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The Inverse of Can’t
Transradial Bifurcation Coronary Intervention

David E. Kandzari, MD, FACC, FSCAI

Chief Scientific Officer
Director, Interventional Cardiology

Piedmont Heart Institute
Atlanta, Georgia
david.kandzari@piedmont.org
Disclosure
   Within the past 12 months, I or my spouse/partner have had a
   financial interest/arrangement or affiliation with the organization(s)
   listed below
   Affiliation/Financial Relationship                         Company
   Grant/Research Support               Abbott Vascular, Cordis Corporation,
                                        Medtronic CardioVascular

   Consulting Fees/Honoraria            Abbott Vascular, Cordis Corporation,
                                        Medtronic CardioVascular, Micell
                                        Technologies, Terumo Medical

   Major Stock Shareholder/Equity       None

   Royalty Income                       None

   Ownership/Founder                    None

   Intellectual Property Rights         None

   Other Financial Benefit              None
Science and Art of Transradial Coronary Intervention for Bifurcation
Disease


  —   What are existing barriers– or opportunities– to
      advancement of TR bifurcation PCI?

  —   Can and how is complex PCI be performed by a
      transradial approach?

  —   How does evidence inform existing limitations and
      challenges of bifurcation TR PCI?
Frequency of Crossover to 2 Stents in Bifurcation PCI


            40.0%              C ros s ov er from 1 s tent to 2 s tents                   Ang iog raphic S B res tenos is

            35.0%
                                                                                 31.0%
            30.0%

            25.0%
                                     19.2%            18.8%
            20.0%                                                                                               TVF due to SB
                                                                                           14.7%                restenosis 2.8%
            15.0%                                                                                               (no angio f-up)
                                                                 9.4%
            10.0%                                                                                               NA
                            4.3%
             5.0%                                                                                        2.8%

             0.0%
                              NO R D IC                     BBK                     C AC T US             B B C O NE



Steigen TK et al. Circulation. 2006;114:1955-1961 Ferenc M et al. Eur Heart J 2008; 29:
2859–2867 Colombo A et al. Circulation. 2009;119:71–78 Hildick-Smith D et al.
Circulation. 2010;121:1235-1243
Inverse of Can’t
Demystifying Complex TR PCI

      Performed with 6 Fr Guide        Cannot Be Performed
       Provisional Single Stent        Crush and Mini-Crush
          T- and modified T                   V-stent

        T and Protrusion (TAP)    Simultaneous Kissing Stents (SKS)

             Step crush
               Culotte
            Reverse Crush
Device Compatibility Considerations


    1. RX notch diameter

    2. Distal shaft diameter*

    3. Mid balloon crimped diameter and nominal size*

    4. Compliant vs non-compliant balloon

    5. Shaft coating



*Assumes PTCA catheter only, without stent
Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters



                              Rx Notch              Distal Shaft
   Sprinter Legend             0.036                   0.034
        Apex                   0.036                   0.031
         Trek                  0.033                   0.030
       NC Trek                 0.035                   0.031
  Xience V/Promus              0.045                   0.041
Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters



                              Rx Notch              Distal Shaft
   Sprinter Legend             0.036                   0.034
        Apex                   0.036                   0.031
         Trek                  0.033                   0.030
       NC Trek                 0.035                   0.031
  Xience V/Promus              0.045                   0.041
Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters



                              Rx Notch              Distal Shaft
   Sprinter Legend             0.036                   0.034
        Apex                   0.036                   0.031
         Trek                  0.033                   0.030
       NC Trek                 0.035                   0.031
  Xience V/Promus              0.045                   0.032
Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters


                       Rx Notch          Distal Shaft    Mid Balloon Size

   Sprinter Legend       0.036             0.034

           Apex          0.036             0.031
  1. The math doesn’t add up
                                                        3.0: 0.032
  2. Deliver stent first, then balloon
      Trek                 0.033           0.030        3.5:
                                                        4.0:
  3. Caution for stressing system (eg, nondeflate, fracture etc.)
                                                        3.0: 0.034
         NC Trek         0.035             0.031        3.5:
                                                        4.0:
  Xience V/Promus        0.045             0.032             0.041*
*Crimp profile
Provisional or Bail-Out Stent Technique
    Options when a 2nd stent is required

                                            • General rule: Avoid bail-out stenting. If you
                                              suspect you will need 2 stents, start with a
                                              planned 2-stent strategy.
                                            But if you need a bail-out stent:
                                            • T-provisional: When you are confident to
                                              obtain perfect positioning of the SB stent
                                              (i.e. a near 90 angle)
                                            • Culotte or Internal crush: When both
                                              branches are of near equal size and the
                                              angle is narrow
             1. Elective T-stenting
             2. Internal (reverse) crush)   • TAP or Internal crush: When SB is smaller
             3. Culotte                       than MB and the angle is narrow
             4. TAP

Louvard Y. Cather Cardiovasc Interv 2008
T Stenting (Planned or Provisional)

  1
                                      1: Wire both branches and
                                         pre-dilate if needed




  2
                                      2: Stent the MB leaving a wire
                                         in the SB.
                                         The stent in the MB can be
                                         deployed at high pressure.
T Stenting (Planned or Provisional)


 3
                                      3: Rewire the SB passing
                                         through the struts of the MB
                                         stent, remove the jailed wire
                                         and dilate toward the SB



 4
                                 4: Advance stent into the SB with no
For a planned 2 stent               MB protrusion and deploy the stent
technique, or if the                  (TAP technique – leave some
result is suboptimal                protrusion). Option: position a
(provisional):                      balloon in the MB to facilitate re-
                                    crossing.
T Stenting (Planned or Provisional)




5
                              5: Perform final kissing inflation, ideally
                                 with 2 non-compliant balloons.
Sidebranch Re-Access




               Courtesy of Corrado Tamburino
Transradial vs Transfemoral Left Main PCI
   Procedural and Clinical Complications
                                          Transradial   Transfemoral
                                                                       P value
                                            N=353          N=468
    Procedural and In-Hospital Outcomes

   Procedural success (%)                    97%            96%         0.57

    MACE                                     4.0%          3.2%         0.57
    TIMI Major Bleeding                      0.6%          2.8%         0.02

    Hospital stay (days)                   8.5±5.9        9.9±5.9      0.001
    Late Clinical Outcomes (Mean 17 mos)
    Cardiac Death                            1.4%          1.7%         0.74
    Non-fatal MI                             4.0%          2.6%         0.26

    LM specific TLR                          5.7%          5.8%         0.95

    MACE                                    10.2%          9.2%         0.63
Yang, Kandzari et al., JACC Interv 2009
Culotte Stenting
Culotte Technique


 1
                    1: Wire both branches and
                       pre-dilate if needed




 2
                    2: Remove or leave the wire in the
                       more straight branch (MB) and
                       deploy a stent in the more
                       angulated branch (SB)
Culotte Stenting
Culotte Technique



 3                  3: Remove the wire from the
                       stented branch and cross with
                       a wire and balloon into the
                       unstented branch (MB)
                       and dilate.



 4
                    4: Place a second stent into the
                       unstented branch (MB) and
                       expand the stent leaving some
                       proximal overlap
Culotte Stenting
Culotte Technique




 4
                    5: Cross the first stent (SB)
                       with a wire and perform
                       kissing balloon inflation.
Culotte Technique Case Example
Culotte Stenting:



          Pre




Pre-dilatation, followed
by 3.5 mm DES in LCX



                           Courtesy of Fajadet J.
Culotte Technique Case Example
Culotte Stenting:



    3.5 mm DES
     in the LAD




     Final kiss
    Final result



                    Courtesy of Fajadet J.
• CTO crossing with
Fielder XT wire
• Predilate with 2.5 mm
balloon
• 3.0 X 30 mm DES
• LCx
⎯Predilate with 2.5X15

⎯2.5X18 DES

⎯Post-dilate with 2.75X15



• Ramus
⎯Direct stent with 3.0X15

DES
⎯2.5X15 PTCA backstop
• Ramus
⎯Direct stent with 3.0X15

DES
⎯3.0X15 PTCA backstop
• Ramus
⎯ Direct stent with 3.0X15

DES
⎯ 2.5X15 balloon backstop
• LAD/LM
⎯ 3.5X28 DES
• LAD/LM
⎯ 3.5X28 DES
• LCx/Ramus/LM
⎯ Kissing non-compliant

balloon post-dilation
• LAD/LM/Ramus
⎯ Kissing non-compliant

balloon post-dilation
• Final IVUS all three
segments
Final Result
Guide Catheter Size for TR PCI:
Smaller, Bigger…Better?
                                                       Accessability
 3, 4 and 5 Fr Guiding Catheters
    Mizuno et al. CCI 2010;75:985-988
    Takeshita et al. CCI 2010;75:735-739
    Mizuno et al. CCI 2010;75:985-988
    Hamon et al. CCI 2002:55;340-343


 7 Fr and 8 Fr Guiding Catheters
    Gioia G, et al. CCI 2000;51:234 –238
    Wu SS, et al. J Invasive Cardiol 2000;12:605–609
                                                        Complications
                                                        Procedural Failu
Advanced Guiding Catheter Technologies
  Asahi Eaucath
 7.5 Fr Sheathless Hydrophilic Guiding Catheter
 Smaller outer diameter < 6Fr sheath, Inner diameter > 7 Fr guide




    Catheter external diameter: 2.49mm (5.5 Fr)
    6F Sheath external diameter: 2.62 mm

Mamas MA et al, CCI 2008;72:357–364; Liang et al. CCI 2010;75:222-224
Advanced Guiding Catheter Technologies
  Asahi Eaucath




Liang et al. CCI 2010;75:222-224
Inverse of Can’t
Demystifying Complex TR PCI

 •      Can’t Achieve good guiding catheter support

 •      Can’t Perform complex PCI with 6 Fr guides

 •      Can’t Engage and perform bypass PCI

 •      Can’t Stent complex bifurcation disease

 •      Can’t Perform complex CTO PCI

 •      Can’t Perform ULM PCI
Inverse of Can’t
Existing Limitations and Opportunities of TR PCI

 •       Anatomy
     –      Left radial

     –      Operator experience
Inverse of Can’t
Existing Limitations and Opportunities of TR PCI

 •           Anatomy
 •           Equipment
     –         TR-specific guiding catheters
     –         Guideliner
     –         6 Fr Guiding Catheter*
         •          2 simultaneous stents or 3 simultaneous balloons
         •          Certain brand PTCA balloons with stent
         •          IVUS and support catheter (eg, Finecross, Tornus)
         •          Balloon and 2.6 Fr Tornus
         •          Rotational atherectomy burr >1.75 mm
     *Note: Increasing sheath/guide size consistently an independent risk factor for vascular and
                                       bleeding complications
Is There a Learning Curve to Transradial Catheterization?


                                                  1.0             28 Operators, 1,672 TR PCIs
               Odds Ratio of Procedural Failure




                                                                        — Odds of procedural failure decreased 32% for every
                                                  0.75                  50 cases
                                                                        — Contrast volume, fluoroscopy time highest among
                                                                        low volume operators
                                                  0.50
                                                                        — Minimum 50 cases required to achieve outcomes
                                                                        similar to high volume operators
                                                  0.25



                                                    0

                                                         0   50      100     150    200         250   300
                                                                   PCI Volume/Operator

Ball et al. Circulation Cardiovasc Intervent 2011
Inverse of Can’t
Existing Limitations and Opportunities of TR PCI


 •       Anatomy

 •       Equipment

 •       Experience

       Complex PCI is achievable by TR vascular access without
         compromising procedural success or late outcomes

 As with all PCI procedures, operator experience will be the greatest
     determinant of procedural outcome as patient and lesion
                        complexity increases!

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Kandzari DE 201110

  • 1. The Inverse of Can’t Transradial Bifurcation Coronary Intervention David E. Kandzari, MD, FACC, FSCAI Chief Scientific Officer Director, Interventional Cardiology Piedmont Heart Institute Atlanta, Georgia david.kandzari@piedmont.org
  • 2. Disclosure Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below Affiliation/Financial Relationship Company Grant/Research Support Abbott Vascular, Cordis Corporation, Medtronic CardioVascular Consulting Fees/Honoraria Abbott Vascular, Cordis Corporation, Medtronic CardioVascular, Micell Technologies, Terumo Medical Major Stock Shareholder/Equity None Royalty Income None Ownership/Founder None Intellectual Property Rights None Other Financial Benefit None
  • 3. Science and Art of Transradial Coronary Intervention for Bifurcation Disease — What are existing barriers– or opportunities– to advancement of TR bifurcation PCI? — Can and how is complex PCI be performed by a transradial approach? — How does evidence inform existing limitations and challenges of bifurcation TR PCI?
  • 4. Frequency of Crossover to 2 Stents in Bifurcation PCI 40.0% C ros s ov er from 1 s tent to 2 s tents Ang iog raphic S B res tenos is 35.0% 31.0% 30.0% 25.0% 19.2% 18.8% 20.0% TVF due to SB 14.7% restenosis 2.8% 15.0% (no angio f-up) 9.4% 10.0% NA 4.3% 5.0% 2.8% 0.0% NO R D IC BBK C AC T US B B C O NE Steigen TK et al. Circulation. 2006;114:1955-1961 Ferenc M et al. Eur Heart J 2008; 29: 2859–2867 Colombo A et al. Circulation. 2009;119:71–78 Hildick-Smith D et al. Circulation. 2010;121:1235-1243
  • 5. Inverse of Can’t Demystifying Complex TR PCI Performed with 6 Fr Guide Cannot Be Performed Provisional Single Stent Crush and Mini-Crush T- and modified T V-stent T and Protrusion (TAP) Simultaneous Kissing Stents (SKS) Step crush Culotte Reverse Crush
  • 6. Device Compatibility Considerations 1. RX notch diameter 2. Distal shaft diameter* 3. Mid balloon crimped diameter and nominal size* 4. Compliant vs non-compliant balloon 5. Shaft coating *Assumes PTCA catheter only, without stent
  • 7. Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters Rx Notch Distal Shaft Sprinter Legend 0.036 0.034 Apex 0.036 0.031 Trek 0.033 0.030 NC Trek 0.035 0.031 Xience V/Promus 0.045 0.041
  • 8. Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters Rx Notch Distal Shaft Sprinter Legend 0.036 0.034 Apex 0.036 0.031 Trek 0.033 0.030 NC Trek 0.035 0.031 Xience V/Promus 0.045 0.041
  • 9. Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters Rx Notch Distal Shaft Sprinter Legend 0.036 0.034 Apex 0.036 0.031 Trek 0.033 0.030 NC Trek 0.035 0.031 Xience V/Promus 0.045 0.032
  • 10. Equipment Limitations for 6 Fr (0.071” ID) Guiding Catheters Rx Notch Distal Shaft Mid Balloon Size Sprinter Legend 0.036 0.034 Apex 0.036 0.031 1. The math doesn’t add up 3.0: 0.032 2. Deliver stent first, then balloon Trek 0.033 0.030 3.5: 4.0: 3. Caution for stressing system (eg, nondeflate, fracture etc.) 3.0: 0.034 NC Trek 0.035 0.031 3.5: 4.0: Xience V/Promus 0.045 0.032 0.041* *Crimp profile
  • 11. Provisional or Bail-Out Stent Technique Options when a 2nd stent is required • General rule: Avoid bail-out stenting. If you suspect you will need 2 stents, start with a planned 2-stent strategy. But if you need a bail-out stent: • T-provisional: When you are confident to obtain perfect positioning of the SB stent (i.e. a near 90 angle) • Culotte or Internal crush: When both branches are of near equal size and the angle is narrow 1. Elective T-stenting 2. Internal (reverse) crush) • TAP or Internal crush: When SB is smaller 3. Culotte than MB and the angle is narrow 4. TAP Louvard Y. Cather Cardiovasc Interv 2008
  • 12. T Stenting (Planned or Provisional) 1 1: Wire both branches and pre-dilate if needed 2 2: Stent the MB leaving a wire in the SB. The stent in the MB can be deployed at high pressure.
  • 13. T Stenting (Planned or Provisional) 3 3: Rewire the SB passing through the struts of the MB stent, remove the jailed wire and dilate toward the SB 4 4: Advance stent into the SB with no For a planned 2 stent MB protrusion and deploy the stent technique, or if the (TAP technique – leave some result is suboptimal protrusion). Option: position a (provisional): balloon in the MB to facilitate re- crossing.
  • 14. T Stenting (Planned or Provisional) 5 5: Perform final kissing inflation, ideally with 2 non-compliant balloons.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20. Sidebranch Re-Access Courtesy of Corrado Tamburino
  • 21.
  • 22.
  • 23.
  • 24. Transradial vs Transfemoral Left Main PCI Procedural and Clinical Complications Transradial Transfemoral P value N=353 N=468 Procedural and In-Hospital Outcomes Procedural success (%) 97% 96% 0.57 MACE 4.0% 3.2% 0.57 TIMI Major Bleeding 0.6% 2.8% 0.02 Hospital stay (days) 8.5±5.9 9.9±5.9 0.001 Late Clinical Outcomes (Mean 17 mos) Cardiac Death 1.4% 1.7% 0.74 Non-fatal MI 4.0% 2.6% 0.26 LM specific TLR 5.7% 5.8% 0.95 MACE 10.2% 9.2% 0.63 Yang, Kandzari et al., JACC Interv 2009
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31. Culotte Stenting Culotte Technique 1 1: Wire both branches and pre-dilate if needed 2 2: Remove or leave the wire in the more straight branch (MB) and deploy a stent in the more angulated branch (SB)
  • 32. Culotte Stenting Culotte Technique 3 3: Remove the wire from the stented branch and cross with a wire and balloon into the unstented branch (MB) and dilate. 4 4: Place a second stent into the unstented branch (MB) and expand the stent leaving some proximal overlap
  • 33. Culotte Stenting Culotte Technique 4 5: Cross the first stent (SB) with a wire and perform kissing balloon inflation.
  • 34. Culotte Technique Case Example Culotte Stenting: Pre Pre-dilatation, followed by 3.5 mm DES in LCX Courtesy of Fajadet J.
  • 35. Culotte Technique Case Example Culotte Stenting: 3.5 mm DES in the LAD Final kiss Final result Courtesy of Fajadet J.
  • 36.
  • 37.
  • 38. • CTO crossing with Fielder XT wire • Predilate with 2.5 mm balloon
  • 39. • 3.0 X 30 mm DES
  • 40. • LCx ⎯Predilate with 2.5X15 ⎯2.5X18 DES ⎯Post-dilate with 2.75X15 • Ramus ⎯Direct stent with 3.0X15 DES ⎯2.5X15 PTCA backstop
  • 41. • Ramus ⎯Direct stent with 3.0X15 DES ⎯3.0X15 PTCA backstop
  • 42. • Ramus ⎯ Direct stent with 3.0X15 DES ⎯ 2.5X15 balloon backstop
  • 45. • LCx/Ramus/LM ⎯ Kissing non-compliant balloon post-dilation
  • 46. • LAD/LM/Ramus ⎯ Kissing non-compliant balloon post-dilation
  • 47. • Final IVUS all three segments
  • 49. Guide Catheter Size for TR PCI: Smaller, Bigger…Better? Accessability 3, 4 and 5 Fr Guiding Catheters Mizuno et al. CCI 2010;75:985-988 Takeshita et al. CCI 2010;75:735-739 Mizuno et al. CCI 2010;75:985-988 Hamon et al. CCI 2002:55;340-343 7 Fr and 8 Fr Guiding Catheters Gioia G, et al. CCI 2000;51:234 –238 Wu SS, et al. J Invasive Cardiol 2000;12:605–609 Complications Procedural Failu
  • 50. Advanced Guiding Catheter Technologies Asahi Eaucath 7.5 Fr Sheathless Hydrophilic Guiding Catheter Smaller outer diameter < 6Fr sheath, Inner diameter > 7 Fr guide Catheter external diameter: 2.49mm (5.5 Fr) 6F Sheath external diameter: 2.62 mm Mamas MA et al, CCI 2008;72:357–364; Liang et al. CCI 2010;75:222-224
  • 51. Advanced Guiding Catheter Technologies Asahi Eaucath Liang et al. CCI 2010;75:222-224
  • 52. Inverse of Can’t Demystifying Complex TR PCI • Can’t Achieve good guiding catheter support • Can’t Perform complex PCI with 6 Fr guides • Can’t Engage and perform bypass PCI • Can’t Stent complex bifurcation disease • Can’t Perform complex CTO PCI • Can’t Perform ULM PCI
  • 53. Inverse of Can’t Existing Limitations and Opportunities of TR PCI • Anatomy – Left radial – Operator experience
  • 54. Inverse of Can’t Existing Limitations and Opportunities of TR PCI • Anatomy • Equipment – TR-specific guiding catheters – Guideliner – 6 Fr Guiding Catheter* • 2 simultaneous stents or 3 simultaneous balloons • Certain brand PTCA balloons with stent • IVUS and support catheter (eg, Finecross, Tornus) • Balloon and 2.6 Fr Tornus • Rotational atherectomy burr >1.75 mm *Note: Increasing sheath/guide size consistently an independent risk factor for vascular and bleeding complications
  • 55. Is There a Learning Curve to Transradial Catheterization? 1.0 28 Operators, 1,672 TR PCIs Odds Ratio of Procedural Failure — Odds of procedural failure decreased 32% for every 0.75 50 cases — Contrast volume, fluoroscopy time highest among low volume operators 0.50 — Minimum 50 cases required to achieve outcomes similar to high volume operators 0.25 0 0 50 100 150 200 250 300 PCI Volume/Operator Ball et al. Circulation Cardiovasc Intervent 2011
  • 56. Inverse of Can’t Existing Limitations and Opportunities of TR PCI • Anatomy • Equipment • Experience Complex PCI is achievable by TR vascular access without compromising procedural success or late outcomes As with all PCI procedures, operator experience will be the greatest determinant of procedural outcome as patient and lesion complexity increases!