Intravenous Treprostinil Delivered by the Implantable Pump Lenus Pro®: A Innovative “Surgical” Approach to Management of PAH

Abstract

Purpose Continuous application of parenteral prostanoids with external pump systems is associated with frequent side effects such as infusion site pain with subcutaneous (s.c.) and rare but possibly life-threatening catheter related infections with intravenous (i.v.) administration. Lenus Pro ® implantable infusion pump was developed to overcome the drawbacks of s.c. administration. Methods and Materials Between September 2010 and October 2012 20 patients underwent implantation at our center. All patients had experienced significant clinical benefits with s.c. Treprostinil but reported serious site pain. All implantations were performed under general anesthesia. Preoperatively single-shot antibiotic prophylaxis was given. After a catheter was placed in the subclavian or cephalic vein, the pump pocket was prepared in the abdominal wall. Lenus Pro® pump was filled intraoperatively, placed in the pump pocket and fixed to the fascia. A catheter was tunneled under the breast tissue and connected with the central venous access by means of a titan connector. No intraoperative complications occurred; postoperatively three patients developed mild seroma. During follow-up, no other complications were observed. More than 300 refill procedures have been performed without any complications. Control of the reflow volume at every refill procedure revealed accurate and constant flow rate of Lenus Pro ® in all patients. Results Parenteral prostanoids are a cornerstone in the treatment of PAH. I.v. Treprostinil administered by Lenus Pro® was safe and effective in our study population, during more than 330 patient-months of treatment there were no pump or catheter related complications, especially no infections. No refill complications were observed. The absence of infusion related side effects is associated with an increase in quality of life, filling intervals of 28 days ensure optimal patient management and compliance. Conclusions We consider this new treatment option a milestone achievement in prostanoid therapy and management of PA.