Implant Eliminates External Pump in Pulmonary Hypertension

Jim Kling

October 29, 2014

AUSTIN, Texas — An implantable, programmable device safely delivers prostanoid treprostinil to patients with pulmonary arterial hypertension, according to new research presented here at CHEST 2014.

"Most pulmonary hypertension doctors believe that prostanoid analogs are one of the key therapies for pulmonary hypertension," said Robert Bourge, MD, from the University of Alabama at Birmingham.

However, their use "has been limited by the administration mechanism of the drug," he told Medscape Medical News. With the external pump, "you're constantly reminded that you have the disease. I've heard doctors ask their patients, 'You don't really want to start an IV drug and carry around a pump, do you?'"

An oral formulation of treprostinil was approved in 2013, but most patients can't tolerate doses that are high enough to treat severe pulmonary arterial hypertension, said Dr Bourge. Subcutaneous options are often painful, and an inhaled version works but can't deliver sufficient doses when the condition worsens.

With this new device, the time between refills can be as long as 12 weeks. It also eliminates the need for an external pump, which can lower the risk for infection.

To ensure the safety of the new combination of drug and device, the researchers conducted a multicenter prospective nonrandomized trial of 60 patients, 80% of whom were female. Mean age was 53 years, and ranged from 24 to 74 years.

Patients with the implant were compared with historic control subjects who used external pump delivery systems. Mean follow-up after device implantation was 367 days (range, 87 - 701).

The rate of catheter-related complications was lower in the implant group than in the control subjects (0.27 vs 2.5 per 1000 patient-days; P < .0001), but no catheter-associated bloodstream infections occurred during the trial.

The mean plasma level of treprostinil was similar in the implant and control subjects (10.5 vs 10.9 mg/mL).

The implantable device was well received. All patients rated the treatment as good, very good, or excellent at 6 weeks and 6 months.

The drug and the pump have already been approved by the US Food and Drug Administration (FDA), but a new catheter had to be developed that wouldn't become occluded, which was a problem with existing catheters.

Meeting FDA Requirements

This study was designed to prove the safety of the drug and device combination, Dr Bourge explained. "There was no problem" and it passed the test, he said.

The device, which could see FDA approval by the end of 2015, has the potential to increase the use of treprostinil.

"The Registry to Evaluate Early and Long-Term PAH Disease Management [REVEAL] estimated that of the people who die with pulmonary hypertension, more than half were never given a prostanoid, which is absurd," Dr Bourge said.

"But the improved quality of life is the real reason I'm pushing this," he said. During his presentation, he recounted the story of a patient with an implanted pump who sent him a picture of herself in a bikini on a Florida beach.

The device could be appropriate for patients who are doing well on prostanoids with an external pump. "It's a very attractive new delivery method for this medication," said Adriano Tonelli, MD, a staff physician in pulmonary medicine at the Cleveland Clinic, who attended the presentation.

"Not having to worry about the external pump makes life a little bit simpler, even allowing the possibility of swimming, which patients with the external pump can't do," he told Medscape Medical News.

Medtronic and United Therapeutics funded the study. Dr Bourge reports receiving consultant fees and being on the speakers bureau or advisory committee for Medtronic and United Therapeutics. Dr Tonelli has disclosed no relevant financial relationships.

CHEST 2014: American College of Chest Physicians Meeting: Abstract 1992942. Presented October 28, 2014.

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