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Advance Heart Failure Therapy
Susan George, APRN- CNP, CCNS, CCRN, CHFN
Epidemiology of Heart Failure
6 More deaths from heart failure (HF )than from all forms of cancer combined
4.9 million symptomatic patients; estimated 10 million in 2037
Incidence: About 550,000 new cases/year
Mortality: 10% within 1st year & 50% within 5yrs
The total estimated cost in 2009 was $27.9 billions
1991 2000 2005 2037
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Heart Disease and Stroke Statistics—2012 Update
Prevalence of HF
Heart Disease and Stroke Statistics—2012 Update
Hospital discharges for HF
Medicare Expenditures for Heart Failure
It is a complex clinical syndrome that can
result from any structural or functional cardiac disorders that impairs ability of the left ventricle to fill with or ejects blood
Definition of HF
Systolic dysfunction: Left ventricular ejection fraction
(LVEF) of less than 40% and is generally due to left ventricular enlargement.
Diastolic dysfunction: Impaired ventricular relaxation and distensibility resulting in an increase in ventricular filling pressures.
HF: Systolic v. Diastolic
Functional classification: NYHA class (I-IV)
Staging of HF: ACC/AHA stages (A,B,C,D)
Classification of Heart Failure
ACC/AHA staging of HF
NEJM. 2003;Volume 348:2007-2018
Life style modification Medications Electrical Therapy Advanced HF therapy - Transplant/ Mechanical
circulatory support (MCS).
Management of HF
Patients with HF have limited exercise capacity because of
dyspnea and fatigue. End stage HF patients have structural and functional
abnormality in skeletal muscle secondary to chronic hypoperfusion and physical deconditioning
Skeletal muscle dysfunction involving the respiratory muscles may contribute to dyspnea.
Heart failure patients have skeletal muscle atrophy and intrinsic skeletal muscular metabolic defects, leading to less efficient use high energy phosphates and more rapid accumulation of lactic acid
Exercise intolerance is also caused by hemodynamic disorders
Heart failure and exercise intolerance
Studies have shown that exercise leads to functional, pathophysiological, and hemodynamic improvement Enhanced peak/maximum VO2 (VO2 max) and
possibly peak cardiac output due to a higher workload achieved, and leg blood flow during exercise
Improved muscle energetics so that oxygen utilization becomes more efficient
Improvement in HF symptoms such as dyspnea and fatigue
Effects of exercise training in HF
Restoring autonomic cardiovascular control towards normal
by reducing sympathetic tone and increasing vagal tone Reduced neurohormaonal activity Improvement in endothelial function leading to vasodilation
of skeletal muscle blood vessel, possibly leading to increase in exercise capacity
Reduction in total peripheral resistance Reduction in plasma brain natriuretic peptide values Significant improvement in six-minute walk distance Significant improvement in NYHA functional class Exercise training may reduce HF related hospitalization and
improve health related quality of life
Effects of exercise training in HF
Advanced/End Stage HF Patient
• Severe exercise intolerance
• Heart failure wasting syndrome
• Cardiorenal syndrome
• Right heart failure
• Inotrope dependence
It is characterized by the presence of structural
myocardial disease and symptoms that limit daily activity (NYHA III/IV or stage D)
300,000 to 800,000 advance HF patients in US 20% stage D patients are younger than 65yrs- that is at
least 60,000 patients Cardiac transplantation provides increased longevity
and symptomatic relief Only 2200 organ donors in US Mechanical circulatory support with LVADs is a rapidly
evolving field and is a life saving therapy for patients with advanced heart failure
Advanced/End Stage HF
Transplant- When conventional medical
therapies are unsuccessful, cardiac transplantation is an option for treatment and to prolong life. Unfortunately, only 2200 patients each year receive heart transplants, because the number of patients awaiting transplants far exceeds the number of organs available.
Mechanical Circulatory support
Advanced HF therapy
Cardiopulmonary exercise testing: VO2 max
<14ml/kg/min if patients intolerant to BB; <12ml/kg/min in the presence of BB; or <50% of predicted VO2 in young patients (<50yrs) and women.
Acceptable pulmonary artery pressure Age <70 Diabetes well controlled Absence on neoplasm Psychosocial support
Listing criteria for Heart transplantation
Bridge to transplantation Bridge to decision Destination therapy Bridge to recovery
MCS Applications
REMATCH (The Randomized Evaluation of
Mechanical Assistance for the Treatment of Congestive Heart Failure) trial was the landmark study that approved the benefit of mechanical support for patients with end stage HF.
LVAD group showed significant improvement in survival and quality of life
MCS landmark Study
Non-reversible systolic HF- NYHA class IV Inotropic support, if tolerated No contraindication for listing as status 1A or
status 1B meet the following - Pulmonary capillary wedge pressure (PCWP) or pulmonary artery diastolic pressure (PAD) >20 mm Hg - Cardiac index < 2.2L/min/m or SBP <90 mm Hg Body surface area >1.2m
Indication for BTT
Advanced HF symptoms (class IIIB or IV) with one of
the following: - On optimal management, but failing to respond - Class III or IV HF and dependent on IABP and/or inotropes - Intolerant to ACE/ARB or BB Body surface are (BSA) >1.2 m Ineligible for cardiac transplant VO2 max <14ml/kg/min or <50% predicted VO2 max LVEF <25%
Indication for DT
Active systemic infection Uncorrectable aortic insufficiency Renal insufficiency that may require dialysis in
the near future History of cardiac transplant Any condition, other than heart failure, which
is expected to limit survival to less than 2 years
Exclusion Criteria
Pre-op MCS evaluation
Assessment of RV function
Nutrition Hemodynamics Renal function Gastrointestinal Hepatic function Hematology Coagulation
Peripheral vascular disease
Pulmonary function Infection Neurologic Psychosocial Psychiatric
MCS pre-op evaluation data is presented to a
multidisciplinary team and the candidacy s determined by the team.
MCS candidacy
Short-term MCS: intended to support a patient
with acute decompensated HF until patient recovers or until further long-term therapy is indicated based on recovery of end-organ function. Usually for few hour to days to less than 2wks.
Long-term MCS
Types of Devices
Left ventricular assist device (LVAD) Biventricular support (BiVAD) Total artificial heart (TAH)
Types of Long-term MCS
Thoratec Paracorporeal VAD (P-VAD) – BTT- for
patients with severe biventricular failure
Biventricular support (BiVAD)
Syncardia TAH – BTT- for patients with
severe biventricular failure
Total artificial heart (TAH)
1st generation- Pulsatile positive displacement
pumps- HeartMate XVE and Thoratec paracorporeal ventricular assist device (PVAD)
2nd generation: Continuous flow axial blood pump with an internal rotor- HeartMate II LVAD
Third generation- currently in development
Evolution of Devices
First generation pumps: HeartMate XVE
Second generation pumps: HeartMate II
HeartMate II is currently FDA approved for BTT and DT
Axial-flow, rotary ventricular assist system
Capable of flows up to 10 liters per minute
HeartMate II
High Speed Rotary Long Life Small Flexible Driveline Quiet Valveless Textured Blood
Contacting Surface Cost Effective
1
HeartMate II
Percutaneous Cable Connection
Bend Relief
Outflow Cannula
Blood Pump
Flex Section
Inflow Cannula
HeartMate II
Flow
Outflow Stator
Outflow Bearings
Rotor
Inflow Bearings
Inflow Stator
HeartMate II
More than 13,000 patients worldwide have now been implanted with the HeartMate II® LVAS.Over 5,500 patients on ongoing support Patients supported ≥ 1 year: 1,576 Patients supported ≥ 2 years: 883 Patients supported ≥ 3 years: 412 Patients supported ≥ 4 years: 161 Patients supported ≥ 5 years: 121 Patients supported ≥ 6 years: 26 Patients supported ≥ 7 years: 11 Patients supported ≥ 8 years: 1
HeartMate II
HM II system Controller
Microprocessor that: Delivers power to the pump Controls pump speed and
power Monitors, interprets &
responds to system performance
Performs diagnostic monitoring Indicates hazard and advisory
alarms Provides complete backup
system Automatic event recording Data logger capabilities
Power sources
- Power Module - Batteries
System Monitor Display Module Battery Charger
Common HM II Externals
ICU stay- 3-5 days IMC/Tele- 7-14 days Rehab- some patients will need inpatient
rehab
HM II Post-op period
Extensive patient and family education
regarding equipment handling and driveline exit site dressing change
Patient completes 7 modules and signs contracts of commitment and understanding
Aggressive PT/OT/Cardiac rehab Stabilize INR Dietary monitoring Set up home health if needed Discharge planning for community training
Post-op period
The HeartMate II is continuous flow, therefore
you may not feel a pulse Heart rate- only detectable by telemetry-
there may not be a palpable pulse! Blood pressure- may or may not be detected
with automatic BP cuff Arterial line monitoring or Doppler At each office visit check mean BP by Doppler Goal blood pressure is 70-90mmHg
HeartMate II
Transportation/Ambulation
Change patient to batteries
Take the black bag, which includes: Charged batteries-
minimum of one pair
Backup system controller
Disposable stethoscope
Many patients will need inpatient rehab Sternal precaution for 3 months No driving for 3 months No shower for 3 months No lifting over 5-10lbs for 2 months; then gradually
increasing Encourage regular exercise but avoid very strenuous
exercise Encourage patients get back to their regular hobbies No swimming or water aerobics Battery and controller should be secured well at all times
Activity instructions
Medications
Aspirin – prevents platelet aggregation Persantine – prevents platelet aggregation Plavix/Effient- occasionally used for platelet
inhibition Antiplatelets are adjusted based thrombo-
elastography (TEG) Coumadin- required, goal INR depends on
patients underlying comorbidities
Anti-Coagulation Guidelines
Bleeding Pump thrombus/Hemolysis Infection Stroke- Ischemic or hemorrhagic Right hear failure- usually immediate post-op
period
Complication