The document discusses left ventricular assist devices (LVADs), which are mechanical pumps that help the failing left ventricle pump blood to the body. It provides background on the history and development of LVAD technology, describing early models and milestones as well as current FDA-approved devices like the HeartMate II. The document also outlines how LVADs work, their uses as either a bridge to transplant or for destination therapy, and outcomes data from clinical trials.

1. Left Ventricular Assist Devices
N John Castro, M.D.
Cardiac Surgeon
Centracare Heart and Vascular Center
Saint Cloud, Minnesota

3. 1) Consultant-Surgeon INOVATE HF Trial
2) LVADS not part of my practice for 17 months
1) University of Minnesota

4.  1952: World’s first successful open-heart surgery
 1954: World’s first successful open-heart surgery using
cross-circulation
 1955: development of world’s first functional heart-lung
machine

5. Approximately how many people in the US
are in Heart Failure?

6.  Heart failure affects over 5.3M patients in the United States 1
 300,000-800,000 Americans have advanced heart failure. 2
 Over 280,000 patients die of heart failure each year 1
1 Lloyd-Jones D, Adams R, Carnethon M, et al. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart
disease and stroke statistics 2009 update: a report from the American Heart Association Statistics Committee and Stroke Stati stics
Subcommittee. Circulation. 2009;119(3):480-6.
2 Adams KF, Zannad F. Clinical definition and epidemiology of advanced heart failure. Am Heart J 1998;135:S204-S215.

7. Class Patient Symptoms
• No limitation of physical activity
I
Mild • No undue fatigue, palpitation or dyspnea
A • Slight limitation of physical activity
II
Mild • Comfortable at rest
• Less than ordinary activity results in fatigue, palpitation, or dyspnea
B • Marked limitation of physical activity
•
III
Moderate Comfortable at rest
•
C
Less than ordinary activity results in fatigue, palpitation, or dyspnea
• Unable to carry out any physical activity without discomfort
IV
•
D
Severe Symptoms of cardiac insufficiency at rest
• Physical activity causes increased discomfort
Criteria Committee of the New York Heart Association, 1964.

8. Data on file, Thoratec Corporation.
Rose EA, et al. Long-term mechanical left ventricular assistance for
end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43.

9. Heart Failure Expected to Become More
Common as Population Ages
Outlook for Heart Failure: Five-year Technology and Business
Assessment. The Advisory Board; 2007.

10. How many hearts are donated
each year?

11. Approximately, 2200 hearts are donated each year and it is on the
decline.
NOW LET’S COMPARE:
600,000 Class IV Heart Failure Patients
vs.
2,200 Heart Donations

12.  Remains the most effective Tx for end-
stage heart disease, although donor
shortage limits its use
 1-year survival:
86% (2002)
 5-year survival: 71%
 10-year survival: 46%
Vitali E, Colombo T, et al. Surgical therapy in advanced heart failure.
Am J Cardiol 2003;91(suppl):88F-94F
Taylor et al. J Heart Lung Transplant 2003;22:616.
American Heart Association. Heart Disease and Stroke Statistics-2009
Update.

15. • A VAD is a mechanical circulatory device that is used to
partially or completely replace the function of a failing
heart
• Goal of device: to direct blood away from the failing
ventricle (Left and/or Right) and provide flow to the
circulation (Systemic and/or Pulmonary)

17.  Pulsatile pumps mimic the natural pulsing action of the
heart
▪ These pumps are also known as volume
displacement pumps
 Continuous flow pumps use either centrifugal pumps or
axial flow pumps
▪ Both types have a central rotor containing
permanent magnets. Controlled electric currents
apply forces to the magnets, which in turn cause the
rotors to rotate

18.  Pump (VAD)
▪ Internal or external placement
 Wearable or portable control system
 Power source
▪ AC power or battery power that is
outside of the body
 The pump can vary in method of operation,
size and placement

19.  A rotary continuous-
flow device in parallel
with the native left
ventricle
 Left ventricle to ascending
aorta
 Percutaneous driveline
 Electrically powered
 Batteries & line power
 Fixed speed operating
mode
 Home discharge

20.  Smaller size
 60% Smaller than HeartMate I
(XVE)
 No requirement for venting
― 40% reduction in the size of
percutaneous lead
 Enhanced patient comfort
 Silent, vibration-free
operation
 Ease of surgical implantation
― Standard sternotomy vs.
extended midline excision
― Smaller preperitoneal pocket
 Designed for extended
durability

21. More than 10000 patients worldwide have now been
implanted with the HeartMate II LVAS.
 Patients supported ≥ 2 years: 1108
 Patients supported ≥ 5 years: 332
 Patients supported ≥ 6 years: 8
 Patients supported ≥ 7 years: 1
As of Sept 2011 *Based on clinical trial and device tracking data

23.  1937 Vladmir Demikhov implanted the first artificial heart in a dog
 1949 Glenn successfully bypassed the heart of a dog for over an
hour using a machine he made out of an erector set, assorted odds
and ends and dime store finds

24.  The modern era of mechanical
circulatory support began in
1953 with the work of Gibbon,
the first surgeon to use CPB
successfully

26. First successful use of an LVAD for postcardiotomy heart failure

27. First successful Heart Transplant

28.  Texas Heart Institute implanted a Total Artificial Heart. Patient lived
64 hours before successful transplant

30.  First use of an LVAD as a bridge to
transplant in a 21 year old post
MVR/AVR. Patient received a heart
transplant 5 days later.
 The pumps was interposed between
the apex of the left ventricle and the
infrarenal abdominal aorta (ALVAD).

31.  Dr. William DeVries implanted the
Jarvik 7 in Barney Clark for
destination therapy. He lived for
112 days

33. 1984 First Successful Bridge-to-Transplant - Thoratec VAD
California Pacific Med Ctr, San Francisco

35. More than 9,000 patients worldwide have now been
implanted with the HeartMate II LVAS.
 Patients supported ≥ 1 year: 3263
 Patients supported ≥ 2 years: 1220
 Patients supported ≥ 3 years: 436
 Patients supported ≥ 4 years: 151
 Patients supported ≥ 5 years: 40
 Patients supported ≥ 6 years: 13
 Patients supported ≥ 7 years: 1
*Based on clinical trial and
device tracking data
On file with Thoratec
As of Jan 2012

36. > 9,000 Patients Implanted
Pivotal Trial Commercial
Pilot Trial Experience
n=1315*
n=53
*as treated n>8000
(+114 XVEs)
Bridge to Transplant
Destination Therapy
n=490 n=825
BTT Approvals DT Approvals
CE Mark: Nov. 2005 Mark: Nov. 2005
CE
FDA: Apr. 2008
Health Canada: May 2009 2010
FDA: Jan.
Health Canada: Nov 2010
On file with Thoratec
As of Jan 2012

38. HM II with
controller and batteries
HM I HM II
Weight (gm) 1250 280
HM I
Volume (ml) 450 63
Noise Audible Silent
Moving parts Many One
HM II Maximal flow 10 10
(l/min)*
Clinical 1.5 Est. > 5
Durability (yr)
* at mean pressure=100 mm Hg

40. Thoratec Laboratories Corp
Thoratec VAD Clinical Trial IVAD Clinical Trial
Founded
1976 Electron / ThermoCardio Systems Inc
Thermo
First LVAD Clinical Trial HeartMate IP
HeartMate VE
REMATCH Trial
Thoratec-TCI HeartMate II Trial
Merger 2001
1980 1990 2000 2010
=FDA Approvals

42. Bristow MK. Management of heart failure. In: Braunwauld E, ed. Heart
Disease: a Textbook of Cardiovascular Medicine. Vol 1. 6th ed.
Philadelphia: W.B. Saunders Company, 2001:635-651

43. When Should the MCS Discussion Begin?
Jessup M, Brozena S. N Engl J Med 2003;348:2007-18.

44.  Bridge to Transplantation
▪ Non-reversible left heart failure
▪ Imminent risk of death
▪ Candidate for cardiac transplantation
 Destination Therapy
▪ NYHA Class IIIB or IV heart failure
▪ Optimal medical therapy 45 of last 60 days
▪ Not candidate for cardiac transplantation

45. Post Approval Study
90% 6-Month Survival
85% 1-Year Survival
Starling, Naka, Boyle JACC, in press 2010

46. • 90% of patients were transplanted,
recovered or had ongoing support at
6 months
• Operative 30-day survival was 96%
• Survival was superior to that which
has been previously reported with
LVAD usage

48. Early Trial vs Mid Trial
100
90 DT Implants mid trial (n=252)
(5-4-07 thru 3-1-09)
80 74 + 3%
Percent Survival
70
68 + 4%
60
DT Implants early trial (n=133) 58 + 4%
50
(3-16-05 thru 5-4-07)
40 (Slaughter, Rogers, Milano NEJM 2009)
30
20
Remaining at Risk:
10 252 194 168 102
133 95 82 69 62
0
0 6 12 18 24
Months
Slaughter MS, presented at ISHLT 2010, Chicago

49. Early Trial vs Mid Trial
Average Support Duration
100
Early trial = 2.0 ± 1.6 years (longest: 5.5 years)
90 Mid trial = 1.5 ± 1.0 years (longest: 3.4 years)
80 74 ± 3% Mid trial (N=281)
64 ± 3%
70
Percent Survival
68 ± 4%
60
Early trial (N=133)
58 ± 4%
50
40
P(log-rank) = 0.134
30 P(adjusted for BSA) = 0.162
20
At Risk:
10 281 215 188 167 94
133 95 82 69 62
0
0 6 12 18 24
Time (Months) * P value adjusted for body surface area
Park, S. presented at AHA 2010, Chicago

50. Background Survival in Destination Therapy Trials2
• Initial HeartMate II Destination
Therapy (DT) trial demonstrated
significant improvements in
outcomes compared to
randomized patients with
pulsatile LVADs1
– 68% survival at 1 year
– 58% survival at 2 years
• Over 500 additional DT patients
have been enrolled under
continued access protocol
(CAP)
1 Slaughter MS, Rogers JG, Milano CA et al: Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51.
2 Fang JC: Rise of Machines – Left Ventricular Assist Devices as Permanent Therapy for Advanced Heart Failure N Engl J Med. 2009 Dec 3;361(23):2282-84.
Source: Park SJ, AHA 2010

51. What is the magnitude of absolute survival
Conclusions benefit with LVAD DT therapy?
• Trend towards improving survival
– Fewer deaths from
hemorrhagic stroke
• Significant reductions in adverse
events:
– Hemorrhagic stroke
>50% reduction
– Device related infections
>35% reduction
– Sepsis
>25% reduction
• Both QoL measures (KCCQ and
MLWHF) demonstrated significant
improvement over baseline values
Source: Park SJ, AHA 2010

52. 80 Centers For Medicare and Medicaid Services
Certified Destination Therapy Facilities (as of April 2010)
Denotes a CMS-certified Destination Therapy facility. Number of facilities = 80
Source: CMS website www.cms.hhs.gov/coverage/lvadfacility.asp

53. Intensity = Incidence of
HF deaths

54. Heart
Failure
Cardiologist
Nurses & Cardiac
Physician Surgeon
Assistants
Patient
And
Family
Community Industry
Agencies Resources

55. Who, when, and where?

57.  Stage A
 Treat diabetes, HTN, CAD
 Stage B
 Beta-blockers, Ace-I, ARB, Aldo antagonist
 Stage C
 Drug therapy + CRT (QRS > 130ms) & ICD
 Diuretics, digoxin
 Stage D

58.  Medical Therapy
 Optimal medical therapy
 Inotropes, diuretics, ultrafiltration
 Heart Transplantation
 Mechanical Circulatory Support
 BTT, BTD, DT
 Palliative Care

59.  Optimal medical therapy
 Unable to tolerate beta-blockers, Ace I
 IV inotropes
 Milrinone, dobutamine
 OPTIME trial, ADHERE registry
 Palliative Care / Hospice

60.  Average survival is 11 years
 Exclusions
 Age
 Systemic illness
 Pulmonary hypertension
 Infection
 Malignancy
 Psychosocial

61. I think LVADs
are great !!!!

65.  Qualifies for a heart transplant, but…
 Likely to have a long wait time
 History of malignancy
 High PRA levels
 Pulmonary hypertension
 Crash & Burn
 Destination Therapy

66.  Stage D Refractory Heart Failure
 On the max tolerated doses of medical Tx
 Recurrent hospitalizations for HF
 Peak VO2 < 14
 Dependent on IV inotropic therapy
 Seattle HF Model
 Predicts survival at 1 year

68.  Chronic HF with acute hemodynamic
compromise
 Acute Myocardial Infarction with
cardiogenic shock
 Myocarditis
 Inability to wean from cardiopulmonary
bypass

69.  On maximum inotropic support and/or
IABP
 Systolic BP < 80 and either:
 PCW > 20
 Cardiac Index < 2.0
 In need of immediate mechanical
circulatory support and may not survive
transfer

70. Conclusions
• Trend towards improving
survival
– Fewer deaths from
hemorrhagic stroke
• Significant reductions in
adverse events:
– Hemorrhagic stroke
>50% reduction
– Device related infections
>35% reduction
– Sepsis
>25% reduction
Source: Park SJ, AHA 2010

71. Unique Features of the HeartWare Pump
• No abdominal surgery or pump • Accurate flow estimation
pocket
• Log files enable flow and power
• Fits in the pericardial space waveform analysis
• Anatomically fits smaller patients • Novel impeller design enables
excellent hemodynamics
• Less surgery; potentially
minimizes blood transfusions

72. University of Minnesota Experience
Continuous Flow Devices
180
160
140
120 DT
Number
100
80 BTT
60
40
20
0
170 33 10
HeartMate II Ventrassist HeartWare

73. Neurologic
Stroke/TIA 9 (8.8%)
Paraplegia 1 (0.98%)
Hemmorhagic
Gastointestinal bleeding 18 (17.6%)
Infectious
Driveline Infection 25 (24.5%)
Pocket Infection 0
Pump Infection 0
RV Failure requiring RVAD 5 (4.9%)
Pump Thrombosis 1 (0.98%)
Device Malfunction 2 (1.9%)
Device Replacement 1 (0.98)
Renal Failure 2 (1.9%)

74. Readmissions with CF LVADs
• Total days of hospital readmission were 1117 days
• Mean duration per readmission at 6.81 days.
• Reasons for readmission:
• Elective procedures 19 (11.6%)
• Heart failure 17 (10.4%)
• GI bleeding 16 (9.8%)
• Driveline infection 13 (7.9%)
• Other 17 (10.4%)

75. Profile Description
1 Critical cardiogenic shock
2 Progressive decline
3 Stable, but inotrope dependant
4 Recurrent advanced heart failure
5 Exertion tolerant
6 Exertion limited
7 Advanced NYHA III

76. Refining Timing of Implant
 May require 24-48 hours of preop support
 Hemodynamic monitoring
 Drug therapy focusing on right atrial
pressure and renal function
 Preop IABP
 Normalize coagulation parameters
 Consider ultrafiltration

77. HeartMate II
Left ®
Ventricular Assist System
Surgical Implant Procedure

79.  Median sternotomy
 Cardiopulmonary bypass
 No cross clamp required
 Preperitoneal vs. Intra-abdominal placement
 Create apical core site and suture the sewing
ring in position
 Anastomose outflow graft to ascending aorta
 Tunnel percutaneous lead & create
percutaneous lead exit site with skin punch

80.  Anesthesia
 Monitoring (PA & Art. Lines)
 Transesophageal ECHO
 Inotropes
 Nitric Oxide, Flolan
 Bleeding/Hemostasis
 Blood products (FFP, PRBC’s, Platelets, Cryoprecipitate)
 Antifibrinolytic agents
 Vitamin K
 Right Heart Dysfunction

81. Issue Possible Solution and Comments
AI must be corrected. Mild AI may progress to moderate
following LVAD implant with reduction in LV pressure
Aortic Insufficiency  Aortic leaflets can be partially oversewn
 Replace with a bioprosthetic valve1
Mitral Regurgitation Generally does not require repair
Mitral Stenosis MV replacement with bioprosthethic valve
3+ to 4+ TR, consider annuloplasty repair (ring or modified
Tricuspid Insufficiency
De Vega reinforced with multiple pledgets)
 Aortic valve: consider replacement with a bioprosthetic
Mechanical Prosthetic valve
Valves  Mitral valve: generally does not require replacement;
consider anticoagulation
1Feldman CM, Silver MA, Sobieski MA, Slaughter MS. Management of aortic insufficiency with continuous flow LVADs: bioprosthetic valve
replacement. J Heart Lung Transplant. In press, 2006.

82. Preperitoneal Placement
Potential Advantages: Potential Issues:
 Patients with:
 Previous abdominal  Pocket hematoma
surgery  Exit site drainage
 Short torso  Infection (pocket and
 Easier explant or
exchange exit site)
 Reduced Risk of:  Wound dehiscence
 Bowel and gastric  Skin erosion over
erosion pump
 Visceral adhesion
 Bowel obstruction
 Diaphragmatic hernia

83. Courtesy Mark Slaughter, MD

84.  Retractor Placement
 Inverted
 CPB Cannulation
 Right atrial single 2 stage or bi-caval
 Aortic

85.  Steps to minimize CPB time:
 Outflow graft anastomosis
 Pump pocket & placement
 Percutaneous lead tunneling
 Adjusting inotropic and afterload-reducing drugs
prior to CPB can help maximize RV function
and reduce PVR while optimizing systemic
perfusion pressure

88.  Point posteriorly toward
mitral valve
 Should not point toward
septum or free wall
 Partial occlusion of inflow
conduit, leading to poor
filling of the LVAD and
possible thromboembolic
complications

89.  Beating heart
 Trendelenburg position
 Arrested heart
 No cardiopulmonary bypass

94. Teflon
strip

99.  Maximize distance between the pump pocket and exit
site
 1 to 2 cm of velour exteriorized
 Gentle loop leaving some internal slack for accidential
tugs

101.  Trendelenburg position
 Needle in outflow graft
 Back bleed from aorta and replace clamp on
graft
 Reduce CPB flow and de-air heart
 Use TEE to check for air in LV and aorta
 Remove LV vent if used
 Reduce CPB flow by half and ventilate

103.  Make sure following alarms are active:
 Pump Off
 Pump Disconnected
 Low Flow
 Remove tunneling bullet & connect
percutaneous lead to system controller
 Initiate pump flow at 6,000 rpm and vent through
needle
 Remove needle and clamp, terminate CPB and
then increase pump speed

104.  Maintain speeds >9,000 rpm to maximize
flow through the pump
 Use TEE to determine optimum speed
 RV function
 Position of septum
 LV unloading
 Aortic valve opening
 Presence & degree of TR, MR, AI

105.  Repeat bubble study
with the LV unloaded
 Previously undetected
PFO may be unmasked
 Some centers visually
inspect the interatrial
septum to rule out PFO
11 Heath MJ, Dickstein ML. Perioperative management of the left ventricular assist device recipient. Prog Cardiovasc Dis.
2000;43(1):47-54.

106.  Evaluate & repair tricuspid valve if necessary
 Avoid RV volume overload – maintain CVP < 16 to 18 mm Hg.
 CVP ≤ 10 mm Hg, volume may improve flow
 Moderate RV dysfunction
 Milrinone, epinephrine, or vasopressin
 ↑ PVR: Inhaled Nitric Oxide or Flolan1-3
 Avoid high LVAD speeds that cause leftward septal shift
 Leaving sternum open for 24 hours may reduce CVP > 16 mm Hg
 Temporary RVAD
 Moderate to high inotropic, pressor support
 CI < 2.0 L/min/m2
 CVP > 16 mm Hg
1 Augoustides JG, Ochroch EA. Pro: inhaled prostaglandin as a pulmonary vasodilator instead of nitric oxide. J Cardiothorac Vasc Anesth. 2005;19(3):400-402.
2 De Wet CJ, Affleck DG, Jacobsohn E, et al. Inhaled prostacyclin is safe, effective, and affordable in patients with pulmonary hypertension, right heart dysfunction,
and refractory hypoxemia after cardiothoracic surgery. J Thorac Cardiovasc Surg. 2004;127(4):1058-1067.
3 Dickstein ML. Con: inhaled prostaglandin as a pulmonary vasodilator instead of nitric oxide. J Cardiothorac Vasc Anesth. 2005;19(3):403-405.

108.  Office visit every 3 months “Shared Care”
 History (HIBSAD)
 Heart Failure ROS
 Infection
 Bleeding
 Stroke
 Alarms
 Device shocks

109.  Beta-blocker
 Ace Inhibitor
 Warfarin (Goal INR 1.5-2.5)
 Diuretic

110.  Vital signs  LVAD interrogation
 Neck veins  PPM-ICD interrogation
 LVAD sounds  Echocardiogram
 Lungs  Septum
 Driveline site  Aortic valve
 Liver size  RV function
 Edema  Inflow cannula
 Pulses  Outflow cannula

111.  CBC
 Chemistry profile
 LDH
 LFTs
 INR (1.5-2.5)

112.  Noon – 1 pm on the 1st Tuesday of the
month
 Led by Ann Rudnicki, R.N.
 Opportunity for LVAD, or potential LVAD
patients to have an opportunity to meet
people in a similar situation
 Share fears, anxieties, experiences
 Ask each other questions, get advice

113.  HeartLine™ (24 Hour Clinical & Technical Support) 800-456-1477 (not for patient
use)
 Published Reference Materials
 www.thoratec.com
▪ http://www.thoratec.com/videos/mp-mcs.aspx
▪ http://www.thoratec.com/videos/pc-considering-vad.aspx
 www.hearthope.com
 Reimbursement
 VADReimbursement@thoratec.com
The HeartMate II LVAS System, HeartMate XVE LVAS System, Thoratec VAD System, Thoratec IVAD System, and the TLC-II have the CE Mark.
Thoratec, the Thoratec logo, HeartMate, HeartMate II, TLC-II, Thoralon, and HeartTouch are registered trademarks, and PVAD, IVAD,
HeartWear and HeartLine are trademarks of Thoratec Corporation. ©2010 Thoratec Corporation B155-1210

114. Product Design Benefits
• Potential for reduced anti-
coagulation, thrombus, and
bleeding
• Ability to induce pulsatility
• Low power consumption
• Compact design – intrathoracic
Ultra-Compact, Fully Mag-Lev VAD placement
• Full support (10L / min) in ultra-
compact size
• Incorporates critical HeartMate family
design elements (e.g. large gaps,
textured surfaces)
• Intrathoracic placement; centrifugal
flow

115. Product Design Benefits
• Dramatic size reduction
– Rapid, less invasive implant
– Versatile cannulation options
• Meets needs of expanded patient pool
– Earlier-stage patients
– RVAD / BiVAD population
• Low power consumption
– Potential for smaller external
batteries and components
• Leverages core HeartMate II
technology
• Versatile platform, capable of providing
partial and full support (1-8 L/min)

117. Thank you!