1. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection
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Tarakji, Khaldoun G, Mittal, Suneet, Kennergren, Charles, Corey, Ralph, Poole, Jeanne E, Schloss, Edward, Gallastegui, Jose, Pickett, Robert A, Evonich, Rudolph, Philippon, François, Mccomb, Janet M, Roark, Steven F, Sorrentino, Denise, Sholevar, Darius, Cronin, Edmond, Berman, Brett, Riggio, David, Biffi, Mauro, Khan, Hafiza, Silver, Marc T, Collier, Jack, Eldadah, Zayd, Wright, David J, Lande, Jeff D, Lexcen, Daniel R, Cheng, Alan, Wilkoff, Bruce L, Edward, Schloss, Jose, Gallastegui, Robert Andrew Drew Pickett, Rudolph, Evonich, François, Philippon, Janet, Mccomb, Steven, Roark, Denise, Sorrentino, Darius, Sholevar, Khaldoun, Tarakji, Edmond, Cronin, Brett, Berman, David, Riggio, Mauro, Biffi, Igor, Diemberger, Hafiza, Khan, Marc, Silver, Jack, Collier, Zayd, Eldadah, David Justin Wright, Joellyn, Moore, Kamel, Addo, R Chris Jones, Robert, Schaller, Joaquin, Martinez-Arraras, Ismaile, Abdalla, Ziad, Issa, Calum, Redpath, Jean, Moubarak, Surinder Kaur Khelea, Berit Thornvig Philbert, Timothy Alexander Simmers, Lucas V, A Boersma, Panagiotis, Korantzopoulos, John, Love, Ralph, Augostini, Havard, Keilegavlen, Svein, Faerestrand, Suneet, Mittal, Scott, Wiggins, Jeff, Healey, Brian, Ramza, Riple, Hansalia, Chad, Brodt, Paul, Wang, Attila, Mihalcz, Daniel, Gras, Ulrika Maria Birgersdotter-Green, Ethan, Fruechte, Douglas, Hodgkin, Daniel, Lustgarten, Gery, Tomassoni, Fozia, Ahmed, Cecilia, Rorsman, Pugazhendhi, Vijayaraman, Judith, Mackall, Harish, Manyam, Allan, Nichols, Serge David Bar-Lev, James, Merrill, Wayne, Adkisson, Juan José Olalla, Nagib, Chalfoun, Eric, Johnson, Jorge, Massare, Camille, Frazier-Mills, John, Chenarides, Mohammad, Jazayeri, Kevin, Boran, John, Schoenhard, Simon, Milstein, John, Bailey, Mark, Kremers, Thomas, Burkart, Wilfried, Mullens, Jay, Franklin, Frederick, Ehlert, Charles, Henrikson, Ilana, Kutinsky, Ignasi, Anguera, Michael, Springer, Grant, Simons, Frederic, Anselme, David, Sandler, Bontempi, Luca, Laurence Marie-Pierre Guedon-Moreau, Sei, Iwai, John, Mcanulty, Eric, Putz, Gregory, Golovchiner, David, Juang, Peter, Ammann, Randy, Jones, Allan, Katz, Malini, Madhavan, Martin, Emert, António Cãndido de Freitas Fernandes Hipólito Reis, Tina, Salo, Christopher, Cole, Stephen, Keim, George, Thomas, Chanta, Chakrabarti, Christina, Murray, Pierce, Vatterott, Robert, Sangrigoli, Theofanie, Mela, Mark John Mason, Robert, Winslow, Shang-Chiun, Lee, Przemyslaw, Mitkowski, Antoine Da Costa, Girish, Nair, Westby, Fisher, Jean-Claude, Deharo, Mark, Castellani, David, Rhine, Hamid, Ghanbari, Gautham, Kalahasty, Daniel, Anderson, Daniel, Frisch, Larry, Chinitz, Charles, Love, Andrew, Rubin, Timothy, Lessmeier, Steven, Compton, Mark, Mitchell, Katherine, Fan, Saeed Bandar Al Ghamdi, Gabriela, Kaliska, Peter, Margitfalvi, Glenn, Meininger, Maria Grazia Bongiorni, Jeffrey, Luebbert, Michael, Pelini, Silvia, Misikova, Jerome, Kuhnlein, Robert, Schweikert, Jean-Manuel, Herzet, Stefano, Pedretti, Byron, Lee, Peter, Santucci, Jonas, Hörnsten, Samir, Saba, Evan, Adelstein, Stuart, Mendenhall, Ngai-Yin, Chan, Shabbar, Jamaly, Javier, Moreno, Tiziano, Moccetti, Paresh, Shah, John Douglas Pappas, Thomas, Blum, Etienne, Pruvot, Anthony, Chu, Chetan, Gangireddy, Joshua, Cooper, Walter, Chien, Ali, Al-Mugamgha, Matthew, Smelley, Heath, Saltzman, Arun, Kolli, William, Kostis, Sluja, Amardeep, Charles, Kennergren, Rajiv, Handa, Emmanuel, Simantirakis, Tony, Simmons, Randel, Smith, Marye, Gleva, George, N Theodorakis, Emad, Aziz, Scott, Burke, Kah Leng Ho, Carlo De Asmundis, Kenneth, Civello, Tan Vern Hsen, Darryl, Wells, Hüseyin, Ince, Sami, Pakarinen, Jodie, Hurwitz, Vinay, Mehta, Imra Zainal Abidin, Michael, Osayamen, Javier, Banchs, Kelly, Kim, Andrzej, Kutarski, João Manuel Frazão, Rodrigues de Sousa, Senthil, Tambidorai, James, Sandberg, Rubén, Aguayo, Darren, Traub, Siddarth, Mukerji, Rajesh, Venaktaraman, Ramesh, Hariharan, Saravanan, Krishinan, Jorge, Silvestre, Vladimir, Rankovic, University of Zurich, and Tarakji, Khaldoun G
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Male ,medicine.medical_specialty ,Pacemaker, Artificial ,Standard of care ,Prosthesis-Related Infections ,Heart Diseases ,Minocycline ,610 Medicine & health ,Kaplan-Meier Estimate ,2700 General Medicine ,030204 cardiovascular system & hematology ,11171 Cardiocentro Ticino ,03 medical and health sciences ,0302 clinical medicine ,Medicine ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Limited evidence ,Antibiotic prophylaxis ,Intensive care medicine ,Aged ,business.industry ,Incidence ,Standard of Care ,General Medicine ,Bacterial Infections ,Middle Aged ,Antibiotic Prophylaxis ,Defibrillators, Implantable ,Anti-Bacterial Agents ,Pacemaker ,Multicenter study ,Artificial ,Disease prevention ,Female ,Implantable ,Rifampin ,business ,Defibrillators - Abstract
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.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.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; P0.001 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).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.).
- Published
- 2019
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