@article{adeb590118fc447da0b0ef2707d1bab1,
title = "Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure",
abstract = "Background Prostacyclins improve symptoms and survival in pulmonary arterial hypertension (PAH). In response to risks associated with external delivery systems, an implantable IV infusion system was developed. A multicenter, prospective, single-arm, clinical trial (DelIVery for PAH) was conducted to evaluate this system for treprostinil in PAH. This analysis describes the findings related to the implant procedure. Methods Patients (N = 64) with PAH (World Health Organization group 1) receiving stable IV treprostinil were enrolled. Patients were transitioned to a temporary peripheral IV infusion catheter prior to the procedure. System implantation was performed at 10 centers under general anesthesia or deep IV sedation by clinicians from various specialties. Central venous access was via the cephalic, subclavian, jugular, or axillary vein. Using an introducer and fluoroscopic guidance, the distal tip of the infusion catheter was placed at the superior caval-atrial junction. The catheter was tunneled from the venous access site to an abdominal subcutaneous pocket, where the pump was placed. Results Of the 64 patients enrolled, four exited prior to implantation. All 60 implant procedures were successful. At baseline, all patients were receiving treprostinil via an external pump at a mean dose of 71.4 ± 27.8 ng/kg/min (range: 22-142 ng/kg/min). The implant averaged 102 ± 32 min (range: 47-184 min). Clinically significant implant procedure-related complications included one pneumothorax, two infections, and one episode of atrial fibrillation. There were three postimplantation catheter dislocations in two patients. Common implant-related events that were not complications included implant site pain (83%) and bruising (17%). Conclusions The procedure for inserting a fully implantable system for treprostinil was successfully performed, with few complications. Trial Registry ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.",
keywords = "implantable, programmable, pulmonary arterial hypertension, pump, treprostinil",
author = "Waxman, {Aaron B.} and McElderry, {Hugh T.} and Mardi Gomberg-Maitland and Burke, {Martin C.} and Ross, {Edgar L.} and Bersohn, {Malcolm M.} and Pangarkar, {Sanjog S.} and Tarver, {James H.} and Zwicke, {Diane L.} and Feldman, {Jeremy P.} and Chakinala, {Murali M.} and Frantz, {Robert P.} and Thompson, {Geoffrey B.} and Fernando Torres and Rauck, {Richard L.} and Kathy Clagg and Louise Durst and Pei Li and Marty Morris and Southall, {Kara L.} and Leigh Peterson and Bourge, {Robert C.}",
note = "Funding Information: Financial/nonfinancial disclosures: The authors have reported to CHEST the following: H. T. M. has received financial support from Medtronic. M. G.-M. has been a consultant and/or on steering committees/Data and Safety Monitoring Board for the following companies: Actelion, Arena, Bayer, Gilead, Liquidia, Medtronic, Merck, UCB, and United Therapeutics. M. C. B. has received minimal research grants from Medtronic, the study sponsor, and St. Jude medical related to this project and others in the cardiac device field; he has received moderate research grants, consulting and speaking honoraria from Boston Scientific for work in the implantable device field. M. M. B. reports consulting for Biotronik and performing clinical research supported by the Sorin Division of LivaNova. J. H. T. participated in United Therapeutics/Lung LLC research studies as Principal Investigator and recently joined the United Therapeutics speaker bureau. D. L. Z. has participated in all clinical trials for medications currently available for the treatment of PAH, as well as ongoing clinical trial development of at least eight new agents in study; she receives no financial income from these trials. D. L. Z. is involved with teaching PAH preceptorships (continuing medical education accredited) 4+ times per year to medical professionals, with financial support from pharmaceutical educational grant monies; she has also participated in advisory boards and round table educational activities as both a participant and teacher, organized and supported by several pharmaceutical companies; she, personally, has no financial relationship and has received no financial support for participating in this study utilizing the implantable system of infusing Remodulin that has been financially supported by the Medtronic Corporation. J.P.F. has served as consultant and speaker for United Therapeutics. M. M. C. discloses relationships with Actelion (advisory boards), Gilead (consulting, advisory boards, speaking), United Therapeutics (consulting, advisory boards, expert testimony), Bayer (consulting, advisory boards, speaking), Medtronic (consulting), SteadyMed (consulting), and Express Scripts (advisory board); all relationships conform to the restrictions of M. M. C.'s home institution. R. P. F. has served on the Data Monitoring Committee for United Therapeutics and the Adjudication Committee for Lung LLC. F. T. participates in multiple pharmaceutical and National Institutes of Health clinical trials; he is also a consultant and speaks on behalf of industry, specifically in the field of pulmonary hypertension. P. L., M. M., and K. L. S. are employees of Medtronic. L. P. is an employee of United Therapeutics Corp. R. C. B. was responsible for grant support for this clinical study, all paid to the University of Alabama at Birmingham. None declared (A. B. W., E. L. R., S. S. P., G. B. T., R. L. R., K. C., L. D.). Publisher Copyright: {\textcopyright} 2017 American College of Chest Physicians",
year = "2017",
month = dec,
doi = "10.1016/j.chest.2017.04.188",
language = "English (US)",
volume = "152",
pages = "1128--1134",
journal = "CHEST",
issn = "0012-3692",
publisher = "American College of Chest Physicians",
number = "6",
}