{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:40:58Z","timestamp":1791999658704,"version":"4.4.0"},"reference-count":24,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"7","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">We aimed to reevaluate randomized controlled trial data on outcomes of cerebral embolic protection device use during transcatheter aortic valve implantation. A conventional meta\u2010analysis followed by trial sequential analysis was conducted to evaluate the strength of the current evidence.<\/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                      Databases were searched for randomized controlled trials. Primary outcomes included all stroke, disabling stroke, and all\u2010cause mortality. Conventional study\u2010level meta\u2010analysis was performed using random\u2010effects modeling. Trial sequential analysis was conducted to generate adjusted significance boundaries, futility boundaries, and the required information size considering a type I error of 5% and a power of 90%. Seven trials were included with a total of 4031 patients, of whom 2171 were treated with a device and 1860 were not. Conventional meta\u2010analysis showed no significant difference in all stroke (relative risk [RR], 0.85 [95% CI, 0.61\u20131.18];\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      =0.339) and disabling stroke (RR, 0.59 [95% CI, 0.30\u20131.13];\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      =0.113) with device use. The trial sequential analysis determined an absence of evidence for all stroke (required information size of 71\u2009650 [5.6%]) and disabling stroke (required information size of 337\u2009256 [1.2%]). Conventional meta\u2010analysis determined no significant difference in all\u2010cause mortality (RR, 1.03 [95% CI, 0.49\u20132.17];\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      =0.928) with device use. The trial sequential analysis determined that the futility boundary was reached (required information size of 5772 [69.3%]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">There are insufficient randomized controlled trial data on cerebral embolic protection device use to provide conclusive meta\u2010analytic findings for stroke outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.124.038869","type":"journal-article","created":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T23:47:33Z","timestamp":1742600853000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta\u2010Analysis With Trial Sequential Analysis"],"prefix":"10.1161","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9871-1219","authenticated-orcid":false,"given":"Nav","family":"Warraich","sequence":"first","affiliation":[{"name":"University of Pittsburgh","place":["Pittsburgh, USA"]},{"name":"UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center","place":["Pittsburgh, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5356-2996","authenticated-orcid":false,"given":"Michel Pompeu","family":"S\u00e1","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Harvard Medical School","place":["Boston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8421-0686","authenticated-orcid":false,"given":"Xander","family":"Jacquemyn","sequence":"additional","affiliation":[{"name":"KU Leuven","place":["Leuven, Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2487-8366","authenticated-orcid":false,"given":"Toshiki","family":"Kuno","sequence":"additional","affiliation":[{"name":"Harvard Medical School","place":["Boston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5991-6385","authenticated-orcid":false,"given":"Derek","family":"Serna\u2010Gallegos","sequence":"additional","affiliation":[{"name":"University of Pittsburgh","place":["Pittsburgh, USA"]},{"name":"UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center","place":["Pittsburgh, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1737-4012","authenticated-orcid":false,"given":"Ibrahim","family":"Sultan","sequence":"additional","affiliation":[{"name":"University of Pittsburgh","place":["Pittsburgh, USA"]},{"name":"UPMC Heart and Vascular Institute, University of Pittsburgh Medical Center","place":["Pittsburgh, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_1_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.09.595"},{"key":"e_1_3_1_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307447"},{"key":"e_1_3_1_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.02.017"},{"key":"e_1_3_1_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.7525"},{"key":"e_1_3_1_6_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV8I1A8"},{"key":"e_1_3_1_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.123.013697"},{"key":"e_1_3_1_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.123.030587"},{"key":"e_1_3_1_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.12.012"},{"key":"e_1_3_1_10_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-9-86"},{"key":"e_1_3_1_11_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0315-7"},{"key":"e_1_3_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.03.013"},{"key":"e_1_3_1_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"e_1_3_1_14_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.328.7454.1490"},{"key":"e_1_3_1_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv191"},{"key":"e_1_3_1_16_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.10302"},{"key":"e_1_3_1_17_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV12I4A84"},{"key":"e_1_3_1_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.10.023"},{"key":"e_1_3_1_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab213"},{"key":"e_1_3_1_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.11.011"},{"key":"e_1_3_1_21_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2204961"},{"key":"e_1_3_1_22_2","doi-asserted-by":"publisher","DOI":"10.1080\/14779072.2024.2385989"},{"key":"e_1_3_1_23_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-22-00713"},{"key":"e_1_3_1_24_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.117.003563"},{"key":"e_1_3_1_25_2","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2023-323359"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.124.038869","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T13:37:36Z","timestamp":1763991456000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.124.038869"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":24,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1161\/JAHA.124.038869"],"URL":"https:\/\/doi.org\/10.1161\/jaha.124.038869","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4]]},"assertion":[{"value":"2024-09-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-21","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e038869"}}