What question did this study set out to answer?

To evaluate the safety and efficacy of left atrial appendage occlusion for thromboembolic prevention in dialysis patients with atrial fibrillation and high hemorrhagic risk.

June 13, 2020Journal of NephrologyOpen Access

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

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Why the study?

In dialysis patients with AF, DOACs are contraindicated and warfarin increases bleeding without fully preventing embolic events, creating an open question on LAA occlusion safety and efficacy.

Does left atrial appendage occlusion reduce thromboembolic events, bleeding, and mortality compared to oral anticoagulation or no therapy in dialysis patients with atrial fibrillation?

Key Points

To evaluate the safety and efficacy of left atrial appendage occlusion for thromboembolic prevention in dialysis patients with atrial fibrillation and high hemorrhagic risk.
Analyzed 92 dialysis patients with atrial fibrillation who underwent left atrial appendage occlusion.
Compared outcomes against two cohorts of dialysis patients with atrial fibrillation receiving warfarin (n=114) or no oral anticoagulation therapy (n=148).
Assessed peri-procedural complications, 2-year thromboembolic and bleeding events, and 2-year mortality using multivariable Cox regression adjusted for confounding factors.
Device implantation succeeded in 100% of cases with two major peri-procedural complications and zero thromboembolic events at 2-year follow-up in the occlusion cohort.
Bleeding risk was significantly higher with warfarin than occlusion during months 4 to 24 (HR 6.48, 95% CI 1.32–31.72), but showed no significant difference in the first 3 months (HR 1.65, 95% CI 0.43–6.33).
Two-year mortality was significantly higher in both the warfarin cohort (HR 2.76, 95% CI 1.31–5.86) and the no-therapy cohort (HR 3.09, 95% CI 1.59–5.98) compared to the left atrial appendage occlusion group.

Structured PICO

Does left atrial appendage occlusion reduce thromboembolic events, bleeding, and mortality compared to oral anticoagulation or no therapy in dialysis patients with atrial fibrillation?

Population

354 patients with end-stage renal disease (ESRD) requiring dialysis and documented atrial fibrillation (CHA2DS2VASc ≥1 in men/≥2 in women, HASBLED ≥3 or contraindications for long-term anticoagulation). Median age 74-76, 56-77% male, Italian cohort.

Intervention

Left atrial appendage (LAA) occlusion (using Amplatzer-Amulet, Watchman, or LAmbre devices)

Comparator

Two reference cohorts: oral anticoagulant therapy (OAT/warfarin, n=114) and no anticoagulant therapy (No-Therapy, n=148)

Outcome

1) Incidence of peri-procedural complications within 30 days, 2) cumulative incidence of 2-year thromboembolic and bleeding events (first event), 3) mortality and cumulative incidence of cardiovascular events at 2-yearshard clinical

In dialysis patients with atrial fibrillation, LAA occlusion was associated with lower 2-year mortality and reduced long-term bleeding risk compared to oral anticoagulation or no therapy.

Limitations

Not a controlled and randomized study
Potential selection bias (physicians may have proposed LAA occlusion to less frail patients)

Implication

Hypothesis-generating for LAA occlusion in dialysis AF; prospective RCTs needed before clinical adoption.

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.