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http://hdl.handle.net/1942/37084
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DC Field | Value | Language |
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dc.contributor.author | Galea, Roberto | - |
dc.contributor.author | De Marco, Federico | - |
dc.contributor.author | Meneveau, Nicolas | - |
dc.contributor.author | Aminian, Adel | - |
dc.contributor.author | Anselme, Frederic | - |
dc.contributor.author | Grani, Christoph | - |
dc.contributor.author | Huber, Adrian T. | - |
dc.contributor.author | Teiger, Emmanuel | - |
dc.contributor.author | Iriart, Xavier | - |
dc.contributor.author | Bosombo, Flora Babongo | - |
dc.contributor.author | Heg, Dik | - |
dc.contributor.author | Franzone, Anna | - |
dc.contributor.author | VRANCKX, Pascal | - |
dc.contributor.author | Fischer, Urs | - |
dc.contributor.author | Pedrazzini, Giovanni | - |
dc.contributor.author | Bedogni, Francesco | - |
dc.contributor.author | Raber, Lorenz | - |
dc.contributor.author | Valgimigli, Marco | - |
dc.date.accessioned | 2022-03-30T09:36:55Z | - |
dc.date.available | 2022-03-30T09:36:55Z | - |
dc.date.issued | 2022 | - |
dc.date.submitted | 2022-03-25T10:27:13Z | - |
dc.identifier.citation | CIRCULATION, 145 (10) , p. 724 -738 | - |
dc.identifier.uri | http://hdl.handle.net/1942/37084 | - |
dc.description.abstract | BACKGROUND: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. METHODS: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. Results: Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. CONCLUSIONS: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. | - |
dc.description.sponsorship | Dr Valgimigli conceived and designed the study. Drs Valgimigli, Galea, Bosombo, and Heg acquired the data and participated in data analysis and data interpretation. All authors participated in enrollment of patients and performed clinical follow-up, along with revising the draft critically for important intellectual content. Drs Valgimigli and Galea wrote the first draft, reviewed, and revised the manuscript. All authors approved the final version of the manuscript and ensured that the accuracy or integrity of any part of the work is appropriately investigated and resolved. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. Images of Amplatzer Amulet device are reproduced with permission of Abbott, © 2021. All rights reserved. Images of Watchman FLX have been provided courtesy of Boston Scientific, The study sponsor, Insel Gruppe AG, Universitätsklinik für Kardiologie, CH-3010 Bern (Switzerland), for the conduction of the study was supported by local available funding and a research grant from Abbott. The funding company was not involved with the study processes, including site selection and management, and data collection and analysis. Dr De Marco reports consultancies and paid expert testimonies from Abbott and Boston-Scientific. Dr Meneveau reports personal fees and other from Abbott and St. Jude-Medical, grants from Boston-Scientific, during the conduct of the study; grants and personal fees from BMS-Pfizer, personal fees from Bayer-HealthCare, Boehringer-Ingelheim, AstraZeneca, outside the submitted work. Dr Aminian is a proctor and consultant for Abbott and Boston-Scientific. Dr Anselme is consultant for Boston-Scientific. Dr Teiger reports personal fees from Abbott for proctoring. Dr Iriart is a proctor for Boston-Scientific and Abbott, and he is a consultant for Philips-Health-Care. Dr Vranckx reports personal fees from AstraZeneca, Bayer-Health-Care, Terumo, and Daiichi‐Sankyo outside the submitted work. Dr Fischer reports grants from Medtronic, other from Medtronic, Stryker and CSL-Behring, outside the submitted work. Dr Bosombo is proctor for Abbott, Boston-Scientific and Medtronic; he reports consultancies from Terumo and Meril. Dr Räber reports research grants to institution by Abbott-Vascular, Boston-Scientific, Biotronik, Infraredx, Heartflow, Sanofi, and Regeneron. He reports speaker/consultation fees by Abbott-Vascular, Amgen, AstraZeneca, CSL-Behring, Canon, Occlutech, Sanofi, Vifor. Dr Valgimigli has received grants and personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott-Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia-Pharmaceuticals-Ltd., Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers-Squibb-SA, iVascular, and Medscape. All other authors have reported that they have no relationships relevant to the contents of this article to disclose. | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.rights | 2021 Boston Scientific Corporation or its affiliates. All rights reserved. | - |
dc.subject.other | atrial appendage | - |
dc.subject.other | computed tomography angiography | - |
dc.title | Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 738 | - |
dc.identifier.issue | 10 | - |
dc.identifier.spage | 724 | - |
dc.identifier.volume | 145 | - |
local.format.pages | 15 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Valgimigli, M (corresponding author), Cardioctr Ticino Inst, Via Tesserete 48, CH-6900 Lugano, Switzerland.; Valgimigli, M (corresponding author), Univ Svizzera Italiana USI, Via Tesserete 48, CH-6900 Lugano, Switzerland. | - |
dc.description.notes | marco.valgimigli@coc.ch | - |
local.publisher.place | TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1161/CIRCULATIONAHA.121.057859 | - |
dc.identifier.pmid | 34747186 | - |
dc.identifier.isi | WOS:000764243700002 | - |
dc.contributor.orcid | Galea, Roberto/0000-0002-2492-9960; Huber, Adrian | - |
dc.contributor.orcid | Thomas/0000-0001-6146-8238; aminian, adel/0000-0002-4667-9181 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Galea, Roberto; Grani, Christoph; Raber, Lorenz; Valgimigli, Marco] Univ Bern, Dept Cardiol, Bern, Switzerland. | - |
local.description.affiliation | [Huber, Adrian T.] Univ Bern, Dept Diagnost Intervent & Pediat Radiol, Bern, Switzerland. | - |
local.description.affiliation | [Fischer, Urs] Univ Bern, Dept Neurol, Bern, Switzerland. | - |
local.description.affiliation | [Bosombo, Flora Babongo; Heg, Dik] Univ Bern, Bern Univ Hosp, Clin Trials Unit, Bern, Switzerland. | - |
local.description.affiliation | [De Marco, Federico; Bedogni, Francesco] IRCCS Policlin San Donato, Dept Cardiol, Milan, Italy. | - |
local.description.affiliation | [Meneveau, Nicolas] Univ Burgundy Franche Comte, Besancon Univ Hosp, Besancon, France. | - |
local.description.affiliation | [Aminian, Adel] Ctr Hosp Univ Charleroi, Dept Cardiol, Charleroi, Belgium. | - |
local.description.affiliation | [Anselme, Frederic] Univ Hosp Rouen, Dept Cardiol, Rouen, France. | - |
local.description.affiliation | [Teiger, Emmanuel] Publ Assistance Hosp Paris, Henri Mondor Hosp, Dept Cardiol, Creteil, France. | - |
local.description.affiliation | [Iriart, Xavier] CHU Bordeaux, Hop Cardiol Haut Leveque, Dept Pediat & Adult Congenital Cardiol, Bordeaux, France. | - |
local.description.affiliation | [Franzone, Anna] Univ Federico II Univ, Dept Adv Biomed Sci, Naples, Italy. | - |
local.description.affiliation | [Vranckx, Pascal] Jessa Ziekenhuis, Dept Cardiol & Crit Care Med, Hartctr Hasselt, Hasselt, Belgium. | - |
local.description.affiliation | [Vranckx, Pascal] Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium. | - |
local.description.affiliation | [Fischer, Urs] Univ Basel, Univ Hosp Basel, Dept Neurol, Basel, Switzerland. | - |
local.description.affiliation | [Pedrazzini, Giovanni; Valgimigli, Marco] Cardioctr Ticino Inst, Via Tesserete 48, CH-6900 Lugano, Switzerland. | - |
local.description.affiliation | [Pedrazzini, Giovanni; Valgimigli, Marco] Univ Svizzera Italiana USI, Via Tesserete 48, CH-6900 Lugano, Switzerland. | - |
local.uhasselt.international | yes | - |
item.fullcitation | Galea, Roberto; De Marco, Federico; Meneveau, Nicolas; Aminian, Adel; Anselme, Frederic; Grani, Christoph; Huber, Adrian T.; Teiger, Emmanuel; Iriart, Xavier; Bosombo, Flora Babongo; Heg, Dik; Franzone, Anna; VRANCKX, Pascal; Fischer, Urs; Pedrazzini, Giovanni; Bedogni, Francesco; Raber, Lorenz & Valgimigli, Marco (2022) Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. In: CIRCULATION, 145 (10) , p. 724 -738. | - |
item.accessRights | Open Access | - |
item.fulltext | With Fulltext | - |
item.validation | ecoom 2023 | - |
item.contributor | Galea, Roberto | - |
item.contributor | De Marco, Federico | - |
item.contributor | Meneveau, Nicolas | - |
item.contributor | Aminian, Adel | - |
item.contributor | Anselme, Frederic | - |
item.contributor | Grani, Christoph | - |
item.contributor | Huber, Adrian T. | - |
item.contributor | Teiger, Emmanuel | - |
item.contributor | Iriart, Xavier | - |
item.contributor | Bosombo, Flora Babongo | - |
item.contributor | Heg, Dik | - |
item.contributor | Franzone, Anna | - |
item.contributor | VRANCKX, Pascal | - |
item.contributor | Fischer, Urs | - |
item.contributor | Pedrazzini, Giovanni | - |
item.contributor | Bedogni, Francesco | - |
item.contributor | Raber, Lorenz | - |
item.contributor | Valgimigli, Marco | - |
crisitem.journal.issn | 0009-7322 | - |
crisitem.journal.eissn | 1524-4539 | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
Amulet or Watchman.pdf | Peer-reviewed author version | 2.03 MB | Adobe PDF | View/Open |
Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure_ Primary Results of the SWISS-APERO Randomized Clinical Trial.pdf Restricted Access | Published version | 2.22 MB | Adobe PDF | View/Open Request a copy |
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