Conference: 2012 International PHA Conference and Scientific Sessions
Release Date: 06.22.2012
Presentation Type: Abstracts
Parker DK, Doran AK, Ivy DD.
Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, CO; United Therapeutics Corp, Research Triangle Park, NC.
BACKGROUND: The safety and acute pharmacodynamic effects of inhaled treprostinil (iTRE) in children with pulmonary arterial hypertension (PAH) is unknown. This study describes the feasibility and safety of delivering iTRE to sedated or anesthetized children during cardiac catheterization.
METHODS: Twelve children, median age 10.9 years (range 4.6-18.8) with known and treated PAH underwent cardiac catheterization as part of routine follow-up while sedated or anesthetized. Diagnoses included IPAH (n=5), PAH-CHD (n= 5), and other APAH (n=2). Standard reactivity testing first was performed with oxygen plus nitric oxide (iNO-O2, 40 ppm). Following return of the hemodynamic status to baseline, 3-6 breaths of iTRE was delivered, followed by 3-6 additional breaths for a maximum of 9 breaths if tolerated. iTRE was administered using the OPTINEB®-ir Model ON-100/7 ultrasonic nebulizer via either a non-self inflating bag or manual mode of the anesthesia system in synchrony with the Optineb’s inhalation indicator.
RESULTS: iTRE was successfully delivered to children during cardiac catheterization. The median tolerated dose was 9 breaths (1.6 mcg/kg). Acute hemodynamic response to iTRE and iNO-O2 were similar. Baseline mPAP of 38 +/- 9 mmHg decreased to 32 +/- 8 mmHg with both agents. Pulmonary resistance index decreased from 7.3 +/- 2.9 units x m2 at baseline to 5.7 +/- 2.6 and 5.6 +/- 2.2 units x m2 with iNO-O2 and iTRE respectively, without a decrease in SVRI overall. A mild fall in systemic blood pressure was noted in 2 children when dosed beyond 6 breaths and one child experienced cough.
CONCLUSION: In a small cohort of pediatric PAH patients, iTRE was successfully delivered during cardiac catheterization. The acute hemodynamic response to iTRE was similar to iNO-O2; however, higher dose iTRE may be associated with a mild fall in systemic blood pressure. Further investigation is warranted regarding use of iTRE the critical care setting and chronic use in children.