{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T01:31:27Z","timestamp":1793496687071,"version":"4.5.0"},"reference-count":24,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"21","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2020,11,3]]},"abstract":"<jats:sec xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Transcatheter aortic valve replacement (TAVR) requires large\u2010bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              This large\u2010scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30\u00a0days and 1\u2010year follow\u2010up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65\u20130.99];\n              <jats:italic>P<\/jats:italic>\n              =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58\u20130.98];\n              <jats:italic>P<\/jats:italic>\n              =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow\u2010up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72\u20131.10];\n              <jats:italic>P<\/jats:italic>\n              =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively;\n              <jats:italic>P<\/jats:italic>\n              =0.001).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short\u2010term, driven by lower bleeding complications.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Registration Information<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">clini\u200bcaltr\u200bials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT02713932.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.120.018042","type":"journal-article","created":{"date-parts":[[2020,10,24]],"date-time":"2020-10-24T09:17:12Z","timestamp":1603531032000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":47,"title":["Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry"],"prefix":"10.1161","volume":"9","author":[{"given":"Sergio","family":"Berti","sequence":"first","affiliation":[{"name":"Department of Diagnostic and Interventional Cardiology Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital Massa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Bedogni","sequence":"additional","affiliation":[{"name":"Department of Clinical and Interventional Cardiology IRCCS Policlinico San Donato Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arturo","family":"Giordano","sequence":"additional","affiliation":[{"name":"Unit\u00e0 Operativa di Interventistica Cardiovascolare Pineta Grande Hospital Castel Volturno Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna S.","family":"Petronio","sequence":"additional","affiliation":[{"name":"Department of Cardiology Azienda Ospedaliero\u2010Universitaria Pisana Pisa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6435-1155","authenticated-orcid":false,"given":"Alessandro","family":"Iadanza","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte Siena Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio L.","family":"Bartorelli","sequence":"additional","affiliation":[{"name":"Centro Monzino IRCCS and Department of Biomedical and Clinical Sciences \u201cLuigi Sacco\u201d University of Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Reimers","sequence":"additional","affiliation":[{"name":"Cardio Center Humanitas Research Hospital IRCCS Rozzano\u2010Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Spaccarotella","sequence":"additional","affiliation":[{"name":"Division of Cardiology CCU and Interventional Cardiology Cardiovascular Research Center University Magna Graecia Catanzaro Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Trani","sequence":"additional","affiliation":[{"name":"Institute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS Universit\u00e0 Cattolica del Sacro Cuore Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiziana","family":"Attisano","sequence":"additional","affiliation":[{"name":"Cardiologia Interventistica Dipartimento Cardio Toraco Vascolare AOU S. Giovanni di Dio e Ruggi D\u2019Aragona Salerno Italt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Marella Cenname","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario A. Gemelli IRCCS Universit\u00e0 Cattolica del Sacro Cuore Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gennaro","family":"Sardella","sequence":"additional","affiliation":[{"name":"Department of Cardiology Policlinico \"Umberto I\" Sapienza University of Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Bonmassari","sequence":"additional","affiliation":[{"name":"Department of Cardiology S. Chiara Hospital Trento Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Medda","sequence":"additional","affiliation":[{"name":"Istituto Clinico Sant\u2019Ambrogio, Gruppo San Donato Milano Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Tomai","sequence":"additional","affiliation":[{"name":"Division of Cardiology European Hospital Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5055-2917","authenticated-orcid":false,"given":"Giuseppe","family":"Tarantini","sequence":"additional","affiliation":[{"name":"A.O. Policlinico Universitario di Padova, Centro Gallucci Padova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2355-4589","authenticated-orcid":false,"given":"Eliano P.","family":"Navarese","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Internal Medicine Interventional Cardiology and Cardiovascular Medicine Research Nicolaus Copernicus University Bydgoszcz Poland"},{"name":"Faculty of Medicine University of Alberta Edmonton Canada"},{"name":"SIRIO MEDICINE Research Network Bydgoszcz Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Italian Society of Interventional Cardiology\u2010GISE\u2020","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_1_2_2","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2012-303095"},{"key":"e_1_3_1_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/1358863X17697832"},{"key":"e_1_3_1_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.07.002"},{"key":"e_1_3_1_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.04.065"},{"key":"e_1_3_1_6_2","doi-asserted-by":"publisher","DOI":"10.1186\/s42155-018-0026-0"},{"key":"e_1_3_1_7_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-18-00769"},{"key":"e_1_3_1_8_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV12I10A213"},{"key":"e_1_3_1_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.08.193"},{"key":"e_1_3_1_10_2","doi-asserted-by":"publisher","DOI":"10.2459\/JCM.0000000000000489"},{"key":"e_1_3_1_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezs533"},{"key":"e_1_3_1_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.201700067"},{"key":"e_1_3_1_13_2","doi-asserted-by":"publisher","DOI":"10.1080\/00273171.2011.568786"},{"key":"e_1_3_1_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/pst.433"},{"key":"e_1_3_1_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.02.022"},{"key":"e_1_3_1_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.04.056"},{"key":"e_1_3_1_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.05.004"},{"key":"e_1_3_1_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2019.01.008"},{"key":"e_1_3_1_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.28295"},{"key":"e_1_3_1_20_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV11I6A137"},{"key":"e_1_3_1_21_2","first-page":"443","article-title":"Comparison of ProGlide vs. prostar in patients undergoing transcatheter aortic valve implantation","author":"Giordano A","year":"2019","unstructured":"Giordano A, Corcione N, Ferraro P, Morello A, Conte S, Testa L, Iadanza A, Sardella G, Mancone M, Berti S, et al. Comparison of ProGlide vs. prostar in patients undergoing transcatheter aortic valve implantation. Minerva Cardioangiol. 2019;443\u2013449.","journal-title":"Minerva Cardioangiol"},{"key":"e_1_3_1_22_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv417"},{"key":"e_1_3_1_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(01)02357-8"},{"key":"e_1_3_1_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.04.034"},{"key":"e_1_3_1_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2019.06.049"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.120.018042","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T11:00:28Z","timestamp":1715598028000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.120.018042"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11,3]]},"references-count":24,"journal-issue":{"issue":"21","published-print":{"date-parts":[[2020,11,3]]}},"alternative-id":["10.1161\/JAHA.120.018042"],"URL":"https:\/\/doi.org\/10.1161\/jaha.120.018042","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11,3]]},"assertion":[{"value":"2020-06-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-10-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e018042"}}