{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T15:25:25Z","timestamp":1786116325991,"version":"build-2736575974"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Fee-for-service (FFS) Medicare linkage to clinical registries has been used to assess medical device performance, quality improvement, and postmarket surveillance, but have excluded Medicare Advantage (MA). We assessed the accuracy and implications of linking registry data to combined Medicare FFS and MA claims.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>Patients \u226565 years old in the Society of Thoracic Surgeons\/American College of Cardiology Transcatheter Valve Therapy Registry undergoing transcatheter aortic valve replacement (TAVR) or mitral transcatheter edge-to-edge repair, were linked using indirect identifiers to MA and FFS claims from January 1, 2016 to December 31, 2021. Primary outcomes were the linkage rate and representativeness of the linked cohort, assessed by comparing patient characteristics and unadjusted 1-year all-cause mortality between linked and unlinked Transcatheter Valve Therapy records before and after the addition of MA data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Among 364\u2009573 eligible Transcatheter Valve Therapy TAVR procedures, 206\u2009116 (57%) were linked to FFS claims and 111\u2009662 (31%) to MA encounter data, for a combined linkage rate of 87%. FFS linkage rates declined steadily from 2016 to 2021. Inclusion of MA data increased the number of linked procedures by 54%, preserved linkage rates over time, and increased Hispanic (2.26-fold) and Black (1.91-fold) linkage. Characteristics of the linked TAVR cohort closely matched the full Transcatheter Valve Therapy registry population, with most absolute differences under 1%. Unadjusted 1-year TAVR mortality was 12.6% and 11.8% among FFS and MA-linked patients (difference, 0.8% [95% CI, 0.6\u20131.1]). Findings were similar in the mitral transcatheter edge-to-edge repair cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>Inclusion of MA claims in Medicare linkage to TAVR or mitral transcatheter edge-to-edge repair increased cohort size, enhanced subgroup representation, and maintained linkage rates despite declining FFS enrollment. These findings support incorporation of MA data into real-world surveillance, clinical evidence generation, and quality initiatives.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.125.016189","type":"journal-article","created":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T09:00:17Z","timestamp":1786006817000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Linking the TVT Registry to Medicare Advantage and Fee-for-Service Claims: Feasibility, Accuracy, and Implications for Real-World Surveillance Infrastructure"],"prefix":"10.1161","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5516-7658","authenticated-orcid":true,"given":"Sean M.","family":"O\u2019Brien","sequence":"first","affiliation":[{"name":"Department of Biostatistics and Bioinformatics (S.M.O.B., A.S.K.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0389-6434","authenticated-orcid":true,"given":"Bradley G.","family":"Hammill","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (B.G.H., S.L.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6266-4414","authenticated-orcid":true,"given":"Marie C.","family":"Bradley","sequence":"additional","affiliation":[{"name":"Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD (M.C.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charu","family":"Gandotra","sequence":"additional","affiliation":[{"name":"Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD (C.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7469-4047","authenticated-orcid":true,"given":"David J.","family":"Graham","sequence":"additional","affiliation":[{"name":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD (D.J.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4151-5185","authenticated-orcid":true,"given":"Andrzej S.","family":"Kosinski","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics (S.M.O.B., A.S.K.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2838-1186","authenticated-orcid":true,"given":"Steven","family":"Lippman","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (B.G.H., S.L.), Duke University School of Medicine, Durham, NC."},{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pratik","family":"Manandhar","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9549-7907","authenticated-orcid":true,"given":"Husam M.","family":"Salah","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1269-9114","authenticated-orcid":true,"given":"Amit","family":"Vora","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT (A.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6500-7471","authenticated-orcid":true,"given":"Tsuyoshi","family":"Kaneko","sequence":"additional","affiliation":[{"name":"Division of Cardiothoracic Surgery, Washington University, St. Louis, MO (T.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4321-4538","authenticated-orcid":true,"given":"Dharam J.","family":"Kumbhani","sequence":"additional","affiliation":[{"name":"Division of Cardiology, University of Texas, Southwestern, Dallas (D.J.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3016-1150","authenticated-orcid":true,"given":"Wayne","family":"Batchelor","sequence":"additional","affiliation":[{"name":"Medicine Service Line and Schar Heart and Vascular, Inova Health System, Fairfax VA (W.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinod H.","family":"Thourani","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA (V.H.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1599-2957","authenticated-orcid":true,"given":"Sreekanth","family":"Vemulapalli","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham NC (S.M.O.B., B.G.H., A.S.K., S.L., P.M., H.M.S., S.V.)."},{"name":"Duke-Margolis Institute for Health Policy, Durham, NC (S.V.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2026,8,6]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.9991"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1609216"},{"key":"e_1_3_3_4_2","volume-title":"Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff","author":"U.S. Food and Drug Administration","year":"2025","unstructured":"U.S. Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff. 2025;Accessed June 1, 2026. https:\/\/www.fda.gov\/media\/174819\/download"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2024.3901"},{"key":"e_1_3_3_6_2","first-page":"65724","article-title":"Medicaid Services. Medicare program; transitional coverage for emerging technologies.","volume":"89","author":"Centers M","year":"2024","unstructured":"Centers M. Medicaid Services. Medicare program; transitional coverage for emerging technologies. Fed Regist. 2024;89:65724","journal-title":"Fed Regist"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2009.04.002"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.111.963280"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e3182181529"},{"key":"e_1_3_3_10_2","volume-title":"Medicare advantage in 2024: enrollment update and key trends. KFF","author":"Freed M","year":"2024","unstructured":"Freed M, Biniek JF, Damico A, Neuman T. Medicare advantage in 2024: enrollment update and key trends. KFF. 2024. Accessed July 30, 2025. https:\/\/www.kff.org\/medicare\/issue-brief\/medicare-advantage-in-2024-enrollment-update-and-key-trends\/"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2021.0235"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2021.00118"},{"key":"e_1_3_3_13_2","volume-title":"Strengths and limitations of CMS administrative data in research","author":"Research Data Assistance Center","year":"2021","unstructured":"Research Data Assistance Center. Strengths and limitations of CMS administrative data in research. 2021. Accessed July 30, 2025. https:\/\/resdac.org\/articles\/strengths-and-limitations-cms-administrative-data-research"},{"key":"e_1_3_3_14_2","volume-title":"Medicare beneficiary enrollment trends and demographic characteristics. U.S. department of health and human services, office of the assistant secretary for planning and evaluation","author":"Tarazi W","year":"2022","unstructured":"Tarazi W, Welch WP, Nguyen N, Bosworth A, Sheingold S, De Lew N, Sommers BD. Medicare beneficiary enrollment trends and demographic characteristics. U.S. department of health and human services, office of the assistant secretary for planning and evaluation. 2022. Accessed July 30, 2025. https:\/\/aspe.hhs.gov\/sites\/default\/files\/documents\/b9ac26a13b4fdf30c16c24e79df0c99c\/medicare-beneficiary-enrollment-ib.pdf"},{"key":"e_1_3_3_15_2","volume-title":"The promise and pitfalls of Medicare Advantage encounter data. Health Affairs Forefront","author":"Creighton S","year":"2019","unstructured":"Creighton S, Duddy-Tenbrunsel R, Michel J. The promise and pitfalls of Medicare Advantage encounter data. Health Affairs Forefront. 2019. Accessed July 30, 2025. https:\/\/www.healthaffairs.org\/content\/forefront\/promise-and-pitfalls-medicare-advantage-encounter-data"},{"key":"e_1_3_3_16_2","volume-title":"Ensuring the accuracy and completeness of Medicare Advantage encounter data. In: Report to the Congress: Medicare and the Health Care Delivery System. Medicare Payment Advisory Commission","author":"MedPAC","year":"2019","unstructured":"MedPAC. Ensuring the accuracy and completeness of Medicare Advantage encounter data. In: Report to the Congress: Medicare and the Health Care Delivery System. Medicare Payment Advisory Commission; 2019. Accessed August 15, 2025. https:\/\/www.medpac.gov\/wp-content\/uploads\/import_data\/scrape_files\/docs\/default-source\/reports\/jun19_ch7_medpac_reporttocongress_sec.pdf"},{"key":"e_1_3_3_17_2","volume-title":"Medicare advantage: limited progress made to validate encounter data used to ensure proper payments. GAO-17-223","author":"United States Government Accountability Office","year":"2017","unstructured":"United States Government Accountability Office. Medicare advantage: limited progress made to validate encounter data used to ensure proper payments. GAO-17-223. 2017. Accessed August 15, 2025. https:\/\/www.gao.gov\/assets\/gao-17-223.pdf"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2022.1684"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.09.595"},{"key":"e_1_3_3_20_2","volume-title":"Rural-urban commuting area codes. based on 2010 decennial census and 2006-2010 American Community Survey","author":"U.S. Department of Agriculture Economic Research Service","unstructured":"U.S. Department of Agriculture Economic Research Service. Rural-urban commuting area codes. based on 2010 decennial census and 2006-2010 American Community Survey. Accessed July 20, 2025. https:\/\/www.ers.usda.gov\/data-products\/rural-urban-commuting-area-codes\/"},{"key":"e_1_3_3_21_2","volume-title":"Using RUCA data","author":"University of Washington Rural Health Research Center","unstructured":"University of Washington Rural Health Research Center. Using RUCA data. Accessed July 20, 2025. https:\/\/depts.washington.edu\/uwruca\/ruca-uses.php"},{"key":"e_1_3_3_22_2","volume-title":"Distressed communities index","author":"Economic Innovation Group","year":"2024","unstructured":"Economic Innovation Group. Distressed communities index. 2024. Accessed July 30, 2025. https:\/\/eig.org\/distressed-communities\/"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2018.12.022"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/31.6.1246"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2019.09.002"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007451"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.119.008231"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.03.049"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910555"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","unstructured":"O\u2019Brien SM O\u2019Brien E Lucas J Setoguchi S. Study 2: estimating the accuracy of record linkage algorithms in the absence of a true gold standard. in: How do patients feel about sharing and linking health data for research? Patient-centered outcomes research institute. 2020; doi: 10.25302\/07.2020.me.131008637","DOI":"10.25302\/07.2020.me.131008637"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.125.016189","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,6]],"date-time":"2026-08-06T09:00:20Z","timestamp":1786006820000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.125.016189"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,6]]},"references-count":29,"alternative-id":["10.1161\/CIRCINTERVENTIONS.125.016189"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.125.016189","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,6]]},"assertion":[{"value":"2025-10-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e016189"}}