“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