Key result
High pre-procedural stroke risk (CHADS2 3-6) was associated with a higher rate of the long-term composite efficacy endpoint after LAAC compared to low risk (HR 2.13; 95% CI 1.28-3.65; P=0.002).
Why the study?
It was unclear whether individual pre-procedural stroke risk affects procedural and long-term clinical outcomes after left atrial appendage closure (LAAC).
Does individual pre-procedural stroke risk (CHADS2 score) affect procedural and long-term clinical outcomes after Amplatzer left atrial appendage closure in patients with nonvalvular atrial fibrillation?
Cohort (n=500)
Yes
Does individual pre-procedural stroke risk (CHADS2 score) affect procedural and long-term clinical outcomes after Amplatzer left atrial appendage closure in patients with nonvalvular atrial fibrillation?
Amplatzer left atrial appendage closure demonstrates comparable procedural safety and relative stroke reduction efficacy across both low and high stroke risk patients, despite higher absolute long-term event rates in the high-risk cohort.
LAAC with Amplatzer devices shows comparable outcomes across stroke risk strata; supports broader use in high-risk patients but leaves open need for randomized confirmation.
Objectives To investigate periprocedural and long‐term outcome of left atrial appendage closure (LAAC) using Amplatzer occluders with respect to individual pre‐procedural stroke risk. Background LAAC is a proven strategy for prevention from stroke and bleeding in patients with nonvalvular atrial fibrillation not amenable to oral anticoagulation. Whether individual pre‐procedural stroke risk may affect procedural and long‐term clinical outcome after LAAC is unclear. Methods Multicenter study of consecutive patients who underwent Amplatzer‐LAAC. Using pre‐procedural CHADS 2 score, outcomes were compared between a low (0–2 points) and a high stroke risk group (3–6 points). Results Five hundred consecutive patients (73.9 ± 10.1 years) who underwent Amplatzer‐LAAC. Two hundred and forty eight had preprocedural CHADS 2 score ≤ 2 points (low‐risk group) and the remaining 252 patients had 3–6 points (high‐risk group). Periprocedural complication rates (6.0% vs. 5.6%, p = .85), procedural success (LAAC without major periprocedural or device‐related complications or major para‐device leaks: 89.4% vs. 87.9%, p = .74), and 30‐day‐mortality (2.4% vs. 2.6%, p = .77) were comparable. After 1,346 patient‐years (PY), the long‐term composite efficacy endpoint (stroke, systemic embolism, cardiovascular, and unexplained death) was reached in 23/653 (3.5/100 PY) versus 52/693 (7.5/100 PY); HR = 2.13; 95%‐CI, 1.28–3.65, p = .002) with stroke rates 67% and 68% lower than anticipated by preprocedural CHADS 2 score. Combined safety endpoint (major periprocedural complications and major, life‐threatening or fatal bleedings) occurred in 22/653 (3.4/100 PY) versus 28/693 (4.0/100 PY); HR = 1.20; 95%‐CI, 0.66–2.20, p = .52). Conclusions Compared with patients at low risk of stroke, LAAC with Amplatzer devices is associated with similar safety and efficacy in high‐risk patients in our study.
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Häner et al. (2020) conducted a cohort in nonvalvular atrial fibrillation not amenable to oral anticoagulation (n=500). High pre-procedural stroke risk (CHADS2 score 3-6) vs. Low pre-procedural stroke risk (CHADS2 score 0-2) was evaluated on long-term composite efficacy endpoint (stroke, systemic embolism, cardiovascular, and unexplained death) (HR 2.13, 95% CI 1.28-3.65, p=0.002). High pre-procedural stroke risk (CHADS2 3-6) was associated with a higher rate of the long-term composite efficacy endpoint after LAAC compared to low risk (HR 2.13; 95% CI 1.28-3.65; P=0.002).
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