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Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal

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Resumo:Introduction: Remote monitoring (RM) is a safe and effective alternative to in-office conventional follow-up. Objective: We aimed to evaluate patient satisfaction with RM and its impact on healthcare resources in a population with cardiac implantable electronic devices. Methods: Randomized, pragmatic, open-label controlled trial, with adult wearers of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with ICD (CRT-D), eligible for the CareLink® system. Patients newly implanted or with previous conventional follow-up were randomized to RM or conventional follow-up (control), and followed for 12 months, according to the centers' practice. The number of in-office visits and adverse events were compared between groups. Patient and healthcare professionals' satisfaction with RM were described. Results: Of the 134 randomized patients (69 RM; 65 control, aged 60±13 years), 80% were male, 23% employed, 72% ICD wearers and 54% newly implanted. Most patients (70%) reported travel costs less than 15€/visit, and 46% daily routine interference with in-office visits. Median physician/technician time with patient was 15 min/15 min, per in-office visit. Excluding baseline and final visits, control patients had more in-office visits in total: median 1 vs. 0, p<0.001. In 81% of the in-office visits, no clinical measures were taken. There were 10 adverse events, with no differences between groups. At the final visit, 95% of RM patients considered RM easy/very easy to use, and would all prefer to maintain RM and recommend it to others. All professionals found the CareLink website easy/very easy to use and were satisfied with transmission data. Conclusions: In a Portuguese population with ICD and CRT-D, RM safely reduced the burden of in-office visits, with high levels of satisfaction among patients and healthcare professionals.
Autores principais:Oliveira, Mário
Outros Autores:Fernandes, Milene; Reis, Hipólito; Primo, João; Sanfins, Victor; Silva, Vânia; Cunha, Pedro Silva; Silva, Mónica; Nicola, Paulo Jorge Morais Zamith
Assunto:Implantable cardioverter-defibrillator Follow-up Remote monitoring
Ano:2022
País:Portugal
Tipo de documento:artigo
Tipo de acesso:acesso aberto
Instituição associada:Universidade de Lisboa
Idioma:inglês
Origem:Repositório da Universidade de Lisboa
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author Oliveira, Mário
author2 Fernandes, Milene
Reis, Hipólito
Primo, João
Sanfins, Victor
Silva, Vânia
Cunha, Pedro Silva
Silva, Mónica
Nicola, Paulo Jorge Morais Zamith
author2_role author
author
author
author
author
author
author
author
author_facet Oliveira, Mário
Fernandes, Milene
Reis, Hipólito
Primo, João
Sanfins, Victor
Silva, Vânia
Cunha, Pedro Silva
Silva, Mónica
Nicola, Paulo Jorge Morais Zamith
author_role author
contributor_name_str_mv Repositório Científico de Acesso Aberto da ULisboa
country_str PT
creators_json_txt [{\"Person.name\":\"Oliveira, Mário\"},{\"Person.name\":\"Fernandes, Milene\",\"Person.identifier.orcid\":\"0000-0002-6603-5092\"},{\"Person.name\":\"Reis, Hipólito\"},{\"Person.name\":\"Primo, João\"},{\"Person.name\":\"Sanfins, Victor\"},{\"Person.name\":\"Silva, Vânia\"},{\"Person.name\":\"Cunha, Pedro Silva\"},{\"Person.name\":\"Silva, Mónica\"},{\"Person.name\":\"Nicola, Paulo Jorge Morais Zamith\",\"Person.identifier.orcid\":\"0000-0003-0175-8457\"}]
datacite.contributors.contributor.contributorName.fl_str_mv Repositório Científico de Acesso Aberto da ULisboa
datacite.creators.creator.creatorName.fl_str_mv Oliveira, Mário
Fernandes, Milene
Reis, Hipólito
Primo, João
Sanfins, Victor
Silva, Vânia
Cunha, Pedro Silva
Silva, Mónica
Nicola, Paulo Jorge Morais Zamith
datacite.date.Accepted.fl_str_mv 2022-01-01T00:00:00Z
datacite.date.available.fl_str_mv 2022-12-16T15:50:07Z
datacite.date.embargoed.fl_str_mv 2022-12-16T15:50:07Z
datacite.rights.fl_str_mv http://purl.org/coar/access_right/c_abf2
datacite.subjects.subject.fl_str_mv Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
datacite.titles.title.fl_str_mv Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
Monitoração remota versus seguimento hospitalar presencial em portadores de cardioversor-desfibrilhador: resultados dum estudo randomizado em Portugal
dc.contributor.none.fl_str_mv Repositório Científico de Acesso Aberto da ULisboa
dc.creator.none.fl_str_mv Oliveira, Mário
Fernandes, Milene
Reis, Hipólito
Primo, João
Sanfins, Victor
Silva, Vânia
Cunha, Pedro Silva
Silva, Mónica
Nicola, Paulo Jorge Morais Zamith
dc.date.Accepted.fl_str_mv 2022-01-01T00:00:00Z
dc.date.available.fl_str_mv 2022-12-16T15:50:07Z
dc.date.embargoed.fl_str_mv 2022-12-16T15:50:07Z
dc.format.none.fl_str_mv application/pdf
dc.identifier.none.fl_str_mv http://hdl.handle.net/10451/55431
dc.language.none.fl_str_mv eng
dc.publisher.none.fl_str_mv Elsevier
dc.rights.cclincense.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.none.fl_str_mv http://purl.org/coar/access_right/c_abf2
dc.subject.none.fl_str_mv Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
dc.title.fl_str_mv Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
Monitoração remota versus seguimento hospitalar presencial em portadores de cardioversor-desfibrilhador: resultados dum estudo randomizado em Portugal
dc.type.none.fl_str_mv http://purl.org/coar/resource_type/c_6501
description Introduction: Remote monitoring (RM) is a safe and effective alternative to in-office conventional follow-up. Objective: We aimed to evaluate patient satisfaction with RM and its impact on healthcare resources in a population with cardiac implantable electronic devices. Methods: Randomized, pragmatic, open-label controlled trial, with adult wearers of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with ICD (CRT-D), eligible for the CareLink® system. Patients newly implanted or with previous conventional follow-up were randomized to RM or conventional follow-up (control), and followed for 12 months, according to the centers' practice. The number of in-office visits and adverse events were compared between groups. Patient and healthcare professionals' satisfaction with RM were described. Results: Of the 134 randomized patients (69 RM; 65 control, aged 60±13 years), 80% were male, 23% employed, 72% ICD wearers and 54% newly implanted. Most patients (70%) reported travel costs less than 15€/visit, and 46% daily routine interference with in-office visits. Median physician/technician time with patient was 15 min/15 min, per in-office visit. Excluding baseline and final visits, control patients had more in-office visits in total: median 1 vs. 0, p<0.001. In 81% of the in-office visits, no clinical measures were taken. There were 10 adverse events, with no differences between groups. At the final visit, 95% of RM patients considered RM easy/very easy to use, and would all prefer to maintain RM and recommend it to others. All professionals found the CareLink website easy/very easy to use and were satisfied with transmission data. Conclusions: In a Portuguese population with ICD and CRT-D, RM safely reduced the burden of in-office visits, with high levels of satisfaction among patients and healthcare professionals.
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institution Universidade de Lisboa
instname_str Universidade de Lisboa
language eng
network_acronym_str ul
network_name_str Repositório da Universidade de Lisboa
oai_identifier_str oai:repositorio.ulisboa.pt:10451/55431
organization_str_mv urn:organizationAcronym:ul
person_str_mv Oliveira, Mário
Fernandes, Milene
Fernandes, Milene
http://orcid.org/0000-0002-6603-5092
0000-0002-6603-5092
Reis, Hipólito
Primo, João
Sanfins, Victor
Silva, Vânia
Cunha, Pedro Silva
Silva, Mónica
Nicola, Paulo Jorge Morais Zamith
Nicola, Paulo Jorge Morais Zamith
https://www.ciencia-id.pt/EC13-192D-69C8
EC13-192D-69C8
http://orcid.org/0000-0003-0175-8457
0000-0003-0175-8457
publishDate 2022
publisher.none.fl_str_mv Elsevier
reponame_str Repositório da Universidade de Lisboa
repository_id_str urn:repositoryAcronym:ul
service_str_mv urn:repositoryAcronym:ul
spelling engElsevierpt_PTIntroduction: Remote monitoring (RM) is a safe and effective alternative to in-office conventional follow-up. Objective: We aimed to evaluate patient satisfaction with RM and its impact on healthcare resources in a population with cardiac implantable electronic devices. Methods: Randomized, pragmatic, open-label controlled trial, with adult wearers of implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with ICD (CRT-D), eligible for the CareLink® system. Patients newly implanted or with previous conventional follow-up were randomized to RM or conventional follow-up (control), and followed for 12 months, according to the centers' practice. The number of in-office visits and adverse events were compared between groups. Patient and healthcare professionals' satisfaction with RM were described. Results: Of the 134 randomized patients (69 RM; 65 control, aged 60±13 years), 80% were male, 23% employed, 72% ICD wearers and 54% newly implanted. Most patients (70%) reported travel costs less than 15€/visit, and 46% daily routine interference with in-office visits. Median physician/technician time with patient was 15 min/15 min, per in-office visit. Excluding baseline and final visits, control patients had more in-office visits in total: median 1 vs. 0, p<0.001. In 81% of the in-office visits, no clinical measures were taken. There were 10 adverse events, with no differences between groups. At the final visit, 95% of RM patients considered RM easy/very easy to use, and would all prefer to maintain RM and recommend it to others. All professionals found the CareLink website easy/very easy to use and were satisfied with transmission data. Conclusions: In a Portuguese population with ICD and CRT-D, RM safely reduced the burden of in-office visits, with high levels of satisfaction among patients and healthcare professionals.application/pdfpt_PTRemote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in PortugalAlternativeTitlept_PTMonitoração remota versus seguimento hospitalar presencial em portadores de cardioversor-desfibrilhador: resultados dum estudo randomizado em PortugalOliveira, MárioPersonalFernandes, MileneDSpacehttp://dspace.org/items/19e0d31e-2a54-4d5d-80b7-4d42ace08111DSpacehttp://dspace.org/items/19e0d31e-2a54-4d5d-80b7-4d42ace08111FernandesMileneORCIDhttp://orcid.org0000-0002-6603-5092Reis, HipólitoPrimo, JoãoSanfins, VictorSilva, VâniaCunha, Pedro SilvaSilva, MónicaPersonalNicola, Paulo Jorge Morais ZamithDSpacehttp://dspace.org/items/b43213c5-6a7a-4779-904e-19909e396b89DSpacehttp://dspace.org/items/b43213c5-6a7a-4779-904e-19909e396b89Morais Zamith NicolaPaulo JorgeCiência IDhttps://www.ciencia-id.ptEC13-192D-69C8ORCIDhttp://orcid.org0000-0003-0175-8457Scopus Author IDhttps://www.scopus.com7003405044HostingInstitutionOrganizationalRepositório Científico de Acesso Aberto da ULisboae-mailmailto:repositorio@reitoria.ulisboa.ptrepositorio@reitoria.ulisboa.ptISSNIsPartOf0870-2551DOIIsPartOf10.1016/j.repc.2021.08.0172022-12-16T15:50:07Z20222022-01-01T00:00:00ZHandlehttp://hdl.handle.net/10451/55431http://purl.org/coar/access_right/c_abf2open accessImplantable cardioverter-defibrillatorFollow-upRemote monitoring727505 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal article2022http://creativecommons.org/licenses/by-nc-nd/4.0/http://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://repositorio.ulisboa.pt/bitstreams/cf112e2d-bd8d-4b4d-bb39-6ebd5f1ae916/downloadRevista Portuguesa de Cardiologia4112987997
spellingShingle Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
Oliveira, Mário
Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
status SINGLETON
subject.fl_str_mv Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
title Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
title_full Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
title_fullStr Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
title_full_unstemmed Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
title_short Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
title_sort Remote versus in-office monitoring for implantable cardioverter defibrillators: results from a randomized pragmatic controlled study in Portugal
topic Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
topic_facet Implantable cardioverter-defibrillator
Follow-up
Remote monitoring
url http://hdl.handle.net/10451/55431
visible 1