Cerebrovascular events, bleeding complications and device related thrombi in atrial fibrillation patients with chronic kidney disease and left atrial appendage closure with the WATCHMAN™ device

Abstract

Background 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). Interventional left atrial appendage closure (LAAC) might be an alternative therapeutic strategy for these patients. Methods We 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. Results One 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/1.73m 2 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. Conclusions Atrial 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).

JCS/JHRS 2021 guideline focused update on non‐pharmacotherapy of cardiac arrhythmias

“…In contrast to OACs, the effectiveness and safety of LAAC in patients with chronic renal failure regardless of severity have been reported. 173,174 However, a significant association between acute kidney disease (an absolute or a relative increase in serum creatinine of >0.3 mg/dL or ≥50% of baseline value) and higher mortality was reported, thus requiring preventive strategies, especially in patients with chronic kidney disease. 175 In the ESC and AHA/ACC/HRS guidelines, 110,176 percutaneous LAAC is classified as a Class IIb indication for stroke prevention in patients at an increased risk of stroke and with contraindications to long-term OAC therapy.…”

Thromboembolic and Bleeding Risk in Atrial Fibrillation Patients with Chronic Kidney Disease: Role of Anticoagulation Therapy

“…Additionally, recent studies have explored its efficacy for thromboembolic prevention in patients with end-stage renal disease [ 131 , 132 , 133 , 134 , 135 ]. Although not yet confirmed in large studies, these preliminary findings are highly promising.…”

“…Several antithrombotic strategies have been empirically adopted in clinical practice to avoid this worrisome complication [ 126 , 127 , 136 , 137 ]. To date, the most common approach is based on the use of aspirin, initially with clopidogrel and then alone, to prevent activation of platelets coming in contact with the atrial surface of the device until complete endothelialization is achieved [ 131 , 132 , 133 , 134 , 135 ]. Randomized clinical trials are needed to identify the best antithrombotic therapy to prevent device-related thrombosis and explore the efficacy of LAAO in high-risk populations with a reduced safety margin between stroke prevention and bleeding risk (e.g., end-stage CKD, elderly).…”

Left atrial appendage closure: A therapy uniquely suited for specific populations of patients with atrial fibrillation

“…In a large observational registry of LAAC with WATCHMAN, advanced CKD and ESRD (eGRR < 30 mL/min/1.73 m 2 ) were not predictive of adjusted risk for stroke (HR, 2.24; 95% CI, 0.27‐17.9; P = .44) or periprocedural adverse events . A smaller study of 189 patients undergoing LAAC found low complication rates in patients with CKD undergoing LAAC, albeit with a trend toward more DRT in patients with eGFR < 30 mL/min/1.73 m 2 (13.3% vs 5.1%; P = .1) . However, reports of LAAC device‐related endocarditis are of particular concern in the ESRD population .…”

“…39 A smaller study of 189 patients undergoing LAAC found low complication rates in patients with CKD undergoing LAAC, albeit with a trend toward more DRT in patients with eGFR < 30 mL/min/1.73 m 2 (13.3% vs 5.1%; P = .1). 40 However, reports of LAAC device-related endocarditis are of particular concern in the ESRD population. 41 Considering the strong rationale for benefit, prospective studies comparing dose-adjusted DOAC to LAAC should be a high priority to advance the care of patients with ESRD with AF.…”