gms | German Medical Science

Objective: In patients with chronic refractory pain or severe spasticity intrathecal drug delivery (IDD) is performed if conservative or pharmacological therapy fails. Different pump systems like electronic pumps or gas pressure pumps are available. An international registry of flexible electronic pumps documents objective data regarding safety, reliability and durability of these devices.

Method: A detailed guideline for IDD considering drug selection or technical device related considerations does not exist. The guidelines of the polyanalgesic consensus conference related to trialing and testing and also management of complications are accepted but can not fully be adopted to national clinical practice. The selection of a drug delivery device is not recommended or regulated. Over 8 years more than 50 centers worldwide registered their electronic pump implants to an international data base with more than 4500 devices and follow-up periods of more than 5 years.

Results: The device stability and durability was 94% and 97% for the previous and currently available model of the pump after 5 years of implantation. According to clinical experience the data for event-free rates is lesser for intrathecal catheters (80–90% after 5 years). It could be evaluated that the variability was ±14.5% and reproducibility ±0.3 % for the constant daily flow-rate.

Conclusions: The results of this international device registry confirm that IDD with electronic flexible pumps is safe and consistently. Complications were mainly related to the catheter systems and led to development of a new catheter, which is available in Germany since 2011. The management of IDD systems and device related complications should only be performed in certified experienced centres. IDD with an implanted pump can significantly reduce pain in selected chronic pain patients and therefore leads to an improvement of quality of life.