Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study.
BACKGROUND
Pacemakers have improved the lives of patients worldwide. Unfortunately, the medical community has had little independent information regarding the performance of these vital medical devices.


OBJECTIVE
The purpose of this study was to examine the reasons pacemaker pulse generators and transvenous leads were removed from service. We evaluated the causes and major adverse clinical events associated with device end-of-service life behavior and how they were detected and managed.


METHODS
Pulse generator and lead data were entered prospectively using a web-based format. Normal battery depletion was signified by the elective replacement indicator appearing >3 years after implant. Lead failure was a device defect causing pacing, sensing, or fixation malfunction, high threshold, or abnormal impedance. Major adverse clinical events were death, angina, heart failure, syncope, and perioperative surgical complications.


RESULTS
From 1998 to 2006, 2,652 pulse generator and 615 leads were removed from service. The average pulse generator was implanted for 7.3 +/- 3.1 years (range <1 day to 26 years). The majority of pulse generators (n = 2,317 [87%]) were replaced for normal battery depletion. Severe and accelerated battery depletion, manufacturers' advisories, and electronic or connector defects accounted for 13% of pulse generator removals. The proportion of pulse generators removed from service as a result of manufacturers' advisories, electronic failure, and housing defects were 4%, 2%, and 1%, respectively. Models with rate response capability had shorter battery longevities than those without rate response capability. Major adverse clinical events due to pulse generator end-of-service life behavior were related to electronic and connector defects, and both normal and severe battery depletion. Median time to lead failure was 7.2 +/- 5.2 years. Insulation defects caused the majority of lead failures, and most of these leads used polyurethane materials. Lead failure was associated with a 16% incidence of major adverse clinical events. No major adverse clinical events occurred when impending lead failure was detected at routine follow-up. Lead extraction was associated with a 5.6% complication rate, including one death.


CONCLUSIONS
Overall pulse generator performance was satisfactory. Differences in battery longevity were observed among models. In some patients, elective replacement indicators signifying normal battery depletion resulted in major adverse clinical events. Pacemaker follow-up effectively identified pulse generator end-of-service life and often detected impending lead failure, thus avoiding major adverse clinical events. Long-term studies are needed to assess chronic lead performance so that appropriate clinical management strategies, including recommendations for lead extraction, can be developed.
Hauser
Robert G
RG
Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA. rhauser747@aol.com
Hayes
David L
DL
Kallinen
Linda M
LM
Cannom
David S
DS
Epstein
Andrew E
AE
Almquist
Adrian K
AK
Song
Susan L
SL
Tyers
G Frank O
GF
Vlay
Stephen C
SC
Irwin
Marleen
M
D016009:Chi-Square Distribution; D020878:Device Removal; D011211:Electric Power Supplies; D004567:Electrodes, Implanted; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors