- LVADs are increasingly being used as a bridge to transplant or destination therapy for advanced heart failure. The number of LVAD implants has grown significantly in recent years and is projected to continue growing as destination therapy becomes more common. LVADs have been shown to improve functional status and quality of life in heart failure patients. While expensive, LVADs can provide survival benefits over medical management for advanced heart failure when transplant is not available. Ongoing research continues to improve device design and outcomes.

1. Future is in Assist Device
Nir Uriel MD
Associate Professor of Medicine
Medical Director of Heart Failure, Heart Transplant and
Mechanical Circulatory Support Program
University of Chicago
ACC March 2015

2. California
2

3. 3

4. King Jon Kobashigawa the 1st
4

6. 1st Heart Transplantation
Professor Christiaan Barnard performed the first human heart transplant on the third of
December 1967

7. Figure 10
The Journal of Heart and Lung Transplantation 2014 33, 996-1008DOI: (10.1016/j.healun.2014.08.003)
The Journal of Heart and Lung Transplantation 2014 33, 996-1008DOI: (10.1016/j.healun.2014.08.003)
Excellent Post Transplant Survival

8. The Prevalence of Heart Failure
• Estimated 23 million people with HF worldwide
• United States: 5.8 million
3.1 million men, 2.7 million women
• 670 000 cases diagnosed each year with over 1 million
hospitalizations and 3.4 million outpatient visits
• The healthcare cost of HF is estimated at $39.2 billion in the United
States for 2010
Prevalence of Common Cardiovascular and Lung Diseases, U.S., 2004, NHLBI report
Death from specific cardiovascular, Lung and Blood Diseases, U.S., 2004 NHLBI report

9. The population of these patients is large: In the US,
~300K AHF patients
~240 M
US Population ≥ 20 years old
6.24 M
HF = 2.6% of the population
3.12 M
Systolic HF = 50% of HF population
124,800
Adv. Stage C / NYHA IIIB
Advanced Stage C = 3-4%
156,000
Stage D / NYHA IV =
0.5-5%
70,200
25% Accessible AHF Patients
30 Patients / 100,000 Population
Potential VAD / TX patient population - National
117 Patients / 100,000 Population
AHF Patients:
Potential VAD / TX Patients:
Incidence: 7 / 100,000 each year

10. Heart Transplants in Major Metropolitan Statistical
Areas (2010)
MSA Population Transplants Per 100,000
New York 21,976,224 110 0.5
Los Angeles 17,775,984 143 0.8
Chicago 9,725,317 76 0.8
Philadelphia 6,382,714 98 1.5
Houston 5,641,077 107 1.9
Total 61,501,316 534 0.9

11. Figure 1
The Journal of Heart and Lung Transplantation 2014 33, 996-1008DOI: (10.1016/j.healun.2014.08.003)
Heart Transplant Not for Every One

13. UNOS
Status
Transplanted
in status
Median
waiting time
1A
1B
2
64%
31%
5%
78 days
224 days
618 days
Stehlik J, Stevenson LW, Mehra MR et al. JHLT Oct 2014.
Median Waiting Time to Transplant

14. Jon Kobashigawa MD , 14 October 2014:
“The marginal donors
of a few years ago are
our standard donors
today”

15. !
US Dept of HHS Scientific Registry of Transplant Recipients
srtr.transplant.hrsa.gov
Death or delisting due to progressive illness while on wait-list: 18%
2008

16. BTT – Survival to Transplantation
150 HM II BTT on UNOS list (1A or 1B) survival compared to medically managed
– BTT older with more co-morbidities
Trivedi et al An Thorac Surg 2014 epub

17. Heart Transplantation

18. Heart Transplant as a Solution?
18

19. LVAD – a New Heart Physiology

20. Decompression of the Heart

21. UP Jorde et al Journal of the American College of Cardiology, Volume 63, Issue 17, 2014, 1751 - 1757
Current Status DT for Advanced Heart Failure
improvement with the HeartMate (HM) II continuous-flow LVAD

22. 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Total Adult Cardiac Transplants w Device
LVAD Bridged De Novo
Uriel N et al. J Heart Lung Transplant. 2013 Feb;32(2):188-95
The Number of LVAD BTT from the Total OHT is Increasing

23. Functional Status – 6 Minute Walk
0
50
100
150
200
250
300
Baseline 1 mo 3 mo 6 mo
LVAD Duration
Meters
271 235 175 128
30 + 88
166 + 168
244 + 218
285 + 235
Pagani F et al. JACC: Vol 54, No 4, 2009.

24. Functional Status – NYHA Class I or II
0
10
20
30
40
50
60
70
80
90
100
Baseline 1 mo 3 mo 6 mo
LVAD Duration
Percentofpatients
NYHA II
NYHA I
59%
83% 82%
0%
259 213 169 120
Pagani F et al. JACC: Vol 54, No 4, 2009.

25. U.S. Chronic VAD Implants vs. Heart
Transplants, 2009-2013
Projected U.S. Chronic VAD implants
by Indication (Analyst Estimates), 2014-2018
131 Destination Therapy centers
in the US today
~3,900
~3,400
~2,750
~2,150
~1,850
~2,500~2,400~2,300~2,200~2,150
20132012201120102009
2,074 2,081 2,127
1,999 2,286
2,638
3,109
3,856
2,1632,158
4,765
20182016
5,268
6,018
2015
4,367
2014
4,073
2017
Transplants
VADs
CAGR
10%
18%
1%
BTT
DT

26. Adverse Events
Uriel et al. Jour Am Col of Card. 2010;56(15):1207-1213.
Garan AR…..Uriel N et al. J Am Coll Cardiol. 2013 May 2
Jorde UP, Uriel N, Circ HF 2014
Uriel N et al. JHLT 2014

28. Expensive
28

29. Fang JC. N Eng J Med. 2009 Dec 3;361(23):2282-5
Schwarzenegger A…Cameron J. Terminator 3: Rise of the Machines 2003

30. • “left on vacation to celebrate 50th anniversary, we went to Paris 1st, the flew to Istanbul
where …..we were away for 18 days and had a great time! How’s that for a medical
miracle?”
30

31. Jarvick 2000

32. HeartMate III

33. HeartMate III
Designed to be Hematologically-Compatible
Leverages Fully Magnetically Levitated Technology
Features
•Fully Magnetically Levitated
•Large pump gaps designed to reduce blood trauma
•Artificial pulse
•Textured blood contacting surfaces
•Wide range of operation
•Full support (2 – 10 L/min)
• Advanced Design for Surgical Ease
•Engineered apical attachment
•Modular Driveline
•Pocket Controller

34. MVAD

35. Circulite – NYAH class III?Circulite

36. Successful Pregnancy
Sims D et al. J Heart Lung Transplant. 2011 Sep;30(9):1065-7.

37. 37

38. Survival After Explant
Age at
Transplant
Years alive
after
Age at
Death
20 15-25 35-45
25 15-25 40-50
30 15-25 45-55
40 15-25 55-65
Transplant
Average follow-up of 1172 ± 948 days
All patients NYHA Class I
Frazier OH, JHLT 2014
LVAD

39. Future of Heart Failure – Regeneration
• Combination of Assist device
with:
– Stem cell
– Gene expression
– Metabolic alteration

40. Jon is Living in a Movie
40

41. Thank you !!
• EMERG group
41Presentation Title Here |

42. Our Advanced Heart Failure Team

43. Destination therapy will drive the
growth of the chronic VAD marketU.S. Chronic VAD Implants vs. Heart
Transplants, 2009-2013
Projected U.S. Chronic VAD implants
by Indication (Analyst Estimates), 2014-2018
131 Destination Therapy centers
in the US today
~3,900
~3,400
~2,750
~2,150
~1,850
~2,500~2,400~2,300~2,200~2,150
20132012201120102009
2,074 2,081 2,127
1,999 2,286
2,638
3,109
3,856
2,1632,158
4,765
20182016
5,268
6,018
2015
4,367
2014
4,073
2017
Source: Thoratec Estimates August 2014; OPTN; Average analyst projections for VAD market (Wells Fargo, Goldman, Credit Suisse, BAML)
r©2014 Thoratec Corporation. All rights reserved. US-HM2-07140015(1)
Transplants
VADs
CAGR
10%
18%
1%
BTT
DT

44. We Need Pulsatility?

45. LVAD speed
Mitral
Regurgitation LVEDD
revolutions/min cm
LVAD implant 8,600 Moderate 6.6
Week 13 and 6 days 9,000 Moderate-Severe 5.4
Week 21 and 6 day 9,400 Moderate 5.8
Week 25 and 6 days 9,400 Severe 6.3
Week 26 and 0 days 9,600 Moderate 5.8
Week 32 and 0 days 9,800 Moderate 6.0
Pregnancy Course (Hemodynamics)

46. UP Jorde et al Journal of the American College of Cardiology, Volume 63, Issue 17, 2014, 1751 - 1757
Results of the DT Post-FDA Approval Study With a Continuous Flow LVAD:
A Prospective Study Using the INTERMACS Registry (Interagency Registry
for Mechanically Assisted Circulatory Support)

47. Survival of UNOS Status IA: VAD v Inotropes (N=5230)
Waiting List Survival Post Transplant Survival
Wozniak et al Ann Thorac Surg 2013