Clinical surveillance of a tined, bipolar, silicone-insulated ventricular pacing lead.
OBJECTIVE
This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy.


RESULTS
Three hundred and thirty leads were implanted and had complete follow-up with us for a minimum of 60 months or up to failure, removal, and/or patient death (mean 40 months, range: 1 day to 81 months). Thirty-two patients (9.6%) had spontaneous lead-related complications: 7 (2.1%) occurred during the first week; 25 (7.6%) had chronic complications, of which 20 (6.1%) necessitated re-operations; 3 (0.9%) were lead material failures. Of the 110 re-operations (90 pacemaker replacements and 20 operations due to complications), 7 additional cases (6.4%) were complicated by unique connector damage that occurred during disconnection of the lead from the connector block. The Kaplan-Meier estimated 5-year lead survival free of lead material failure and free of any significant lead complication were 97.9 and 87%, respectively.


CONCLUSIONS
The S80TB lead demonstrates an acceptable rate of acute and chronic spontaneous complications and very few lead material failures over 5 years of follow-up. However, there seems to be a relatively high incidence of connector damage during disconnection from the connector block. Extra caution is required during those procedures in patients with this lead.
Lipchenca
Igor A
IA
Heart Institute Sheba Medical Center, Tel Hashomer, Israel.
Bar-Lev
David S
DS
Luria
David M
DM
Gurevitz
Osnat T
OT
Granit
Chava
C
Rotstein
Zeev
Z
Ovsyshcher
Eli I
EI
Eldar
Michael
M
Glikson
Michael
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000401:mortality / Q000628:therapy*