“Ventricular Assist Device“

ESC Congress 2010, Stockholm

Martin Strueber, M.D.

Cardio-Thoracic,

Transplantation and Vascular Surgery

LVAD Implant: 5th July 2005

Ongoing Days: 1856

LVAD Implant: 29th Oct 2005

Ongoing Days: 1742

LVAD Implant: 12th Nov 2005

Ongoing Days: 1729

Cardio-Thoracic,

Transplantation and Vascular Surgery

Cardio-Thoracic,

Transplantation and Vascular Surgery

N Engl J Med. 2009 Dec

Cardio-Thoracic,

Transplantation and Vascular Surgery

N Engl J Med. 2009 Dec

Figure 2: The data

shown are for the 192

patients who received a

left ventricular assist

device (LVAD). Of the

59 patients who had a

pulsatile-flow LVAD, 20

had the device replaced

during the study period,

with 18 (31%) receiving

a continuous-flow LVAD

instead of another

pulsatile-flow LVAD. By

2 years, only 2 patients

had a pulsatile-flow

LVAD, both of whom

had replacement

devices.

Kaplan–Meier Estimates of Survival from the As-Treated Analysis,

According to Treatment Group

Cardio-Thoracic,

Transplantation and Vascular SurgeryN Engl J Med. 2009 Dec

Cardio-Thoracic,

Transplantation and Vascular Surgery

N Engl J Med. 2009 Dec

Figure 1: The curves

labeled 2009 are those

reported by Slaughter

and colleagues in this

issue of the Journal2;

those labeled 2001

were reported for the

REMATCH trial.1

Survival Rates in Two Trials of Left Ventricular Assist Devices (LVADs) as

Destination Therapy

Cardio-Thoracic,

Transplantation and Vascular Surgery

Lahpor, Strueber , Eur J Cardiothorac Surg. 2010;37:357 - 61

Competing outcomes analysis for HeartMate II LVAD patients (n=411)

% transplanted,

recovered, or

ongoing device

support

recovery

ongoing support

death

transplanted

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Heart Lung Transplant. 2010 Sep

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Heart Lung Transplant. 2010 Sep

Figure 2: Kaplan–Meier

observed survival with

LVAD placement (gray)

as compared with pre-

operative SHFM

predicted survival with

medical management

(black).

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Heart Lung Transplant. 2010 Sep

Figure 3: Variation by

year of LVAD

implantation in

predicted 1-year

survival with medical

management.

Cardio-Thoracic,

Transplantation and Vascular SurgeryWieselthaler...Strueber: JHLT 2010

Cardio-Thoracic,

Transplantation and Vascular Surgery

Seattle Heart Failure Model – Heartware LVAD

Levy WC, AHA 2009

Cardio-Thoracic,

Transplantation and Vascular Surgery

Clinical vignette - Online publish-ahead-of-print 13 May 2008

Cardio-Thoracic,

Transplantation and Vascular SurgeryShin, MHH

Cardio-Thoracic,

Transplantation and Vascular Surgery

Hypothesis 1:

There are long term VADs for heart failure as an alternative to

Heart Transplantation

Hypothesis 2:

Predictive models or markers are required for timely VAD implantation

Unsolved Problems:

acq. von Willebrand disease and bleeding

Biventricular support

Physical capabilities and QoL

Cardio-Thoracic,

Transplantation and Vascular Surgery

Acquired von Willebrand disease in VAD patients

Malehsa..Strueber. EJCTS (2009) 1091—1093

Membrane

with

Epinephrine

or ADP vWF

Erythrocyte

Capillary

Flow

PFA 100

Cardio-Thoracic,

Transplantation and Vascular Surgery

Acq. vWS is present in all VAD patients

It persists during support

It is reversibel after removal of VAD

Cardio-Thoracic,

Transplantation and Vascular Surgery

Cardio-Thoracic,

Transplantation and Vascular Surgery

Bleeding complications and thromboembolic events after LVAD

implantation

Nr

Months after

implantation Type of bleeding Thromboembolic event INR Platelet

(1,000/μl)

1 5 gastrointestinal 2.90/1.53 287

6 25

suspected device thrombosis 2.23 229

7 10 hematuria 2.16 311

10 4 gastrointestinal 2.17 153

14 7 epistaxis 3.46 327

18 2 epistaxis 2.09 213

21 7 gingiva 2.82 198

22 19 gingiva 1.97 133

23

1

2

gastrointestinal

device thrombosis

2.35

2.25

354

371

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Am Coll Cardiol. 2010 Jun

Cardio-Thoracic,

Transplantation and Vascular Surgery

Figure 1: Major bleeding

events occurred more

frequently in older

patients, with patients

older than age 66 years

with twice the risk of

bleeding during device

support compared with

patients younger than

the age of 44. Age

groups: 18 to 44 years, n

20; 45 to 59 years, n 19;

60 to 66 years, n 19; 66

years (n 20); p 0.027.

Bleeding Frequency per Quartile Age Group

J Am Coll Cardiol. 2010 Jun

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Am Coll Cardiol. 2010 Apr

Cardio-Thoracic,

Transplantation and Vascular Surgery

J Am Coll Cardiol. 2010 Apr

Figure 4: Serial assessment

of metabolic equivalent task

score (METs). At baseline,

90% of patients in both trials

described their level of

function as low or very low.

At 6 months, approximately

two-thirds of patients

described their level of

function as moderate to very

high (p 0.001 vs. baseline).

LVAD left ventricular assist

device.

Patient-Reported

Exercise Ability

Following LVAD

Cardio-Thoracic,

Transplantation and Vascular Surgery

Hypothesis 3:

We learned how to deal with RV dysfunction at LVAD implantation

to avoid pneumatic BVAD systems

Does this lead to long term impairment by RV dysfunction ?

Is a deconditioning of skeletal muscle an irreversible state ?

Is it a combination of both ?

Cardio-Thoracic,

Transplantation and Vascular Surgery

BIVAD

Cardio-Thoracic,

Transplantation and Vascular Surgery

Total artificial heart

Steuergerät

Cardio-Thoracic,

Transplantation and Vascular SurgeryHerz-, Thorax-, Transplantations- und Gefäßchirurgie

HVAD™

Pump as BiVAD

Strueber et al, JTCVS 2010

Cardio-Thoracic,

Transplantation and Vascular Surgery

Cardio-Thoracic,

Transplantation and Vascular Surgery

Screeningn=102

LVAD-Groupn=42

HTx-Groupn=60

Met Inclusion criteria

n=58

Exclusion criteria

n=2

Participation

n=54

Refusal

n=4

Follow-up T2

n=54

Baseline T1

n=54

Met Inclusion criteria

n=40

Participation

n=36

Follow-up T2

n=27

Baseline T1

n=36

Exclusion criteria

n=2

Refusal

n=4

Drop outs

n= 9

Qol and physical status after htx and LVAD

Kugler C…Strueber M: JHLT, in press

Cardio-Thoracic,

Transplantation and Vascular Surgery

Figure 4: Changes in Physical Exercise Tolerance

0

10

20

30

40

50

60

70

80

90

T1 T2 T1 T2

HTx LVAD

Workload (% of predicted value) VO2max (% of predicted value)

*p = 0.01

*p = 0.01

*p = 0.01

*p = 0.01**HTxT2 vs. LVADT2

**HTxT2 vs. LVADT2 p = 0.05

Kugler C…Strueber M: JHLT, in press

Cardio-Thoracic,

Transplantation and Vascular Surgery

0

10

20

30

40

50

60

70

80

90

100

PF RP BP GH VITA SF RE MH

T1 T2 Norm

0

10

20

30

40

50

60

70

80

90

100

PF RP BP GH VITA SF RE MH

p = 0.03

A HRQoL (SF-36): HTx – Group

B HRQoL (SF-36): LVAD – Group

Figure 2: Changes in Health-related Quality of Life Outcomes (SF-36)

Kugler C…Strueber M: JHLT, in press

Cardio-Thoracic,

Transplantation and Vascular Surgery

Summary• VADs as alternatives to HTX exist

• Patients with heart failure should be screened

for VAD indications

• vWS and GI Bleeding are a current challenge in

chronic VAD therapy

• Biventricular support and right heart dysfunction

should be addressed

• External components should become

„lifestyle“products

• VAD patients should be followed long term by

specialised outpatient care

Cardio-Thoracic,

Transplantation and Vascular Surgery