Sixty Pulmonary Hypertension Patients Receive Implanted-pump Therapy-delivery Systems
Researchers implanted a long-term, intravenous therapy-delivery system consisting of internal pumps and catheters in 60 pulmonary arterial hypertension (PAH) patients, according to a clinical trial.
The IV infusion system, developed by Medtronic, delivers Remodulin (treprostinil). The research team said the system should be easier to use than current therapy-delivery methods. It also has the potential to reduce infections and complications associated with other methods, they said.
They discussed the implants in an article titled “Totally Implantable Intravenous Treprostinil Therapy in Pulmonary Hypertension: Assessment of the Implantation Procedure” in the journal Chest.
United Therapeutics‘ Remodulin is a prostacyclin analog that the U.S. Food and Drug Administration approved for treating PAH. It widens arteries so more oxygen-carrying blood can get to the lungs. It also inhibits platelet aggregation and clotting that could block arteries.
Remodulin is usually administered by IV, but can also be administered by external pumps or catheters. All of these methods can lead to complications that impact patients’ quality of life, causing some of them to be reluctant to accept the therapy.
The DelIVery clinical trial (NCT01321073) involved researchers implanting SynchroMed II drug pumps and Model 10642 catheters in 60 PAH patients at 10 U.S. medical facilities.
The original trial group consisted of 64 patients with stable PAH who were receiving Remodulin intravenously through an external drug infusion pump.
Researchers ruled out an implant for one patient whose condition was worsening. The other three who received no implants either had infections from other drug-delivery catheters or were too small to accommodate the new delivery system.
Overall, the implants were well tolerated. About 80 percent of the patients who received them complained of implant site pain, and 17 percent showed signs of bruising, adverse effects that were expected.
Only three severe adverse events associated with the implant procedures were reported. One was a case of pneumothorax, or accumulation of air in the space between the lungs and chest walls. Two patients had infections, and one an irregular heartbeat.
Despite the problems, “procedural success was demonstrated, as 100% of the attempted implants were successfully completed,” the researchers wrote. “PAH therapy, anticoagulation, and other co-morbidities [medical conditions] were safely managed during the surgical procedure and post-operatively. The implant procedure was successfully performed with a low complication rate by clinicians with a diverse range of specialty training.”
