april 23, 2013
DESCRIPTION
Outcome of Patients with Advanced Heart Failure who Receive Device-Based Therapy for Primary Prevention of Sudden Cardiac Death . M. Suleiman , G. Amit , N. Samniah , A. Pekar , S. Ben- Zvi , R. Rosso , N. Gavrielov- Yusim , I. Marai , I. Goldenberg, M. Glikson. April 23, 2013. - PowerPoint PPT PresentationTRANSCRIPT
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National ICD Registry
Outcome of Patients with Advanced Heart Failure who Receive Device-
Based Therapy for Primary Prevention of Sudden Cardiac Death
M. Suleiman, G. Amit, N. Samniah, A. Pekar, S. Ben-Zvi, R. Rosso, N. Gavrielov-Yusim, I. Marai, I. Goldenberg, M. Glikson
April 23, 2013
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National ICD Registry
Background
• Approximately 50% of deaths among patients with HF are sudden.
• The percentage of SCD decreases as NYHA class increases
• It is widely believed that patients with more advanced HF symptoms are less likely to die from a VA and therefore would not benefit from ICD implantation
• Results of landmark ICD trials were inconsistent
Sweeney MO. Pacing Clin Electrophysiol 2001;24:871-88.Kjekshus J. Am J Cardiol 1990;65:42I-48I.
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National ICD Registry
Purpose
• To examine the effect of HF functional class on the outcome of patients who receive device therapy in a real world setting.
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National ICD Registry
Methods
• Israeli ICD Registry Database• Period: Jul 2010-June 2012• 2108 primary prevention patients• Study end points
• Death• Appropriate ICD therapies for VA• Readmission to hospital for HF• The combined endpoints of HF or death, VA or
death
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National ICD Registry
Baseline Characteristics
VariableNYHA class
I+II(n=1185, 56%)
III+IV(n=923, 44%)
p
Age, mean ± SD 64±12 66±11 <0.001
Female gender)%( 14 21 <0.001
Ethnicity )%( 0.87
Jews 56 44
Arabs 56 44
Medical History
Old MI)%( 68 63 0.28
CABG)%( 30 34 0.002
PCI)%( 58 55 0.86
Dilated CM)%( 21 30 <0.001
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National ICD Registry
Baseline Characteristics
VariableNYHA class
I+II(n=1185, 56%)
III+IV(n=923, 44%)
p
Atrial fibrillation 16 28 <0.001
Cerebrovascular disease 7 10 0.02
Diabetes 33 47 <0.001
Hypertension 63 65 0.20
Dyslipidemia 52 61 <0.001
Chronic lung disease 8 16 <0.001
Chronic kidney disease
)GFR<60( 28 47 <0.001
Currently on dialysis 2 5 0.006
Smoker 33 29 0.02
Sleep apnea 5 13 <0.001
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National ICD Registry
Baseline Characteristics
Variable
NYHA class I+II
(n=1185, 56%) III+IV
(n=923, 44%) p
Meds on admission% ,
Beta Blockers 80 87 <0.001
ACE- inhibitors/ARB ant 75 80 0.006
Diuretics 64 90 <0.001
Oral anticoagulants 12 15 0.02
Anti-arrhythmic drugs 9 14 <0.001
Amiodaron 5 10 0.01
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National ICD Registry
Baseline Characteristics
VariableNYHA class
I+II(n=1185, 56%)
III+IV(n=923, 44%)
p
Diagnostic studies
LVEF, mean)%( 29±11 25 ±10 <0.001
LVEF<30% 609( 52%) 680( 74%) <0.001
QRS dur, mean )ms( 110± 26 136± 30 <0.001
QRS<120 ms 313( 27%) 572( 62%) <0.001
Electrophysiologic study 273( 23%) 108( 12%) <0.001
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National ICD Registry
Device implanted
Single Dual CRTD0
10
20
30
40
50
60
70
80
90
25
51
24
1014
77
I-II III-IV
P<0.001
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National ICD Registry
Outcomes
• 1016 unselected registry patients were prospectively followed for the occurrence of clinical outcomes.
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National ICD Registry
Death o HF in the General Population
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National ICD Registry
Death or HF According to Device Type
In ICD recipients In RCTD recipients
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National ICD Registry
Death or VA in the General Population
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National ICD Registry
Change in NYHA class during 1-year of follow-up in the ICD and the CRTD groups
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National ICD Registry
Multivariate analysis: Risk of endpoints by NYHA class ≥III vs. <III
Endpoint Total Population ICD Recipients CRTD RecipientsHR p HR P HR p
HF or death┼
NYHA class ≥III vs. <III
3.21
<0.001
3.28
<0.001
0.97
0.92
HFNYHA class ≥III vs. <III
2.53
0.005
4.58
<0.001
1.42
0.42
VT/VF or deathNYHA class ≥III vs. <III
0.52
0.04
0.81
0.80
0.43
0.01
VT/VFNYHA class ≥III vs. <III
0.34
0.02
0.34
0.23
0.36
0.03
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National ICD Registry
Multivariate analysis: Risk of VA/Death by age category (reference group =age<65)
Endpoint Total Population ICD Recipients CRTD Recipients
HR p HR P HR pVT/VF or death
Age 66-75
1.95
0.003
2.62
0.001
1.01
0.82
Age>75 2.78 <0.001 3.61 <0.001 2.07 0.04
VT/VF Age 66-75
2.08
0.01
2.17
0.02
1.72
0.33
Age>75
2.07 0.02 2.25 0.02 1.75 0.35
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National ICD Registry
Main Findings
• Of new ICDs and CRTDs implanted in Israel, <50% are in patients <65 yo and <20% in patients <75 yo
• Elderly patients• have higher risk profile• more likely to receive CRTD device• < secondary prevention indication
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National ICD Registry
Main Findings
• Our data add to and support the existing evidence from previous studies that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices.
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National ICD Registry
Main Findings
• Elderly patients implanted with ICDs experienced a significant increase in the cumulative probability of the combined end-points of appropriate ICD therapy or death and HF or death
• In contrast, the risk of both HF and arrhythmic outcomes was attenuated among elderly patients implanted with CRT-D devices.