{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T04:12:38Z","timestamp":1787371958306,"version":"build-2736575974"},"reference-count":41,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T00:00:00Z","timestamp":1751500800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cardiovasc. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The Perclose ProStyle\u2122\/ProGlide\u2122 Suture-Mediated Closure and Repair (SMCR) System is designed to close the common femoral artery (CFA) access during percutaneous endovascular procedures. Instructions for use (IFU) recommend the use of at least two devices, per single access, and the pre-close technique for arterial sheath sizes greater than 8 F. Besides, recent clinical studies suggest that a single ProStyle\u2122\/ProGlide\u2122 pre-implantation can safely close percutaneous access for larger diameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The purpose of this study was to analyse the efficacy of a single pre-implanted ProStyle\u2122\/ProGlide\u2122 in closing the Common Femoral Artery (CFA) access site in patients undergoing aortic endovascular procedures using sheaths with diameter 12\u201316 French (F).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a prospective study including 72 consecutive patients who underwent aortic endovascular surgery from December 2022 to June 2024 in our University Hospital. In this group, only a single pre-implanted ProStyle\u2122\/ProGlide\u2122 was used to close the access site in the CFA after using sheaths with diameters 12\u201316 F. The primary endpoint was technical success, defined as the absence of intraoperative open surgical conversion. The secondary endpoint was clinical success, defined as the absence of bleeding, pseudoaneurysms, and arteriovenous fistulas in the peri and postoperative period. We compared the results of this group with a cohort of patients in whom two ProStyle\u2122\/ProGlide\u2122 were used to close the access site in the CFA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Result<\/jats:title>\n                    <jats:p>Technical success was achieved in all cases (100%). Clinical success was achieved in 98% of cases. Only two minor bleedings occurred: one resulted in a small pseudoaneurysm, completely thrombosed 48\u2005h after the procedure. One patient suffered from CFA dissection, requiring an open surgical endarterectomy. There were no statistically significant differences of clinical and technical success rates between the two groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study demonstrates that a Single ProStyle\u2122\/ProGlide\u2122 preimplantation can be safe and effective in the closure of vascular accesses up to 16 Fr, with a low complication rate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcvm.2025.1559131","type":"journal-article","created":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T01:27:20Z","timestamp":1751506040000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and effectiveness of single ProStyle\u2122\/ProGlide\u2122 for aortic endovascular procedures: single-style study"],"prefix":"10.3389","volume":"12","author":[{"given":"Rocco","family":"Cangiano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Di Girolamo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Ascione","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Miceli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carola","family":"D\u2019Amico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Molinari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ada","family":"Dajci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Sterpetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Gagliardo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"di Marzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wassim","family":"Mansour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,7,3]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1016\/j.jvs.2017.10.044","article-title":"The society for vascular surgery practice guidelines on the care of patients with an abdominal aortic aneurysm","volume":"67","author":"Chaikof","year":"2018","journal-title":"J Vasc Surg"},{"key":"B2","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1016\/j.ejvs.2018.09.020","article-title":"Editor\u2019s choice\u2014European society for vascular surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms","volume":"57","author":"Wanhainen","year":"2019","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"B3","doi-asserted-by":"publisher","first-page":"749","DOI":"10.1007\/s10016-005-6858-9","article-title":"1992: Parodi, Montefiore, and the first abdominal aortic aneurysm stent graft in the United States","volume":"19","author":"Veith","year":"2005","journal-title":"Ann Vasc Surg"},{"key":"B4","doi-asserted-by":"publisher","first-page":"273","DOI":"10.23736\/S0021-9509.23.12906-5","article-title":"Insight from an Italian Delphi consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR study","volume":"65","author":"Sirignano","year":"2024","journal-title":"J Cardiovas Surg"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1181","DOI":"10.1016\/j.jvs.2013.10.101","article-title":"A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial)","volume":"59","author":"Nelson","year":"2014","journal-title":"J Vasc Surg"},{"key":"B6","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1016\/j.jvs.2015.01.058","article-title":"Percutaneous versus femoral cutdown access for endovascular aneurysm repair","volume":"62","author":"Buck","year":"2015","journal-title":"J Vasc Surg"},{"key":"B7","doi-asserted-by":"publisher","first-page":"919","DOI":"10.1016\/j.jvs.2007.12.029","article-title":"Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the Preclose technique","volume":"47","author":"Lee","year":"2008","journal-title":"J Vasc Surg"},{"key":"B8","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1016\/S0741-5214(02)75454-2","article-title":"Endovascular suture versus cutdown for endovascular aneurysm repair: a prospective randomized pilot study","volume":"38","author":"Torsello","year":"2003","journal-title":"J Vasc Surg"},{"key":"B9","doi-asserted-by":"publisher","first-page":"770","DOI":"10.1067\/mva.2000.107987","article-title":"Percutaneous endovascular repair of infrarenal abdominal aortic aneurysms: a feasibility study","volume":"32","author":"Traul","year":"2000","journal-title":"J Vasc Surg"},{"key":"B10","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1177\/152660280100800112","article-title":"Percutaneous access and closure of femoral artery access sites associated with endoluminal repair of abdominal aortic aneurysms","volume":"8","author":"Howell","year":"2001","journal-title":"J Endovasc Ther"},{"key":"B11","doi-asserted-by":"publisher","first-page":"418","DOI":"10.1053\/ejvs.2001.1495","article-title":"Use of the percutaneous vascular surgery device for closure of femoral access sites during endovascular aneurysm repair: lessons from our experience","volume":"22","author":"Teh","year":"2001","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"B12","doi-asserted-by":"publisher","first-page":"278","DOI":"10.1055\/s-0035-1556826","article-title":"Current status of percutaneous endografting","volume":"32","author":"Patel","year":"2015","journal-title":"Semin Intervent Radiol"},{"key":"B13","doi-asserted-by":"publisher","first-page":"270","DOI":"10.1016\/j.jvs.2005.11.004","article-title":"Totally percutaneous aortic aneurysm repair: experience and prudence","volume":"43","author":"Starnes","year":"2006","journal-title":"J Vasc Surg"},{"key":"B14","doi-asserted-by":"publisher","first-page":"261","DOI":"10.1016\/j.ejvs.2006.01.022","article-title":"Percutaneous repair of aortic aneurysms: a prospective study of suture-mediated closure devices","volume":"32","author":"Watelet","year":"2006","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"B15","doi-asserted-by":"publisher","first-page":"43","DOI":"10.1007\/s10016-001-0127-3","article-title":"Percutaneous endovascular abdominal aortic aneurysm repair","volume":"16","author":"Rachel","year":"2002","journal-title":"Ann Vasc Surg"},{"key":"B16","doi-asserted-by":"publisher","first-page":"502","DOI":"10.3390\/jcm14020502","article-title":"Early and mid-term outcomes of isolated type 2 endoleak refractory to an embolization procedure","volume":"14","author":"Miceli","year":"2025","journal-title":"J Clin Med"},{"key":"B17","doi-asserted-by":"publisher","first-page":"567","DOI":"10.1007\/s00270-013-0593-3","article-title":"The preclose technique in percutaneous endovascular aortic repair: a systematic literature review and meta-analysis","volume":"36","author":"Jaffan","year":"2013","journal-title":"Cardiovasc Intervent Radiol"},{"key":"B18","doi-asserted-by":"publisher","first-page":"1095","DOI":"10.1016\/j.jvs.2007.01.050","article-title":"Total percutaneous access for endovascular aortic aneurysm repair (\u201cPreclose\u201d technique)","volume":"45","author":"Lee","year":"2007","journal-title":"J Vasc Surg"},{"key":"B19","doi-asserted-by":"publisher","first-page":"887","DOI":"10.1016\/j.jvs.2018.05.019","article-title":"A systematic review of vascular closure devices for femoral artery puncture sites","volume":"68","author":"Noori","year":"2018","journal-title":"J Vasc Surg"},{"key":"B20","doi-asserted-by":"publisher","first-page":"E1544","DOI":"10.4244\/EIJ-D-19-00547","article-title":"Endovascular aortic repair in patients with challenging anatomies: the EXTREME study","volume":"16","author":"Sirignano","year":"2021","journal-title":"EuroIntervention"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.23736\/S1824-4777.22.01559-5","article-title":"Multicenter real-life study on access-related outcomes after EVAR: percutaneous is the way","volume":"29","author":"Melani","year":"2023","journal-title":"Ital J Vasc Endovasc Surg"},{"key":"B22","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1016\/j.avsg.2020.11.021","article-title":"Pledget reinforcement and tractional compression as adjunctive techniques for suture-mediated closure (SMC) in percutaneous endovascular aneurysm repair (pEVAR): a retrospective observational cohort study","volume":"73","author":"Najem","year":"2021","journal-title":"Ann Vasc Surg"},{"key":"B23","first-page":"889","article-title":"Italian Percutaneous EVAR (IPER) registry: outcomes of 2381 percutaneous femoral access sites' Closure for aortic stent-graft","volume":"56","author":"Pratesi","year":"2015","journal-title":"J Cardiovasc Surg (Torino)"},{"key":"B24","doi-asserted-by":"publisher","first-page":"209","DOI":"10.1024\/0301-1526\/a000688","article-title":"Loco-regional versus general anaesthesia for elective endovascular aneurysm repair\u2014results of a cohort study and a meta-analysis","volume":"47","author":"Hajibandeh","year":"2018","journal-title":"Vasa"},{"key":"B25","doi-asserted-by":"publisher","first-page":"191","DOI":"10.4244\/EIJV10I2A32","article-title":"Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population","volume":"10","author":"Kerr\u00e9","year":"2014","journal-title":"EuroIntervention"},{"key":"B26","first-page":"567","article-title":"Comparison of anesthesia technique on outcomes of endovascular repair of abdominal aortic aneurysms: a five-year review of monitored anesthesia care with local anesthesia vs. general or regional anesthesia","volume-title":"J Cardiovasc Surg (Torino)","author":"Franz","year":"2011"},{"key":"B27","doi-asserted-by":"publisher","first-page":"766","DOI":"10.1016\/j.amjcard.2006.10.032","article-title":"A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention","volume":"99","author":"Resnic","year":"2007","journal-title":"Am J Cardiol"},{"key":"B28","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1002\/ccd.10294","article-title":"Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions","volume":"57","author":"Rickli","year":"2002","journal-title":"Catheter Cardiovasc Interv"},{"key":"B29","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1016\/j.carj.2017.08.003","article-title":"Financial impact of PEVAR compared with standard endovascular repair in Canadian hospitals","volume":"69","author":"Roche-Nagle","year":"2018","journal-title":"Can Assoc Radiol J"},{"key":"B30","doi-asserted-by":"publisher","first-page":"306","DOI":"10.23736\/S0392-9590.24.05146-0","article-title":"RIvaroxaban and vascular surgery (rIVaS): insights from a multicenter, worldwide web-based survey","volume":"43","author":"Troisi","year":"2024","journal-title":"Int Angiol"},{"key":"B31","doi-asserted-by":"publisher","first-page":"1441","DOI":"10.1007\/s00270-024-03839-1","article-title":"Inter- and intra-observer agreement of the peripheral arterial calcium scoring system in patients undergoing (infra)Popliteal endovascular interventions","volume":"47","author":"Nugteren","year":"2024","journal-title":"Cardiovasc Intervent Radiol"},{"key":"B32","doi-asserted-by":"publisher","first-page":"2736","DOI":"10.1161\/CIRCULATIONAHA.110.009449","article-title":"Standardized bleeding definitions for cardiovascular clinical trials (BARC)","volume":"123","author":"Mehran","year":"2011","journal-title":"Circulation"},{"key":"B33","article-title":"Perclose\u2122 ProStyle\u2122 SMCR System Instrucition for Use","year":"2025"},{"key":"B34","doi-asserted-by":"publisher","first-page":"585","DOI":"10.1016\/j.jvs.2015.08.111","article-title":"Safety and utility of total percutaneous endovascular aortic repair with a single Perclose ProGlide closure device","volume":"63","author":"Ichihashi","year":"2016","journal-title":"J Vasc Surg"},{"key":"B35","doi-asserted-by":"publisher","first-page":"e110","DOI":"10.1016\/j.jvs.2019.07.047","article-title":"Safety and effectiveness of single proglide vascular access in patients undergoing endovascular aneurysm repair","volume":"70","author":"Dunn","year":"2019","journal-title":"J Vasc Surg"},{"key":"B36","doi-asserted-by":"publisher","first-page":"43","DOI":"10.21470\/1678-9741-2016-0065","article-title":"Totally percutaneous access using perclose proglide for endovascular treatment of aortic diseases","volume":"32","author":"Saadi","year":"2017","journal-title":"Braz J Cardiovasc Surg"},{"key":"B37","doi-asserted-by":"publisher","first-page":"3370","DOI":"10.1093\/eurheartj\/ehv417","article-title":"Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation","volume":"36","author":"Barbash","year":"2015","journal-title":"Eur Heart J"},{"key":"B38","doi-asserted-by":"publisher","first-page":"E55","DOI":"10.1002\/ccd.26686","article-title":"Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) Japanese multicenter registry","volume":"90","author":"Kodama","year":"2017","journal-title":"Catheter Cardiovasc Interv"},{"key":"B39","doi-asserted-by":"publisher","first-page":"442","DOI":"10.1002\/ccd.28585","article-title":"The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: insights from Cleveland clinic aortic valve center","volume":"96","author":"Bazarbashi","year":"2020","journal-title":"Catheter Cardiovasc Interv"},{"key":"B40","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1016\/j.ijcard.2021.01.043","article-title":"Single versus double use of a suture-based closure device for transfemoral aortic valve implantation","volume":"331","author":"Reifart","year":"2021","journal-title":"Int J Cardiol"},{"key":"B41","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1016\/j.avsg.2021.06.024","article-title":"Sheath size up and down with single proglide\u2014a technique for achieving hemostasis with use of large size delivery system during endovascular graft placement","volume":"78","author":"Singh","year":"2022","journal-title":"Ann Vasc Surg"}],"container-title":["Frontiers in Cardiovascular Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2025.1559131\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,3]],"date-time":"2025-07-03T01:27:20Z","timestamp":1751506040000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcvm.2025.1559131\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,3]]},"references-count":41,"alternative-id":["10.3389\/fcvm.2025.1559131"],"URL":"https:\/\/doi.org\/10.3389\/fcvm.2025.1559131","relation":{},"ISSN":["2297-055X"],"issn-type":[{"value":"2297-055X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,3]]},"article-number":"1559131"}}