1. Advance Heart Failure Therapy
Susan George, APRN- CNP, CCNS, CCRN, CHFN

2. Epidemiology of Heart Failure10 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
Heart Failure Patients in US
(millions)
4.9
4.8
3.5
1991
2000
2005
2037

3. Prevalence of HF Heart Disease and Stroke Statistics—2012 Update
Prevalence of heart failure by sex and age (National Health and Nutrition Examination Survey: 2005–2008). Source: National Center for Health Statistics and National Heart, Lung, and Blood Institute.

4. Hospital discharges for HF
Heart Disease and Stroke Statistics—2012 Update
Hospital discharges for heart failure by sex (United States: 1979–2009). Note: Hospital discharges include people discharged alive, dead, and status unknown. Source: National Hospital Discharge Survey/National Center for Health Statistics and National Heart, Lung, and Blood Institute.

5. Medicare Expenditures for Heart Failure
According to 2009 report direct and indirect cost of HF was 27.9 billion dollars

6. Definition of HF
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
The cardinal manifestation of HF are dyspnea and fatigue, which may limit exercise tolerance and fluid retention, which may lead to pulmonary congestion and peripheral edema

7. HF: Systolic v. Diastolic
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.
Heart Failure due to myocardial dysfunction is separated into two categories: Systolic and Diastolic dysfunction.

8. Classification of Heart Failure
Functional classification: NYHA class (I-IV)
Staging of HF: ACC/AHA stages (A,B,C,D)

9. ACC/AHA staging of HF
NEJM. 2003;Volume 348:

10. Management of HF Life style modification Medications
Electrical Therapy
Advanced HF therapy - Transplant/ Mechanical circulatory support (MCS).

11. Heart failure and exercise intolerance
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
In the 1970’s exercise training of HF pts was discouraged due to concerns of worsening symptoms and detriment to the disease process itself. Early observations in the 1980’s documented improvements in exercise function for patients with HF with a low rate of complications. These observations were followed by a series of studies that demonstrated that significant biochemical and functional abnormality in skeletal muscle are present in patients with HF and play a large role in the exercise intolerance. Inactivity is in part responsible, leading to muscle atrophy. In addition skeletal muscle utilizes high energy phosphates in an inefficient manner, as a result lactic acid accumulates at a more rapid rate than in normal controls, contributing muscle fatigue and limited exercise capacity. Skeletal muscle dysfunction can also involve the respiratory muscles, which may contribute to fatigue and dyspnea on exertion. These biochemical and functional abnormalities, when added to deconditioning can result in even greater impact on physical function
Limitations of activity not only may impair exercise capacity but also may produce adverse psychological effects and impair peripheral vasodilatory response

12. Effects of exercise training in HF
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
VO2 max (also maximal oxygen consumption, maximal oxygen uptake, peak oxygen uptake or maximal aerobic capacity) is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise, which reflects the physical fitness of the individual. The name is derived from V - volume, O2 - oxygen, max - maximum.
Accurately measuring VO2 max involves a physical effort sufficient in duration and intensity to fully tax the aerobic energy system. In general clinical and athletic testing, this usually involves a graded exercise test (either on a treadmill or on a cycle ergometer) in which exercise intensity is progressively increased while measuring ventilation and oxygen and carbon dioxide concentration of the inhaled and exhaled air. VO2 max is reached when oxygen consumption remains at steady state despite an increase in workload.

13. 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
Reduced neurohormaonal activity with decreased resting levels of angiotensin, aldosterone, vasopressin and natriuretic peptide

14. Advanced/End Stage HF Patient
Severe exercise intolerance
Heart failure wasting syndrome
Cardiorenal syndrome
Right heart failure
Inotrope dependence

15. Advanced/End Stage HF
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

16. Advanced HF therapy
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

17. Listing criteria for Heart transplantation
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

18. MCS Applications Bridge to transplantation Bridge to decision
Destination therapy
Bridge to recovery
A VAD can be used as a bridge to cardiac transplantation, as a bridge to decision (regarding transplant eligibility), as destination therapy (or permanent) therapy, or as a bridge recovery of heart function. Most patient receiving MCS for these indications receive an LVAD with <15% receiving biventricular support in the form of BiVAD or TAH.
BTT- Short-term or long-term LVADs can be used as BTT in patients with advanced HF with deteriorating clinical status who are or may be a candidate for heart transplantation but are too unstable to wait any longer without circulatory support. Not only LVADs life saving in these deteriorating patients who might otherwise die before a donor heart becomes available, but they can also improve secondary organ function prior to transplantation, reduce pulmonary hypertension, and enable improvement in nutritional status, all of which are associate with improved post-transplant survival. Due to stagnant number of donor hearts, an increasing number of patients have been requiring LVAD support for survival prior to transplantation
BTD- Many patients receive LVAD before a final decision regarding transplantation eligibility has been able to be reached. This is because many patients on inotropic agents or IABP support have secondary organ dysfunction or other potentially reversible medical conditions, which may be temporary contraindication for transplantation.
DT- Refers to long-term use of LVADs as an alternative to transplantation in patients with end stage HF who are considered to be ineligible for transplantation
BTR- There is now sufficient evidence that LV unloading with a LVAD can promote recovery of myocardial function

19. MCS landmark Study
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
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.
In the REMATCH trial 129 patients with end stage HF deemed ineligible for cardiac transplantation were randomly assigned to receive either optimal medical therapy or HM1 LVAD as permanent therapy. One year survival in the LVAD group was 52% in the LVAD group compared to 23% in the OMT group. Overall, all-cause mortality was reduced by 48% in the LVAD group. NYHA class and measures of QOL was significantly improved at 1yr f/u.
2yr survival was 23% in the LVAD group compared to 8% in OMT

20. Indication for BTT 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

21. Indication for DT
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%
On OMM including dietary/fluid restriction, diuretics, digitalis, BB, ald blockade agents, ACEI/ARB, but failing to respond
Analysis of mortality in LVAD patients shows that many die from irreversible organ dysfunction or comorbidities in the early post-op setting. These patients likely would have benefited from device insetrtion earlier in their disease course.
With increasing experience it is cler that an implant for DT should be performed on an elective basis, not a salvage procedulre. The patient must be a reasonable candidate for cardiac surgery with acceptable risk

22. Exclusion Criteria 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

23. 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

24. MCS candidacy
MCS pre-op evaluation data is presented to a multidisciplinary team and the candidacy s determined by the team.

25. Types of Devices
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
Short-term MCS: intended to support a patient with acute decompensated HF until patient recovers cardiac function 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. Indications are acute cardiogenic shock; postcardiotomy shock; cardiopulmonary failure; and high risk PCI

26. Types of Long-term MCS Left ventricular assist device (LVAD)
Biventricular support (BiVAD)
Total artificial heart (TAH)

27. Biventricular support (BiVAD)
Thoratec Paracorporeal VAD (P-VAD) – BTT- for patients with severe biventricular failure

28. Total artificial heart (TAH)
Syncardia TAH – BTT- for patients with severe biventricular failure

29. Evolution of Devices
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
First generation- Pulsatile positive displacement pumps which include HM XVE and Thoratec P-VAD. These devices provide excellent hemodynamic support and improved survival but have limitations, particularly limited long-term device durability, the need for extensive surgical dissection to implant , the presence of a large external lead, an audible pump and the need for medium-large body habitus.
HM II- Much smaller long lasting devices. Pump weighs 350 g and it approximately 7cm in length and 4cm at its largest diameter.

30. First generation pumps: HeartMate XVE
First generation- Pulsatile positive displacement pumps which include HM XVE and Thoratec P-VAD. These devices provide excellent hemodynamic support and improved survival but have limitations, particularly limited long-term device durability, the need for extensive surgical dissection to implant , the presence of a large external lead, an audible pump and the need for medium-large body habitus. Pump weighs 3.74 lbs. Average life expectancy of the pump was months

31. 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
The HeartMate II has been approved for BTT since 2008 and approved for DT in The device is an axial-flow system, similar to how a jet engine would work. It has a rotor that spins at high speeds to propel the blood through the pump. The pump normally sustains flows of 4-8 liters, but can pump up to 10 liters.
An axial-flow pump, or AFP, is a common type of pump that essentially consists of a propeller (an axial impeller) in a pipe. The propeller can be driven directly by a sealed motor in the pipe or by electric motor or petrol/diesel engines mounted to the pipe from the outside or by a right-angle drive shaft that pierces the pipe

32. HeartMate II High Speed Rotary Long Life Small Flexible Driveline
Quiet
Valveless
Textured Blood Contacting Surface
Cost Effective
Compared to the XVE, the HM II has many benefits. The high speed rotary system allows for greater and smoother flow. The HM II has an average life expectancy of 4-5 years instead of 18 months-2 years with the XVE. The HM II is smaller, quieter, and vibration free. Because of its small size it can be placed in patient’s with a smaller BSA. The driveline is smaller and more flexible which decreases infection risk. It is valveless which decreases the chance for clots forming. The textured blood surface allows for endothelial growth to occur which allows for smoother blood flow.

33. HeartMate II 1 Outflow Cannula Inflow Cannula Bend Relief Flex Section
Blood Pump
Percutaneous Cable Connection

34. HeartMate II Flow Inflow Stator Rotor Outflow Stator Outflow Bearings
The inflow and outflow stators straighten the path of blood as it flows through the pump. The bearings hold the rotor in place and allow it to spin at high speeds with ease
Inflow Stator
Outflow Stator
Rotor
Outflow Bearings
Inflow Bearings

35. HeartMate II

36. 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
The clinical basis from which hypotheses regarding the HeartMate II can be derived is rapidly growing.
Patients have been supported in excess of eight years.
There are over 5,500 patients currently on support worldwide

37. 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

38. Common HM II Externals Power sources System Monitor Display Module
- Power Module
- Batteries
System Monitor
Display Module
Battery Charger
Power module- Supplies main power to LVAD
Lithium batteries 12 – 14 hours of support on a pair of batteries
Simultaneously charges 4 batteries
Takes about 4 hours to charge a battery
Is lightweight and portable

39. HM II Post-op period ICU stay- 3-5 days IMC/Tele- 7-14 days
Rehab- some patients will need inpatient rehab

40. 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

41. HeartMate II
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

42. Transportation/Ambulation
Change patient to batteries
Take the black bag, which includes:
Charged batteries- minimum of one pair
Backup system controller
Disposable stethoscope

43. Activity instructions
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

44. Anti-Coagulation Guidelines
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

45. Complication Bleeding Pump thrombus/Hemolysis Infection
Stroke- Ischemic or hemorrhagic
Right hear failure- usually immediate post-op period

46. Quality of life means something different to every person.
Our goal in LVAD therapy is to increase quality of life as well as quantity….. But the focus is on quality.
We hope to restore hope in the lives of these patients and their family. Allow them to re-engage in day to day activities that most of us take for granted