{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:34:05Z","timestamp":1790620445689,"version":"4.1.0"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"18","license":[{"start":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T00:00:00Z","timestamp":1762214400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"British Heart Foundation","award":["CS\/20\/1\/34732"],"award-info":[{"award-number":["CS\/20\/1\/34732"]}]},{"name":"Boston Scientific Corporation","award":["ISRCAR00332"],"award-info":[{"award-number":["ISRCAR00332"]}]}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2025,11,4]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>In addition to the risk of stroke, patients undergoing transcatheter aortic valve implantation (TAVI) are susceptible to a decline of neurocognitive function. This may occur because of embolization of material (eg, valve or calcium) to the brain. Cerebral embolic protection (CEP) devices are engineered to capture this debris, potentially mitigating its incidence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>This is a secondary analysis of the BHF PROTECT-TAVI trial (British Heart Foundation Randomized Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation), in which participants with aortic stenosis from across 33 centers in the United Kingdom were randomly assigned at a 1:1 ratio to undergo TAVI with a CEP device (SENTINEL, Boston Scientific; SENTINEL CEP group) or TAVI without a CEP device (control group). This analysis is restricted to those who underwent cognitive assessment. The primary outcome was the mean change in the telephone version of the Montreal Cognitive Assessment (t-MoCA) between baseline and 6 to 8 weeks after TAVI. The secondary outcome was a \u22653-point drop in total t-MoCA score between baseline and 6 to 8 weeks after TAVI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      A total of 3535 participants, 1763 in the SENTINEL CEP group and 1772 in the control group (mean age 81.0 years, 37.7% women) randomized in BHF PROTECT-TAVI were included in the modified intention-to-treat population for this analysis. The median t-MoCA at presentation was 18 (interquartile range, 16\u201320). The median t-MoCA at 6 to 8 weeks was 20 (interquartile range, 17\u201321). The mean change in total t-MoCA score between baseline and 6 to 8 weeks adjusted for the baseline score was 0.83 (95% CI, 0.70\u20130.96) in the SENTINEL CEP group and 0.91 (95% CI, 0.79\u20131.04) in the control group. There was no difference in means between the treatment groups (\u22120.07 [95% CI, \u22120.22 to 0.09],\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.42). The incidence of a \u22653-point drop in the total t-MoCA score was 154 of 1763 (8.7%) in the SENTINEL CEP group and 142 of 1772 (8.0%) in the control group. The corresponding risk difference was 0.72% (95% CI, \u22121.10 to 2.55;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.44). These findings were robust to sensitivity analyses. There was no evidence of an interaction between treatment assignment and any of the subgroups assessed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>In the BHF PROTECT-TAVI trial, the use of CEP did not impact cognition after TAVI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.isrctn.com\/ISRCTN16665769\">https:\/\/www.isrctn.com<\/jats:ext-link>\n                      ; Unique identifier: ISRCTN16665769.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.125.076761","type":"journal-article","created":{"date-parts":[[2025,8,30]],"date-time":"2025-08-30T16:15:06Z","timestamp":1756570506000},"page":"1268-1278","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Impact of Cerebral Embolic Protection on Cognitive Function After Transcatheter Aortic Valve Implantation: Data From the BHF PROTECT-TAVI Randomized Trial"],"prefix":"10.1161","volume":"152","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9083-672X","authenticated-orcid":true,"given":"James","family":"Kennedy","sequence":"first","affiliation":[{"name":"Radcliffe Department of Medicine, University of Oxford, Oxford, UK (J.K., R.K.K.)."},{"name":"National Institute for Health and Care Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK (J.K., R.K.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9039-6130","authenticated-orcid":true,"given":"Daniel J.","family":"Blackman","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK (D.J.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6207-6604","authenticated-orcid":true,"given":"Matthew","family":"Dodd","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (M.D., L.R., Z.J., R.E., T.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8694-0129","authenticated-orcid":true,"given":"Anna","family":"Poggesi","sequence":"additional","affiliation":[{"name":"NEUROFARBA Department, University of Florence, Florence, Italy (A.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1085-0995","authenticated-orcid":true,"given":"Laura","family":"Read","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (M.D., L.R., Z.J., R.E., T.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3817-6795","authenticated-orcid":true,"given":"Zahra","family":"Jamal","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (M.D., L.R., Z.J., R.E., T.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4101-2131","authenticated-orcid":true,"given":"Richard","family":"Evans","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (M.D., L.R., Z.J., R.E., T.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1266-3288","authenticated-orcid":true,"given":"Tim","family":"Clayton","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit, Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK (M.D., L.R., Z.J., R.E., T.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5356-2395","authenticated-orcid":true,"given":"Rajesh K.","family":"Kharbanda","sequence":"additional","affiliation":[{"name":"Radcliffe Department of Medicine, University of Oxford, Oxford, UK (J.K., R.K.K.)."},{"name":"National Institute for Health and Care Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK (J.K., R.K.K.)."},{"name":"Department of Cardiovascular Medicine, John 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