ONLINE APPENDIX
The following investigators and institutions participated in the conception of the registry, and
in the organisation, collection, storage and analysis of the data:
Co-principal Investigators: Serge Boveda, MD, Clinique Pasteur, Toulouse; Eloi Marijon, MD,
PhD, Hôpital Européen Georges Pompidou, Paris, France. Conceived, designed and organized
the registry in 2009.
Co-investigators in charge of the data collection and analysis at each medical centre:
Vincent Algalarrondo, MD, PhD, CHU Antoine Béclère, Clamart; Dominique Babuty, MD, PhD,
CHU Trousseau, Tours; Pierre Bordachar, MD, PhD, CHU Haut Lévêque, Bordeaux; Abdeslam
Bouzeman, MD, Serge Boveda, MD, Rui Providencia, MD, MS, Clinique Pasteur, Toulouse;
Pascal Defaye, MD, CHU Michallon, Grenoble; Daniel Gras, MD, Nouvelles Cliniques Nantaises,
Nantes; Jean-Claude Deharo, MD, PhD, CHU La Timone, Marseille; Didier Klug, MD, PhD, CHRU
Lille, Lille; Christophe Leclercq, MD, PhD, CHU Pontchaillou, Rennes; Eloi Marijon, MD, PhD;
Hôpital Européen Georges Pompidou, Paris; Olivier Piot, MD, Centre Cardiologique du Nord,
Saint Denis; Nicolas Sadoul, MD, PhD, CHU Brabois, Nancy.
Data storage, quality control, and statistical analyses: Frankie Beganton, MS, Marie-Cecile
Perier, MS, Cardiovascular Epidemiology Unit, Paris Cardiovascular Research Center (INSERM
Unit 970), Hôpital Européen Georges Pompidou, Paris.
Steering Committee: Serge Boveda, MD, Clinique Pasteur, Toulouse; Pascal Defaye, MD, CHU
Michallon, Grenoble; Christophe Leclercq, MD, PhD, CHU Pontchaillou, Rennes; Eloi Marijon,
MD, PhD; Hôpital Européen Georges Pompidou, Paris; Nicolas Sadoul, MD, PhD, CHU Brabois,
Nancy.
Table 1. Outcomes during follow-up.
Follow-up and Outcomes
Follow-up duration
2.96±2.07
(years)
427 (17.7%)
Mortality
5.9 per 100
patient-years
Death in the first year
126 (6.0%)
post-implant
506 (21.3%)
Appropriate therapies
8.3 per 100
patient-years
Death prior to receiving
315 (38.4%)
an appropriate therapy
149 (6.3%)
Inappropriate shocks
2.1 per 100
patient-years
Table 2. Accuracy of the risk score regarding death during the first year after implant.
Number
of Risk
Factors
≥1
≥2
≥3
≥4
≥5
Number
of Risk
Factors
≥1
≥2
≥3
≥4
≥5
General Sample
PPV*
6.8%
8.5%
11.9%
15.7%
20.0%
NPV*
98.9%
98.3%
97.2%
95.7%
94.3%
Sens
97.6%
89.7%
70.6%
40.5%
9.5%
Ischemic Cardiomyopathy
Spec
14.1%
38.7%
66.5%
86.1%
96.9%
PPV
7.9%
9.9%
13.3%
16.2%
18.9%
NPV
99.0%
98.0%
96.9%
95.1%
93.7%
Dilated Cardiomyopathy
PPV
5.2%
6.6%
9.4%
14.0%
14.3%
NPV
98.4%
98.9%
95.5%
96.7%
95.5%
Sens
97.5%
87.7%
69.1%
38.3%
8.6%
Spec
18.4%
43.3%
67.9%
85.9%
97.4%
Sens
97.6%
92.9%
71.4%
42.9%
11.9%
Spec
7.8%
32.1%
64.2%
86.3%
96.3%
CRT-D
PPV
8.5%
9.6%
12.5%
15.7%
16.9%
NPV
100%
98.8%
96.4%
94.1%
92.1%
Sens
100%
97.9%
80.7%
47.3%
11.8%
Spec
1.28%
16.0%
48.1%
76.8%
94.7%
Legend: PPV = positive predictive value; NPV = negative predictive value; Sens = Sensitivity;
Spec = Specificity. * Note: PPV refers to patients with values equal or above and NPV to those
with values below the number of risk factors.
Table 3. Discriminative capability of the Goldenberg risk score in patients with non-CRT ICDs.
Patients implanted with ICD
c-statistic
Endpoint
95% CI
0.603
Mortality
0.552-0.654
0.486
Appropriate therapies
0.446-0.526
Death in the first year
0.698
post-implant
0.602-0.795
Death prior to receiving
0.604
an appropriate therapy
0.539-0.669
P
<0.001
0.492
<0.001
0.002
Table 4. Analysis of the variables composing the Goldenberg risk score in patients with CRT-Ds and Non-CRT ICDs and their impact on mortality.
NYHA
≥ III
age >
70
QRS >
120
AF
eGFR
< 60
CRT-D
Univariate
Multivariate
HR
P
HR
P
95%CI
95%CI
2.67
<0.001 2.27
<0.001
1.92-3.72
1.63-3.18
1.61
<0.001 1.27-2.04
0.98
0.930
0.64-1.50
1.71
<0.001 1.41
0.008
1.33-2.19
1.10-1.81
2.49
<0.001 2.21
<0.001
1.95-3.19
1.72-2.83
Non-CRT ICDs
Univariate
Multivariate
HR
P
HR
P
95%CI
95%CI
2.28
<0.001 2.05
<0.001
1.62-3.21
1.45-2.90
1.55
0.019
1.07-2.23
0.96
0.803
0.68-1.35
1.74
0.005
1.55
0.028
1.18-2.57
1.05-2.30
2.45
<0.001 2.28
<0.001
1.76-3.41
1.63-3.17
Table 5. Discriminative capability of the Goldenberg risk score in patients with CRT-Ds according to QRS duration.
Patients implanted with CRT-D and QRS > 150ms
c-statistic
Endpoint
P
95% CI
0.716
Mortality
<0.001
0.670-0.762
0.504
Appropriate therapies
0.901
0.448-0.559
Death in the first year
0.714
<0.001
post-implant
0.645.783
Death prior to receiving
0.687
<0.001
an appropriate therapy
0.616-0.757
Patients implanted with CRT-D and QRS ≤ 150ms
c-statistic
Endpoint
P
95% CI
0.651
Mortality
<0.001
0.603-0.699
0.499
Appropriate therapies
0.973
0.444-0.544
Death in the first year
0.660
<0.001
post-implant
0.586-0.735
Death prior to receiving
0.637
<0.001
an appropriate therapy
0.567-0.706