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Josef Stehlik, MD, MPH Associate Professor of Medicine
Medical Director, Heart Transplant Program
University of Utah School of Medicine
Director, ISHLT Transplant Registry
Mechanical assist – patient selection,
device selection, and outcomes
• 5,000,000 individuals with HF
• 300,000 deaths /550,000 new diagnoses annualy
• Most frequent cause of hospitalization in >65 yrs
Epidemiology of HF
• Advanced/ refractory / stage D
approx. 5% of HF population
• How to identify patients who should be evaluated
for advanced HF therapies?
• How to decide which of the stage D patients
should receive advanced HF therapies?
Low-risk
cost-effective
therapies
Higher-risk
resource intensive
therapies
Tx / LVAD
High risk / comorbidities
Medical
therapy
Low risk / good prognosis
Medical
therapyTx / LVAD
Selection of appropriate therapies
Medical
therapy
Tx / LVAD
Appropriate candidate
Beta-blockers
ACE/ARB
Aldosterone antagonists
0
25
50
75
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Su
rviv
al (%
)
Years
Half-life = 10 years
Conditional half-life = 13 years
CONSENSUS
Class IV
PRAISE
Class III-IV
PROMISE
Class III-IV
Survival after heart transplant
Heart transplant
Lund L, Stehlik J et al. JHLT Oct 2013
Months
0 6 12 18 24
Perc
en
t S
urv
iva
l
0
10
20
30
40
50
60
70
80
90
100
Medical Management(REMATCH, NEJM 2001)
LVAD Destination Therapy(HMII Post Approval Study)
Figure courtesy Ulrich Jorde, MD
DT LVAD - Survival in HF stage D
HF patients in ‘trouble’
• not tolerating optimal medical therapy
• multiple admissions
• cardiorenal syndrome
• persistent poor exertional tolerance
major lifestyle adjustments
poor quality of life
• rapidly remodeling LV
• worsening pulmonary hypertension
Strategies for advanced HF patients
• Heart transplant
• LVAD bridge to transplant/transplant eligibility
• LVAD permanent (destination) therapy
• LVAD bridge to recovery
Bridge to transplantation – HeartMate II
- HeartMate II
- 133 patients
- no control group
• Primary outcome:
transplantation, recovery or ongoing
mechanical support while remaining eligible
for transplantation, at 180 days
Bridge to transplantation – HeartMate II
Miller LW et al. NEJM, 2007 Aug 30;357(9)
Miller LW et al. NEJM, 2007 Aug 30;357(9)
HeartMate II BTT trial, primary outcome
75% 68%
Functional status after LVAD implant
0
50
100
150
200
250
300
Baseline 1 mo 3 mo 6 mo
Time since LVAD implant
Six
-min
ute
wa
lk t
es
t (m
ete
rs)
Miller LW et al. NEJM, 2007 Aug 30;357(9)
HeartWare BTT trial, primary outcome
Aaronson KD, Circulation, 2012
HeartWare H-VAD BTT trial
Aaronson KD, Circulation, 2012
LVAD – evolving clinical indications
• Acute cardiogenic shock
• Deterioration in a patient awaiting heart
transplantation
• Poor quality of life in a patient awaiting heart
transplantation
Patients bridged to transplant with MCS
0
10
20
30
40
50
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
% o
f p
ati
en
ts
Year
JHLT Oct 2014
2014Lund L, Stehlik J et al. JHLT Oct 2014
0
10
20
30
40
50
18-39 40-59 60-69
% o
f p
ati
en
ts
TAH
LVAD+RVAD
RVAD
LVAD
2011ECMO is excluded.
JHLT Oct 2013
2013Lund, Stehlik. JHLT Oct 2013
BTT MCS in patients of different ages
Destination therapy
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
0.90
1.00
0 6 12 18 24 30 36 42 48 54
Months Post Enrollment
Perc
ent S
urvi
val
VE LVAS (n=71)
OMM (n=61)P = 0.0012
P = 0.0004
Rose, et al NEJM Nov, 2001
Destination therapy: REMATCH Trial
Slaughter MS et al , NEJM Dec 2009;361(23)
HeartMate II DT Trial
Destination LVAD - survival
Months
0 6 12 18 24
Perc
en
t S
urv
iva
l
0
10
20
30
40
50
60
70
80
90
100
HM II DT Slaughter NEJM 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
HM II DT Park CIRC HF 2012
HM II DT Jorde ISHLT 2013
Jorde U, JACC 2013
Patient selection and post-VAD survival
Patient acuity (INTERMACS Profile)
Patient acuity (INTERMACS Profile)
Implants 2008-2013
Kirklin JK et al, JHLT 2014. 6th Intermacs Report
Age
Kirklin JK et al, JHLT 2014. 6th Intermacs Report
CF LVAD and BiVAD – implants 2008-2013
Quality of life after LVAD implant
Grady et al, ISHLT 2014
Right heart failure risk
Kirklin JK et al, JHLT 2014. 6th Intermacs Report
CF LVAD and BiVAD – implants 2008-2013
Renal failure
Kirklin JK et al, JHLT 2014. 6th Intermacs Report
CF LVAD and BiVAD – implants 2008-2013
Device replacement
Kirklin JK et al, JHLT 2014. 6th Intermacs Report
Future?
Drakos SG, JACC 2014
Engineered pulsatility of VAD flow
HeartMateIII, in clinical trials
Fully implantable systems
HeartMate fully implantable system, in development
Mobile Tethered Free
Wireless energy transfer
Further reduction in VAD size
HeartMate X, in development
• Role for partial support?
Better biocompatibility
?Reduced need for:
- anticoagulation
- antiplatelet therapy
Conclusions
- VAD therapy outcomes have dramatically
improved in the past decade
- VAD therapy provides a favorable therapeutic
option for a wide range of patients with
advanced HF
- Risk factors for poor outcome should be
recognized
- Future technology improvements are likely to
further enhance survival and patient
satisfaction after VAD implant
HMII – adverse events
Jorde et al. JACC 2014
HVAD
– adverse events
Rehospitalization after LVAD implant
Takeda et al., JTCS 2014
Jarvik 2000
• Implant: thoracotomy
(no sternotomy)• Postauricular
configuration
