User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-15
Tab le D-7. Patients hospitalized during treatment period
All Patients
NYHA Class III/IV
Reason for Hospitalization
a
CRT
(N = 245)
No CRT
(N = 245)
Total
(N = 490)
CRT
(N = 117)
No C RT
(N = 110)
Total
(N = 227)
Heart f ailure
32 39 71 23 27 50
Cardiac, other
20 25 45 14 14 28
Noncardiac 26 19 45 14 14 28
Total Hospitalizations 66 70 136 40 46 86
a. All patients implanted and active at 31 days post-implant; N = 490.
Peak VO
2
––the Peak VO
2
was determined from a standardized protocol for
exercise testing as a means of measuring a patient’s capacity for performing
physical activity. Figure D-3 on page D-15 and Table D-8 on page D-15 provide
the change in Peak VO
2
.
15
13
12
14
11
Time (months)
Peak VO
2
(ml/kg/min)
06
All Patients
∆ = 0.8 ± 0.4
p = 0.030
Mean ± SE
CRT (n = 216)
No CRT (n = 201)
Time (months)
06
NYHA Class III/IV
∆ = 1.8 ± 0.6
p = 0.003
CRT (n = 96)
No CRT (n = 80)
Figure D-3. Change in Peak VO2
Table D-8. Change in Peak VO2
All Patients
NYHA Class III/IV
Peak VO
2
(ml/kg/min)
CRT
(N = 216)
No CRT
(N = 201)
P-value
a
CRT
(N = 96)
No CRT
(N = 80)
P-value
a
Post-recovery Visit 13.5 ± 0.2 13.5 ± 0.2
––
12.0 ± 0.3 12.0 ± 0.3
––
- DRAFT -