Devices in Chronic Heart Failure : An Update · Clinical Laboratory Imaging Risk Scores • > 1 HF...

Devices in Chronic Heart Failure : An Update

Christos Ε. Charitos, MD, PhD, FECTSCardiac Surgery Division“Evaggelismos” Hospital

Athens - Greece

Συσκευές στη Χρόνια Καρδιακή Ανεπάρκεια :Νεότερα Δεδομένα

«Evaggelismos» Hospital – Cardiac Surgery Dpt

Disclosures


❑ None

HeartMate II(July, 2000)

Axial Blood Flow

HeartWare(March, 2006)

Centrifugal Blood Flow

HeartMate 3(June, 2014)

Left Ventricular Assist Devices - LVADs


Jarvik 2000(May, 2000)

INTERMACS Heart Failure Classification Profiles (NlH, June 2006)

1

2

3

4

7

5

6

PROFILE DESCRIPTION

«Crash and burn»

«Sliding on inotropes»

«Dependent stability»

«Frequent flyer»

«Housebound»

«Walking wounded»

«Placeholder»

Critical cardiogenic shock

Progressive decline on inotropic support

Stable but inotropic dependent

Resting symptoms – home on oral therapy

Exertion intolerance

Exertion limited

Advanced NYHA Class III symptomsNo Inotropes

HEMODYNAMIC - CLINICAL STATUS

InotropesInotropes

No Inotropes


10

15

20

25

30

35

40

2013 2014 2015 2016 2017

INTE

RM

AC

S p

atie

nt

pro

file

(%

)

15% 15%

19%

21%

16%

Goldstein DJ, JHLT 2019;38:352

INTERMACS 1

INTERMACS Patient Profiles : Distribution by Year of Implantation


10

15

20

25

30

35

40

2013 2014 2015 2016 2017

INTE

RM

AC

S p

atie

nt

pro

file

(%

)

15% 15%

33%33%

31%

33%

35%36%

33%

36%

32%

19%

17%

21%

16%


INTERMACS 1

INTERMACS 3


INTERMACS 2


10

15

20

25

30

35

40

2013 2014 2015 2016 2017

INTE

RM

AC

S p

atie

nt

pro

file

(%

)

15% 15%

33%33%

31%

33%

35%36%

33%

36%

32%

22%

19%

17%

21%

16%17%

15%

13%


INTERMACS 1

INTERMACS 4-7

INTERMACS 3


INTERMACS 2


15

20

25

30

35

40

45

50

2013 2014 2015 2016 2017

42.6%

38.9%

40.9%

43.2%45.2%

Dev

ice

Str

ate

gy (

%)

Destination

Device Strategy : Distribution by Year of Device Strategy Implantation



15

20

25

30

35

40

45

50

2013 2014 2015 2016 2017

42.6%

31.8

25.8%

38.9%

40.9%

43.2%

31.6%

45.2%

24.9%

33.6%

27.7%28.6%

24.1%26.0%

27.5%

Dev

ice

Str

ate

gy (

%)

Destination

Candidacy

Transplantation

Device Strategy : Distribution by Year of Device Strategy Implantation



10

20

30

40

50

60

70

80

2013 2014 2015 2016 2017

72%

64% 64%60%

46%

Pu

mp

Typ

e (

%)Axial Flow

Pump

Device Type : Distribution by Year of Pump Type



10

20

30

40

50

60

70

80

2013 2014 2015 2016 2017

54%

72%

64% 64%60%

28%

40%

46%

36%36%Pu

mp

Typ

e (

%)Axial Flow

Pump

CentrifugalPump

Device Type : Distribution by Year of Pump Type



ISHLT Mechanically Assisted Circulatory Support Registry :Third Annual Report

Centrifugal Flow LVAD (n = 6183)

Axial Flow LVAD (n = 10103)

Centrifugal vs Axial Continuous-Flow Left Ventricular Assist Devices : Survival


Months after

Implant

Centrifugal Flow LVAD

Axial Flow LVAD

12 81.1% 82.1%

24 72.4% 72.2%

36 65.8% 62.9%

48 60.5% 55.5%


HRAE : major bleeding, cerebrovascular accident, pump thrombosis, or thromboembolism

Centrifugal vs Axial Flow LVADs : Freedom from first hemocompatibility-related adverse event (HRAE)

Centrifugal Flow LVAD (n = 6183)

Axial Flow LVAD (n = 10103)

ISHLT Mechanically Assisted Circulatory Support Registry :Third Annual Report

Months after

Implant

Centrifugal Flow LVAD

Axial Flow LVAD

12 49.4% 61.0%

24 39.4% 51.4%

36 32.5% 46.3%

48 28.2% 43.0%



Event Pts (n) % Pts (95% CI) Events (n)

Any infection 163 35.2 (30.9 – 39.8) 241

Sepsis 42 9.1 (6.6 – 12.1) 47

Driveline 54 11.7 (8.9 – 14.9) 60

Bleeding 116 25.1 (21.2 – 29.3) 177

Requiring surgery 47 10.2 (7.6 – 13.3) 59

Castro-intestinal 28 6.1 (4.1 – 8.6) 35

Right Heart Failure 68 14.7 (11.6 – 18.2) 70

Requiring RVAD 31 6.7 (4.6 – 9.4) 31

Stroke 25 5.4 (3.5 – 7.9) 25

Ischaemic 18 3.9 (2.3 – 6.1) 18

Haemorrhagic 7 1.5 (0.6 – 3.1) 7

Neurologic dysfunction 19 4.1 (2.5 – 6.3) 20

Haemolysis 2 0.4 (0.1 – 1.6) 2

Pump thrombosis 0 0 (0 – 0.8) 0

Infection 35%

Bleeding 25%

Right Heart Failure 15%

Stroke 5%

Pump Thrombosis 0%

Gustafsson F, EHJ 2018;39:345

HM 3 : Adverse Events within 6 Months Post LVAD Implantation


“ The medical challenge is to match the right technologyto the right patientsat the right time, observing and respecting nature’s limits, thereby maximizing the chance of a successful outcome ”

O. H. Frazier

Improving Long-term Outcomes with LVADs


Improving Long-term Outcomes with LVADs

▪ Right Time = Referral

▪ Right Patient = Selection

▪ Right Device = Technology

▪ Nature’s limits = Experience

Infection 35%

Bleeding 25%


Stroke 5%

Pump Thrombosis 0%


Clinical Risk ScoresImagingLaboratory

• > 1 HF hospitalization in last year

• NYHA class III – IV

• Intolerance of GDMT HF drug

• Increasing diuretic requirement

• SBP < 90mmHg

• Inability to perform CPET

• 6MWT

• non-responder CRT

• Cachexia, weight loss

• Kansas City C/M Q Score (KCCQ)

• Minnesota Living with HF Q

• eGFR < 45 mL/min

• SCr > 1.8 mg/dL

• K+ > 5.2 or < 3.5 mmol/L

• Hyponatraemia

• Hb < 12 g/dL

• NT – proBNP > 1000 pg/ml

• Abnormal liver function tests

• Low albumin

• LVEF < 30%

• Large areas of akinesis/dyskinesia

• LV aneurysm

• Moderate / Severe Mitral

regurgitation

• RV dysfunction

• PA Systolic pressure > 50 mmHg

• Moderate / Severe Tricuspid

regurgitation

• Difficult to grade aortic stenosis

• Without respiratory variations IVC

• Seattle Heart Failure Model

(SHFM)

predicted survival < 80%

at 1 year

• Meta-Analysis Global Group

in Chronic HF

(MAGGIC)

predicted survival < 80%

at 1 year

Criteria to Trigger Referral


INTERMACS Heart Failure Classification Profiles (NlH, June 2006)

1

2

3

4

7

5

6

PROFILE DESCRIPTION

«Crash and burn»

«Sliding on inotropes»

«Dependent stability»

«Frequent flyer»

«Housebound»

«Walking wounded»

«Placeholder»

Critical cardiogenic shock

Progressive decline on inotropic support

Stable but inotropic dependent

Resting symptoms – home on oral therapy

Exertion intolerance

Exertion limited

Advanced NYHA Class III symptomsNo Inotropes

HEMODYNAMIC - CLINICAL STATUS

Inotropes

No Inotropes


Inotropes

«Golden»Period

forLVAD

Implantation

Patient’s Selection for Long-Term Mechanical Circulatory Support

Can we save this patient with NYHA class IV

and an EF<25% with an LVAD ?

Indications


Contraindications

• Life expectancy limited by non-cardiac origin to < 12 months

• Active, uncontrolled infection

• Intolerance to anticoagulant or/and antiplatelet therapies

• Refractory severe organ dysfunction / failure with any of the following :

❑ INR > 2.0 not due to anticoagulant therapy

❑ Total bilirubin > 2.5 mg/dl, shock liver, or biopsy proven liver cirrhosis

• COPD defined as FEV1/FVC < 0.7 and FEV1 < 50% predicted

• History of stroke within 90 days of LVAD implant

• Significant Peripheral Vascular Disease (PVD) with rest pain or ulcers

• Psychiatric disease / disorder, irreversible cognitive dysfunction, or psychosocial issues

Patient’s Selection for Long-Term Mechanical Circulatory Support


HepaticFunction Pulmonary

Function

NeurologicFunction

MultiorganFailure

Malignancy

Body Size

Age

RenalFunction

Psychosocial &Psychiatric conditions

InfectiousDiseases

NutritionalStatus

Non-CardiovascularConsideration

Intracardiacshunt Endocardial Tumor,

Thrombi

Ischemic Heart Disease

Right VentricularFunction

InotropicSupport

Arrhythmias

ValvularDisease

PulmonaryHypertension

Re-operation

CardiovascularConsideration

Selection of the Appropriate Candidate for a LVAD


Infections : The Most Common Adverse Event Post Implantation

▪ non – VAD infections (67%)

▪ VAD – specific infections (26%)

▪ VAD – related infections ( 7%)

Infection 35%

Bleeding 25%


Stroke 5%


Infections : The Most Common Adverse Event Post Implantation

▪ non – VAD infections (67%) Pneumonia 34%Blood Stream 31%Urinary Tract 24%Gastro-Intestinal 10%

▪ VAD – specific infections (26%) Mediastinitis 48%Blood Stream 48%Endocarditis 4%

▪ VAD – related infections ( 7%) Drive Line 83%Pocket 13%Pump / Cannula 4%

Infection 35%

Bleeding 25%


Stroke 5%


VAD – related Infections

Pocket InfectionDrive Line Infection :The Achilles' heel of the LVADS


The CET system replaces the

original LVAD controller, battery,

and monitor and eliminates the

need for a drive-line connection

7.2 hours

Wireless Coplanar Energy Transfer (CET) system in LVAD


Centrifugal – Flow LVADs : No Pocket, Intrapericardial Position


• Surgical Implant Technique• Systemic Inflammation• Oxidative Stress• Pump Flow Changes• Anticoagulation

• Loss of vWF Function• Angiodysplasias• Antiplatelet therapy• Anticoagulation

• Septic emboli• Left cavities thrombi • Aortic & carotid thrombi• Hypertension• Antiplatelet therapy

Hemocompatibility Mechanics

Pre-Implant Factors• Female sex• Prothrombotic geno/phenotype• Stroke or Vascular disease• Left Ventricular Aneurysm• Atrial fibrillation

PumpThrombosis

GIBleeding

Emboli

Hemocompatibility Related Adverse Events : major bleeding, cerebrovascular accident, pump thrombosis, or thromboembolism

Infection 35%

Bleeding 25%


Stroke 5%


vWF is a multimericglycoprotein synthesized andreleased by the endothelialcells involved in hemostasis &angiogenesis.

vWF defect reflects thebalance between degradationinduced by the shear stressand the endothelial release ofnew VWF triggered by thepulsatility.

von Willebrand Factor (vWF)


S

D

Mehra MR, NEJM 2019;380:1618

Minimizing the Risk of GI Bleeding


Minimizing the Risk of Pump Thrombosis and Stroke

Mehra MR, NEJM 2019;380:1618


Minimizing the Anti-Coagulation Target

INR : 1.5 – 1.9


JHLT. 2018;37:579

Chronic Mechanical Circulatory Support : Right Heart Failure

▪ Pre-Operatively

▪ Perioperatively

▪ Late-PostOperatively


ISHLT MCS Registry :Third Annual Report

Infection 35%

Bleeding 25%


Stroke 5%


Pre-Operative Evaluation of the Right Ventricular Function

1. Hemodynamic Data (RHC)

Right Ventricular Systolic Work

Index (RVSWI)

Pulsatility Index (PAPi)

2. Echo Data

Right Ventricular Dimensions

Tricuspid regurgitation

TAPSE

RV fractional area change – FAC

RV free wall peak longitudinal

strain

3. Laboratory Findings

Creatinine

Bilirubin

INR

Platelets

Albumins


Intra-Operative Side-effects on the Right Ventricle

ExtracorporealCirculation

Transfusions

Microthrombi /Air Embolism

Coronary Arteries Trauma

Hypoxic Pulmonary Vasoconstriction

Right VentricularTrauma

EndothelialDysfunction

TNF, IL-1b, IL-6


LVAD : Late-onset Right Ventricular Dysfunction

During the follow-up period (mean duration3.4 + 1.9 years, median duration 2.9 years,range 1.2 to 7.1 years,) 45% of the patientssupported with a Left Ventricular AssistDevice (LVAD) developed Right VentricularDysfunction with clinical manifestations ofperipheral congestion.

Charitos C, Nanas J, JHLT 2015;34:1604


Minimizing the Risk of Stroke

CONCLUSIONS AF may be associated with increasedmortality and HF hospitalization. Patients with AF alsomay have thromboembolic events at higher INR levels.

Enriquez AD, JACC 2014;64:1883

Left Atrial Appendage OcclusionInfection 35%

Bleeding 25%


Stroke 5%


Chronic Mechanical Circulatory Support : Progress in Survival

Months

Surv

ival

(%

)

Sidhu K, Trends Cardiovasc Med 2019 Jun 4. pii: S1050-1738(19)30077


HM 3 vs Heart Transplantation : Survival

84%78%

82%78%


Mechanical Circulatory Support in Chronic Heart Failure : An Update

1. There is no doubt that a lot of progress has been made in the field of chronic mechanical circulatory support

2. Particularly emphasized the improvements on survival, the decrease of GI Hemocompatibility Related Adverse Events (bleeding, and stroke) and the elimination of pump thrombosis

3. The rates of infections and right heart failure are still unacceptably high

4. Improvement in chronic MCS requires improved referral, selection, experience and technology

Conclusions


Devices in Chronic Heart Failure : An Update · Clinical Laboratory Imaging Risk Scores • > 1 HF...

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