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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
An
nu
al S
urv
ival
Rat
e
Ho
spit
aliz
atio
ns
/ ye
ar
.1
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