Implantation of Latest Generation

Ventricular Assist Devices

Adult Cardiac Skills and Decision Making

AATS 2013

Mark S. Slaughter, MD

Professor and Chief

Division Thoracic and Cardiovascular Surgery

University of Louisville

Disclosure

• HeartWare - Education/training grant support

• APK - SBIR research grant support

• SCR – consultant

• *I will discuss off label use of VADs

The Evolution of MCS Devices

Paracorporeal

Pneumatic

Pulsatile

Uni- or

Biventricular

Implantable

Electric

Pulsatile

Large

Multiple

moving parts

Implantable

Electric

Continuous

flow

Axial design

Smaller

Single moving

part

Implantable

Electric

Continuous

flow

Centrifugal

design

Smaller

Bearingless

Implantable

Electric

Continuous

flow

Axial design

Smaller

Partial support

Months

0 6 12 18 24

Perc

en

t S

urv

ival

0

10

20

30

40

50

60

70

80

90

100

HM II BTT Miller NEJM 2007

HM II DT Slaughter NEJM 2009

HM II BTT Pagani JACC 2009

HM II BTT Starling HFSA 2009

VE DT LVAD REMATCH Rose NEJM 2001

XVE DT LVAD Slaughter NEJM 2009

OMM REMATCH Rose NEJM 2001

OMM INTrEPID Rogers JACC 2007

Novacor DT LVAD INTrEPID Rogers JACC 2007

Improving Survival in LVAD Trials

100

90

80

70

60

50

40

30

20

10

0 0 6 12 18 24

HMII BTT Starling HFSA 2009

HMII BTT Pagani JACC 2009

HMII BTT Miller NEJM 2007

HMII DT Slaughter NEJM 2009

VE DT LVAD REMATCH Rose NEJM 2001

XVE DT LVAD Slaughter NEJM 2009 Novacor DT LVAD INTrEPID Rogers JACC 2007

OMM REMATCH Rose NEJM 2001 OMM INTrEPID Rogers JACC 2007

% Survival

Months

Continuous vs. Pulsatile Flow

Kirklin, J.K., et al., The Fourth INTERMACS Annual Report: 4,000 implants and counting. The Journal of Heart and Lung Transplantation, 2012. 31(2): p. 117-126.

Kirklin, J.K., et al., The Fourth INTERMACS Annual Report: 4,000 implants and counting. The Journal of Heart and Lung Transplantation, 2012. 31(2): p. 117-126.

Kirklin, J.K., et al., The Fourth INTERMACS Annual Report: 4,000 implants and counting. The Journal of Heart and Lung Transplantation, 2012. 31(2): p. 117-126.

U.S. Chronic VAD Implants at Transplant Centers and Open Heart Centers

Transplant Centers Open Heart Centers Source: Thoratec Corporation estimates as of April 2013

20112010200920082007 2012

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2,200

2,400

2,600

2,800

3,000

3,200

3,400

3,600

~3,200

~94%

~2,750

~97%

~2,150

~99%

~1,850

~99%

~1,325

100%

~3,500

~89%

~1%

~1%

~3%

~6%

~11%

Pulsatility and VAD

• Pulsatile flow VAD (PVAD) and current CVAD have different affects on blood flow pulsatility. – PVAD can augment pulsatility – CVAD can only attenuate pulsatility

Pu

lsat

ility

EEP ≈ MAP

EEP >> MAP

Healthy Heart Heart

Failure CVAD

PVAD

HeartMate II LVAD

HM II Surgical Implant Procedure Requires creation of a Pump Pocket

Courtesy Mark Slaughter, MD

HM II Surgical Implant Procedure Apical Sewing Ring

HMII LV Cannulation

HeartMate II LVAD

HeartMate II Driveline Configuration

Incisions for MICS HeartMate II Insertion

MICS HeartMate II

Alternate Incisions LV apex exposure

HVAD® Miniaturized Implantable Blood Pump

• About the size of a “D” battery

• Provides full support for Class IV patients

• Centrifugal design, continuous flow

• Hybrid magnetic /

hydrodynamic impeller

suspension

• Optimizes flow, pump

surface washing, and

hemocompatibility

Heartware HVAD Resides within Pericardial Space

HVAD® Pump Surgical Implant

• No abdominal surgery or pump pocket

• Fits in the pericardial space

• Accommodates smaller body sizes

• Less invasive surgery - potentially minimizes blood transfusions

• Thin driveline, with fatigue resistant cables, may exit right or left side

HVAD LV Cannulation

Apical Sewing Ring Attachment

HVAD® Pump Placement

Outflow Graft

Pediatric HDE Right Ventricular HDE

Thoracotomy Registry

Potential Indication Expansion for HVAD® Pump

CAUTION – Investigational Device. Limited by United States law to investigational use.

Less Invasive Implant Techniques

Less Invasive Implant Techniques

Less Invasive Implant Techniques

Less Invasive Implant Techniques

HVAD Alternative Outflow (Arnt Fiane, MD, PhD)

Circulite Synergy

32

Outflow Graft

Percutaneous Lead

Inflow Cannula

Micro-Pump System

Micro-pump

Flow Rate: 1.8 – 4.2 L/min

Synergy Implant

33

• Pump in subcutaneous pacemaker pocket • Right sided mini-Thoracotomy • Off pump

CircuLite Implant

36

CircuLite Endovascular Implant

Clinical Use of CF VADs for Biventricular Support

• Bi-ventricular support

• Total artificial heart (TAH)

• Special considerations - RV anatomy - differences in vascular resistance - setting/managing right and left flow

Adjustment for RV Anatomy

HVAD BVADs (diaphragmatic surface)

HVAD BVADs

HVAD BVADs

(RV anterior wall)

HeartWare Biventricular Support

HeartMate II TAH (Frazier and Cohn, THI)

HeartMate II TAH (Frazier and Cohn, THI)

LV Apex Access: Reducing Adverse Events

Conclusions

• Majority of pumps currently implanted are CF LVADs

• Some differences between axial vs centrifugal flow

• Assessing right heart function critical when deciding on pump choice/therapy

• Smaller LVADs and less invasive techniques will allow potential access to “less sick” patients

• Renewed interest in pulse pressure and making CF pumps have pulsatility

Thank You!

“I have gathered what I observed to be useful, and brought it together as a single body”

Vitruvius

Ten Books on Architecture (c. 25 B.C.)