Comparison in Patients < 75 Years of Age - Versus – Those > 75 Years on One-year-Events With Atrial Fibrillation and Left Atrial Appendage Occluder (From the Prospective Multicenter German LAARGE Registry)
Section snippets
Methods
The German left atrial appendage occlusion registry (LAARGE) is a prospective, nonrandomized, multicenter real-world registry that encompasses consecutive patients with the indication to receive a LAAC from 38 voluntary participating centers. Recruitment into the registry started in July 2014 and ended in December 2015. Patients should have been treated according to current recommendations. 12 Patients ≥18 years planned for LAAC with all 3 types of non-valvular AF, a CHA2DS2-VASc score ≥2 and
Results
A total 638 patients were included in the registry. Of them 402 (63%) were aged ≥ 75 years at the time of the procedure. Baseline characteristics of the study population stratified according to age group are presented in Table 1. Compared with patients < 75 years, patients aged ≥75 had a lower proportion of structural heart disease, a higher prevalence of coronary artery disease, higher prevalence of permanent atrial fibrillation, and higher CHA2DS2-VASC and HAS-BLED scores. There were no
Discussion
The main findings of the present analysis are (1) the identical LAAC procedural success rates in patients aged ≥75 and <75 years, (2) similar rates of stroke and significant bleeding in both groups after 1 year, (3) a higher all-cause mortality triggered by a higher non-cardiovascular mortality rate in the elderly.
In PCI an age older than or equal to 75 years of age constitutes an independent high-risk variable (Bauer et al)18 and the higher prevalence of cardiac and noncardiac diseases
Conclusion
Therapies must be tailored to elderly patients, with particular attention to co-morbidities and bleeding risk. Elderly patients are at increased risk for thromboembolic events und thromboembolic protection is therefore of major importance in this population. LAAC should be kept as alternative in suitable patients and this study adds to the evidence that LAAC is effective in reducing the risk of stroke and major bleeding in AF with a low rate of complications also in the elderly population.
Authors contribution
Author agreement/statement: Aref El Nasasra,MD: writing original draft, completion final draft and editing. Johannes Brachmann, MD: writing review and editing. Thorsten Lewalter, MD: writing review; Ibrahim Akin, MD: writing review and editing; Horst Sievert, MD: writing review. Christoph A. Nienaber, MD: writing review. Christian Weiß, MD: writing review. Sven T. Pleger, MD: writing review. Hüseyin Ince, MD: writing review. Jens Maier, MD: writing review. Stephan Achenbach, MD: writing review.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relations that could have appeared to influence the work reported in this study.
References (31)
- et al.
Appendage obliteration to reduce stroke in cardiac surgical patients with AF
Ann Thorac Surg
(1996) - et al.
on behalf of the PROTECT AF investigators. percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial
Lancet
(2009) - et al.
Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the prevail trial
J Am Coll Cardiol
(2014) - et al.
Age as a risk factor for stroke in atrial fibrillation patients: implications for thromboprophylaxis
J Am Coll Cardiol
(2010) - et al.
Comparison of efficacy and safety of left atrial appendage occlusion in patients aged <75 to ≥ 75 years
Am J Cardiol
(2016) - et al.
Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN randomized trial experience
JACC Cardiovasc Interv
(2015) - et al.
5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials
J Am Coll Cardiol
(2017) - et al.
Left atrial appendage closure versus direct oral anticoagulants in high-risk patients with atrial fibrillation
J Am Coll Cardiol
(2020) - et al.
Atrial fibrillation as an independent risk factor for stroke: the Framingham Study
Stroke
(1991) - et al.
Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study
Circulation
(2014)
2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Eur Heart J
ANMCO/AIAC/SICI-GISE/SIC/SICCH consensus document: percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation patients: indications, patient selection, staff skills, organisation, and training
Eur Heart J Suppl
EHRA/EAPCIexpert consensus statement on catheter-based left atrial appendage occlusion
Europace
Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation 2.3-year follow-up of the PROTECTAF (Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation) Trial
Circulation
following investigators and institutions participated in the EWOLUTION study. Evaluating real-world clinical outcomes in atrial fibrillation patients receiving the watchman left atrial appendage closure technology: final 2-year outcome data of the Ewolution trial focusing on history of stroke and hemorrhage
Circ Arrhythm Electrophysiol
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The present Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) was conducted independently from industry and only scientifically and financially sponsored by the Stiftung Institut für Herzinfarktforschung (IHF) Ludwigshafen, Germany.For the biometrical analyses of the present work, the IHF was financially supported by an unrestricted grant from Boston Scientific.