The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk

Christoffer Læssøe Madsen; Jesper Park-Hansen; Akhmadjon Irmukhamedov; Christian Lildal Carranza; Sulman Rafiq; Rafael Rodríguez Lecoq; Neiser Palmer Camino; Ivy Susanne Modrau; Emma C Hansson; Anders Jeppsson; Rakin Hadad; Angel Moya-Mitjans; Anders Møller Greve; Robin Christensen; Helle Gervig Carstensen; Nis Baun Høst; Ulrik Dixen; Christian Torp-Pedersen; Lars Køber; Ismail Gögenur; Thomas Clement Truelsen; Christina Kruuse; Ahmad Sajadieh; Helena Domínguez

doi:10.1016/j.ahj.2023.06.003

The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk

Christoffer Læssøe Madsen, Jesper Park-Hansen, Akhmadjon Irmukhamedov, Christian Lildal Carranza, Sulman Rafiq, Rafael Rodríguez Lecoq, Neiser Palmer Camino, Ivy Susanne Modrau, Emma C Hansson, Anders Jeppsson, Rakin Hadad, Angel Moya-Mitjans, Anders Møller Greve, Robin Christensen, Helle Gervig Carstensen, Nis Baun Høst, Ulrik Dixen, Christian Torp-Pedersen, Lars Køber, Ismail GögenurThomas Clement Truelsen, Christina Kruuse, Ahmad Sajadieh, Helena Domínguez^*

^*Corresponding author af dette arbejde

18 Citationer (Scopus)

Abstract

BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score.

METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%).

CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery.

TRIAL REGISTRATION: NCT03724318.

Originalsprog	Engelsk
Tidsskrift	American Heart Journal
Vol/bind	264
Sider (fra-til)	133-142
Antal sider	10
ISSN	0002-8703
DOI	https://doi.org/10.1016/j.ahj.2023.06.003
Status	Udgivet - 2023

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Citationsformater

Madsen, C. L., Park-Hansen, J., Irmukhamedov, A., Carranza, C. L., Rafiq, S., Lecoq, R. R., Camino, N. P., Modrau, I. S., Hansson, E. C., Jeppsson, A., Hadad, R., Moya-Mitjans, A., Greve, A. M., Christensen, R., Carstensen, H. G., Høst, N. B., Dixen, U., Torp-Pedersen, C., Køber, L., ... Domínguez, H. (2023). The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. American Heart Journal, 264, 133-142. https://doi.org/10.1016/j.ahj.2023.06.003

The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. / Madsen, Christoffer Læssøe; Park-Hansen, Jesper; Irmukhamedov, Akhmadjon et al.
I: American Heart Journal, Bind 264, 2023, s. 133-142.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Madsen, CL, Park-Hansen, J, Irmukhamedov, A, Carranza, CL , Rafiq, S, Lecoq, RR, Camino, NP, Modrau, IS, Hansson, EC, Jeppsson, A, Hadad, R, Moya-Mitjans, A, Greve, AM , Christensen, R, Carstensen, HG, Høst, NB, Dixen, U , Torp-Pedersen, C , Køber, L, Gögenur, I, Truelsen, TC , Kruuse, C , Sajadieh, A & Domínguez, H 2023, 'The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk', American Heart Journal, bind 264, s. 133-142. https://doi.org/10.1016/j.ahj.2023.06.003

Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL , Rafiq S, Lecoq RR et al. The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. American Heart Journal. 2023;264:133-142. doi: 10.1016/j.ahj.2023.06.003

Madsen, Christoffer Læssøe ; Park-Hansen, Jesper ; Irmukhamedov, Akhmadjon et al. / The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. I: American Heart Journal. 2023 ; Bind 264. s. 133-142.

@article{a41c7c6b66454e65bf619af370e1cebb,

title = "The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk",

abstract = "BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score.METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60\% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90\%).CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery.TRIAL REGISTRATION: NCT03724318.",

author = "Madsen, \{Christoffer L{\ae}ss{\o}e\} and Jesper Park-Hansen and Akhmadjon Irmukhamedov and Carranza, \{Christian Lildal\} and Sulman Rafiq and Lecoq, \{Rafael Rodr{\'i}guez\} and Camino, \{Neiser Palmer\} and Modrau, \{Ivy Susanne\} and Hansson, \{Emma C\} and Anders Jeppsson and Rakin Hadad and Angel Moya-Mitjans and Greve, \{Anders M{\o}ller\} and Robin Christensen and Carstensen, \{Helle Gervig\} and H{\o}st, \{Nis Baun\} and Ulrik Dixen and Christian Torp-Pedersen and Lars K{\o}ber and Ismail G{\"o}genur and Truelsen, \{Thomas Clement\} and Christina Kruuse and Ahmad Sajadieh and Helena Dom{\'i}nguez",

note = "Copyright {\textcopyright} 2023. Published by Elsevier Inc.",

year = "2023",

doi = "10.1016/j.ahj.2023.06.003",

language = "English",

volume = "264",

pages = "133--142",

journal = "American Heart Journal",

issn = "0002-8703",

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TY - JOUR

T1 - The Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial protocol Rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk

AU - Madsen, Christoffer Læssøe

AU - Park-Hansen, Jesper

AU - Irmukhamedov, Akhmadjon

AU - Carranza, Christian Lildal

AU - Rafiq, Sulman

AU - Lecoq, Rafael Rodríguez

AU - Camino, Neiser Palmer

AU - Modrau, Ivy Susanne

AU - Hansson, Emma C

AU - Jeppsson, Anders

AU - Hadad, Rakin

AU - Moya-Mitjans, Angel

AU - Greve, Anders Møller

AU - Christensen, Robin

AU - Carstensen, Helle Gervig

AU - Høst, Nis Baun

AU - Dixen, Ulrik

AU - Torp-Pedersen, Christian

AU - Køber, Lars

AU - Gögenur, Ismail

AU - Truelsen, Thomas Clement

AU - Kruuse, Christina

AU - Sajadieh, Ahmad

AU - Domínguez, Helena

PY - 2023

Y1 - 2023

N2 - BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score.METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%).CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery.TRIAL REGISTRATION: NCT03724318.

AB - BACKGROUND: Current recommendations regarding the use of surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence. Patients undergoing open-heart surgery often have several cardiovascular risk factors and a high occurrence of postoperative atrial fibrillation (AF)-with a high recurrence rate-and are thus at a high risk of stroke. Therefore, we hypothesized that concomitant LAA closure during open-heart surgery will reduce mid-term risk of stroke independently of preoperative AF status and CHA2DS2-VASc score.METHODS: This protocol describes a randomized multicenter trial. Consecutive participants ≥18 years scheduled for first-time planned open-heart surgery from cardiac surgery centers in Denmark, Spain, and Sweden are included. Both patients with a previous diagnosis of paroxysmal or chronic AF, as well as those without AF, are eligible to participate, irrespective of their CHA2DS2-VASc score. Patients already planned for ablation or LAA closure during surgery, with current endocarditis, or where follow-up is not possible are considered noneligible. Patients are stratified by site, surgery type, and preoperative or planned oral anticoagulation treatment. Subsequently, patients are randomized 1:1 to either concomitant LAA closure or standard care (ie, open LAA). The primary outcome is stroke, including transient ischemic attack, as assigned by 2 independent neurologists blinded to the treatment allocation. To recognize a 60% relative risk reduction of the primary outcome with LAA closure, 1,500 patients are randomized and followed for 2 years (significance level of 0.05 and power of 90%).CONCLUSIONS: The LAACS-2 trial is likely to impact the LAA closure approach in most patients undergoing open-heart surgery.TRIAL REGISTRATION: NCT03724318.

UR - https://www.scopus.com/pages/publications/85164342012

U2 - 10.1016/j.ahj.2023.06.003

DO - 10.1016/j.ahj.2023.06.003

M3 - Journal article

C2 - 37302738

SN - 0002-8703

VL - 264

SP - 133

EP - 142

JO - American Heart Journal

JF - American Heart Journal

ER -