Cardiogenic Shock: Risks and Benefits of Available Treatment - - PowerPoint PPT Presentation

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Cardiogenic Shock: Risks and Benefits of Available Treatment - - PowerPoint PPT Presentation

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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 Speakers Bureau Clinical

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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

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SLIDE 2

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 device

2 Early diagnosis and early MCS intervention

Which MCS device is appropriate for the stage

  • f 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?

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Cardiac Support Strategies

Strategy Therapy / Device Mechanism Medical Management Inotropes Increase Contractility, HR Counterpulsation IABP Aortic Pressure Augmentation Extracorporeal Bypass Pump TandemHeart LA -> AO flow ECMO RA -> AO flow Implantable Transvalvular Pump Impella 2.5 LV -> AO flow Impella cVAD Impella 5.0

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Comparison of devices

J Inv Cardiol 2015; 27: 148-54

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Cardiac Power Output (Watts) Estimated In-Hospital Mortality (%) 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

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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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Onset systole deflate Adjust timing

Diastolic pressure  CO  MAP  LV Wall Tension  PCWP  Oxygen Demand  LV Volume  Coronary Blood Flow  or ➔

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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

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Using the 50 cc IABP

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  • 8 Fr Catheter
  • 20-30% More Displacement
  • 20-30% Greater Diastolic

Augmentation

  • 20-30% Greater Afterload

Reduction

n =

Pre- IABP Post- IABP

P 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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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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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%

  • f 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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NEJM 2012; 367: 1287- 96

87% of IABP placed after PCI 10% 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

  • utcomes with newer devices

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Randomized Data – IABP vs PVAD in AMICS

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IABP vs Impella CP 6 Month Mortality 50%

Equivalent in Both Arms

IABP vs Impella 2.5 30 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;152:469 Seyfarth M, et al. J Am Coll Cardiol 2008;52:1584 Ouweneel D, et al. J Am Coll Cardiol 2017;69:358 Ouweneel D, et al. J Am Coll Cardiol 2017;69:278 Cheng 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=25

Seyfarth M, et al. J Am Coll Cardiol 2008;52:1584

Impress Trial, IABP vs Impella CP N=48

Ouweneel D, et al. J Am Coll Cardiol 2017;69:358

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Matched Data: Impella vs IABP-Shock II

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

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Matched Data: Impella vs IABP-Shock II

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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

  • f cardiogenic shock

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Hospital cost of PCI with cardiogenic shock was

more than 2X

for 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 Assessment

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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 2004-12 PVAD 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 Shock

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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

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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 24

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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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