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4/24/2017 1 Treatment Strategies for End Stage Heart Failure: Medications, Heart Transplantation and Pumps 1 1 Cesar Guerrero-Miranda M.D. Transplant Cardiology, Heart Failure and Mechanical Circulatory Support Baylor University Medical Center April 29 nd , 2017 Disclosures: No industry relationship. 2 2 Objectives How to define end stage heart failure. Review treatment options and strategies. Review indications and contraindications for heart transplantation and mechanical circulatory support. 3 3 Allen L A et al. Circulation 2012;125:1928-52 Clinical Course of Heart Failure 4 4 HF Stage D Terminology: Advanced HF Refractory HF End-stage HF Patients with marked HF symptoms even at rest equals definition of NYHA Class IV HF Recurrent hospitalizations despite GDMT Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5 5 5 Clinical Course & Events: Useful for Identifying Patients With Advanced HF Repeated (≥2) hospitalizations or ED visits for HF in the past year. Progressive deterioration in renal function (e.g., rise in BUN and creatinine). Weight loss without other cause (e.g., cardiac cachexia). Intolerance to ACE inhibitors due to hypotension and/or worsening renal function. Intolerance to beta-blockers due to worsening HF or hypotension. Frequent systolic blood pressure <90 mm Hg. Persistent dyspnea with dressing or bathing requiring rest. Inability to walk 1 block on the level ground due to dyspnea or fatigue. Recent need to escalate diuretics to maintain volume status. Progressive decline in serum sodium, usually to <133 mEq/L. Frequent ICD shocks. Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5

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Page 1: 14 Treatment Strategies for End Stage Heart Failure

4/24/2017

1

004/24/2017 04/24/2017 0

Treatment Strategies for End Stage Heart Failure: Medications, Heart Transplantation and Pumps

11

Cesar Guerrero-Miranda M.D. Transplant Cardiology, Heart Failure and Mechanical

Circulatory SupportBaylor University Medical Center

April 29nd, 2017

Disclosures: No industry relationship.

22

Objectives

How to define end stage heart failure. Review treatment options and strategies. Review indications and contraindications for

heart transplantation and mechanical circulatory support.

33

Allen L A et al. Circulation 2012;125:1928-52

Clinical Course of Heart Failure

44

HF Stage D

Terminology:

Advanced HF

Refractory HF

End-stage HF

Patients with marked HF symptoms even at rest

equals definition of NYHA Class IV HF

Recurrent hospitalizations despite GDMT

Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5

55

Clinical Course & Events: Useful for Identifying Patients With Advanced HF

Repeated (≥2) hospitalizations or ED visits for HF in the past year. Progressive deterioration in renal function (e.g., rise in BUN and creatinine). Weight loss without other cause (e.g., cardiac cachexia). Intolerance to ACE inhibitors due to hypotension and/or worsening renal

function. Intolerance to beta-blockers due to worsening HF or hypotension. Frequent systolic blood pressure <90 mm Hg. Persistent dyspnea with dressing or bathing requiring rest. Inability to walk 1 block on the level ground due to dyspnea or fatigue. Recent need to escalate diuretics to maintain volume status. Progressive decline in serum sodium, usually to <133 mEq/L. Frequent ICD shocks.

Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5

Page 2: 14 Treatment Strategies for End Stage Heart Failure

4/24/2017

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66

Treatment Options in Advanced HF

Inotropes

Transplantation

LVADs

Palliative care

77

Inotropic Therapy: Historical Data

Source: ACC.17 Presentations

88

Inotropic Therapy: New data

Source: ACC.17 Presentations

99

Inotropic Harm

Long-term use of either continuous or intermittent, intravenous parenteral positive inotropic agents, in the absence of specific indications or for reasons other than palliative care, is potentially harmful in the patient with HF.

Use of parenteral inotropic agents in hospitalized patients without documented severe systolic dysfunction, low blood pressure, or impaired perfusion, and evidence of significantly depressed cardiac output, with or without congestion, is potentially harmful.

I IIa IIb III

I IIa IIb III

Harm

Harm

Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5

1010

Cardiac Transplantation

Evaluation for cardiac transplantation is indicated for carefully selected patients with stage D HF despite GDMT, device, and surgical management.

I IIa IIb III

Cardiac transplantation considered gold standard for treatment of refractory end-stage HF

Yancy CW et al. 2013 HF Guidelines. J Am Coll Cardiol 2013 Jun 5

1111

In December 3, 1967Christiaan Barnardperformed the firsthuman-to-humanheart transplant atthe Groote SchuurHospital in CapeTown, South Africa.

1st Human Heart Transplant - 1967

Page 3: 14 Treatment Strategies for End Stage Heart Failure

4/24/2017

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1212

Indications for Heart Transplant1. Cardiogenic shock with reversible organ dysfunction.

2. Low cardiac output state or refractory HF requiring inotropes.

3. Class III-IV HF with poor exercise tolerance:

RHC: PSAP < 50 mmHg AND TPG < 15 OR PVR <3 WU AND SBP > 85 mmHG

4. Refractory ventricular arrhythmia.

5. Refractory angina.

The Journal of Heart and Lung Transplantation, Vol 35, No 1, January 2016

1313

Special Considerations

Congenital heart disease with or without associated ventricular dysfunction

Restrictive cardiomyopathies: Infiltrative (sarcoid, amyloid, Fabry’s ds,

hemochromatosis, endomyocardial fibrosis).

Idiopathic (must rule out constriction).

Hypertrophic, non obstructive cardiomyopathy.

Arrhythmogenic Right Ventricular Cardiomyopathy

The Journal of Heart and Lung Transplantation, Vol 35, No 1, January 2016

1414

Contraindications for Cardiac Transplant Severe systemic disease with poor survival. Severe peripheral vascular disease. Irreversible pulmonary hypertension (PVR >3) Severe COPD, emphysema or pulmonary dz. CVA with severe cognitive impairment. Uncontrolled diabetes with proteinuria, renal disease,

vasculopathy, neuropathy. Active infection, malignancy or bleeding. Ongoing substance abuse, smoking or other psychosocial

serious problems. Lack of family support or adequate financial resources. Severe obesity (BMI > 35, IBW >140%).

The Journal of Heart and Lung Transplantation, Vol 35, No 1, January 2016

1515

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

Surv

iva

l (%

)

Years

1982-1991 (N=21,391)

1992-2001 (N=39,913)

2002-2008 (N=24,485)

2009-6/2014 (N=20,577)

Adult Heart TransplantsKaplan-Meier Survival by Era

Median survival (years):1982-1991=8.5; 1992-2001=10.4; 2002-2008=11.9; 2009-6/2014=NA

All pair-wise comparisons were significant at p < 0.05.

(Transplants: January 1982 – June 2014)

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

The most effective treatment for end-stage heart disease Median survival 11.9

years 1-year survival: 88% 5-year survival: 75% 10-year survival: now

approximately 56%

1616

6954

116

48

12 5 6 50

10

20

30

40

50

60

0

20

40

60

80

100

120

1-4 5-9 10-19 20-29 30-39 40-49 50-74 75+

% o

f tr

an

spla

nts

Nu

mb

er o

f ce

nte

rs

Average number of heart transplants per year

Number of centers Percentage of transplants

Adult and Pediatric Heart TransplantsAverage Center Volume (Transplants: January 2009 – June 2015)

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

1717

Adult and Pediatric Heart Transplants:The number of transplants has remained flat over the last 15 years

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

Nu

mb

er o

f tr

an

spla

nts

Other

North America

Europe

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

Page 4: 14 Treatment Strategies for End Stage Heart Failure

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1818

Source: ACC.17 Presentations

1919

Types of Durable LVAD

Source: ACC.17 Presentations

2020

Indications for LVAD Placement• Bridge to Decision

• Bridge to Transplant

• Destination Therapy

• Bridge to Recovery

2121

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

ati

en

ts

Year of Transplant * LVAD, RVAD, TAH, ECMO

Adult Heart Transplants

% of Patients Bridged with Mechanical Circulatory Support*(Transplants: January 2000 – December 2014)

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

2222

Destination LVAD Eligibility

Broadly similar to transplant Coexistent illness with limiting prognosis Psychosocial instability, substance abuse, etc.

Less inclusive (compared to Tx) Severe Right heart failure

More inclusive (compared to Tx) Older patients (over 70 yrs old)Obesity: BMI up to 40 Creatinine up to 2pulmonary hypertension with PVR >3 DM, PVD, some infections not as problematic.

2323

Source: ACC.17 Presentations

Page 5: 14 Treatment Strategies for End Stage Heart Failure

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2424

Longterm Complications

GI Bleeding

Driveline Infections

Device Thrombosis

Hemolysis

AI

Stroke

Late RV failure

2525

Conclusions

Landscape of advanced HF has changed due to emergingspecialized therapies.

Heart transplantation remains the most successful therapyfor end stage cardiomyopathy, although severe donorshortage limits its beneficial only for a small fraction of thesepatients.

LVAD utilization is gaining increased acceptance as devicetechnology improves and transplantation rates remains flat.

Efforts to improve DT LVAD outcomes, perhaps nottransplantation, represents the greatest hope for addressingend stage heart failure.

2626

Baylor Heart Center App

2727

[email protected]

Thank you