Surgical Therapy for the Stage D Heart Failure: Transplantation and Ventricular Assist Devices Edwin C. McGee, Jr., MD Division of Cardiothoracic Surgery Surgical Director,Heart Transplantation Mechanical Assistance Bluhm Cardiovascular Institute Assistant Professor of Surgery Northwestern University’s Feinberg School of Medicine Relevant Financial Relevant Financial Relationship Relationship Disclosure Statement Disclosure Statement I will discuss off label use and/or investigational use of drugs/devices I will discuss off label use and/or investigational use of drugs/devices The following relevant financial relationships exist related to this The following relevant financial relationships exist related to this presentation: presentation: CardiacAssist, Inc CardiacAssist, Inc Scientific Advisory Board Scientific Advisory Board Speaker Speaker’ s Bureau s Bureau Thoratec Thoratec Consultant Consultant Heart Transplantation
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Surgical Therapy for theStage D Heart Failure:Transplantation and
Ventricular AssistDevices
Edwin C. McGee, Jr., MD Division of Cardiothoracic Surgery
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
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
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