{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T13:19:58Z","timestamp":1788268798011,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Deflectable delivery systems have been introduced to enhance coaxial alignment and procedural efficacy during left atrial appendage occlusion (LAAO), yet randomized comparisons with conventional fixed\u2010curve systems are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The GUIDE\u2010LAAO trial evaluated whether the TruSteer deflectable delivery system is non\u2010inferior to the FXD Double Curve (FXD DC) delivery system for procedural success in patients undergoing LAAO with the Watchman FLX Pro device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this prospective, randomized, all\u2010comers trial, 50 patients with non\u2010valvular atrial fibrillation undergoing LAAO were assigned 1:1 to TruSteer (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200925) or FXD DC (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200925). The primary endpoint was procedural success, defined as successful device implantation without major procedural or periprocedural complications. Secondary endpoints included technical success, device success, procedural efficiency, and safety outcomes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Procedural success occurred in 100% of TruSteer\u2010treated patients and 84% of FXD DC\u2013treated patients (risk difference 16%; 95% confidence interval \u22126.9% to 34.7%), meeting criteria for non\u2010inferiority; superiority was not demonstrated (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.11). Technical and device success were 100% with TruSteer and 92% with FXD DC. Procedural time (34.6\u2009\u00b1\u20097.1 vs. 36.5\u2009\u00b1\u200913.0\u2009min), fluoroscopy time (22.3\u2009\u00b1\u20094.4 vs. 22.1\u2009\u00b1\u20097.2\u2009min), and contrast volume (34.5\u2009\u00b1\u200912.1 vs. 36.8\u2009\u00b1\u200913.5\u2009mL) were similar. Periprocedural complications occurred in 4% and 16%, respectively, with no deaths or strokes.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this first randomized comparison of LAAO delivery systems, TruSteer was non\u2010inferior to a standard fixed\u2010curve system, with comparable efficiency and safety in an unselected population. These findings provide randomized evidence supporting deflectable delivery technology in contemporary LAAO practice and inform future studies in anatomically complex subsets.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.70739","type":"journal-article","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T08:41:07Z","timestamp":1783327267000},"page":"899-907","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Randomized Controlled Trial Comparing the TruSteer and FXD Double Curve Delivery Systems for Left Atrial Appendage Occlusion With the Watchman FLX Pro Device\u2014The GUIDE\u2010LAAO Study"],"prefix":"10.1002","volume":"108","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4287-3371","authenticated-orcid":false,"given":"Philippe","family":"Taieb","sequence":"first","affiliation":[{"name":"Harrington Heart &amp; Vascular Institute University Hospitals Cleveland Medical Center Cleveland Ohio USA"},{"name":"Jesselson Integrated Heart Center Shaare Zedek Medical Center and Hebrew University Faculty of Medicine Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6543-7567","authenticated-orcid":false,"given":"Marco","family":"Frazzetto","sequence":"additional","affiliation":[{"name":"Harrington Heart &amp; Vascular Institute University Hospitals Cleveland Medical Center Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro Soares","family":"Teixeira","sequence":"additional","affiliation":[{"name":"Harrington Heart &amp; Vascular Institute University Hospitals Cleveland Medical Center Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8364-1732","authenticated-orcid":false,"given":"Steven J.","family":"Filby","sequence":"additional","affiliation":[{"name":"Harrington Heart &amp; Vascular Institute University Hospitals Cleveland Medical Center Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,6]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"WATCHMAN TruSteerTM Access System.www.bostonscientific.com Accessed February 6 2026 https:\/\/www.bostonscientific.com\/en-US\/products\/laac-system\/watchman-trusteer-access-system.html."},{"key":"e_1_2_9_3_1","unstructured":"WATCHMAN TruSteer Access System \u2010 Deployment \u2010 WATCHMAN FLX www.watchman.com. Accessed February 6 2026 https:\/\/www.watchman.com\/en-us-implanter\/device\/trusteer-access-system.html."},{"key":"e_1_2_9_4_1","unstructured":"The National Cancer Institute's Division of Cancer Prevention.Clinical Trial Randomization Tool. Accessed September 14 2025 https:\/\/ctrandomization.cancer.gov."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10554-016-1050-6"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.15548"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2020.09.021"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.01.011"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV12I1A18"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.123.013750"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.25270\/jic\/25.00081"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2025.03.666"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(25)01354-3"},{"key":"e_1_2_9_14_1","unstructured":"C.Hudded. Procedure Characteristics and Early Clinical Outcomes of Left Atrial Appendage Occlusion Using Novel Steerable Access System: A Sub\u2010Analysis of HEAL\u2010LAA.Presented at: New York Valves2025."},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2024.04.050"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.05.045"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.70739","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ccd.70739","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.70739","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T12:44:10Z","timestamp":1788266650000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.70739"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,6]]},"references-count":15,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/ccd.70739"],"URL":"https:\/\/doi.org\/10.1002\/ccd.70739","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,6]]},"assertion":[{"value":"2026-03-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}