Transcript Minneapolis Heart Institute

TCT 2012
Hypothermia in STEMI,
CRT 2013 WashingtonTherapeutic
DC
Cardiac Arrest and Cardiogenic Shock
Michael R. Mooney MD, FACC
Director Interventional Cardiology
Minneapolis Heart Institute
AMI
David Hildebrandt,RN
Director, CV Emergencies MHI
ACS/AMI - Update on Drugs, Devices and
Approaches
Michael R. Mooney, MD, FACC
Director, Interventional Cardiology
Michael R. Mooney, MD
I/we have no real or apparent conflicts of interest to report.
ACS Management: what are our goals
and priorities?
Goals
Priorities
n Treat Sx
n Rapid treatment
n Risk stratification
n Balance risk of thrombosis
with risk of bleeding
n Integrate strategies into
invasive or conservative
management
n Attenuate myocardial
damage
n Reduce the risk of recurrent
ischemic events
l Short-term (in-hospital)
l Long-term
l Recognize duration of
treatment course
n Reduce LOS/Costs
ACS Management: State-of-the-art
NSTE-ACS
STEMI
n Management options
n
n
n
n
l Individualized therapy vs.
one-size-fits-all
n Risk stratification
l Initial triage*
l Invasive vs. conservative
STEMI Networks
Pharmacotherapy
Stent type
Vascular access*
Management options – NSTE ACS
NSTE ACS
O2, NTG, ASA
Clopidogrel
UFH
Ticagrelor
Enoxaparin
Invasive
CABG
PCI
Prasugrel
Fondaparinux Bivalirudin
Conservative
Radial
DES
Femoral
BMS
CRUSADE Bleeding Score Nomogram
Predictor
Baseline Hematocrit (%)
Creatinine Clearance (mL/min)
Heart rate (bpm)
Sex
Signs of CHF at presentation
Prior Vascular Disease
Diabetes Mellitus
Systolic blood pressure (mm Hg)
Range
< 31
31-33.9
34-36.9
37-39.9
≥ 40
≤ 15
>15-30
>30-60
>60-90
>90-120
>120
≤ 70
71-80
81-90
91-100
101-110
111-120
≥ 121
Male
Female
No
Yes
No
Yes
No
Yes
≤ 90
91-100
101-120
121-180
181-200
≥ 201
Score
9
7
3
2
0
39
35
28
17
7
0
0
1
3
6
8
10
11
0
8
0
7
0
6
0
6
10
8
5
1
3
5
Subherwal S, et. al. ACC 2008
http://www.crusadebleedingscore.org
CRUSADE Bleeding Risk Score
n
Patients were categorized into quintiles of risk
groups based on their CRUSADE Bleeding
Score
Risk
N
Min Score Max Score Bleeding
Very low
19,486
1
20
3.1%
Low
12,545
21
30
5.5%
Moderate
11,530
31
40
8.6%
High
10,961
41
50
11.9%
Very High
15,210
51
91
19.5%
Subherwal S, et. al. ACC 2008
TIMACS Trial
N=3031 ACS patients randomized to early or delayed angiography
Mehta SR et al NEJM 2009
RIFLE STEACS - flow chart
Design
1001 patients enrolled between January
2009 and July 2011 in 4 clinical sites in Italy
• DESIGN:
Prospective, randomized (1:1),
parallel group, multi-center trial.
Femoral arm
(N=501)
• INCLUSION CRITERIA:
all ST Elevation Acute Coronary
Syndrome (STEACS) eligible for
primary percutaneous coronary
intervention.
• ESCLUSION CRITERIA:
contraindication to any of both
percutaneous arterial access.
international normalized ratio
(INR) > 2.0.
Radial arm
(N=500)
access shift
6.1% (61)
Femoral arm
(N=534)
Radial arm
(N=467)
Clinical follow-up at
1 month in 100%
Clinical follow-up at
1 month in 100%
Intention-to-treat analysis
Romagnoli E, et. al. JACC 2012
RIFLE STEACS – results
30-day NACE rate
overall
femoral arm
radial arm
p = 0.003
21.0
17.3
p = 0.029
p = 0.026
11.4
12.2
13.6
10.0
9.3
7.8
7.2
NACE
MACCE
Bleeding (BARC ≥2)
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target lesion revascularization, stroke
• Bleeding Academic Research Consortium (BARC) = bleeding definition adopted
Romagnoli E, et. al. JACC 2012
RIFLE STEACS – results
30-day MACCE rate
overall
femoral arm
radial arm
p = 0.020
9.2
7.2
5.2
p = 1.000
1.3
Cardiac death
1.4
p = 0.604
1.5
1.2
Myocardial
Infarction
1.8
1.2
Target Lesion
Revascularization
Romagnoli E, et. al. JACC 2012
p = 0.725
0.7
0.6
0.8
Cerebrovascular
Accident
RIFLE STEACS – results
BARC definitions*
Access site
related bleeding
• TYPE 1: bleeding not actionable and
6.8%
47%
does not cause unscheduled studies,
treatment or hospitalization
2.6%
• TYPE 2: any overt, actionable sign of
p = 0.002
hemorrhage that does not fit the
criteria for type 3, 4, or 5
• TYPE 3:
•overt bleeding plus Hb drop >3g/dL
•any transfusion with overt bleeding
•cardiac tamponade
•bleeding requiring surgical
intervention
•bleeding requiring intravenous
vasoactive agents
Non access site
related bleeding
• TYPE 4: CABG-related bleeding
• TYPE 5: fatal bleeding
Romagnoli E, et. al. JACC 2012
5.4%
53%
p = 1.000
5.2%
Radial vs. Femoral in STEMI
N=3347 pts from randomized, case-control, and cohort studies incl. RIVAL
Mortality
Bleeding
Procedure time (min)
Joyal D, et. al. AJC 2012
ESC Updated STEMI Guidelines
The guidelines also support the use of transradial
primary PCI over the use of transfemoral, but only
in the hands of experienced operators…
Steg PG, James SK, Atar D, et. al. EHJ 2012
ACS: State-of-the-art
Accelerated developments in ACS management make
the “optimal” strategy a constantly moving target
The benefit-risk ratio of the chosen strategy may be influenced
by the patient’s baseline risk
Nomograms to assess a patient’s risk of death,
death/MI, and bleeding in the short- and intermediateterm are available
STEMI care has improved significantly
The future is to reduce complications (bleeding, vascular),
develop networks, STE-NoMI?
Radial approach supported by trials, observational data,
and guidelines
No D2B consistently reported, mechanism of benefit unclear
Need a large multicenter trial that reports clinical outcomes and
D2B
Challenges to Rapid Triage and Transport in the US and
Data/Trial Interpretation
TYPES OF HEMODYNAMIC SUPPORT
• Intra Aortic Balloon Pump (IABP)
• Percutaneous Left Ventricular Assist Devices
– Impella LP
– Tandem Heart
• Extra corporeal Life support (ECMO)
IABP-SHOCK II Trial
The use of IABP did not
significantly reduce 30day mortality in patients
with cardiogenic shock
complicating STEMI
Thiele H et al. N Engl J Med 2012;367:1287-1296
When Might We Consider Hemodynamic
Support for STEMI?
• Severe LV dysfunction:
• Large Ischemic burden
• Compromise of coronary flow
• High risk of no reflow (i.e., SVGs, Rota,
STEMI)
• Cardiogenic shock
• Cardiac arrest
Anemia and Prognosis
in ACS Patients
Meta Analysis of 241,293 patients
OR
95%CI
Short term mortality
2.77
2.09-3.65
Long term mortality
2.03
1.52-2.71
Heart failure
1.96
1.47-2.62
Cardiogenic shock
1.95
1.04-2.64
Major bleeding
4.28
1.05-17.14
Liu et al J Int Med Res 2012;40(1) 43-55
STEMI Due to Stent Thrombosis:
Increased Rate
Frequency of STEMI Resulting From Stent Thrombosis as a Percentage of all
STEMI Patients Treated With Primary Percutaneous Coronary Intervention From
2003 Through 2010. (n 2,086 pts)
J Am Coll Cardiol. 2012;():. doi:10.1016/j.jacc.2012.07.043
STEMI and Stent Thrombosis:
Higher Risk with SAT
J Am Coll Cardiol. 2012;():. doi:10.1016/j.jacc.2012.07.043
STEMI Outcomes
Impact of Stent Design Xami Trial
MACE-Free Survival at 1 Year
J Am Coll Cardiol. 2012;60(5):381-387. doi:10.1016/j.jacc.2012.01.073
Impact of Thrombus Aspiration during Primary
PCI on Mortality in STEMI
Retrospective analysis of 2,567 STEMI pts who underwent primary PCI,
with or without manual thrombectomy, between 2008 and 2011.
Thrombectomy Nonthrombectomy
Mortality
(n = 1,095)
(n = 1,472)
P Value
In-hospital
2.7%
5.8%
0.027
9.9 Months
5.7%
11.6%
0.028
An interaction was noted between thrombectomy and total ischemic time at
a cut-off point of 180 minutes (P for interaction = 0.024).
Conclusion: The findings support the use of manual thrombectomy
during primary PCI for STEMI, especially in pts with short ischemic times.
Noman A, et al. Eur Heart J.
2012;Epub ahead of print.
Early PCI Benefits Latecomers with Acute STEMI
Korea AMI Registry study of stable STEMI pts. who received elective PCI or
medical therapy 12 to 72 hrs. after symptom onset.
PCI
Medical Therapy
(n = 1,889)
(n = 455)
Death
3.1%
10.1%
< 0.001
Death or MI
3.8%
11.2%
< 0.001
1-Year Follow-up
P Value
After adjustment for propensity score, results remained significant.
Conclusion: In stable patients with STEMI presenting 12 to 72 hrs. after
symptom onset, PCI was associated with significant improvement in 12-month
clinical outcomes.
Sim DS, et al. Am J Cardiol.2012;Epub ahead of print.
Improving Door to Balloon Time
Pre Hospital EKG
mVisum STEMI
Alert System by
mVisum, Inc.
No STEMI
(n = 9,328) vs. STEMI
J Am Coll Cardiol. 2012;60(9):806-811. doi:10.1016/j.jacc.2012.03.071
patients (n = 303)
SRB TCT 2012
ST-Segment Resolution as a Predictor of
Death and MACE after Primary PCI in
STEMI: The HORIZONS-AMI Trial
2,484 pts with interpretable baseline and 60-minute post-PCI ECGs
ST-segment resolution > 70%
ST-segment resolution 30-70%
ST-segment resolution < 30%
30
ST resolution at 60’
Partial (30%-70%)
712 (28.7%)
Absent (<30%)
514 (20.7%)
Death (%)
Complete (>70%)
1,258 (50.5%)
25
20
15
10
P=0.03
5
0
0
2
4
6
8
10 12 14 16 18 20 22 24 26 28 30 32 34 36
Time in Months
Number at Risk
>70%
1258
30-70%
712
<30%
514
1213
690
484
1203
682
483
1188
678
480
1173
669
465
Farkouh ME et al from Stone 2012.
1167
665
461
1154
659
457
1129
645
445
1119
641
443
744
445
327
ACS Admissions in the US
SRB TCT 2012
What About STEMI and TH?
Therapeutic Hypothermia (TH):
• The gold standard treatment for reperfusion
injury
• Reperfusion injury is important in both cardiac
arrest/anoxic encephalopathy and acute MI
• TH is pluripotent
• TH is standard of care for CA
• TH is an emerging treatment for Acute MI
• TH may have efficacy in post MI cardiogenic
shock
• TH is markedly underutilized
Contribution of Lethal Reperfusion Injury to Final Myocardial
Infarct Size
Yellon D, Hausenloy D. N Engl J Med 2007;357:1121-1135
Major Mediators of Lethal Reperfusion Injury
•
reactive oxygen species
• oxygen paradox
• Ca paradox - sarcolemma
• cytokines
• activated complement
• activated mitocondrial PTPpermeability transition pore accelerated
by Ca.
• neutrophil vascular plugging
• hypercontractile myocyte
• uncoupled oxidative-phos
• all leading to lethal reperfusion Injury
Yellon D, Hausenloy D. N Engl J Med 2007;357:1121-1135
Anterior Myocardial Infarct Size vs Temp at Reperfusion
Source- O’Neill, “Novel Myocardial Preservation Therapies: Past Frustrations and Future Promise”, TCT 2006
Intravascular Cooling
InnerCool - Phillips
Rapid MI-ICE study summary
• 20 pts w/ STEMI randomized iced saline and intravascular
cooling v. control (Innercool)
• Core temp <35 in 40 min D2B 43 min
• 1500 cc 4 deg. Saline . Demerol , buspirone, Bear Hugger
,intravascular cooling
• Day 4 - cMRI T2 v. Gadolinium -- Hedstrom E,J AmColl Cardiol
Cardiovasc Imaging. 2009;2:569 –576.
• Troponin T elution curves
• No difference in clinical outcomes
Rapid MI-ICE Study - Lund,Sweden (Gotberg , Olivecrona )
cMRI Findings
A Pilot Study of Rapid Cooling by Cold Saline and
Endovascular Cooling Before Reperfusion in Patients With
ST-Elevation Myocardial Infarction
Circ Cardiovasc Interv published online Aug 24, 2010
Rapid MI-ICE Study - Lund,Sweden (Gotberg , Olivecrona )
Troponin Elution Curves
Peritoneal Cooling - Velomedix™, Inc
Automated Peritoneal
Lavage System (APLS)
• Efficient heat exchange
• Tight control for cooling and
warming
• Does not restrict access
• Fully automated system
Why Use the Peritoneal Cavity?
• Efficient heat exchange
– > 50% of total blood flow
– Large surface area
• Time to target (10 - 15 minutes to
34°C)
• Eliminates femoral access interference
• Eliminates upper chest and neck area
interference
Insertion / Access: Animation (1 of 5)
40
© 2011 Velomedix, Inc. All rights reserved. Proprietary and
Insertion / Access: Animation (2 of 5)
41
© 2011 Velomedix, Inc. All rights reserved. Proprietary and
Insertion / Access: Animation (3 of 5)
42
© 2011 Velomedix, Inc. All rights reserved. Proprietary and
Karl Storz EndoTIP peritoneal access technique using liquid
entry detection
 The EndoTIP is a unique device that…
– Requires minimal downward force to penetrate through tissue layers
– Engages the muscle and fascia with threads, which allows these tissues and
peritoneal membrane to be lifted off the underlying viscera
– Has a blunt (non-cutting) tip that minimizes vascular injury
 Liquid entry detection is not a new concept – it is commonly done in DPL
procedures and laparoscopic entry procedures using the Veress needle
(“hanging drop” technique) 1
1. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2009, 17:13
43
© 2011 Velomedix, Inc. All rights reserved. Proprietary and
CAMARO Trial Treatment Times
Treatment Timing Based On CAMARO Results
Summary of 43 cardiac arrest and 3 AMI cases
12 °C/hr
All Data
(n=46)
27
0
Patient
Arrives @ ER
10
20
13
30
40
50
60
70
80
Elapsed Time (min)
Patient Screening/Consenting + Stabilization
Time to 34°C
90
Cath Lab Flow Process
Cath -Lab
Arrival
Reperfusion
Normal Cath-Lab Team duties
Gen prep
Consent
Groin/Radial & Abdom. prep
Arterial access
Wire/guide cath placement
Diagnostics
Time
(min)
0
Device
setup
and
prime
5
I/E screen
10
Consent
15
Ran
do
miz
e
Esophageal probe
placement
20
25
30
Peritoneal cath and connect
Buspirone PO + Meperidine bolus/drip + skin counter-warming
Hypothermia Team duties
*For walk-in patients: I/E screen, Consent, Randomize, and Esophageal
Probe placement can be done in the ED
35
Cooling to 34.9°C
40
Conclusions
 Recent Guideline Updates have focused on
– incorporating new antiplatelet and antithrombin therapies
– Identification of at risk subgroups
• Women
• Elderly
• CKD
• Anemia
 Outcomes from large databases continues to reinforce the positive impact from
systems of care and care plans
Conclusions
 The role of coronary revascularization continues to show benefit, particularly in
higher risk patients
– High risk populations
– Early revascularization in STEMI patients who present late even
when clinically stable
– Improved outcomes in elderly patients
– New DES improve outcomes in STEMI
 We continue to search for adjunctive therapies that
– Enhance myocardial perfusion
– Improve outcomes in high risk STEMI patients (shock etc.)
– TH may prove to be an important advance in STEMI
care
Thank You