{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T20:30:26Z","timestamp":1790800226349,"version":"4.1.0"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>\n              Food and Drug Administration\u2013mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with\n              <jats:italic>International Classification of Diseases-Tenth Revision<\/jats:italic>\n              (\n              <jats:italic>ICD-10<\/jats:italic>\n              ) codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>\n              We linked Evolut Low Risk trial patients to the Medicare Provider Analysis and Review database. We calculated sensitivity, specificity, positive predictive value, negative predictive value, and\n              <jats:italic>\u03ba<\/jats:italic>\n              agreement statistic of claims to detect clinical end points through 2 years in trial patients. We additionally compared end points across treatment arms using trial-adjudicated outcomes versus claims-based outcomes.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>\n              Trial-adjudicated deaths were perfectly identified by claims. Claims had good performance in identifying trial-adjudicated disabling stroke (sensitivity 68.8%, specificity 99.0%, positive predictive value 64.7%, negative predictive value 99.1%,\n              <jats:italic>\u03ba<\/jats:italic>\n              =0.66) and pacemaker placement (sensitivity 85.2%, specificity 98.4%, positive predictive value 90.4%, negative predictive value 97.5%,\n              <jats:italic>\u03ba<\/jats:italic>\n              =0.86), but more modest performance in identifying trial-adjudicated myocardial infarction (\n              <jats:italic>\u03ba<\/jats:italic>\n              =0.46) and vascular complications (\n              <jats:italic>\u03ba<\/jats:italic>\n              =0.45). There was no difference between treatment arms for the primary end point of death or disabling stroke using trial data (hazard ratio, 0.83 [95% CI, 0.41\u20131.68]) or claims data (hazard ratio, 0.89 [95% CI, 0.43\u20131.81]; interaction\n              <jats:italic>P<\/jats:italic>\n              =0.71).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>Claims-based end points performed well in ascertaining death, disabling stroke, and pacemaker placement and were able to reproduce principal trial findings. These results support the selective use of claims-based end points for transcatheter aortic valve replacement postmarketing surveillance.<\/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.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT02701283.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circinterventions.124.014592","type":"journal-article","created":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T19:00:26Z","timestamp":1737486026000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial"],"prefix":"10.1161","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct02701283","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6937-4041","authenticated-orcid":true,"given":"Neel M.","family":"Butala","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Medicine, Rocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.)."},{"name":"Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora (N.M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Lalani","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archana","family":"Tale","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Song","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7107-3667","authenticated-orcid":true,"given":"Dhaval","family":"Kolte","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (D.K., S.B.)."},{"name":"Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8319-5637","authenticated-orcid":true,"given":"Suzanne","family":"Baron","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (D.K., S.B.)."},{"name":"Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6592-6141","authenticated-orcid":true,"given":"Jordan","family":"Strom","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)."},{"name":"Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9163-724X","authenticated-orcid":true,"given":"David J.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Cardiovascular Research Foundation, New York City, NY (D.J.C.)."},{"name":"St. Francis Hospital and Heart Center, Roslyn, NY (D.J.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0564-4468","authenticated-orcid":true,"given":"Robert W.","family":"Yeh","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)."},{"name":"Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.24.4.928"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.03.049"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/circoutcomes.120.006589"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.119.008231"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.09.595"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.12.020"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1816885"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2019.02.007"},{"key":"e_1_3_3_10_2","unstructured":"Freed M Biniek J Damico A Neuman T. Medicare advantage 2022 spotlight: enrollment update and key trends. 2022. Accessed December 6 2024. https:\/\/www.kff.org\/medicare\/issue-brief\/medicare-advantage-2022-spotlight-first-look\/"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.09.001"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.123.013698"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.2105\/ajph.82.2.243"},{"key":"e_1_3_3_14_2","unstructured":"Jarosek S. Death information in the research identifiable Medicare data. 2018. Accessed December 6 2024. https:\/\/resdac.org\/articles\/death-information-research-identifiable-medicare-data"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007451"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700456"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1514616"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n450"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.120.047729"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.120.046159"},{"key":"e_1_3_3_21_2","unstructured":"21st Century Cures Act H.R. 34 114th Cong. 2015. Accessed December 6 2024. https:\/\/www.congress.gov\/bill\/114th-congress\/house-bill\/34\/text"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.124.014592","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T19:00:49Z","timestamp":1737486049000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.124.014592"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.124.014592"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.124.014592","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"2024-07-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-18","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-21","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}