TY - JOUR
T1 - Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure
AU - Waxman, Aaron B.
AU - McElderry, Hugh T.
AU - Gomberg-Maitland, Mardi
AU - Burke, Martin C.
AU - Ross, Edgar L.
AU - Bersohn, Malcolm M.
AU - Pangarkar, Sanjog S.
AU - Tarver, James H.
AU - Zwicke, Diane L.
AU - Feldman, Jeremy P.
AU - Chakinala, Murali M.
AU - Frantz, Robert P.
AU - Thompson, Geoffrey B.
AU - Torres, Fernando
AU - Rauck, Richard L.
AU - Clagg, Kathy
AU - Durst, Louise
AU - Li, Pei
AU - Morris, Marty
AU - Southall, Kara L.
AU - Peterson, Leigh
AU - Bourge, Robert C.
N1 - Publisher Copyright:
© 2017 American College of Chest Physicians
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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.
KW - implantable
KW - programmable
KW - pulmonary arterial hypertension
KW - pump
KW - treprostinil
UR - https://www.scopus.com/pages/publications/85038246972
U2 - 10.1016/j.chest.2017.04.188
DO - 10.1016/j.chest.2017.04.188
M3 - Article
C2 - 28583617
AN - SCOPUS:85038246972
SN - 0012-3692
VL - 152
SP - 1128
EP - 1134
JO - CHEST
JF - CHEST
IS - 6
ER -