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1. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial

Author

Melanie Meersch, Mira Küllmar, Carola Wempe, Alexander Zarbock, Ke Peng, Sigismond Lasocki, Thomas Rimmele, Maria Martin, Olivier Desebbe, Michele Rossi, Matthias Heringlake, Christina Massoth, Raphael Weiss, Andreas Höhn, Gael Pradel, Ana Kowark, Ahmed mohamed Ibrahim, Orestis Ioannidis, Andrea Cortegiani, Maxime Leger, Emmanuel Rineau, Pierre-Yves Egreteau, Andrea Russo, Laura Kerschke, Savino Spadaro, Carole Ichai, Vincent Cottenceau, Sebastian Ziemann, Maria Gomez, Julien Nadaud, Olivier Pérus, Philippe Magazzeni, Philippe Montravers, Deniz Karakaya, Christophe Aveline, Alexander Bentley, Tulay Ozkan Seyhan, Jean-François Pittet, Sébastien Ponsonnard, Pierre Garcon, Ana Serrano, Gulay Ok, Pierre Vautier, Jean François Gautier, Sergi Sabaté, Yusuf Tunali, Valérie Cerro, Stephanie Suria, Khaschayar Saadat-Gilani, Hichem Makhloufi, Anis Cherak, Lamine Lakhel Ghanem, Zohier Gouaglia, Dina Nasrine Guadouri, Fayrouz Naouel Hama, Mustafa Kara, Omayma Saadi, Rachida Sakhraoui, Fadila Bourou, Abdelhadi Cherifi, Rahmoune Ghania Sadaoui, Amel Ouyahia, Ilhem Ouahab, Souad Bouaoud, Meriem Abdoun, Anisse Tidjane, Benali Tabeti, Nabil Boudjenan-Serradj, Carlos Jose Pérez Rivera, Paulo Cabrer, Julián Corso, Juan Pablo García, Sharon Idarraga, Christopher Montoya, Rafael Figueroa, Eduar Aldana, María Alejandra Torrado, Zheng-min Ma, Yu-fan Yang, Ya-juan Zhu, Peter Sklienka, Michal Frelich, Vojtech Jarkulis, Pavel Sevcik, Vojtech Vodicka, Mohamed Gamal Elbahnasawy, Shady Elsalhawy, Sara Motawea, Zeinab Othman, Mohamed Sahma, Ahmed Mahmoud Nafea, Nermin Ahmed, Doaa Ali Attia, Moataz Maher Emara, Mohamed Mamdouh Bonna, Mohamed Ahmed Gabr, Amany Ismail Tarbay, Ibrahim Abdelmonaem Abdehaleem, Esraa Elsayed Mohamed, Amr Mahmoud Eldeeb, Ahmed Mohamed Abbas, John Ashraf Magdy, Zyad Hassan Hamed, Hany Mostafa Esmaeil Osman, Mostafa Samy Abbas, Oliver Joannes-Boyau, Nicolas Barraud, Corentin Berthelot, Thibault Camus, Anissa Dahmi, Mylène Defaye, Sébastien Derville, Younes El-Boustani, Elsa Deloge, Hélène Jacob, Simon Monziols, Fred Priem, Jean-Jacques Robin, Vincent Legros, Therry Floch, Salvatore Muccio, Claire Geneve, Marie Lim Legouge, Stéphanie Tao Mauny, Willy Mfam, Léa Pascot, Mireille Chartier, Benjamin Duteurtre, Aidren Le Cousin, Nathalie Begel, Claire-Annissa Chekirine, Vincent Derlon, Elodie Grein, Marie-Annick Lehair, Laurent Magazzeni, Carsten Potter, Catherine Roth, Florence Voivret, Jamil Elmawieh, Annabelle Stoclin, Cédric Cirenei, Gregoire Andrieu, Sven Couloumy, Jeremy Falcone, Marion Fajardy, Arsène Gagneuil, Emeline Girardet, Agnès Mazereeuw, Mélanie Bertel, Simon Bocher, Vanessa Carn, Lenaïg Le Guen, Guillaume Le Loup, Montaine Lefevre, Amanita Diop, Vanessa Jean-Michel, Sylvie Devlieger, Juliette Duthoit, Mohamed El Kadiri, Viviane Cassisa, Charline Masson, Pierre Verrier, Axel Coquerel, Enora Atchade, Charles-Edouard Rochon, Céline Delerue, Vidal Quentin, Vanessa Latry, Nina Queixalos, Thierry Braun, Saad Bouzoubaa, Basile Christ, Audrey Geiger, Joachim Gomille, Vianney Kieffer, Simone Mangeant, Christelle Prochilo, Christian Schmitt, Stefan Skwirba, Hubert Grand, Frédérique Boury, Nicolas Mayeur, Marie Pasquie, Vincent Bruckert, Vincent Arnould, Mona Bonciu, Thibault Chapelle, Luc Facchino, Florence Fagot-Gandet, Andrea Iachim, Elena Mannu, Rémi Plattier, Romain Rozier, Michel Boudinaud, Marie-Hélène Hausermann, My Hue Nguyen, Andersen Ramorasata, Amélie Barreau, Anne-Hélène Boivin, Céline Ravry, Nicolas Mottard, Johanne Beuvelot, Florence Prunier Bossion, Christian Dörr, Thilo Caspar von Groote, Linda Grüßer, Pia Wittig, Timo Brandenburger, Thomas Dimski, Niklas Döhmen, Laura Huthmann, Daniela Kaierle, Claude Pelletier, Manon Schleß, Sebastian Cleophas, Stephanie Haunhorst, Marina Jansen, Alexandra Schmitt, Julia Soisch, Kilian Sturm, Peter Rosenberger, Alexander Bendig, Lena Flohr, Helene Häberle, Pascal Hofmann, Jonathan Kuhle, Nora Michaela Leser, Kathrin Pfister, Stefanie Prohaska, Franziska Sennholz, Lena Stetz, Kathrin Weber, Sebastian Stehr, Stephan Klaus, Marco Sadlo, Matthias Boschin, Christian Sengelhoff, Ulrich Michael Göbel, Jan Gerrit Haaker, Carina-Kristin Göttker, Matthias Gründel, Romina Baumgärtel, Astrid Berggren, Madeleine Gülzow, Lennart Muras, Hauke Paarmann, Serge Thal, Dschamil El-Masri, Eleni Arnaoutoglou, Maria Ntalouka, Paula Stratigopoulou, Anastasia Analytis, Efthymios Mavrommatis, Petros Tzimas, Agathi Karakosta, Danai Pantazi, Antonia Dimakopoulou, Katerina Dimitropoulou, Humam Jalaawiy, Aeshah Anwar, Hashim Talib Hashim, Hogir Imad Rasheed Aldawoody, Giulia Catalisano, Gilia Ingoglia, Mariachiara Ippolito, Silvia De Rosa, Lucia Cattin, Andrea Bianchin, Marisa Barone, Gianluca Paternoster, Salvatore Lucio Cutuli, Liliana Sollazzi, Laura Cascarano, Massimo Antonelli, Paola Aceto, Bruno Romanò, Vincenzo Francesco Tripodi, Rosamaria Scappatura, Maria Cristina Vadalà, Diego Fiume, Maria Teresa Strano, Giulia Oddo, Clemente Santorsola, Bilal Abu Hussain, Adnan Raed Alnaser, Anas Hassouneh Ghassan, Khaled Hasanein, Mohammed Theab, Seokyung Shin, Seungho Jung, Kyuho Lee, Sung Mee Jung, Jongyoon Baek, Muhammed K. Elhadi, Issa Abuzeid, Mohammed Albaraesi, Sarah Aldressi, Wegdan Khalel, Eman Abdulwahed, Akram Abdulhamid Ashur Abujrad, Amer Almaghrabi, Muhand Mohammed Alteleeb, Entisar Ahmed Ali Alshareea, Marwa Isa Biala, Abdulqudus Deeknah, Dooua Ali Gheddim, Reem Ghmagh, Nawras Salih Ali AbuIkhrays, Marwa Sinan, Enas Soula, Sumayyah Ghayth Bahroun, Khawla Derwish, Aya Munir Mohamed, Eman Sayed Younes, Rayet Al Islam Benjouira, Mohamed Aliwa, Najwa Abdullah Altashani, Mohammed Omar Alteb, Ahmed Msherghi, Fatima Alagelli, Sufyan Albarouni, Ahmed Albishti, Sarah Aljamal, Mohamed Alsori, Taha Ekhuja, Suha Elzwai, Mohammed Ghula, Tahani Mustafa, Ahmed Tuwaib, Haifa Zriba, Hamza Mahmoud Agilla, Toky Andriamahefa Rafanomezantsoa, Anne Marie Camilleri Podesta, Denise Mifsud Bonnici, Tiziana Pirotta, Gilberto Adrián Gasca López, Maja Mojsova Mijovska, Tatjana Davitkovska, Aleksandra Gavrilovska, Sanja Lukikj, Marija Vesova, Dina Zafirova, Sarah Amro, Baraa N. F. Hajjaj, Muawia Alkhazendar, Yousuf Barakat, Sewar Abdulaziz Elejla, Ahmed Elhissi, Ahmed Khader, Ali Salem, Rita de Freitas Regufe, André Filipe de Oliveira Eloy, Lisbete Marisa Neto Cordeiro Perdigão, Evgeny Grigoriev, Artem Ivkin, Roman Kornelyuk, Michael Yaroustovsky, Marina Abramyan, Ekaterina Komardina, Nataliya Lesteva, Medina Aybazova, Elmira Kumykova, Svetlana Lesina, Gennady Rybakov, Alexey Shestov, Abdulnaser Ahmad Ahmad Barmou, Bushra Lotfi Altayeb Ahmed, Aisha Mohammad Eliyas, Yousra Emadeldin, Alexander Kaserer, Clara Castellucci, Julian Rössler, Samira Akbas, Andreja Möller Petrun, Irena Gregorcic, Vesna Sok, Roman Čičak, Elizabeth Bárcena, Antonio Guisado, Ismail Wi, Javier Ripollés Melchor, Ángel Becerra-Bolaños, Sergio Cabrera-Doreste, Ancor Domínguez-Arbelo, María Candelaria Delgado-Alonso, Virginia Muiño-Palomar, Aurelio Rodríguez-Pérez, Javier Mata Estévez, Maria Begona Covas Munoz, Juan Mulet Matas, Sara Perez Palao, Maria Dolores Mira Quirós, Alisia Cezara Teslev, Mercedes Garcia Alvarez, Marga Argilaga, María Campos, Albert Bainac, Astrid Batalla, Marta Giné, Gracia Herránz, Ignacio Hinojal, Margarita Logroño Ejea, Noelia de la Rosa Ruiz, María Gastaca Abasolo, Carla Rosario Houhton Acuna, Ibai Iriarte Zaranton, Ana Mendigurenmurua, María José Munoz Sanz, Erika Olea de la Fuente, María Pilar Pérez Vaquero, Ana Soto Iglesias, Ana Ugarte Mieres, Alaitz Urtiaga Urrestizala, Lourdes Ferreira, Félix Lobato, Marta Aguado Sevilla, Andres Erazo, Pere Miró, Diana Vernetta, Berta Castellano Paulis, Anabel Adell Perez, Marta Aseguinolaza Pagola, Elena delVal Peciña, Ainhoa Garmendia Odriozola, Amaia Lopetegi Aizpurua, Olatz Pavón Piquer, Pilar Plou Garcia, Paula Ortega Rezola, Antia Osorio Lopez, Isabel de la Calle Gil, Rosalía Navarro Casado, Peter Adamove, Roser Bayona Domenge, Francho Miguel Blasco Blasco, Adriana Alexandra Rueda Villamizar, Maria Antonia Perelló Llaneras, Jose Ignacio García-Sánchez, Laura Fernandez Téllez, Sara García Zamorano, Natalia Gijón Herreros, Andrea Rodriguez Esteve, Pablo Monedero Rodríguez, Isabel García Trigo, Agustín Alcaraz, Andrea Lara Jiménez, Iñigo Rubio, Nuria García, Raquel Callejas, Angel Manuel Candela Toha, Eli Claros, Pilar Cobeta, Pascual Crespo, Trini Dorado, Elena Elías, Javier Felices, Diego Gil, Nuria Mané, Adolfo Martínez, Lucía Pereira, Alberto Balvis Noemí Samaranch, Carlos Tiscar, Judith VillaHoz, Patricia Galán Menéndez, Elena Cardona, Anna Conesa, Veronica Estepa, Laura Llinares Espí, Yuri Loaiza Aldeán, Susana Manrique, Víctor Morales Ariza, Laura Villarino Villa, Elfayadh Saidahmed Mohamed Amed Suliman, Hytham Hamid, Modather Mohamed Saeed, Orhan Sungur Mukadder, Demet Altun, Nur Canbolat, Müşerref Beril Dinçer, Serap Aktaş Yıldırım, Müzeyyen İyigün, Davut Yapıcı, Levent Özdemir, Aslinur Sagun, Neval Boztug, Yesim Cetintas, Bora Dinc, Emel Gündüz, Hakkı Ünlügenç, Demet Lafli Tunay, Ozgur Komurcu, Özlem Korkmaz Dilmen, Eren Fatma Akcil, Eda Tok Alsina, Özge Hakli, Cengiz Polat, Namigar Turgut, Nurcan Kızılcık, Özge Köner, Öznur Şen, Nurdan Aydin, Burcu Basaran, Emre Sertac Bingul, Kamil Darcin, Semra Ugur, Kemal Tolga Saracoglu, Asli Demir, Özgök Aysegül, Eda Balci, Behic Girgin, Aygun Guler, Ümit Karadeniz, Nihal Özaslan, Yigit Özay Hülya, Namik Ozcan, Aysun Postaci, Mehmet Sahap, Nevriye Salman, Özlem Sağır, Bulent Atik, Murat Bicakcioglu, Hafize Fisun Demir, Ugün Fatih, Nazan Kocaoglu, Hüseyin ilksen Toprak, Duygu Demiröz Aslan, Yusuf Ziya Colak, Mustafa Soner Ozcan, Mehmet Yilmaz, Umran Karaca, Sevtap Hekimoglu Sahin, Özlem Ersoy Karka, Gizem Demir Şenoğlu, Süheyla Erkoç Karadağ, Neslihan Alkis, Volkan Baytaş, Engin Erturk, Ali Akdogan, Ahmet Besir, Dilek Kutanis, Sedat Saylan, Ersagun Tugcugil, Pinar Ayvat, Berrin Günaydın, Beyza Mehri Büyükgebiz, Omer Faruk Boran, Feyza Calisir, Yavuz Orak, Bahar Kuvaki Balkan, Sibel Büyükcoban, Erol Gökel, Sakize Ferim Günenc, Sule Özbilgin, Suna Göre, Selcan Akesen, Seda Cansabuncu, Natalia Momot, Anna Panchenko, and Kristen Rutledge

Subjects
Medicine
Abstract

Introduction More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI.Methods and analysis EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI.Ethics and dissemination EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials.Trial registration number NCT04165369.

Published
2021
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2. Comparable clinical course between coagulase-negative staphylococcal and Staphylococcus aureus endocarditis

Author

Marie Bourget, Marie Pasquie, Hélène Charbonneau, and Eric Bonnet

Subjects
Microbiology (medical), Coagulase, Staphylococcus aureus, Infectious Diseases, Endocarditis, Staphylococcus, Humans, General Medicine, Endocarditis, Bacterial, Staphylococcal Infections, Retrospective Studies
Abstract

Staphylococcus aureus (SA) is involved in almost one-third of endocarditis events (known as E-SA) and is frequently associated with unfavorable outcomes compared to infectious endocarditis (IE) caused by other pathogens including coagulase-negative staphylococci (CNS). The aim of this study was to compare the morbidity and mortality of patients with E-SA and endocarditis due to CNS (known as E-CNS).A monocentric retrospective cohort analysis was conducted including all patients admitted with IE from January 2010 to December 2017. Lengths of stay, complications, in-hospital and 1-year mortality were described from medical records and compared between E-SA and E-CNS.Among the 428 patients included, 102 had staphylococcus (50 E-SA and 52 E-CNS). Half of the IE events due to staphylococcus occurred in the year following a cardiac procedure [p = 0.029]. A septic embolism occurred in 41% and 48% of patients with E-CNS and E-SA, respectively [p = 0.439]. Cardiac surgery was indicated in 50% of E-SA and 48% of E-CNS cases [p = 0.846]. The intra-hospital and 1-year mortality rates were 25% and 31% for E-CNS and 34% and 45% for E-SA [p = 0.699, p = 0.234].Embolic complications, surgical management rate and mortality rates of E-SA and E-CNS were comparable, which may suggest a similar morbidity and mortality irrespective of the pathogen involved in IE.

Published
2021

3. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial

Author

Weiss, Raphael, Saadat-Gilani, Khaschayar, Kerschke, Laura, Wempe, Carola, Meersch, Melanie, Zarbock, Alexander Hichem Makhloufi, Anis, Cherak, Lamine Lakhel Ghanem, Zohier, Gouaglia, Dina Nasrine Guadouri, Fayrouz Naouel Hama, Mustafa, Kara, Omayma, Saadi, Rachida, Sakhraoui, Fadila, Bourou, Abdelhadi, Cherifi, Rahmoune Ghania Sadaoui, Amel, Ouyahia, Ilhem, Ouahab, Souad, Bouaoud, Meriem, Abdoun, Anisse, Tidjane, Benali, Tabeti, Nabil, Boudjenan-Serradj, Carlos Jose Pérez Rivera, Paulo, Cabrer, Julián, Corso, Juan Pablo García, Sharon, Idarraga, Christopher, Montoya, Rafael, Figueroa, Eduar, Aldana, María Alejandra Torrado, Peng, Ke, Zheng-Min, Ma, Yu-Fan, Yang, Ya-Juan, Zhu, Peter, Sklienka, Michal, Frelich, Vojtech, Jarkulis, Pavel, Sevcik, Vojtech, Vodicka, Mohamed Gamal Elbahnasawy, Shady, Elsalhawy, Sara, Motawea, Zeinab, Othman, Mohamed, Sahma, Ahmed Mahmoud Nafea, Nermin, Ahmed, Doaa Ali Attia, Moataz Maher Emara, Mohamed Mamdouh Bonna, Mohamed Ahmed Gabr, Amany Ismail Tarbay, Ibrahim Abdelmonaem Abdehaleem, Esraa Elsayed Mohamed, Amr Mahmoud Eldeeb, Ahmed Mohamed Abbas, John Ashraf Magdy, Zyad Hassan Hamed, Hany Mostafa Esmaeil Osman, Mostafa Samy Abbas, Oliver, Joannes-Boyau, Nicolas, Barraud, Corentin, Berthelot, Thibault, Camus, Anissa, Dahmi, Mylène, Defaye, Sébastien, Derville, Younes, El-Boustani, Elsa, Deloge, Hélène, Jacob, Simon, Monziols, Fred, Priem, Jean-Jacques, Robin, Vincent, Legros, Therry, Floch, Salvatore, Muccio, Claire, Geneve, Marie Lim Legouge, Stéphanie Tao Mauny, Willy, Mfam, Léa, Pascot, Christophe, Aveline, Mireille, Chartier, Benjamin, Duteurtre, Jean Francois Gautier, Aidren Le Cousin, Pierre, Vautier, Julien, Nadaud, Nathalie, Begel, Claire-Annissa, Chekirine, Vincent, Derlon, Elodie, Grein, Marie-Annick, Lehair, Laurent, Magazzeni, Philippe, Magazzeni, Carsten, Potter, Catherine, Roth, Florence, Voivret, Thomas, Rimmelé, Valérie, Cerro, Stéphanie, Suria, Jamil, Elmawieh, Annabelle, Stoclin, Cédric, Cirenei, Gregoire, Andrieu, Sven, Couloumy, Jeremy, Falcone, Marion, Fajardy, Arsène, Gagneuil, Emeline, Girardet, Agnès, Mazereeuw, Sébastien, Ponsonnard, Pierre-Yves, Egreteau, Mélanie, Bertel, Simon, Bocher, Vanessa, Carn, Lenaïg Le Guen, Guillaume Le Loup, Montaine, Lefevre, Carole, Ichai, Amanita, Diop, Vanessa, Jean-Michel, Sylvie, Devlieger, Juliette, Duthoit, Mohamed El Kadiri, Maxime, Léger, Viviane, Cassisa, Sigismond, Lasocki, Charline, Masson, Emmanuel, Rineau, Pierre, Verrier, Axel, Coquerel, Philippe, Montravers, Enora, Atchade, Charles-Edouard, Rochon, Céline, Delerue, Vidal, Quentin, Vanessa, Latry, Nina, Queixalos, Vincent, Cottenceau, Thierry, Braun, Saad, Bouzoubaa, Basile, Christ, Audrey, Geiger, Joachim, Gomille, Vianney, Kieffer, Simone, Mangeant, Christelle, Prochilo, Christian, Schmitt, Stefan, Skwirba, Hubert, Grand, Frédérique, Boury, Nicolas, Mayeur, Marie, Pasquie, Pierre, Garçon, Vincent, Bruckert, Vincent, Arnould, Mona, Bonciu, Thibault, Chapelle, Luc, Facchino, Florence, Fagot-Gandet, Andrea, Iachim, Elena, Mannu, Olivier, Perus, Rémi, Plattier, Romain, Rozier, Gaël, Pradel, Michel, Boudinaud, Marie-Hélène, Hausermann, My Hue Nguyen, Andersen, Ramorasata, Amélie, Barreau, Anne-Hélène, Boivin, Céline, Ravry, Nicolas, Mottard, Johanne, Beuvelot, Florence Prunier Bossion, Olivier, Desebbe, Alexander, Zarbock, Christian, Dörr, Thilo Caspar von Groote, Mira, Küllmar, Christina, Massoth, Melanie, Meersch, Khaschayar, Saadat-Gilani, Raphael, Weiss, Carola, Wempe, Sebastian, Ziemann, Linda, Grüßer, Ana, Kowark, Pia, Wittig, Timo, Brandenburger, Thomas, Dimski, Niklas, Döhmen, Laura, Huthmann, Daniela, Kaierle, Claude, Pelletier, Manon, Schleß, Andreas, Hohn, Sebastian, Cleophas, Stephanie, Haunhorst, Marina, Jansen, Alexandra, Schmitt, Julia, Soisch, Kilian, Sturm, Peter, Rosenberger, Alexander, Bendig, Lena, Flohr, Helene, Häberle, Pascal, Hofmann, Jonathan, Kuhle, Nora Michaela Leser, Kathrin, Pfister, Stefanie, Prohaska, Franziska, Sennholz, Lena, Stetz, Kathrin, Weber, Sebastian, Stehr, Stephan, Klaus, Marco, Sadlo, Matthias, Boschin, Christian, Sengelhoff, Ulrich Michael Göbel, Jan Gerrit Haaker, Carina-Kristin, Göttker, Matthias, Gründel, Matthias, Heringlake, Romina, Baumgärtel, Astrid, Berggren, Madeleine, Gülzow, Lennart, Muras, Hauke, Paarmann, Serge, Thal, Alexander, Bentley, Dschamil, El-Masri, Anne, Sebastiani, Eleni, Arnaoutoglou, Maria, Ntalouka, Paula, Stratigopoulou, Anastasia, Analytis, Efthymios, Mavrommatis, Petros, Tzimas, Agathi, Karakosta, Danai, Pantazi, Antonia, Dimakopoulou, Katerina, Dimitropoulou, Orestis, Ioannidis, Humam, Jalaawiy, Aeshah, Anwar, Hashim Talib Hashim, Hogir Imad Rasheed Aldawoody, Andrea, Cortegiani, Giulia, Catalisano, Gilia, Ingoglia, Mariachiara, Ippolito, De Rosa, Silvia, Lucia, Cattin, Andrea, Bianchin, Marisa, Barone, Gianluca, Paternoster, Salvatore Lucio Cutuli, Andrea, Russo, Liliana, Sollazzi, Laura, Cascarano, Massimo, Antonelli, Paola, Aceto, Bruno, Romanò, Savino, Spadaro, Vincenzo Francesco Tripodi, Michele, Rossi, Rosamaria, Scappatura, Maria Cristina Vadalà, Diego, Fiume, Maria Teresa Strano, Giulia, Oddo, Clemente, Santorsola, Bilal Abu Hussain, Adnan Raed Alnaser, Anas Hassouneh Ghassan, Khaled, Hasanein, Mohammed, Theab, Seokyung, Shin, Seungho, Jung, Kyuho, Lee, Sung Mee Jung, Jongyoon, Baek, Muhammed, K Elhadi, Issa, Abuzeid, Mohammed, Albaraesi, Sarah, Aldressi, Wegdan, Khalel, Eman, Abdulwahed, Akram Abdulhamid Ashur Abujrad, Amer, Almaghrabi, Muhand Mohammed Alteleeb, Entisar Ahmed Ali Alshareea, Marwa Isa Biala, Abdulqudus, Deeknah, Dooua Ali Gheddim, Reem, Ghmagh, Nawras Salih Ali AbuIkhrays, Marwa, Sinan, Enas, Soula, Sumayyah Ghayth Bahroun, Khawla, Derwish, Aya Munir Mohamed, Eman Sayed Younes, Rayet Al Islam Benjouira, Mohamed, Aliwa, Najwa Abdullah Altashani, Mohammed Omar Alteb, Ahmed, Msherghi, Fatima, Alagelli, Sufyan, Albarouni, Ahmed, Albishti, Sarah, Aljamal, Mohamed, Alsori, Taha, Ekhuja, Suha, Elzwai, Mohammed, Ghula, Tahani, Mustafa, Ahmed, Tuwaib, Haifa, Zriba, Hamza Mahmoud Agilla, Toky Andriamahefa Rafanomezantsoa, Anne Marie Camilleri Podesta, Denise Mifsud Bonnici, Tiziana, Pirotta, Gilberto Adrián Gasca López, Maja Mojsova Mijovska, Tatjana, Davitkovska, Aleksandra, Gavrilovska, Sanja, Lukikj, Marija, Vesova, Dina, Zafirova, Sarah, Amro, Baraa N, F Hajjaj, Muawia, Alkhazendar, Yousuf, Barakat, Sewar Abdulaziz Elejla, Ahmed, Elhissi, Ahmed, Khader, Ali, Salem, Rita de Freitas Regufe, André Filipe de Oliveira Eloy, Lisbete Marisa Neto Cordeiro Perdigão, Evgeny, Grigoriev, Artem, Ivkin, Roman, Kornelyuk, Michael, Yaroustovsky, Marina, Abramyan, Ekaterina, Komardina, Nataliya, Lesteva, Medina, Aybazova, Elmira, Kumykova, Svetlana, Lesina, Gennady, Rybakov, Alexey, Shestov, Abdulnaser Ahmad Ahmad Barmou, Bushra Lotfi Altayeb Ahmed, Aisha Mohammad Eliyas, Yousra, Emadeldin, Alexander, Kaserer, Clara, Castellucci, Julian, Rössler, Samira, Akbas, Andreja Möller Petrun, Irena, Gregorcic, Vesna, Sok, Roman, Čičak, Elizabeth, Bárcena, Antonio, Guisado, Ismail, Wi, Javier Ripollés Melchor, Ángel, Becerra-Bolaños, Sergio, Cabrera-Doreste, Ancor, Domínguez-Arbelo, María Candelaria Delgado-Alonso, Virginia, Muiño-Palomar, Aurelio, Rodríguez-Pérez, Javier Mata Estévez, Maria Begona Covas Munoz, Juan Mulet Matas, Sara Perez Palao, Maria Dolores Mira Quirós, Alisia Cezara Teslev, Mercedes Garcia Alvarez, Marga, Argilaga, María, Campos, Albert, Bainac, Astrid, Batalla, Marta, Giné, Gracia, Herránz, Ignacio, Hinojal, Margarita Logroño Ejea, Noelia de la Rosa Ruiz, María Gastaca Abasolo, Carla Rosario Houhton Acuna, Ibai Iriarte Zaranton, Ana, Mendigurenmurua, María José Munoz Sanz, Erika Olea de la Fuente, María Pilar Pérez Vaquero, Ana Soto Iglesias, Ana Ugarte Mieres, Alaitz Urtiaga Urrestizala, Lourdes, Ferreira, Félix, Lobato, Marta Aguado Sevilla, Andres, Erazo, Pere, Miró, Sergi, Sabaté, Diana, Vernetta, Berta Castellano Paulis, Anabel Adell Perez, Marta Aseguinolaza Pagola, Elena delVal Peciña, Ainhoa Garmendia Odriozola, Amaia Lopetegi Aizpurua, Olatz Pavón Piquer, Pilar Plou Garcia, Paula Ortega Rezola, Antia Osorio Lopez, Isabel de la Calle Gil, Rosalía Navarro Casado, Peter, Adamove, Roser Bayona Domenge, Francho Miguel Blasco Blasco, Adriana Alexandra Rueda Villamizar, Maria Antonia Perelló Llaneras, Jose Ignacio García-Sánchez, Laura Fernandez Téllez, Sara García Zamorano, Natalia Gijón Herreros, Andrea Rodriguez Esteve, Pablo Monedero Rodríguez, Isabel García Trigo, Agustín, Alcaraz, Andrea Lara Jiménez, Iñigo, Rubio, Nuria, García, Raquel, Callejas, Angel Manuel Candela Toha, Eli, Claros, Pilar, Cobeta, Pascual, Crespo, Trini, Dorado, Elena, Elías, Javier, Felices, Diego, Gil, María, Gómez, Nuria, Mané, María, Martín, Adolfo, Martínez, Lucía, Pereira, Alberto Balvis Noemí Samaranch, Ana, Serrano, Carlos, Tiscar, Judith, Villahoz, Patricia Galán Menéndez, Elena, Cardona, Anna, Conesa, Veronica, Estepa, Patricia, Galán, Laura Llinares Espí, Yuri Loaiza Aldeán, Susana, Manrique, Víctor Morales Ariza, Laura Villarino Villa, Elfayadh Saidahmed Mohamed Amed Suliman, Hytham, Hamid, Ahmed Mohamed Ibrahim, Modather Mohamed Saeed, Orhan Sungur Mukadder, Demet, Altun, Nur, Canbolat, Müşerref Beril Dinçer, Tulay Özkan Seyhan, Serap Aktaş Yıldırım, Müzeyyen, İyigün, Davut, Yapıcı, Levent, Özdemir, Aslinur, Sagun, Neval, Boztug, Yesim, Cetintas, Bora, Dinc, Emel, Gündüz, Hakkı, Ünlügenç, Demet Lafli Tunay, Deniz, Karakaya, Burhan, Dost, Ozgur, Komurcu, Özlem Korkmaz Dilmen, Eren Fatma Akcil, Yusuf, Tunali, Gülay, Ok, Eda Tok Alsina, Özge, Hakli, Cengiz, Polat, Namigar, Turgut, Nurcan, Kızılcık, Özge, Köner, Öznur, Şen, Nurdan, Aydin, Burcu, Basaran, Emre Sertac Bingul, Yavuz, Gürkan, Kamil, Darcin, Semra, Ugur, Kemal Tolga Saracoglu, Asli, Demir, Özgök, Aysegül, Eda, Balci, Behic, Girgin, Aygun, Guler, Ümit, Karadeniz, Nihal, Özaslan, Yigit Özay Hülya, Namik, Ozcan, Aysun, Postaci, Mehmet, Sahap, Nevriye, Salman, Özlem, Sağır, Bulent, Atik, Murat, Bicakcioglu, Hafize Fisun Demir, Ugün, Fatih, Nazan, Kocaoglu, Hüseyin Ilksen Toprak, Duygu Demiröz Aslan, Yusuf Ziya Colak, Mustafa Soner Ozcan, Mehmet, Yilmaz, Umran, Karaca, Sevtap Hekimoglu Sahin, Özlem Ersoy Karka, Gizem Demir Şenoğlu, Süheyla Erkoç Karadağ, Neslihan, Alkis, Volkan, Baytaş, Engin, Erturk, Ali, Akdogan, Ahmet, Besir, Dilek, Kutanis, Sedat, Saylan, Ersagun, Tugcugil, Pinar, Ayvat, Berrin, Günaydın, Beyza Mehri Büyükgebiz, Omer Faruk Boran, Feyza, Calisir, Yavuz, Orak, Bahar Kuvaki Balkan, Sibel, Büyükcoban, Erol, Gökel, Sakize Ferim Günenc, Sule, Özbilgin, Suna, Göre, Selcan, Akesen, Seda, Cansabuncu, Natalia, Momot, Anna, Panchenko, Jean-Francois, Pittet, Kristen, Rutledge, Tıp Fakültesi, Weiss, R, Saadat-Gilani, K, Kerschke,L, Wempe,C, Meersch, M, Zarbock, A, Cortegiani, A, and Ippolito, M

Subjects
Epidemiology, urologic and male genital diseases, acute renal failure, Adult Intensive & Critical Care, Anaesthesia, Cohort Studies, surgery, chronic renal failure, Humans, Multicenter Studies as Topic, Prospective Studies, adult intensive & critical care, urogenital system, Incidence, General Medicine, Acute Kidney Injury, female genital diseases and pregnancy complications, critical care, Renal Replacement Therapy, Observational Studies as Topic, epidemiology, Acute Renal Failure, Surgery, adult intensive &amp, Chronic Renal Failure
Abstract

Sağır, Özlem (Balikesir Author), Introduction More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI. Methods and analysis EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI. Ethics and dissemination EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials. Trial registration number NCT04165369. ©

Published
2021

4. Patient blood management in elective bypass cardiac surgery: A 2-step single-centre interventional trial to analyse the impact of an educational programme and erythropoiesis stimulation on red blood cell transfusion

Author

Jean Marc Ferradou, Madeleine Croute-Bayle, Pierre Brunel, Laurent Mallet, Olivier Garcia, Laurence Taillefer, Nicolas Mayeur, Jean François Quedreux, Olivier Vahdat, Marie Pasquie, Mimoun M'rini, Yves Jansou, Gérard Autones, Olivier Anglès, Benoit Richard, Philippe Soula, Anne Laure Berthelot, Valérie Julien, Marc Bousquet, Issam Abouliatim, Hélène Charbonneau, Pierre Berthoumieu, David Duterque, Claude Breil, Nicolas Savy, Yannick Gabiache, Isabelle Decramer, and Laurent Sidobre

Subjects
medicine.medical_specialty, Blood management, medicine.medical_treatment, Psychological intervention, Anaemia, Red blood cell transfusion, Article, Group B, 03 medical and health sciences, 0302 clinical medicine, Medicine, 030212 general & internal medicine, Erythropoietin, Pharmacology, lcsh:R5-920, Rehabilitation, business.industry, Iron deficiency, General Medicine, Perioperative, Cardiac surgery, medicine.disease, Emergency medicine, business, lcsh:Medicine (General), 030217 neurology & neurosurgery, medicine.drug
Abstract

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery. This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation. The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. Trials registrations ClinicalTrials.gov, NCT04040023: registered 29 July 2019.

Published
2020

5. Preoperative plasma fibrinogen level and transfusion in cardiac surgery: a biphasic correlation

Author

Hélène Charbonneau, Nicolas Mayeur, and Marie Pasquie

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Coronary Disease, 030204 cardiovascular system & hematology, Postoperative Hemorrhage, Fibrinogen, Preoperative care, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Risk factor, Cardiac Surgical Procedures, Aged, Retrospective Studies, business.industry, Retrospective cohort study, Perioperative, Middle Aged, Cardiac surgery, Red blood cell, medicine.anatomical_structure, 030228 respiratory system, Anesthesia, Surgery, Female, Cardiology and Cardiovascular Medicine, Complication, business, Erythrocyte Transfusion, medicine.drug
Abstract

Coagulopathic bleeding is a serious complication of cardiac surgery. A very low preoperative plasma fibrinogen level (PFL) has been previously described as a risk factor for red blood cell (RBC) transfusion in the perioperative setting. Nevertheless, contradictory results have been published concerning preoperative fibrinogen infusion to decrease RBC transfusion. These results highlight the need for a better description of the relation between preoperative PFL and RBC transfusion. In this single-centre retrospective study, we showed that both high and low PFLs are associated with an increase in RBC transfusion. A pro-inflammatory preoperative status could be involved in the association between high PFL and the increase in RBC transfusion. This non-linear relation between PFL and RBC transfusion could explain the difficulty of decreasing postoperative bleeding using only an algorithm aimed at increasing preoperative PFL.

Published
2020

6. Comparison between open simple prostatectomy and green laser enucleation of the prostate for treating large benign prostatic hyperplasia: a single-centre experience

Author

Benjamin Elman, Benoit Bordier, Kevin C. Zorn, Vincent Misrai, Marie Pasquie, Jean Michel Lhez, and Julien Guillotreau

Subjects
Male, Nephrology, Comparative Effectiveness Research, medicine.medical_specialty, Urology, medicine.medical_treatment, Operative Time, Enucleation, Prostatic Hyperplasia, 030232 urology & nephrology, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Prostate, Internal medicine, medicine, Humans, Aged, Prostatectomy, Green laser, business.industry, Transurethral Resection of Prostate, Organ Size, Perioperative, Length of Stay, Middle Aged, Hyperplasia, medicine.disease, Surgery, Outcome and Process Assessment, Health Care, medicine.anatomical_structure, 030220 oncology & carcinogenesis, France, Laser Therapy, business, Cohort study
Abstract

This study sought to compare perioperative outcomes and morbidities for open simple prostatectomy (OSP) and endoscopic green laser enucleation of the prostate (GreenLEP). In a single department, all consecutive patients who underwent OSP between January 2005 and December 2010 were retrospectively reviewed, and all consecutive patients undergoing GreenLEP between July 2013 and January 2017 were prospectively enrolled. Perioperative data, information regarding early postoperative complications for up to 6 months and outcomes were collected and retrospectively compared. Overall, 204 patients were enrolled in each group. The baseline characteristics of patients in both groups were comparable. Intraoperative time was significantly longer for the OSP group than for the GreenLEP group (67 versus 60 min; p

Published
2018
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7. First open label study to investigate the use, safety and tolerability of octaplaslg® in patient blood management in two cardiac surgery centres in France

Author

Nicolas Mayeur, J.-F. Charbonnel, C. Cornillot, A. Aouifi, J.-C. Crave, Marie Pasquie, E. Lapeyre, Hélène Charbonneau, A. Martel, and V. Frebault

Subjects
medicine.medical_specialty, Blood management, business.industry, medicine.disease, Intensive care unit, law.invention, Cardiac surgery, Anesthesiology and Pain Medicine, Tolerability, law, Blood product, Anesthesia, medicine, Fresh frozen plasma, Cardiology and Cardiovascular Medicine, Adverse effect, business, Transfusion-related acute lung injury
Abstract

Introduction Fresh Frozen Plasma (FFP) is used to correct haemostatic function after cardiac surgery with cardio-pulmonary bypass (CPB). As a blood product, availability of FFP can be challenging. OctaplasLG®, a solvent/detergent (SD) treated and pooled human plasma, has been recently introduced in France. As a drug, it is delivered by hospital pharmacists. The main objective of this study was to describe the use of OctaplasLG® infusion in cardiac surgery patients. Feasibility, safety and drug tolerability of OctaplasLG® were assessed by monitoring Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs) like allergic reaction, transfusion related acute lung injury (TRALI) events or transmitted transfusion diseases during 24 hours following each administration. Methods This observational and prospective study was conducted in 2 main French cardiac surgery centres from 27-Feb-2019 to 24-Feb-2020. All patients included in this study received OctaplasLG® because of abnormal peri-operative blood loss or haemostatic disorders in the peri-operative settings of cardio-vascular surgery. Data collected and analysed were demographic characteristic of patients, indications modalities, efficacy and safety outcomes of OctaplasLG® infusions. Results 99 adult patients were included, mean age 68.9 ± 11.6 years (67% male). OctaplasLG® indications were coagulopathy (70 %) and moderate haemorrhage (30%). OctaplasLG® was used 70% in the operating room and 30% in the intensive care unit (ICU). Cardiac surgery with CPB was performed in 83 patients. Infusion was done through a central venous line in 80% of patients. Emergency level of infusion was defined by physicians as immediate vital emergency, vital emergency, relative emergency and planned intervention for 24%, 38%, 32% and 5% respectively. Mean ± SD total dose of OctaplasLG® infused per patient was 2.9 ± 1.7 units (median 3 units of 200 ml). In addition to OctaplasLG®, patients received red blood cells (52%), platelets (37%) and fibrinogen concentrate (44%). No ADRs was reported during the 24h follow-up period. Six SAE were reported but not related to OctaplasLG®, 5 of which had a fatal outcome. OctaplasLG® infusion was evaluated as successful in 97 % of cases by investigators. Discussion Cardiac surgery is associated with a substantial risk of bleeding, frequently requiring the administration of FFP. In this descriptive study, the use of OctaplasLG®, a SD treated plasma, as a new drug for haemostatic disorders following cardio-vascular surgery seems feasible, readily available, safe and effective.

Published
2020
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9. Accuracy of the preoperative PSA level for predicting clinically significant incidental transitional zone-prostate cancer before endoscopic enucleation of very large adenoma

Author

Julien Guillotreau, Kevin C. Zorn, Eric Bruguière, Alexandre Gryn, Vincent Misrai, Morgan Rouprêt, Benjamin Pradere, Benoit Bordier, Marie Pasquie, and Julien Palasse

Subjects
Nephrology, Male, medicine.medical_specialty, Adenoma, Urology, Enucleation, 030232 urology & nephrology, Prostatic Hyperplasia, urologic and male genital diseases, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Prostate, Predictive Value of Tests, Internal medicine, medicine, Humans, Aged, Retrospective Studies, Incidental Findings, business.industry, Prostatic Neoplasms, Reproducibility of Results, Endoscopy, Perioperative, Middle Aged, Prostate-Specific Antigen, medicine.disease, Patient counselling, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Preoperative Period, Kallikreins, Prostatic obstruction, business
Abstract

To analyse the accuracy of high preoperative PSA levels for predicting transitional zone incidental PCa (TZ-PCa) in men with very large prostates.Perioperative data from 375 consecutive patients who underwent endoscopic enucleation of the prostate (EEP) for benign prostatic obstruction between July 2013 and December 2018 were retrospectively reviewed. Patients were stratified into three groups according to the preoperative PSA level: low-PSA ( 4 ng/mL), intermediate-PSA (4 ≤ PSA 10 ng/mL) and high-PSA (≥ 10 ng/mL). Men in each group were propensity score matched by age, 5α-reductase inhibitor (5-ARI) use, prostate volume and mpMRI. The TZ-PCa incidence rate was retrospectively compared by preoperative PSA level in a propensity score model including all predetermined variables.Age, prostate volume, 5-ARI use were similar between patient groups. The median PSA levels in the low-, intermediate- and high-PSA groups were 3 [2.3; 3.4], 6.6 [5.3; 8.1] and 12.7 [11; 16.7] ng/mL, respectively. The median prostate volume was 100 grams in all groups (108, 105 and 120 cc, respectively). The T1a-Gleason 6 incidental TZ-PCa rate was statistically comparable between the three groups (3.4, 5.1 and 8.6% in the low-, intermediate- and high-PSA groups, respectively). The detection rate of clinically significant TZ-PCa was low for preoperative PSA levels 4 ng/mL (1.7%); with no difference between the intermediate- and high-PSA groups.In men with large glands, the clinically significant incidental TZ-PCa detection rate was similar regardless of the preoperative PSA level stratum. Such details may help with patient counselling during BPH surgical management.

Published
2019

10. The surgical learning curve for endoscopic GreenLight™ laser enucleation of the prostate: An international multicentre study

Author

M. Rouprêt, Sébastien Vincendeau, Benoit Peyronnet, Benjamin Pradere, Fernando Gomez-Sancha, Shahin Tabatabaei, Zine-Eddine Khene, Romain Mathieu, Marie Pasquie, Giovanni Ferrari, A. Gasmi, R. Huet, Enrique Rijo, and Vincent Misrai

Subjects
Male, medicine.medical_specialty, Urology, Enucleation, 030232 urology & nephrology, lcsh:RC870-923, lcsh:RC254-282, 03 medical and health sciences, 0302 clinical medicine, Case mix index, Prostate, medicine, Humans, Aged, Retrospective Studies, Prostatectomy, business.industry, Retrospective cohort study, Endoscopy, Perioperative, Middle Aged, lcsh:Diseases of the genitourinary system. Urology, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Surgery, Treatment Outcome, medicine.anatomical_structure, Greenlight laser, Learning curve, 030220 oncology & carcinogenesis, International Prostate Symptom Score, Laser Therapy, business, Learning Curve
Abstract

OBJECTIVES To investigate the effect of surgical experience on the perioperative outcomes of endoscopic GreenLight™ (Boston Scientific Corporation, Marlborough, MA, USA) laser enucleation of the prostate (GreenLEP). SUBJECTS/PATIENTS AND METHODS A multicentre retrospective study of the first patients treated with GreenLEP by six surgeons was conducted. For each patient, surgical experience was coded as the total number of procedures performed by the surgeons before the patient's operation. The learning curve was analysed in terms of changes over time for the following variables: enucleation time, morcellation time, occurrence of intraoperative complications (IOCs), 3-month postoperative International Prostate Symptom Score (IPSS) reduction, and the rate of Pentafecta achievement. RESULTS In total, 922 patients were analysed. At multivariable regression analyses adjusted for case mix, surgical experience was associated with shorter enucleation and morcellation time (P

Published
2020
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11. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial

Author

L. Corbel, Emmanuel Della Negra, Abdel-Rahmène Azzouzi, Marie Pasquie, Sébastien Vincendeau, Valerie Fuzier, Franck Bruyère, Benoit Peyronnet, Benjamin Pradere, Atul Pathak, Georges Fournier, Aurélien Descazeaud, Thibaut Culty, Hélène Charbonneau, Pierre Albaladejo, Gilles Karsenty, C. Thuillier, Audrey Hesbois, Gaelle Fiard, Jean-Luc Descotes, Souhil Lebdai, C. Ballereau, Nicolas Savy, Nicolas Barry-Delongchamps, J. Calves, Vincent Misrai, Romain Mathieu, Pierre Colin, Charles Marc Samama, Felipe Guerrero, Jean-Alexandre Long, Clinique Pasteur [Toulouse], Service d'urologie [Rennes] = Urology [Rennes], Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service d'urologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Privé des Côtes d'Armor (HPCA), Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Gestes Medico-chirurgicaux Assistés par Ordinateur (TIMC-IMAG-GMCAO), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019])-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service d'urologie [CHU Grenoble], Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'urologie [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Laboratoire d'Annecy de Physique des Particules (LAPP), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry])-Centre National de la Recherche Scientifique (CNRS), Institut de Mathématiques de Toulouse UMR5219 (IMT), Université Toulouse Capitole (UT Capitole), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Université de Toulouse (UT)-Institut National des Sciences Appliquées (INSA)-Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Centre National de la Recherche Scientifique (CNRS), Techniques pour l'Evaluation et la Modélisation des Actions de la Santé (TIMC-IMAG-ThEMAS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS), CHU Toulouse [Toulouse], Service d'urologie [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre National de la Recherche Scientifique (CNRS)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA), Université Toulouse 1 Capitole (UT1), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Université Fédérale Toulouse Midi-Pyrénées-Institut National des Sciences Appliquées (INSA)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10

Subjects
Male, medicine.medical_specialty, Time Factors, Complications, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Prostatic Hyperplasia, 030232 urology & nephrology, Oral anticoagulation, Administration, Oral, Medicine (miscellaneous), Laser, Equivalence Trials as Topic, Drug Administration Schedule, law.invention, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Lower Urinary Tract Symptoms, Randomized controlled trial, law, Prostate, Lower urinary tract symptoms, medicine, Humans, Multicenter Studies as Topic, Pharmacology (medical), Transurethral resection of the prostate, lcsh:R5-920, business.industry, Anticoagulants, GreenLight, Perioperative, Evidence-based medicine, Heparin, medicine.disease, Confidence interval, 3. Good health, Surgery, Treatment Outcome, medicine.anatomical_structure, 030220 oncology & carcinogenesis, France, Laser Therapy, Benign prostatic obstruction, lcsh:Medicine (General), business, medicine.drug
Abstract

Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score

Published
2018
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12. Does mechanical morcellation of large glands compromise incidental prostate cancer detection on specimen analysis? A pathological comparison with open simple prostatectomy

Author

Nathalie Rioux-Leclercq, Romain Mathieu, Vincent Misrai, Benoit Bordier, Marie Pasquie, Virginie Guillotreau, Sébastien Kerever, Sébastien Vincendeau, Enrique Rijo, Eva-Maria Compérat, Julien Guillotreau, Benoit Peyronnet, R. Huet, Julien Palasse, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )

Subjects
Nephrology, Male, medicine.medical_specialty, Histology, Urethral Obstruction, Urology, medicine.medical_treatment, Enucleation, 030232 urology & nephrology, Prostatic Hyperplasia, [SDV.CAN]Life Sciences [q-bio]/Cancer, Morcellation, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Prostate, Internal medicine, medicine, Humans, Pathological, ComputingMilieux_MISCELLANEOUS, Aged, Neoplasm Staging, Prostatectomy, Incidental Findings, business.industry, Transurethral Resection of Prostate, Prostatic Neoplasms, Middle Aged, medicine.disease, Prostate-specific antigen, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Propensity score matching, Laser Therapy, Benign prostatic obstruction, business
Abstract

This study sought to compare the incidental prostate cancer (iPCa) detection rate between pathological specimens from green laser enucleation of the prostate (GreenLEP) and open simple prostatectomy (OSP). In two institutions, the charts of all consecutive patients who underwent OSP between January 2005 and December 2010 were retrospectively reviewed, and the data of all consecutive patients who underwent GreenLEP with tissue morcellation between July 2013 and January 2018 were also collected. Preoperative demographics and pathological findings were recorded. iPCa detection rate was retrospectively compared between the GreenLEP and OSP groups in a propensity score model, including all predetermined variables: Age, preoperative PSA level and prostate volume. Of 738 patients, 402 were included in the propensity-score matching analysis, and they were equally distributed among groups. The overall iPCa detection rates were similar in both groups (9.9% vs. 8.5%; p = 0.73), and there were no statistically significant differences in terms of tumour stage, Gleason score or the rate of clinically significant iPCa, although the number of cassettes analysed was significantly higher in the morcellation group than in the OSP group. No predictive factors for iPCa were identified. The results of the present study suggest that the mechanical morcellation of large glands had no influence on iPCa detection. Compared with a specimen from standard OSP, a large morcellated tissue sample allows adequate pathological evaluation and does not alter a pathologist’s ability to detect iPCa.

Published
2018
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13. MP73-02 COMPARISON OF OUTCOMES OBTAINED AFTER LIVE OPERATIVE SURGICAL CASES VERSUS REGULAR SURGERY. A SINGLE-CENTRE EXPERIENCE WITH GREEN LASER ENUCLEATION OF THE PROSTATE

Author

Vincent Misrai, Thomas R. W. Herrmann, Benoit Peyronnet, Henry H. Woo, Marie Pasquie, Benoit Bordier, Julien Guillotreau, and Fernando Gomez-Sancha

Subjects
medicine.medical_specialty, Single centre, medicine.anatomical_structure, Green laser, Prostate, business.industry, Urology, Enucleation, medicine, business, Surgery
Published
2018
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14. MP62-13 COMPARISON BETWEEN OPEN SIMPLE PROSTATECTOMY AND GREEN LASER ENUCLEATION OF THE PROSTATE FOR TREATING LARGE BENIGN PROSTATIC HYPERPLASIA: A SINGLE-CENTRE EXPERIENCE

Author

Vincent Misrai, Marie Pasquie, Kevin C. Zorn, Benoit Bordier, Julien Guillotreau, and Benoit Peyronnet

Subjects
medicine.medical_specialty, business.industry, Prostatectomy, Green laser, Urology, medicine.medical_treatment, Enucleation, Hyperplasia, medicine.disease, Single centre, medicine.anatomical_structure, Prostate, Simple (abstract algebra), Medicine, business
Published
2018
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15. Comparison of Outcomes Obtained After Regular Surgery Versus Live Operative Surgical Cases: Single-centre Experience with Green Laser Enucleation of the Prostate

Author

Henry H. Woo, Marie Pasquie, Cyrille Guillot-Tantay, Julien Guillotreau, Fernando Gomez-Sancha, Thomas R. W. Herrmann, Vincent Misrai, and Benoit Bordier

Subjects
Male, medicine.medical_specialty, Teaching Materials, Urology, Enucleation, 030232 urology & nephrology, Prostatic Hyperplasia, Education, 03 medical and health sciences, Patient safety, 0302 clinical medicine, Prostate, medicine, Humans, Aged, Prostatectomy, business.industry, Green laser, Teaching, Perioperative, Surgical training, Surgery, Single centre, medicine.anatomical_structure, Treatment Outcome, 030220 oncology & carcinogenesis, Baseline characteristics, Laser Therapy, business
Abstract

Background Live surgery remains controversial. Although it may improve surgical training and accelerate the dissemination of technical steps of surgical procedures, controversy exists regarding patient safety in live surgery. Objective To compare the perioperative outcomes of "en bloc" green laser enucleation of the prostate (GreenLEP) performed in workshops during live case demonstration (LCD) and in standard conditions (SCs). Design, setting, and participants Between June 2015 and January 2017, all consecutive patients who underwent GreenLEP for benign prostatic obstruction performed by a single surgeon were prospectively enrolled. Perioperative data and early postoperative complications according to Clavien–Dindo classification were collected. Workshop programmes started locally according to the European Association of Urology policy on live surgical events in June 2015 to enrol small groups of urologists in the GreenLEP technique. Intervention Endoscopic enucleation of the prostate using a GreenLight fibre. Outcome measurements and statistical analysis Outcomes were compared between the LCD and SC groups. Results and limitations Of the 126 performed procedures, 37 were performed live during 17 LCDs with a median attendee number of 3. The patients' baseline characteristics were similar in both groups. Intraoperative parameters were comparable: total energy of 62 [53; 77] versus 56kJ [44; 69] ( p =0.068), operative time of 61 [53; 71] versus 55min [45; 66] ( p =0.1), and morcellating time of 3 [3; 5] versus 4min [2; 6] ( p =0.82) in the LCD versus SC group. The catheterisation time (2d [1; 2]) and length of hospital stay (2d [2; 3]) were similar. The overall complication rate was comparable in the LCD (18.9%) and SC (24.7%) groups ( p =0.64). Preoperative parameters significantly improved from baseline without any significant differences between the two groups. Limitations included a small number of attendees/workshop, and case selections were made by the surgeon himself. Conclusions GreenLEP was safe and provided satisfactory functional outcomes in both conditions. From this preliminary study, it seems that LCD did not jeopardise the surgeon's skill or technique. Similar studies are required to further assess patient safety and outcomes associated with live surgical events. Patient summary According to the surgeon expertise, endoscopic enucleation of the prostate performed during live case demonstration provided similar functional outcomes to that performed in standard condition and could therefore be considered a safe potential educational tool.

Published
2017

17. Patient blood management in elective bypass cardiac surgery: A 2-step single-centre interventional trial to analyse the impact of an educational programme and erythropoiesis stimulation on red blood cell transfusion

Author

Hélène Charbonneau, Marie Pasquié, Pierre Berthoumieu, Nicolas Savy, Gérard Autones, Olivier Anglès, Anne Laure Berthelot, Madeleine Croute-Bayle, Isabelle Decramer, David Duterque, Yannick Gabiache, Valérie Julien, Laurent Mallet, Mimoun M'rini, Jean François Quedreux, Benoit Richard, Laurent Sidobre, Laurence Taillefer, Philippe Soula, Olivier Garcia, Issam Abouliatim, Olivier Vahdat, Marc Bousquet, Jean Marc Ferradou, Yves Jansou, Pierre Brunel, Claude Breil, and Nicolas Mayeur

Subjects
Red blood cell transfusion, Anaemia, Iron deficiency, Erythropoietin, Cardiac surgery, Medicine (General), R5-920
Abstract

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery.This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation.The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. Trials registrations: ClinicalTrials.gov, NCT04040023: registered 29 July 2019.

Published
2020
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18. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial

Author

Hélène Charbonneau, Marie Pasquié, Benoit Peyronnet, Aurélien Descazeaud, Nicolas Barry-Delongchamps, Emmanuel Della Negra, Romain Mathieu, Gilles Karsenty, Jean-Alexandre Long, Charles Ballereau, Abdel-Rahmène Azzouzi, Benjamin Pradère, Franck Bruyère, Georges Fournier, Souhil Lebdai, Jehanne Calves, Luc Corbel, Sébastien Vincendeau, Gaelle Fiard, Caroline Thuillier, Jean-Luc Descotes, Pierre Colin, Thibaut Culty, Audrey Hesbois, Valerie Fuzier, Nicolas Savy, Atul Pathak, Pierre Albaladejo, Charles Marc Samama, Felipe Guerrero, and Vincent Misraï

Subjects
Benign prostatic obstruction, GreenLight, Laser, Oral anticoagulation, Complications, Medicine (General), R5-920
Abstract

Abstract Background Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. Methods This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score

Published
2018
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