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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!!!