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N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection.

Collaborators (198)

Schloss E, Gallastegui J, Pickett RAD, Evonich R, Philippon F, McComb J, Roark S, Sorrentino D, Sholevar D, Tarakji K, Cronin E, Berman B, Riggio D, Biffi M, Diemberger I, Khan H, Silver M, Collier J, Eldadah Z, Wright DJ, Moore J, Addo K, Jones RC, Schaller R, Martinez-Arraras J, Abdalla I, Issa Z, Redpath C, Moubarak J, Khelea SK, Philbert BT, Simmers TA, Boersma LVA, Korantzopoulos P, Love J, Augostini R, Keilegavlen H, Faerestrand S, Mittal S, Wiggins S, Healey J, Ramza B, Hansalia R, Brodt C, Wang P, Mihalcz A, Gras D, Birgersdotter-Green UM, Fruechte E, Hodgkin D, Lustgarten D, Tomassoni G, Ahmed F, Rorsman C, Vijayaraman P, Mackall J, Manyam H, Nichols A, Bar-Lev SD, Merrill J, Adkisson W, Olalla JJ, Chalfoun N, Johnson E, Massare J, Frazier-Mills C, Chenarides J, Jazayeri M, Boran K, Schoenhard J, Milstein S, Bailey J, Kremers M, Burkart T, Mullens W, Franklin J, Ehlert F, Henrikson C, Kutinsky I, Anguera I, Springer M, Simons G, Anselme F, Sandler D, Bontempi L, Guedon-Moreau LM, Iwai S, McAnulty J, Putz E, Golovchiner G, Juang D, Ammann P, Jones R, Katz A, Madhavan M, Emert M, de Freitas Fernandes Hipólito Reis AC, Salo T, Cole C, Keim S, Thomas G, Chakrabarti C, Murray C, Vatterott P, Sangrigoli R, Mela T, Mason MJ, Winslow R, Lee SC, Mitkowski P, Costa AD, Nair G, Fisher W, Deharo JC, Castellani M, Rhine D, Ghanbari H, Kalahasty G, Anderson D, Frisch D, Chinitz L, Love C, Rubin A, Lessmeier T, Compton S, Mitchell M, Fan K, Al Ghamdi SB, Kaliska G, Margitfalvi P, Meininger G, Bongiorni MG, Luebbert J, Pelini M, Misikova S, Kuhnlein J, Schweikert R, Herzet JM, Pedretti S, Lee B, Santucci P, Hörnsten J, Saba S, Adelstein E, Mendenhall S, Chan NY, Jamaly S, Moreno J, Moccetti T, Shah P, Pappas JD, Blum T, Pruvot E, Chu A, Gangireddy C, Cooper J, Chien W, Al-Mugamgha A, Smelley M, Saltzman H, Kolli A, Kostis W, Amardeep S, Kennergren C, Handa R, Simantirakis E, Simmons T, Smith R, Gleva M, Theodorakis GN, Aziz E, Burke S, Ho KL, De Asmundis C, Civello K, Hsen TV, Wells D, Ince H, Pakarinen S, Hurwitz J, Mehta V, Abidin IZ, Osayamen M, Banchs J, Kim K, Kutarski A, Frazão JM, de Sousa R, Tambidorai S, Sandberg J, Aguayo R, Traub D, Mukerji S, Venaktaraman R, Hariharan R, Krishinan S, Silvestre J, Rankovic V.

Author information

1
From the Cleveland Clinic, Cleveland (K.G.T., B.L.W.), and the Lindner Research Center, Cincinnati (E.S.) - both in Ohio; Valley Health System, Ridgewood (S.M.), and Lourdes Cardiology Services, Cherry Hill (D. Sholevar) - both in New Jersey; Sahlgrenska University Hospital, Göteborg, Sweden (C.K.); Duke Clinical Research Institute, Durham (R.C.), and WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh (M.T.S.) - both in North Carolina; University of Washington School of Medicine, Seattle (J.E.P.); Clearwater Cardiovascular and Interventional Consultants, Safety Harbor (J.G.), and Cardiology Associates of Gainesville, Gainesville (S.F.R.) - both in Florida; Saint Thomas Research Institute, Nashville (R.A.P.); Upper Michigan Cardiovascular Associates, Marquette (R.E.); Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC, Canada (F.P.); the Newcastle upon Tyne Hospitals, Newcastle upon Tyne (J.M.M.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - both in the United Kingdom; Iowa Heart Center, West Des Moines (D. Sorrentino); Hartford Hospital, Hartford, CT (E.C.); Chula Vista Cardiac Center, Chula Vista, CA (B.B.); Arizona Arrhythmia Consultants, Scottsdale (D.R.); Policlinico Sant' Orsola-Malpighi, Bologna, Italy (M.B.); Baylor Research Institute, Plano, TX (H.K.); Oklahoma Heart Hospital, Oklahoma City (J.C.); MedStar Heart and Vascular Institute, Washington, DC (Z.E.); and Medtronic, Mounds View, MN (J.D.L., D.R.L., A.C.).

Abstract

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.

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. (Funded by Medtronic; WRAP-IT ClinicalTrials.gov number, NCT02277990.).

PMID:
30883056
DOI:
10.1056/NEJMoa1901111

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