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Published on: February 26, 2013
Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results
Usama A Daimee1, Yongfei Wang2, Frederick A Masoudi3
1Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD (U.A.D.).
Insights
The Watchman device is used for stroke risk reduction in patients unsuitable for anticoagulation. Common reasons for implantation include high thromboembolic risk, bleeding history, and fall risk, with fall risk linked to adverse events.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Practice
Background:
- FDA approved the Watchman device for left atrial appendage occlusion in patients at increased stroke risk.
- Broad approval criteria necessitate clarification in real-world clinical practice.
- Limited studies evaluate Watchman implantation indications in large US patient cohorts.
Purpose of the Study:
- To assess procedural indications for Watchman implantation in the US.
- To evaluate the association between indications and in-hospital adverse events.
Main Methods:
- Utilized the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (2016-2018).
- Analyzed data from 38,314 Watchman procedures.
- Assessed patient demographics, risk scores (CHA2DS2-VASc, HAS-BLED), and procedural indications.
Main Results:
- Most patients (71.9%) had multiple indications for Watchman implantation.
- Common indications included increased thromboembolic risk (64.8%), history of major bleeding (64.3%), and high fall risk (35.5%).
- High fall risk was associated with a modest increase in in-hospital adverse events (aOR, 1.12; P=0.025).
Conclusions:
- Key indications for Watchman implantation are thromboembolic risk, bleeding history, and fall risk.
- Multiple indications are common in patients receiving the Watchman device.
- High fall risk is a potential factor for increased adverse events post-implantation.
Background:
The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States.
Methods:
We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events.
Results:
A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA2DS2-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication.
Conclusions:
Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.
