TY - JOUR
T1 - Antibacterial Envelope to Prevent Cardiac Implantable Device Infection
AU - WRAP-IT Investigators
AU - Tarakji, Khaldoun G
AU - Mittal, Suneet
AU - Kennergren, Charles
AU - Corey, Ralph
AU - Poole, Jeanne E
AU - Schloss, Edward
AU - Gallastegui, Jose
AU - Pickett, Robert A
AU - Evonich, Rudolph
AU - Philippon, François
AU - McComb, Janet M
AU - Roark, Steven F
AU - Sorrentino, Denise
AU - Sholevar, Darius
AU - Cronin, Edmond
AU - Berman, Brett
AU - Riggio, David
AU - Biffi, Mauro
AU - Khan, Hafiza
AU - Silver, Marc T
AU - Collier, Jack
AU - Eldadah, Zayd
AU - Wright, David J
AU - Lande, Jeff D
AU - Lexcen, Daniel R
AU - Cheng, Alan
AU - Wilkoff, Bruce L
AU - Mihalcz, Attila
N1 - Publisher Copyright:
© 2019 Massachussetts Medical Society. All rights reserved.
PY - 2019/5/16
Y1 - 2019/5/16
N2 - 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. 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). 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.
AB - 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. 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). 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.
KW - Aged
KW - Anti-Bacterial Agents/administration & dosage
KW - Antibiotic Prophylaxis
KW - Bacterial Infections/epidemiology
KW - Defibrillators, Implantable/adverse effects
KW - Female
KW - Heart Diseases/therapy
KW - Humans
KW - Incidence
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Minocycline/administration & dosage
KW - Pacemaker, Artificial/adverse effects
KW - Prosthesis-Related Infections/epidemiology
KW - Rifampin/administration & dosage
KW - Single-Blind Method
KW - Standard of Care
UR - http://www.scopus.com/inward/record.url?scp=85063807596&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1901111
DO - 10.1056/NEJMoa1901111
M3 - Journal article
C2 - 30883056
SN - 0028-4793
VL - 380
SP - 1895
EP - 1905
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 20
ER -