Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Abstract Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes o...

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Autores principales:	Ángel Ferrero-De-Loma-Osorio, Rocío Cózar, Arcadio García-Alberola, Ermengol Valles, Alberto Barrera, Jorge Toquero, Jose Miguel Ormaetxe, Juan Martínez Sánchez, Ricardo Ruiz-Granell, Pablo Bastos Amador, Jose Manuel Rubio, Julio Martí-Amor, Patricia Pascual, Irene Molina, Jesús Daniel Martínez-Alday, RECABA Investigators
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/30128020f3b14feaa42ab407aae856a8
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spelling	oai:doaj.org-article:30128020f3b14feaa42ab407aae856a82021-12-02T16:35:05ZPrimary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study10.1038/s41598-021-96655-32045-2322https://doaj.org/article/30128020f3b14feaa42ab407aae856a82021-08-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-96655-3https://doaj.org/toc/2045-2322Abstract Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use. ClinicalTrials.gov number: NCT02785991.Ángel Ferrero-De-Loma-OsorioRocío CózarArcadio García-AlberolaErmengol VallesAlberto BarreraJorge ToqueroJose Miguel OrmaetxeJuan Martínez SánchezRicardo Ruiz-GranellPablo Bastos AmadorJose Manuel RubioJulio Martí-AmorPatricia PascualIrene MolinaJesús Daniel Martínez-AldayRECABA InvestigatorsNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Ángel Ferrero-De-Loma-Osorio Rocío Cózar Arcadio García-Alberola Ermengol Valles Alberto Barrera Jorge Toquero Jose Miguel Ormaetxe Juan Martínez Sánchez Ricardo Ruiz-Granell Pablo Bastos Amador Jose Manuel Rubio Julio Martí-Amor Patricia Pascual Irene Molina Jesús Daniel Martínez-Alday RECABA Investigators Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
description	Abstract Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use. ClinicalTrials.gov number: NCT02785991.
format	article
author	Ángel Ferrero-De-Loma-Osorio Rocío Cózar Arcadio García-Alberola Ermengol Valles Alberto Barrera Jorge Toquero Jose Miguel Ormaetxe Juan Martínez Sánchez Ricardo Ruiz-Granell Pablo Bastos Amador Jose Manuel Rubio Julio Martí-Amor Patricia Pascual Irene Molina Jesús Daniel Martínez-Alday RECABA Investigators
author_facet	Ángel Ferrero-De-Loma-Osorio Rocío Cózar Arcadio García-Alberola Ermengol Valles Alberto Barrera Jorge Toquero Jose Miguel Ormaetxe Juan Martínez Sánchez Ricardo Ruiz-Granell Pablo Bastos Amador Jose Manuel Rubio Julio Martí-Amor Patricia Pascual Irene Molina Jesús Daniel Martínez-Alday RECABA Investigators
author_sort	Ángel Ferrero-De-Loma-Osorio
title	Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
title_short	Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
title_full	Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
title_fullStr	Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
title_full_unstemmed	Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study
title_sort	primary results of the spanish cryoballoon ablation registry: acute and long-term outcomes of the recaba study
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/30128020f3b14feaa42ab407aae856a8
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Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

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