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Implantable System for Remodulin®: A Real-World Experience Study in Patients with Pulmonary Arterial Hypertension

Robert Bourge


Shelley Shapiro


Patti Pozella

David Harris

Erick Borg

A. C. Nelsen

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Conference: 2018 PHA International PH Conference & Scientific Sessions

Release Date: 06.28.2018

Presentation Type: Abstracts

File Download: Conference 2018_1047

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2018 International PH Conference and Scientific SeAbstract presented at the 2018 International PH Conference and Scientific Sessions in Orlando, Fla., June 28-July 1, 2018.

Background

The inherent risks and complex nature of intravenous (IV) and subcutaneous (SC) delivery of treprostinil with external pumps affect patient quality of life and limit use. The Implantable System for Remodulin was developed as an alternative route for treprostinil delivery and consists of an implantable pump, internal catheter tunneled from pump to central venous site, and handheld programmer. The pump is filled percutaneously with treprostinil as needed. The frequency of fills is determined by infusion rate and patient size and varies from every 1 to 3 months. Results of the open-label clinical trial evaluating the safety of the system have previously been described (DelIVery for Pulmonary Arterial Hypertension (PAH); NCT01321073). The purpose of this study was to gain a better understanding of the experience of patients participating in the clinical trial that continue to receive treprostinil with the system.

Methods

Patients logged into a secure interactive website once a day for 6 days and completed a series of mixed-methods, quantitative and qualitative activities. Survey questions were pre-tested with PAH nurses and were designed to assess the effect of the implantable system on quality of life, satisfaction, and activities of daily living relative to patients’ previous experience with external IV/SC pumps. Tasks included selection of photos representing life before and after the implantable system and a hypothetical letter writing activity to describe their experience. Data were collected between January and November 2017. The study received approval from Western Institutional Review Board. Note that data were not collected on patient experience with external pumps prior to implantation of the system as a comparator.

Results

21 patients from DelIVery participated. Mean (SD) patient age was 52.14 (12.54) years. Mean (SD) patient reported time on the implantable system was 4.98 (0.70) years. 14 had been on IV treprostinil and 12 on SC treprostinil prior to implantation of the system (5 had used both). Over 70% of patients reported equal or more emergency room visits on their previous external pumps compared to the implantable system. Over 80% of patients reported that their previous external pumps took more time overall than the implantable system (travel and clinic time included). Over 80% of patients reported a better experience shopping for groceries and working. Over 90% of patients reported improved ability to do housework, sleep, and independence. All patients reported improved overall quality of life (Figure 1), improved confidence out in public, improved ability to travel long distances, a better bathing experience, and a better experience getting dressed. Finally, all patients reported that the benefits of the implantable system are worth the risks of the implanted system (long-term study results manuscript in preparation).

Conclusions

Treprostinil patients report an improved overall experience with the implantable system compared to their prior IV/SC external pumps, specifically in areas of quality of life, satisfaction, and activities of daily living. Patient perspective data continues to be an increasingly important aspect of the healthcare landscape.

Patient Reported Overall Quality of Life with the Implantable System