BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 53 / 176

Lumax Technical Manual 45
Table 16: Hospitalization, ER Visits and Outpatient Visits
Medical Visits
Study
(N=128)
Control
(N=65)
Hospital
Admissions
Patients
Hospitalizations
Patients
Hospitalizations
CHF Related:
20 (15.6%)
28
All causes:
68 (53.1%)
76
CHF Related:
5 (7.7%)
9
All causes:
29 (44.6%)
46
Emergency
Room Visits
Patients
Visits
Patients
Visits
CHF Related:
1 (0.8%)
1
All causes:
13 (10.1%)
16
CHF Related:
0 (0.0%)
0
All causes:
2 (3.1%)
2
Outpatient Visits
Patients
Visits
Patients
Visits
CHF Related:
1 (0.8%)
1
All causes:
5 (3.9%)
5
CHF Related:
0 (0.0%)
0
All causes:
2 (3.1%)
2
A large percentage of All Cause hospitalizations can be
attributed to pacing lead revisions, device infections, or other
device-related interventions (e.g., pocket revision or device
replacements for ERI or device recall). The CHF
hospitalization rate for both the study and control groups is
clinically acceptable considering the enrollment CHF status of
the patients.