Heart Mate II- An

Innovative Solution to
End Stage Heart
Failure
TRANSLATIONAL CHALLENGES IN DIAGNOSTICS, DEVICES AND THERAPEUTICS FINAL
PRESENTATION
BO GUAN
Heart Failure

 Incidence is 5.8 million in this country and over 23 million worldwide

 Annual cost in the United States is over 39 billion dollars.
 Symptoms
 Shortness of breath
 Fatigue and weakness
 Rapid or irregular heartbeat
 Increased need to urinate
Heart Failure Pathophysiology

 Any damaging or overloading that reduces the

efficiency of the heart can cause heart failure.
 Common causes
 Myocardial infarction
 Hypertension
 Amyloidosis
 Consequences of failure
 Fluid in the lungs
 Edema in the body for right side heart failure
 Fluid retention by the kidneys
Heart Transplant

 First developed in the 1960s

 Gold standard of therapy for end-stage heart failure
 Contemporary one- and three-year survival of 90% and 82%
 Limited number of organs available, about 4,000
 Mortality on the waiting list up to 45%.
LVAD

 Mechanical devices that circulates

blood throughout the body
 Used when the heart is too weak to
pump blood on its own
 Divert blood into an external circulatory
circuit
 Connects the left atrium or ventricle to
the aorta
 Consists of three components:
 The internal component of pump
implanted to the left ventricle
 A percutaneous driveline
 External components of a controller and
batteries.
Heart Mate II Indications

 A “bridge to transplantation”
 For candidates at risk of imminent death from non-reversible left
ventricle failure.
 “Destination therapy”
 For patients who are not candidates for heart transplant
 New York Heart Association Class IIIB or IV end-stage left ventricular
failure
 Places of use
 Inside and outside of the hospital,
 In ground ambulance, airplane, or helicopter.
Heart Mate II
Heart Mate II
Heart Mate II
Heart Mate II Installation

 Median sternotomy to open up the thoracic cavity

 Installation key steps
 Subdiaphragmatic pocket
 Anastomosis of outflow graft to lateral wall of ascending aorta
 Coring of apex of the left ventricle
 Inflow cannula placement in the left ventricle
 Driveline tunneling and fixation
 Initiation of pump support with inotropic support.
Apex of the Ventricle
Post Operative
 Intensive Care Unit
 Weaning of inhaled medications
 Extubation
 Weaning of inotropic support.
 Early mobilization and ambulation
 Daily physical therapy
 Nutrition is critical
 Enteral supplementation for patients who can’t eat
 Anticoagulation and antiplatelet therapy
 LVAD education
 Comfort and familiarity with alarms and accessories
 Care of the driveline
Complications

 GI bleeds
 Pump thrombosis
 Driveline infection
 Late aortic insufficiency
 Late RHF
Future Improvements
-3rd Generation
 Contact versus noncontact bearings
 3rd generation uses magnetic levitation,
 Allows for rotation without friction or wear
 Advantages
 Reduces clotting at prothrombic sites
 More efficient and durable
 DuraHeart™,Incor®, and HeartMate III
Future Improvements
-Beyond 3rd Generation
 Elimination of driveline- Primary goal
 Eliminates source of infection
 Power source is the main barrier
 Transcutaneous energy transfer- potential solution
 Reliability demonstrated at max of 2 years

 Efforts in making the device use more widespread

 Need to decrease the cost
 Need to ascertain efficacy in different patient populations
Outcomes- Positives

 Better quality of life

 More satisfaction with health and functioning
 Less distressed by symptoms from immediately pre-
operatively to post-operatively.
 Psychological distress was low
 Improvement in anxiety and depression
Outcomes- Negatives

 Quality of life scores of patients receiving LVAD

therapy are still lower compared with transplant
recipients
 Impose certain restrictions on social functioning
 Need to live close to a health care facility
 Travel can be hazardous because of the potential
development of emergency complications
 More self-care disability
 More dissatisfaction with socioeconomic areas of life
Economics of Heart Mate II

 Mean cost per quality-adjusted life-year $414,275

 Overall, not a cost-effectiveness strategy as a bridge-to-transplant
compared to traditional strategies
 Acquisition cost of the device is high: $150,720
 In the U.S- Insurance coverage varies between policies
 People paying out of pocket have very little chance of being able
to afford this device
Personal Take

 Heart Mate II really represents the best of biomedical innovations

 Enlightening to see the bio design process used in an invasive
device
 Very encouraging that the device is improving quality of life
 Validation of the process
 High price tag is temporary
 The “ultimate way” to improve healthcare