Safety, Efficacy of Treprostinil Delivery System for PAH Examined
The most common adverse events related to the implant procedure included pain at the implant site (83%) and bruising (17%).
A newly developed intravenous implantable infusion system for treprostinil was found to be safe and effective in adults with pulmonary arterial hypertension, according to a study published in Chest.
"The key findings [of this study] are that this pump and catheter system are safe, comfortable, reliable, and afford patients a whole new freedom and improved quality of life," said Aaron B. Waxman, MD, PhD, FACP, FCCP, associate professor of medicine at the Harvard Medical School, executive director of the Center for Pulmonary-Heart Diseases, and director of the Pulmonary Vascular Disease Program at the Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts, in an email interview with Pulmonology Advisor.
"This will have a tremendous impact on patient care from the aspect of safety and patient's satisfaction," he added.
The multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension; ClinicalTrials.gov identifier: NCT01321073) enrolled 64 patients with pulmonary arterial hypertension from June 2011 to November 2012 at 10 medical centers across the United States. All study participants were older than 18 years and received treprostinil (mean dose at baseline, 71.4±27.8 ng/kg/min) before the implant procedure, which took place under general anesthesia or deep intravenous sedation. Four participants opted to drop out of the study before the procedure. In the remaining participants (n=60), the catheter was introduced via the cephalic, jugular, subclavian, or axillary vein and advanced to the abdominal subcutaneous pocket where the pump was positioned.
The implant procedure took, on average, 102±32 min (range, 47-184 min); all 60 procedures were deemed successful. Clinically significant complications related to the procedure included 2 cases of pneumothorax, 2 infections, and 1 episode of atrial fibrillation; 3 postprocedure catheter dislocations were observed in 2 patients. Pain at the implant site (83%) and bruising (17%) were commonly reported, implant-related adverse events.
"We eliminate all the hassles of an indwelling Hickman catheter," said Dr Waxman. "The risks associated with this pump are minimal and would include leakage of the drug at the time of refill, which causes slight pain but is temporary. The infection risk is reduced to near zero."
Dr Waxman is hopeful that the long-term implications of his research will make intravenous therapy or subcutaneous therapy, among other forms of prostacyclin therapy, effective in a way that improves patient quality of life.
"I think this will open the door to other patients who have been reluctant to go on prostacyclins because of the complexity of the therapy, and the inherent risks of long-term indwelling Hickman catheters," said Dr Waxman. "When you look at the overall treatment paradigm for advanced pulmonary vascular disease and pulmonary arterial hypertension, many patients don't go on prostacyclins because of the difficulties."
"This will offer them a new opportunity for the best therapy available," he concluded.
Waxman AB, McElderry HT, Gomberg-Maitland M, et al. Totally implantable intravenous treprostinil therapy in pulmonary hypertension: assessment of the implantation procedure [published online June 2, 2017]. Chest. doi: 10.1016/j.chest.2017.04.188