User Manual Part 4

CLINICAL STUDY - COMPANION
B-25
For a given cardiac hospitalization, patients may have events in more than
one category, and if there are multiple occurrences in a single category, then
only the first occurrence was counted.
ADDITIONAL ST UDY DATA
Implant Disposition
Table B-9 on page B-25 identifies the number of initial and subsequent implant
procedures attempted in patients randomized to CRT-D and the rate of success
for each additional implant procedure. There were 81 CRT-D patients that
had an unsuccessful initial implant for the CRT-D system. Fifty (50) of these
patients had a second implant procedure, of which 33 were successful and 17
were unsuccessful. Three patients had a third implant procedure, of which one
was successful. Therefore, there were 541 patients implanted with the CRT-D
system.
Table B-9. CRT-D system implant disposition
Attempt
successful
Failed implant Reattempt not
done after this
procedure
Initial implants
588 ( 98.8% ) 507 (85.0%) 81 (14.0%) 31 (5.2%)
First reattem p t
50 (8.4%) 33 (5.5%) 17 (2.9%) 14 (2.3%)
Second reattempt 3 (0.5%) 1 (0.2%) 2 (0.3%) 2 (0.34%)
ADDITIONAL OUTCOME MEA SUR ES
First Heart Failure Hosp italizations
An additional outcome that was not pre-specified in the protocol provides
further insight into the results observed in the composite primary endpoint.
This post-hoc analysis was conducted using cause-specific hospitalizations as
adjudicated by the morbidity and mortality committee and therefore should
be interpreted with caution.
The outcome of a ll-ca use mortality or first heart failure hospitalization was
analyzed on an intention-to-treat basis and time to fi rst event.
Hospitalizations were defined per any of the following:
• Care provided at a hospital for any reason in which the duration is
associated with a date change
- DRAFT -