One year outcome and analysis of peri-device leak of left atrial appendage occlusion devices

Abstract

Background The prevalence of peri-device leak (PDL) of left atrial appendage occlusion (LAAO) devices has been previously reported. However, there have been only few data that compared different existing devices. The aim of this study was to assess the incidence of PDL with both devices WATCHMAN® and AMPLAZER Amulet®, and to evaluate the clinical outcome at 12 months. Methods Consecutive patients who underwent LAAO between January 2018 and 2020 were randomly assigned to either WATCHMAN or AMPLATZER Amulet implantation based on a systematic two-week alternation between both devices. LAA measurements were assessed using cardiac computed tomography angiography (CCTA) prior to, and transesophageal echocardiography (TEE) during the procedure. At 8 weeks post-LAAO, patients underwent TEE and/or CCTA to identify the presence of PDL and/or device-related complications. Patients were then followed for 12 months to identify major adverse cardiovascular/embolic events. Results The cohort consisted of 51 patients (25 WATCHMAN, 26 AMPLATZER Amulet; mean age 76±7 years; male gender 76%). Both groups were identically matched for demographics, comorbidities and indication for LAAO. There were 19 patients who had PDL (13 WATCHMAN vs 6 AMPLATZER Amulet, P-value=0.033). Of them, 8 (15%) patients had significant PDL (7 WATCHMAN vs. 1 AMPLATZER Amulet, P-value=0.018). On CCTA, the landing zone maximal diameter of the AMPLATZER Amulet device had the strongest correlation with the final deployed device size (Spearman'rho 0.92, P-value<0.0001). In the multivariate analysis, male gender and device type were independent predictors of any PDL (P-values 0.016 and 0.031, respectively). On a mean follow-up of 12 months, the total number of events was more prevalent in the WATCHMAN group (P-value 0.008), but the incidence of cardio-embolic events reached borderline significance (16% vs. 0%, P-value=0.051). Conclusions Among patients who underwent LAAO, almost 15% had significant PDL with the majority belonging to the WATCHMAN group. Still, larger studies are warranted to evaluate its effectiveness in stroke prevention. FUNDunding Acknowledgement Type of funding sources: None. Table 1 Table 2

Safety and efficacy of the Amplatzer Amulet and Watchman 2.5 for left atrial appendage occlusion: A systematic review and meta‐analysis

“…A total of 2926 patients from seven studies (Table 2) 12,[15][16][17][18][19][20] underwent LAAO, with a total of 1508 patients in the Watchman 2.5 group and 1418 patients in the Amplatzer Amulet group included in the meta-analysis (Figure 1 and Table 2). Seven total studies, including TA B L E 1 Quality assessment of included studies by NOS…”

“…The equipment system includes a 14.4 −16.5 Fr (outer diameter) delivery sheath, lobe and stabilizing hook, as well as a fixed-size cover disk. 18 The mechanism of action of the Watchman 2.5 is via closure of the distal body of the LAA. 13 The Watchman has been the LAAO most thoroughly researched.…”

Comparison between Amplatzer and Watchman Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation: A Systematic Review and Meta-Analysis

“…Our comparative findings were not completely consistent with a previous meta-analysis [41], which showed similar safety and efficacy outcomes between the Amplatzer and Watchman groups. It is partially because our meta-analysis included more new research and 3 RCTs [14][15][16], comprising data from 4,676 patients, while the other article only included 6 studies, with a total population of 614. Well-designed RCTs provide more convincing evidence in a specific, selected, well-defined target population.…”

“…It is worth noting that most studies in our meta-analysis used TEE to identify the presence of PDL. Both TEE and/or cardiac computed tomography angiography were performed in the SWISS-APERO trial [15] and Mansour et al [16] study. PDL occurrence is substantially higher with CT than TEE [38].…”

“…Amplatzer Cardiac Plug and the 2nd generation Amplatzer Amulet devices featured favorable outcomes in some observational studies [11][12][13]. There were several observational studies [14][15][16][17][18][19][20][21][22][23][24] and randomized controlled trials (RCTs) [25][26][27][28] directly comparing Amplatzer and Watchman devices. However, results from these studies were not consistent and were underpowered to evaluate rare outcomes such as stroke.…”