BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 46 / 176

38 Lumax Technical Manual
1.6.2.8 Post-hoc Safety Analysis
BIOTRONIK did not meet the pre-specified objective performance
criteria of 85% within 10% for the safety endpoint. Therefore, a
post-hoc safety analysis was conducted. It was noted that
79.80% (39 out of 49 events) of the complications were right atrial
lead, right ventricular ICD lead, left ventricular lead and procedure
related. The atrial, ICD and LV leads used during this study are
legally marketed devices.
This post-hoc analysis evaluated the LV lead complications that
were “related” or “possibly related” to the Tupos LV/ATx CRT-D,
but excludes the complications that were “not related” to the
Tupos LV/ATx device (see Table 9). There were 11 patients who
had an attempt to implant the LV lead, but the physician was
unsuccessful in either obtaining coronary sinus (CS) access or
unable to find a stable position for the LV lead. Additionally, there
were 4 patients with a documented LV lead dislodgement that has
no direct relationship to the implanted Tupos LV/ATx.
Table 9: Complications at 6-Months (Excluding LV Lead
Related) - Study versus Control
Category
Study
N=133
Control
N=67
Difference
Study vs
Control
Procedure Related
6 (4.51%) 2 (2.99%) 1.53%
Atrial Lead Related
3 (2.26%) 1 (1.49%) 0.76%
ICD Lead Related
3 (2.26%) 0 (0%) 2.26%
LV Lead Related
11 (8.27%) 1 (1.49%) 6.78%
Device Related
7 (5.26%) 5 (7.46%) -2.20%
Other Medical Related
9 (6.77%) 2 (2.99%) 3.78%
Total Procedure,
Lead and Device
Related
27
(20.30%)
8
(11.94%)
8.36%
Total
35
(26.32%)
10
(14.93%)
11.39%