Left atrial appendage closure: First in man with the 4th generation WATCHMAN device.
Catheter Cardiovasc Interv
; 87(4): 787-94, 2016 Mar.
Article
em En
| MEDLINE
| ID: mdl-26354821
ABSTRACT
OBJECTIVES:
To evaluate the feasibility and safety of the fourth generation WATCHMAN device.BACKGROUND:
The WATCHMAN left atrial appendage (LAA) closure device has been shown to be non-inferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with non-valvular atrial fibrillation. A new (fourth) generation of the WATCHMAN device was designed to facilitate easier delivery and improve safety.METHODS:
We conducted a prospective, non-randomized study of LAA closure with use of the 4(th) generation WATCHMAN device in 36 patients with non-valvular atrial fibrillation. Follow-up was performed at 45 days, 6 months and 12 months following implantation.RESULTS:
The mean age of the population was 73 ± 6 years and 67% were male. The mean CHADS2 and CHA2 DS2-VASc Score were 2.5 and 4.5, respectively. The device was implanted successfully in 34/36 (94%). No serious hospital complications related to the device or procedure occurred. During 12 month follow-up, three ischemic strokes (8%), one hemorrhagic stroke (3%), one TIA (3%) and three deaths (9%) occurred. Device-associated thrombus formation was detected in one patient (3%) during six-month follow-up and was treated successfully with low molecular weight heparin.CONCLUSIONS:
LAA closure with the 4(th) generation WATCHMAN device is feasible and safe. New technical features may contribute to a better performance of the occluder, particularly regarding the risk of pericardial effusions.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desenho de Prótese
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Fibrilação Atrial
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Cateterismo Cardíaco
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Ataque Isquêmico Transitório
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Implantação de Prótese
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Apêndice Atrial
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Acidente Vascular Cerebral
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Evaluation_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article