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Single Center Experience With
  Trans-Radial Approach for
         Primary PCI
 Aharon Frimerman, Simcha Meisel,
  Michael Shochat, Rinat Malka, Avi
                Shotan
 Hillel Yaffe Medical Center, Hadera,
                 Israel
What is the rationale for
trans- radial approach in
      primary PCI?
Typical scenario at the ICCU
after trans-femoral approach
Not very rare outcome after
             trans-femoral approach

• Hematoma
• Retro-
peritoneal
bleeding
• Pseudo-
aneurysm
• Fistula
Trans-Radial approach
setup at the Cath Lab
The radial sheath is pulled-out at the Cath
Lab immediately at the end of the procedure
both diagnostic or therapeutic




                            Radial Sheath
The patient is mobile and can
leave the Cath Lab walking
Radial entry site several hours
after the end of the procedure
Radial VS Femoral approach
           MACE




Agostoni P Et Al:Radial versus femoral approach for percutaneous coronary
diagnostic and interventional procedures; Systematic overview and meta-analysis
of randomized trials.J Am Coll Cardiol. 2004 Jul 21;44(2):349-56.
Radial VS Femoral approach
   Entry site complications




Agostoni P Et Al:Radial versus femoral approach for percutaneous coronary
diagnostic and interventional procedures; Systematic overview and meta-
analysis of randomized trials.J Am Coll Cardiol. 2004 Jul 21;44(2):349-56.
PRIMARY PCI, is a Bleeding
       Prone Scenario
Anti aggregation therapy during PPCI:
Aspirin, Plavix, Prasogrel, Anti 2b3a
(ReoPro, Integrilin, Aggrastat).
• Anti coagulation therapy during PPCI:
Heparin, Clexane, Bivalirudin,
• Sometimes thrombolytic therapy on board!
• Sometimes the patient is on Coumadin
Mortality closely tied to major
                   bleeds at primary PCI
    HORIZONS-AMI (9/08): >3600 patients getting PCI for acute ST-segment-
      elevation MI (STEMI) randomized to get bivalirudin or unfractionated
                       heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor

  Hazard ratiosa (HR) for primary-end point components as
        predictors of 30-day mortality in HORIZONS-AMI
                                      multivariate analysis
                                                                                          Major non-CABG-related bleeding
End point          	
           HR (95% CI)        	
            p   	
                      as well as reinfarction were both
                                                                                          significant predictors of 30-day all-
Reinfarction                  	
   9.13 (2.62-31.85)	
   <0.001	
                                  cause mortality in the trial,
Stroke   	
                     2.65 (0.74-9.43)          	
     0.13       	
              independent of baseline features
                                                                                               and all other clinical events. A
Ischemia-                       1.15 (0.31-4.20)          	
     0.83       	
             major bleeding event, on its own,
driven TVR             	
                                                                 raised the mortality risk by a factor
                                                                                           of up to five (p<0.001), depending
Major                           5.08 (3.10-8.35)          	
     <0.001            	
                          on the analysis.
bleedingb       	
  
Mortality closely tied to major
               bleeds at primary PCI
                     Pooled analysis from three major bivalirudin trials—
                     REPLACE-2, ACUITY, and HORIZONS: PCI during
                                   ACS-STEMI (from the last four years)

          Independent hazard ratio of non-CABG-related major
        bleeding and MI within 30 days on mortality within one
                                                          year

Event       	
                Hazard ratio                                    	
   	
  
                                                          Deaths within 1 y, n p
                              (95% CI)   	
  
Non-CABG                      3.1 (2.4-3.9)     	
        104      	
          <0.001     	
  
major bleed            	
  
MI   	
                       2.8 (2.2-3.6)        	
     77	
                 <0.001     	
  
                   Data presented at the European Society of Cardiology 9/09 Congress-Barcelona
Studies of the Impact of Blood Transfusion on Mortality After PCI
                                                                                       Impact of
                                                                                       Transfusion on
                                                                     Frequency of      Mortality [95%
                                       Patient           STEMI       Blood             Confidence
    Author (Ref. #)     Patients (n)   Population        Included?   Transfusion (%)   Interval]          p Value




    Jani et al. (12)    4,623          Anemic patients   Yes         22.3              In-hospital,       <0.0001
                                       with MI                                         adjusted OR:
                                                                                       2.02 [1.47–
                                                                                       2.79]
    Doyle et al. (6)    17,901         Unselected        Yes         6.8               30 days, 1–2 U     <0.0001
                                                                                       adjusted HR:
                                                                                       8.9 [6.3–12.6]
                                                                                       3+ U adjusted      <0.0001
                                                                                       HR: 18.1 [13.7–
                                                                                       24]
    Kinnaird et al.     10,974         Unselected        Yes         5.4               1 year, OR per     <0.0001
    (1)                                                                                unit transfused:
                                                                                       1.47 [1.36–
                                                                                       1.55]
    Kim et al. (5)*     567*           Severe bleeding   Yes         25.7              1 year, RR: 2.03   0.0028
    Chase et al. (13)   38,872         Unselected        Yes         3.5               30-day adjusted    <0.0001
                                                                                       OR: 4.01 [3.08–
                                                                                       5.22]
Doyle, B. J. et al. J Am Coll Cardiol 2009;53:2019-2027                                1-year adjusted    <0.0001
                                                                                       OR: 3.58 [2.94–
                                                                                       4.36]
Possible Mechanisms Linking Post-Percutaneous Coronary Intervention Bleeding With
                               Increased Mortality




                                                                                     In 85% of cases!!!




                  Doyle, B. J. et al. J Am Coll Cardiol 2009;53:2019-2027


                                        Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.
The Hillel Yaffe Medical
 Center Experience with
Trans-Radial Approach for
       Primary PCI
Trans-Radial Approach for
              Primary PCI

Methods: More than 90% of the procedures in our
Cath Lab are done as trans-radial approach. Since
January 2007 we adopted the radial approach for all
new patients with STEMI referred to primary PCI.
Patients with weak radial pulse, severe
dysrhythmias, CHF or hypotension were excluded.
We used published world data on primary PCI for
time table, fluoroscopy time and contrast volume
reference.
Trans-Radial Approach for
            Primary PCI

Results: 98 STEMI patients, 88 males, 10
females, mean age 58±12 years, underwent
primary PCI/TRA as a routine procedure (right
radial all).
IRA were: LAD: 42, LCX: 15, RCA: 41.
Full patency restoration of the IRA was achieved
in 100% of the patients.
Trans-Radial Approach for
             Primary PCI
 In 32 cases we used thrombus aspiration
devices.
 In 5 patients a bifurcation PCI with kissing
balloon was performed successfully.
 Ten patients had slow reflow phenomenon
resolved after IC Adenosine injection.
 In 4 cases IABP was inserted trough the
femoral artery due to low blood pressure
and slow reflow.
Trans-Radial Approach for
            Primary PCI
There were no major bleeding, pseudo-aneurysm
or fistula. There was no need for blood transfusion
In one case (treated by Integrilin Heparin and
Plavix) there was a large hematoma in groin (IABP
insertion site) and small one in the forearm. There
were 5 more cases with minor hematoma in the
forearm.
There was no cerebral ischemic event.
Time Table, Fluoroscopy time,
                  Contrast volume
                       World data                     Our experience in PCI/
                                                      TRA
Symptom onset          Median 218 min                 90-840 (median 267)
to Balloon                                            min

Hospital door to       83-120 (median 116)            45-180 (median 72) min
Balloon                min

Cath Lab door to       20-53 min                      20-35 (median 27) min
Balloon
Fluoroscopy time 18.3 ± 12.2 min                      8±5 min

Contrast volume        265±130 ml                     161±63 ml


   PCI/TRA: Primary PCI using trans-radial approach
Trans-Radial Approach for
            Primary PCI

Conclusions: Following a meticulous
learning curve, the trans-radial approach
can be applied for primary PCI with high
success rate, short door to balloon
interval, and low complication rate. This
approach improves patient’s convenience
and well being.
Trans-Radial Approach for
            Primary PCI
The very low bleeding and vascular
complication rate increases the safety margin
for this procedure that involves intense use of
anti-coagulation/aggregation medications and
can improves long term survival.

We are now in a process of assessing the
long term outcome of these patients.
Thank You

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Frimerman A

  • 1. Single Center Experience With Trans-Radial Approach for Primary PCI Aharon Frimerman, Simcha Meisel, Michael Shochat, Rinat Malka, Avi Shotan Hillel Yaffe Medical Center, Hadera, Israel
  • 2. What is the rationale for trans- radial approach in primary PCI?
  • 3. Typical scenario at the ICCU after trans-femoral approach
  • 4. Not very rare outcome after trans-femoral approach • Hematoma • Retro- peritoneal bleeding • Pseudo- aneurysm • Fistula
  • 6. The radial sheath is pulled-out at the Cath Lab immediately at the end of the procedure both diagnostic or therapeutic Radial Sheath
  • 7. The patient is mobile and can leave the Cath Lab walking
  • 8. Radial entry site several hours after the end of the procedure
  • 9. Radial VS Femoral approach MACE Agostoni P Et Al:Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials.J Am Coll Cardiol. 2004 Jul 21;44(2):349-56.
  • 10. Radial VS Femoral approach Entry site complications Agostoni P Et Al:Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta- analysis of randomized trials.J Am Coll Cardiol. 2004 Jul 21;44(2):349-56.
  • 11. PRIMARY PCI, is a Bleeding Prone Scenario Anti aggregation therapy during PPCI: Aspirin, Plavix, Prasogrel, Anti 2b3a (ReoPro, Integrilin, Aggrastat). • Anti coagulation therapy during PPCI: Heparin, Clexane, Bivalirudin, • Sometimes thrombolytic therapy on board! • Sometimes the patient is on Coumadin
  • 12. Mortality closely tied to major bleeds at primary PCI HORIZONS-AMI (9/08): >3600 patients getting PCI for acute ST-segment- elevation MI (STEMI) randomized to get bivalirudin or unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor Hazard ratiosa (HR) for primary-end point components as predictors of 30-day mortality in HORIZONS-AMI multivariate analysis Major non-CABG-related bleeding End point   HR (95% CI)   p   as well as reinfarction were both significant predictors of 30-day all- Reinfarction   9.13 (2.62-31.85)   <0.001   cause mortality in the trial, Stroke   2.65 (0.74-9.43)   0.13   independent of baseline features and all other clinical events. A Ischemia- 1.15 (0.31-4.20)   0.83   major bleeding event, on its own, driven TVR   raised the mortality risk by a factor of up to five (p<0.001), depending Major 5.08 (3.10-8.35)   <0.001   on the analysis. bleedingb  
  • 13. Mortality closely tied to major bleeds at primary PCI Pooled analysis from three major bivalirudin trials— REPLACE-2, ACUITY, and HORIZONS: PCI during ACS-STEMI (from the last four years) Independent hazard ratio of non-CABG-related major bleeding and MI within 30 days on mortality within one year Event   Hazard ratio     Deaths within 1 y, n p (95% CI)   Non-CABG 3.1 (2.4-3.9)   104   <0.001   major bleed   MI   2.8 (2.2-3.6)   77   <0.001   Data presented at the European Society of Cardiology 9/09 Congress-Barcelona
  • 14. Studies of the Impact of Blood Transfusion on Mortality After PCI Impact of Transfusion on Frequency of Mortality [95% Patient STEMI Blood Confidence Author (Ref. #) Patients (n) Population Included? Transfusion (%) Interval] p Value Jani et al. (12) 4,623 Anemic patients Yes 22.3 In-hospital, <0.0001 with MI adjusted OR: 2.02 [1.47– 2.79] Doyle et al. (6) 17,901 Unselected Yes 6.8 30 days, 1–2 U <0.0001 adjusted HR: 8.9 [6.3–12.6] 3+ U adjusted <0.0001 HR: 18.1 [13.7– 24] Kinnaird et al. 10,974 Unselected Yes 5.4 1 year, OR per <0.0001 (1) unit transfused: 1.47 [1.36– 1.55] Kim et al. (5)* 567* Severe bleeding Yes 25.7 1 year, RR: 2.03 0.0028 Chase et al. (13) 38,872 Unselected Yes 3.5 30-day adjusted <0.0001 OR: 4.01 [3.08– 5.22] Doyle, B. J. et al. J Am Coll Cardiol 2009;53:2019-2027 1-year adjusted <0.0001 OR: 3.58 [2.94– 4.36]
  • 15. Possible Mechanisms Linking Post-Percutaneous Coronary Intervention Bleeding With Increased Mortality In 85% of cases!!! Doyle, B. J. et al. J Am Coll Cardiol 2009;53:2019-2027 Copyright ©2009 American College of Cardiology Foundation. Restrictions may apply.
  • 16. The Hillel Yaffe Medical Center Experience with Trans-Radial Approach for Primary PCI
  • 17. Trans-Radial Approach for Primary PCI Methods: More than 90% of the procedures in our Cath Lab are done as trans-radial approach. Since January 2007 we adopted the radial approach for all new patients with STEMI referred to primary PCI. Patients with weak radial pulse, severe dysrhythmias, CHF or hypotension were excluded. We used published world data on primary PCI for time table, fluoroscopy time and contrast volume reference.
  • 18. Trans-Radial Approach for Primary PCI Results: 98 STEMI patients, 88 males, 10 females, mean age 58±12 years, underwent primary PCI/TRA as a routine procedure (right radial all). IRA were: LAD: 42, LCX: 15, RCA: 41. Full patency restoration of the IRA was achieved in 100% of the patients.
  • 19. Trans-Radial Approach for Primary PCI In 32 cases we used thrombus aspiration devices. In 5 patients a bifurcation PCI with kissing balloon was performed successfully. Ten patients had slow reflow phenomenon resolved after IC Adenosine injection. In 4 cases IABP was inserted trough the femoral artery due to low blood pressure and slow reflow.
  • 20. Trans-Radial Approach for Primary PCI There were no major bleeding, pseudo-aneurysm or fistula. There was no need for blood transfusion In one case (treated by Integrilin Heparin and Plavix) there was a large hematoma in groin (IABP insertion site) and small one in the forearm. There were 5 more cases with minor hematoma in the forearm. There was no cerebral ischemic event.
  • 21. Time Table, Fluoroscopy time, Contrast volume World data Our experience in PCI/ TRA Symptom onset Median 218 min 90-840 (median 267) to Balloon min Hospital door to 83-120 (median 116) 45-180 (median 72) min Balloon min Cath Lab door to 20-53 min 20-35 (median 27) min Balloon Fluoroscopy time 18.3 ± 12.2 min 8±5 min Contrast volume 265±130 ml 161±63 ml PCI/TRA: Primary PCI using trans-radial approach
  • 22. Trans-Radial Approach for Primary PCI Conclusions: Following a meticulous learning curve, the trans-radial approach can be applied for primary PCI with high success rate, short door to balloon interval, and low complication rate. This approach improves patient’s convenience and well being.
  • 23. Trans-Radial Approach for Primary PCI The very low bleeding and vascular complication rate increases the safety margin for this procedure that involves intense use of anti-coagulation/aggregation medications and can improves long term survival. We are now in a process of assessing the long term outcome of these patients.