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30 Stratos LV/LV-T Technical Manual
Table 4: AVAIL CLS/CRT Complication-Free Rate at
6 months – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Device-Related
Pocket
Infection/Pain
1
1.3%
2 0.03
Total 1 1.3% 2 0.03
LV Lead Related
High Threshold
No Capture
1
1.3%
1 0.02
Diaphragmatic
Stimulation
1
1.3%
1 0.02
Dislodgement 2
2.7%
2 0.03
Total 4 5.3% 4 0.06
RV Lead Related
High Threshold
/ No Capture
4 5.3% 4 0.06
Total 4 5.3% 4 0.06
Procedure
Pneumothorax 1
1.3%
1 0.02
User error 1
1.3%
1 0.02
Hematoma 1 1.3% 1 0.02
Total 3 4.0% 3 0.05
Total Lead
and
Procedure
Related
11 14.7% 13 0.20