{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T01:09:53Z","timestamp":1785460193761,"version":"3.56.0"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,3,20]],"date-time":"2023-03-20T00:00:00Z","timestamp":1679270400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Abbott"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,5,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and\/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx\u2122, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>The SMART Registry is an international prospective observational study. The main endpoints were ICM safety (incidence of serious adverse device and procedure-related events (SADEs) at 1 month), ICM clinical value (incidence of device-detected true arrhythmias and of clinical diagnoses and interventions), and patient-reported experience measurements (PREMs). A total of 1400 subjects were enrolled. ICM indications included syncope (49.1%), AF (18.8%), unexplained palpitations (13.6%), risk of ventricular arrhythmia (6.6%), and cryptogenic stroke (6.0%). Freedom from SADEs at 1 month was 99.4% (95% Confidence Interval: 98.8\u201399.7%). In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant proportion of patients; in particular, a pacemaker implant was performed after bradycardia detection in 8.9% of subjects who received an ICM for syncope and oral anticoagulation therapy was indicated after AF detection in 15.7% of subjects with cryptogenic stroke. PREMs showed that 78.2% of subjects were satisfied with the remote monitoring patient app.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euad068","type":"journal-article","created":{"date-parts":[[2023,3,20]],"date-time":"2023-03-20T07:44:49Z","timestamp":1679298289000},"source":"Crossref","is-referenced-by-count":12,"title":["New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry"],"prefix":"10.1093","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1605-0059","authenticated-orcid":false,"given":"Fabio","family":"Quartieri","sequence":"first","affiliation":[{"name":"Arcispedale Santa Maria Nuova , Viale Risorgimento, 80, 42123 Reggio Emilia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9394-1018","authenticated-orcid":false,"given":"Manyam","family":"Harish","sequence":"additional","affiliation":[{"name":"Erlanger Medical Center , 975 E 3rd St, Chattanooga, TN 37403 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6062-5286","authenticated-orcid":false,"given":"Leonardo","family":"Cal\u00f2","sequence":"additional","affiliation":[{"name":"Policlinico Casilino , Via Casilina, 1049, 00169 Roma , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7106-5619","authenticated-orcid":false,"given":"Iftikhar","family":"Ebrahim","sequence":"additional","affiliation":[{"name":"Netcare Unitas Hospital , 866 Clifton Ave, Die Hoewes, Centurion, 0163 , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Fusco","sequence":"additional","affiliation":[{"name":"Casa di Cura Pederzoli , Via Monte Baldo 24, 37019 Peschiera del Garda, Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Mester","sequence":"additional","affiliation":[{"name":"Bay Area Cardiology Associates , 635 Eichenfeld Dr, Brandon, FL 33511 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2088-8070","authenticated-orcid":false,"given":"Filippo","family":"Cauti","sequence":"additional","affiliation":[{"name":"Ospedale S. Giovanni Calibita Fatebenefratelli , Via di Ponte Quattro Capi 39, 00186 Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3288-0594","authenticated-orcid":false,"given":"Seung-Jung","family":"Park","sequence":"additional","affiliation":[{"name":"Samsung Medical Center , 81 Ilwon-ro, Gangnam-gu, 06351 Seoul , South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0306-7764","authenticated-orcid":false,"given":"Pietro","family":"Francia","sequence":"additional","affiliation":[{"name":"Ospedale S. Andrea , Via di Grottarossa, 1035, 00189 Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8345-3990","authenticated-orcid":false,"given":"Marco","family":"Giovagnoni","sequence":"additional","affiliation":[{"name":"Casa Di Cura Citta di Aprilia , Via delle Palme, 25, 04011 Aprilia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3729-3137","authenticated-orcid":false,"given":"Pedro","family":"Adragao","sequence":"additional","affiliation":[{"name":"Hospital de Santa Cruz , Av. Prof. Dr. Reinaldo dos Santos, 2790, 134 Carnaxide, Lisbon , Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Vezi","sequence":"additional","affiliation":[{"name":"Busamed Gateway Private Hospital , 36-38 Aurora Dr, Umhlanga Rocks, Umhlanga 4319 , South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjiao","family":"Lin","sequence":"additional","affiliation":[{"name":"Abbott , 15900 Valley View Ct, Sylmar, CA 91342 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chananit Sintuu","family":"Hutson","sequence":"additional","affiliation":[{"name":"Abbott , 15900 Valley View Ct, Sylmar, CA 91342 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6204-8745","authenticated-orcid":false,"given":"Andrea","family":"Grammatico","sequence":"additional","affiliation":[{"name":"Abbott , Corporate Village Da Vincilaan 11, 1935 Zaventem , 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ACCF\/AHA\/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation\/American Heart Association task force on practice guidelines","volume":"9","author":"Tracy","year":"2012","journal-title":"Heart Rhythm"},{"key":"2023053008535378300_euad068-B7","doi-asserted-by":"crossref","first-page":"2893","DOI":"10.1093\/eurheartj\/ehw210","article-title":"2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS","volume":"37","author":"Kirchhof","year":"2016","journal-title":"Eur Hear J"},{"key":"2023053008535378300_euad068-B8","doi-asserted-by":"crossref","first-page":"2478","DOI":"10.1056\/NEJMoa1313600","article-title":"Cryptogenic stroke and underlying atrial fibrillation","volume":"370","author":"Sanna","year":"2014","journal-title":"N Engl J 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