2Epidemiology of Heart Failure 106More deaths from heart failure (HF )than from all forms of cancer combined4.9 million symptomatic patients; estimated 10 million in 2037Incidence: About 550,000 new cases/yearMortality: 10% within 1st year & 50% within 5yrsThe total estimated cost in 2009 was $27.9 billionsHeart Failure Patients in US(millions)126.96.36.199991200020052037
3Prevalence 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.
4Hospital discharges for HF Heart Disease and Stroke Statistics—2012 UpdateHospital 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.
5Medicare Expenditures for Heart Failure According to 2009 report direct and indirect cost of HF was 27.9 billion dollars
6Definition of HFIt 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 bloodThe 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
7HF: 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.
8Classification of Heart Failure Functional classification: NYHA class (I-IV)Staging of HF: ACC/AHA stages (A,B,C,D)
10Management of HF Life style modification Medications Electrical TherapyAdvanced HF therapy - Transplant/ Mechanical circulatory support (MCS).
11Heart 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 deconditioningSkeletal 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 acidExercise intolerance is also caused by hemodynamic disordersIn 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 functionLimitations of activity not only may impair exercise capacity but also may produce adverse psychological effects and impair peripheral vasodilatory response
12Effects of exercise training in HF Studies have shown that exercise leads to functional, pathophysiological, and hemodynamic improvementEnhanced peak/maximum VO2 (VO2 max) and possibly peak cardiac output due to a higher workload achieved, and leg blood flow during exerciseImproved muscle energetics so that oxygen utilization becomes more efficientImprovement in HF symptoms such as dyspnea and fatigueVO2 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.
13Effects of exercise training in HF Restoring autonomic cardiovascular control towards normal by reducing sympathetic tone and increasing vagal toneReduced neurohormaonal activityImprovement in endothelial function leading to vasodilation of skeletal muscle blood vessel, possibly leading to increase in exercise capacityReduction in total peripheral resistanceReduction in plasma brain natriuretic peptide valuesSignificant improvement in six-minute walk distanceSignificant improvement in NYHA functional classExercise training may reduce HF related hospitalization and improve health related quality of lifeReduced neurohormaonal activity with decreased resting levels of angiotensin, aldosterone, vasopressin and natriuretic peptide
15Advanced/End Stage HFIt 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 US20% stage D patients are younger than 65yrs- that is at least 60,000 patientsCardiac transplantation provides increased longevity and symptomatic reliefOnly 2200 organ donors in USMechanical circulatory support with LVADs is a rapidly evolving field and is a life saving therapy for patients with advanced heart failure
16Advanced HF therapyTransplant- 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
17Listing 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 pressureAge <70Diabetes well controlledAbsence on neoplasmPsychosocial support
18MCS Applications Bridge to transplantation Bridge to decision Destination therapyBridge to recoveryA 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 transplantationBTD- 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 transplantationBTR- There is now sufficient evidence that LV unloading with a LVAD can promote recovery of myocardial function
19MCS landmark StudyREMATCH (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 lifeREMATCH (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
20Indication for BTT Non-reversible systolic HF- NYHA class IV Inotropic support, if toleratedNo 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 HgBody surface area >1.2m
21Indication for DTAdvanced 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/orinotropes- Intolerant to ACE/ARB or BBBody surface are (BSA) >1.2 mIneligible for cardiac transplantVO2 max <14ml/kg/min or <50% predicted VO2 maxLVEF <25%On OMM including dietary/fluid restriction, diuretics, digitalis, BB, ald blockade agents, ACEI/ARB, but failing to respondAnalysis 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
22Exclusion Criteria Active systemic infection Uncorrectable aortic insufficiencyRenal insufficiency that may require dialysis in the near futureHistory of cardiac transplantAny condition, other than heart failure, which is expected to limit survival to less than 2 years
23Pre-op MCS evaluation Assessment of RV function Nutrition Hemodynamics Renal functionGastrointestinalHepatic functionHematologyCoagulationPeripheral vascular diseasePulmonary functionInfectionNeurologicPsychosocialPsychiatric
24MCS candidacyMCS pre-op evaluation data is presented to a multidisciplinary team and the candidacy s determined by the team.
25Types of DevicesShort-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 MCSShort-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
26Types of Long-term MCS Left ventricular assist device (LVAD) Biventricular support (BiVAD)Total artificial heart (TAH)
27Biventricular support (BiVAD) Thoratec Paracorporeal VAD (P-VAD) – BTT- for patients with severe biventricular failure
28Total artificial heart (TAH) Syncardia TAH – BTT- for patients with severe biventricular failure
29Evolution of Devices1st 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 LVADThird generation- currently in developmentFirst 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.
30First 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
31Second generation pumps: HeartMate II HeartMate II is currently FDA approved for BTT and DTAxial-flow, rotary ventricular assist systemCapable of flows up to 10 liters per minuteThe 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
32HeartMate II High Speed Rotary Long Life Small Flexible Driveline QuietValvelessTextured Blood Contacting SurfaceCost EffectiveCompared 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.
33HeartMate II 1 Outflow Cannula Inflow Cannula Bend Relief Flex Section Blood PumpPercutaneous Cable Connection
34HeartMate 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 easeInflow StatorOutflow StatorRotorOutflow BearingsInflow Bearings
36HeartMate IIMore than 13,000 patients worldwide have now been implanted with the HeartMate II® LVAS.Over 5,500 patients on ongoing supportPatients supported ≥ 1 year: 1,576Patients supported ≥ 2 years: 883Patients supported ≥ 3 years: 412Patients supported ≥ 4 years: 161Patients supported ≥ 5 years: 121Patients supported ≥ 6 years: 26Patients supported ≥ 7 years: 11Patients supported ≥ 8 years: 1The 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
37HM II system Controller Microprocessor that:Delivers power to the pumpControls pump speed and powerMonitors, interprets & responds to system performancePerforms diagnostic monitoringIndicates hazard and advisory alarmsProvides complete backup systemAutomatic event recordingData logger capabilities
38Common HM II Externals Power sources System Monitor Display Module - Power Module- BatteriesSystem MonitorDisplay ModuleBattery ChargerPower module- Supplies main power to LVADLithium batteries 12 – 14 hours of support on a pair of batteriesSimultaneously charges 4 batteriesTakes about 4 hours to charge a batteryIs lightweight and portable
39HM II Post-op period ICU stay- 3-5 days IMC/Tele- 7-14 days Rehab- some patients will need inpatient rehab
40Post-op periodExtensive patient and family education regarding equipment handling and driveline exit site dressing changePatient completes 7 modules and signs contracts of commitment and understandingAggressive PT/OT/Cardiac rehabStabilize INRDietary monitoringSet up home health if neededDischarge planning for community training
41HeartMate IIThe HeartMate II is continuous flow, therefore you may not feel a pulseHeart rate- only detectable by telemetry- there may not be a palpable pulse!Blood pressure- may or may not be detected with automatic BP cuffArterial line monitoring or DopplerAt each office visit check mean BP by DopplerGoal blood pressure is 70-90mmHg
42Transportation/Ambulation Change patient to batteriesTake the black bag, which includes:Charged batteries- minimum of one pairBackup system controllerDisposable stethoscope
43Activity instructions Many patients will need inpatient rehabSternal precaution for 3 monthsNo driving for 3 monthsNo shower for 3 monthsNo lifting over 5-10lbs for 2 months; then gradually increasingEncourage regular exercise but avoid very strenuous exerciseEncourage patients get back to their regular hobbiesNo swimming or water aerobicsBattery and controller should be secured well at all times
44Anti-Coagulation Guidelines MedicationsAspirin – prevents platelet aggregationPersantine – prevents platelet aggregationPlavix/Effient- occasionally used for platelet inhibitionAntiplatelets are adjusted based thrombo-elastography (TEG)Coumadin- required, goal INR depends on patients underlying comorbidities
45Complication Bleeding Pump thrombus/Hemolysis Infection Stroke- Ischemic or hemorrhagicRight hear failure- usually immediate post-op period
46Quality 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