Use of antibiotic envelopes to prevent cardiac implantable electronic device infections: A meta‐analysis

Koerber, Scott; Turagam, Mohit K.; Winterfield, Jeffery; Gautam, Sandeep; Gold, Michael R.

doi:10.1111/jce.13436

Cited by 28 publications

(26 citation statements)

References 25 publications

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“…Strategies to minimize the risk of CDIs include local antisepsis during implantation or the use of commercially available antibacterial envelopes (TYRX Absorbable Antibacterial Envelope, Medtronic Inc., Mounds View, MN, USA), the latter of which have been demonstrated to reduce the CDI rate in multiple studies. 6,[22][23][24][25][26][27] Two recent contributions to the literature now provide a consensus on the prevention of infections in CIED patients, as well as a survey of different practice across the world. 28,29 One large randomized controlled trial (PADIT) 30 was recently completed comparing the standard pre-operative systemic IV antibiotic dosing regimen to an incremental systemic antibiotic dosing regimen that included an additional pre-operative IV antibiotic, a perioperative antibiotic pocket wash, and post-operative antibiotics.…”

Section: Discussionmentioning

confidence: 99%

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Eby

Bengtson

Johnson

et al. 2020

Journal of Medical Economics

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Aims: Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective. Materials and Methods: A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members !18 years with !1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapypacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan-Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs. Results: A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG ¼ 0.91%; ICD ¼ 1.63%; CRT-p ¼ 1.50%; CRT-D ¼ 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) ¼ 2.1-2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572-$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) ¼ 11.356; 95% CI ¼ 7.923-16.276], undergoing a CIED replacement procedure (OR ¼ 1.644; 95% CI ¼ 1.361-1.987), implantation of a high-power device (OR ¼ 1.354; 95% CI ¼ 1.115-1.643), and younger age (age < 65) (OR ¼ 1.607; 95% CI ¼ 1.307-1.976). Conclusions: The CDI rate at one year ranged from 0.91%-2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.

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Section: Discussionmentioning

confidence: 99%

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Eby

Bengtson

Johnson

et al. 2020

Journal of Medical Economics

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“…This relationship was demonstrated by a clinical study of sternal wound infection, which reported that treatment of wound infection using a collagen implant impregnated with gentamicin was effective, even when antibiotic‐resistant S. epidermidis was present, presumably due to high local concentrations of gentamicin 36 . Indeed, the clinical efficacy of local delivery of gentamicin for prevention of surgical site infection has been demonstrated across multiple indications, including cardiac, orthopedic, and gastrointestinal procedures, without risk of systemic exposure 28,29,37–40 . The very high local gentamicin concentrations achieved in this study suggest that bacterial killing should occur rapidly for key bacterial species.…”

Section: Discussionmentioning

confidence: 62%

“…Earlier studies have demonstrated reduced infection rates with local application of gentamicin containing collagen sponge during CIED implantation. 28,29 Furthermore, Deering et al 30 demonstrated that after hydration of ECM envelope in different antibiotics solution, elution was observed for a period of up to 6 days. In this same study, subsequent experiments performed using an animal model of cardiac device pocket infection showed that the released antibiotics (vancomycin or gentamicin) substantially reduced colonization by two strains of Staphylococcus on CIED devices.…”

Section: F I G U R E 1 Extracellular Matrix Envelopementioning

confidence: 99%

“…Local gentamicin delivery to the site that potentially harbors pathogens, may overcome some of these risks. Earlier studies have demonstrated reduced infection rates with local application of gentamicin containing collagen sponge during CIED implantation 28,29 . Furthermore, Deering et al 30 demonstrated that after hydration of ECM envelope in different antibiotics solution, elution was observed for a period of up to 6 days.…”

Section: Introductionmentioning

confidence: 99%

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Preclinical evaluation of efficacy and pharmacokinetics of gentamicin containing extracellular‐matrix envelope

Sohail

Garrigos

Elayi

et al. 2020

Pacing Clinical Electrophis

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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.

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“…Gleiches gilt für antibiotikahaltige Wundspülungen, die in dieser Arbeit sogar einen Trend zu vermehrten Wundinfektionen aufwiesen. Auch die in anderen Untersuchungen durchaus positiv bewerteten antibakteriell beschichteten Netze [1,2] zeigten hier keinen protektiven Effekt, so dass ihr Einsatz im Alltag derzeit auf Reimplantationen, insbesondere bei Austausch des Fremdmaterials aufgrund einer Infektion, beschränkt werden sollte [3].…”

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Implantierbare kardiale Devices: Risikofaktoren und effektive Präventionsmaßnahmen

2020

Krankenh.hyg. up2date

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Use of antibiotic envelopes to prevent cardiac implantable electronic device infections: A meta‐analysis

Abstract: The use of antibiotic envelopes in CIED implant is associated with a significantly lower rate of infection.

Cited by 28 publications

References 25 publications

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Preclinical evaluation of efficacy and pharmacokinetics of gentamicin containing extracellular‐matrix envelope

Implantierbare kardiale Devices: Risikofaktoren und effektive Präventionsmaßnahmen

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