Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial

Background: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. Methods and Results: This prospective, randomized, multicenter, noninferiority st...

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Autores: Ferrero-de-Loma-Osorio Á, GARCIA, A., Castillo-Castillo J, Izquierdo-de-Francisco M, Ibáñez-Críado A, Moreno-Arribas J, Martínez A, Bertomeu-González V, López-Mases P, Ajo-Ferrer M, Núñez C, Bondanza-Saavedra L, Sánchez-Gómez JM, MARTINEZ, J., Chorro-Gascó FJ, Ruiz-Granell R
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p4410
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/4410
Access Level:acceso abierto
Palabra clave:atrial fibrillation
cryosurgery
cryotherapy
heart atria
humans
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spelling Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority TrialFerrero-de-Loma-Osorio ÁGARCIA, A.Castillo-Castillo JIzquierdo-de-Francisco MIbáñez-Críado AMoreno-Arribas JMartínez ABertomeu-González VLópez-Mases PAjo-Ferrer MNúñez CBondanza-Saavedra LSánchez-Gómez JMMARTINEZ, J.Chorro-Gascó FJRuiz-Granell Ratrial fibrillationcryosurgerycryotherapyheart atriahumansBackground: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. Methods and Results: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Delta=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.62 versus 9.92.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3 +/- 7 versus 19.4 +/- 4.3 minutes; P<0.001), left atrium time (104 +/- 25 versus 92 +/- 23 minutes; P<0.01), and total procedure time (135 +/- 35 versus 119 +/- 31 minutes; P<0.01). No differences were observed in complications or acute reconnections. Conclusions: The new time-to-effect-based cryotherapy dosage protocol led to shorter cryotherapy and procedure times, with equal safety, and similar acute and 1-year follow-up results, compared with the conventional approach.LIPPINCOTT WILLIAMS & WILKINS2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/4410Circulation-Arrhythmia and ElectrophysiologyISSN: 19413149ISSNe: 19413084reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p44102026-06-11T12:45:17Z
dc.title.none.fl_str_mv Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
title Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
spellingShingle Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
Ferrero-de-Loma-Osorio Á
atrial fibrillation
cryosurgery
cryotherapy
heart atria
humans
title_short Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
title_full Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
title_fullStr Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
title_full_unstemmed Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
title_sort Time-to-Effect-Based Dosing Strategy for Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation Results of the plusONE Multicenter Randomized Controlled Noninferiority Trial
dc.creator.none.fl_str_mv Ferrero-de-Loma-Osorio Á
GARCIA, A.
Castillo-Castillo J
Izquierdo-de-Francisco M
Ibáñez-Críado A
Moreno-Arribas J
Martínez A
Bertomeu-González V
López-Mases P
Ajo-Ferrer M
Núñez C
Bondanza-Saavedra L
Sánchez-Gómez JM
MARTINEZ, J.
Chorro-Gascó FJ
Ruiz-Granell R
author Ferrero-de-Loma-Osorio Á
author_facet Ferrero-de-Loma-Osorio Á
GARCIA, A.
Castillo-Castillo J
Izquierdo-de-Francisco M
Ibáñez-Críado A
Moreno-Arribas J
Martínez A
Bertomeu-González V
López-Mases P
Ajo-Ferrer M
Núñez C
Bondanza-Saavedra L
Sánchez-Gómez JM
MARTINEZ, J.
Chorro-Gascó FJ
Ruiz-Granell R
author_role author
author2 GARCIA, A.
Castillo-Castillo J
Izquierdo-de-Francisco M
Ibáñez-Críado A
Moreno-Arribas J
Martínez A
Bertomeu-González V
López-Mases P
Ajo-Ferrer M
Núñez C
Bondanza-Saavedra L
Sánchez-Gómez JM
MARTINEZ, J.
Chorro-Gascó FJ
Ruiz-Granell R
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv atrial fibrillation
cryosurgery
cryotherapy
heart atria
humans
topic atrial fibrillation
cryosurgery
cryotherapy
heart atria
humans
description Background: The optimal dosage of cryotherapy during cryoballoon ablation of pulmonary veins is still unclear. This trial tested the noninferiority of a novel, individualized, cryotherapy-dosing strategy for each vein. Methods and Results: This prospective, randomized, multicenter, noninferiority study included 140 patients with paroxysmal atrial fibrillation, which was refractory to antiarrhythmic drugs. Patients were randomly assigned to a conventional strategy of 180-second cryoballoon applications per vein with a bonus freeze (control group, n=70) or to a shorter-time application protocol, with 1 application that lasted the time required for electric block time to effect plus 60- and a 120-second freeze bonus (study group, n=70). Patients were followed with a long-term monitoring system of 30 days. At 1-year follow-up, no difference was observed in terms of free atrial fibrillation-recurrence rates: 79.4% in control versus 78.3% in study group (Delta=1.15%; 90% confidence interval, -10.33% to 12.63%; P=0.869). Time to effect was detected in 72.1% of veins. The control and study groups had similar mean number of applications per patient (9.62 versus 9.92.4; P=0.76). Compared with controls, the study group had a significantly shorter cryotherapy time (28.3 +/- 7 versus 19.4 +/- 4.3 minutes; P<0.001), left atrium time (104 +/- 25 versus 92 +/- 23 minutes; P<0.01), and total procedure time (135 +/- 35 versus 119 +/- 31 minutes; P<0.01). No differences were observed in complications or acute reconnections. Conclusions: The new time-to-effect-based cryotherapy dosage protocol led to shorter cryotherapy and procedure times, with equal safety, and similar acute and 1-year follow-up results, compared with the conventional approach.
publishDate 2017
dc.date.none.fl_str_mv 2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/4410
url https://fisabio.portalinvestigacion.com/publicaciones/4410
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
publisher.none.fl_str_mv LIPPINCOTT WILLIAMS & WILKINS
dc.source.none.fl_str_mv Circulation-Arrhythmia and Electrophysiology
ISSN: 19413149
ISSNe: 19413084
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.811543

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