Advanced Heart Failure Therapies

Including LVAD

_________________George Lui, MD

Medical Director,

Adult Congenital Heart Program at Stanford

Prevalence of Heart Failure

1.2-2.2% of adults in the United States between ages 40-59 have heart failure

> 10% of adults over 80 years of age have heart failure

Affects about 5.7 million Americans

Over 500,000 new cases per yearMozzafarian D et al. Circulation 2016; 133: e38

What does the Normal heart do?

Pumps blood to the lungs and the body

Deoxygenated blood returns from the body and then goes to the lung to receive oxygen

Oxygenated blood returns to the heart and then is pumped to the rest of the body

What causes Heart Failure?

Congenital heart disease Coronary artery disease

– “heart attack” Valve disease Hypertension Diabetes Heart muscle disease Alcohol or drug use Abnormal rhythm

ACHD = Heart Failure

Bolger AP et al. Eu Heart J 2003; 24: 970-6

ACHD = Heart Failure

Alshawabkeh Curr Heart Fail rep 2016; 13: 247

ACHD = Heart FailureUnderlying Pathophysiology Examples

Cyanosis Eisenmenger Syndrome

Shunting ASD with left to right shunt

Abnormal anatomic/physiologic connection

Baffle stenosis in TGA Mustard/Senning

Multi-organ venous congestion Fontan circulation

Atrial arrhythmias TGA Mustard/Senning, Tetralogy of Fallot

Iatrogenic myocardial infarction Transecting coronary artery crossing RVOT

Pulmonary Hypertension Shunt related pulmonary hypertension

Dyssynchrony Chronic RV pacing

Increased LV mass and stiffness Coarctation of the aorta

Decreased systemic ventricular function

Systemic RV dysfunction in ccTGA

Decreased lung reserve Restrictive lung disease

Alshawabkeh Curr Heart Fail rep 2016; 13: 247

Symptoms of Heart Failure

Shortness of breath◦ Shortness of breath with exertion◦ Shortness of breath when lying flat

(orthopnea)◦ Shortness of breath at night (paroxysmal

noctural dyspnea) Swelling of the legs, abdomen Weight gain Fatigue

Stage A

At high risk, no structural disease

65 million pts/yr

Stage B

Structural heart disease,

asymptomatic10 mllion pts/yr

Stage D

Refractory HF

200,000 pts/yr

Therapy

• Treat Hypertension

• Treat lipid disorders

• Encourage regular exercise

• Discourage alcohol intake

• ACE inhibition

Therapy

• All measures under stage A

• ACE inhibitors in appropriate patients

• Beta-blockers in appropriate patients

Therapy

• All measures under stage A

Drugs:

• Diuretics

• ACE inhibitors

• Beta-blockers

• Digitalis

• Dietary salt restriction

Therapy

• All measures under stages A,B, and C

• Mechanical assist devices

• Heart transplantation

• Continuous (not intermittent) IV inotropic infusions for palliation

• Hospice care

Stage C

Structural heart dx prior/current

symptoms of HF5 milion pts/yr

Hunt, SA et al. ACC/AHA Guidelines CHF, 2001.

Treatment of Heart Failure

What is Stage D Heart Failure

Persistent shortness of breath at home

Recurrent volume overload despite maximal medical therapy

Recurrent hospitalizations

Hypotension or renal failure

Need for inotrope

Survival with Stage D Heart Failure

NEJM 2001; 345: 1435

Advanced Heart Failure Treatment Options

Chronic inotropes

Devices:

◦ Ventricular Assist Device (VAD)

◦ ECMO: Extracorporeal Membrane Oxygenation

Heart Transplant

Compassionate end-of-life care/hospice

Palliative Care Consultation

Adler Circulation 2009; 120: 2597

Devices

Implanted Cardiac Defibrillator (ICD)

Biventricular pacemaker (CRT)

Ventricular Assist Device (VAD)

ECMO(Extracorporeal Membrane

Oxygenation)

ICD indications

Khairy Heart Rhythm 2014; 11: e102-e165

CRT indications

Khairy Heart Rhythm 2014; 11: e102-e165

VAD indications

Bridge to transplant

Destination therapy

Bridge to candidacy

Bridge to recovery

What is a VAD?

Mechanical pump that assists the heart in pumping blood

VAD = Ventricular Assist Device LVAD = left sided VAD RVAD = right sided VAD

1st generation: Pump 2nd generation: Continuous (axial) 3rd generation: Continuous

(axial/centrifugal)

0

10

20

30

40

50

60

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

% o

f P

atie

nts

Year of Transplant

* LVAD, RVAD, TAH, ECMO

Adult Heart Transplants

% of Patients Bridged with Mechanical Circulatory Support*

2016

JHLT. 2016 Oct; 35(10): 1149-1205

(Transplants: January 2000 – December 2014)

Survival with VAD

NEJM 2009; 361: 2282

Complications with VAD

Infection

Bleeding

Thrombosis

Stroke

Sensitization

VAD in Congenital Heart Disease

Gelow JM et al JHLT 2013; 32: 1059

• Anatomic placement issues

• Scar tissue (multiple prior surgeries)

• Single ventricle s/p Fontan

VAD in Congenital Heart Disease

TGA s/p MustardSingle ventricle s/p Fontan

Total artificial heart

NEJM 2005; 351: 849

First Heart Transplant in the U.S.Norman Shumway - 1968

Adult and Pediatric Heart TransplantsNumber of Transplants by Year

18

7 32

2

67

1 1,2

61

2,3

57 2,9

98

3,5

25

3,8

22 4,5

28

4,7

54

4,7

35

4,9

39

4,8

38

4,8

02

4,6

83

4,6

02

4,5

15

4,2

00

4,1

10

4,0

44

3,9

13

3,8

38

3,8

07

3,9

36

4,0

01

4,0

13

4,0

42

4,0

71

4,1

63

4,2

33

4,2

54

4,4

77

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

Nu

mb

er

of

tran

spla

nts

NOTE: This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry. As such, the presented data may not mirror the changes in the number of heart transplants performed worldwide.

JHLT. 2014 Oct; 33(10): 996-1008

2015

JHLT. 2015 Oct; 34(10): 1244-1254

0

25

50

75

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Surv

ival

(%)

Years

CHD (N=2,217) ICM (N=42,892) NICM (N=46,174)

Retransplant (N=2,907) VCM (N=3,691)

Adult Heart TransplantsKaplan-Meier Survival by Diagnosis

2016

JHLT. 2016 Oct; 35(10): 1149-1205

Median survival (years):CHD=14.8; ICM=9.5; NICM=11.7; Retransplant=6.2; VCM=10.8

All pair-wise comparisons were significant at p < 0.05 except CHD vs. NICM.

(Transplants: January 1982 – June 2014)

Transplant Indications in CHD

Patients with Stage D HF refractory to medical therapy who will not benefit significantly from surgical, interventional or EP intervention

CHD patients with associated near-sudden death or life-threatening arrhythmias refractory to all therapeutic modalities

Patients with Stage C HF associated with reactive pulmonary HTN and a potential risk of developing fixed, irreversible pulm HTN

Ross HJ et al. Circulation 2016; 133: 802-820.

Challenges for ACHD patients

Complex anatomy

Pulmonary hypertension

Kidney, Lung, Liver disease

Obesity

Substance abuse

Allosensitization

Ross HJ et al. Circulation 2016; 133: 802-820.

Future Direction

Next generation VAD

Percutaneous VAD

Stem cell therapy

Gene therapies

Lacour-Gayet et al. Ann Thorac Surg 2009; 88: 17Rodefeld MD JTCVS 2010; 140: 529

Thank YouAdult Congenital Heart Program

Sue Fernandes, LPD, PA (Program Director)

Stafford Grady, MD

Christiane Haeffele, MD, MPH

Daniel Murphy, MD

Ian Rogers, MD, MPH

Anitra Romfh, MD

Joseph Wu, MD, PhD

Tara Drake, PA

Emily Dong, PA

Carrie Scribner, NP

Christy Sillman, RN, MSN

Jana Rubin

Maria Tirador

Chantel Cazarez-Davila

ACHD Sonographers

Beth Casilli

Anne Depucci

Xiu Tang

Lexi Vincent

Adult Congenital Cardiac Surgery

Frank Hanley, MD (Surgical Director)

Katsuhide Maeda, MD

Olaf Reinhartz, MD

Joseph Woo, MD