vads; how far have we come?

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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.

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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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