Procedural safety of a fully implantable pump for delivery of intravenous prostanoids in severe pulmonary hypertension: A two-center observational study

Background: In patients with severe pulmonary arterial hypertension (PAH), subcutaneous or catheter-based intravenous application of prostanoids carries a risk of local side effects or systemic infections, which limits their use and acceptance. Recently, a fully implantable pump for continuous application of intravenous treprostinil was approved in Germany. However, surgery is a major risk for patients with severe PAH. The purpose of this study was to investigate the safety of a fully implantable pump inserted under local or general anesthesia in patients with severe pulmonary hypertension (PH). Methods and Results: All patients with PH undergoing pump implantation for the continuous application of intravenous treprostinil were included from two German centers. Surgery was performed under local or general anesthesia according to the protocol of the recruiting center. Intraoperative safety and 30-day in-hospital complications were analyzed for the two different implantation regimens. In total, 51 patients were included. No major intraoperative complications were recorded. During the observation period, 2 patients died of progressive right heart failure not related to the pump implantation, and 2 patients required treatment in the intensive care unit for acute right heart decompensation and respiratory failure. Conclusions: Our observational study provides preliminary evidence supporting the procedural safety of a fully implantable pump inserted under local or general anesthesia for patients with severe PH. Future trials are required to provide further evidence for the long-term safety and efficacy of the pump using this approach.