Percutaneous Left Atrial Appendage Closure With the Ultraseal Device Insights From the Initial Multicenter Experience

被引：21

作者：

Asmarats, Lluis ^{[1
]}

Masson, Jean-Bernard ^{[2
]}

Pagnotta, Paolo A. ^{[3
]}

Cook, Stephan ^{[4
]}

Foresti, Mike ^{[5
]}

Ibrahim, Reda ^{[6
]}

Sukiennik, Adam ^{[7
]}

Sabiniewicz, Robert ^{[8
]}

Maffeo, Diego ^{[9
]}

Carballo, Julio ^{[10
]}

Cruz-Gonzalez, Ignacio ^{[11
]}

Grasso, Carmelo ^{[12
]}

Pisano, Francesco ^{[13
]}

Senatore, Gaetano ^{[14
]}

Tarantini, Giuseppe ^{[15
]}

Kasongo, Adolphe ^{[2
]}

Chiarito, Mauro ^{[3
]}

Puricel, Serban ^{[4
]}

Messas, Nathan ^{[6
]}

Carlos Moreno-Samos, Jose ^{[11
]}

O'Hara, Gilles ^{[1
]}

Rodes-Cabau, Josep ^{[1
]}

机构：

[1] Laval Univ, Quebec Heart & Lung Inst, Dept Cardiol, Quebec City, PQ, Canada

[2] Ctr Hosp Univ Montreal, Dept Cardiol, Montreal, PQ, Canada

[3] Humanitas Res Hosp, Cardio Ctr, Dept Cardiol, Rozzano Milan, Italy

[4] Fribourg Univ & Hosp, Dept Cardiol, Fribourg, Switzerland

[5] Kliniken Maria Hilf GmbH Monchengladbach, Dept Cardiol, Monchengladbach, Germany

[6] Montreal Heart Inst, Dept Cardiol, Montreal, PQ, Canada

[7] Nicolaus Copernicus Univ, Dept Cardiol, Bydgoszcz, Poland

[8] Med Univ Gdansk, Dept Cardiol, Gdansk, Poland

[9] Fdn Poliambulanza, Dept Cardiol, Brescia, Italy

[10] Hosp El Pilar CM Teknon, Dept Cardiol, Barcelona, Spain

[11] Univ Hosp Salamanca, Dept Cardiol, Salamanca, Spain

[12] Ferrarotto Hosp, Dept Cardiol, Catania, Italy

[13] Reg Hosp Aosta, Dept Cardiol, Aosta, Italy

[14] Presidio Osped Ivrea Cirie, Dept Cardiol, Turin, Italy

[15] Univ Padua, Dept Cardiol, Med Sch, Padua, Italy

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2018年 / 11卷 / 19期

关键词：

atrial fibrillation; left atrial appendage closure; stroke; Ultraseal; AMPLATZER CARDIAC PLUG; ORAL ANTICOAGULANTS; CONSENSUS DOCUMENT; STROKE PREVENTION; WARFARIN THERAPY; CLINICAL IMPACT; AMULET DEVICE; FIBRILLATION; OCCLUSION; DEFINITIONS;

D O I：

10.1016/j.jcin.2018.05.023

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVES This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. BACKGROUND The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. METHODS This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. RESULTS A total of 126 patients (mean age 75 +/- 8 years; mean CHA(2)DS(2)-VASc score 5 +/- 2; mean HAS-BLED score 4 +/- 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartite range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. CONCLUSIONS In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very tow incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembotic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device. (C) 2018 by the American College of Cardiology Foundation.

引用

页码：1932 / 1941

页数：10

共 30 条

[1] Left atrial appendage: anatomy and imaging landmarks pertinent to percutaneous transcatheter occlusion [J].