6 Fr(and 7 Fr) GC extensor (Guideliner, Vascular solu-tions). Of note, the use of such devices may be

TABLE II. Compatibility of CTO PCI Techniques With Different Guiding Catheters

GUIDING CATHETERS

5 Fr Sheath

þ GC

6 Fr Sheath

þ GC

6.5 Fr

Sheathless

7 Fr Sheath

þ GC

7.5 Fr

Sheathless

8 Fr Sheath

þ GC

Internal diameter (inches) 0.56–0.58 0.70–0.71 0.70 0.78–0.81 0.81 0.88–0.90

External diameter at the arterial access site (mm) 2.30 2.52–2.60 2.16 2.85–3.10 2.49 3.20–3.50

Parallel Wire Technique (Antegrade CTO PCI Technique)

Wire þ 1 microcatheter Yes Yes Yes Yes Yes Yes

2 microcatheters No Yes Yes Yes Yes Yes

1 microcatheter þ 1 OTW balloon No No No Yes Yes Yes

2 OTW balloons No No No No No Yes

Side-Branch Anchoring Balloon and Balloon Trapping (Useful for Both Antegrade and Retrograde CTO PCI Techniques)

1 monorail balloon þ 1 microcatheter No Yesa Yesa Yes Yes Yes

1 monorail balloon þ 1 OTW balloon No Yesb Yesb Yes Yes Yes

CTO PCI: IVUS-Guidance (Useful for Both Antegrade and Retrograde CTO PCI Techniques)

With simultaneous wire inside Yes Yes Yes Yes Yes Yes

With simultaneous microcatheter inside No No No Yes Yes Yes

Adjunctive Devices (Useful for Both Antegrade and Retrograde CTO PCI Techniques)

Rotablator 1.25–1.75 mm burr No Yesc Yes Yes Yes Yes

Rotablator 2.0–2.25 mm burr No No No Yes Yes Yes

Laser 0.9–1.4 mm Yes Yes Yes Yes Yes Yes

Laser 1.7–2.2 mm No No No Yes Yes Yes

Tornus 2.1 F No Yes Yes Yes Yes Yes

Tornus 2.6 F No Yes Yes Yes Yes Yes

Corsair No Yes Yes Yes Yes Yes

CrossBoss Catheter No Yes Yes Yes Yes Yes

Stingray CTO Re-entry device No Yes Yes Yes Yes Yes

Data from bench testing with the following materials:

Guiding Catheters (GC): 5, 6, 7, and 8 Fr Vista Brite Tip (Cordis) and Sherpa NX Active and Launcher (medtronic), Eucath Sheathless 6.5 and 7.5

Fr (Asahi).

Microcatheters: Finecross (Terumo); Quickcross (Spectranetis); over-the-wire (OTW).

Monorail Balloons: Sprinter Legend 1.25 mm (Medtronic); Mini Trek 1.20 mm (Abbott), Ryujin 1.25 mm (Terumo), Emerge 1.25mm (Boston).

IVUS: Atlantis Pro (Boston Scientific).aFeasible with Finecross, Quick cross, Tornus 2.1 Fr microcatheters but not with Corsair and Bridgepoint device.bFeasible but not advisable (too much friction)cWith 1.75 mm burr feasible but not advisable (too much friction)

GC, guiding catheter.



facilitated by less complex guiding catheter curves (forexample, JR 4 instead of Amplatz for RCA CTO).

UPCOMING IMPROVEMENTS

The process of angioplasty equipment miniaturiza-tion is actually ongoing and is expected to improvethe feasibility of TRA CTO interventions by increas-ing the number of techniques which can be performedthrough small sheaths. The avenues of research aredouble: To develop smaller GC with sufficient inter-nal lumen and to realize smaller interventional devi-ces (wires, balloons, stents) reducing the GC lumenrequirement.

Among the GC improvements, two novel types havebeen developed and their use reported for CTOs. A 5Fr Sheathless guiding catheter (Virtual 3 Fr, Medikit,Japan) with inner diameter comparable to a standard 5Fr GC and outer diameter comparable to a 3-Fr intro-ducer has been successfully used to treat by radialapproach two patients with CTO [43]. Moreover, anovel GC (Kiwami, Heartrail II, Terumo) compatiblewith a 4-Fr introducer with an inner diameter of 0.05000

has been tested in four CTO (as well as in other lesiontypes) [46].

In the field of coronary interventional devices, a rev-olutionary advancement is potentially constituted by0.01000 guidewires and 0.01000-compatible balloons. Thefirst series of such devices is represented by the“Slender System” (Japan Lifeline) and two studiesreported their use in the setting of CTO [25,47].

STUDY LIMITATIONS

The main limitation of this literature review on TRAin CTO PCI is that all the studies entered the revieware registries because no randomized data are presenton TRA use in CTO lesions PCI. Moreover, all regis-tries are single centre or single operator and are con-ducted by operators with a specific experience in TRAPCI so that the reported results cannot be extended todifferent settings.

Other important limitations are the lack of a consist-ent classification of the type of CTO lesions treated,the different definitions of procedural success and TRAcross-over among the studies, the lack of a systematic

Fig. 4. Example of radial approach for PCI on an left anterior descending CTO with no visi-ble stump. (A and B) Left radial approach is used for right coronary cannulation, whereasright radial approach is used for left coronary cannulation with 8 Fr extra backup 3.5 guidingcatheter. The CTO has no stump and is located immediately after diagonal branch take off.(C) IVUS-guided proximal cap puncture using Miracle 3 guidewire supported by Finecrossmicrocatheter. (D) Final result after stenting.

54 Burzotta et al.


comparison between TRA and TFA and the incompletereporting of access-site complications (like radial arteryocclusion).

CONCLUSIONS

The radial access constitutes a valuable alternativeto trans-femoral approach to treat patients undergoingCTO PCI in centres with high volume of transradialprocedures. A specific knowledge in the material com-patibility and techniques to gain support is needed.

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