Preclinical evaluation of efficacy and pharmacokinetics of gentamicin containing extracellular-matrix envelope.
Pacing Clin Electrophysiol
; 43(3): 341-349, 2020 03.
Article
in En
| MEDLINE
| ID: mdl-32067241
ABSTRACT
BACKGROUND:
Using synthetic antibiotic-eluting envelope (ABE) is an effective intervention for prevention of cardiovascular implantable electronic device (CIED) infection. The biologic extracellular-matrix envelope (ECME), may offer potential advantages over the synthetic ABE. To further minimize the risk of infection, the ECME can be hydrated in gentamicin prior to CIED implantation. We aimed to evaluate the efficacy and pharmacokinetics (PK) of gentamicin containing ECME in an animal model.METHODS:
For all experiments, the ECME was hydrated in gentamicin (40 mg/Ml) (treatment) for 2 min. In vitro antimicrobial efficacy against six different bacterial species was assessed. In vivo experiments were conducted using a rabbit model of CIED pocket infection. Serum and ECM gentamicin concentrations were measured. Five different organisms were inoculated into the device pocket of control (ECME hydrated in 0.9% saline) and treatment groups. Macroscopic appearance and colony forming units from CIED, ECME, and tissue were determined.RESULTS:
No bacteria were recovered from any culture after 12 h of exposure to the gentamicin containing ECME. Serum gentamicin levels dropped below the limit of quantification at 15 h after implant. Gentamicin concentration in the ECME remained relatively stable for up to 7 days. Signs of clinical infection were observed in the control but not in the treatment group. In the presence of gentamicin, statistically significant reduction was demonstrated across all tested bacterial species.CONCLUSIONS:
In this preclinical animal infection model, gentamicin containing ECME was highly effective in reducing bacterial burden in the implant pocket, while systemic exposure after implantation remained low.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pacemaker, Artificial
/
Gentamicins
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Prosthesis-Related Infections
/
Anti-Bacterial Agents
Limits:
Animals
Language:
En
Journal:
Pacing Clin Electrophysiol
Year:
2020
Type:
Article