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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Hemodialysis: An International, Multicentric
Lukas Urbanek1, Gunnar H Heine2, Claudia Reddavid3
1Cardioangiologisches Centrum Bethanien, Agaplesion Markus-Krankenhaus, Frankfurt am Main, Germany.
Insights
Left atrial appendage closure (LAAC) is a safe and effective alternative to oral anticoagulation for hemodialysis patients with atrial fibrillation, showing reduced stroke and bleeding risks.
Area of Science:
- Cardiology
- Nephrology
- Interventional Cardiology
Background:
- Oral anticoagulation's benefit is uncertain in end-stage renal disease (ESRD) patients on hemodialysis (HD).
- Left atrial appendage closure (LAAC) is an emerging alternative, but evidence in HD patients is limited.
Purpose of the Study:
- To evaluate the feasibility and safety of LAAC in patients with atrial fibrillation on HD.
- To assess clinical outcomes, including stroke and bleeding rates, following LAAC in this population.
Main Methods:
- An international multicenter registry collected data from 147 ESRD patients on HD undergoing LAAC.
- Baseline characteristics, procedural success, complications, and follow-up data were recorded.
Main Results:
- Technical success for LAAC was high (98%), with low major complication rates (4.7%).
- During a median follow-up of 427 days, the annual stroke rate was 0.9% (88% relative risk reduction) and major bleeding was 4.5% (55% relative risk reduction).
- No device-related thrombi were detected, and peridevice leaks ≥5 mm were 1.7%.
Conclusions:
- LAAC demonstrates an acceptable safety profile in ESRD patients on HD.
- LAAC is associated with significantly reduced stroke and bleeding rates compared to historical data.
- This procedure offers a promising alternative for stroke risk reduction in this high-risk group.
Background:
The net benefit of oral anticoagulation in patients with end-stage renal disease on hemodialysis (HD) is uncertain. In recent years, left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation; however, there is scant evidence of LAAC in patients on HD.
Objectives:
This study aimed to assess the feasibility and safety of LAAC in patients on HD.
Methods:
In an international multicenter registry, patients' baseline characteristics and procedural and follow-up data were recorded from all patients on HD with atrial fibrillation who underwent LAAC.
Results:
A total of 147 patients from 9 centers were included. The mean age was 72.6 ± 10.4 years; the mean CHA2DS2-VASc-score was 4.6 ± 1.5, and the mean HAS-BLED-score was 4.7 ± 1.1. Antithrombotic treatment regimens prior to implantation were notably diverse, encompassing more than 12 distinct combinations. Technical successful LAA at first procedure was achieved in 144 of 147 (98%) patients and major complications were observed in 4.7% (7 of 149 procedures). The median follow-up was 427 days (Q1-Q3: 184-797 days), no device-related thrombi were detected, and peridevice leaks ≥5 mm were 1.7% at first imaging control. The most common post-implantation antithrombotic therapy was single antiplatelet therapy with 165.9 patient-years (py). During follow-up of 222.9 py, the annual stroke rate was 0.9%, reflecting an 88% relative risk reduction (P < 0.001) compared to historical data. Similarly, the annual rate of major bleeding was 4.5%, signifying a 55% relative risk reduction (P = 0.023). Throughout follow-up, 29 deaths (19.9%) were recorded.
Conclusions:
LAAC in end-stage renal disease patients on HD demonstrated an acceptable safety profile, coupled with a notably low incidence of strokes. This was paralleled by low bleeding rates.
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