Trends in service time of pacemakers in the Netherlands: a long-term nationwide follow-up study

Abstract

AimsAfter decades of experience and strongly improved technology, service time of pacemaker generators is expected to increase. To test this hypothesis, we conducted a retrospective review of a large cohort of patients with a pacemaker.MethodsWe reviewed data collected between 1984 and 2006 in the first national Dutch pacemaker registry. This registry covered 96% of all generators implanted. We analysed the time of and reason for explantation of pacemaker generators. A 7-year follow-up interval after first implantation and following replacements was used to analyse changes over time.ResultsDuring 22 years of data collection, nearly 97,000 first pacemaker generators were implanted. A total of 27,937 (22.4%) generators were explanted within a mean of 6.3 (standard deviation 3.3) years. Reasons for approximately 60% of these explantations were ‘end of life’ of the pacemaker generator or elective system change. Complications or failures such as infections and recalls accounted for approximately 20% of the explantations. For the remaining 20%, the reasons for explantation had not been registered.ConclusionDespite progress in technology, a substantial proportion of pacemaker generators is explanted before its expected service time, with one in five generators being replaced due to technical failures, infections or other complications. Furthermore, the time interval between pacemaker implantation and explantation due to normal ‘end of life’ (battery EOL) decreased. Infections continue to rank highly as a cause for pacing system replacement, despite all current preventive measures.

Predictors of long-term survival prior to permanent pacemaker implantation in octogenarians or older

“…The duration of time from the initial implantation to replacing a PPM generator varied between 6 and 7 years in different studies [ 17 , 18 ]. In our study, survival duration was from less than 1 year to longer than 10 years.…”

Trends in replacement of pacemaker leads in the Netherlands: A long‐term nationwide follow‐up study

“…We are aware that up to 60% of deaths have not been registered in SPRN . Therefore, it is expected that a large proportion of patients may have died during follow‐up.…”

“…For this purpose, first implantations during the years 1984–2000 could be used, while data from 2001 to 2007 were used for follow‐up only. We chose a 7‐year follow‐up period because the mean duration of follow‐up for explanted pacemaker generators falls within this time interval …”

The ethics of explantation

“…Implants that last longer, thereby reducing the risks associated with explantation and replacement, could reduce the profits of manufacturers and profit-driven healthcare providers. This may be the reason why pacemakers are not built to last as long as would be technologically possible [15,17]. The major manufacturers put new pacemaker models on the market about every 6 or 12 months, often with new, not very urgent functionalities that draw upon the battery [18,19].…”