Introduction
The WATCHMAN FLX Pro device offers a promising alternative to long-term anticoagulation therapy for patients with non-valvular atrial fibrillation (AF). This device is designed to reduce the risk of stroke in patients by sealing the left atrial appendage (LAA), the location where blood clots most commonly originate in AF. This article explores the functionality, benefits, and patient considerations related to the WATCHMAN FLX Pro device.
Understanding Atrial Fibrillation and Stroke Risk
Atrial fibrillation is a common cardiac arrhythmia characterized by irregular and often rapid heartbeats. This condition affects millions of people worldwide and significantly increases the risk of stroke. The irregular heartbeats cause blood pooling in the LAA: a small, pouch-like structure in the left atrium of the heart. Due to poor blood circulation in the LAA during AF, clots may form and embolize to distal blood vessels leading to strokes or other organ ischemia.
Patients with AF are risk stratified using the CHA2DS2-VASc score[1] and are prescribed blood-thinning medications such as warfarin, apixaban, dabigatran or rivaroxaban to mitigate stroke occurrence if their risk score is elevated. However, long-term use of these medications comes with its own set of challenges, including an increased risk of spontaneous bleeding, dietary restrictions, and frequent blood tests to monitor therapy levels.
What is the WATCHMAN FLX Pro Device?
The WATCHMAN FLX Pro is the third generation of the Watchman device, which initially received FDA approval in 2015. To date, almost 400,000 Watchman devices have been implanted world-wide. The WATCHMAN FLX Pro device is an umbrella-shaped implant with six sizes that is composed of a self-expanding, nickel-titanium (Nitinol) frame and overlayed with a thromboresistant coating. The device is designed to completely occlude the LAA and prevent migration of clots.
Implantation of the WATCHMAN FLX Pro device is minimally invasive and performed under general anesthesia. The implanter uses a catheter to guide the device up the femoral vein into the right atrium to subsequently gain access to the left atrium (and LAA) through transseptal puncture. Once positioned in the LAA, the device is deployed, where it expands to fit and seal the LAA. Over time, tissue grows over the device, permanently sealing off the LAA. The procedure time is often less than 30 minutes, and many patients are discharged home the same day. Complications include: vascular damage, pericardial effusion, device-related thrombosis, embolization or leak. Clinical data has shown that these events happen in less than one percent of patients.[2],[3]
Benefits of the WATCHMAN FLX Pro Device
Protection from stroke without oral anti-coagulation
Clinical studies have demonstrated that the WATCHMAN FLX Pro device is effective in reducing the risk of stroke in patients with non-valvular AF. The device provides a physical barrier to prevent clots from escaping the LAA, offering an equivalent level of stroke prevention to long-term anticoagulation therapy.[4]
Improved Quality of Life
By reducing the reliance on anticoagulants, patients with the WATCHMAN FLX Pro device often experience an improved quality of life. They can enjoy greater peace of mind knowing that their stroke risk is managed without the ongoing challenges of medication compliance and monitoring.
Patient Considerations
Who is a Candidate for the WATCHMAN FLX Pro Device?
The WATCHMAN FLX Pro device is indicated for patients with non-valvular AF with a CHA2DS2-VASc score of three or greater and have a reason to seek an alternative to long-term anticoagulation therapy. Sample candidates include those who:
- Have a history of bleeding (e.g. gastrointestinal, hematuria, epistaxis, intracranial)
- Are at an increased fall risk due to age, comorbid conditions, or lifestyle factors.
- Have difficulty maintaining therapeutic INR levels while on warfarin.
- Have a preference to avoid long-term medication use.
Conclusion
The WATCHMAN FLX Pro device is a safe, effective alternative to oral anti-coagulation for qualifying patients with non-valvular AF. Adverse procedural events occur infrequently and implantation allows patients to be liberated from oral anti-coagulation.
[1] The CHA2DS2-VASc score is comprised of: congestive heart failure, hypertension, age ³ 75, age 65-75, diabetes, stroke/TIA, vascular disease or female gender. Two or more points in men or three or more in women is considered an elevated risk for stroke.
[2] Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation.2021May4;143(18):1754-1762.
[3] Real-world Experience with WATCHMAN FLX: Outcomes at one-year from SURPASS. Kapadia et al. Late Breaking Clinical Trial Presentation, CRT 2023.
[4] 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec, 70(24) 2964-2975