User Manual Part 4

D-26
CLINICAL STU DY - CONTAK CD
ratewas14.5%(95%CI[11.5–17.5%]). TableD-21onpageD-26reports
lead-related adverse events observed during the CONTAK CD Study.
Tab le D-21. EASYTRAK lea d-rel ated adverse events
Adverse Events
a
Total
% of pts (95% Cl)
Lead-Related, N = 448
Loss of ca pture/ lead dislodgment
31
b
6.9 (4.6–9.3)
Ventricular oversensing 11
2.5 (1.0–3.9)
Extracardiac stimulation 9
2.0 (0.7–3.3)
Insulation breach 2
0.4 (0.0–1.1)
Procedure-Related, N = 517
Transient AV block 6
1.2 (0.2–2.1)
Coronary venous dissection
5
1.0 (0.1–1.8)
Coronary venous perforation
5
1.0 (0.1–1.8)
Transient renal failure
5
1.0 (0.1–1.8)
Pericardial effusion
2
0.4 (0.0–0.9)
Finishing wire left in lead
1
0.2 (0.0–0.6)
Right ventricular lead dislodgment 1
0.2 (0.0–0.6)
Guide wire fracture
1
0.2 (0.0–0.6)
Hypotension due to blood loss 1
0.2 (0.0–0.6)
Total (unique patients)
75
14.5 (11.5–17.5)
a. All patients implanted, N = 448; All patients attempted, N = 517.
b. Twenty-six events were successfully corrected in a repeat procedure.
The most common of the 53 lead-related adverse events (>1% incidence)
included the following:
• Loss of left ventricular capture (31 patients, 6.9%)
• Ventricular oversensing (11 patients, 2.5%)
• Extracardiac stimulation (9 patients, 2. 0%)
These events were typically resolved with su rgic al intervention.
The most common of the 27 procedure-related adverse events (> 1%
incidence) included the following:
• Coronary venous trauma (10 patients, 2.0%)
• Transient atrioventricular block (6 patients, 1.2%)
- DRAFT -