Impact of sex differences on outcomes in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure: A single-center experience.

Female patients affected by non-valvular atrial fibrillation (NVAF) have a higher risk of stroke compared with male patients. Left atrial appendage (LAA) closure has been demonstrated as a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF. However, the impact of sex-related differences on outcomes in patients undergoing LAA closure (LAAC) remains unclear. Our study investigated the differences in LAAC efficacy and safety endpoints between sexes. 387 consecutive patients undergoing WATCHMAN device implantation were enrolled and stratified by sex. Baseline clinical characteristics, procedural data, severe peri-procedural complications and long-term outcomes were compared between men and women. Measurements of LAA width and depth, device implantation success rate, and the frequency of severe peri-procedural complications were comparable between the two groups. After an average follow-up length of two years post LAAC, no significant differences were observed in the risks for composite thromboembolic events (P = 0.096), major bleeding (P = 0.129), and combined primary (co-primary) efficacy events (P = 0.231) between sexes, but the risk of all-cause death decreased significantly in women compared with men (P = 0.045). After performing propensity matching adjustment for residual confounders, the sex-related differences in the cumulative ratio of freedom from all-cause death did not reach statistical significance (P = 0.062), as was also observed with the cumulative ratio of freedom from composite thromboembolic events (P = 0.104), major bleeding (P = 0.134), and co-primary efficacy events (P = 0.241). The observed annual rate of thromboembolic events was significantly decreased by 67.1% (P < 0.01) and 52.5% (P < 0.05) and the observed annual rate of bleeding was reduced by 33.6% (P < 0.05) and 43.5% (P < 0.05) in men and women when compared with the predicted risk based on CHA2DS2VASc score and HAS-BLED score, respectively. LAAC can be considered as an effective and safe strategy in preventing thromboembolic events and decreasing bleeding risks in NVAF patients, regardless of sex. LAAC appears to normalize the sex-specific differences in NVAF patients both in terms of safety and efficacy.

Efficacy and safety of left atrial appendage closure in non-valvular atrial fibrillation in patients over 75 years.

Percutaneous left atrial appendage closure (LAAC) may decrease risks of stroke and bleeding in elderly patients with non-valvular atrial fibrillation (NVAF), but it is still lacking of evidence. The present study aimed at evaluating the efficacy and safety of LAAC in patients with NVAF over 75 years. 351 patients with NVAF who underwent LAAC were retrospectively analyzed on the LAAC procedure characteristics and the clinical follow-up according to age (age ≥ 75 years or < 75 years). Out of the 351 patients, LAA were successfully closed in 347 patients (98.9%), including 341 with Watchman (WM) device and 6 with Amplatzer cardiac plug (ACP) device because of the WM device-incompatible anatomy. There were no significant differences in total LAAC success rate and procedure-related major complications within 7 days between the groups aged ≥ 75 years and aged < 75 years. After a nearly 2-year follow-up, there was an increased trend of major bleedings and all bleedings in the group aged ≥ 75 years, but there were no significant differences between both groups in all-cause death, cardiovascular death, stroke/TIA/system embolism, device thrombus and device gap (> 5 mm). Kaplan-Meier analysis revealed that the relative risk of annual thromboembolic events between the observed values and the expected ones based on CHA2DS2-VASc score in the group aged ≥ 75 years decreased more obviously (61.9% vs. 54.3%); however, the relative risk of bleedings between the observed values and the expected ones based on HAS-BLED score in the younger group aged < 75 years decreased more significantly (59.6% vs. 29.2%). LAAC in patients with advanced age (age ≥ 75 years), has the same level of efficacy, safety and feasibility as in the younger patients aged < 75 years. Thus, LAAC may be an ideal choice to prevent stroke in NVAF patients with advanced age.

Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure).

OBJECTIVES: To report long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure. METHODS: A retrospective study of 370 consecutive patients undergoing LAAC procedures using the Watchman (WM) device. Data were compared between 330 cases only with LAAC procedure (Group I) and 25/5 (PFO/ASD) cases with sequential procedures of LAAC and PFO/ASD closure (Group II). RESULTS: Compared to Group I, Group II had more males (86.7% vs. 65.8%, p < 0.05) and a higher rate of stroke (33.3% vs. 10.6%, p < 0.01), but there were no statistical differences in the remaining patient characteristics. During the follow-up period, there were no significant differences between the two groups in embolism events (6.1% vs. 0%, p = 0.39), device related thrombus (5.8% vs 3.3%, p = 1.0), major bleeding (9.4% vs. 6.7%, p = 1.0) and cardiac death (3.6% vs. 0%, p = 0.61). The observed rate of all thromboembolic events by Kaplan-Meier analysis was decreased by 39.9% and 100% and the observed annual rate of bleeding was reduced by 32.9% and 57.6% in Group I and Group II, respectively. CONCLUSIONS: LAAC combined with PFO/ASD closure might be an ideal choice to prevent stroke and other thrombotic complications in patients with both NVAF and PFO/ASD.

Real-world survival data of device-related thrombus following left atrial appendage closure: 4-year experience from a single center.

This study aimed to estimate the incidence and risk factors of device-related thrombus (DRT) following percutaneous left atrial appendage closure (LAAC) in real-world practices. Between February 2012 and December 2016, 319 consecutive patients with atrial fibrillation underwent percutaneous LAAC using WATCHMAN, WATCHMAN Flx, Amplatzer cardiac plug, and Amulet devices. All patients underwent transesophageal echocardiography (TEE) at a minimum of three time points; periprocedurally, at 45 days, and at 6 months. Other clinical parameters were also evaluated, and a comparison between patients with DRT and those not suffering from DRT was done. The percutaneous LAAC was successfully performed in 97.8% of the patients. DRT was detected in 14 (4.49%) patients; of the 14 patients, DRT was detected in 3 patients at acute phase, 8 patients at subacute phase, 2 patients at late phase and 1 patient at very late phase. Most of the DRT originated from the central screw of device. In 6 out of 14 patients, DRT was successfully resolved by oral anticoagulation. Higher HAS-BLED score (4.1 ± 1.2 vs. 3.5 ± 1.1, p = 0.042) was more frequent in patients with DRT. Multivariable analysis showed that residual peri-device leak may result in a predisposition to DRT (p = 0.023). The incidence of DRT after percutaneous LAAC was acceptable, as a part of the DRT was resolved with oral anticoagulation. Residual peri-device leak was associated with DRT. Optimal implantation without peri-device gap, individual antithrombotic regimens, and careful monitoring with TEE follow-up could be conducive to the prevention of DRT.

Percutaneous left atrial appendage closure with complex anatomy by using the staged 'kissing-Watchman' technology with double devices.

BACKGROUND: Left atrial appendage closure (LAAC) is an efficient alternative of oral anticoagulation to prevent stroke in patients with non-valvular atrial fibrillation (NVAF). Due to complexities of LAA anatomy, a complete closure may not always be obtained with a single device. The aim of this study was to evaluate the feasibility and safety of the staged 'kissing-Watchman' technology to occlude the LAA with complex anatomy. METHODS: In our center, among 300 cases underwent LAAC with Watchman device from February 2012 to December 2016, 7 complex LAAs were implanted double devices using the staged 'kissing-Watchman' technology. The anatomic morphology, procedure characteristics and safety were analyzed. RESULTS: Of the 7 LAAs, the anatomic morphology includes 6 cauliflowers and 1 chicken wings, each has 2 big lobes and a large common ostium. In the two-staged LAAC procedures, there were no differences in X-ray exposure time, but the total procedure time (p = 0.0634), contrast volume (p = 0.0802) and X-ray dose (p = 0.0803) in the first procedure showed a tendency over the second. All the procedures were successful, except for one case with a 2 mm of peri-device leakage, there were no severe complications or major adverse events including device dislocation, thrombosis, obvious peri-device leakage (≥5 mm), pericardial effusion/tamponade, stroke/transient ischemic attack/systemic embolism, death and major bleeding during the 7-day perioperative period and the 6-month follow-up. CONCLUSIONS: The staged 'kissing-Watchman' technology is feasible and safe, which might provide a strategy to occlude the LAA with complex anatomy when an incomplete closure is inevitable with a single device.

Impact of chronic kidney disease on Watchman implantation: experience with 300 consecutive left atrial appendage closures at a single center.

The prevalence of chronic kidney disease (CKD) is high in patients with atrial fibrillation (AF). Left atrial appendage closure (LAAC) has been recognized as an efficient alternative to oral anticoagulation for the prevention of thromboembolic events in patients with non-valvular AF (NVAF); however, the long-term safety and efficacy of LAAC in patients with CKD remain unclear. This study was designed to provide data regarding the safety and efficacy of LAAC in NVAF patients with CKD. A real-world analysis of the safety and efficacy of LAAC was performed on a cohort of 300 NVAF patients with or without CKD who underwent LAAC using the Watchman (WM) device at our center. The patients with CKD (n = 151) were significantly older (77.0 ± 7.2 vs. 73.2 ± 7.8 years, respectively, P < 0.0001) and had a higher CHA2DS2-VASc score (4.3 ± 1.5 vs. 3.4 ± 1.4, respectively, P < 0.0001) and HAS-BLED score (4.0 ± 1.0 vs. 3.0 ± 1.0, respectively, P < 0.0001) than the patients without CKD (n = 149). However, there were no differences between groups with respect to the device implant success rate (98.7 vs. 97.3%, respectively, P = 0.446) or severe periprocedural complications within 7 days. The patients were followed up for 637 ± 398 days, and all patients received repeat transesophageal echocardiography (TEE). Thirteen (4.3%) device-related thrombi, 3 (1.0%) ischemic strokes, and 19 (6.3%) non-procedural major bleeding cases were documented, and there were no differences in these complications between groups. The observed rate of all thromboembolic events by Kaplan-Meier analysis decreased by 68.8% (CKD) and 48.6% (non-CKD); moreover, the observed annual rate of bleeding was reduced by 57.5% (CKD) and 11.4% (non-CKD). Our results indicate that LAAC with the WM device is safe and effective in preventing stroke in NVAF patients with and without CKD.