No abstract

Aims No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). Methods and results All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160–0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0–36) vs. 40 (6–115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100–0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. Conclusions In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.

Background Percutaneous left atrial appendage closure (LAAC) has emerged as a valid option for prevention of thromboembolic events in patients with non-valvular atrial fibrillation and contraindications for oral anticoagulation. The most recent devices have been created to improve the intervention efficiency and to allow the procedure in a wider range of anatomies. The new-generation Watchman FLX (WMFLX) features a new design but its in vivo performances have not been compared to the previous WATCHMAN 2.5 (WM2.5) prosthesis. Hence, the data regarding conformability, compression and device-related LAA remodeling are scarce. Purpose To compare the anatomical results of WM2.5 and WMFLX implantation and impact on LAA dimensions. Methods This study included LAAC patients from the WATCH-DUAL registry who benefited from a pre- and post-intervention CT scan. The WATCH-DUAL study was a dual center observational study including all the LAAC procedures prospectively collected in local registries from two high-volume centres between November 2017 and December 2020. The LAA and device dimensions were measured in a centralized core lab by 3D CT scan reconstruction methods, focusing on the device landing zone (LZ/defined as the cross section of the appendage that was perpendicular to its axis and connected the circumflex artery to a point 1 to 2 cm inside the LAA). Results This analysis included n=107 patients (n=58 WMFLX, n=49 WM2.5). The patients clinical profiles didn't differ, except for a higher proportion of coronary artery disease in WM2.5 group. The LAA dimensions were comparable between groups. There was a significantly higher proportion of chickenwing shapes in the WMFLX patients. The mean device baseline diameter was in the WMFLX compared to the WM2.5 patients (28.8±0.5 vs. 25.7±0.4 mm, p<0.001). The median delay for CT control was 48 (43–62) days. The LZ area (451 (363–521) vs. 366 (260–459) mm2, p<0.001) and minimal diameter (23.0 (20.7–24.8) vs. 18.7 (15.9–21.8) mm, p<0.001) significantly increased after implantation among patients. The LZ area increase absolute value and percentage were 101 (18–151) mm2 and 28 (4–54) % respectively. The LZ dimensions increase was more pronounced in the WMFLX group: these patients exhibited post LAAC larger LZ area and dimensions compared to the WM2.5 cases. The LAA eccentricity was reduced after implantation: the ratio LZ maximal/LZ minimal diameter significantly decreased for all patients (r=1.28 (1.18–1.40) vs. 1.06 (1.05–1.09), p<0.001). Comparable results were observed in WMFLX and WM2.5 patients. A multivariable regression analysis demonstrated that baseline LAA length, baseline LZ eccentricity and WM FLX use were independent predictors of LAA remodeling/dimensions increase. Conclusion LAA dimensions increased over time at the site of WM prosthesis implantation suggesting a local positive appendage remodeling after procedure. This phenomenon appears to be more pronounced with the WMFLX device. FUNDunding Acknowledgement Type of funding sources: None.

No abstract

No abstract