Transcript Folie 1

Herzinsuffizienz Register (HIR)
Austria 2006-2009
1648 Patienten wurden von 5/06-3/09
eingeschlossen
Bei 1246 Patienten war 1 Jahres FU
möglich
Bei 768 Patienten (62%) wurde das 1 J FU
tatsächlich durchgeführt:
Hospitalisierung wegen kardialer
Dekompensation
9.6%
1 Jahresmortalität
10.3%
Kandidaten für Gerätetherapie im
Österrreichischen HIR
NYHA III/IV
 LSB
30% / 1.7%
27%
LVEF <35% (HIR < 40%) 66%
Optimized Medical Therapy ?
Richtliniengetreue HI Therapie
bei Erstvorstellung
90
80
70
60
50
40
30
20
10
0
Med. Klasse
>50% Zieldosis
100% Zieldosis
m
A
A
A
%
%
on
ar
a
tik
re
d
io
iu
D
%
%
r%
ke
B
c
lo
ab
R
/A
EI
et
B
C
A
Optimierung der HI Therapie im
HIR
20
18
16
14
12
10
8
6
4
2
0
Delta >50%
Delta 100%
r
ke
oc
ab
B
EI
et
B
R
A
C
A
„Nahezu
drei Viertel der Patienten erhielten nach 1 Jahr
mehr als 50% der Zieldosis“
Geräte Therapie im HIR
7,00
6,00
5,00
4,00
3,00
2,00
1,00
0,00
T
T
R
+C
%
%
D
IC
A
R
C
D
IC
A
%
Erstvorstellung
1 Jahr
Offene Fragen:
Auswahl der geeigneten Patienten mit
Herzinsuffizienz zur Gerätetherapie
Auswahl des geeigneten Gerätes bei
Herzinsuffizienz: AICD oder CRT oder
CRT+AICD
Überweisung an Rhythmologen oder HI
Ambulanz
Nachsorge nach Implantation:
Niedergelassener Bereich
Herzinsuffizienzambulanz
CRT Ambulanz / PM Ambulanz
AICD Ambulanz
Echokardiographielabor
Herzinsuffizienz vor/bei AICD
Implantation
40%
60%
HF %
No HF %
AICD 10 Jahres Überlebensrate in Abhängigkeit
von Herzinsuffizienz (n=633)
No HF; n=251
P<0.0001P<0.001
n=..
HF; n=382
AICD 10 Jahres Überlebensrate in Abhängigkeit von
Herzinsuffizienz und LSB
P<0.001
P<0.001
COMPANION (3):
All-cause death: reduced only for CRT/ICD
(4) Bristow MR, N Engl J Med 2004;350:2140-50.
(4) Bristow MR, N Engl J Med 2004;350:2140-50
It is important to note that the study was not
designed or powered to evaluate effects on
total mortality nor to compare CRT-P and CRTD, and conclusive data comparing the effect of
CRT-P to CRT-D are not available (1).
Furthermore, COMPANION was prematurely
terminated (median follow-up of only 16
months)
(1) ESC guidelines 2008
Recommendations for cardiac
resynchronization therapy (1)
NYHA III/IV and QRS>120ms and LVEF<35%
under optimized medical therapy:
Class I Level A
To improve symptoms/reduce hospitalization:
Class I Level A
To reduce mortality:
Class I Level A
(1) ESC guidelines 2008
(3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37.
(2) Cleland JG, N Engl J Med 2005;352:1539-49.
(2) Cleland JG, N Engl J Med 2005;352:1539-49.
SCD in CARE-HF
(6) J Card Fail. 2008 Oct;14(8):670-5.
Conclusion
CRT monotherapy is an effective treatment (2)
No effect of an ICD in SCD-HEFT in patients
with NYHA III (3)
No difference between CRT and CRT/ICD (4)
Stating that CRT/ICD is superior to CRT based
on COMPANION is in contradiction to the
NYHA III population of SCD-HEFT.
(2) Cleland JG, N Engl J Med 2005;352:1539-49.
(3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37.
(4) Bristow MR, N Engl J Med 2004;350:2140-50
CRT n=95
p<0.001
CRT/ICD n=110
No.at risk
CRT
CRT/ICD
95
110
68
56
44
31
34
8
3
1
Adlbrecht C, et al. Eur J Clin Invest. 2009
CRT vs CRT+ICD Gesamtmortalität
1. 00
0. 75
CRT-Mono; n=95
0. 50
CRT/ICD; n=110
P=0.7
0. 25
0. 00
0
10
20
30
40
50
Dauer
STRATA:
CRT_M
O
NO
_CRTDEFI =1
CRT_M
O
NO
_CRTDEFI =2
Censor ed CRT_M
O
NO
_CRTDEFI =1
Censor ed CRT_M
O
NO
_CRTDEFI =2
60
The survival advantage of CRT/ICD vs. CRT
has never been adequately addressed.
Due to the documented effectiveness of ICD
therapy in the prevention of sudden cardiac
death, the use of a CRT/ICD device is
commonly preferred in clinical practice in
patients satisfying CRT criteria including an
expectation of survival with good functional
status for >1 year (1).
(1) HF guidelines ESC 2008
Geräte Therapie im HIR
7,00
6,00
5,00
4,00
3,00
2,00
1,00
0,00
T
T
R
+C
%
%
D
IC
A
R
C
D
IC
A
%
Erstvorstellung
1 Jahr
Offene Fragen:
Nachsorge nach Implantation:
Niedergelassener Bereich
Herzinsuffizienzambulanz
CRT/PM Ambulanz
AICD Ambulanz
Echokardiographielabor
As in “the real world”, medical therapy is not
always up-titrated to the desirable dosages, this
provides the opportunity to evaluate the impact of
optimizing medical therapy in patients who had
received a device therapy
Although recommended, the need for optimization of medical
therapy following device implantation has never been proven.

We hypothesized that failure to optimize medical therapy
impacts on outcome of patients with CRT or CRT/ICD although
device therapy itself has been demonstrated to affect outcome.
(8) Adlbrecht C, et al. Eur J Clin Invest. 2009,
p=0.003
Optimized patients n=56
Non-optimized patients n=148
No.at risk
Optimized
56
Non-optimized 147
46
78
24
51
16
26
0
4
Optimierung der HI Therapie im
HIR
20
18
16
14
12
10
8
6
4
2
0
Delta >50%
Delta 100%
r
ke
oc
ab
B
EI
et
B
R
A
C
A
„Nahezu
drei Viertel der Patienten erhielten nach 1 Jahr
mehr als 50% der Zieldosis“
Conclusion
Our data showing worse outcome for CRT/ICD
patients should be interpreted with caution, but
underscore the fact, that combined systems should
not be implanted routinely.
The impact of quality of baseline pharmacotherapy
exceeds the effect of the device implanted.
Pharmacotherapy must be optimized before device
and re-evaluated after implantation.
At present no general advise for the selection of
patients who will profit most of CRT/ICD can be
made.
Finally, the higher costs of a CRT/ICD compared to a
CRT device have to be kept in mind.
Die Bedeutung der
Echokardiographie zur
AV Optimierung nach CRT
Implantation
p<0.001
p<0.001
„evaluated“
„not scheduled“
„evaluated“
„not scheduled“
A
Patients at risk:
“Evaluated”:
“Not scheduled”:
B
Patients at risk:
133
72
99
34
79
23
56
11
30
6
6
2
“Evaluated”:
133
“Not scheduled”: 72
128
53
122
43
91
24
52
15
14
3
p<0.001
„optimized“
„judged fine“
„not scheduled“
„impossible“
Patients at risk:
“Optimized”:
“Judged fine”:
“Not scheduled”:
“Impossible:
58
46
72
29
48
35
34
16
43
28
23
8
30
21
11
4
16
12
6
2
3
3
2
0
Zusammenfassung 1:
Obwohl 27% der Patienten im HIR einen LSB
aufweisen, ist die Zahl der CRT Kandidaten
nicht bekannt
Bei Erstvorstellung ist eine leitliniengestützte
Pharmakotherapie selbst bei einem positiv
selektionierten Krankengut vebesserungswürdig
Für die vermehrte Implantation von
Kombinationsgeräten mangelt es an Evidenz
Auswahl und Nachsorge der Patienten sollte in
erster Linie über Herzinsuffizienz- und CRT
Ambulanz erfolgen.
Zusammenfassung 2:
Morbidität und Mortalität wird durch
AV-Optimierung und
Pharmakologische Optimierung verbessert
ABER NICHT DURCH vermehrte Implantation
von Kombinationsgeräten
Danke
Prof. Pölzl und Prof. Fruhwald für die HIR
Daten
Prof. Graf und Prof. Binder für die
Echokardiographiedaten
Prof. Gwechenberger für die Daten der
AV-Optimierung
Dr. Adlbrecht für die Daten der
medikamentösen Optimierung
Fa. Guidant/Boston Scientific und Fa.
Medtronic für die Stiftung des
Echocardiographiegerätes
(6) Auricchio A, Am J Cardiol 2007;99:232–238
REVERSE (REsynchronization
reVErses Remodeling in Systolic
left vEntricular dysfunction) trial (4)
CRT, in combination with optimal medical
therapy, reduces the risk for heart failure
hospitalization and improves ventricular
structure and function in NYHA functional
class I and II patients with previous HF
symptoms.
(5) Linde C, JACC, 2008
Predictors of mortality from pump failure
and sudden cardiac death in patients with
systolic heart failure and left ventricular
dyssynchrony: results of the CARE-HF trial.
There was a risk reduction for SCD
by CRT of 0.47 (95% confidence
interval 0.29-0.76; P =0.002)
(7) Uretsky BF, J Card Fail. 2008 Oct;14(8):670-5.
Methods
This observational cohort study (n=205) retrospectively
assessed the “real life“- impact of concomitant
pharmacotherapy and the effect of CRT compared to CRT/ICD
therapy on outcome.
Outcome of patients with guideline recommended reninangiotensin system inhibitor and ß-blocker dosages were
compared to patients who did not receive the desired dosages.
Co-morbidities were accounted for by application of a risk
stratification score which included age, NYHA functional class,
renal function, atrial fibrillation, and QRS duration. The validity
of this score has already been proven for device patients (9).
(9) Goldenberg I, et al. JACC 2008;51:288-96.
Age (years)
Male sex n (%)
Failed RAAS_BL_100% BL
HF unit follow-up n (%)
Diuretics n (%)
Aldosterone antagonist n (%)
Digitalis n (%)
Ischemic heart disease
Hypertension
n (%)
Diabetes n (%)
Sodium (mmol/L)
Hemoglobin (mg/dL)
GFR_MDRD (mL/min/1.73 m2)
NT-proBNP (pg/mL)
QRS duration (ms)
NYHA
NYHA II n (%)
NYHA III n (%)
NYHA IV n (%)
LVEF (%)
Risk stratification score (3)
0
I
II
III
IV
non-optimized
(n=148)
optimized
(n=56)
p-value
67.1±11.1
112 (76)
137 (93)
34 (23)
109 (74)
87 (59)
43 (29)
75 (51)
102 (69)
30 (21)
138.0±3.6
12.9±1.8
54.2±20.8
3861.9±5065.0
155±34
61.8±11.3
46 (82)
17 (30)
41 (73)
41 (73)
34 (61)
13 (23)
19 (34)
42 (75)
17 (30)
138.7±2.6
13.1±1.8
58.9±24.0
4863.4±6848.4
156±30
3 (2)
124 (84)
21 (14)
27.2±10.0
2 (4)
45 (80)
9 (16)
27.8±8.5
p=0.003
p=0.324
p<0.001
p<0.001
p=0.950
p=0.843
p=0.404
p=0.032
p=0.395
p=0.177
p=0.172
p=0.526
p=0.191
p=0.513
p=0.993
p=0.759
0 (0)
13 (9)
65 (44)
45 (30)
25 (17)
1 (2)
5 (9)
28 (50)
19 (34)
3 (5)
p=0.722
p=0.132
p=0.004
Optimized patients n=56
Non-optimized patients n=148
No.at risk
Optimized
56
Non-optimized 147
56
117
56
86
14
38
2
7
Stepwise multivariate Cox
regression: All cause death
Including failed pharmacotherapy
optimization at follow-up, the co-morbidity
score and CRT/ICD vs. CRT
Failed RAAS_BB_FU
Wald
HR
5.296
10.4
CI
1.416-76.923
significance
0.021
Stepwise multivariate Cox
regression: All cause death
and cardiac hospitalisation
B
SE
Wald
Sig.
HR
95% CI
Failed RAAS_BL_100% FU 0.732
0.295
6.154
0.013
2.080
1.166-3.710
CRT/ICD versus CRT
0.245
14.078
<0.001
2.504
1.550-4.045
0.918
Stepwise Cox regression model including the co-morbidity risk stratification score, failure to
reach 100% of the recommended ß-blocker and RAAS antagonist dosages at follow-up and
the device mode (CRT vs. CRT/ICD).
Goldenberg Score I
Goldenberg Score II
To test the validity of the Goldenberg
score in our population at baseline we
assessed the prognostic value of this
score (0-4) on mortality, receiving a proof
for generalizability of the score for our
patients (HR=1.728 [1.114-2.679],
p=0.015).
ESC guidelines 2008
In COMPANION, CRT-P and CRT-D were both associated with
a 20% reduction in the primary combined end-point of all-cause
mortality and all-cause hospitalization (P , 0.01). CRT-D was
associated with a significant decrease in total mortality
(P=0.003), whereas reduction in mortality associated with CRTP was not statistically significant (P=0.059).
It is important to note that the study was not designed or
powered to evaluate effects on total mortality nor to compare
CRT-P and CRT-D, and conclusive data comparing the effect of
CRT-P to CRT-D are not available.
In the CARE-HF trial, CRT-P was associated with a significant
reduction of 37% in the composite end-point of total death and
hospitalization for major cardiovascular events (P=0.001) and
of 36% in total mortality (P=0.002).
MADIT CRT (5):
NYHA I & II ischemics, NYHA II non-ischemics, QRS≥
130 ms, LVEF≤ 30%
(5) Moss A et al. N Engl J Med 2009;10.1056/NEJMoa0906431
ESC CRT guidelines 2007
Class I, level of evidence A: For CRT to
reduce morbidity and mortality
Class I, level of eviddence B: CRT/ICD is
an acceptable option for patients who
have expectancy of survival with a good
functional status for more than 1 year.
(6) Auricchio A, Am J Cardiol 2007;99:232–238
(6) J Card Fail. 2008 Oct;14(8):670-5.
Macht der ICD als Add-on zum
CRT Sinn? –
Risiko versus Effekt
Christopher Adlbrecht
Medical University of Vienna, Department of
Internal Medicine II, Division of Cardiology,
Vienna, Austria
CRT n=95
p=0.031
CRT/ICD n=110
No.at risk
CRT
CRT/ICD
95
110
84
84
61
55
43
14
6
2
Adlbrecht C, et al. Eur J Clin Invest. 2009, in press
p<0.001
CRT n=95
CRT/ICD n=110
No.at risk
CRT
CRT/ICD
95
110
68
56
44
31
34
8
3
1
p=0.031
CRT n=95
CRT/ICD n=110
No.at risk
CRT
CRT/ICD
95
110
84
84
61
55
43
14
6
2
(3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37.
(3) Bardy GH, N Engl J Med. 2005 Jan 20;352(3):225-37.
Auswahl der geeigneten Patienten mit
Herzinsuffizienz zur Gerätetherapie
Auswahl des geeigneten Gerätes bei
Herzinsuffizienz: AICD oder CRT oder
CRT+AICD
Überweisung an Rhythmologen oder HI
Ambulanz