{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T06:34:37Z","timestamp":1790836477252,"version":"4.1.0"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T00:00:00Z","timestamp":1496275200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006520","name":"Edwards Lifesciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006520","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2017,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The Placement of AoRtic TraNscathetER Valves trials (PARTNER) showed favorable safety and efficacy versus medical or surgical therapy in inoperable, high, and intermediate surgical risk patients with severe aortic stenosis. However, the biological responses to transcatheter aortic valves have not been well characterized.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The aim of this study was to perform pathologic assessment of Edwards SAPIEN transcatheter aortic valves removed either at autopsy or surgically during the PARTNER I and II clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Explanted valves and frame were evaluated for pathologic responses including extent of thrombus, inflammation, neointima, and leaflet degeneration\/calcification according to semiquantitative grading by implant duration (\u226430 days; 31\u201390 days; &gt;90 days).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 22 cases (median age 82.0 years, 45% men) were included, with a duration of implantation that ranged from 0 to 1739 days (median duration 16.5 days [interquartile range, 2.8\u201368.3]). Valve thrombosis resulting in severe aortic stenosis was observed in one case. Moderate leaflet thrombus was seen in 14% of cases (<jats:italic>n<\/jats:italic>\u2009=\u20093) and all were asymptomatic. Calcification was seen in two valves: one with severe leaflet calcification had severe aortic stenosis requiring surgical replacement, while the other showed early calcification. Mild structural leaflet changes were exclusively seen in valve implants &gt;90 days. Valve inflammation and thrombus formation was mild in majority of the cases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Overall, our study demonstrates moderate thrombus formation in 14% and calcification in only 2 valves, \u22654 years duration. In this short\u2010duration study, acceptable durability and biocompatibility of the Edwards SAPIEN transcatheter valve system was demonstrated; however, further studies are required to confirm the significance and application of our findings.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27160","type":"journal-article","created":{"date-parts":[[2017,6,1]],"date-time":"2017-06-01T07:43:05Z","timestamp":1496302985000},"page":"1048-1057","source":"Crossref","is-referenced-by-count":17,"title":["Pathology of balloon\u2010expandable transcatheter aortic valves"],"prefix":"10.1002","volume":"90","author":[{"given":"Kazuyuki","family":"Yahagi","sequence":"first","affiliation":[{"name":"CVPath Institute Inc Gaithersburg Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Ladich","sequence":"additional","affiliation":[{"name":"CVPath Institute Inc Gaithersburg 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