Antibacterial Envelope to Prevent Cardiac Implantable Device Infection
Khaldoun G Tarakji, Suneet Mittal, Charles Kennergren, Ralph Corey, Jeanne E Poole, Edward Schloss, Jose Gallastegui, Robert A Pickett, Rudolph Evonich, François Philippon, Janet M McComb, Steven F Roark, Denise Sorrentino, Darius Sholevar, Edmond Cronin, Brett Berman, David Riggio, Mauro Biffi, Hafiza Khan, Marc T Silver, Jack Collier, Zayd Eldadah, David J Wright, Jeff D Lande, Daniel R Lexcen, Alan Cheng, Bruce L Wilkoff, WRAP-IT Investigators, 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, Luca Bontempi, 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, Khaldoun G Tarakji, Suneet Mittal, Charles Kennergren, Ralph Corey, Jeanne E Poole, Edward Schloss, Jose Gallastegui, Robert A Pickett, Rudolph Evonich, François Philippon, Janet M McComb, Steven F Roark, Denise Sorrentino, Darius Sholevar, Edmond Cronin, Brett Berman, David Riggio, Mauro Biffi, Hafiza Khan, Marc T Silver, Jack Collier, Zayd Eldadah, David J Wright, Jeff D Lande, Daniel R Lexcen, Alan Cheng, Bruce L Wilkoff, WRAP-IT Investigators, 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, Luca Bontempi, 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
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.).
Copyright © 2019 Massachusetts Medical Society.
Source: PubMed