Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure Laura Coyle, MSN, ACNP-BC VAD Coordinator Advocate.

Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure

Laura Coyle, MSN, ACNP-BC

VAD Coordinator

Advocate Christ Medical Center

Impact of Heart Failure with an Aging Population

5+ million Americans*

Nearly 700,000 new cases per year*

More than 280,000 patients die of heart failure in the US each year*

- 2nd highest mortality at one year with optimal medical management

Impact of Heart Failure with an Aging Population

Nearly 250,000 patients are considered at high risk for repeated hospitalizations-More than 1 million hospitalized for worsening heart failure at a cost of nearly 35 billion*- 20% of hospitalizations are persons over 65*Currently 100,000 patients have advanced end-stage heart failure characterized by:- frequent hospitalizations- reduced quality of life- a complex therapeutic regimen, and a high mortality

rate+

*Rosamond W, Flegal K, Furie K, et al. Heart Disease and stroke statistics 2008 update: a report from the American Heart Association Statistics Committee and Stoke Statistics Subcommittee. Circulation. 2008: 117(4): 25-146

+American Heart Association. Heart Disease and Stroke Statistics: 2007 Update. Dallas, Texas: www.americanheart.org.

INJURY

Decreased Cardiac Function

Ventricular DilationDiastolic WallStress/Stretch

NeurohormonalActivation

Ventricular Remodeling

Heart Failure Symptoms(NYHA Class, Hospitalizations)

Death

CardiacSupport Device

Progression of Heart Failure

100

75

50

25

0I II III IV

1

10

NYHA CLASS

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Deceased

Adapted from Bristow, MR Management of Heart Failure, Heart Disease: A Textbook of Cardiovascular Medicine, 6th edition, ed. Braunwald et al.

Class III

25% of HF Patients

Frequent hospitalizations

Worsening symptoms despite drug therapy

Significant opportunity for new therapies

Survival RateHospitalizations

Natural History of Heart Failure

Treatment Options for Advanced Heart Failure

Optimal Medical TherapyBeta Blockers, ACE Inhibitors, ARBs, Aldosterone Antagonists, Diuretic Therapy, Oral Nitrates and Hydralazine, etc.

Electrophysiologic Testing and the Use of Devices in Heart Failure-Prophylactic ICD Placement-Biventricular Resynchronization Pacing

2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of hEart Failure in Adults. J. Am. Coll.

Cardiol. Published March 26, 2009

Advanced Surgical Interventions for End-Stage Heart Failure

Cardiac Transplantation “gold standard”-Severely limited by shortage of donors; only 2,163 heart transplants in 2008 in US*Ventricular Assist Device for Bridge to Transplant or Destination Therapy for patients ineligible for heart transplantation.

United States Department of Health and Human Services. www.unos.org Accessed April 23, 2009.

What is a Ventricular Assist Device?

A ventricular assist device (VAD) is an implantable device designed to partially replace the function of the failing heart, restoring circulation of blood flow to the body through mechanical circulatory support.

VADs are designed to assist either the right (RVAD) or left (LVAD) ventricle, or both at once (BiVAD). Which of these types is used depends primarily on the underlying heart disease and the pulmonary arterial resistance that determines the load on the right ventricle

Advanced Surgical Interventions for End-Stage Heart Failure

Use of Left Ventricular Assist Devices- Bridge to Decision

- Bridge to Recovery

- Bridge to Transplant

- Permanent Use for “Destination Therapy”

Non Study Device Implants

REMATCH Trail

Multi-Center Randomized Controlled Study designed for patients in Class IV (NYHA) end stage heart failure who did not qualify for a heart transplant. 68 patients randomized to XVE HeartMate LVAD61 patients randomized to optimal medical therapy

REMATCH Conclusion

DT51% 1-year survival in the LVAD group

27% 2-year survival in the LVAD group

OMT28% 1-year survival in the OMT

10% 2-year survival in the OMT

CHF Reunionat One Year

OMM Therapy Group

VAD Therapy Group

28 Alive52 Alive

CHF Reunionat Two YearsOMM Therapy

8 Alive

VAD Therapy

29 Alive

Beginning of Destination Rematch Study Conclusion- Therapy

Risk from death from any cause was 48% lower in the LVAD group

“Using an LVAD in patients with advanced heart failure improves survival and quality of life. An LVAD is an acceptable alternative therapy in some CHF patients”

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

Improved survival and quality of life with a LVAD

Long JW et al. Long-term Destination Therapy with the HeartMate XVE left Ventricular Assist Device: improved outcomes since the REMATCH study. CHF. 2005;11:133-138.

Patient Selection: Who benefits from a VAD?

New York Heart Association (NYHA) Functional Class III to IV or Refractory Heart FailureLeft Ventricular Ejection Fraction ≤ 25%Peak VO2 < 14 ml/kg/minSevere HF symptoms despite optimal medical therapy Inability to tolerate medical therapyRequiring inotropesDo not respond to biventricular pacingOne or more heart failure related hospital admissions in past 6 monthsIneligible for cardiac transplantation

Ventricular Assist DevicesProvide mechanical circulatory support to restore the circulation of blood flow to the body.

Decreases preloadDecreases cardiac workloadIncreases systemic circulation & tissue perfusionDecreases neurohormonal response

Indications for UseBridge to Decision/ Postcardiotomy/Failure to wean from BypassBridge to RecoveryBridge to TransplantPermanent Use for “Destination Therapy”

Ventricular Assist Devices

A VAD runs on electrical power 24 hours a day 365 days of the year.

Patients may connect to a power base unit to provide consistent power or connect to a set of batteries which must be changed every few hours (varies per device) to maintain a reliable power source. Patients must be connected to power at ALL times.

Ventricular Assist Devices

There are several many different VADs. All VADs have the following four parts:

An inflow cannula which takes blood from the ventricular to the pump

A pump

An outflow cannula that takes the pumped blood to the ascending aorta

A power source for the pump

Types of Ventricular Assist Devices: Pulsatile vs. Continuous Flow

Pulsatile VADs – mimic the natural pulsing action of the heart using positive displacement

Device Specific – preload/volume dependent

Continuous Flow – normally use either a centrifugal pump or an axial flow pump

Device Specific – HVAD vs. HM II LVAD

Indications for Use:Pulsatile vs. Continuous Flow

Pulsatile Devices

PVAD

IVAD

Heartmate XVE LVAD

Continuous Flow

Heartmate II LVAD

Heartware HVAD

FDA Approved Devices for Bridge to Transplant

PVAD/IVADHeartmate XVE LVADHeartmate II LVADHeartware HVAD (currently undergoing clinical trials)

FDA Approved Device for Destination Therapy

Heartmate XVE LVADHeartmate II LVAD (pending FDA approval 2009-2010)

IVAD PVAD

Biventricular Support

Portable TLC-II Driver

TLC-II® Portable VAD Driver

Mode ButtonMode

ButtonScroll ButtonScroll Button

Alarm Silence Button

Alarm Silence Button

Message DisplayMessage Display

External Power Light

External Power Light

VAD Full Lights

VAD Full Lights

Change Batt. A Light

Change Batt. A Light

Battery A

Battery A

Battery B

Battery B

Change Batt. B Light

Change Batt. B Light

External Power

External Power

Computer Input

Computer Input

Key Switch

Key Switch

Pneumatic ConnectionsPneumatic Connections

Full Signal InputsFull Signal Inputs

Normal Alarm

Normal Alarm

Urgent AlarmUrgent Alarm

Battery Clip

Battery Clip

TLC-II® Interface and Control Panel

Heartmate XVE Heartmate II

Components of a Ventricular Assist Device

Carry On Components of a Ventricular Assist DevicePower Base Unit System Display ModuleAll Batteries Emergency Power Pack Back-up System Controller/Driver Battery Module Battery Clips Battery Holster/Pocket Pack Cell Phone Daily Driveline Dressing Supplies Emergency Contact Information *Total Weight 72.5 lbs

Components of a Ventricular Assist Device

Heartware HVAD

HeartWare® System PeripheralsIN 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

SO why want a Ventricular Assist Device?IMPROVED Survival-Improved end organ function-Reduced hospitalizations for HFIMPROVED Quality Of Life-Return to normal activities of daily living-Live independently-Drive-Work-Travel

What They Look LikeCHF Infusion Clinic

PatientVAD Referral in ICU

Enjoying a Ride on his Motorcycle

Distance Traveled

Patient vacationing in San Juan, Puerto Rico

Patient in Puerto Rico following instruction to avoid bathes, swimming pools, and oceans

Patient enjoying the streets of

Madrid, Spain

Patient sightseeing in Seattle, Washington

Patient visiting New Orleans, Louisiana