User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-23
300
200
0
BiV Lead Impedance (Ω)
02418126
Acceptance Boundary
Implant Duration (months)
400
Lower Bound
of 95% CI
Figure D-9. EASYTRAK biventricular pacing impedance
Tab le D-17. EASYTRAK biventricular pacing impedance
Statistic
a
Implant 3 Months 6 Months 12 Mon ths 18 Months 24 Months
N 436 355 336 237 107 26
Mean ± SD
340 ± 46 352 ± 47 349 ± 50 351 ± 51 347 ± 46 356 ± 67
Range 243 - 550 248 - 519 186 - 534 237 - 513 254 - 507 267 - 520
95% CI (336, 344) (347, 357) (344, 355) (345, 358) (338, 356) (329, 383)
EASYTRAK Lead Placement Success Rate––the EASYTRAK lead was
implanted in 448/517 (87%) of patients who underwent the implant procedure.
Table D-18 on page D -2 3 shows the reasons for inability to place the
EASYTRAK lead. Table D-19 on page D-24 provides the EASYTRAK lead
implant success rate.
Tab le D-18. Reasons for unsuccessful EASYTRA K lead implant
Reason
#ofpts
a
%
Inability to locate or cannu late the coronary sinus 29 42
Dislodgment of EASYTRAK lead while removing guide catheter
13 18.8
Inability to advance the lead to a stable position 11 15.9
Inability to obtain adequate pacing thresholds 6 8.7
Procedure stopped due to coronary sinus dissection or perforation
5
7.2
Procedure stopped due to transient AV block 1 1.4
Procedure stopped due to venous perforation during s ubclavian stick
11.4
Reason not stated 11.4
- DRAFT -