{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:43:22Z","timestamp":1792082602376,"version":"4.4.0"},"reference-count":19,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,4,28]],"date-time":"2016-04-28T00:00:00Z","timestamp":1461801600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Keystone Heart"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2017,2,15]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard\u2122HDH in patients undergoing TAVR.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR\u2010related embolic events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (\u00b12) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard\u2122HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post\u2010procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, <jats:italic>P<\/jats:italic>\u2009=\u20090.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, <jats:italic>P<\/jats:italic>\u2009=\u20090.049].<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study showed the feasibility and safety of using the TriGuard\u2122HDH for cerebral protection during TAVR. This device did not decrease the number of post\u2010procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. \u00a9 2016 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.26566","type":"journal-article","created":{"date-parts":[[2016,4,28]],"date-time":"2016-04-28T11:49:18Z","timestamp":1461844158000},"page":"470-477","source":"Crossref","is-referenced-by-count":27,"title":["TriGuard<sup>\u2122<\/sup> HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement"],"prefix":"10.1002","volume":"89","author":[{"given":"Mariam","family":"Samim","sequence":"first","affiliation":[{"name":"Department of Cardiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart","family":"van der Worp","sequence":"additional","affiliation":[{"name":"Department of Neurology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierfrancesco","family":"Agostoni","sequence":"additional","affiliation":[{"name":"Department of Cardiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen","family":"Hendrikse","sequence":"additional","affiliation":[{"name":"Department of Radiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo P.J.","family":"Budde","sequence":"additional","affiliation":[{"name":"Department of Radiology Erasmus University Medical Centre Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Freek","family":"Nijhoff","sequence":"additional","affiliation":[{"name":"Department of Cardiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faiz","family":"Ramjankhan","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter A.","family":"Doevendans","sequence":"additional","affiliation":[{"name":"Department of Cardiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter R.","family":"Stella","sequence":"additional","affiliation":[{"name":"Department of Cardiology University Medical Centre Utrecht  the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,4,28]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1103510"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1400590"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2010.09.008"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.12.026"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.07.036"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2011-300065"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.109.855866"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)12978-9"},{"key":"e_1_2_7_10_1","first-page":"475","article-title":"Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: Comparison of transfemoral and trans\u2010apical approaches using Edwards Sapiens valve","volume":"40","author":"Astarci P","year":"2011","journal-title":"Eur J Cardiothorac Surg"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehn341"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022066"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00392-014-0798-8"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.110981"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2010.05.022"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV8I1A9"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV8I1A8"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2011.05.109"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2014.05.097"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.04.019"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.26566","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.26566","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.26566","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T22:59:06Z","timestamp":1695509946000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.26566"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,4,28]]},"references-count":19,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2017,2,15]]}},"alternative-id":["10.1002\/ccd.26566"],"URL":"https:\/\/doi.org\/10.1002\/ccd.26566","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,4,28]]}}}