high risk pci with impella 2.5: registry perspectives and an ongoing … · registry perspectives...
TRANSCRIPT
Brij Maini, MD, FACCPinnacle Health, Harrisburg, PA
On behalf of all USpella Registry Investigators
High Risk PCI With Impella 2.5:
Registry Perspectives
and an Ongoing Trial
1
Conflict of Interest
• Investigator: PROTECT II, RECOVER II,
USPELLA
• Member Advisory Board: ABIOMED
• Member: Impella Trials Steering Committee
Impella 2.5 Technology
Clinical Adoption in US
FDA Clearance in June’08
1000+ patients treated
300+ US Centers
2 Trials OpenUSpella Registry
3
USpella Registry
• Retrospective look at patients supported with 510(k) device
• All sites with N> 4 patients invited to participate on June 10th 09
• All “comers” considered without limitation of indications
• Data obtained after IRB submission
• 16 sites have responded so far for a total of 181 patients
4
Main Indications For Support(N=181)
5
Others includes Elective CABG, Myocarditis with shock, Post-cardiotomy shock, septic shock, toxic shock, post partum cardiomyopathy,
other cardiomyopathies with shock
Without
Shock
(20%)Elective
(37%)
With Shock
(14%)
Urgent
(18%)
ADHF
w/ Shock
(6%)
Other
(5%)
Acute
Myocardial
Infarction
(34%)
High Risk
PCI
(55%)
Analysis By Sub-Group
• High Risk PCI
• Acute Myocardial Infarction
6
69 ± 11
74 %
65 % vs 35%
32 ± 17
58 %
85 %
2 ± 1
6 ± 5
39 ± 16
60
2.1 ± 0.2
Age (yrs)
Gender (Male in %)
Procedure (Elective vs Urgent)
LVEF (%)
Un protected LM or LPC
Multivessel Disease
Nb of lesions treated
STS Score
Syntax Score
Median Duration of support (min)
Average Pump Flow
Patient Characteristics Mean ± SD or %
High Risk PCI Demographics (N=99)7
Patient CharacteristicsIn 85% of the cases, CABG was declined
(when requested) because of Patient’s Morbidity
0%
20%
40%
60%
80% 74%
Class IV
(42%)
Class III
(58%)
64%
49%
38%
21% 20%
29%
70%
USpella 8
Very Complex Anatomy
0
5
10
15
20
25
30
% O
bse
rva
tio
ns
0 10 20 30 40 50 60 70 80Syntax Score
USpella High Risk PCI Population Presents with Much Complex
Anatomy than SYNTAX Trial and Registry Populations
SYNTAX Population USPella Population*
Mean~23 Mean=39
*Only 3VD and LM considered
USpella 9
Effective RevascularizationUSpella
*All comers, including SVG revascularization
0
10
20
30
40
50
60
70
80
Syn
tax S
co
re in
US
pell
a
Hig
hR
isk P
CI P
op
ula
tio
n*
Post PCIPre-PCI
p<0.0001
Median =38
Median =18
10
Effective RevascularizationUSpella
0
2
4
6
8
10
12
14
16
18
-10 10 30 50 70 90Pre-PCI Syntax Score
0
2
4
6
8
10
12
14
16
% O
bse
rvatio
ns
-10 10 30 50 70 90
Post PCI Syntax Score
% O
bse
rvatio
ns
Shift in the distribution
post-PCI towards lower
Syntax Score
Median= 38Events Free MACCE
According to SYNTAX Score
USpella HR PCI Population
11
Median= 18
Ejection Fraction ImprovementUSpella
p = 0.01
LVEF Within Subject Pair wise Comparison
(N=22*)
*N=22 subjects have LVEF measurements available Pre and Post PCI
** Longest available follow-up from PCI
Pre-PCI
29±15
0%
10%
20%
30%
40%
Post-PCI**
34±14
12
30-Day Reported MACE
USpella
0
2.5
5.0
7.5
Death MI Revasc. Em CABG Stroke/TIA MACE
Incid
en
ce (
%)
N=99
10.0
12.5
3% 3%
1%
3%
0%
6%
Aortic Insufficiency
Aortic Valve Injury
Renal Failure
Bleeding requiring surgery
Bleeding requiring transfusion*
Hypotension on support
Device Malfunction
Hemolysis
Infection
Vascular Complications (not requiring surgery)
Ventricular Tachycardia or CPR
Hematoma
30-day Reported Adverse Events n (%)
Other USpella Safety Profile
0 (0%)
0 (0%)
4 (4%)
0 (0%)
9 (9%)
3 (3%)
0 (0%)
0 (0%)
4 (4%)
3 (3%)
4 (4%)
5 (5%)
*The manufacturer has introduced a new sheath that has addressed the groin site bleeding
Registry 6 Month Follow-upUSpella
*All comers, including SVG revascularization
15
30 day survival = 97%
.6
.7
.8
.9
1
Su
rviv
al
(%)
0 20 40 60 80 100 120 140 160 180
Follow-up (days)
Censored
Death
USpella 16
Other Modalities
In-Hospital Available AE rate
AE Rate for Elective Support in HR PCI Reported Data: Impella vs other Modalities
• Age (yrs)
• History of CHF (%)
• Multivessel disease (%)
• Left Main Disease (%)
• LVEF<35% (%)
• Mean EF (%)
• In-Hospital MAE
• Death (%)
• Q-wave MI (%)
• Non Q-wave MI (%)
• Stroke (%)
• CABG (%)
• Angiographic failure (%)
• Vascular repair (%)
• Hypotension (%)
• Any Revascularization (%)
Cumulative MAE Range
IABP*
66 11
35
89
22
62
32 14
8.7
2.2
NR
1.1
6.5
13
3
NR
NR
13-34.5
(n=58)
CPS*
63 9
59
95
28
77
26 13
12.0
3.4
NR
3.4
1.7
1
14
NR
NR
14-35.5
(n=91)
Maini et al(2009)
69 11
80
85
58
70
32 17
3
1
2
0
3
1
0
3
1
3-13
(n=99)
Shreiber et al(1998)
Vogel et al(1995)
65
85
90
15
NR
28
7 - 18
1
NR
NR
2.5
7
NR
NR
NR
18-28.5
(n=576*)
NHLBI CPS registry*
MAE = Major Adverse Events; NR: Not reported. * Only prophylactic support reported here; All events are in-hospital events except **at 1 mo.
‡ Sjauw et al – Europella registry 30 day-MAE Amer. Jr of Cardiology – Vol 102 (Suppl 8A) -487 pp 186i; JACC 2009 (in press)
USpellaRegistry
Briguori et al(2006)
67 12
-
NR
100
<22
53 15
1.4**
5.8
NR
NR
2.9
6
12
10
NR
12-38.1
(n=69)
IABP*
Mishra et al(2006)
69 10
39
20
9
~35
29 13
4**
0
20
NR
0
2
4
10
NR
20-40
(n=69)
IABP*
Urban et al(2004)
~65 13
NR
NR
NR
NR
~35 15
~11
NR
NR
NR
NR
NR
NR
NR
NR
11-?
(n=69)
IABP*
Sjauw et al(2008)
71.8 10
NR
82
53
~50-64
26 6
5.5**
0**
0**
0.7**
0**
NR
4.0**
NR
NR
5.5-10.2
(n=144)
EuropellaRegistry‡
Impella
30-Day AE rate
Analysis By Sub-Group
• High Risk PCI
• Acute Myocardial Infarction
17
USpella AMI Population18
Baseline CharacteristicsMean ± SD or % Mean ± SD or %
ShockNo Shockp-value
64 ± 16
92 %
69% (31%)
31 ± 14
50 %
91 %
65% / 23% / 12%
14%
2.2 ± .4
Age (yrs)
Gender (Male in %)
STEMI (NSTEMI)
LVEF (%)
Unprotected LM or LPC
Multivessel Disease
Revasc (PCI/CABG/None)
Impella placement Pre-PCI
Pump Flow (L/min)
74 ± 10
72 %
3% (97%)
33 ± 15
50 %
75 %
100% / 0 / 0
95%
2.2 ± .3
0.003
0.04
<0.001
0.6
0.9
0.2
0.002
0.001
0.9
USpella AMI Shock Patients
Impella Used After Failed Conventional Therapies
(i.e, Revascularization, Inotropes and IABP)
USpella 19
Emergent
Revascularization
High Dose
Inotropes
Already on
IABP
0%
25%
50%
75%
100%88%
68%
88%
Th
era
py U
sa
ge
Pre
-Im
pe
lla
Su
pp
ort
Cardiac Index
Ca
rdia
c In
de
x(l
/min
/m2)
Wedge Pressure
0
1.6
1.8
2.0
2.2
2.4
2.6
On
Impella
PC
WP
(mm
Hg
)
0
20
24
28
22
26
30
Pre
Impella*
1.9 0.5
SVR
SV
R(x
1000 d
yn
es/s
ec x
cm
-5)
0
1.2
1.4
1.6
1.8
2.0
1.0
1.8 0.7
Impella Improves Hemodynamicsin AMI Shock
On
Impella
Pre
Impella*On
Impella
Pre
Impella*
2.5 0.6
28 8
20 10
p=0.02
p=0.001p=0.01
Mean Arterial Pressure
62 19
87 16p=0.003
*Pre-Impella measurements were recorded with optimal medical management measures (inotropes + IABP)
1.3 0.5M
AP
(mm
Hg
)
0
50
60
70
80
90
On
Impella
Pre
Impella*
100
LVEF Improvement Post SupportUSpella
p = 0.01
*N=25 subjects have LVEF measurements available Pre and Post PCI
** Longest available follow-up from PCI
0%
10%
20%
30%
40%
21
Pre-
PCI
29±12
Post-
PCI**
Pre-
PCI
Post-
PCI**
Pre-
PCI
Post-
PCI**
All AMICombined
AMINo Shock
AMIShock
37±15 37±17 37±12
30±1228±12
Survival to Discharge
By Indication
0%
25%
50%
75%
100%
AMI with
Shock
(n=36)
89%
(n=26)
58%
USpella 22
Impella Supported the AMI Refractory Shock Patients Successfully
Patients in AMI Refractory
Shock Support with Impella
N=26
Recovery
N=12
Bridge to Other
Support Devices
N=5
Death
N=4
Transplant
N=1
Transplant
N=1
Death
N=8
69% Survival to the Next Therapy or
to Recovery (18 out of 26), 58% to Discharge
Conclusion
USPella is the largest study reported so far for
Impella 2.5 that confirms prior results:
- Impella 2.5 is Safe and Easy to Use
- Provides excellent support to stabilize the
patients during high risk interventions and
restore the hemodynamics in unstable
conditions and refractory shock
USpella
Acknowledgements25
Brij Maini, MD, Anita Todd, RN, (Moffitt Heart & Vascular Group)
Simon Dixon, MD, Jim Wegner, RN (William Beaumont Hospital)
Theordore Schreiber, MD, Deb King, RN (Harper Hospital)
Srihari S. Naidu, MD, Dipti Patel, RN, (Winthrop University Hospital)
Chat Rihal, MD, Lynn Polk, RN (Mayo Clinic)
David Wohns, MD, Brianna Beilfuss, RN (Spectrum Memorial Hospital)
David Roberts, MD, Beverly Seiler, RN (Sutter Memorial Hospital)
Yakubov, MD & Anthony Chapekis, MD, Greta Robb, RN (Riverside Methodist Hospital)
Igor F. Palacios, MD, Maureen Daher, RN (Massachusetts General Hospital)
Chandan Devireddy, MD, Elizabeth Bleakley, RN, (Emory University Hospital Midtown)
James Revenaugh, MD, Bev Campbell , RN (Intermountain Medical Center)
Neeraj Jolly, MD, Bridge Galetti, RN (University of Chicago)
Suresh Mulukutla, MD, Lisa Baxendell, RN (UPMC)
Ali E. Denktas, MD, Yolanda Stiner, RN (University of Texas Herman)
James Blankenship, MD, Michelle Zarko, RN (Geisinger Medical Center)
Renzo Cecere, MD, Charlene Barber, RN (Royal Victoria Hospital)
Additional sites that have joined later the USpella:
William O’Neill, MD, Barbara Lang, RN (University of Miami)
Samin Sharma, MD, Michael Fusilero, MD (Mt. Sinai)
Michael Collins, MD & Jeffrey Moses, MD, Diana Wong, RN (Columbia Presbyterian)
Peter Reyes, MD, Dana Beach, RN (University of Maryland)
Alan Gass, MD, Mary-Evelyn Kennelty, RN (Westchester)
Neal Kleiman, MD, Nicole Hakala, RN (Methodist Debakey)
Laura Mauri, MD, Denise Cinamon, RN (Brigham & Women)
Paul Kramer, MD, Millie L. Salkind, RN (Shawnee Mission)
Thank You !
USpella
USpella Registry: Definitions
• Survival = Reported survival at 30-day or discharge whichever
is longer
• Adverse event definitions = FDA approved Protect II and
Recover II protocol definitions
• Syntax Score and Angiographic analysis performed at single
location (Pinnacle Health, PA, Brij Maini, MD, FACC)
• All statistical tests were two tailed and considered significant
when p-value<0.05
27
LV Unloading Correlates With Pump
Speed
60%
65%
70%
75%
80%
85%
90%
95%
100%
Baseline P2 P4 P6 P8 P9
Pt1
Pt2
Pt 3
Pt4
Pt5
Pump Speed Level
LV
En
d D
iasto
lic V
olu
me
(% f
rom
baselin
e)
28
LV Unloading Correlates With Pump SpeedUsing 3D Trans-Thoracic Echo
Pump Speed Level
LV
E
nd
Dia
sto
lic V
olu
me
(% f
rom
baselin
e)
70%
75%
80%
85%
90%
95%
100%
Baseline P2 P4 P6 P8 P9
p<0.001
29
Survival to Discharge
By Indication
0%
25%
50%
75%
100%
High Risk
PCI
AMI With
Shock
(n=99)
98%
(n=36)
89%
(n=26)
58%
USPella 30
Procedure Characteristics
Time to 1st Balloon
Inflation*
Median Time to
1st Balloon
Inflation
(N=51)
12 min.
USpella
* Median time from Impella insertion in the sheath to the first PCI balloon inflation or stent deployment in the target vessel
** Pump run in average at a performance level 7 (of a 9 scale, maximum)
Average Pump Flow
During PCI**
Median Duration
of Support*
(N=92)
2.1± 0.2 L/min
During
Procedure
Pump Flow
(N=59)
60 min.
[0.1-72hrs]
31