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Building a Successful TRI
     STEMI Program
      Christopher Pyne M.D.
    Lahey Clinic Medical Center
     Burlington, Massachusetts
               U.S.A.
Disclosure
• Modest consulting arrangement with
  Terumo
Fundamentals of TRI in STEMI
• Reduction in vascular
  complications and
  mortality
• Increase in procedure
  failures – heavily
  dependent on volume
• Volume requirements
  for a default STEMI
  program are unknown.
Impact of TRI on Death in RIVAL
              n=       Radial     Femoral                     P=
                       Death       Death
STEMI        1958       1.3           3.2                    .026

ALL          7021       1.3           1.5                       .5


• STEMI death and overall MACE were
  significantly reduced in the radial arm, despite
  no significant reduction in major bleeding.

                                 Jolly: Lancet DOI 10.1016; April 2011
TRI will reduce Transfusion rates in STEMI

   Radial          Radial n = 220
   Femoral
                   Femoral n= 856
                                                Etiology         Umber of patients
                                                                 with transfusions
           10
            9                              CABG                         11
            8
            7                              IABP/VAD                      5
  Percent
            6                              GI Bleed                      1
 Patients   5
Transfused
            4                              Other                         3
            3
            2
            1
            0
   Non CABG Transfusion rates for STEMI    Etiologies of RBC Transfusion in Radial
   Patients @ Lahey Clinic over 4 years.               STEMI patients

                                                            Kahan AHA 2010
Potential Disadvantages of TRI in
                STEMI
• Increase procedural
  failure and crossover
  to the femoral
  approach
• Potential for D2B
  delays
• Need for large vessel
  support
TRI in STEMI questions:
• Are there
  procedural volume
  prior to default
  STEMI therapy with
  TRI

• Are there time limits
  at which the
  approach should be
  abandoned?
Selected TRI STEMI D2B and Crossover data

           Study       Patients   Crossover to    Reperfusion
                     randomized     femoral         times
Brasselet et al         114           12%         Not reported
Heart 2007


Rival                  7021           7.6%        No D2B times
Lancet 2011
                                                    Procedure
                                                 times the same
Cantor et al            50             4%        TRI 6 minutes
AHJ 2005
                                                    slower
Chotor et al            240             0%       TRI 11 minutes
Cardiol Journ 2009                                   slower
Decisions on Transitioning to
     Primary PCI are volume related




Likely anywhere form 50 – 100 successful non-STEMI Radial PCI should be
       completed prior to considering a default radial STEMI program.

                                     Ball et al: Circ Cardio Interv 2011;4:336-341
Impact of Learning Curve on STEMI
Re-Perfusion Times in a Single Center

                                                          Early Radial:
                                                           Pre - 2008




                                                          Late Radial:
                                                          2008 - 09




 Conversion to default approach after several years of TRI experience.

 With experience – TRI times comparable to femoral times

                                            Frelich SCAI Scientific sessions: 2009
Institutional Volume and Crossover Rates
                  in RIVAL
     Center        Median                Crossover
     Volume     Operator Case              Rate
                   Volume
       Low           < 60                     8.8%

     Medium        60 - 142                   9.7%

      High          > 142                     4.4%

   Overall Femoral crossover rate of 2.0 %
                            Jolly: Lancet DOI 10.1016; April 2011
You Can Learn LRA Faster




     LRA Fluoro. times                    RFRA Fluoro. times

• TALENT investigators compared trainees and
  experienced operators for fluoroscopy times .
• Divided trainees into volume stages and compared Left
  vs. Right
• Fellows equaled attendings @ 300 cases on the left –
  did not equal them on the right
                           Schiahbasi A: Am Journ of Cardiol 2011;108:185-188
Etiologies of failure in operators
                learning TRI
        Cause           0 -50   51-100   101 -150       151 – 300          Control
                        cases   cases     cases           cases
Spasm                    15       5         1                 1                4
Subclavian Tortuosity    7        0         2                 1                1
Poor guide support       8        1         2                 0                0
Failed puncture          6        1         0                 0                0

Radial Loop              4        1         0                 0                0



        Roughly 40 % of TRI failures for new operators
                     are side specific.

                                            Ball et al: Circ Cardio Interv 2011;4:336-341
Left approach yields high success
in STEMI – in high risk failure pts.
                Left (50) Right (85)           P=
 Age (yrs.)      69.7         60            <.001
 % Female         40          20               .01
 Height (cm.)    169         173               .02
 Crossover         0          1.2              .45
 rate
 RTB (Min.)       31          30               .73

                          Larsen: CCI DOI 10.1002/22843: 2011
“Rough” STEMI approach @
         Lahey:




                  Larsen ACC 2010
TRI in Shock




65 y.o. , 340 lbs, ASMI, borderline
      hemo-dynamics, Cr. 4
Impella assisted TRI cont.




               Bell et al, CCI: DOI 10.1002: 2011
“Physicians can approach high risk and hemodynamically unstable patients through
the radial approach confident that lower extremity support devices can quickly be
employed if felt necessary to patient management.
                                              Bell et al, CCI: DOI 10.1002: 2011
Evolution to Default STEMI at Lahey:




• Long lag time of single operator low risk program

• Marked ramp – up of STEMI with new operators.
                                 Waxman and Iqtidar: SCAI 2011
TRI Success and time conclusions:
• Early operators will
  see high crossover
  rates and D2B delays
• Improved operator
  and lab experience
  will generate
  competitive quality
  metrics.
                         Single Center STEMI D2B times: TRI vs. Femoral.



                                      Pancholy CCI 75:991-995 (2010)
Case Presentation
• 58 yo male – presents with IMI
• Stable hemo-dynamics
• S/P CABG – 11 years ago
  – LIMA to LAD
  – SVG to D1
  – SVG to OM
  – RCA not grafted – Rx with DES 4 years prior
• Left radial approach selected
Native Vessels
2Patent Grafts
Closed OM - SVG
• Ongoing ST changes
  with pain

• No realistic chance
  @ acute native CTO

• Plan:
  – Thrombectomy
  – Stenting
  – Heavy anticoag/anti-
    platet
SVG PCI
Embolic protection with 2B – 3A
      receptor blockade
Final Result

• Sheaths out
• No bleeding or T-
  fusion:
  – ACT > 350
  – 24 hours of 2B/3A
  – Prasugrel


• Uneventful course
TRI in STEMI Conclusions:
• Use of TRI in STEMI can improve
  outcomes
• TRI can reduce bleeding
• TRI will have higher procedural failures,
  but these will improve with operator
  experience
• All types of MI can be performed – shock
  is not an absolute contra-indication.
TRI in STEMI Conclusions:
• Specific numbers for experience, failure
  rates, and perfusion delays to guide
  training do not exist.

• It is likely that mentoring and supportive
  environments will shorten the learning
  curve for individual operators

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Pyne C 201110

  • 1. Building a Successful TRI STEMI Program Christopher Pyne M.D. Lahey Clinic Medical Center Burlington, Massachusetts U.S.A.
  • 2. Disclosure • Modest consulting arrangement with Terumo
  • 3. Fundamentals of TRI in STEMI • Reduction in vascular complications and mortality • Increase in procedure failures – heavily dependent on volume • Volume requirements for a default STEMI program are unknown.
  • 4. Impact of TRI on Death in RIVAL n= Radial Femoral P= Death Death STEMI 1958 1.3 3.2 .026 ALL 7021 1.3 1.5 .5 • STEMI death and overall MACE were significantly reduced in the radial arm, despite no significant reduction in major bleeding. Jolly: Lancet DOI 10.1016; April 2011
  • 5. TRI will reduce Transfusion rates in STEMI Radial Radial n = 220 Femoral Femoral n= 856 Etiology Umber of patients with transfusions 10 9 CABG 11 8 7 IABP/VAD 5 Percent 6 GI Bleed 1 Patients 5 Transfused 4 Other 3 3 2 1 0 Non CABG Transfusion rates for STEMI Etiologies of RBC Transfusion in Radial Patients @ Lahey Clinic over 4 years. STEMI patients Kahan AHA 2010
  • 6. Potential Disadvantages of TRI in STEMI • Increase procedural failure and crossover to the femoral approach • Potential for D2B delays • Need for large vessel support
  • 7. TRI in STEMI questions: • Are there procedural volume prior to default STEMI therapy with TRI • Are there time limits at which the approach should be abandoned?
  • 8. Selected TRI STEMI D2B and Crossover data Study Patients Crossover to Reperfusion randomized femoral times Brasselet et al 114 12% Not reported Heart 2007 Rival 7021 7.6% No D2B times Lancet 2011 Procedure times the same Cantor et al 50 4% TRI 6 minutes AHJ 2005 slower Chotor et al 240 0% TRI 11 minutes Cardiol Journ 2009 slower
  • 9. Decisions on Transitioning to Primary PCI are volume related Likely anywhere form 50 – 100 successful non-STEMI Radial PCI should be completed prior to considering a default radial STEMI program. Ball et al: Circ Cardio Interv 2011;4:336-341
  • 10. Impact of Learning Curve on STEMI Re-Perfusion Times in a Single Center Early Radial: Pre - 2008 Late Radial: 2008 - 09 Conversion to default approach after several years of TRI experience. With experience – TRI times comparable to femoral times Frelich SCAI Scientific sessions: 2009
  • 11. Institutional Volume and Crossover Rates in RIVAL Center Median Crossover Volume Operator Case Rate Volume Low < 60 8.8% Medium 60 - 142 9.7% High > 142 4.4% Overall Femoral crossover rate of 2.0 % Jolly: Lancet DOI 10.1016; April 2011
  • 12. You Can Learn LRA Faster LRA Fluoro. times RFRA Fluoro. times • TALENT investigators compared trainees and experienced operators for fluoroscopy times . • Divided trainees into volume stages and compared Left vs. Right • Fellows equaled attendings @ 300 cases on the left – did not equal them on the right Schiahbasi A: Am Journ of Cardiol 2011;108:185-188
  • 13. Etiologies of failure in operators learning TRI Cause 0 -50 51-100 101 -150 151 – 300 Control cases cases cases cases Spasm 15 5 1 1 4 Subclavian Tortuosity 7 0 2 1 1 Poor guide support 8 1 2 0 0 Failed puncture 6 1 0 0 0 Radial Loop 4 1 0 0 0 Roughly 40 % of TRI failures for new operators are side specific. Ball et al: Circ Cardio Interv 2011;4:336-341
  • 14. Left approach yields high success in STEMI – in high risk failure pts. Left (50) Right (85) P= Age (yrs.) 69.7 60 <.001 % Female 40 20 .01 Height (cm.) 169 173 .02 Crossover 0 1.2 .45 rate RTB (Min.) 31 30 .73 Larsen: CCI DOI 10.1002/22843: 2011
  • 15. “Rough” STEMI approach @ Lahey: Larsen ACC 2010
  • 16. TRI in Shock 65 y.o. , 340 lbs, ASMI, borderline hemo-dynamics, Cr. 4
  • 17. Impella assisted TRI cont. Bell et al, CCI: DOI 10.1002: 2011
  • 18. “Physicians can approach high risk and hemodynamically unstable patients through the radial approach confident that lower extremity support devices can quickly be employed if felt necessary to patient management. Bell et al, CCI: DOI 10.1002: 2011
  • 19. Evolution to Default STEMI at Lahey: • Long lag time of single operator low risk program • Marked ramp – up of STEMI with new operators. Waxman and Iqtidar: SCAI 2011
  • 20. TRI Success and time conclusions: • Early operators will see high crossover rates and D2B delays • Improved operator and lab experience will generate competitive quality metrics. Single Center STEMI D2B times: TRI vs. Femoral. Pancholy CCI 75:991-995 (2010)
  • 21. Case Presentation • 58 yo male – presents with IMI • Stable hemo-dynamics • S/P CABG – 11 years ago – LIMA to LAD – SVG to D1 – SVG to OM – RCA not grafted – Rx with DES 4 years prior • Left radial approach selected
  • 24. Closed OM - SVG • Ongoing ST changes with pain • No realistic chance @ acute native CTO • Plan: – Thrombectomy – Stenting – Heavy anticoag/anti- platet
  • 26. Embolic protection with 2B – 3A receptor blockade
  • 27. Final Result • Sheaths out • No bleeding or T- fusion: – ACT > 350 – 24 hours of 2B/3A – Prasugrel • Uneventful course
  • 28. TRI in STEMI Conclusions: • Use of TRI in STEMI can improve outcomes • TRI can reduce bleeding • TRI will have higher procedural failures, but these will improve with operator experience • All types of MI can be performed – shock is not an absolute contra-indication.
  • 29. TRI in STEMI Conclusions: • Specific numbers for experience, failure rates, and perfusion delays to guide training do not exist. • It is likely that mentoring and supportive environments will shorten the learning curve for individual operators