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Early Results With New Watchman FLX LAA Occlusion Device
Quick Takes
- This small registry study reports that Watchman FLX is safe and effective for left atrial appendage occlusion (LAAO) in a wide range of LAA anatomies.
- Additional studies with larger sample size such as the Pinnacle FLX trial and with longer follow-up periods are required to confirm these preliminary results.
Study Questions:
What is the early experience with the new-generation Watchman FLX left atrial appendage occlusion (LAAO) device?
Methods:
The investigators enrolled 165 patients undergoing LAAO with Watchman FLX in a prospective, multicenter registry at 12 centers participating in the European limited market release program. During follow-up, adverse events were registered, including death, neurological and hemorrhagic events, pericardial effusion, tamponade, and late device-related complications. Categorical variables were expressed as frequencies and percentages, and continuous variables as mean ± standard deviation.
Results:
Mean age was 75.4 ± 8.9 years and CHA2DS2-VASc score was 4.4 ± 1.4. A total of 128 (77.6%) patients had a history of major bleeding, including previous intracranial hemorrhage in 55 (33.3%) cases. LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 (78.2%) and a second device was required in six (3.6%) cases. Procedure-related complications occurred in three (1.8%) patients: two (1.2%) access-related and one (0.6%) pericardial effusion. No periprocedural strokes, deaths, or device embolizations occurred. Forty-nine (29.7%) patients were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just one peridevice leak ≥5 mm and seven (4.7%) device-related thrombosis. During a median follow-up of 55 days (interquartile range, 45-148 days), there were six (4.8%) hemorrhagic complications, one (0.8%) patient suffered an ischemic stroke, and one (0.8%) died. No late device embolizations occurred.
Conclusions:
The authors concluded that LAAO with Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.
Perspective:
This registry study reports that Watchman FLX is safe and effective for LAAO in a wide range of LAA anatomies. Furthermore, it was associated with a low number of periprocedural complications, and provided outstanding device sealing at follow-up, with no cases of device embolization and a similar rate of device-related thrombosis compared to previous studies. Of note, the study was limited by the small sample size and follow-up period that precluded definite conclusions. Additional studies with larger sample size such as the Pinnacle FLX trial (NCT02702271) and with longer follow-up periods are required to confirm these preliminary results.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Noninvasive Imaging, Pericardial Disease, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Vascular Medicine
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Appendage, Brain Ischemia, Cardiac Tamponade, Coronary Occlusion, Diagnostic Imaging, Geriatrics, Hemorrhage, Intracranial Hemorrhages, Patient Discharge, Pericardial Effusion, Platelet Aggregation Inhibitors, Primary Prevention, Stroke, Thromboembolism, Thrombosis, Vascular Diseases
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