0
Original Research |

Totally Implantable Intravenous Treprostinil Therapy in Pulmonary Hypertension: Assessment of the Implantation Procedure

Aaron B. Waxman, MD, PhD; Hugh T. McElderry, MD; Mardi Gomberg-Maitland, MD, MSc; Martin C. Burke, DO; Edgar L. Ross, MD; Malcolm M. Bersohn, MD, PhD; Sanjog S. Pangarkar, MD; James H. Tarver, MD; Diane L. Zwicke, MD; Jeremy P. Feldman, MD; Murali M. Chakinala, MD; Robert P. Frantz, MD; Geoffrey B. Thompson, MD; Fernando Torres, MD; Richard L. Rauck, MD; Kathy Clagg, RN; Louise Durst, RN; Pei Li; Marty Morris; Kara L. Southall; Leigh Peterson; Robert C. Bourge, MD
Author and Funding Information

Clinical Trials.gov identifier: NCT01321073

Guarantor: Aaron B. Waxman, M.D., Ph.D. Pulmonary and Critical Care Medicine, Department of Medicine. Brigham and Women’s Hospital. Clinics 3, 75 Francis Street, Boston, MA 02115.

Contributorship: All authors have read and approved the final manuscript. Aaron B. Waxman, MD, PhD, Mardi Gomberg-Maitland,MD, Marty Morris, Kara L. Southall, Leigh Peterson, and Robert C. Bourge, MD were responsible for study conception, design, execution, and writing the manuscript. All of the authors were responsible for study execution, data acquisition and analysis, and review of the final manuscript.

Conflicts of Interest: Dr. McElderry has received financial support from Medtronic. Dr. Gomberg Maitland has been a consultant and/or on steering committees/DSMB for the following companies: Actelion, Arena, Bayer, Gilead, Liquidia, Medtronic, Merck, UCB, and United Therapeutics. Dr. Burke 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. Dr. Bersohn reports consulting for Biotronik, performing clinical research supported by the Sorin Division of LivaNova. Dr. Tarver participated in United Therapeutics / Lung LLC research studies as Principal Investigator and recently joined the United Therapeutics Speaker's bureau. Dr. Zwicke has participated in all clinical trials for medications currently available for treatment of PAH, as well as ongoing clinical trials development of at least eight new agents in study. She receives no financial income from these trials. She is involved with teaching PAH preceptorships (CME 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. Dr. Feldman has served as consultant and speaker for United Therapeutics. Dr. Chakinala 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 Dr. Chakinala's home institution. Dr. Frantz has served on Data Monitoring Committee for United Therapeutics and Adjudication Committee for Lung LLC. Dr. Torres participates in multiple pharmaceutical and NIH clinical trials. He also is a consultant and speaks on behalf on industry specifically in the field of pulmonary hypertension. Drs. Li, Morris and Southall are employees of Medtronic. Dr. Peterson is an employee of United Therapeutics Corp. Dr. Bourge was responsible for grant support for this clinical study, all paid to the University of Alabama at Birmingham.

aBrigham & Women's Hospital, Boston, MA

bUniversity of Alabama at Birmingham, Birmingham, AL

cThe University of Chicago Medical Center, Chicago, IL

dVA Greater Los Angeles Healthcare System, Los Angeles, CA

eOrlando Regional Medical Center, Orlando Health, Orlando, FL

fAurora Cardiovascular Services, Milwaukee, WI

gArizona Pulmonary Specialists, Ltd., Phoenix, AZ

hWashington University School of Medicine, Saint Louis, MO

iMayo Clinic, Rochester, MN

jThe University of Texas (UT) Southwestern Medical Center, Dallas, TX

kCarolinas Pain Institute, Wake Forest University Medical School, Winston Salem, NC

lBasic Home Infusion, Wayne, NJ

mMedtronic, Mounds View, MN

nUnited Therapeutics Corporation, Research Triangle Park, NC

Address for Correspondence: Aaron B. Waxman, MD, Ph.D Director Pulmonary Vascular Disease Program Brigham and Women's Hospital, Department of Medicine Pulmonary Division 75 Francis Street PBB CA-3 Boston, MA 02115.


Copyright 2017, . All Rights Reserved.


Chest. 2017. doi:10.1016/j.chest.2017.04.188
Text Size: A A A
Published online

Abstract

Background  Prostacyclins improve symptoms and survival in pulmonary arterial hypertension (PAH). In response to risks associated with external delivery systems, an implantable intravenous 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 (WHO Group 1) receiving stable intravenous treprostinil were enrolled. Patients were transitioned to a temporary peripheral intravenous infusion catheter prior to the procedure. System implantation was performed at 10 centers under general anesthesia or deep intravenous 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 implant. 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 to 142 ng/kg/min). The implant averaged 102 ± 32 minutes (range 47 to 184 minutes). Clinically significant implant procedure-related complications included 1 pneumothorax, 2 infections and 1 episode of atrial fibrillation. There were 3 post-implant catheter dislocations in 2 patients. Common implant-related events that were not complications included implant site pain (83%) and bruising (17%).

Conclusion  The procedure for inserting a fully implantable system for treprostinil was successfully performed with few complications.


Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
Guidelines
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543