Background: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). Methods: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. Results: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). Conclusions: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.
Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study / Giancarlo Accarino, Federico Accrocca, Giuseppe Alba, Antonino Alberti, Vittorio Alberti, Sara Allevi, Francesco Aloisi, Bruno Amato, Alessio Amico, Francesco Andreoli, Domenico Angiletta, Antonio Antico, Lorenzo Antico, Michele Antonello, Domenico Baccellieri, Giovanni Badalamenti, Gennaro Bafile, Claudio Baldi, Chiara Barillà, David Barillà, Stefano Bartoli, Giusi Basile, Giuseppe Battaglia, Cesare Battocchio, Ailin Belloni, Raffello Bellosta, Domenico Benevento, Giulia Bernardini, Giulia Bertagna, Luca Bertoglio, Claudio Bianchini Massoni, Daniel Bisacco, Michelangelo Bischetti, Luca Boccalon, Paolo Bonanno, Stefano Bonardelli, Raul Borioni, Maria P Borrelli, Antonio Bozzani, Umberto M Bracale, Stefano Camparini, Aldo Canciglia, Francesco Canova, Laura Capoccia, Alessandro Cappelli, Pierlugi Cappiello, Chiara Carluccio, Alfonso Casalino, Francesco Casella, Giulia Casilli, Claudio Castagno, Patrizio Castelli, Tommaso Castrucci, Matteo Cavallo, Carlo Cavazzini, Gianluca Ceccanei, Pietro Cefalì, Gianni Celoria, Mauro Cevolani, Roberto Chiappa, Emiliano Chisci, Carlo Comande, Rita Compagna, Andrea Cumino, Simone Cuozzo, Patrizia Dalla Caneva, Ilaria D'Alessio, Giuseppe D'Arrigo, Giovanni DE Caridi, Gianmarco DE Donato, Gabriele DE Donno, Claudio Desantis, Francesco DE Santis, Alessandro DE Troia, Tommaso Dezi, Domenico A Diaco, Rossella DI Domenico, Michele DI Filippo, Alessia DI Girolamo, Carlo P Dionisi, Ettore Dinoto, Francesco DI Stefano, Lucia DI Stefano, Mario D'Oria, Andrea Esposito, Davide Esposito, Ludovica Ettore, Gian F Fadda, Gianluca Faggioli, Aaron T Fargion, Stefano Fazzini, Nicoletta Fermani, Giulia Ferrante, Mauro Ferrari, Stafanio Ferraro, Ciro Ferrer, Luca Ferretto, Ilaria Ficarelli, Federico Filippi, Gianluigi Fino, Enzo Forliti, Martina Formiconi, Loris Flora, Mauro Fresilli, Paolo Frigatti, Dalmazio Frigerio, Alberto Froio, Antonio Freyrie, Sergio Furgiuele, Roberto Gabrielli, Andrea Gaggiano, Luca Galassi, Giuseppe Gallelli, Enrico Gallitto, Francesco Gallo, Giuseppe Galzerano, Mauro Gargiulo, Luca Garriboli, Genadi G Genadiev, Lucia Gentile, Alessia Giaquinta, Lorenzo Gibello, Raffaele Grande, Viviana Grassi, Arnaldo Ippoliti, Sandro Irsara, Andrea Kahlberg, Nikolakopoulos Konstantinos, Francesco LA Corte, Gaetano Lanza, Antonio Lauricella, Elisa Lazzeri, Massimo Lenti, Marco Leopardi, Sandro Lepidi, Andrea Li Destri, Federica Locatelli, Chiara Lomazzi, Francesco Lombardi, Antonio Lorido, Claudia Maggiore, Wassim Mansour, Vittorio Marcucci, Daniele Mascia, Mafalda Massara, Giovanni Mastrangelo, Costanza Margheritini, Gabriele Maritati, Eugenio Martelli, Ombretta Martinelli, Antonio Marzano, Francesca Mauri, Daniela Mazzacaro, Andrea Melloni, Roberto Mezzetti, Stefano Michelagnoli, Bruno Migliara, Mattia Migliari, Massimiliano Millarelli, Maria Misuraca, Pietro Modugno, Diego Moniaci, Nunzio Montelione, Andrea Monti, Nicola Monzio-Compagnoni, Mario Moro, Lorenzo Mortola, Gaddiel Mozzetta, Aldo Musilli, Giovanni Nano, Mariateresa Occhiuto, Fabio M Oddi, Bernardo Orellana, Paola Orlando, Matteo Orrico, Maria A Pacilè, Gabriele Pagliariccio, Cristina Pallini, Armando Palmieri, Martina Palughi, Marco Panagrasso, Claudia Panzano, Chiara Panzera, Francesco Pascucci, Rocco Pasqua, Leonardo Pasquetti, Eduardo Pasqui, Alberto Pecchio, Felice Pecoraro, Ilaria Peluttiero, Federico F Pennetta, Paolo Perini, Michele Piazza, Rodolfo Pini, Narayana Pipito, Chiara Pranteda, Barbara Praquin, Carlo Pratesi, Carlo F Porreca, Raffaele Pulli, Nicola Reina, Luigi F Rinaldi, Luigi Rizzo, Elisa Romano, Sonia Ronchey, Federica Ruggiero, Massimo Ruggiero, Marianna Sallustro, Gianna Saviane, Enrico Sbarigia, Paolo Scovazzi, Vittorio M Segramor, Giuseppe Sena, Carlo Setacci, Francesco Setacci, Carmen E Setteducati, Alberto M Settembrini, Andrea Siani, Simona Sica, Francesco Speziale, Francesco Squizzato, Nazzareno Stella, Francesco Stilo, Gemmi Sufali, Elisabetta Tanda, Giovanni Tinelli, Francesca Tomei, Filomena Tosti, Santi Trimarchi, Nicola Troisi, Yamume Tshomba, Davide Turchino, Valerio Turriziani, Alessandro Ucci, Vincenzo Veneto, Gianfranco Veraldi, Paola Wiesel, Andrea Xodo, Sergio Zacà, Francesco Zaraca, Glaudiol Zenunaj. - In: JOURNAL OF CARDIOVASCULAR SURGERY. - ISSN 0021-9509. - STAMPA. - (In corso di stampa), pp. 0-0.
Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study
Rossella DI Domenico;Aaron T FargionMembro del Collaboration Group
;Carlo Pratesi;Raffaele Pulli;
In corso di stampa
Abstract
Background: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). Methods: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. Results: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). Conclusions: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.
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