Surgical Therapy for theStage D Heart Failure:Transplantation and

Ventricular AssistDevices

Edwin C. McGee, Jr., MD Division of Cardiothoracic Surgery

Surgical Director,Heart Transplantation MechanicalAssistance

Bluhm Cardiovascular InstituteAssistant Professor of Surgery

Northwestern University’s Feinberg School of Medicine

Relevant FinancialRelevant FinancialRelationshipRelationship

Disclosure StatementDisclosure Statement

I will discuss off label use and/or investigational use of drugs/devicesI will discuss off label use and/or investigational use of drugs/devices

The following relevant financial relationships exist related to thisThe following relevant financial relationships exist related to thispresentation:presentation:

CardiacAssist, IncCardiacAssist, IncScientific Advisory BoardScientific Advisory BoardSpeakerSpeaker’’s Bureaus Bureau

ThoratecThoratecConsultantConsultant

Heart Transplantation

HEART TRANSPLANTATIONKaplan-Meier Survival (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 16 17 18 19 20 21 22

Years

Su

rviv

al

(%)

Half-life = 10.0 years

Conditional Half-life = 13.0 years

N=74,267

ISHLT 2008

N at risk at 22years: 70

HEART TRANSPLANTATIONKaplan-Meier Survival (1/1982-6/2006)

J Heart Lung Transplant 2008;27: 937-983

Congenital

2%

ReTX

2%

Myopathy

45%

Misc.

4%

Valvular

3%

CAD

44%

1/1982-6/2007

DIAGNOSIS IN ADULT HEART TRANSPLANTS

2030

4050

6070

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

% o

f C

ases

Myopathy CAD

CAD

35% Valvular

2%

Misc.

14%

Myopathy

44%

ReTX

2%

Congenital

3%

1/2004-6/2007

ISHLT 2008 J Heart Lung Transplant 2008;27: 937-983

NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR

189318

665

1182

2159

2713

31363363

40034171 4203

4364 4429 43964263 4199

38643581

3433 33903283 3226

30653185 3205

0

500

1000

1500

2000

2500

3000

3500

4000

4500

1982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006

Nu

mb

er

of

Tra

ns

pla

nts

ISHLT 2008

NOTE: This figure includes only the heart transplants that arereported to the ISHLT Transplant Registry. As such, thisshould not be construed as evidence that the number ofhearts transplanted worldwide has declined in recent years.

J Heart Lung Transplant 2008;27: 937-983

Ventricular Assistance

Vad Physiology• Left ventricle →

Pumping chamberto Filling Chamber

• VAD pulls bloodfrom LV and pumpsto Aorta

• Pulsatile flow• Continous flow• RV Functions to Fill

the LVAD• LV an Atrium

First Generation VADS

First Generation: Heartmate XVE

• Pusher Plate• VAD fills and

empties• Vents air to outside• Aspirin Only• Intraperitoneal or

Abd Wall Pocket• Device related

infection up to 40%• 18 month durability

Frazier JHLT 2001 122 (6) 1186Frazier JHLT 2001 122 (6) 1186

REMATCH100100

8080

6060

4040

2020

00

Surv

ival

(%)

Surv

ival

(%)

00 66 1212 1818 2424 3030

MonthsMonths

LV assist deviceLV assist device

Medical therapyMedical therapy

Rose E NEJM 2001Rose E NEJM 2001

Post REMATCH Survival

Long JW et al. CHF 2005; 11:133-8.Long JW et al. CHF 2005; 11:133-8.

Second Generation VADS

Second Generation: Heartmate II

• Axial flow rotarypump

• Mechanical Bearing• FDA approved

bridge to transplant• Small• Durable• DT trial completed• No longer

randomizing

XVE to Heartmate II conversion

Third Generation VADS

Ventracor Ventrassist

• Centrifugal Pump• Hydrodynamic

bearing• CE Mark• BTT Completed• DT trial ongoing• Modular driveline

Fig 1. Magnets and copper coils

Fig 2. Rotor within pump

• Rotor contains high-strength magnets

• Controller deliverspower to copper coilsvia percutaneous lead

• Magnetic forces fromthe coils spin the rotor

VentrAssist® LVAD drive system

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 12Months

Pat

ient

s (%

)

Transplantation, or ≥180 days Support

Transplantation (54%)

Ongoing Support (32%)

Death (14%)

At 6 months 86% of patients were transplanted or on support.

VentrAssist® LVAD US Feasibility trialCompeting Outcomes Graph

VentrAssist® LVAD surgicalcomponents

Inflow cannulae - choice of10, 40 or 60 mm length

(10mm length not available in US)

VentrAssist® LVADwith Percutaneous

Lead

Outflow Cannula –GELWEAVE® woven polyester,

no need for pre-clotting

Extracorporeal lead

NMH Ventrassist BTT pt

• Optimal Cannulaplacement is atMitral Valve

• Harder with Longerinlet cannula

• Can obstruct onseptum or lateralwall

Heartware European Trial CompetingOutcomes (n = 50)

90%

46%

32%

16%

6%

84%84%86%

Strueber ISHLT 2009

% o

f Pat

ient

s

Survival to 180days, Transplant,RecoveryTransplant

Recovery

Death

Alive on Pump

Bluhm Cardiovascular InstituteAdvanced Heart Failure Program

Milestones• March 2005 UNOS approval• April 2005: First Pt listed• June 2005: First Transplant• July 2005: First VAD (XVE)• September 2006: Medicare Approval• 2007: Blue Cross Tx Center of Excellence• 2008 Optum Health Tx Center of Excellence• 2009: Joint Commission Approval for Destination

therapy• 2008: #1 in ILLINOIS

#18 in USA (140 programs nationally)

Bluhm Cardiovascular InstituteHeart Transplant Program

• Status as of 9/17/09• 96 Transplants

- 2005 5- 2006 22- 2007 23- 2008 27- 2009 19

• 3 8 BTT (40%)• 2008 16/27 (59%) BTT• 2009 13/19 (70%) BTT• 3 redo HTX

(vasculopathy)• 3 Heart/kidney

Bluhm Cardiovascular Institute - Northwestern Memorial HospitalHeart Transplant Program Donor Sites (n=39)

Westfield, MA

Chicagoland 15

Indianapolis, IN 2

Lincoln, NE

Mt. Clemens, MI

Kansas City, MO

Peoria, IL

Little Rock, AR

Milwaukee, WI

Des Moines, IA

Charleston, WV

Kingsbury, TN

Madison, WI 2

Quincy, IL

Evansville, INBloomington, IL

Columbus, OH

Greenville, SC

Chapel Hill, NC

Munster, IN

Columbia, MO

Joplin, MO

Fargo, ND

AVERAGE CENTER VOLUMEHeart Transplants: January 1, 1992 - June 30, 1996

and January 1, 2002 – June 30, 2006

58 59

81

49

15

40

55

80

2515 3 4 3455

0

10

20

30

40

50

60

70

80

90

1-4 5-9 10-19 20-29 30-39 40-49 50-74 75+

Average number of heart transplants per year

Nu

mb

er

of

ce

nte

rs

.

1992-6/1996

2002-6/2006

ISHLT 2008 Last updated based on data as of December 2006 J Heart Lung Transplant 2008;27: 937-983

Heart Transplant Actuarial SurvivalTransplanted as of December 31, 2008

(n = 77)

Type n(YTD)

1 year 3 year

HT 77 97% 95%

Bluhm Cardiovascular InstituteMechanical Assistance Program

• 72 (BTT/DT)• N= 27 in 2008• N= 17 2009• Currently supported patients

- 10 Heartmate II- Heartware- 1 Ventrassist- 1 Heartmate XVE

Bluhm Cardiovascular InstituteVAD Program (n=52 patients)

Implanted as of December 31, 2008

Type n (YTD) 1 month 1 year 2 year

LVAD asBTT

36 97% 94% 94%

BiVAD asBTT

12 75% n/a n/a

DT 4 100% 75% n/a

*1 DT patient was transplanted; As a result,patient’s data is captured in LVAD as bridge inthis Kaplan Meier analysis

Case

• 24 y.o familial Cardiomyopathy• Listed 1b on Milrinone• 1hr CPR• Tandemheart Temporary VAD• Heartmate II Implantable VAD• Successful Bridge to Transplant 6/7/09

TandemHeart LVAD Application

Inotropes

• 36 pts• All referred for TX• Declined or

ineligible for TX

Hershberger. J Card Fail 2003 9(3) 180Hershberger. J Card Fail 2003 9(3) 180

Contemporay Inotrope Usage

• All HF pts dc’d oninotropes 2002-2007

• 48% readmission• 14% died in Hosp• 15 pt VAD and or Tx• 47% overall survival• 39% among those that

did not get VAD or TX• Conclusion: Hospice

indicated for those ptsuable to receive VAD orTx

Ishlt 2009Ishlt 2009

VAD Pitfalls- Anatomic

• Aortic Insufficiency• Small Ventricle• Sick Right Ventricle• Mechanical Valves• VAD + other procedures (long

pump/ischemic time)

VAD Pitfalls – Pt factors

• End Organ Dysfunction• Multiple Cardiac Operations• Hostile Abdominal Wall (For those

needing pocket)• Lack of Support• Noncompliance

VAD Indicated

• Inotropes• Hospital Admission for Hospital

Excerbation• ACEI / Beta Blocker Intolerant• CRT non responder• High Pulmonary Vascular Resistance

PVR Improving with Vad

Salzberg SP et al. EJCTS 2005; 27: 222-225Salzberg SP et al. EJCTS 2005; 27: 222-225

Congestive Heart Failure

..

Future Generations

• Smaller lessinvasive pumps

• No pocket• No Driveline• Completely

Implantable• Non Sternotomy

approach• Earlier Implants in

less ill patientsHeartware MVADHeartware MVAD

Worldheart Levacor

• Centrifugal pump• Fully magnetically

levitated rotor• Modular drive line• Can turn speed

down• BTT to Start ???

World Heart Levacor

• CompletelyImplantable

• Current limitation isBattery Charge life

Summary

• Heart Transplantation- Great Results- Donor Limited

• VADs:- Smaller- Simpler- More Durable- Less Morbid- Outcomes approaching Heart transplant

• Individualize therapy for each pt

Thank You for your attention!!!