Radial Approach for PCI
Femoral Approach for LV Support
Mauricio G. Cohen, MD
Director, Cardiac Cath Lab
Associate Profess...
History	
  
—  75-­‐year-­‐old	
  gentleman	
  	
  
—  Hypertension	
  
—  Diabetes	
  
—  Non-­‐ST	
  elevation	
  my...
Cath	
  @	
  VA	
  –	
  July	
  10	
  
Cath	
  @	
  VA	
  –	
  July	
  10	
  
Pa6ent	
  is	
  transferred	
  to	
  UMH	
  
—  Hypotensive	
  –	
  somewhat	
  lethargic	
  
—  Sepsis	
  with	
  posit...
Percutaneous Support Devices

Desai N R , Bhatt D L Eur Heart J 2009;30:2073-2075
Comparison of Support Devices
IABP

TandemHeart

Impella

Catheter Size

7.5-9.0

21/17/15

9

Cannula Size

8.5-10

21/17...
Mostly Anecdotal Experience
Percutaneous Hemodynamic Support Devices
I IIa IIb III

I IIa IIb III

Elective insertion of an appropriate hemodynamic su...
Defining High Risk PCI à 2 Dimensions

< 19

EuroSCORE

0-2
3-6
>6

19-27

> 27

L

L

I

L

L

I

I

I

H

GRC = The Glo...
Low EF is Associated with Severe
Comorbidities and Poorer Outcomes
NHLBI Registry

N= 1458 Reported PCI cases

EF≤40%
(n=1...
High Risk PCI: Randomized Data
BCIS Study

PROTECT II Study

Extensive CAD (Jeopardy
Score ≥ 8)
and LVEF ≤ 30% (N=301)

Un...
BCIS Study:
Results Do Not Support Prophylactic Use of IABP
MACCE at Discharge
p=0.85
15.2% 	
  

16.0%	
  

N= 151 	
  

...
PROTECT II Study:
Reduction of Major Adverse Events in Favor of
IMPELLA Compared to IABP
MACCE Events
p=0.023
↓ 22% MAE

p...
Hemodynamic Support Effectiveness
Cardiac Power Output
(Secondary Endpoint)

Maximal Decrease in CPO on device Support fro...
PROTECT II: NYHA Improvement Post PCI
p<0.001
Class IV

58%
reduction
Class III

in Class III,IV

Class II

Class I

Basel...
When Should We Consider Support?
n  Unprotected LM/Last Patent Conduit
n  3 Vessel Disease

AND
n  Severe LV dysfunctio...
Spectrum of Risk
Clinical and Angiographic
STS score

SYNTAX
score

SYNTAX

BCIS
PROTECT II
CARDIOGENIC SHOCK
IABP Shock II Trial
790 Pts with AMI and
Cardiogenic Shock
600 randomized
IABP (n=301)

Control (n=299)

IABP = 288
No IAB...
Primary Endpoint: 30-day Mortality

Thiele H, et al. N Engl J Med 2012; 367:1287-1296
Hemodynamic Parameters: IABP vs.
“Other Devices”

Thiele:
TandemHeart
Burkhoff: TandemHeart
Seyfarth: Impella

Cheng J M e...
Outcome: Survival to Discharge Post PCI
Timing of Support Initiation
60.0%

Survival to Discharge
For ALL Patients
p=0.007...
ACCESS RELATED ISSUES
Outcomes at “Femoral” and “Radial”
Centers	


70% Transradial

22% Transradial

519 PCI/Hosp/year

657 PCI/Hosp/year

Adj ...
FAUST Trial: CFA Cannulation Success
n=1,015
p = 0.15

p = 0.11

Fluoroscopy	

Ultrasound	
33 (6.6)	

0.25	

CFA	

408 (83...
Procedural Outcomes
First Pass Success Rate

Number of Attempts
100%

5

90%

p < 0.000001

82.7%

80%

3

70%
60%

3

46....
Complications

Fluoroscopy

Ultrasound

N=501

N=503

Hematoma >5 cm*

11 (2.2%)

3 (0.6%)

0.034

Pseudoaneurysm

0

1

N...
Exit Strategy

O’Neill BP et al , et al. CCI 2013
Bleeding according to Pre-Closure use
20%

No Pre-Closure
Pre-Closure

15.1%

Patients (%)

15%

14.5%

11.3%
9.4%

10%

7...
Effect of Pre-Closure on Death, MI, and
Acute Vascular Injury
20%

Patients (%)

No-Preclosure
15%

Preclosure
p=0.08

10%...
Strategy	
  
Complex	
  transradial	
  bifurcation	
  PCI	
  
Percutaneous	
  LVAD	
  
Impella	
  2.5	
  
Remove	
  at	
  ...
Radial PCI + Femoral LV support
The Perfect Marriage
n  Transradial access associated with lower

vascular complication a...
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
Cohen MG - AIMRADIAL 2013 - Complex PCI
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Cohen MG - AIMRADIAL 2013 - Complex PCI

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Radial approach for PCI and femoral for LV support

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Transcript of "Cohen MG - AIMRADIAL 2013 - Complex PCI"

  1. 1. Radial Approach for PCI Femoral Approach for LV Support Mauricio G. Cohen, MD Director, Cardiac Cath Lab Associate Professor of Medicine
  2. 2. History   —  75-­‐year-­‐old  gentleman     —  Hypertension   —  Diabetes   —  Non-­‐ST  elevation  myocardial  infarction   —  Cathed  and  treated  with  an  IABP  for  48-­‐72  hs   —  Ejection  fraction  15%,  severe  anterior  hypokinesis   —  Severe  MR,  RVSP  52  mmHg   —  Viability  anterior  wall  
  3. 3. Cath  @  VA  –  July  10  
  4. 4. Cath  @  VA  –  July  10  
  5. 5. Pa6ent  is  transferred  to  UMH   —  Hypotensive  –  somewhat  lethargic   —  Sepsis  with  positive  blood  cultures   —  Severe  Anemia   —  Patient  is  Jehovah's  witness.   —  Refuses  blood  transfusions   Albumin:  3.6     Total  Bilirubin:  1.5  (H)     Alkaline  Phosphatase:  103     ALT:  717  (H)     AST:906  (H)   —  After  a  week  of  antibiotics  and  fluid  resuscitation  the   patient  goes  back  to  VA   127      89            38             5.3            25            2.4   130   26.2   8.2   25.0   180  
  6. 6. Percutaneous Support Devices Desai N R , Bhatt D L Eur Heart J 2009;30:2073-2075
  7. 7. Comparison of Support Devices IABP TandemHeart Impella Catheter Size 7.5-9.0 21/17/15 9 Cannula Size 8.5-10 21/17/15 12 1 + 2 ++/+++ 1 + No Yes No Limb ischemia + +++ + Priming volume No Yes No Unloads Directly LV No No Yes Requires stable rhythm Improve hemodynamics Yes + No +++ No ++/+++ # Insertion Sites Anticoagulation Transeptal
  8. 8. Mostly Anecdotal Experience
  9. 9. Percutaneous Hemodynamic Support Devices I IIa IIb III I IIa IIb III Elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients. A hemodynamic support device is recommended for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacologic therapy.
  10. 10. Defining High Risk PCI à 2 Dimensions < 19 EuroSCORE 0-2 3-6 >6 19-27 > 27 L L I L L I I I H GRC = The Global Risk Classification 96.1% 94.6% 90 80 78.1% P = 0.004* 70 LOW INTERMEDIATE HIGH 60 SYNTAX score 24 12 Time (months) 0 100 Cardiac death free survival (%) SYNTAX score Cardiac death free survival (%) 100 98.4% 90 84.0% 80 P < 0.001* 70 LOW INTERMEDIATE HIGH 60 0 * log rank test; n = 255 LM patients undergoing PCI Capodanno et al, Am Heart J 2010:159:103-9 12 Time (months) 68.6% GRC 24
  11. 11. Low EF is Associated with Severe Comorbidities and Poorer Outcomes NHLBI Registry N= 1458 Reported PCI cases EF≤40% (n=166) Age >65 yrs 54.5% Previous MI 70.3% Known Heart Failure 35.5% Multi-vessel disease 75.3% Any total occlusion 59.0% In-hospital Adverse Events Death 3.0% Death/MI 6.0% One-year Adverse Events Death 11.0% Death/MI 18.0% EF 41%-49% EF≥50% p-value (n=126) (n=866) 48.4% 60.0% 13.6% 65.9% 46.0% 42.8% 36.7% 5.1% 56.6% 28.6% 0.004 <0.001 <0.001 <0.001 <0.001 1.6% 5.6% 0.1% 2.9% <0.001 0.024 4.5% 9.6% 1.9% 6.9% <0.001 <0.001 Keelan and al , Am J Cardiol 2003; 91:1168-1172
  12. 12. High Risk PCI: Randomized Data BCIS Study PROTECT II Study Extensive CAD (Jeopardy Score ≥ 8) and LVEF ≤ 30% (N=301) Unprotected LM and LVEF≤ 35% Or 3 VD and LVEF ≤ 30% (N=448) R 1:1 R 1:1 Prophylactic Support: EQUIPOISE Prophylactic IABP Provisional IABP Prophylactic Support: REQUIRED IABP + PCI IMPELLA+ PCI MACCE @ Discharge 30 day Major Adverse Events 6 mo mortality F/U: 90 day Major Adverse Events
  13. 13. BCIS Study: Results Do Not Support Prophylactic Use of IABP MACCE at Discharge p=0.85 15.2%   16.0%   N= 151   N= 150   Elective IABP Not Planned IABP Perera et al. JAMA 2010 Aug 25;304(8):867-74
  14. 14. PROTECT II Study: Reduction of Major Adverse Events in Favor of IMPELLA Compared to IABP MACCE Events p=0.023 ↓ 22% MAE p=0.092 Death, Stroke, MI, Repeat revasc. IABP IMPELLA N=427, Log rank test, p=0.043 N=211 N=216 N=210 N=215 O’Neill W et al. Circulation 2012;126:1717-1727 MAE = Composite of 10 Major adverse events including Death, Stroke, MI, Repeat Revasc. MACCE= Death, Stroke, MI*, Repeat revasc. (*Stone et al, Circulation 2001;104:642-647 )
  15. 15. Hemodynamic Support Effectiveness Cardiac Power Output (Secondary Endpoint) Maximal Decrease in CPO on device Support from Baseline (in x0.01 Watts) IABP Impella N=138 N=141 - 4.2 ± 24 p=0.001 - 14.2 ± 27 CPO data available only for 279 patients (N=138 IABP and N=141 Impella) CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (Fincke R, Hochman J et al JACC 2004; 44:340-348)
  16. 16. PROTECT II: NYHA Improvement Post PCI p<0.001 Class IV 58% reduction Class III in Class III,IV Class II Class I Baseline 90 days NYHA Class Distribution N=223 patients with NHYA assessment available at baseline and 90 days
  17. 17. When Should We Consider Support? n  Unprotected LM/Last Patent Conduit n  3 Vessel Disease AND n  Severe LV dysfunction < 30-35% " support for ischemic stress and contrast load n  LV dysfunction with prospect of uncontrolled interruption of coronary flow " Difficult wiring " Difficult stent delivery " High risk of no reflow (i.e., SVGs, Roto)
  18. 18. Spectrum of Risk Clinical and Angiographic STS score SYNTAX score SYNTAX BCIS PROTECT II
  19. 19. CARDIOGENIC SHOCK
  20. 20. IABP Shock II Trial 790 Pts with AMI and Cardiogenic Shock 600 randomized IABP (n=301) Control (n=299) IABP = 288 No IABP = 13 No IABP = 269 IABP = 30 Primary PCI = 288 Primary CABG = 3 No Revasc = 8 Primary PCI = 287 Primary CABG = 3 No Revasc = 1 30-day Follow up Thiele H, et al. N Engl J Med 2012; 367:1287-1296
  21. 21. Primary Endpoint: 30-day Mortality Thiele H, et al. N Engl J Med 2012; 367:1287-1296
  22. 22. Hemodynamic Parameters: IABP vs. “Other Devices” Thiele: TandemHeart Burkhoff: TandemHeart Seyfarth: Impella Cheng J M et al. Eur Heart J 2009;30:2102-2108
  23. 23. Outcome: Survival to Discharge Post PCI Timing of Support Initiation 60.0% Survival to Discharge For ALL Patients p=0.007 64.6% 37.7% STEMI N=25 Pre-PCI N=61 Post-PCI Impella Support Initiation 69.6% 39.4% 50.0% NSTEMI N=48 Pre-PCI N=71 Post-PCI Impella Support Initiation N=23 Pre-PCI N=10 Post-PCI Impella Support Initiation
  24. 24. ACCESS RELATED ISSUES
  25. 25. Outcomes at “Femoral” and “Radial” Centers 70% Transradial 22% Transradial 519 PCI/Hosp/year 657 PCI/Hosp/year Adj Mortality of TFA in TRA hospital vs TFA hospital OR 0.86, 95% CI 0.76-0.99, p=0.032 Ratib, Routledge, Mamas, Ludman, Fraser and Nolan, AIM-Radial 2012
  26. 26. FAUST Trial: CFA Cannulation Success n=1,015 p = 0.15 p = 0.11 Fluoroscopy Ultrasound 33 (6.6) 0.25 CFA 408 (83.3) 431 (86.4) 0.15 Low stick 58 (11.8) 35 (7.0) <0.01 p <0.01 P-value 24 (4.9) p = 0.78 High stick Seto A et al. JACC Intv. 2010;3;751-758
  27. 27. Procedural Outcomes First Pass Success Rate Number of Attempts 100% 5 90% p < 0.000001 82.7% 80% 3 70% 60% 3 46.4% 50% 1.3 2 40% 30% 20% 1 10% 0 0% Fluoroscopy Fluoroscopy Ultrasound Risk of Venipuncture 20% Ultrasound Time to Sheath Insertion 300 15.8% 213 p = 0.016 185 15% p < 0.000001 10% 2.4% 5% 0% Seconds Attempts 4 p < 0.000001 200 100 0 Fluoroscopy Ultrasound Fluoroscopy Ultrasound Seto A et al. JACC Intv. 2010;3;751-758
  28. 28. Complications Fluoroscopy Ultrasound N=501 N=503 Hematoma >5 cm* 11 (2.2%) 3 (0.6%) 0.034 Pseudoaneurysm 0 1 NS Dissection 3 2 NS Access bleeding, transfusion 2 1 NS Hematoma, DVT 1 0 NS Complication Any complication 17 (3.4%) 7 (1.4%) P-value 0.041 *Blinded hematoma assessments: 8F, 0 US, p<0.01 Seto A et al. JACC Intv. 2010;3;751-758
  29. 29. Exit Strategy O’Neill BP et al , et al. CCI 2013
  30. 30. Bleeding according to Pre-Closure use 20% No Pre-Closure Pre-Closure 15.1% Patients (%) 15% 14.5% 11.3% 9.4% 10% 7.4% 5% 4.5% 5.6% 4.1% 0% VARC TIMI GUSTO BARC≥3 O’Neill BP et al , et al. CCI 2013, in press
  31. 31. Effect of Pre-Closure on Death, MI, and Acute Vascular Injury 20% Patients (%) No-Preclosure 15% Preclosure p=0.08 10% 5% P=0.12 p=0.04 10.1% 8.2% 4.1% 5.0% 4.8% 2.2% 0% Death MI Acute Vascular Injury O’Neill BP et al , et al. CCI 2013, in press
  32. 32. Strategy   Complex  transradial  bifurcation  PCI   Percutaneous  LVAD   Impella  2.5   Remove  at  the  end  of  the  case  
  33. 33. Radial PCI + Femoral LV support The Perfect Marriage n  Transradial access associated with lower vascular complication and bleeding risk " These complications ↑ mortality, especially in high risk patients n  Transradial operators are better “Femoralists” –  Ratib, Routledge, Mamas, Ludman, Fraser and Nolan n  Expand choices in patients with PVD and limited access options " Optimal and perfect femoral access –  Fluoro and U/S guidance n  Challenges in radial puncture in patients with shock " " LV support first, then radial access Ultrasound guidance

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