Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
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42 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />
Table 17: Hospitalization, ER Visits <strong>and</strong> Outpatient Visits<br />
Medical Visits Study (N=128) Control (N=65)<br />
Hospital Admissions<br />
Patients<br />
Hospitalizations<br />
Patients<br />
Hospitalizations<br />
Emergency Room<br />
Visits<br />
Patients<br />
Visits<br />
Patients<br />
Visits<br />
Outpatient Visits<br />
Patients<br />
Visits<br />
Patients<br />
Visits<br />
CHF Related:<br />
20 (15.6%)<br />
28<br />
All causes:<br />
68 (53.1%)<br />
76<br />
CHF Related:<br />
1 (0.8%)<br />
1<br />
All causes:<br />
13 (10.1%)<br />
16<br />
CHF Related:<br />
1 (0.8%)<br />
1<br />
All causes:<br />
5 (3.9%)<br />
5<br />
CHF Related:<br />
5 (7.7%)<br />
9<br />
All causes:<br />
29 (44.6%)<br />
46<br />
CHF Related:<br />
0 (0.0%)<br />
0<br />
All causes:<br />
2 (3.1%)<br />
2<br />
CHF Related:<br />
0 (0.0%)<br />
0<br />
All causes:<br />
2 (3.1%)<br />
2<br />
A large percentage <strong>of</strong> All Cause hospitalizations can be attributed<br />
to pacing lead revisions, device infections, or other device‐related<br />
interventions (e.g., pocket revision or device replacements for ERI<br />
or device recall). The CHF hospitalization rate for both the study <strong>and</strong><br />
control groups is clinically acceptable considering the enrollment CHF<br />
status <strong>of</strong> the patients.<br />
The purpose <strong>of</strong> Secondary Endpoint 7 is to evaluate the observation rate.<br />
Observations are defined as clinical events that do not require additional<br />
invasive intervention to resolve. For the study group, there were<br />
210 observations in 104 patients with cumulative implant duration <strong>of</strong><br />
1240.4 months (101.9 patient years). 78.2% <strong>of</strong> the enrolled study patients<br />
have a reported observation. The rate <strong>of</strong> observations per patient‐year is<br />
2.06. For the control group, there were 81 observations in 44 patients<br />
with cumulative implant duration <strong>of</strong> 596.5 months (49.0 patient years).<br />
65.7% <strong>of</strong> the enrolled control patients had a reported observation. The<br />
rate <strong>of</strong> observations per patient‐year was 1.65.
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