Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System: Results of the DelIVery for PAH Trial

Robert C. Bourge, Aaron B. Waxman, Mardi Gomberg-Maitland, Shelley M. Shapiro, James H. Tarver, Dianne L. Zwicke, Jeremy P. Feldman, Murali M. Chakinala, Robert Frantz, Fernando Torres, Jeffrey Cerkvenik, Marty Morris, Melissa Thalin, Leigh Peterson, Lewis J. Rubin

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov

Original languageEnglish (US)
Pages (from-to)27-34
Number of pages8
JournalChest
Volume150
Issue number1
DOIs
StatePublished - Jul 1 2016

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Pulmonary Hypertension
Catheters
Catheter-Related Infections
Time Management
Subcutaneous Infusions
treprostinil
Patient Satisfaction
Prostaglandins
Registries
Clinical Trials
Physicians
Pain
Equipment and Supplies

Keywords

  • central venous catheters
  • drugs
  • health-related quality of life
  • pulmonary arterial hypertension
  • pulmonary hypertension
  • treprostinil

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System : Results of the DelIVery for PAH Trial. / Bourge, Robert C.; Waxman, Aaron B.; Gomberg-Maitland, Mardi; Shapiro, Shelley M.; Tarver, James H.; Zwicke, Dianne L.; Feldman, Jeremy P.; Chakinala, Murali M.; Frantz, Robert; Torres, Fernando; Cerkvenik, Jeffrey; Morris, Marty; Thalin, Melissa; Peterson, Leigh; Rubin, Lewis J.

In: Chest, Vol. 150, No. 1, 01.07.2016, p. 27-34.

Research output: Contribution to journalArticle

Bourge, RC, Waxman, AB, Gomberg-Maitland, M, Shapiro, SM, Tarver, JH, Zwicke, DL, Feldman, JP, Chakinala, MM, Frantz, R, Torres, F, Cerkvenik, J, Morris, M, Thalin, M, Peterson, L & Rubin, LJ 2016, 'Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System: Results of the DelIVery for PAH Trial', Chest, vol. 150, no. 1, pp. 27-34. https://doi.org/10.1016/j.chest.2015.11.005
Bourge, Robert C. ; Waxman, Aaron B. ; Gomberg-Maitland, Mardi ; Shapiro, Shelley M. ; Tarver, James H. ; Zwicke, Dianne L. ; Feldman, Jeremy P. ; Chakinala, Murali M. ; Frantz, Robert ; Torres, Fernando ; Cerkvenik, Jeffrey ; Morris, Marty ; Thalin, Melissa ; Peterson, Leigh ; Rubin, Lewis J. / Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System : Results of the DelIVery for PAH Trial. In: Chest. 2016 ; Vol. 150, No. 1. pp. 27-34.
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abstract = "Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5{\%} upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov",
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T2 - Results of the DelIVery for PAH Trial

AU - Bourge, Robert C.

AU - Waxman, Aaron B.

AU - Gomberg-Maitland, Mardi

AU - Shapiro, Shelley M.

AU - Tarver, James H.

AU - Zwicke, Dianne L.

AU - Feldman, Jeremy P.

AU - Chakinala, Murali M.

AU - Frantz, Robert

AU - Torres, Fernando

AU - Cerkvenik, Jeffrey

AU - Morris, Marty

AU - Thalin, Melissa

AU - Peterson, Leigh

AU - Rubin, Lewis J.

PY - 2016/7/1

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N2 - Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov

AB - Background The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. Methods A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. Results Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P <.0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P <.0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months’ postimplantation (P <.0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. Conclusions The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov

KW - central venous catheters

KW - drugs

KW - health-related quality of life

KW - pulmonary arterial hypertension

KW - pulmonary hypertension

KW - treprostinil

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