mechanical assist patient selection, device selection, and...

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

Transplant

Registry

josef.stehlik@hsc.utah.edu

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