{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T15:36:51Z","timestamp":1788536211268,"version":"build-2803163510"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T00:00:00Z","timestamp":1700438400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T00:00:00Z","timestamp":1700438400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100010662","name":"H2020 Excellent Science","doi-asserted-by":"publisher","award":["101017523"],"award-info":[{"award-number":["101017523"]}],"id":[{"id":"10.13039\/100010662","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004913","name":"Universit\u00e0 degli Studi di Palermo","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004913","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cardiovasc Eng Tech"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat patients with severe aortic valve stenosis. However, there is limited knowledge on the material properties of the aortic root in TAVI patients, and this can impact the credibility of computer simulations. This study aimed to develop a non-invasive inverse approach for estimating reliable material constituents for the aortic root and calcified valve leaflets in patients undergoing TAVI. <\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The identification of material parameters is based on the simultaneous minimization of two cost functions, which define the difference between model predictions and cardiac-gated CT measurements of the aortic wall and valve orifice area. Validation of the inverse analysis output was performed comparing the numerical predictions with actual CT shapes and post-TAVI measures of implanted device diameter.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A good agreement of the peak systolic shape of the aortic wall was found between simulations and imaging, with similarity index in the range in the range of 83.7% to 91.5% for n.20 patients. Not any statistical difference was observed between predictions and CT measures of orifice area for the stenotic aortic valve. After TAVI simulations, the measurements of SAPIEN 3 Ultra (S3) device diameter were in agreement with those from post-TAVI angio-CT imaging. A sensitivity analysis demonstrated a modest impact on the S3 diameters when altering the elastic material property of the aortic wall in the range of inverse analysis solution.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Overall, this study demonstrates the feasibility and potential benefits of using non-invasive imaging techniques and computational modeling to estimate material properties in patients undergoing TAVI.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s13239-023-00699-7","type":"journal-article","created":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T21:03:09Z","timestamp":1700514189000},"page":"95-109","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["On the Material Constitutive Behavior of the Aortic Root in Patients with Transcatheter Aortic Valve Implantation"],"prefix":"10.1007","volume":"15","author":[{"given":"Chiara","family":"Catalano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahir","family":"Turgut","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Zahalka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nils","family":"G\u00f6tzen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Cannata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Gentile","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Agnese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Gandolfo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4841-2560","authenticated-orcid":false,"given":"Salvatore","family":"Pasta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,11,20]]},"reference":[{"issue":"21","key":"699_CR1","doi-asserted-by":"publisher","first-page":"1306","DOI":"10.1093\/eurheartj\/ehu388","volume":"36","author":"D Mylotte","year":"2015","unstructured":"Mylotte, D., A. Andalib, P. Theriault-Lauzier, M. Dorfmeister, M. Girgis, W. Alharbi, M. Chetrit, C. Galatas, S. Mamane, I. Sebag, J. Buithieu, L. Bilodeau, B. de Varennes, K. Lachapelle, R. Lange, G. Martucci, R. Virmani, and N. Piazza. Transcatheter heart valve failure: a systematic review. Eur. Heart J. 36(21):1306\u20131327, 2015. https:\/\/doi.org\/10.1093\/eurheartj\/ehu388.","journal-title":"Eur. Heart J."},{"issue":"11","key":"699_CR2","doi-asserted-by":"publisher","first-page":"2547","DOI":"10.1016\/j.jbiomech.2014.06.007","volume":"47","author":"S Morganti","year":"2014","unstructured":"Morganti, S., M. Conti, M. Aiello, A. Valentini, A. Mazzola, A. Reali, and F. Auricchio. Simulation of transcatheter aortic valve implantation through patient-specific finite element analysis: two clinical cases. J. Biomech. 47(11):2547\u20132555, 2014. https:\/\/doi.org\/10.1016\/j.jbiomech.2014.06.007.","journal-title":"J. Biomech."},{"issue":"12","key":"699_CR3","doi-asserted-by":"publisher","first-page":"2513","DOI":"10.1016\/j.jbiomech.2015.10.048","volume":"49","author":"S Morganti","year":"2016","unstructured":"Morganti, S., N. Brambilla, A. S. Petronio, A. Reali, F. Bedogni, and F. Auricchio. Prediction of patient-specific post-operative outcomes of TAVI procedure: The impact of the positioning strategy on valve performance. J Biomech. 49(12):2513\u20132519, 2016. https:\/\/doi.org\/10.1016\/j.jbiomech.2015.10.048.","journal-title":"J Biomech."},{"key":"699_CR4","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.27990","author":"J Brouwer","year":"2018","unstructured":"Brouwer, J., L. Gheorghe, V. J. Nijenhuis, J. M. Ten Berg, B. Rensing, J. A. S. van der Heyden, and M. J. Swaans. Insight on patient specific computer modeling of transcatheter aortic valve implantation in patients with bicuspid aortic valve disease. Catheter Cardiovasc. Interv. 2018. https:\/\/doi.org\/10.1002\/ccd.27990.","journal-title":"Catheter Cardiovasc. Interv."},{"issue":"3","key":"699_CR5","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1007\/s13239-019-00427-0","volume":"10","author":"G Luraghi","year":"2019","unstructured":"Luraghi, G., F. Migliavacca, A. Garc\u00eda-Gonz\u00e1lez, C. Chiastra, A. Rossi, D. Cao, G. Stefanini, and J. F. R. Matas. On the modeling of patient-specific transcatheter aortic valve replacement: a fluid\u2013structure interaction approach. Cardiovasc. Eng. Technol. 10(3):437\u2013455, 2019.","journal-title":"Cardiovasc. Eng. Technol."},{"key":"699_CR6","doi-asserted-by":"publisher","DOI":"10.1115\/1.4040457","author":"W Mao","year":"2018","unstructured":"Mao, W., Q. Wang, S. Kodali, and W. Sun. Numerical parametric study of paravalvular leak following a transcatheter aortic valve deployment into a patient-specific aortic root. J. Biomech. Eng. 2018. https:\/\/doi.org\/10.1115\/1.4040457.","journal-title":"J. Biomech. Eng."},{"key":"699_CR7","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1016\/j.ymeth.2020.01.011","volume":"185","author":"M Viceconti","year":"2021","unstructured":"Viceconti, M., F. Pappalardo, B. Rodriguez, M. Horner, J. Bischoff, and F. M. Tshinanu. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods. 185:120\u2013127, 2021.","journal-title":"Methods"},{"issue":"2","key":"699_CR8","doi-asserted-by":"publisher","first-page":"435","DOI":"10.1007\/s10237-018-1094-8","volume":"18","author":"M Bianchi","year":"2019","unstructured":"Bianchi, M., G. Marom, R. P. Ghosh, O. M. Rotman, P. Parikh, L. Gruberg, and D. Bluestein. Patient-specific simulation of transcatheter aortic valve replacement: impact of deployment options on paravalvular leakage. Biomech. Model. Mechanobiol. 18(2):435\u2013451, 2019. https:\/\/doi.org\/10.1007\/s10237-018-1094-8.","journal-title":"Biomech. Model. Mechanobiol."},{"key":"699_CR9","doi-asserted-by":"publisher","DOI":"10.1007\/s11517-020-02138-4","author":"S Pasta","year":"2020","unstructured":"Pasta, S., S. Cannata, G. Gentile, M. Di Giuseppe, F. Cosentino, F. Pasta, V. Agnese, D. Bellavia, G. M. Raffa, M. Pilato, and C. Gandolfo. Simulation study of transcatheter heart valve implantation in patients with stenotic bicuspid aortic valve. Med. Biol. Eng .Comput. 2020. https:\/\/doi.org\/10.1007\/s11517-020-02138-4.","journal-title":"Med. Biol. Eng .Comput."},{"issue":"1","key":"699_CR10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1038\/s41598-020-66899-6","volume":"10","author":"GM Bosi","year":"2020","unstructured":"Bosi, G. M., C. Capelli, M. H. Cheang, N. Delahunty, M. Mullen, A. M. Taylor, and S. Schievano. A validated computational framework to predict outcomes in TAVI. Sci. Rep. 10(1):1\u201311, 2020.","journal-title":"Sci. Rep."},{"issue":"9","key":"699_CR11","doi-asserted-by":"publisher","first-page":"952","DOI":"10.1016\/j.jcin.2021.01.042","volume":"14","author":"A Attinger-Toller","year":"2021","unstructured":"Attinger-Toller, A., E. Ferrari, D. Tueller, C. Templin, O. Muller, F. Nietlispach, S. Toggweiler, S. Noble, M. Roffi, R. Jeger, C. Huber, T. Carrel, T. Pilgrim, P. Wenaweser, M. Togni, S. Cook, D. Heg, S. Windecker, J. J. Goy, and S. Stortecky. Age-related outcomes after transcatheter aortic valve replacement. JACC Cardiovasc. Int. 14(9):952\u2013960, 2021. https:\/\/doi.org\/10.1016\/j.jcin.2021.01.042.","journal-title":"JACC Cardiovasc. Int."},{"key":"699_CR12","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1016\/j.jmbbm.2018.05.032","volume":"85","author":"M Peirlinck","year":"2018","unstructured":"Peirlinck, M., M. De Beule, P. Segers, and N. Rebelo. A modular inverse elastostatics approach to resolve the pressure-induced stress state for in vivo imaging based cardiovascular modeling. J. Mech. Behav. Biomed. Mater. 85:124\u2013133, 2018. https:\/\/doi.org\/10.1016\/j.jmbbm.2018.05.032.","journal-title":"J. Mech. Behav. Biomed. Mater."},{"key":"699_CR13","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1016\/j.compbiomed.2019.04.022","volume":"109","author":"F Cosentino","year":"2019","unstructured":"Cosentino, F., V. Agnese, G. M. Raffa, G. Gentile, D. Bellavia, M. Zingales, M. Pilato, and S. Pasta. On the role of material properties in ascending thoracic aortic aneurysms. Comput. Biol. Med. 109:70\u201378, 2019. https:\/\/doi.org\/10.1016\/j.compbiomed.2019.04.022.","journal-title":"Comput. Biol. Med."},{"key":"699_CR14","doi-asserted-by":"publisher","first-page":"148","DOI":"10.1016\/j.jmbbm.2017.05.001","volume":"72","author":"M Liu","year":"2017","unstructured":"Liu, M., L. Liang, and W. Sun. A new inverse method for estimation of in vivo mechanical properties of the aortic wall. J. Mech. Behav. Biomed. Mater. 72:148\u2013158, 2017. https:\/\/doi.org\/10.1016\/j.jmbbm.2017.05.001.","journal-title":"J. Mech. Behav. Biomed. Mater."},{"key":"699_CR15","doi-asserted-by":"publisher","DOI":"10.3390\/jpm10020028","author":"F Cosentino","year":"2020","unstructured":"Cosentino, F., G. M. Raffa, G. Gentile, V. Agnese, D. Bellavia, M. Pilato, and S. Pasta. Statistical shape analysis of ascending thoracic aortic aneurysm: correlation between shape and biomechanical descriptors. J. Pers. Med. 2020. https:\/\/doi.org\/10.3390\/jpm10020028.","journal-title":"J. Pers. Med."},{"issue":"8","key":"699_CR16","doi-asserted-by":"publisher","first-page":"906","DOI":"10.1016\/j.healun.2017.03.016","volume":"36","author":"F Scardulla","year":"2017","unstructured":"Scardulla, F., S. Pasta, L. D\u2019Acquisto, S. Sciacca, V. Agnese, C. Vergara, A. Quarteroni, F. Clemenza, D. Bellavia, and M. Pilato. Shear stress alterations in the celiac trunk of patients with a continuous-flow left ventricular assist device as shown by in-silico and in-vitro flow analyses. J. Heart Lung Transplant. 36(8):906\u2013913, 2017. https:\/\/doi.org\/10.1016\/j.healun.2017.03.016.","journal-title":"J. Heart Lung Transplant."},{"issue":"9","key":"699_CR17","doi-asserted-by":"publisher","first-page":"E92","DOI":"10.1111\/aor.12866","volume":"41","author":"S Pasta","year":"2017","unstructured":"Pasta, S., G. Gentile, G. M. Raffa, F. Scardulla, D. Bellavia, A. Luca, M. Pilato, and C. Scardulla. Three-dimensional parametric modeling of bicuspid aortopathy and comparison with computational flow predictions. Artif. Organs. 41(9):E92\u2013E102, 2017. https:\/\/doi.org\/10.1111\/aor.12866.","journal-title":"Artif. Organs"},{"key":"699_CR18","unstructured":"Catalano, C., O. Zahalka, T. Turgut, N. G\u00f6tzen, and S. Pasta. Verification and validation of transcatheter heart valve implantation in a virtual human cohort. 18th International Symposium on Computer Methods in Biomechanics and Biomedical Engineering, Paris, 2023."},{"key":"699_CR19","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1016\/j.yjmcc.2019.04.010","volume":"130","author":"M Di Giuseppe","year":"2019","unstructured":"Di Giuseppe, M., G. Alotta, V. Agnese, D. Bellavia, G. M. Raffa, V. Vetri, M. Zingales, S. Pasta, and M. Pilato. Identification of circumferential regional heterogeneity of ascending thoracic aneurysmal aorta by biaxial mechanical testing. J. Mol. Cell Cardiol. 130:205\u2013215, 2019. https:\/\/doi.org\/10.1016\/j.yjmcc.2019.04.010.","journal-title":"J. Mol. Cell Cardiol."},{"key":"699_CR20","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1016\/j.jbiomech.2018.02.017","volume":"71","author":"GM Bosi","year":"2018","unstructured":"Bosi, G. M., C. Capelli, M. H. Cheang, N. Delahunty, M. Mullen, A. M. Taylor, and S. Schievano. Population-specific material properties of the implantation site for transcatheter aortic valve replacement finite element simulations. J. Biomech. 71:236\u2013244, 2018.","journal-title":"J. Biomech."},{"issue":"7","key":"699_CR21","doi-asserted-by":"publisher","first-page":"733","DOI":"10.1080\/10255842.2015.1058928","volume":"19","author":"J Bailey","year":"2016","unstructured":"Bailey, J., N. Curzen, and N. W. Bressloff. Assessing the impact of including leaflets in the simulation of TAVI deployment into a patient-specific aortic root. Comput. Methods Biomech. Biomed. Eng. 19(7):733\u2013744, 2016. https:\/\/doi.org\/10.1080\/10255842.2015.1058928.","journal-title":"Comput. Methods Biomech. Biomed. Eng."},{"key":"699_CR22","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1016\/j.jbiomech.2018.05.020","volume":"76","author":"M Abbasi","year":"2018","unstructured":"Abbasi, M., D. Qiu, Y. Behnam, D. Dvir, C. Clary, and A. N. Azadani. High resolution three-dimensional strain mapping of bioprosthetic heart valves using digital image correlation. J. Biomech. 76:27\u201334, 2018. https:\/\/doi.org\/10.1016\/j.jbiomech.2018.05.020.","journal-title":"J. Biomech."},{"key":"699_CR23","doi-asserted-by":"publisher","DOI":"10.1016\/j.bprint.2023.e00285","volume":"32","author":"C Catalano","year":"2023","unstructured":"Catalano, C., S. Cannata, V. Agnese, G. Gentile, C. Gandolfo, and S. Pasta. On the spectrum of transcatheter mitral valve replacement: In silico and in vitro assessment of neo-LVOT area in ViR, ViV and ViMAC. Bioprinting.32:e00285, 2023.","journal-title":"Bioprinting."},{"issue":"1","key":"699_CR24","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1007\/s10439-015-1374-8","volume":"44","author":"O Trabelsi","year":"2016","unstructured":"Trabelsi, O., A. Duprey, J. P. Favre, and S. Avril. Predictive models with patient specific material properties for the biomechanical behavior of ascending thoracic aneurysms. Ann. Biomed. Eng. 44(1):84\u201398, 2016. https:\/\/doi.org\/10.1007\/s10439-015-1374-8.","journal-title":"Ann. Biomed. Eng."},{"key":"699_CR25","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1016\/j.jmbbm.2013.03.014","volume":"27","author":"A Wittek","year":"2013","unstructured":"Wittek, A., K. Karatolios, P. Bihari, T. Schmitz-Rixen, R. Moosdorf, S. Vogt, and C. Blase. In vivo determination of elastic properties of the human aorta based on 4D ultrasound data. J. Mech. Behav. Biomed. Mater. 27:167\u2013183, 2013. https:\/\/doi.org\/10.1016\/j.jmbbm.2013.03.014.","journal-title":"J. Mech. Behav. Biomed. Mater."},{"issue":"1","key":"699_CR26","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1583\/11-3456.1","volume":"19","author":"AP Tierney","year":"2012","unstructured":"Tierney, A. P., A. Callanan, and T. M. McGloughlin. Use of regional mechanical properties of abdominal aortic aneurysms to advance finite element modeling of rupture risk. J. Endovasc. Ther. 19(1):100\u2013114, 2012. https:\/\/doi.org\/10.1583\/11-3456.1.","journal-title":"J. Endovasc. Ther."},{"issue":"1","key":"699_CR27","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1016\/j.athoracsur.2011.08.002","volume":"93","author":"AN Azadani","year":"2012","unstructured":"Azadani, A. N., S. Chitsaz, P. B. Matthews, N. Jaussaud, J. Leung, T. Tsinman, L. Ge, and E. E. Tseng. Comparison of mechanical properties of human ascending aorta and aortic sinuses. Ann. Thorac. Surg. 93(1):87\u201394, 2012. https:\/\/doi.org\/10.1016\/j.athoracsur.2011.08.002.","journal-title":"Ann. Thorac. Surg."},{"issue":"1","key":"699_CR28","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1016\/j.ejcts.2010.08.056","volume":"40","author":"C Martin","year":"2011","unstructured":"Martin, C., T. Pham, and W. Sun. Significant differences in the material properties between aged human and porcine aortic tissues. Eur. J. Cardiothorac. Surg. 40(1):28\u201334, 2011. https:\/\/doi.org\/10.1016\/j.ejcts.2010.08.056.","journal-title":"Eur. J. Cardiothorac. Surg."},{"issue":"5","key":"699_CR29","doi-asserted-by":"publisher","first-page":"735","DOI":"10.1007\/s13239-022-00614-6","volume":"13","author":"NW Bressloff","year":"2022","unstructured":"Bressloff, N. W. Leaflet stresses during full device simulation of crimping to 6 mm in transcatheter aortic valve implantation, TAVI. Cardiovasc. Eng. Technol. 13(5):735\u2013750, 2022. https:\/\/doi.org\/10.1007\/s13239-022-00614-6.","journal-title":"Cardiovasc. Eng. Technol."}],"container-title":["Cardiovascular Engineering and Technology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13239-023-00699-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s13239-023-00699-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s13239-023-00699-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T21:29:32Z","timestamp":1708637372000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s13239-023-00699-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,20]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["699"],"URL":"https:\/\/doi.org\/10.1007\/s13239-023-00699-7","relation":{},"ISSN":["1869-408X","1869-4098"],"issn-type":[{"value":"1869-408X","type":"print"},{"value":"1869-4098","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,20]]},"assertion":[{"value":"13 May 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 November 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 November 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was approved by the IRCCS ISMETT Ethics Committee (approval no. IRRB04\/04). All participants provided written informed consent prior to enrolment in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval and Consent to Participate"}},{"value":"All authors were fully involved in the study and preparation of the manuscript which contribution originality can be confirmed by members of ISMETT and the University of Palermo. All authors approve the submission.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}}]}}