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Stratos LV/LV-T Technical Manual 35
Table 6: Summary of Observations – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Observations
per patient-
year
Other Medical
Dizziness 3 4.0% 3 0.05
Other Medical 24 32.0% 34 0.53
Worsening CHF 8 10.7% 8 0.12
Ventricular
arrhythmias
2 2.7% 2 0.03
Shortness of
Breath
5 6.7% 5 0.08
Stroke / TIA 1 1.3% 1 0.02
Non-CHF
cardiac
symptoms
1 1.3% 1 0.02
Total
35 46.7% 54 0.84
Total—All
Patients and
Categories
45 60.0% 76 1.18
Number of Patients = 75 Number of Patient-Years = 64.4
There have been 3 patient deaths reported for the Stratos LV
groups (out of 75 Stratos LV patients). None of the deaths were
related to the implanted CRT-P system. Table 7
provides a
summary of reported patient deaths.
Table 7: Summary of Patient Deaths
Stratos LV Patients
(N = 75)
Sudden Cardiac 1
Non-Cardiac 2
All Causes
3