Radial approach for PCI and femoral for LV support

1. Radial Approach for PCI
Femoral Approach for LV Support
Mauricio G. Cohen, MD
Director, Cardiac Cath Lab
Associate Professor of Medicine

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. Cath
@
VA
–
July
10

4. Cath
@
VA
–
July
10

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. Percutaneous Support Devices
Desai N R , Bhatt D L Eur Heart J 2009;30:2073-2075

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. Mostly Anecdotal Experience

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. 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. 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. 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. 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. 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. 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. 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. 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. Spectrum of Risk
Clinical and Angiographic
STS score
SYNTAX
score
SYNTAX
BCIS
PROTECT II

19. CARDIOGENIC SHOCK

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. Primary Endpoint: 30-day Mortality
Thiele H, et al. N Engl J Med 2012; 367:1287-1296

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. 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. ACCESS RELATED ISSUES

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. 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. 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. 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. Exit Strategy
O’Neill BP et al , et al. CCI 2013

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. 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. Strategy
Complex
transradial
bifurcation
PCI
Percutaneous
LVAD
Impella
2.5
Remove
at
the
end
of
the
case

44. 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