Watchmen trial atrial fibrillation

Stroke or systemic embolism occurred in 7. This device demonstrated a noninferior rate of cardiovascular death, stroke, or systemic embolism, compared with warfarin alone, which was sustained to 5 years of follow-up. The rate of all strokes ischemic or hemorrhagic was noninferior between the groups, and there were significantly less hemorrhagic strokes in the device group.

Adverse outcomes were higher in the device group due to a high occurrence of pericardial effusion. In a pooled analysis of four trials, device-related thrombus was detected in 3. The procedural and long-term safety of this device will need to be balanced against the reduction in hemorrhagic strokes afforded from discontinuation of warfarin. It is also possible that this device may prove to reduce ischemic strokes; however, long-term follow-up will be needed to assess this.

Circulation ;May [Epub ahead of print]. Non-valvular Afib can mean a lifetime of blood thinners. It can also mean a lifetime of worry about issues like bleeds and falls. And he continues to counsel patients about this life-changing procedure today. This can cause blood to pool in an area of the heart called the left atrial appendage, or LAA.

There, blood cells can stick together and form a clot. When a blood clot escapes from the LAA and travels to another part of the body, it can cut off the blood supply to the brain, causing a stroke. Science always looks for ways to make effective treatments even better. The WATCHMAN FLX design is an advancement that enables the implant to fit a greater number of patients, giving more people than ever a safe, effective alternative to blood thinners should they need one.

The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.

This trial is active and has reached full enrollment. If you have patients that have had, or will have, an AF ablation and would like a non-pharmacological option for stroke risk reduction post-ablation, they may be eligible to participate in our OPTION trial.

Rx only. In considering the use of the WATCHMAN FLX Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account.

Details regarding the indications, contraindications, warnings, and precautions for oral anticoagulants approved for patients with non-valvular atrial fibrillation are provided in their respective Instructions for Use. Of note:. Potential adverse events in alphabetical order which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:.

There may be other potential adverse events that are unforeseen at this time. Patients are generally receptive to it and express an overall interest.

It strikes conversation because of the common worry around blood thinners. First and foremost, the common denominator with all patients is risk of stroke, which can be a scary reality.

We also closely look at where our patients are in life. The decision is challenging. We want to protect against stroke on one hand, and then on the other hand, appropriately manage the related risks. We follow every one of our patients for several years.

Everyone is different. If and when we get to this juncture, it would be nice to offer patients something tailored to their own desires. This website uses cookies to give you the very best experience.