Treatment with ventricular assist devices

WHEN IT’S LATE

BUT NOT “TOO LATE” IN

HEART FAILURE:Ventricular Assist Devices

Mariell Jessup MD FESC, FAHA

Professor of Medicine

University of Pennsylvania

Philadelphia, Pennsylvania

Presenter Disclosure InformationWHEN IT’S LATE

BUT NOT “TOO LATE” IN HEART FAILURE:

Ventricular Assist Devices

I will discuss off label use or investigational use in my presentation.

I have financial relationships to disclose:

Employee of: University of Pennsylvania

Consultant for: none

Stockholder in: none

Research support to my program from:

Thoratec, HeartWare

Honoraria from: none

VADsventricular assist devices

Step #1:Evaluating the patient and

the full extent of the heart failure syndrome

Step # 2:The choice of VADsthe right pump for the right patient

• The good news

– Lots of pumps to choose from

• The bad news

– Limited availability at most hospitals

– Comparative trials infrequent

– Physician preference clouds a lot of the discussion

Sick patient

Temporary supportChronic support

Unclear situation

1. Support circulation

2. Oxygenate patient

Choice dictated by clinical status:

temporary support

ECMO

Durable VADspulsatile

non-pulsatile

Temporary support:Background

• Cardiogenic shock

– Compromise of cardiac output leading to end-

organ hypo-perfusion

– Complex cascade of end-organ dysfunction

combined with activation of inflammatory

pathways

– Complicates about 7% of ST segment elevation

MI1 and about 2.5% of non-ST segment

elevation MI2

1Holmes DR Jr, Berger PB, et. al. Circulation 1999; 100:2067–2073.2Hasdai D, Harrington RA, et. al JACC 2000;36:685–692.

Who would benefit from temporary support?

Acute cardiogenic shock

Acute myocardial infarction

Acute myocarditis

Complications post MI

Papillary muscle rupture

Ventricular septal defect

Post cardiotomy failure

Acute on chronic (end-stage) heart failure

Electrical “storm”, or post-VT ablation

Drug overdose with myocardial depression

HypothermiaWindecker S. Curr Opin Crit Care 13:521–527. 2007

The pump choices for

the acutely ill patient.

• Intra-aortic balloon pump

• Extracorporeal membrane oxygenation

(peripheral cardio-pulmonary bypass)

• Tandem Heart

• Impella

• Traditional ventricular assist devices

• Total Artificial Heart

Percutaneous

Surgical

Advantages of Percutaneous Device

• Placed quickly

• Avoid need for “open surgery”

• Placed at many centers even those without

VAD or transplant program

• More easily removed in setting of recovery

• Placed by interventional cardiologists and

surgeons

• Allow for recovery or transport to another

center

Disadvantages of Percutaneous Devices

Bleeding

Limited to left ventricular support (except

ECMO)

Not for biventricular support

Not for RV support (?yet)

Ventricular arrhythmias

Ischemic limb

Unable to mobilize or rehab

Sepsis

ECMO

http://www.emedicine. medscape.com/article/904996-overview

ECMO - Advantages

Cardio-pulmonary bypass

Can be placed peripherally (without

thoracotomy)

The only percutaneous option for biventricular

support

The only option in the setting of lung injury

ECMO - Disadvantages

• Requires trained team and equipment

availability on-site and early in resuscitation

• Higher risk of infection, bleeding and

vascular injury

The Data - ECMO

• Several centers have reported their

experience with ECMO in the setting of

CPR/Cardiogenic shock

– Survival rates of 31 to 63%

Hoefer D, Ruttmann E, et. al. Ann Thorac Surg 2006;82:28 –34

Chen Y, Chao A, et. al. JACC 41:2, 2003: 197-203

Linden H, Wiklund L. et.al. Scand Cardiovasc J.2009

Intra-aortic Balloon Pump

IABP - Advantages

• Easily placed in the catheterization

laboratory or operating room

• Improves coronary perfusion

• Decreases afterload

• Decreases myocardial oxygen demand

• Can transport patient to another center

• Established technology that is widely

available

IABP Disadvantages

• Does not directly support cardiac output

• Limited support in the setting of tachycardia

and arrhythmia

• May be less effective in older patients with

significant atherosclerosis in aorta

Impella

Impella Advantages

• Small rotary pump

• Can be placed percutaneously from femoral

artery across aortic valve without need of

trans-septal puncture or venous access

• Can be easily removed

Impella Disadvantages

• Hemolysis – although not felt to be

clinically relevant

• Provides partial cardiac output support – up

to 2.5 liters/minute in percutaneous model

• Difficult to place in setting of severe

peripheral vascular disease

Impella: Datathe ISAR-SHOCK trial

Seyfarth M, Sibbing D., et. al. JACC 2008;52:1584–8

Improved cardiac power index No difference in survival

Tandem Heart

Tandem Heart Advantages

• Can be placed easily in the catheterization

laboratory

• Can supply up to 5 l/min flow

• Can be easily removed

Tandem Heart Disadvantages

• Requires trans-septal placement

• Difficult to place in setting of severe

peripheral vascular disease

Tandem Heart Data

• Compared to IABP in acute MI with shock

(n=41) (Single Center)

– Improved cardiac power index, decreased

lactate, improved renal function as compared to

IABP

– No difference in 30 day survival and more

complications in Tandem Heart group

Thiele H, Sick P, et al. Eur Heart J 2005; 26:1276–1283.

Tandem Heart Data

• Multi-center trial comparing Tandem Heart

and IABP in acute MI with shock (N=42)

– Tandem Heart improved cardiac output,

decreased PCWP and increased mean arterial

pressure as compared to IABP

– No difference in 30 day survival

– Similar complication rates

Burkhoff D, Cohen H. Amer Heart J, 152:3, September 2006.

Cheng, JM et al. European Heart J 2009; 30: 2102

30-day mortality

Cheng, JM et al. European Heart J 2009; 30: 2102

Limitations

• Studies done to date have been small and at

a limited number of centers

• Inclusion and exclusion criteria are

challenging in the setting of sudden shock

• Populations studied have been somewhat

heterogeneous including acutely and

chronically ill patients

• The data for “prophylactic use” to support

procedures is very encouraging

Conclusions: Percutaneous devices

• Circulatory support in the setting of

cardiogenic shock improves outcomes

• Most centers do not have access to surgical

ventricular assist devices

• Percutaneous assist devices play an

important role in providing rapid support in

cardiogenic shock and support for high risk

procedures and can be used at many centers

• Additional studies are needed to define the

role of these important tools

Sick patient

Temporary supportChronic support

Unclear situation

1. Support circulation

2. Oxygenate patient

Choice dictated by clinical status:

temporary support

ECMO

Durable VADspulsatile

non-pulsatile

Blood Pump TechnologyBlood Pumps

Pulsatile TAHRotary

• Thoratec PVAD

• HeartMate XVE

• WorldHeart, Novacor

•Arrow LionHeart

• Thoratec IVAD

•AbioMed, AB5000

• Berlin Heart EXCOR

• Medos HIA

• WorldHeart, HeartSaver

White font = FDA/CE Orange font = CE Mark(* US clinical trial)

Yellow font = R or D phase

Axial

• MicroMed DeBakey*

• Berlin Heart INCOR

• Jarvik 2000

• HeartMate II

•Circulite

•Impella

Centrifugal

• VentraCor, VentrAssist

• HeartMate III

. Terumo, DuraHeart

• HeartWare

• WorldHeart/Levacor

• Arrow, CorAide

•Levotronics

•Tandem Heart

• Abiomed, AbioCor

• CardioWest

Red font -No longer available

Issues in the implantation of

durable VADs

• Proper selection of patients

– Recognizing the patient who is “too sick”, with end-

organ damage

– Recognizing the patient who is too debilitated or

malnourished

– Recognizing the patient who needs bi-ventricular

support

• Timing of surgery

– Especially important in the elderly “destination”

patient

HFA/ESC: Advanced heart failure

HFA/ESC: Advanced heart failure

1. Critical Cardiogenic Shock: low BP unresponsive to support, compromised

organ perfusion.

2. Progressive Decline: not in imminent danger but worsening despite inotropic

support, with declining renal function, nutrition, ambulation, other.

3. Stable but Inotrope dependent: unable to be weaned from inotropic support.

4. Recurrent advanced heart failure: recurrent congestion despite good

maintenance, needing repeated interventions beyond escalation of oral

diuretics.

5. Exertion intolerant: comfortable at rest without obvious fluid overload but

limited activities of daily living (ADL).

6. Exertion limited: comfortable at rest and with ADL but meaningful activity

limited.

7. Advanced NYHA Class 3.

Clinical Patient Profiles

Stevenson et. al. JHLT 2009;28: 535

Profiling the patient with

severe

heart failure…….

The profile determines

the prognosis

Stevenson et. al. JHLT 2009;28

Evolution Toward Rotary Pumps

INTERMACS: Survival after LVAD Implant

0

50

100

150

200

250

300

350

400

450

2006 Jul-Dec 2007 Jan-Jun 2007 Jul-Dec 2008 Jan-Jun 2008 Jul-Dec 2009 Jan - Jun

Pulsatile

Intracorporeal

Pump

Continuous Flow

Intracorporeal Pump

Imp

lan

ts/ 6 m

on

ths

Cont Intra Pump 1 0 0 108 323 355

Puls Intra Pump 71 122 99 103 40 21

Puls Para Pump 10 10 16 17 8 9

Pulsatile

Paracorporeal

Pump

Rogers et al. presented at ISHLT 2010

Early Constant

Risk Factor Hazard ratio p-value Hazard ratio p-value

Female 1.71 0.04 --- ---

Age (older) 1.141 0.006 1.131 0.008

Previous CABG 2.71 <0.0001 --- ---

Previous Valve Surgery 1.99 0.01 --- ---

Dialysis (current) 2.45 0.01 --- ---

INR (higher) 1.492 0.003 --- ---

Ascites 2.32 0.002 --- ---

RVEF: Severe --- --- 2.33 0.04

RA Pressure (higher) 1.523 0.02 --- ---

Cardiogenic Shock 1.98 0.003 --- ---

BTC or DT --- --- 3.00 0.01

Pulsatile pump --- --- 3.02 0.001

1 Hazard ratio denotes the increased risk with a 20 year increase in age

2 Hazard ratio denotes the increased risk with a 1.0 increase in INR

3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure

INTERMACS: Survival After LVAD Implant

Adult Primary Intracorporeal LVADs (n=1366)

Rogers et al. presented at ISHLT 2010

Patient thresholds for LVAD insertion parallel

objective survival and functional data. HF patients

would be receptive to referral for discussion of

LVAD by the time expected mortality is

12 months and activity remains limited to 1 block.

“one year or 1 block”

Sick patient

Temporary supportChronic support

Unclear situation

1. Support circulation

2. Oxygenate patient

Choice dictated by clinical status:

temporary support

ECMO

Durable VADspulsatile

non-pulsatile