the detrimental impact of chronic renal insufficiency · case presentation •transferred, in...

Cardiogenic Shock:

Risks and Benefits of Available Treatment Options

Arnold Seto, MD, MPA

Chief, Cardiology

Long Beach VA Medical Center

Associate Clinical Professor

University of CA, Irvine

Disclosure: Getinge Speaker’s Bureau

Cardiogenic

Shock

(±MI)

Complex PCI

Support

Acute Coronary

Syndrome

(AMI)

Clinical Uses for

Percutaneous Circulatory Support

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Key considerations for choosing an MCS devicePage 2

Early diagnosis and

early MCS intervention

Which MCS device is

appropriate for the stage

of cardiogenic shock?

Which MCS device would be

appropriate for ‘high-risk’

PCI?

Risks

vs benefits

What are the clinical

considerations of the

selected device?

Economic

impact

What is the total

cost of care with

the selected

device?


Cardiac Support Strategies

Strategy Therapy / Device Mechanism

Medical

ManagementInotropes

Increase

Contractility, HR

Counterpulsation IABPAortic Pressure

Augmentation

Extracorporeal

Bypass Pump

TandemHeart LA -> AO flow

ECMO RA -> AO flow

Implantable

Transvalvular

Pump

Impella 2.5

LV -> AO flowImpella cVAD

Impella 5.0


Comparison of devices

J Inv Cardiol 2015; 27: 148-54


Cardiac Power Output (Watts)

Esti

mate

d I

n-H

osp

ital M

ort

ali

ty (

%)

Cardiac support increases CPO

Hemodynamic support in AMI Cardiogenic Shock and Survival

- Fincke et al. J AM Coll Cariol 2004 July; (44)2: 340-8

n==189 From SHOCK trial

registry


Intra-Aortic Balloon

Diastole

Systole

• Aortic Counterpulsation

(reduces afterload)

• Single femoral artery access

• 7-8 Fr

• ~5 min set-up & insertion

• Synchronous operation requires

maintenance of ECG or pressure

waveform

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7

Onset systole

deflateAdjust timing

Diastolic pressure

CO

MAP

LV Wall Tension

PCWP

Oxygen Demand

LV Volume

Coronary Blood Flow or

➔


7

8

Effects of IABP• Decreased work

• Afterload

• Reduces wall stress

• Decreases oxygen demand

• Increases MAP

• Increases peak diastolic pressure

• Increases proximal coronary velocity

• Does not increase flow across stenotic lesion

• Augmented renal flow

• Enhanced thrombolysis

• Enhanced endothelium-derived NO release

•Kahn JK, Almany SL in Practical Interventional Cardiology, 1997

•Richenbacher WE, Pierce WS in Heart Disease, Ed Braunwald E, 5th Edition, Saunders 1997. Fuchs RM et al, Circulation

1983;68:117-23

•Kern MJ et al, Circulation 1993;87:500-11. Kern MJ et al, JACC 1993;21:359-68


8

9

Using the 50 cc IABP9

• 8 Fr Catheter

• 20-30% More Displacement

• 20-30% Greater Diastolic

Augmentation

• 20-30% Greater Afterload

Reduction n = Pre-

IABP

Post-

IABPP value

Diast Aug (mm

Hg)115 - 42

PASP (mm Hg) 87 55 45 < 0.01

PADP (mm Hg) 87 28 22 < 0.01

mPAP (mm Hg) 87 38 29 < 0.01

C.O. (l/min) 79 3.56 4.50 < 0.01

C.I. (l/min/m2) 79 1.76 2.32 < 0.01

Cath Cardiovasc Intervent 2017; 90: e63-72

50 cc “IABP First” Strategy in AMICS (n = 31)

→ IABP with Survival to Discharge 61%

→ IABP to VAD to Discharge 7%

→ IABP to Transplant to Discharge 3%

→Death 29%

50 cc in AMICS – Responders and Non-Responders

n = 16

n = 60

Baran, et al Cath Cardiovasc Intervent 2017; epub

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Complications of MCS devices

Int J Cardiol. 2015 Apr 1;184:36-46.

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https://www.ncbi.nlm.nih.gov/pubmed/25697869

Vascular Complications: Size Matters

90 patients with Impella

74% with cardiogenic shock

12/90 pts with limb ischemia J Vasc Surg. 2015 Aug;62(2):417-23.

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https://www.ncbi.nlm.nih.gov/pubmed/26054591

Major Bleeding

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Impella Hemolysis

Incidence of Hemolysis in Patients with Cardiogenic Shock

Treated with Impella Percutaneous Left Ventricular Assist

Device

Badiye, ASAIO Journal62(1):11-14, January/February

2016.

Defined as LDH rise, Hgb drop, 62.5%

of patients developed detectable

hemolysis after 6 hrs. 17% transfused

(n=40)

Other studies show clinical rates of

7.5% (EUROSHOCK)-10.3% (USpella)

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https://journals.lww.com/asaiojournal/Fulltext/2016/01000/Incidence_of_Hemolysis_in_Patients_with.4.aspx

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NEJM 2012; 367: 1287- 96

87% of IABP placed after PCI10% Cross-over in Control Arm – if 2/3 of these crossovers survived because of IABP, p = 0.04

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J Am Coll Cardiol. 2008;52(19):1584-8.

The cardiac power index was higher

for Impella at 30 minutes only (0.49 ±

0.46 l/min/m2) vs IABP (0.11 ± 0.31

l/min/m2); there were no significant

differences at any other time points

No difference in 30-day mortality

CI=cardiac index; LVEF=left ventricular ejection fraction;

PCWP=pulmonary capillary wedge pressure;

SVR=systemic vascular resistance.

IABP Impella

CI at baseline (I/min/m2) 1.7 1.7

CI with support 2.25 2.23

LVEF at baseline 28% 27%

LVEF at discharge 45% 35%

PCWP at baseline (mmHg) 22 22

PCWP after

implementation

20 19

SVR at baseline (dynes-s-

cm-5)

1,546 1,617

SVR after implementation 1,333 1,457

30-day mortality 46% 46%

ISAR-Shock RCT (n=26)

Hemodynamic Values Before and After Device Implantation

Improved hemodynamics has not translated into improved

outcomes with newer devices

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Randomized Data – IABP vs PVAD in AMICS16

IABP vs Impella CP6 Month Mortality 50%

Equivalent in Both Arms

IABP vs Impella 2.530 Day Mortality 46%Equivalent in Both Arms

TandemHeart Investigators n = 33

IABP (n=14) vs TandemHeart (n=19)

30 Day Mortality 36% vs 46%

Equivalent in Both Arms

ISAR-SHOCK n = 26 IMPRESS n = 48

Meta-Analysis 2017

Burkhoff D, et al. Am Heart J 2006;152:469Seyfarth M, et al. J Am Coll Cardiol 2008;52:1584Ouweneel D, et al. J Am Coll Cardiol 2017;69:358Ouweneel D, et al. J Am Coll Cardiol 2017;69:278Cheng J, et al. Eur Heart J 2009;30:2102

Transfusion, Bleeding Higher with PVAD

Meta-Analysis 2009

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The RCTs are Too Small, Too Underpowered

to Look at Clinical Outcomes…

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Serum Lactate Levels

ISAR-SHOCK, IABP vs Impella 2.5 N=25Seyfarth M, et al. J Am Coll Cardiol 2008;52:1584

Impress Trial, IABP vs Impella CP N=48Ouweneel D, et al. J Am Coll Cardiol 2017;69:358

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Matched Data: Impella vs IABP-Shock II18

Schrage et al. Circulation 2019; 139:1249-1258

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Matched Data: Impella vs IABP-Shock II19

48.5% vs

46.4%, p=0.64



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Matched Data: Impella vs IABP-Shock II cohort

• No difference in mortality

• No subgroups with benefit

• Higher rate of complications

Severe or life-threatening bleed (8.5% vs 3.0%, p<0.01)

Peripheral vascular complications (9.8% vs 3.8%, p=0.01)

Sepsis (35.3% vs 19.4%, p0.01)

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Value? Resource Impact?

J Inv Cardiol 2015; 27: 148-54

• Patient Level versus Practice Level Decisions

• Significant Impact of Novel Devices

• Tiered Approach to Device Choice

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With more complications come higher risk of mortality

and greater costs1

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1. Redfors B, Watson BM, McAndrew T, et al. Mortality, length of stay, and cost implications of procedural bleeding after

percutaneous interventions using large-bore catheters. JAMA Cardiol. 2017;2(7):798-802.

• In a retrospective study of patients (n=1,816) receiving transcatheter intervention

with large-bore catheters (PVAD), showed incidence of bleeding was 25.8% with

27.6% of those patients having more than one transfusion1

• Receiving more than one transfusion was associated with increased in-hospital

mortality. The mortality risk, hospital stay, and costs increased as the number of

transfusions increased1

Cost

Number of

transfusions

Patients with bleeding complications

were hospitalized 3 X as long as

patients without bleeding

complications and costs were 2 X

higher

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IABP delivers clear cost advantages in the treatment

of cardiogenic shock

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Hospital cost of PCI with

cardiogenic shock was

more than 2Xfor PVADs vs IABP1

J Invasive Cardiol. 2015 Mar;27(3):148-54

Tandem Heart/

Impella

IABP

$74,457

$36,584

(evaluation of 2010 and 2011 Medicare MEDPAR data)

INCREASED associated costs

with newer devices, including1:

• Increased use of blood

products

and associated lab costs

• Higher use of the OR due

to longer length of stay

DECREASED associated

costs with IABP, including1:

• Shorter intensive care (ICU) and

hospital length of stay (LOS)

• ICU: 7.11 vs. 8.74 days

• Hospital: 8.5 vs. 10.70 days

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Technology Assessment24

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Impella, a uniquely American device?

Sales 2017

US Outside US

Abiomed 2017 Annual Report

91% of Impella devices were

sold in the USA

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Trends in MCS use – The Risk Treatment Paradox

NIS Data 2004 – 2012 127,000 Patients with MCS + PCI

MCS increased from 1.3% to 3.4% of PCIs between 2004-12PVAD patients – older, more CHF, more CKD, more elective cases (lower risk!)IABP patients – c/w pVAD more likely to have

Acute MI 90% vs 52%Cardiogenic Shock 50% vs 23%Mechanical Ventilation 29% vs 16%

Unadjusted mortality lower (12.8% vs 20.9% with pVAD) but adjusted was similar OR 0.88 (0.70-1.09)

Khera et al. Am J Cardiol 2016; 117: 10-16

J Am Coll Cardiol 2014;64:1407–15

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Not sick enough? Detroit CSI Algorithm

1. In 41 pts, 85% survival to explant (up from 51% in historical controls)

2. Survival to discharge was 76%

3. LVEDP of >15?

4. RV involvement?

Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461

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Takeaways

• Use your best clinical judgment

• Nothing is free – more support = more cost / risk

• Goal: Use hemodynamics to guide you to the right device for the right patient

as soon as possible

before multisystem organ failure develops.

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Support in Cardiogenic Shock29

Atkinson et al., A practical approach to MCS

J Am Coll Cardiol Interv 2016; 9: 871-83

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Case Presentation

• 55 yo man with HTN became unresponsive and pulses immediately after coitus with his wife.

• He had been complaining of chest pains on exertion for 2-3 weeks

Saw ER twice, ruled out

Scheduled for output nuclear stress

• Wife started CPR and called EMS

• Arrived to OSH in PEA arrest.

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Case Presentation

• 3 rounds of epinephrine → Vfib.

• Amiodarone 300 mg IV + 200 J → ROSC

• 20 minutes of ‘down’ time

• ECG showed ST elevation anteriorly

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Case Presentation

• Transferred, in transit has recurrence of PEA arrest on arrival. CPR. Epi 1 mg x 2, Amio→Vfib. and Defib x 2 to sinus 92 bpm, BP 130/60.

Additional 10 minutes of down time

• Lactate >10.0

• ABG pH 6.96, pCO2 66, pO2 57, bicarb 17. Sat 72% on 100% FiO2 PEEP 12.

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Should we take this guy now?

• Severe lactic acidosis

• Low pH

• Prolonged down time

• PEA arrest initially

• Unstable arrhythmia

• Witnessed arrest

• Bystander CPR

• Vfib rhythm

• Young age, male

• Lack of comorbidities

• Cardiac cause

• Purposeful movements

33

Unfavorable prognostic factors Favorable prognostic factors

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Echo

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Case Presentation

• 4 hour lactate 4.2, 24 hours 1.8

• Resolution of acidemia, hypoxemia at 12 hours

• Weaning of vasopressors, FiO2

• EEG, CT negative

• IABP removed HD#3

• Extubated HD#4

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1 week later

• MMSE 29

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Case

• 63 yo woman with HTN, HLP, DM, PAF, MVR (RHD) p/w palpitations 2 hours after MVA

• Initially felt fine after accident, +seatbelt, but has sensation of racing heart. No SOB, dizzy, LOC, edema. Chest pressure 2 hours after.

• ED: BP 140/91, HR 120, RR 16, 99% RA

Comfortable conversant, walking around ED

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Case

• CT-Angio negative

• ECG Afib with RVR

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Case

Troponin–

I

Lactate Anion

Gap

BNP

Presentation 0.32 3.9 13 62

7 hrs 4.0 7.1 572

13 hrs 5.41 >11,

pH 7.07,

pCO2 36,

pO2 404

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CXR

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Cath

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Echo

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Other points

• After Impella CP placement,

• Lactate 11 -> 5.0 -> 2.9 over 12 hours

• Transfer to LVAD center

• After 4 days hemolysis led to replacement with TandemHeart

• Full recovery without LVAD

• EF recovers over several weeks back to normal

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the detrimental impact of chronic renal insufficiency · case presentation •transferred, in...

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