Decennial Analysis of Interventional Left Atrial Appendage Closure.

Data on long-term follow-up (LTFU) after interventional closure of the left atrial appendage (LAAC) in patients with nonvalvular atrial fibrillation (AF) are scarce. We sought to determine the outcome of patients after LAAC with the first generation device. The Cardioangiologisches Centrum Bethanien (CCB) LAAC registry database was analyzed. Between October 2001 and July 2007, 45 AF patients (23 male, mean age 71 ± 6 years; mean CHA2 DS2 -VaSc 4.3 ± 1.7 [range 1-7]; mean HASBLED score 3.3 ± 1.2 [1-5]) received LAAC. Postimplant dual-platelet inhibition with clopidogrel 75 mg/day and aspirine (ASA) 300 mg/day was prescribed for 6 months, followed by ASA 300 mg indefinitely. The primary endpoint was defined as any thrombembolic complication and/or any bleeding complication. The median FU was 7.4 years (1-12.4 years) resulting in 292 patient years. Fourteen patients died due to heart failure (n = 4), noncardiac reasons (n = 7), or due to unknown etiology (n = 3). No patient died from a bleeding or a stroke. Five ischemic strokes occurred at a median of 794 days (range 304-3,706 days) after LAAC. The observed annual stroke rate was 1.7% (RR 0.43; 95% CI 0.24-0.74; P = 0.0028). In 6 patients bleeding occurred (2 acute procedural, 4 during follow-up). The observed annual bleeding rate was 2.1% (RR 0.56; 95% CI 0.48-0.66; P < 0.0001). During LTFU after LAAC in patients with nonvalvular AF, lower event rates than expected are observed for both thrombembolic and bleeding complications.

Schmidt B ，Bordignon S ，Fuernkranz A ，Perrotta L ，Scherer D ，Chun KRJ ... -  《-》

Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk.

Seeger J ，Bothner C ，Dahme T ，Gonska B ，Scharnbeck D ，Markovic S ，Rottbauer W ，Wöhrle J ... -  《-》

Short-term dual antiplatelet therapy after interventional left atrial appendage closure with different devices.

Weise FK ，Bordignon S ，Perrotta L ，Konstantinou A ，Bologna F ，Nagase T ，Chen S ，Chun KRJ ，Schmidt B ... -  《-》

Percutaneous left atrial appendage closure followed by single antiplatelet therapy: Short- and mid-term outcomes.

After left atrial appendage closure (LAAC), various antithrombotic protocols have been suggested, but the optimal post-procedural antithrombotic strategy is still under debate. To investigate the efficacy and safety of LAAC with an AMPLATZER™ Cardiac Plug (ACP) device (St. Jude Medical, Minneapolis, MN, USA) followed by single antiplatelet therapy. Consecutive patients with non-valvular atrial fibrillation and a contraindication for oral anticoagulants who underwent LAAC with an ACP device between 2012 and 2014 in two French centres were included. Follow-up included clinical evaluation at 1, 3, 6 and 12 months, and yearly thereafter, and a cardiac computed tomography scan at 3 months to assess device position, device-related thrombus and residual leak. Single antiplatelet therapy was prescribed after the procedure for at least 12 months. A total of 76 patients underwent successful LAAC (mean age: 73 years; 59% men; mean CHA2DS2-VASc score 4.4±1.3; mean HAS-BLED score 3.4±0.9). Three major complications occurred during the periprocedural period (one cardiac tamponade and two access site haematomas). Device thrombosis was observed at 3 months in five (6.8%) patients who remained asymptomatic. After a mean follow-up of 13 months, the rates of death, stroke and major bleeding were 2.6%, 4.0% and 1.3%, respectively. Embolic and bleeding events were less frequent than expected from CHA2DS2-VASc (4.0% vs 9.9%; P<0.001) and HAS-BLED (1.3% vs 4.3%; P<0.001) risk scores. LAAC using an ACP device followed by single antiplatelet therapy could be a reasonable alternative for stroke prevention.

Jalal Z ，Dinet ML ，Combes N ，Pillois X ，Renou P ，Sibon I ，Iriart X ，Thambo JB ... -  《-》

Propensity-Matched Comparison of Oral Anticoagulation Versus Antiplatelet Therapy After Left Atrial Appendage Closure With WATCHMAN.

In this propensity-matched analysis of post-left atrial appendage closure antithrombotic therapy, the safety and effectiveness of oral anticoagulation (OAC) and antiplatelet therapy (APT) were compared. Left atrial appendage closure with the WATCHMAN device is an alternative to OAC in patients with nonvalvular atrial fibrillation, who are at high bleeding risk. Initial trials included 45 days of post-implantation OAC, but registry data suggest that APT may suffice. Patients from the PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), CAP (Continued Access to PROTECT-AF), CAP2 (Continued Access to PREVAIL), ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology), and EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization) trials receiving either OAC or APT post-implantation were matched and compared for nonprocedural bleeding and stroke or systemic thromboembolism over 6 months following implantation. Each patient on APT was matched with 2 patients on OAC, with propensity scores derived from age, sex, congestive heart failure, hypertension, diabetes, prior transient ischemic attack or stroke, peripheral vascular disease, left ventricular ejection fraction, renal impairment, and different atrial fibrillation subtypes. The cohort on OAC (n = 1,018; 95% receiving warfarin and 5% receiving nonwarfarin OAC) was prescribed 45-day OAC post-implantation (92% also received single APT), followed by 6-month single or dual APT. The cohort on APT (n = 509; 91% receiving dual APT and 9% receiving single APT) received APT for variable durations. Six-month freedom from nonprocedural major bleeding was similar (OAC, 95.7%; APT, 95.5%; p = 0.775) despite more early bleeds with OAC. Freedom from thromboembolism beyond 7 days was similar between groups (OAC, 98.8%; APT, 99.4%; p = 0.089). However, device-related thrombosis was more frequent with APT (OAC, 1.4%; APT, 3.1%; p = 0.018). After left atrial appendage closure with the WATCHMAN, although device-related thrombosis was more common with APT, both APT and OAC strategies resulted in similar safety and efficacy endpoints.

Søndergaard L ，Wong YH ，Reddy VY ，Boersma LVA ，Bergmann MW ，Doshi S ，Kar S ，Sievert H ，Wehrenberg S ，Stein K ，Holmes DR Jr ... -  《-》