{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T20:30:08Z","timestamp":1790800208920,"version":"4.1.0"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2019,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of\n                      <jats:italic>International Classification of Diseases,<\/jats:italic>\n                      <jats:italic>Ninth and<\/jats:italic>\n                      <jats:italic>Tenth<\/jats:italic>\n                      <jats:italic>Revisions, Clinical Modification<\/jats:italic>\n                      billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4\n                      <jats:italic>International Classification of Diseases, Ninth Revision, Clinical Modification<\/jats:italic>\n                      codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3\n                      <jats:italic>International Classification of Diseases, Tenth Revision, Clinical Modification<\/jats:italic>\n                      codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      In linked clinical trial and Medicare claims data, 4\n                      <jats:italic>International Classification of Diseases, Ninth Revision, Clinical Modification<\/jats:italic>\n                      and 3\n                      <jats:italic>International Classification of Diseases, Tenth Revision, Clinical Modification<\/jats:italic>\n                      billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.119.008231","type":"journal-article","created":{"date-parts":[[2019,11,7]],"date-time":"2019-11-07T05:00:24Z","timestamp":1573102824000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement"],"prefix":"10.1161","volume":"12","author":[{"given":"Jordan B.","family":"Strom","sequence":"first","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuansong","family":"Zhao","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamil F.","family":"Faridi","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hector","family":"Tamez","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neel M.","family":"Butala","sequence":"additional","affiliation":[{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Division of Cardiology, Massachusetts General Hospital, Boston (N.M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda R.","family":"Valsdottir","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeptha","family":"Curtis","sequence":"additional","affiliation":[{"name":"Yale University School of Medicine, New Haven, CT (J.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Matthew","family":"Brennan","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, NC (J.M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changyu","family":"Shen","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Boulware","sequence":"additional","affiliation":[{"name":"Medtronic, Inc, Minneapolis, MN (M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey J.","family":"Popma","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert W.","family":"Yeh","sequence":"additional","affiliation":[{"name":"The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., R.W.Y.)"},{"name":"Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center (J.B.S., Y.Z., K.F.F., H.T., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Harvard Medical School (J.B.S.,Y.Z., K.F.F., H.T., N.M.B., L.R.V., C.S., J.J.P., R.W.Y.)"},{"name":"Baim Institute for Clinical Research, Boston, MA (R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1400590"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.10.023"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.21037\/jtd.2018.01.151"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.991075"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2017.1460"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.02.556"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700456"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2016.06.002"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.111.963280"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2017.11.010"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.117.008230"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.117.004397"},{"key":"e_1_3_4_14_2","volume-title":"Are Outcomes Assessed In Medicare Claims Valid Surrogates For Clinical Trial Adjudicated Endpoints? 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Accessed August 19 2019."},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.12.005"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezs533"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.018610"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.114.005512"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.113.000743"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.2010.02915.x"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.119.008231","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,12]],"date-time":"2024-05-12T22:17:59Z","timestamp":1715552279000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.119.008231"}},"subtitle":["Findings From the EXTEND Study"],"short-title":[],"issued":{"date-parts":[[2019,11]]},"references-count":20,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2019,11]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.119.008231"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.119.008231","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,11]]},"assertion":[{"value":"2019-06-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-08-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-07","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e008231"}}