Stratos LV/LV-T Technical Manual 35

Table 6: Summary of Observations – Stratos LV

 

 

Number

% of

Number of

Observations

 

 

Category

of

per patient-

 

 

Patients

Complications

 

 

 

Patients

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

2

2.7%

2

0.03

 

 

arrhythmias

 

 

 

 

 

 

 

 

Shortness of

5

6.7%

5

0.08

 

 

Breath

 

 

 

 

 

 

 

 

Stroke / TIA

1

1.3%

1

0.02

 

 

Non-CHF

 

 

 

 

 

 

cardiac

1

1.3%

1

0.02

 

 

symptoms

 

 

 

 

 

 

Total

35

46.7%

54

0.84

 

 

Total—All

45

60.0%

76

1.18

 

 

Patients and

 

 

Categories

 

 

 

 

 

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