30 Stratos LV/LV-T Technical Manual

Table 4: AVAIL CLS/CRT Complication-Free Rate at

6 months – Stratos LV

 

 

Number

% of

Number of

Complications

 

 

Category

of

per patient-

 

 

Patients

Complications

 

 

 

Patients

year

 

 

 

 

 

 

 

 

 

Device-Related

 

 

 

Pocket

1

1.3%

2

0.03

 

 

Infection/Pain

 

 

 

 

 

 

 

 

Total

1

1.3%

2

0.03

 

 

 

LV Lead Related

 

 

 

High Threshold

1

1.3%

1

0.02

 

 

No Capture

 

 

 

 

 

 

 

 

Diaphragmatic

1

1.3%

1

0.02

 

 

Stimulation

 

 

 

 

 

 

 

 

Dislodgement

2

2.7%

2

0.03

 

 

Total

4

5.3%

4

0.06

 

 

 

RV Lead Related

 

 

 

High Threshold

4

5.3%

4

0.06

 

 

/ No Capture

 

 

 

 

 

 

 

 

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

11

14.7%

13

0.20

 

 

Procedure

 

 

 

 

 

 

 

 

Related