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Published on: July 19, 2011
Left atrial appendage occlusion study III-Kidney substudy
Kevin S Kim1, Emilie P Belley-Côté2, Michael Walsh2
1Department of Health Research Methodology, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Perioperative and Surgery Research Program, Population Health Research Institute, Hamilton, Ontario, Canada.
Insights
Left atrial appendage occlusion effectively reduces stroke risk in patients with atrial fibrillation and chronic kidney disease. This procedure showed consistent benefits across varying kidney function levels without increasing adverse events.
Area of Science:
- Cardiology
- Nephrology
- Medical Devices
Background:
- Optimal anticoagulation for atrial fibrillation (AF) in chronic kidney disease (CKD) patients remains unclear.
- The efficacy of left atrial appendage occlusion (LAAO) may vary in CKD patients.
- This study is a secondary analysis of the LAAOS III trial.
Purpose of the Study:
- To investigate the effect of LAAO on stroke risk and safety outcomes in patients with AF and varying degrees of kidney function.
- To determine if baseline kidney function influences the effectiveness of LAAO.
Main Methods:
- Secondary analysis of the LAAOS III trial (NCT01516151) involving 4,768 participants with AF undergoing cardiac surgery.
- Estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI 2021 equation.
- Cox-proportional hazards models used to assess LAAO effects, with kidney function as a continuous and categorical variable.
Main Results:
- LAAO was associated with a significant reduction in stroke risk (HR 0.67; P = .001) compared to no occlusion, irrespective of eGFR.
- No significant differences observed in all-cause mortality, cardiovascular deaths, heart failure hospitalizations, major bleeding, or myocardial infarction between groups.
- No significant interaction between eGFR and LAAO for any outcome.
Conclusions:
- Surgical LAAO demonstrates consistent efficacy in reducing stroke risk for AF patients with impaired kidney function.
- LAAO is a safe alternative for stroke prevention in AF patients with CKD, without increasing the risk of major adverse events.
Background:
Optimal anticoagulation in patients with chronic kidney disease and atrial fibrillation is unclear. Effect of left atrial appendage occlusion may differ in these patients. We conducted a secondary analysis of the Left Atrial Appendage Occlusion Study (LAAOS III) to investigate METHODS: LAAOS III randomized 4,811 participants with atrial fibrillation undergoing cardiac surgery. Baseline serum creatinine measurement was available for 4,768 participants (99.9%). We estimated the Glomerular Filtration Rate (eGFR) using the 2021 Chronic Kidney Disease -Epidemiology Collaboration equation. We investigated the effect of left atrial appendage occlusion using Cox-proportional hazards model with baseline kidney function as continuous and categorical variables.
Results:
Among 4,768 participants, 67.5% were men and the median age was 71.2 years. Occluding the left atrial appendage demonstrated similar effects after adjusting for eGFR; occlusion was associated with significant reduced risk of stroke compared to no occlusion (HR0.67, 95% CI 0.53-0.85, P = .001). There was no difference in all-cause mortality (HR0.99, 95% CI 0.88-1.12, P = .88), cardiovascular deaths (HR0.93, 95% CI 0.80-1.09, P = .36), hospitalizations for heart failure (HR1.13, 95% CI 0.91-1.39, P = 0.27), major bleeding (HR0.92, 95% CI 0.78-1.10, P = .37), and myocardial infarction (HR0.86, 95% CI 0.59-1.27, P = .45). The P-value for interaction for eGFR was not significant for any outcome.
Conclusion:
The effects of surgical left atrial appendage occlusion in participants with impaired kidney function was consistent with findings from LAAOS III. Left atrial appendage occlusion was associated with reduced stroke without increased risk of serious adverse events.
Trial Registration:
LAAOS III ClinicalTrials.gov number: NCT01516151. https://clinicaltrials.gov/study/NCT01561651.
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