Purpose

Sacral nerve neuromodulation (SNM) is a safe and effective therapy for the management of fecal and/or urinary incontinence. The generators InterStim™ and InterStim™ II (Medtronic™) are non-rechargeable active implantable medical devices with a limited lifespan. The aims of this study were to assess the generators’ median lifespan for all indications and the long-term hospital costs of the therapy.

Methods

This was a retrospective monocentric study that included 215 patients aged over 18 years who were treated by SNM for fecal incontinence and/or urinary incontinence. Lifespan was considered as the amount of time between definitive implantation and observed battery depletion by the surgeon and was assessed by the Kaplan–Meier method. Costs were assessed according to the activity-based pricing of the French public health care system.

Results

The median observed lifetime of stimulators implanted in our center was 7.29 years and 5.9 years for InterStim™ and InterStim™ II, respectively. The difference observed between the two generations was statistically significant. The modelling of primary implantation and renewal costs allowed us to observe that the decrease in the lifetime of Interstim™ II is associated with an increase in hospital costs over time. The retrospective study design is one limitation and we did not take into consideration stimulation’s settings.

Conclusions

The InterStim™ II lifespan is shorter than the first-generation device. This is associated with an increase of the long-term hospital costs. Additional information about the new neuromodulator will be required to choose the most appropriate IPG for the patient while optimizing the costs.

中文翻译：

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法国医院中心骶神经调节器植入的回顾性研究：寿命和医院费用评估

目的

骶神经神经调节（SNM）是治疗大便和/或尿失禁的安全有效的疗法。InterStim™ 和 InterStim™ II (Medtronic™) 发生器是不可充电的有源植入式医疗设备，使用寿命有限。本研究的目的是评估发电机在所有适应症下的中位寿命以及治疗的长期住院费用。

方法

这是一项回顾性单中心研究，纳入了 215 名年龄超过 18 岁且因大便失禁和/或尿失禁接受 SNM 治疗的患者。寿命被认为是从最终植入到外科医生观察到的电池耗尽之间的时间量，并通过卡普兰-迈耶方法进行评估。成本根据法国公共医疗保健系统基于活动的定价进行评估。

结果

我们中心植入的 InterStim™ 和 InterStim™ II 刺激器的观察到的中位寿命分别为 7.29 年和 5.9 年。两代人之间观察到的差异具有统计学意义。初次植入和更新成本的建模使我们能够观察到 Interstim™ II 寿命的缩短与医院成本随时间的增加有关。回顾性研究设计是一种限制，我们没有考虑刺激的设置。

结论

InterStim™ II 的使用寿命比第一代设备短。这与长期住院费用的增加有关。需要有关新型神经调节剂的更多信息，才能为患者选择最合适的 IPG，同时优化成本。