Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System: Results of the DelIVery for PAH Trial.

Academic Article

Abstract

  • BACKGROUND: The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. METHODS: A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. RESULTS: Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P < .0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P < .0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months' postimplantation (P < .0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. CONCLUSIONS: The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.
  • Authors

    Published In

  • Chest  Journal
  • Keywords

  • central venous catheters, drugs, health-related quality of life, pulmonary arterial hypertension, pulmonary hypertension, treprostinil, Adult, Antihypertensive Agents, Catheter Obstruction, Catheter-Related Infections, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions, Epoprostenol, Female, Humans, Hypertension, Pulmonary, Infusion Pumps, Implantable, Male, Middle Aged, Outcome and Process Assessment (Health Care), Prospective Studies, United States
  • Digital Object Identifier (doi)

    Author List

  • Bourge RC; Waxman AB; Gomberg-Maitland M; Shapiro SM; Tarver JH; Zwicke DL; Feldman JP; Chakinala MM; Frantz RP; Torres F
  • Start Page

  • 27
  • End Page

  • 34
  • Volume

  • 150
  • Issue

  • 1