Presented at the 2012 AAPM Annual Meeting « Back

Study of Catheter Complications with Prometra Intrathecal Programmable Infusion Pump

John E. Barsa, MD, jbarsa@mac.com, AAPM, APS, American Society of Neuromodulation, American Medical Association, American Society of Regional Anesthesia, American Society of Anesthesiologists, Hillsborough County (Florida) Medical Society, Florida Society of Anesthesiologists, Tampa, Florida

Introduction: Catheter-related complications remain an associated risk and cost in implantable intrathecal drug delivery systems. In 110 patients studied over approximately four years, catheter complications were analyzed and compared to prior published data.¹ ² Materials and Methods: The PUMP study was an multicenter, IRB-approved, prospective, open-label evaluation of a new programmable infusion intrathecal pump (Prometra®, Medasys, Inc., Mt. Olive, NJ), to treat chronic pain with MSO4. The 110 patients in the study (age 56 ± 13, gender: 51F) were followed on a monthly basis for the first 6 months post-implant and then quarterly. Catheter complications were tracked and the data was tabulated by an independent third party (inVentiv Clinical Solutions, The Woodlands, TX). Results: After a total of 100,632 device days of follow-up, Prometra® catheter complications were statistically similar to prior published data¹. The majority of complications remain procedure based. One interesting observation was the absence of Hygroma development. Conclusions: Adherence to proper implantation technique is emphasized to reduce catheter complications as has been previously published.¹ ² Further studies are needed to establish the relationship of this new Prometra® catheter design and its lower incidence of Hygromas from those of currently approved designs for intrathecal therapies. References: 1)1. Follett KA, Burchiel K, Deer T, DuPen S, Prager J, Turner MS, Coffey RJ. Prevention of Intrathecal Drug Delivery Catheter-Related Complications. Neuromodulation 2003;6:32-41. 2)2. Penn RD. J Neurosurg 1995;83:215-17.

Funding: None