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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Published on: February 28, 2012

Stroke in atrial fibrillation--hope on the horizon?

Shahnaz Jamil-Copley¹, Prapa Kanagaratnam

¹St Mary's Hospital, Imperial College NHS Trust, London W2 1NY, UK. shahnazjamil@hotmail.com

Journal of the Royal Society, Interface

|October 1, 2010

Insights

Atrial fibrillation (AF) stroke risk can be managed with warfarin or new options like the Watchman device. The Watchman device shows comparable stroke prevention to warfarin with fewer bleeding risks, offering an alternative for specific patients.

Area of Science:

Cardiology
Medical Devices
Pharmacology

Background:

Atrial fibrillation (AF) is a common arrhythmia with a fivefold increased risk of stroke.
Warfarin is the standard therapy for stroke risk reduction in AF but has limitations including drug/food interactions and variable efficacy.
Newer pharmacologic and non-pharmacologic treatments are emerging for AF stroke prevention.

Purpose of the Study:

To evaluate the safety and efficacy of the Watchman device as a non-pharmacological alternative to warfarin for stroke prevention in patients with atrial fibrillation.
To compare the incidence of stroke, cardiovascular death, systemic emboli, and bleeding events between the Watchman device and warfarin therapy.

Main Methods:

The PROTECT-AF study compared the Watchman device to warfarin in patients with AF.
Outcomes assessed included stroke, cardiovascular death, systemic emboli, and bleeding events over a 3-year period.

Main Results:

The Watchman device was found to be non-inferior to warfarin in preventing stroke, cardiovascular death, or systemic emboli.
The Watchman device group experienced fewer intracranial hemorrhages compared to warfarin.
Early events in the Watchman group were primarily procedural complications, expected to decrease with experience.

Conclusions:

The Watchman device is a viable non-pharmacological alternative to warfarin for stroke prevention in AF patients, particularly those with contraindications or intolerance to anticoagulation.
While early procedural complications exist, the Watchman device offers a favorable safety profile regarding bleeding events.
The availability of the Watchman device provides a crucial alternative after 50 years of warfarin dominance in AF stroke prevention.

Read full analysis

Abstract:

Atrial fibrillation (AF), a chaotic and irregular contraction of the atria, remains the most common cardiac arrhythmia affecting up to 1.5 per cent of the world population. It has significant economic and personal implications primarily owing to the associated fivefold increase in risk of thromboembolic stroke. The mainstay of risk reduction therapy remains warfarin, use of which can be limited owing to a multitude of issues ranging from drug and food interactions to under-treatment reflected in sub-therapeutic blood levels despite adequate compliance. Pursuit of novel drug alternatives have led to the licence of a new contender (Dabigatran) with a more attractive pharmacotherapeutic profile, some 50 years after warfarin was introduced for human use. A recent non-pharmacological alternative is the Watchman device which has received licence for use. Tested in the PROTECT-AF study, the Watchman device was found to be non-inferior to warfarin in the occurrence of stroke, cardiovascular or unexplained death, or systemic emboli for up to 3 years with less intracranial haemorrhages. The events in the watchman group occurred early and were related to the procedure. These peri-procedural complications are likely to diminish with improved operator experience and ongoing development of the technology. For now, patients with AF who would benefit tremendously from but cannot be treated with warfarin owing to contraindication to, or intolerance of, anticoagulation are considered for device implantation. Despite promising new pharmacotherapeutic advances in the prevention of strokes related to AF, it has taken 50 years for alternative non-pharmacological approaches to become available for clinical use.

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