heart failure and vads: bridges for broken hearts

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Heart Failure and VADs Heart Failure and VADs Bridges for Broken Hearts Bridges for Broken Hearts Priya Gaiha MD MBA Priya Gaiha MD MBA May 26 May 26 th th 2010 2010 University of Kentucky University of Kentucky Grand Rounds Grand Rounds

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Page 1: Heart Failure and VADs: Bridges for Broken Hearts

Heart Failure and VADsHeart Failure and VADsBridges for Broken HeartsBridges for Broken Hearts

Priya Gaiha MD MBAPriya Gaiha MD MBAMay 26May 26thth 2010 2010

University of Kentucky University of Kentucky Grand RoundsGrand Rounds

Page 2: Heart Failure and VADs: Bridges for Broken Hearts

ObjectivesObjectives

What is the pathophysiology of heart failure?What is the pathophysiology of heart failure?

Why is heart failure relevant?Why is heart failure relevant?

What is the history of mechanical circulatory support?What is the history of mechanical circulatory support?

What are the various types of ventricular assist devices What are the various types of ventricular assist devices (VADs)?(VADs)?

How and when are VADs used?How and when are VADs used?

What is the next generation of VADs?What is the next generation of VADs?

Page 3: Heart Failure and VADs: Bridges for Broken Hearts

Etiologies of cardiac failureEtiologies of cardiac failure

Coronary artery disease Coronary artery disease Idiopathic cardiomyopathyIdiopathic cardiomyopathy Peripartum cardiomyopathyPeripartum cardiomyopathyDilated cardiomyopathyDilated cardiomyopathyIschemic cardiomyopathyIschemic cardiomyopathyAcute valvular diseaseAcute valvular diseaseArrhythmia (supraventricular or ventricular) Arrhythmia (supraventricular or ventricular) Myocarditis Myocarditis Congenital heart disease Congenital heart disease Drug induced Drug induced Diabetes mellitus Diabetes mellitus Hypertension Hypertension

Page 4: Heart Failure and VADs: Bridges for Broken Hearts

Pathogenesis of Heart FailurePathogenesis of Heart Failure

Mann, D. Circulation 1999;100;999-1008

Page 5: Heart Failure and VADs: Bridges for Broken Hearts

NYHA classesNYHA classesClassClass Patient SymptomsPatient Symptoms

Class I (Mild)Class I (Mild) No limitation of physical activity. Ordinary physical No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).dyspnea (shortness of breath).

Class II (Mild)Class II (Mild) Slight limitation of physical activity. Comfortable at Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.palpitation, or dyspnea.

Class III Class III (Moderate)(Moderate)

Marked limitation of physical activity. Comfortable Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.palpitation, or dyspnea.

Class IV (Severe)Class IV (Severe) Unable to carry out any physical activity without Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, rest. If any physical activity is undertaken, discomfort is increased.discomfort is increased.

www.americanheart.org

Page 6: Heart Failure and VADs: Bridges for Broken Hearts

Relevance

Page 7: Heart Failure and VADs: Bridges for Broken Hearts
Page 8: Heart Failure and VADs: Bridges for Broken Hearts
Page 9: Heart Failure and VADs: Bridges for Broken Hearts

NCHS 2006NCHS 2006

2581

242315

5048120

831

21101

138 16585

560

0

200

400

600

800

1,000

<45 45-54 55-64 65-74 75-84 85+ Total

Ages

Dea

ths

in T

ho

usa

nd

s

CVD Cancer

CVD deaths vs. cancer deaths by age (US)CVD deaths vs. cancer deaths by age (US)

Page 10: Heart Failure and VADs: Bridges for Broken Hearts

A CVD A CVD B CancerB CancerC AccidentsC Accidents

D Chronic Lower Respiratory D Chronic Lower Respiratory DiseasesDiseasesE Diabetes MellitusE Diabetes MellitusF Alzheimer’s DiseaseF Alzheimer’s Disease

NCHS and NHLBI 2006

290,069

59,260

269,819

398,563

78,94136,006

432,709

65,32351,281

42,658

0

100,000

200,000

300,000

400,000

500,000

A B C D E A B D F C

Dea

ths

Males Females

CVD and other major causes of death for all males and females

Page 11: Heart Failure and VADs: Bridges for Broken Hearts

NHDS/NCHS and NHLBI 2006NHDS/NCHS and NHLBI 2006

1.6

1.7

2.0

2.0

2.4

3.0

3.5

3.5

4.1

6.2

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0

Neoplasms 140-239

Endocrine System 240-279

Musculoskeletal System 710-739

Genitourinary System 580-629

Mental 290-319

External: Injuries, etc. 800-999

Respiratory System 460-519

Digestive System 520-579

Obstetrical V27

Cardiovascular 390-459

Hospital Discharges (in millions) for the 10 Leading diagnostic GroupsHospital Discharges (in millions) for the 10 Leading diagnostic Groups

Page 12: Heart Failure and VADs: Bridges for Broken Hearts

Economic Ramifications

www.americanheart.org

Prevalence 1-2% population 5 million individuals

Cost 1-2% total health care spending

$35 billion

Incidence (per year) 550,000 new diagnoses 300,000 deaths

Hospitalizations 6 days (average) 50% rehospitalized within 6 months

Page 13: Heart Failure and VADs: Bridges for Broken Hearts

Options for Advanced CHFOptions for Advanced CHF

Transplant ($$$$$$)Transplant ($$$$$$)

Assist Device ($$$)Assist Device ($$$)

Die($)Die($)– Preceded by 6-12 months of medical therapyPreceded by 6-12 months of medical therapy– Multiple hospital re-admissionsMultiple hospital re-admissions– Hospice ($$$)Hospice ($$$)

Page 14: Heart Failure and VADs: Bridges for Broken Hearts

Transplant

Page 15: Heart Failure and VADs: Bridges for Broken Hearts
Page 16: Heart Failure and VADs: Bridges for Broken Hearts

UK

Page 17: Heart Failure and VADs: Bridges for Broken Hearts

ADULT HEART TRANSPLANTATIONADULT HEART TRANSPLANTATION Kaplan-Meier Survival by Era Kaplan-Meier Survival by Era (Transplants: 1/1982 – 6/2005)(Transplants: 1/1982 – 6/2005)

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Years

1982-1991 (N=18,844)

1992-2001 (N=34,987)

2002-6/2005 (N=9,459)

All comparisons significant at p < 0.0001

HALF-LIFE 1982-1991: 8.9 years; 1992-2001: 10.3 years; 2002-6/2005: NA

Su

rviv

al (

%)

ISHLT 2007 J Heart Lung Transplant 2007;26: 769-781

Page 18: Heart Failure and VADs: Bridges for Broken Hearts

ADULT HEART RECIPIENTSADULT HEART RECIPIENTS Functional Status of Surviving RecipientsFunctional Status of Surviving Recipients

(Follow-ups: 1995 - June 2008)(Follow-ups: 1995 - June 2008)

0%

20%

40%

60%

80%

100%

1 Year (N = 16,084) 3 Years (N = 14,221) 5 Years (N = 12,160) 7 Years (N = 9,651)

No Activity Limitations Performs with Some Assistance Requires Total Assistance

ISHLT

2009

Page 19: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

Page 20: Heart Failure and VADs: Bridges for Broken Hearts

John GibbonJohn GibbonBorn in 1903 in PhiladelphiaBorn in 1903 in Philadelphia

4th generation physician4th generation physician

1931: watched a young woman 1931: watched a young woman postop from cholecystectomy postop from cholecystectomy die from PEdie from PE

Worked for 20 years on dogs to Worked for 20 years on dogs to refine bypass machinerefine bypass machine

Received financial and technical Received financial and technical support from Thomas Watson support from Thomas Watson of IBMof IBM

1953: first successful use of 1953: first successful use of machine on patient during ASD machine on patient during ASD repairrepair

Page 21: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

Page 22: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1967: Barnard performs first heart transplant

Page 23: Heart Failure and VADs: Bridges for Broken Hearts

Christian Barnard Christian Barnard Born in South Africa in 1922Born in South Africa in 1922

Studied heart surgery at the Studied heart surgery at the University of Minnesota then University of Minnesota then returned to set up a cardiac unit returned to set up a cardiac unit in Cape Town.in Cape Town.

December 1967: transplanted the December 1967: transplanted the heart of a road accident victim heart of a road accident victim into a 59 year old patient into a 59 year old patient

Patient only survived 18 days Patient only survived 18 days due to infectious complicationsdue to infectious complications

Page 24: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1967: Barnard performs first heart transplant

1968: Shumway performs first heart transplant in US

Page 25: Heart Failure and VADs: Bridges for Broken Hearts

Norm ShumwayNorm Shumway

Stanford UniversityStanford University

1959: transplanted the heart of a 1959: transplanted the heart of a dog into a 2-year-old mongreldog into a 2-year-old mongrel

1968: performed the first heart 1968: performed the first heart transplant in the US on a 54 year transplant in the US on a 54 year old steel worker who lived 14 old steel worker who lived 14 daysdaysPioneered immunosuppressionPioneered immunosuppression1981: performed the world’s 1981: performed the world’s first successful heart-lung first successful heart-lung transplant transplant

Page 26: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1967: Barnard performs first heart transplant

1969: Cooley implants VAD as bridge to transplant

1968: Shumway performs first heart transplant in US

Page 27: Heart Failure and VADs: Bridges for Broken Hearts

Willem KolffWillem Kolff““Father of artificial organs”Father of artificial organs”1911: Born in the 1911: Born in the NetherlandsNetherlands1940: Established the first 1940: Established the first blood bank in Europe blood bank in Europe 1943: Developed the first 1943: Developed the first artificial kidney artificial kidney 1957: Developed the first 1957: Developed the first artificial heart that was artificial heart that was successfully transplanted successfully transplanted into an animalinto an animal

Page 28: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1984: implantation of Jarvik-7 artificial heart by DeVries

1967: Barnard performs first heart transplant

1969: Cooley implants VAD as bridge to transplant

1968: Shumway performs first heart transplant in US

Page 29: Heart Failure and VADs: Bridges for Broken Hearts

William DeVriesWilliam DeVriesBorn in 1943Born in 1943Trained at the University of Trained at the University of Utah and Duke UniversityUtah and Duke UniversityWorked with Kolff to Worked with Kolff to implant artificial heart in implant artificial heart in animalsanimals1982: Implanted first 1982: Implanted first artificial heart into Seattle artificial heart into Seattle dentist Barney Clarkdentist Barney Clark1985: Implanted 2nd 1985: Implanted 2nd Jarvik into Bill Schroeder Jarvik into Bill Schroeder in Louisville KYin Louisville KY

Page 30: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1984: implantation of Jarvik-7 artificial heart by DeVries

1994: FDA approval of LVAD as bridge to transplant

1967: Barnard performs first heart transplant

1969: Cooley implants VAD as bridge to transplant

1968: Shumway performs first heart transplant in US

Page 31: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1984: implantation of Jarvik-7 artificial heart by DeVries

1994: FDA approval of LVAD as bridge to transplant

1967: Barnard performs first heart transplant

2004: REMATCH trial1969: Cooley implants VAD as bridge to transplant

1968: Shumway performs first heart transplant in US

Page 32: Heart Failure and VADs: Bridges for Broken Hearts

Historical EventsHistorical Events

1950 1960 1970 1980 1990 2000 2010

1953: Gibbon’s heart-lung machine successfully used during ASD repair

1963: DeBakey implants first VAD in patient with postcardiotomy shock

1984: implantation of Jarvik-7 artificial heart by DeVries

1994: FDA approval of LVAD as bridge to transplant

1967: Barnard performs first heart transplant

2004: REMATCH trial1969: Cooley implants VAD as bridge to transplant

1968: Shumway performs first heart transplant in US

Heart mate II approved for destination therapy

Page 33: Heart Failure and VADs: Bridges for Broken Hearts
Page 34: Heart Failure and VADs: Bridges for Broken Hearts
Page 35: Heart Failure and VADs: Bridges for Broken Hearts

Criteria for patient selectionCriteria for patient selection

Class IV HFClass IV HFFailing hemodynamicsFailing hemodynamicsPersistent pulmonary edemaPersistent pulmonary edemaNeurologic impairment or renal failure due Neurologic impairment or renal failure due to low perfusionto low perfusionFluid and electrolyte imbalance related to Fluid and electrolyte imbalance related to low cardiac outputlow cardiac outputSevere arrhythmias despite medical Severe arrhythmias despite medical therapy therapy

Page 36: Heart Failure and VADs: Bridges for Broken Hearts

Indications for supportIndications for support

SBP<80 mm HgSBP<80 mm Hg

MAP<65 mm HgMAP<65 mm Hg

CI<2.0 L/min/mCI<2.0 L/min/m22

PCWP>20 mm HgPCWP>20 mm Hg

SVR>2100 dynes-sec/cmSVR>2100 dynes-sec/cm

Circulation 2005; 112: 438-448

Page 37: Heart Failure and VADs: Bridges for Broken Hearts

Patient Profile/ Status: INTERMACS Levels

1. Critical cardiogenic shock

2. Progressive decline

3. Stable but inotrope dependent

4. Recurrent advanced HF

5. Exertion intolerant

6. Exertion limited

7. Advanced NYHA III

INTERMACS: Patient Selection

Page 38: Heart Failure and VADs: Bridges for Broken Hearts

PROFILE-LEVELPROFILE-LEVEL # Pts# Pts

Yr 1Yr 1

Official ShorthandOfficial Shorthand General time frame General time frame for supportfor support

INTERMACSINTERMACS

LEVEL 1LEVEL 1

8282 ““Crash and burn”Crash and burn” HoursHours

INTERMACSINTERMACS

LEVEL 2LEVEL 2

8181 ““Sliding fast”Sliding fast” Days to weekDays to week

INTERMACSINTERMACS

LEVEL 3LEVEL 3

1818 Stable but Stable but DependentDependent

WeeksWeeks

INTERMACSINTERMACS

LEVEL 4LEVEL 4

99 ““Frequent flyer”Frequent flyer” Weeks to few Weeks to few months, if baseline months, if baseline restoredrestored

INTERMACSINTERMACS

LEVEL 5LEVEL 5

44 ““Housebound”Housebound” Weeks to monthsWeeks to months

INTERMACSINTERMACS

LEVEL 6LEVEL 6

33 ““Walking wounded”Walking wounded” Months, if nutrition Months, if nutrition and activity and activity maintainedmaintained

INTERMACSINTERMACS

LEVEL 7LEVEL 7

44 Advanced Class III Advanced Class III

Page 39: Heart Failure and VADs: Bridges for Broken Hearts

INTERMACS ProfilesINTERMACS Profiles

0

10

20

30

40

50

60

70

80

90

100

1 2 3 4 5 6 7

Inotrope Dependent 2006-2007 data

Page 40: Heart Failure and VADs: Bridges for Broken Hearts

Short term Device optionsShort term Device options

Bridge to recoveryBridge to decision

IABP

ECMO

Tandem Heart

Impella

AbioMed 5000Centrimag

Circulation 112 (3): 438

Page 41: Heart Failure and VADs: Bridges for Broken Hearts

Intraaortic Balloon Pump (IABP)Intraaortic Balloon Pump (IABP)Developed in late 1960s Developed in late 1960s

Counterpulsation is synchronized to the EKG or Counterpulsation is synchronized to the EKG or arterial waveformsarterial waveforms

Increase coronary perfusion Increase coronary perfusion

Decrease left ventricular stroke work and Decrease left ventricular stroke work and myocardial oxygen requirementsmyocardial oxygen requirements

Most widely used form of mechanical circulatory Most widely used form of mechanical circulatory supportsupport

Indications for its use includeIndications for its use include

– Failure to wean from cardiopulmonary bypassFailure to wean from cardiopulmonary bypass

– Cardiogenic shock after MICardiogenic shock after MI

– Heart failureHeart failure

– Refractory ventricular arrhythmias with Refractory ventricular arrhythmias with ongoing ischemiaongoing ischemia

Page 42: Heart Failure and VADs: Bridges for Broken Hearts

Bridge to bridge: ECMOBridge to bridge: ECMOImmediately stabilize circulationImmediately stabilize circulation

Improve end organ perfusionImprove end organ perfusion

Overall survival comparable Overall survival comparable between ECMO + LVAD versus between ECMO + LVAD versus LVAD aloneLVAD alone

Clinical indicators of poor outcome Clinical indicators of poor outcome after ECMO: consider VAD after ECMO: consider VAD implantation carefullyimplantation carefully– Elevated blood lactate levelsElevated blood lactate levels– Elevated LFTsElevated LFTs

Pagani et al. Ann Thorac Surg 2000; 70:1977-85

Page 43: Heart Failure and VADs: Bridges for Broken Hearts

Case #1Case #157 yo male57 yo maleTransferred to UK for cardiogenic Transferred to UK for cardiogenic shock secondary to heart failureshock secondary to heart failureTaken to cath lab for emergent IABP Taken to cath lab for emergent IABP placement placement – EF<10%EF<10%– Sv02 20sSv02 20s– Maximal inotropic support: 4 pressorsMaximal inotropic support: 4 pressors

Stabilized on VA-ECMOStabilized on VA-ECMOSupported for 7 daysSupported for 7 daysImprovement in hepatic and renal Improvement in hepatic and renal dysfunctiondysfunctionHeartmate II implantedHeartmate II implanted

Page 44: Heart Failure and VADs: Bridges for Broken Hearts

Centrifugal pumpsCentrifugal pumps

Acute hemodynamic supportAcute hemodynamic supportContinuous flowContinuous flowExtracorporealExtracorporealLV, RV or biventricular LV, RV or biventricular supportsupportWide availabilityWide availabilityEase of useEase of useRelatively low costRelatively low costLimited duration of supportLimited duration of supportBridge to recoveryBridge to recoveryBridge to decisionBridge to decision

Hoy et al. Ann Thorac Surg 2000; 70:1259-63

Page 45: Heart Failure and VADs: Bridges for Broken Hearts

Tandem hearts Tandem hearts

Acute hemodynamic supportAcute hemodynamic supportCentrifugal pumpCentrifugal pumpPercutaneous placementPercutaneous placementLV support via transseptal LV support via transseptal cannulacannulaUsed in high risk cardiac Used in high risk cardiac catheterization procedurescatheterization proceduresRisk of vascular injuries due to Risk of vascular injuries due to cannula sizecannula size

Page 46: Heart Failure and VADs: Bridges for Broken Hearts

Levitronix CentrimagLevitronix CentrimagNewer generationNewer generationCentifugal pumpCentifugal pumpContinuous flowContinuous flowExtracorporeal Extracorporeal Impellar within the Impellar within the pump rotates in pump rotates in contact-free mannercontact-free mannerIncreased durabilityIncreased durabilityMinimal thrombus Minimal thrombus formation and formation and hemolysis of RBCshemolysis of RBCs

Page 47: Heart Failure and VADs: Bridges for Broken Hearts

Abiomed 5000Abiomed 5000

ExtracorporealExtracorporeal

Pneumatic pulsatile pumpsPneumatic pulsatile pumps

Uni- or biventricular Uni- or biventricular supportsupport

Bridge to transplantBridge to transplant

Easy to insert and operate Easy to insert and operate so used in community so used in community hospitalshospitals

Flows 6L/minFlows 6L/min

Circulation. 2005;112:438-448.

Page 48: Heart Failure and VADs: Bridges for Broken Hearts

Impella Impella Axial flow pumpsAxial flow pumpsAcute hemodynamic Acute hemodynamic supportsupportMiniaturized impellar pump Miniaturized impellar pump in catheterin catheterHelical catheter tip placed Helical catheter tip placed across aortic valve and left across aortic valve and left ventricleventriclePercutaneous or direct Percutaneous or direct placementplacementFlow 4.5L/minFlow 4.5L/minBridge to recoveryBridge to recovery

Page 49: Heart Failure and VADs: Bridges for Broken Hearts

Case #2Case #2

54 yo male54 yo malePostcardiotomy cardiogenic shock after mitral Postcardiotomy cardiogenic shock after mitral valve repair and CABGx 4v valve repair and CABGx 4v Came off CPB but then decompensatedCame off CPB but then decompensatedInitially treated with Impella placementInitially treated with Impella placementDeveloped hemolysis: converted to Abiomed Developed hemolysis: converted to Abiomed 5000 BVS pump 48hrs later5000 BVS pump 48hrs laterTransferred to UKTransferred to UKSuccessfully explanted after 7 days of supportSuccessfully explanted after 7 days of supportFunctional at home, EF~45%Functional at home, EF~45%

Page 50: Heart Failure and VADs: Bridges for Broken Hearts

Long term Device optionsLong term Device options

Bridge to transplant

Heartmate II

Jarvik 2000 CardioWest TAH

Heartmate XVE

Circulation 112 (3): 438

Thoratec

Page 51: Heart Failure and VADs: Bridges for Broken Hearts

Thoratec Thoratec Pneumatic pumpPneumatic pump

LVAD, RVAD or LVAD, RVAD or biventricular supportbiventricular support

DurableDurableCan be used in smaller Can be used in smaller

patientspatientsFlows 7L/minFlows 7L/minBridge to recoveryBridge to recoveryBridge to transplantBridge to transplant

Circulation. 2005;112:438-448.

Page 52: Heart Failure and VADs: Bridges for Broken Hearts

Case #3Case #3

31 yo male31 yo male Severe end-stage heart failure secondary Severe end-stage heart failure secondary

to idiopathic cardiomyopathyto idiopathic cardiomyopathy Symptoms refractory to medical Symptoms refractory to medical

managementmanagement Biventricular Thoratec device implanted Biventricular Thoratec device implanted

along with closure of PFO and removal of along with closure of PFO and removal of LV apical thrombusLV apical thrombus

Duration of device 96 daysDuration of device 96 days Developed thrombus in inflow cannulaDeveloped thrombus in inflow cannula

– Upgraded status on UNOS waiting listUpgraded status on UNOS waiting list Orthotopic heart transplant performedOrthotopic heart transplant performed Discharged POD#13Discharged POD#13 Doing well with no evidence of rejection Doing well with no evidence of rejection

Page 53: Heart Failure and VADs: Bridges for Broken Hearts

Long term Device optionsLong term Device options

Bridge to transplant Destination therapy

Heartmate IIHeartmate XVE

Page 54: Heart Failure and VADs: Bridges for Broken Hearts

Heartmate XVEHeartmate XVE

Pneumatic or vented electric Pneumatic or vented electric platesplates

Textured internal surfacesTextured internal surfaces Only left-sided supportOnly left-sided support Flows 10L/minFlows 10L/min Bridge to transplantBridge to transplant First device to be approved First device to be approved

for destination therapyfor destination therapy Need BSA>1.5Need BSA>1.5 Limited durability: half life 18 Limited durability: half life 18

monthsmonths Infection risk with Infection risk with

percutaneous drive linepercutaneous drive line

Circulation. 2005;112:438-448.

Page 55: Heart Failure and VADs: Bridges for Broken Hearts

Case #4Case #4 58 yo male58 yo male Ischemic cardiomyopathy after MIIschemic cardiomyopathy after MI Symptoms progressively refractory to medical Symptoms progressively refractory to medical

therapytherapy– EF <20%EF <20%– Required intermittent inotropic supportRequired intermittent inotropic support

BMI >40: VAD versus transplantBMI >40: VAD versus transplant Heartmate XVE implantedHeartmate XVE implanted Device began to fail after 18 months Device began to fail after 18 months Heartmate II Heartmate II

implantedimplanted Continues with daily activitiesContinues with daily activities VAD as destination therapyVAD as destination therapy

Page 56: Heart Failure and VADs: Bridges for Broken Hearts

Heartmate IIHeartmate II

Axial flow Axial flow LV supportLV supportFlows 10L/minFlows 10L/minLong term durabilityLong term durabilityBridge to transplantBridge to transplantApproved January 2010 Approved January 2010

for destination therapyfor destination therapyOver 4000 devices Over 4000 devices

implanted to dateimplanted to date

Page 57: Heart Failure and VADs: Bridges for Broken Hearts

Case #5Case #5 64 yo male64 yo male Ischemic cardiomyopathy due to large anterolateral MI since 1982Ischemic cardiomyopathy due to large anterolateral MI since 1982 Medical management worked until clinical decompensation in 2008Medical management worked until clinical decompensation in 2008

– Inotropic supportInotropic support– SV02 in 20sSV02 in 20s

Not a favorable transplant candidate:Not a favorable transplant candidate:– Severe pulmonary hypertension: PAP >70-80sSevere pulmonary hypertension: PAP >70-80s– High PVR > 5 Wood unitsHigh PVR > 5 Wood units– MalnutritionMalnutrition– multiorgan system failure: hepatic, renalmultiorgan system failure: hepatic, renal

Heartmate II implantedHeartmate II implanted Improvement in pulmonary hypertension, renal dysfunction and Improvement in pulmonary hypertension, renal dysfunction and

nutritional statusnutritional status Duration of therapy 9 monthsDuration of therapy 9 months Orthotopic transplant successful August 2009Orthotopic transplant successful August 2009

Page 58: Heart Failure and VADs: Bridges for Broken Hearts

Implantation of deviceImplantation of device

N Engl J Med 2007;357:885-N Engl J Med 2007;357:885-9696

Page 59: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 60: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 61: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 62: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 63: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 64: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 65: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 66: Heart Failure and VADs: Bridges for Broken Hearts

Implantation Implantation

Page 67: Heart Failure and VADs: Bridges for Broken Hearts

Device complicationsDevice complications

EarlyEarly– BleedingBleeding– Right sided heart failureRight sided heart failure– Progressive multiorgan system failureProgressive multiorgan system failure

LateLate– InfectionInfection

NosocomialNosocomialDevice relatedDevice related

– ThromboembolismThromboembolism– Failure of deviceFailure of device

Page 68: Heart Failure and VADs: Bridges for Broken Hearts

Next generation of VADsNext generation of VADs

Miniaturized Miniaturized Improved durabilityImproved durability

– Bearing-less technologyBearing-less technology

Blood compatible surfacesBlood compatible surfaces– NonthrombogenicNonthrombogenic

Transcutaneous Transcutaneous – Drive line Drive line – Power sourcesPower sources

Page 69: Heart Failure and VADs: Bridges for Broken Hearts

Thank you.

Page 70: Heart Failure and VADs: Bridges for Broken Hearts

Additional slidesAdditional slides

Page 71: Heart Failure and VADs: Bridges for Broken Hearts

Cellular benefits of VADsCellular benefits of VADs

Normalization of fiber orientationNormalization of fiber orientationRegression of myocyte hypertrophyRegression of myocyte hypertrophyReduction in contraction band necrosisReduction in contraction band necrosisReverse ventricular dilationReverse ventricular dilation

– Improvement in EDPVRImprovement in EDPVR

Improved efficiency of myocardial mitochondriaImproved efficiency of myocardial mitochondriaReduction in abnormalities along neurohormonal Reduction in abnormalities along neurohormonal

and cytokine pathwaysand cytokine pathways

Circulation. 1998;98:2367-2369.

Page 72: Heart Failure and VADs: Bridges for Broken Hearts

Indicators of poor clinical Indicators of poor clinical outcomeoutcome

Advanced ageAdvanced age– Independent predictor of poor survivalIndependent predictor of poor survival– Independent predictor of poor bridge to transplantIndependent predictor of poor bridge to transplant– 37% post 30-day LVAD mortality37% post 30-day LVAD mortality– Age limit? >65 yo contraindication to transplantAge limit? >65 yo contraindication to transplant

FemaleFemale– Independent predictor of poor survivalIndependent predictor of poor survival– Independent predictor of poor bridge to transplantIndependent predictor of poor bridge to transplant– Higher mortalityHigher mortality

Longer waiting time to transplant due to size criteriaLonger waiting time to transplant due to size criteria

– Increased operative mortalityIncreased operative mortalitySmaller BSASmaller BSAImpaired wound healingImpaired wound healing

JCTS 2005:130;5: 1302-1311

Page 73: Heart Failure and VADs: Bridges for Broken Hearts

Indicators of poor clinical Indicators of poor clinical outcomeoutcome

Diabetes mellitusDiabetes mellitus– 4-fold increased risk of early death4-fold increased risk of early death– Associated with end organ failureAssociated with end organ failure

Renal failureRenal failure

– Increased allograft vasculopathy after transplantIncreased allograft vasculopathy after transplant– Type I DM is contraindication to transplantType I DM is contraindication to transplant

Low preoperative serum albuminLow preoperative serum albumin– Surrogate measure of nutritional statusSurrogate measure of nutritional status– Increased infections and impaired wound healingIncreased infections and impaired wound healing– For every 1 mg/dL increase in albumin, had 19.2 times For every 1 mg/dL increase in albumin, had 19.2 times

increased likelihood for bridge to transplantincreased likelihood for bridge to transplant

JCTS 2005:130;5: 1302-1311

Page 74: Heart Failure and VADs: Bridges for Broken Hearts

Myocardial recoveryMyocardial recovery

Certain proportion of Certain proportion of idiopathic dilated idiopathic dilated cardiomyopathy patients cardiomyopathy patients have potential for have potential for complete cardiac complete cardiac recovery: 15-20%recovery: 15-20%– Younger ageYounger age– Shorter history of heart Shorter history of heart

failurefailure– Faster and more complete Faster and more complete

restoration of pump functionrestoration of pump function– Diminished fibrosis seen in Diminished fibrosis seen in

myocyte biopsiesmyocyte biopsies Ann Thorac Surg 2001; 71:S109-13

Page 75: Heart Failure and VADs: Bridges for Broken Hearts

Myocardial recoveryMyocardial recoveryDisease statesDisease states

– Fulminant myocarditisFulminant myocarditis– Postcardiotomy shockPostcardiotomy shock

Improvements in pathophysiologyImprovements in pathophysiology– Normalization in circulating neurohormonal Normalization in circulating neurohormonal

and cytokine levelsand cytokine levels Improvements in LV: “reverse Improvements in LV: “reverse

remodeling”remodeling”– Regression of LV hypertrophyRegression of LV hypertrophy– Normalization of LV volume-pressure curvesNormalization of LV volume-pressure curves

Page 76: Heart Failure and VADs: Bridges for Broken Hearts

Myocardial recoveryMyocardial recovery

Circulation 2005;112;I-32-I-36

EF

White: ischemic

Gray: nonischemic, maintained recovery

Striped: nonischemic

Page 77: Heart Failure and VADs: Bridges for Broken Hearts

Parameters to predict recoveryParameters to predict recovery

EchoEcho– Decreased LV diameterDecreased LV diameter– Improved EF (>40%)Improved EF (>40%)

HistologyHistology– Resolution of myocyte fibrosis and necrosisResolution of myocyte fibrosis and necrosis

HemodynamicsHemodynamics– Decreased PCWPDecreased PCWP– Decreased PVRDecreased PVR– Improved peak oxygen exercise consumptionImproved peak oxygen exercise consumption