Watchman FLX vs. Watchman 2.5 in a Dual-Center Left Atrial Appendage Closure Cohort: the WATCH-DUAL study

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.

Real‐world experience with the new Watchman FLX device: Data from two high‐volume Sicilian centers. The FLX‐iEST registry

“…Smaller LAAC registries with Watchman FLX have already been published, presenting some limitations: namely small series, focus on imaging guidance, several enrolling centers with low inclusion rates and different levels of experience, and a high rate of “non‐FLX” devices used for LAAC compromising the consecutiveness of data collection 14–16 . A recent dual‐center study from Galea et al 17 (WATCH‐DUAL study) compared the two generations of Watchman devices in a smaller cohort of 144 patients (n. 71 Watchman 2.5 and n. 73 FLX); compared to the previous generation, Watchman FLX was associated with improved sealing properties (higher LAA coverage) and lower DRT (at 45 days computed tomography scan and TEE), despite no differences resulted in terms of clinical outcomes (procedure‐related complications and 6‐months net adverse cardiovascular events).…”

“…Smaller LAAC registries with Watchman FLX have already been published, presenting some limitations: namely small series, focus on imaging guidance, several enrolling centers with low inclusion rates and different levels of experience, and a high rate of "non-FLX" devices used for LAAC compromising the consecutiveness of data collection. [14][15][16] A recent dual-center study from Galea et al 17 In both the enrolling centers involved in our registry, the Watchman FLX represented the main LAAC device, used in more than 95% of cases.…”

Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

“…Watchman FLX achieved a near 100% implantation success and a substantial decrease in the occurrence of periprocedural complications as compared to Amplatzer Amulet occlusion 36 . Watchman FLX also had a lower DRT at 45 days 37 and a higher sealing rate at 3 months as compared to the Watchman device in small sample size of clinical trials 38 . Watchman FLX is the commonly implanted device, but it has not been widely used in most developing countries.…”

Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis

“…Watchman FLX achieved near 100% implantation success and a substantial decrease in the occurrence of periprocedural complications compared to Amplatzer Amulet occlusion ( 11 , 37 ). Watchman FLX also had a lower DRT at 45 days ( 38 ) and a higher sealing rate at 3 months compared to the Watchman device in a small sample size of clinical trials ( 39 ). Larger RCTs are needed to evaluate the superiority of Watchman FLX.…”