Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis

Abstract

Background In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk. Methods Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors. Results The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43-6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32-31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31-5.86)] and No-Therapy [HR 3.09 (95% CI 1.59-5.98)] cohorts compared to LAA occlusion patients. Conclusions The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

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).…”

‘Will the king ever be dethroned?’ The relationship and the future of oral anticoagulation therapy versus LAA closure devices

“…However, as the experience of various centers increased, complications declined (e.g., the results of PROTECT-AF at four years [8]: the rate of composite primary safety events was similar in the two groups -3.6 events per 100 patient-years in the device group vs. 3.1 in the warfarin group (HR, 1.21; 95% CI, 0.78-1.94, P = 0.41). It is also important to note that, even in such a fragile population as that of Genovesi et al (two major peri-procedural complications were recorded in 92 patients), the complication rate is certainly acceptable, even if not negligible [20].…”

“…Indeed, in this population, where the prevalence of AF is very high, VKAs are associated with a high incidence of bleeding, and DOACs are contraindicated [7]. Initial encouraging data suggest that LAAO occlusion in dialysis patients has a good efficacy and safety profile [20]. A Spanish study is currently underway in ESRD patients (WATCH-HD, NCT03446794), including two arms, the Watchman device vs. no-therapy.…”

Association of chronic kidney disease and end-stage renal disease with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: Insights from the national inpatient sample of 36,065 procedures

“… 14 , 15 Additionally, few retrospective and largely single-center studies have demonstrated conflicting outcomes after LAAO with Watchman implantation in AF patients with CKD and ESRD. 17 , 18 , 19 , 20 The purpose of the current study is to assess the association of CKD or ESRD with risk of procedural complications and inpatient adverse events in AF patients implanted with a Watchman device from a large, nationally representative, and contemporary sample of the United States population.…”