Efficacy Issues: Two studies published in 2018, one from Watchman investigators, [2] and the other from independent French researchers, [3] found high rates of device-related thrombus on follow-up echocardiograms (Translation: clot stuck to the device). The newest data on Watchman have reinforced my negative view. Shady Henien, Lauren Rousseau, Alan Miller, Rachel Karo, and ; Antony Chu; Shady Henien. The Watchman occluder is a device for percutaneous LAA occlusion and is at present investigated in the PROTECT AF trial. Introduction: Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. Patients with the Watchman Device can typically stop strong blood thinning medication such as Coumadin 45 days after the device is implanted therefore decreasing the chance of bleeding complications and the need to take daily medicines. It is possible that the LAA could rupture while the device is deployed. Yes, the device helps people but it's also expense and carries potential complications. Risks of LAA Closure. Watchman in the Real World: Reports on Use in High-Risk Patients and Overall Safety. LAA occlusion reduces stroke by preventing blood clots from forming in the left atrial appendage. PREVAIL 5-year data and a patient-level meta-analysis nudge the Watchman left atrial appendage device to meeting noninferiority, but the devil is in the details, notes Dr Mandrola. Findings from three Cleveland Clinic real-world studies suggest a wider range of patients stand to benefit from the left atrial appendage closure device. with WATCHMAN . Arrhythmias and Clinical EP. with WATCHMAN . Search for more papers by this author , Lauren Rousseau. The Watchman device is a good example of the double-edged sword that is modern medicine. Procedures to implant the WATCHMAN left atrial occlusion device had a high implant success rate and a low rate of in-hospital complications in … During the Watchman clinical trials, a small percentage of people suffered stroke, clots around the device, or fluid buildup (pericardial effusion) in the membrane surrounding the heart. The device can apply pressure on the LAA. The left atrial appendage is a relatively thinly walled structure. As the procedure has become the standard of care, these complications have become less frequent. WATCHMAN COMPLICATIONS REPORTED IN THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE. 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