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Journal Article
Observational Study
First experience with the Watchman FLX occluder for percutaneous left atrial appendage closure.
BACKGROUND: We aimed to evaluate efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyze procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients.
METHODS AND RESULTS: Twelve consecutive non-valvular atrial fibrillation patients (age 76.6±7.8years) at high risk for stroke (CHA2 DS2 -VASc-Score 5.5±0.9) and bleeding (HAS-BLED-Score 3.8±0.9), received LAA closure with the Watchman FLX. Bench testing demonstrated easy repositioning as well as optimized sealing and anchoring. Follow-up was done at 30days, and at 3 and 6months including transesophageal echocardiography after 3months. Compression was calculated as occluder size to diameter at shoulder in final position. The device was successfully implanted in all patients. Partial recapture was necessary in 6 (50%) of cases, and full recapture in one (8.3%). There were no procedure-related complications. In 83.3% of cases (N=10/12) compression was between 10 and 27%, and mean compression was 24.0±11.1%. Mean implantation depth was 4.0±4.4mm distal of LAA ostium. There was no residual flow. Proximal shift in device position was noticed in 2 patients. One device was embolized at 30day follow-up, and another device showed thrombus formation. There was no disabling or non-disabling stroke through 6months of follow-up with dual antiplatelet therapy for 3months.
CONCLUSION: LAA closure with the new Watchman FLX is associated with a good periprocedural safety, complete sealing of the LAA and simple repositioning.
SUMMARY: We evaluated the efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyzed procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. This is a first observational study demonstrating procedural safety, complete sealing of the LAA and simple technique for repositioning. There was no stroke within a 6month follow-up.
METHODS AND RESULTS: Twelve consecutive non-valvular atrial fibrillation patients (age 76.6±7.8years) at high risk for stroke (CHA2 DS2 -VASc-Score 5.5±0.9) and bleeding (HAS-BLED-Score 3.8±0.9), received LAA closure with the Watchman FLX. Bench testing demonstrated easy repositioning as well as optimized sealing and anchoring. Follow-up was done at 30days, and at 3 and 6months including transesophageal echocardiography after 3months. Compression was calculated as occluder size to diameter at shoulder in final position. The device was successfully implanted in all patients. Partial recapture was necessary in 6 (50%) of cases, and full recapture in one (8.3%). There were no procedure-related complications. In 83.3% of cases (N=10/12) compression was between 10 and 27%, and mean compression was 24.0±11.1%. Mean implantation depth was 4.0±4.4mm distal of LAA ostium. There was no residual flow. Proximal shift in device position was noticed in 2 patients. One device was embolized at 30day follow-up, and another device showed thrombus formation. There was no disabling or non-disabling stroke through 6months of follow-up with dual antiplatelet therapy for 3months.
CONCLUSION: LAA closure with the new Watchman FLX is associated with a good periprocedural safety, complete sealing of the LAA and simple repositioning.
SUMMARY: We evaluated the efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyzed procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. This is a first observational study demonstrating procedural safety, complete sealing of the LAA and simple technique for repositioning. There was no stroke within a 6month follow-up.
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