Abstract
BackgroundImpaired renal function increases the bleeding risk, leading to a conservative prescription and frequent discontinuation of oral anticoagulation in atrial fibrillation patients with chronic kidney disease (CKD). Interventional left atrial appendage closure (LAAC) might be an alternative therapeutic strategy for these patients.MethodsWe aimed to prospectively assess cerebrovascular (CE) and bleeding events, as well as peri-procedural and long-term complications in a cohort of consecutive patients undergoing interventional LAAC using the WATCHMAN™ device, with focus on CKD patients.ResultsOne hundred and eighty-nine consecutive patients undergoing interventional LAAC were included in this analysis; 171 (90.5%) patients had a reduced estimated glomerular filtration rate (eGFR; patients for each CKD stage: II = 66; IIIa = 32; IIIb = 43; IV = 18; V = 12). During a follow-up of 310 patient years three (1.0%) patients suffered a CE (two strokes, one transitory ischemic attack) and five (1.6%) other ones a bleeding complication. The observed stroke rate was more than two-thirds and the bleeding risk more than half lower than expected. Device related thrombi (DRT) were detected in twelve (6.5%) patients; women had significantly more DRT than men (12.5% vs. 2.6%; p = 0.009). Patients with an eGFR< 30 ml/min/1.73m2 showed a trend to a higher DRT rate as compared to the opposite group (13.3% vs. 5.1%; p = 0.10). Thrombus resolved with temporary oral anticoagulation therapy in ten patients without sequelae; thrombus consolidation was confirmed by serial TEE controls in the remaining two patients.ConclusionsAtrial fibrillation patients with CKD have low CE and bleeding rates after LAAC with the WATCHMAN™ device. DRT risk is higher in female and patients with severe CKD. More frequent post-interventional TEE controls might be justified for early DRT detection and safe management of patients at high DRT risk.Trial registration(German Clinical Trials Register ID: DRKS00 010768; Registration Date 07.07.2016).
Highlights
Impaired renal function increases the bleeding risk, leading to a conservative prescription and frequent discontinuation of oral anticoagulation in atrial fibrillation patients with chronic kidney disease (CKD)
A major corner stone in the management of Non-valvular atrial fibrillation (NVAF) patients at moderate or high risk of thromboembolic complications is the preventive oral anticoagulation (OAC) therapy tailored on a risk to benefit relation, which can both be estimated by appropriate risk scores (e.g. CHA2DS2Vasc and HAS-BLED scores) [3, 4]
Non-vitamin-K antagonist oral anticoagulant (NOAC) therapy is not recommended in stage V chronic kidney disease (CKD) patients and the benefit of vitamin K antagonists (VKA)-therapy has not been unambiguously demonstrated in that cohort [14]
Summary
Impaired renal function increases the bleeding risk, leading to a conservative prescription and frequent discontinuation of oral anticoagulation in atrial fibrillation patients with chronic kidney disease (CKD). Since NVAF patients with CKD are at increased risk of both stroke and bleeding complications [15,16,17,18,19], the net clinical benefit of the OAC therapy in these patients needs to be carefully evaluated. LAA closure is an alternative therapeutic strategy to a lifelong anticoagulation in NVAF patients with moderate or high thromboembolic risk and a high bleeding risk or bleeding history [20,21,22,23], but data on short- and long-term efficacy or safety of interventional LAA-closure in patients with CKD are scarce
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