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Margarita Camacho MD, FACS

Surgical Director

Cardiac Transplant and Mechanical Assist Device Program

RWJ/Barnabas Health Heart Centers at

Newark Beth Israel Medical Center

Newark, NJ

Chronic Mechanical Support for

Heart Failure

Chronic Mechanical Support for

Heart Failure

• Sunshine Heart, Inc. Consultant

DisclosuresDisclosures

1. JACC HF. 2013;1:1-20.

2. Rose EA, et al. Long-term mechanical left ventricular assistance for end-stage heart failure.

N Engl J Med. Nov. 2001;5;345(20):1435-43.4. Rogers, Butler, Lansman, et al. J Am Coll Cardiol. 2007;50:741-47.

5. Hershberger, Nauman, Walker, et al. J Card Fail. 2003;22:616-24.

6. Gorodeski, Chu, Reese, et al. Circ Heart Fail. 2009;2:320-24.

7. Data on file. Pleasanton, Calif: Thoratec Corp.

Heart failure is a growing issue in the US…

•~6.0 million adults (2.8%) in the US have heart failure

–670,000 new cases each year

•#1 reason for hospitalization in people >65

–After 4 hospitalizations, median survival is <6 months

• More costly than all forms of cancer combined

Heart Failure is a major driver of morbidity and mortality in the US1-7

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1. Current estimates of adult patients with advanced heart failure (HF) in the United States, with projected left ventricular assist device (LVAD) candidates. U.S. population estimate is derived from U.S. Census data. Estimate of HF prevalence is derived

from latest American Heart Association (AHA) statistics.2. UNOS Website: http://optn.transplant.hrsa.gov

3. O’Connell. Advanced Heart Failure Therapies Forum, Atlanta. 2013.

Transplants are considered the ‘gold standard,’ but

the supply of donor hearts is limited1

“Proposing heart transplantation to cure heart failure is analogous to proposing the lottery to cure poverty.”

– LW Stevenson3

2

11 2

1

HEART TRANSPLANTSKaplan-Meier Survival

(Transplants: January 1982 - June 2010)

HEART TRANSPLANTSKaplan-Meier Survival

(Transplants: January 1982 - June 2010)

ISHLT 2012 Survival is based on adult and pediatric transplant recipients

N = 96,273

N at risk at 25 years = 112

J Heart Lung Transplant. 2012 Oct; 31(10): 1045-1095

Adult Heart Transplants

% of Patients Bridged with Mechanical Circulatory Support* (Transplants: January 2000 – December 2013)

Adult Heart Transplants

% of Patients Bridged with Mechanical Circulatory Support* (Transplants: January 2000 – December 2013)

* LVAD, RVAD, TAH, ECMO

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

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

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Timing – earlier referral is bestTiming – earlier referral is best

• Identify candidates who will benefit from MCS

• Avoid end-organ damage

• Improve quality of life

• More rapid post-operative recovery if referred

before co-morbidities begin to appear, i.e. renal

dysfunction

• If referred earlier, they can be kept on the radar

and receive timely intervention, rather than no

intervention due to “too late” referral

• Avoid patients who are “too sick” to benefit

� Bridge to Transplant

� Non-reversible left heart failure

� Imminent risk of death

� Candidate for cardiac transplantation

� Destination Therapy

� NYHA Class IIIB or IV heart failure

� Optimal medical therapy

� Not candidate for cardiac transplantation

� Bridge to Recovery

� Young patients with myocarditis or post-partum cardiomyopathy

BTT vs. DT

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Profiling the patient with severe heart failureProfiling the patient with severe heart failure

• Profile 1: Cardiogenic shock

• Profound hypotension despite rapidly escalating

inotropic support; acidosis; “crash and burn”

• Profile 2: Progressive decline

• Declining function despite IV inotropes, possible

worsening renal function; “sliding on inotropes”

• Profile 3: Stable but inotrope-dependent

• Continuous IV inotropes +/- IABP or other mechanical

supposrt, unable to be weaned

Profiling the Patient…….Profiling the Patient…….

• Profile 4: Resting symptoms

• Daily congestion at rest or during ADL (activities of

daily living)

• Profile 5: Exertion intolerant

• Comfortable at rest or with ADL, but unable to engage

in any other activity, living predominantly within house

• Profile 6: Exertion limited

• Comfortable at rest and with ADL.

• Profile 7: Advanced NYHA III

• Living comfortably with meaningful activity limited to

mild physical exertion

Mechanical Circulatory Support (MCS)Mechanical Circulatory Support (MCS)

• Mechanical pumps using either axial or centrifugal flow that supplement or

replace the blood flow generated by the native heart

First generation HM XVE

Second generation HM II

Third generation HM 3/ HVAD

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� NYHA FC IV

� Life expectancy <2 years

� Failure to respond to optimal medical management

� LVEF ≤25%

� Refractory cardiogenic shock or cardiac failure

� VO2 ≤12 mL/kg/min

� Need for IV inotropes therapy

� Recurrent symptomatic sustained VT or VF in the

presence of an untreatable arrhythmogenic substrate

Indications for LVAD Placement

� Age >75 years

� CKDz with creatinine > 2.5 mg/dL

� Severe chronic malnutrition (BMI <21 (M) / <19 (F)

� Morbid obesity (BMI >40 kg/m2)

� Mechanical ventilation

� Severe mitral stenosis or moderate to severe aortic

insufficiency

Relative contraindications

Contraindications

� Potentially reversible cause of heart failure

� High surgical risk for successful implantation

� Recent or evolving stroke

� Neurological deficits impairing the ability to manage device

� Coexisting terminal condition (eg, metastatic cancer,

cirrhosis)

� Abdominal aortic aneurysm ≥5 cm

� Biventricular failure in patients older than 65 years

� Active systemic infection or major chronic risk for infection

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� Fixed pulmonary or portal hypertension

� Severe pulmonary dysfunction (eg, FEV1 <1 L)

� Impending renal or hepatic failure

� Multisystem organ failure

� Significant underlying psychiatric illness or lack of social

support that may impair ability to maintain and operate

VAD

Contraindications

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VAD ComplicationsVAD Complications

• Right ventricular (RV) failure

• Aortic insufficiency

• GI bleed

• Pump thrombosis and hemolysis

• Drive – line infections (very rare in our

institution) = 0.06% ( compared to the 20%

in INTERMACS data)

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Ventricular device innovation

dramatically improves outcomes for patients with advanced heart failure

Ventricular device innovation

dramatically improves outcomes for patients with advanced heart failure

Pulsatile

Technology

Continuous Flow

Technology:

Full MagLev

Technology

Continuous Flow

Technology:

Axial Design

HeartMate XVE

HeartMate II

HeartMate 3

FDA Approved 2008

FDA Approved 2001

Investigational*

HeartMate® SNAP-VE LVADHeartMate® SNAP-VE LVAD

External control system promotes patient discharge

and mobility

Textured surfaces minimize

thromboembolic events and

anti-coagulation therapy

Able to supply up to 10 liters

per minute

HeartMateHeartMate

• Patients can ambulate and attend exercise classes

• Patients can be discharged home

• Important reduction in the complications of bed

rest

• Pulmonary insufficiency

• Bone demineralization

• Reduced muscular tone

• Decreased activity tolerance

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REMATCHREMATCH

Long-Term Use of a Left Ventricular

Assist Device for End-Stage Heart

Failure

N Engl J Med 2001; 345:1435-1443, Nov 15, 2001

REMATCHREMATCH

• Results (2-year follow-up)

• 54/61 (88%) medical patients died

• 41/68 (60%) LVAD patients died

LVAD therapy renders significant survival and

quality of life benefits compared with optimal

medical management for patients with end-stage

heart failure.

Park SJ, Tector A, Piccioni W, Raines E, Geljins A, Moskowitz A, Rose E, Holman W, Furukawa S, Frazier OH, Dembitsky W: Left

ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005 Jan;129(1);9-17

From extended follow-up (up to four years)

of REMATCH patients:

From extended follow-up (up to four years)

of REMATCH patients:

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REMATCH HeartMate PatientsREMATCH HeartMate Patients

HeartMate Destination PatientsHeartMate Destination Patients

Inflow CannulaInserted into the apex of the left ventricle

Outflow GraftAnastomosed to the ascending aorta

Preload Dependent Volume is important for VAD patients

Afterload SensitiveMaintain blood pressure MAP 70 – 80 mmHg

HeartMate II Design Features

Inflow Conduit

Outflow Graft

Bend Relief

Blood Pump

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Park SJ. AHA Scientific Sessions, November 2010.

Contemporary Destination Therapy Results

59%

83% 82%

0%

n= 259 213 169 120

Functional Status – NYHA Class I or IIFunctional Status – NYHA Class I or II

98 percent of patients were NYHA Class IV at baseline.

Pagani F, Miller L, Russell S,

JAAC: Vol 54, No 4, 2009.

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Adverse Event Rates

HM II Pilot Study vs HeartMate I

Adverse Event Rates

HM II Pilot Study vs HeartMate I

HM II Pilot

(n=46)

HM I BTT Study

(n=280)

Bleeding* 0.7 1.5

Driveline Infection 0.3 0.8

Stroke 0.1 0.4

TIA 0.1 0.2

Other Neuro 0.2 0.6

*Defined as bleeding events that require surgery to resolve bleed or result in death

(Events / Patient Year)

Improved Survival in High-Risk Patients with Smaller Implantable LVAD’s:

Single-Center Experience over 3 YearsM. Camacho M.D., D.A. Baran M.D., A. Martin NP, M.J. Zucker, M.D

Newark Beth Israel Medical Center, Newark, NJ

Improved Survival in High-Risk Patients with Smaller Implantable LVAD’s:

Single-Center Experience over 3 YearsM. Camacho M.D., D.A. Baran M.D., A. Martin NP, M.J. Zucker, M.D

Newark Beth Israel Medical Center, Newark, NJ

Materials & Methods

Results: Graphs

Results

Conclusion

The availability of smaller

implantable left ventricular assist

devices (LVAD’s) is associatedwith decreased in-hospital

mortality despite no decrease in

the acuity of this patient

population.

The single-institution, single-

surgeon experience is reported

over the past three years, from

August 2005 to September

2008. Seventy-one implantable

LVAD ’ s were implanted (30

Heartmate XVE ’ s, 34

Heartmate II ’ s, 2 MicroMed

DeBakey, 4 VentrAssist). The

majority of these devices were

placed as destination therapy.

The overall hospital mortality in

this high-risk group of patients

was 24.6%, with a significant

decrease in mortality

From 33% in 2005 to 12.5% in

2008. This coincided with a

trend towards the use of

smaller implantable LVAD ’ s

(22.2% in 2005 vs. 83.3% in

2008). While the hospital

survival in patients on

ventilatory supportpreoperatively (3 with

Heartmate XVE, 7 with

Heartmate II) was better than

overall survival (80% vs.

74.4%), the two deaths in this

group occurred in two of the

three Heartmate XVE patients.

The hospital mortality after

Heartmate XVE implant was

more than double that after

Heartmate II implant (26.7% vs.

11.8%).

A large single-center, single-

surgeon experience suggests

that the use of smaller

implantable LVAD ’ s isassociated with significantly

improved hospital survival

despite little or no change in

the acuity of this patient

population

Purpose

All patients were inpatients at

the time of surgery. 14% of the

patients were on ventilatory

support pre-operatively (4 in

2006, 3 in 2007, 3 in 2008) and

50% were in cardiogenic shock

on both intra-aortic balloon and

inotropic support prior to LVAD

implant.Materials & Methods

No deaths were attributed to

device malfunction or failure.

Causes of death included

prolonged sepsis with death

greater than one month

postoperatively (5), respiratory

arrest (4), coagulopathy (2),

progressive multi-organ failure

(2), hepatic failure (1), renal

failure due to atheroembolism

(1), intracranial hemorrhage (1),

depression and failure-to-thrive(1).

ResultsMaterials & Methods

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Inflow ConduitInserted into the apex of the left ventricle

Outflow GraftAnastomosed to the ascending aorta

Preload Dependent Volume is important for VAD patients

Afterload SensitiveMaintain blood pressure <90 mmHg

HeartHMate 3 Design Features

Inflow

ConduitOutflow

Graft

Driveline

Blood Pump

Fully Magnetically Levitated Left Ventricular

Assist System

Fully Magnetically Levitated Left Ventricular

Assist System

Three important feature design:

1) True magnetic levitation2) Artificial pulse

3) Internal sintering with textured titanium microsphere to allow for a

biocompatible surface

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HeartMate III*: Full MagLev Technology

Key Design Benefits: Optimized Geometry

–HeartMate III secondary flow paths are ~0.5 mm along the side, and ~1.0

mm pump above and below the rotor.

–Conversely, hydrodynamic bearings are typically operated with much

smaller gaps, 0.05 of a millimeter or so.

*In development. Not approved for clinical use

~ 0.5 mm along the side

~ 1.0 mm

top and

bottom

Fully Magnetically Levitated Left Ventricular

Assist System

Fully Magnetically Levitated Left Ventricular

Assist System

Augmenting the pulsatility – might benefit in AI/ bleeding/ thrombogenesis

System Monitor – Clinical ScreenSystem Monitor – Clinical Screen

Heart Mate II Heart Mate III

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Stroke: 12% (higher than expected)

- ischemic: 8%- hemorrhagic: 4%

Mild neuro: SZ or TIA : 8%

Bleeding: 38 % - post-op : 30%

- GI bleed: 8% (vs25%)

Infection: 36%- respiratory: 28%

- sepsis: 16%- drive line: 10%

Momentum 3 TrialMomentum 3 Trial

• The MOMENTUM 3 U.S. IDE Clinical Trial is a prospective,

multi-center, unblinded randomized study comparing the

HeartMate 3 LVAS to the HeartMate II® LVAS in advanced

stage heart failure patients (cls III/IV) as a non-inferiority trial

• Primary Endpoint

• Composite of survival to transplant/ recovery/ 6/ 24-

months of LVAD support free of debilitating stroke or

reoperation to replace the pump

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HM3 Inflow

cannula

HM3 Outflow cannula

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HM3 3D Inflow cannula

HM3 3D Inflow color cannula

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HM3

HM3

DeBakey DeBakey DeBakey DeBakey VADVADVADVAD®®®®

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Adult and Pediatric Size Jarvik 2000 Hearts

Jarvik 2000 FlowMaker®

Before-implant After-implant

Jarvik 2000 FlowMaker®

Before-implant After-implant

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Pericardial benefits

• No abdominal surgery

• No pump pocket

Cutaway of the HVAD™ Pump

HVAD™ Pump contains redundant stators (dual motors)

• Designed to function on a single stator without loss of therapeutic support.

• mitigates pump stoppage due to motor, pump connector, or driveline circuitry

failure.

Redundant Dual Motor Stators

Pump Motor Construction

The HeartWare® Ventricular Assist System

• Up to 10 liters of flow

• Advanced Impeller is the only moving part

� Hybrid magnetic / hydrodynamic suspension

� Wear-less system

• Two motors designed to provide power

redundancy

• Thin (4.2 mm), flexible driveline with fatigue

resistant cables

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Pericardial Placement of HVAD™ Pump

Pericardial Placement of HVAD™ Pump

HeartWare® System PeripheralsHeartWare® System Peripherals

IN THE HOSPITAL

AT HOME

HeartWare™ Controller with LCD display, audible alarms and 30 day data storage

HeartWare™ Monitor with pump parameters & flow waveforms

HeartWare™ Batteries & Charger: 2 Li-ION batteries last up to 12 hours

Cardiowest Total Artificial HeartCardiowest Total Artificial Heart

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hTEE IN MECHANICAL CIRCULATORY SUPPORT:

A COLLABORATIVE APPROACH

MARGARITA CAMACHO MDSurgical Director, Cardiac Transplantation and Mechanical

CLAUDIA GIDEA MDAttending, Advanced Heart Failure and Heart

Filling and Function are the Keys to Cardiac Performance

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Post-Op ManagementPost-Op Management

• Wean nitric oxide if used

• Plasma-free hemoglobin (normal less than

0.03) to rule out hemolysis

• Extubate after diuresis

• OOB in chair, and ambulate when Swan

removed

• Aggressive physical mobilization

• LVAD-only or RVAD-only support: judicious

weaning of inotropes

HeartMate Fully Implantable System*

Flexible Lifestyle

Eliminates the driveline and “around the

clock” worn equipment.

Forgiving Energy Transfer

High-efficiency, user-friendly wireless energy

transfer across a distance

Designed for Advanced Implantation and Robust

Battery Technology

Custom battery technology

Expected to last >3 yrs

Slow degradation

Reduced size

Increased reliability of electronics

Mobile Tethered Free

Breakthrough technology to advance mechanical circulatory support.

*In development. Not approved for clinical use.

Much improved but far from perfect……Much improved but far from perfect……

• GI Bleeding

• Von Willebrand factor deficiency

• Does non-pulsatility compromise vascular integrity?

• Pump Thrombosis

• Increasing incidence? (in the news….)

• Aortic Insufficiency

• High-risk re-operation to replace aortic valve

• Infection

• Less driveline (fixation/immobilization), occasional

pocket

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