TY - JOUR
T1 - Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)
T2 - protocol for a prospective observational nationwide study
AU - Kowalewski, Mariusz
AU - Wańha, Wojciech
AU - Litwinowicz, Radoslaw
AU - Kołodziejczak, Michalina
AU - Pasierski, Michal
AU - Januszek, Rafal
AU - Kuźma, Łukasz
AU - Grygier, Marek
AU - Lesiak, Maciej
AU - Kapłon-Cieślicka, Agnieszka
AU - Reczuch, Krzysztof
AU - Gil, Robert
AU - Pawłowski, Tomasz
AU - Bartuś, Krzysztof
AU - Dobrzycki, Sławomir
AU - Lorusso, Roberto
AU - Bartuś, Stanislaw
AU - Deja, Marek Andrzej
AU - Smolka, Grzegorz
AU - Wojakowski, Wojciech
AU - Suwalski, Piotr
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/9/21
Y1 - 2022/9/21
N2 - INTRODUCTION: Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient's ischaemic burden without augmentation in their anticoagulation profile.METHODS AND ANALYSIS: Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER) will be conducted in 10 heart surgery and cardiology centres across Poland to assess the outcomes of LAAO performed by fully thoracoscopic-epicardial, percutaneous-endocardial or hybrid endo-epicardial approach. The registry will include patients with nonvalvular AF at a high risk of thromboembolic and bleeding complications (CHA2DS2-VASc Score ≥2 for males, ≥3 for females, HASBLED score ≥2) referred for LAAO. The first primary outcome is composite procedure-related complications, all-cause death or major bleeding at 12 months. The second primary outcome is a composite of ischaemic stroke or systemic embolism at 12 months. The third primary outcome is the device-specific success assessed by an independent core laboratory at 3-6 weeks. The quality of life (QoL) will be assessed as well based on the QoL EQ-5D-5L questionnaire. Medication and drug adherence will be assessed as well.ETHICS AND DISSEMINATION: Before enrolment, a detailed explanation is provided by the investigator and patients are given time to make an informed decision. The patient's data will be protected according to the requirements of Polish law, General Data Protection Regulation (GDPR) and hospital Standard Operating Procedures. The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was granted by the local Bioethics Committee of the Upper-Silesian Medical Centre of the Silesian Medical University in Katowice (decision number KNW/0022/KB/284/19). The results will be published in peer-reviewed journals and presented during national and international conferences.TRIAL REGISTRATION NUMBER: NCT05144958.
AB - INTRODUCTION: Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient's ischaemic burden without augmentation in their anticoagulation profile.METHODS AND ANALYSIS: Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER) will be conducted in 10 heart surgery and cardiology centres across Poland to assess the outcomes of LAAO performed by fully thoracoscopic-epicardial, percutaneous-endocardial or hybrid endo-epicardial approach. The registry will include patients with nonvalvular AF at a high risk of thromboembolic and bleeding complications (CHA2DS2-VASc Score ≥2 for males, ≥3 for females, HASBLED score ≥2) referred for LAAO. The first primary outcome is composite procedure-related complications, all-cause death or major bleeding at 12 months. The second primary outcome is a composite of ischaemic stroke or systemic embolism at 12 months. The third primary outcome is the device-specific success assessed by an independent core laboratory at 3-6 weeks. The quality of life (QoL) will be assessed as well based on the QoL EQ-5D-5L questionnaire. Medication and drug adherence will be assessed as well.ETHICS AND DISSEMINATION: Before enrolment, a detailed explanation is provided by the investigator and patients are given time to make an informed decision. The patient's data will be protected according to the requirements of Polish law, General Data Protection Regulation (GDPR) and hospital Standard Operating Procedures. The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was granted by the local Bioethics Committee of the Upper-Silesian Medical Centre of the Silesian Medical University in Katowice (decision number KNW/0022/KB/284/19). The results will be published in peer-reviewed journals and presented during national and international conferences.TRIAL REGISTRATION NUMBER: NCT05144958.
KW - Animals
KW - Anticoagulants/therapeutic use
KW - Atrial Appendage/surgery
KW - Atrial Fibrillation/complications
KW - Brain Ischemia/complications
KW - Female
KW - Hemorrhage/chemically induced
KW - Humans
KW - Male
KW - Observational Studies as Topic
KW - Quality of Life
KW - Registries
KW - Stroke/complications
KW - Thromboembolism/etiology
KW - Treatment Outcome
KW - Urodela
U2 - 10.1136/bmjopen-2022-063990
DO - 10.1136/bmjopen-2022-063990
M3 - Article
C2 - 36130748
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e063990
ER -