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1
VADS; How far have we
come?
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Most Recent Period Estimates of Relative Survival Rates for Prostate
and Breast Cancer
Brenner H. Lancet. 2002;360:1131–1135.
Relative Survival Rate, % (SE)*
5 Years 10 Years 15 Years 20 Years
Breast cancer 86.4 (0.4) 78.3 (0.6) 71.3 (0.7) 65.0 (1.0)
Prostate cancer 98.8 (0.4) 95.2 (0.9) 87.1 (1.7) 81.1 (3.0)
*Rates derived from SEER 1973–1998 database (both sexes, all ethnic groups).
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HEART FAILURE SURVIVAL
3 NEJM 2009;361(23):2241-51. NEJM 2001;345(20):1435-43.
4
Heart failure is in first place
®300,000 deaths in US per year
®500 deaths per 100,000 people per year in central Florida
®20,000 deaths in central Florida each year
®Progresses rapidly
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Heart Failure Options
Optimal medical management
Transplantation
Ventricular assist devices
–Rescue
–Bridge
–Destination
Text Text
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First heart transplant- 1905
–Alexis Carrel
–Canine model
–Brief survival due to lack of immunosuppresion
First human heart transplant……
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University of Mississippi Medical Center
90 minute survival
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December, 1967
Groot de Schoor Hospital, South Africa
Louis Washkansky
18 day survival
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Donor limited
Graft failure
Transplant CAD
Immunosuppression
Cancer
10.6 year mean survival
NUMBER OF HEART TRANSPLANTS REPORTED BY
YEAR
ISHLT 2008
NOTE: This figure includes only the heart transplants that are
reported to the ISHLT Transplant Registry. As such, this should
not be construed as evidence that the number of hearts
transplanted worldwide has declined in recent years.
J Heart Lung Transplant 2008;27: 937-983
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300,000 Heart Failure Deaths Per Year in U.S.
2500 transplants per year
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History
D. C. is a 53 year-old male with progressive congestive heart failure secondary to ischemic cardiomyopathy
CABG 9 years prior to presentation
Mitral valve replacement (St. Jude prosthesis) 3 years prior
Biventricular pacer/AICD placed 8 months prior
Being maintained on milrinone infusion
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Exam
WDWN male with mild dyspnea
Bilateral distended neck veins
Lungs- bibasilar rales
Heart- RRR crisp valve click
Ext- 1-2+ edema
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CXR
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Summary
53 year old male with severe worsening CHF, ischemic cardiomyopathy, two previous median sternotomies, and a prosthetic mitral valve
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Operation
Jarvik 2000 LVAD implanted through left thoracotomy
Inflow/pump placed in left ventricular apex
Outflow placed in descending aorta
Device adjusted intra-operatively to ensure prosthetic mitral valve opening and closure
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De-airing
25 Freiburg, 8/01
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Post Operative Course
Placed on aspirin, clopidogrel, and coumadin
No thrombo-embolic events
Had a barely palpable pulse, and no evidence of peri-valvular thrombosis
Transplanted 1 year later
Runs a barn building business
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“It’s been a pleasure to be able to help people
and maybe you folks learned something” 1982
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Pulsatile VADs
1.0
0.8
0.6
0.4
0.2
0.0
0 6 12 18 24 30 36
Pr
[ali
ve]
Time (months)
OMM (n=61) +
+ + +
LVAD (n=68)
+ +
+ + + + + + +
+ + +
+ + +
* Rose et al,Long-term mechanical left ventricular assist
for end-stage heart failure.N Eng J Med.,2001;345:1435-1443
Transplantation
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What has changed since
REMATCH?
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Fluid Dynamic Blood Pumps
Axial flow
Centrifugal flow
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More is not better.
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Overflowing an LVAD leads to
right ventricular failure
• septum bows left
• RV architecture changes
• The RV is thin walled, so changes in
volume lead to large changes in wall stress
• Propofol can exacerbate right heart failure
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In acute RV failure, unloading
almost always leads to recovery
• post MI
• post PE
• post cardiotomy
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The heart can recover*.
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Acute Cardiogenic Shock Cells “hibernate” before they die
Rest Heart for Recovery Cells can recover
Infarct
LAD occlusion
WITHOUT
ventricular
unloading Massive Myocardial
Damage
LAD occlusion WITH
ventricular unloading Up to 5-times Reduction in Infarct
Size
•– Flameng et al JACC 2001
Acute Recovery with Ventricular assistance
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Acute Devices
• Impella
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Centrimag
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Acute Cardiogenic Shock
• G.C.
• 57 yo male
• presented with acute LAD MI, EF<10%
• PCI- Reflow but no improvement in LV
function
• Multiple inotropes, pressors, Impella 2.5
• Transferred to our facility
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Echo
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QuickTime™ and aMicrosoft Video 1 decompressorare needed to see this picture.
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POD#5
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QuickTime™ and aMicrosoft Video 1 decompressorare needed to see this picture.
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Earlier is better
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IABP Score
Based on assessment one hour after implantation of IABP
Assigns points for
– High dose pressors (two points)
– Low urine output
– Low SVO2
– High PCWP
Circulation. 2002;106[suppl I]:I-203-I-206
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Temporary bridging can be important
Preserve end organ function
Salvage myocardium
Allow for complete evaluation
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FULL EVALUATION!
THERE ARE NO EMERGENCY DURABLE VAD IMPLANTS!
THERE ARE NO EMERGENCY CARDIAC TRANSPLANTS!
If the patient is too sick to be bridged, they are too sick for advanced therapy.
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Survival PRESENT DT HM II EXPERIENCE
1.0
0.8
0.6
0.4
0.2
0.0
0 6 12 18 24 30 36
Pr
[ali
ve]
Time (months)
OMM (n=61) +
+ + +
+ +
+ + + + + + +
+ + +
+ + +
Slaughter,et al NEJM 2009
Transplantation
HM II DT
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Yale experience with
Heartmate II
• November 2008- July 2011
• 15 patients
–13 bridge
–2 destination
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Survival Yale HM II EXPERIENCE
1.0
0.8
0.6
0.4
0.2
0.0
0 6 12 18 24 30 36
Pr
[ali
ve]
Time (months)
OMM (n=61) +
+ + +
+ +
+ + + + + + +
+ + +
+ + +
Slaughter,et al NEJM 2009
Transplantation
HM II DT
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Challenges
• Human factors
• Thromboembolism
• Mechanical/physiologic issues
• RV failure
• Bleeding
• Infection
• Power delivery
• Cost 49
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Human Factors
• Changing and charging batteries
• Taking anticoagulants
• Driveline care
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NATOPS
• 1950’s- 54 mishaps per 10,000 flight hours
• 1961- NATOPS established
• Current mishap rate- 2 per 10,000 flight
hours
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Mechanical/physiologic
• Axial flow pumps have not been pumped to
failure
• Aortic valve issues
• inflow conduit migration
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Unusual Aortic Valve Demands
• Continuous coaptation=fusion
• Persistent high trans-mural gradient =AI
Karen May-Newman, et al,”Geometry and Fusion of Aortic Heart Valves from Pulsatile Flow
Ventricular Assist Device Patients”Journal of Heart Valve Disease 2011;20: ??
AoV ΔP=0 AoV ΔP=60
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Continuous flow LVAD: Adverse
Effects on the Aortic Valve
3 years
May-newman K, Biomechanics of the aortic valve in the continuous flow
VAD-assisted heart. Am Soc Artif Intern Organs J 2010;56:301-308
Leaflet Elongation Leaflet Fusion
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• This aortic insufficiency occurs throughout
the cardiac cycle
• Potential solutions
– lower the gradient
–allow pulsatility
–close the aortic valve
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Inflow Conduit Migration
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Our Solution
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Thrombosis: Expect the
unexpected
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QuickTime™ and aCinepak decompressor
are needed to see this picture.
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Infection and
Thromboembolism are Tightly
Coupled
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Driveline infections
• Better now
• ?Iatrogenic?
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Can we deliver power
wirelessly?
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Wardenclyffe 1901
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Witricity
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Thoratec Announces Development Agreement
With WiTricity For Proprietary Energy Transfer
Technology
By PR Newswire
05/10/11 - 04:30 PM EDT
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Cost
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Cost
• 1996- $50,000 per QALY
• 2008- $59,000
–Bridge to transplant VAD- $48,000-$78,000
–Destination/long term use VAD- $56,000
• Costs will decrease as competition hits the
market
• Cost per QALY will improve as technology,
knowlege and execution improve 68
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Summary
• VAD technology is making rapid progress
• The remaining challenges have plausible
solutions
• VADs will be in the next decade what
coronary bypass was at the end of the
twentieth century
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Long Term
• Heartmate II
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Resurrection Devices
• ???
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It takes a village
• Multi-disciplinary team
–Evaluation
–Pre-op optimization
–Peri-op management
–Long term follow-up
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The Future
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Questions?
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