Antibacterial Envelope to Prevent Cardiac Implantable Device Infection.

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Citation: New England Journal of Medicine. 380(20):1895-1905, 2019 05 16.PMID: 30883056Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Anti-Bacterial Agents/ad [Administration & Dosage] | *Antibiotic Prophylaxis | *Bacterial Infections/pc [Prevention & Control] | *Defibrillators, Implantable/ae [Adverse Effects] | *Heart Diseases/th [Therapy] | *Minocycline/ad [Administration & Dosage] | *Pacemaker, Artificial/ae [Adverse Effects] | *Prosthesis-Related Infections/pc [Prevention & Control] | *Rifampin/ad [Administration & Dosage] | Aged | Anti-Bacterial Agents/ae [Adverse Effects] | Bacterial Infections/ep [Epidemiology] | Bacterial Infections/mo [Mortality] | Female | Humans | Incidence | Kaplan-Meier Estimate | Male | Middle Aged | Minocycline/ae [Adverse Effects] | Prosthesis-Related Infections/ep [Epidemiology] | Prosthesis-Related Infections/mo [Mortality] | Rifampin/ae [Adverse Effects] | Single-Blind Method | Standard of CareYear: 2019ISSN:
  • 0028-4793
Name of journal: The New England journal of medicineAbstract: BACKGROUND: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections.CONCLUSIONS: Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.).Copyright (c) 2019 Massachusetts Medical Society.METHODS: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months.RESULTS: A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (+/-SD) duration of follow-up was 20.7+/-8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98).All authors: Berman B, Biffi M, Cheng A, Collier J, Corey R, Cronin E, Eldadah Z, Evonich R, Gallastegui J, Kennergren C, Khan H, Lande JD, Lexcen DR, McComb JM, Mittal S, Philippon F, Pickett RA, Poole JE, Riggio D, Roark SF, Schloss E, Sholevar D, Silver MT, Sorrentino D, Tarakji KG, the WRAP-IT Investigators, Wilkoff BL, WRAP-IT Investigators, Wright DJFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-06-21
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Journal Article MedStar Authors Catalog Article 30883056 Available 30883056

BACKGROUND: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections.

CONCLUSIONS: Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.).

Copyright (c) 2019 Massachusetts Medical Society.

METHODS: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months.

RESULTS: A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (+/-SD) duration of follow-up was 20.7+/-8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98).

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