Pub Date : 2024-08-15eCollection Date: 2024-10-01DOI: 10.24875/RECIC.M24000472
Sandra Ofelia Rosillo Rodríguez
{"title":"[Debate: ECMO in patients with cardiogenic shock due to myocardial infarction. A clinician's perspective].","authors":"Sandra Ofelia Rosillo Rodríguez","doi":"10.24875/RECIC.M24000472","DOIUrl":"10.24875/RECIC.M24000472","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"6 4","pages":"343-345"},"PeriodicalIF":1.2,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-13eCollection Date: 2025-04-01DOI: 10.24875/RECIC.M24000461
Ignacio Cruz-González, Pablo Antúnez-Muiños, Soraya Merchán-Gómez, Javier Rodríguez-Collado, Pedro L Sánchez-Fernández, Sergio López-Tejero
{"title":"[[Transcatheter mitral paravalvular leak closure with the KONAR occluder device]].","authors":"Ignacio Cruz-González, Pablo Antúnez-Muiños, Soraya Merchán-Gómez, Javier Rodríguez-Collado, Pedro L Sánchez-Fernández, Sergio López-Tejero","doi":"10.24875/RECIC.M24000461","DOIUrl":"https://doi.org/10.24875/RECIC.M24000461","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"7 2","pages":"127-129"},"PeriodicalIF":1.2,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144174044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-27eCollection Date: 2024-07-01DOI: 10.24875/RECIC.M24000445
Ernest Spitzer, José M de la Torre Hernández, Ingibjörg Jóna Guðmundsdóttir, Eugene McFadden, Claes Held, Claude Hanet, Eric Boersma, Claire B Ren, Victoria Delgado, David Erlinge, Armando Pérez de Prado, Jeroen J Bax, Jan G P Tijssen
On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.
{"title":"[Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory].","authors":"Ernest Spitzer, José M de la Torre Hernández, Ingibjörg Jóna Guðmundsdóttir, Eugene McFadden, Claes Held, Claude Hanet, Eric Boersma, Claire B Ren, Victoria Delgado, David Erlinge, Armando Pérez de Prado, Jeroen J Bax, Jan G P Tijssen","doi":"10.24875/RECIC.M24000445","DOIUrl":"10.24875/RECIC.M24000445","url":null,"abstract":"<p><p>On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.</p>","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"6 3","pages":"213-223"},"PeriodicalIF":1.2,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097302/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-04eCollection Date: 2024-04-01DOI: 10.24875/RECIC.M23000429
Fernando Mané, Rui Flores, Rodrigo Silva, Inês Conde, Ana Sofia Ferreira, João Costa, Catarina Quina-Rodrigues, Carlos Galvão-Braga, Jorge Marques
Introduction and objectives: In patients with ST-segment elevation myocardial infarction (STEMI) treatment delay significantly affects outcomes. The effect of admission time in STEMI patients is unknown when percutaneous coronary intervention (PCI) is the preferred reperfusion strategy. This study aimed to determine the association between STEMI outcomes and the timing of admission in a PCI center in south-western Europe.
Methods: This retrospective cohort study analyzed the local electronic data from 1222 consecutive STEMI patients treated with PCI. On-hours were defined as admission from Monday to Friday between 8:00 AM and 6:00 PM on non-national holidays.
Results: A total of 439 patients (36%) were admitted on-hours and 783 patients (64%) were admitted off-hours. Baseline characteristics were well-balanced between the 2 groups, including the percentage of patients admitted in cardiogenic shock (on-hours 5% vs off-hours 4%; P = .62). The median time from first medical contact to reperfusion did not differ between the 2 groups (on-hours 120 minutes vs off-hours 123 minutes, P = .54) and no association was observed between admission time and in-hospital mortality (on-hours 5% vs off-hours 5%, P = .90) or 1-year mortality (on-hours 10% vs off-hours 10%, P = .97). Survival analysis showed no differences in on-hours PCI vs off-hours PCI (HR, 1.1; 95%CI, 0.74-1.64; P = .64).
Conclusions: In a contemporary emergency network, the timing of STEMI patients' admission to the PCI center was not associated with reperfusion delays or increased mortality.
{"title":"[On- vs off-hours primary percutaneous coronary intervention: a single-center 5-year experience].","authors":"Fernando Mané, Rui Flores, Rodrigo Silva, Inês Conde, Ana Sofia Ferreira, João Costa, Catarina Quina-Rodrigues, Carlos Galvão-Braga, Jorge Marques","doi":"10.24875/RECIC.M23000429","DOIUrl":"10.24875/RECIC.M23000429","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>In patients with ST-segment elevation myocardial infarction (STEMI) treatment delay significantly affects outcomes. The effect of admission time in STEMI patients is unknown when percutaneous coronary intervention (PCI) is the preferred reperfusion strategy. This study aimed to determine the association between STEMI outcomes and the timing of admission in a PCI center in south-western Europe.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed the local electronic data from 1222 consecutive STEMI patients treated with PCI. On-hours were defined as admission from Monday to Friday between 8:00 AM and 6:00 PM on non-national holidays.</p><p><strong>Results: </strong>A total of 439 patients (36%) were admitted on-hours and 783 patients (64%) were admitted off-hours. Baseline characteristics were well-balanced between the 2 groups, including the percentage of patients admitted in cardiogenic shock (on-hours 5% vs off-hours 4%; <i>P</i> = .62). The median time from first medical contact to reperfusion did not differ between the 2 groups (on-hours 120 minutes vs off-hours 123 minutes, <i>P</i> = .54) and no association was observed between admission time and in-hospital mortality (on-hours 5% vs off-hours 5%, <i>P</i> = .90) or 1-year mortality (on-hours 10% vs off-hours 10%, <i>P</i> = .97). Survival analysis showed no differences in on-hours PCI vs off-hours PCI (HR, 1.1; 95%CI, 0.74-1.64; <i>P</i> = .64).</p><p><strong>Conclusions: </strong>In a contemporary emergency network, the timing of STEMI patients' admission to the PCI center was not associated with reperfusion delays or increased mortality.</p>","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"6 2","pages":"76-82"},"PeriodicalIF":1.1,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-04eCollection Date: 2025-04-01DOI: 10.24875/RECIC.M24000447
Carmen Garrote-Coloma, Tomás Benito, Armando Pérez de Prado, Ignacio Iglesias, María López-Benito, Felipe Fernández-Vázquez
{"title":"[[A new echocardiographic view for the TricValve system]].","authors":"Carmen Garrote-Coloma, Tomás Benito, Armando Pérez de Prado, Ignacio Iglesias, María López-Benito, Felipe Fernández-Vázquez","doi":"10.24875/RECIC.M24000447","DOIUrl":"https://doi.org/10.24875/RECIC.M24000447","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"7 2","pages":"125-126"},"PeriodicalIF":1.2,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12118560/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-06DOI: 10.24875/recic.m23000373
María Álvarez-Fuente, María Toledano, Ignacio Hernández, Elvira Garrido-Lestache, Natalia Rivero, Inmaculada Sánchez, Isabel Molina, Itziar García Ormazábal y, María Jesús del Cerro
{"title":"Experiencia inicial con la nueva v�lvula pulmonar percut�nea autoexpandible Venus P","authors":"María Álvarez-Fuente, María Toledano, Ignacio Hernández, Elvira Garrido-Lestache, Natalia Rivero, Inmaculada Sánchez, Isabel Molina, Itziar García Ormazábal y, María Jesús del Cerro","doi":"10.24875/recic.m23000373","DOIUrl":"https://doi.org/10.24875/recic.m23000373","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"15 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135545581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-06DOI: 10.24875/recic.m23000381
Alfonso Jurado-Román, Antonio Gómez-Menchero, Ignacio J. Amat-Santos, Juan Caballero-Borrego, Soledad Ojeda, Raymundo Ocaranza-Sánchez, Santiago Jiménez-Valero, Guillermo Galeote, Duarte Cacela, y Raúl Moreno
{"title":"Dise�o del estudio ROLLERCOASTR: aterectom�a rotacional, litotricia o l�ser para el tratamiento de estenosis coronarias calcificadas","authors":"Alfonso Jurado-Román, Antonio Gómez-Menchero, Ignacio J. Amat-Santos, Juan Caballero-Borrego, Soledad Ojeda, Raymundo Ocaranza-Sánchez, Santiago Jiménez-Valero, Guillermo Galeote, Duarte Cacela, y Raúl Moreno","doi":"10.24875/recic.m23000381","DOIUrl":"https://doi.org/10.24875/recic.m23000381","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"28 9","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135584185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-06DOI: 10.24875/recic.m23000408
José M. de la Torre-Hernández, Fernando Alfonso, Raúl Moreno, Soledad Ojeda, Armando Pérez de Prado y, Rafael Romaguera
{"title":"El a�o del primer �impacto� para REC: Interventional Cardiology","authors":"José M. de la Torre-Hernández, Fernando Alfonso, Raúl Moreno, Soledad Ojeda, Armando Pérez de Prado y, Rafael Romaguera","doi":"10.24875/recic.m23000408","DOIUrl":"https://doi.org/10.24875/recic.m23000408","url":null,"abstract":"","PeriodicalId":34295,"journal":{"name":"REC Interventional Cardiology","volume":"28 8","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135584186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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