Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use |
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Affiliation: | 1. Columbia University Medical Center, NY, New York, USA;2. Catholic Medical Center, Manchester, New Hampshire, USA;3. Baylor Scott & White, Plano, Texas, USA;4. Lankenau Heart Institute, Wynnewood, Pennsylvania, USA;5. Yale University School of Medicine, New Haven, Connecticut, USA;6. Conformal Medical, Nashua, New Hampshire, USA;7. Heart & Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA |
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Abstract: | ObjectivesThe authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.BackgroundThe CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.MethodsPatients with atrial fibrillation at high stroke risk (CHA2DS2-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year.ResultsTwenty-two patients (63.7% with CHA2DS2-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization.ConclusionsThis first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC. |
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Keywords: | atrial fibrillation left atrial appendage closure oral anticoagulant agents stroke AF" },{" #name" :" keyword" ," $" :{" id" :" kwrd0035" }," $$" :[{" #name" :" text" ," _" :" atrial fibrillation CLAAS" },{" #name" :" keyword" ," $" :{" id" :" kwrd0045" }," $$" :[{" #name" :" text" ," _" :" Conformal LAA Seal LAA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0055" }," $$" :[{" #name" :" text" ," _" :" left atrial appendage LAAC" },{" #name" :" keyword" ," $" :{" id" :" kwrd0065" }," $$" :[{" #name" :" text" ," _" :" left atrial appendage closure DRT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0075" }," $$" :[{" #name" :" text" ," _" :" device-related thrombus OAC" },{" #name" :" keyword" ," $" :{" id" :" kwrd0085" }," $$" :[{" #name" :" text" ," _" :" oral anticoagulation TEE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0095" }," $$" :[{" #name" :" text" ," _" :" transesophageal echocardiographic |
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