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

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

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; Carranza, Christian Lildal; Rafiq, Sulman; Rodriguez-Lecoq, Rafael; Palmer-Camino, Neiser; Modrau, Ivy Susanne; Hansson, Emma C.; Jeppsson, Anders; Hadad, Rakin; Moya-Mitjans, Angel; Greve, Anders Møller; Christensen, Robin; Carstensen, Helle Gervig; Høst, Nis Baun; Dixen, Ulrik; Torp-Pedersen, Christian; Køber, Lars; Gögenur, Ismail; Truelsen, Thomas Clement; Kruuse, Christina; Sajadieh, Ahmad; Domínguez, Helena; LAACS-2 trial Investigators.

In: American Heart Journal, Vol. 264, 2023, p. 133-142.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Madsen, CL, Park-Hansen, J, Irmukhamedov, A, Carranza, CL, Rafiq, S, Rodriguez-Lecoq, R, Palmer-Camino, N, 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 & LAACS-2 trial Investigators 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, vol. 264, pp. 133-142. https://doi.org/10.1016/j.ahj.2023.06.003

APA

Madsen, C. L., Park-Hansen, J., Irmukhamedov, A., Carranza, C. L., Rafiq, S., Rodriguez-Lecoq, R., Palmer-Camino, N., 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., ... LAACS-2 trial Investigators (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

Vancouver

Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL, Rafiq S, Rodriguez-Lecoq R 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. https://doi.org/10.1016/j.ahj.2023.06.003

Author

Madsen, Christoffer Læssøe ; Park-Hansen, Jesper ; Irmukhamedov, Akhmadjon ; Carranza, Christian Lildal ; Rafiq, Sulman ; Rodriguez-Lecoq, Rafael ; Palmer-Camino, Neiser ; Modrau, Ivy Susanne ; Hansson, Emma C. ; Jeppsson, Anders ; Hadad, Rakin ; Moya-Mitjans, Angel ; Greve, Anders Møller ; Christensen, Robin ; Carstensen, Helle Gervig ; Høst, Nis Baun ; Dixen, Ulrik ; Torp-Pedersen, Christian ; Køber, Lars ; Gögenur, Ismail ; Truelsen, Thomas Clement ; Kruuse, Christina ; Sajadieh, Ahmad ; Domínguez, Helena ; LAACS-2 trial Investigators. / 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. In: American Heart Journal. 2023 ; Vol. 264. pp. 133-142.

Bibtex

@article{cca10212fe294592a8ebb9310d42b44d,
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 Rafael Rodriguez-Lecoq and Neiser Palmer-Camino 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 and {LAACS-2 trial Investigators}",
note = "Publisher Copyright: {\textcopyright} 2023 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",
publisher = "Mosby Inc.",

}

RIS

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 - Rodriguez-Lecoq, Rafael

AU - Palmer-Camino, Neiser

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

AU - LAACS-2 trial Investigators

N1 - Publisher Copyright: © 2023 Elsevier Inc.

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.

U2 - 10.1016/j.ahj.2023.06.003

DO - 10.1016/j.ahj.2023.06.003

M3 - Journal article

C2 - 37302738

AN - SCOPUS:85164342012

VL - 264

SP - 133

EP - 142

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -

ID: 360261774