SESSION TITLE: DVT/PE/Pulmonary Hypertension Posters III
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM
PURPOSE: Patients with PAH often require PP therapy to improve symptoms and signs of PAH. Some patients develop PP complications such as catheter-related infections and/or intolerable adverse effects. Prior retrospective analyses have reported PP to inhaled prostanoid (IP) transition feasibility. We report the results of a prospective, protocol- driven transition from PP to IP, with continuous invasive hemodynamic monitoring during transition, and pre/post exercise gas exchange measurements.
METHODS: Three PAH speciality centers recruited patients in which a clinical decision to transition from PP to IP was made by the treating physician. To ensure study safety, rigid inclusion criteria had to be met to qualify for transition, including PP dose <30 ng/kg/min, NYHA functional class (FC) <3, and pulmonary vascular resistance (PVR) < 6 Woods Units (WU). Of the 9 patients meeting initial inclusion criteria, PVR was >6 WU in 3 patients. During transition of the remaining 6 patients, the PP was weaned off while the IP trepostinil was titrated up to 12 breaths QID over 24-36 hours with continuous hemodynamic monitoring. Six minute walk distance (6MWD) and FC were measured at baseline (BL), Wks 1, 4 and 12. Peak VO2 (pVO2) was measured at BL and Wk 12.
RESULTS: All 6 pts were successfully weaned off of PP over 24-36 hours. PVR acutely decreased with most IP doses, but varied throughout the transition periods. By the end of transition, pre- inhalation PVR was 10-47 % lower in 3 patients and 6-48% higher in 3 patients. All patients tolerated IP 6-12 breaths QID by the end of transition with no treatment-limiting adverse events (AEs). At Wk 12, FC was unchanged. In 5/6 pts, 6MWD and pVO2 were within 10% of BL. In 1 pt, 6MWD increased >50% due to a low BL value from knee pain. After up to 29 months of IP, all pts were alive and remained on IP without serious AEs or additional PAH therapy.
CONCLUSIONS: Using a strict transition protocol, PP to IP transition appeared safe and well-tolerated and did not result in clinical deterioration over 12 Wks. Considerable hemodynamic variability noted acutely during transition in our study did not adversely affect successful transition.
CLINICAL IMPLICATIONS: Clinically stable PAH patients can be safely transitioned from PP to IP using a strict transition protocol with careful monitoring and proper selection of eligible patients.
DISCLOSURE: Teresa De Marco: Grant monies (from industry related sources): United Therapeutics, Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics Franz Rischard: Grant monies (from industry related sources): United Therapeutics, Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics Ronald Oudiz: Grant monies (from industry related sources): United Therapeutics, Consultant fee, speaker bureau, advisory committee, etc.: United Therapeutics The following authors have nothing to disclose: Manyoo Agarwal
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