title: An off-the-shelf plasma-based material to prevent pacemaker pocket infection.
abstract: Bacterial infection of subcutaneous "pockets" housing cardiovascular implantable electronic devices is a significant clinical complication. In this study, pacemakers encapsulated in a blood plasma-based material (PBM) composited with antibiotics were investigated for use as prophylactics against such infections. PBMs, which are made from pooled allogeneic plasma and platelets, are off-the-shelf biomaterials that can be manufactured in the form of complex 3D shapes, extrudable putties, or injectable pastes. In vitro studies with PBM pastes formulated with rifampicin and minocycline demonstrated antibiotic release over 6 days, activity against Escherichia coli, and reduced cytotoxic effects of the antibiotics on fibroblasts. The materials were also evaluated in vivo in a rabbit model in which pacemaker pockets were inoculated with methicillin-resistant Staphylococcus aureus (S. aureus) strain and examined 1 week later. The pockets containing the pacemaker plus S. aureus were grossly purulent and culture positive, whereas pockets into which PBM with antibiotics were injected around the pacemaker were free of purulence and culture negative (p < 0.001). None of the pockets into which PBM without antibiotics were placed demonstrated purulence, but 60% were culture positive. These results demonstrate the potential of PBMs to deliver antibiotics to diminish the incidence of pocket infections for pacemakers and other implantable devices.
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, UPMC Presbyterian, B535, Pittsburgh, PA 15213, USA.
authors.forename: David
authors.initials: D
authors.lastname: Schwartzman
authors.affiliation: Division of Clinical Microbiology, University of Pittsburgh, Rm 6025, 3477 Euler Way, Pittsburgh, PA 15261, USA.
authors.forename: A William
authors.initials: AW
authors.lastname: Pasculle
authors.affiliation: Carmell Therapeutics Corporation, 3636 Boulevard of the Allies, Pittsburgh, PA 15213, USA.
authors.forename: Kyra D
authors.initials: KD
authors.lastname: Ceceris
authors.affiliation: Carmell Therapeutics Corporation, 3636 Boulevard of the Allies, Pittsburgh, PA 15213, USA.
authors.forename: Jason D
authors.initials: JD
authors.lastname: Smith
authors.affiliation: The Robotics Institute and Dept. of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA.
authors.forename: Lee E
authors.initials: LE
authors.lastname: Weiss
authors.affiliation: The Institute for Complex Engineered Systems and Dept. of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA, USA. Electronic address: pcampbel@cs.cmu.edu.
authors.forename: Phil G
authors.initials: PG
authors.lastname: Campbell
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001672:Biocompatible Materials / Q000737:chemistry; D004337:Drug Carriers / Q000737:chemistry*; D016503:Drug Delivery Systems; D004926:Escherichia coli / Q000187:drug effects; D004927:Escherichia coli Infections / Q000209:etiology / Q000517:prevention & control; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects; D008911:Minocycline / Q000008:administration & dosage* / Q000627:therapeutic use; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D010949:Plasma / Q000737:chemistry*; D019736:Prostheses and Implants / Q000009:adverse effects; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000517:prevention & control*; D011817:Rabbits; D012293:Rifampin / Q000008:administration & dosage* / Q000627:therapeutic use; D013203:Staphylococcal Infections / Q000209:etiology / Q000517:prevention & control
chemical_list: D000900:Anti-Bacterial Agents; D001672:Biocompatible Materials; D004337:Drug Carriers; D008911:Minocycline; D012293:Rifampin
keywords: Antibiotic delivery; Drug delivery; Implantable devices; Platelets