Successful Left Atrial Appendage Closure with Watchman Device Implantation in Two Patients with Inferior Vena Cava Filters

Percutaneous procedures through femoral access in patients with inferior vena cava (IVC) filter may be at risk of complications. We evaluated the feasibility and safety of left atrial appendage closure (LAAC) through femoral access in patients previously implanted with IVC filter. We described the WatchmanTM device implantation in two patients with formal contraindication for oral anticoagulation. First patient had a GreenfieldTM filter and the second one an OpteaseTM filter, and in this patient an attempt to withdrawal the filter immediately before the LAAC procedure failed. A femoral approach was performed in both patients using a 14 Fr sheath. Before crossing IVC filters, venographies did not detect any thrombus. All steps of IVC filter crossing were performed under fluoroscopic guidance. No immediate or intrahospital complications related to the procedure occurred. Herein, we presented two cases of successful LAAC closure with Watchman device in patients with two different kinds of IVC filters.

478 Clinical outcomes of patients at very high stroke risk undergoing watchman implantation

Aims Left atrial appendage occlusion (LAAO) with the Watchman device is an effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation at high thromboembolic risk. We sought to evaluate the safety and effectiveness of LAAO for stroke and bleeding prevention in patients at very high stroke risk. Methods and results Data were extracted from a prospective database of 488 AF patients who underwent LAA closure with a Watchman device. Periprocedural complications, thromboembolic (TE), and bleeding event rates among patients with a CHA2DS2-VASc ≥ 5 were reported. Predicted annual rates of TE or major bleeding events were compared to the annualized observed risk of the population. Overall, 209 patients with a CHA2DS2-VASc ≥5 (CHA2DS2-VASc: 6.0 ± 1.0; HAS-BLED: 3.7 ± 1.1) were included in the study. The mean age was 78 ± 6 years and 52.2% (n = 109) were males. Watchman implantation was successful in all patients. Overall procedure-related complication rate was 3.3% (n = 7). Two major complications were observed (1.0%): one pericardial tamponade requiring surgery and one major bleeding event at 3 days post-procedure. The incidence of minor complications was 2.3% (n = 5). Specifically, two patients experienced a pericardial effusion that required drainage and three had a groin hematoma. During a mean follow-up duration of 12 ± 5 months (193 pt/years), six TE events (2.9%/annualized rate: 3.1%) were documented after a median of 6.3 months (IQR: 2.2–9.6). Based on the estimated annual TE risk according to the CHA2DS2-VASc score (8.5%), the % risk reduction after LAAO was 63.5%. Four major bleeding events [1.9% (median time to event: 2.1 months; IQR: 1.0–3.4)] and five minor bleeding events occurred (2.5%) during follow-up. Compared to the expected rate of bleeding events as assessed by the HAS-BLED of the population (8.03%), LAAO led to a 42% reduction of bleeding risk. Conclusions In a population at very high TE risk, LAAO with the Watchman device was a safe and effective approach, and led to a 63.5% of stroke risk.

473 Propensity-matched comparison of left atrial appendage occlusion and direct oral anticoagulation for thromboembolic prevention in octogenarians

Aims A significant amount of atrial fibrillation patients does not receive appropriate anticoagulation, owing to contraindications and side effects. Octogenarians have higher competing comorbidities with a remarkable bleeding/thromboembolic (TE) risk. We aimed at analysing the clinical outcomes of LAAO compared with direct oral anticoagulation (DOAC) in octogenarians. Methods and results Data were extracted from two prospective databases including 488 LAAO and 825 DOAC patients. Patients aged 80 years or older accounted for 37.1% (n = 181) and 39.5% (n = 326). In order to attenuate the imbalance in covariates between the groups, a propensity score matching technique was used (covariates: age, sex, CHA2DS2-VASc, and HAS-BLED scores, follow-up duration; tolerance 0.02). This method resulted in matched populations with 108 octogenarian patients per group. The annual stroke/transient ischaemic attack (TIA) risk was estimated based on the CHA2DS2-VASc, and compared to the annualized observed risk, owing to calculate the % risk reduction associated with the two treatment strategies. A total of 216 octogenarians were included in the analysis (84 ± 3 years; CHA2DS2-VASc: 4.9 ± 1.4, HAS-BLED: 3.1 ± 0.9). A Watchman device was successfully deployed in all LAAO ≥ 80 patients; periprocedural adverse events were observed in 2.8% (n = 3) of LAAO patients. During a follow-up of 13 ± 4 months, 3 (2.8%) TE complications (1 stroke, 2 TIA) occurred in LAAO ≥ 80 pts and 4 (3.7%; 1 stroke, 3 TIA) in DOAC ≥ 80 pts (P = 0.99). The annualized risk of stroke/TIA was 2.5% in the first and 3.5% in the second group. Based on the estimated annual TE risk according to the CHA2DS2-VASc score, the % risk reduction after LAAO and DOAC was 54.5% and 36.4%, respectively. Major bleeding events were 3 [1 intracranial, 2 gastrointestinal (GI)] LAAO ≥ 80 pts, and 3 (2 intracranial, 1GI) in DOAC ≥ 80 pts (2.8% in both groups). Minor bleeding events were significantly higher in DOAC ≥ 80 pts [13.0% (n = 14) vs. 2.7% (n = 3); RR: 4.7, 95% CI: 1.4–15.7; P = 0.009]. Conclusions LAAO was safe and similar to DOAC at preventing ischaemic/major bleeding events in a matched population of patients aged ≥80 years. A significantly higher incidence of minor bleeding events was observed in the DOAC group.

475 Is left atrial appendage device compression rate a predictor of incomplete occlusion in patients undergoing watchman device implantation?

Aims Transesophageal echocardiography (TEE) is a standard peri-procedural imaging modality in patients undergoing percutaneous left atrial appendage (LAA) occlusion. An accurate device sizing is pivotal to assess stability and achieve successful closure. In this prospective study, we sought to evaluate the correlation between Watchman device compression rates (DCRs) and risk of incomplete LAA occlusion at follow-up in patients undergoing Watchman device implantation. Methods and results Two-dimensional TEE via a commercially available transducer (Vivid, Philips) was performed during the procedure and within 3 months after the procedure. LAA size, morphology, and DCRs [(original device size—size after deployment)/original device size; %] were assessed in a mid-oesophageal view at 0°, 45°, 90° and 135°, according to company recommendations. Residual leaks ≥ 3 mm were classified as significant. Between 2016 and 2018, 116 patients underwent LAA occlusion with a Watchman device at our institution. The mean age was 74 ± 9 years and 60.4% (n = 70) were males. The average CHA2DS2-VASc and HAS-BLED scores were 4.7 ± 1.7 and 2.5 ± 1.1, respectively. The final device size was 21 mm in 11 (9.5%) patients, 24 mm in 28 (24.1), 27 mm in 27 (23.3%), 30 mm in 26 (22.4%), and 33 mm in 24 (20.7). At follow-up TEE, 16 (13.8%) patients were found to have a significant (≥3 mm) residual leak. The average DCRs measured at different angles in patients with and without leak were not significantly different (24 ± 8% vs. 26 ± 7% at 0°, P = 0.47; 23 ± 9% vs. 25 ± 7% at 45°, P = 0.58; 23 ± 8% vs. 23 ± 6% at 90°, P = 0.61; 22 ± 8% vs. 21 ± 7% at 135°, P = 0.61). At receiver operating characteristic (ROC) analysis, the areas under the curve to discriminate between patients with/without leak were 0.58, 0.57, 0.55, and 0.46 for DCRs measured at 0°, 45°, 90°, and 135° angles. Conclusions Peri-procedural assessment of DCRs does not appear to be an accurate method to predict LAA complete occlusion in patients undergoing Watchman device implantation.

Troponin T Elevation After Percutaneous Left Atrial Appendage Occlusion

Background: Cardiac troponin T (cTNT) has been widely used in detecting cardiac damage. Elevated cTNT level has been reported to be associated with increased mortality in multiple cardiac conditions. It is not uncommon to observe an increased level of cTNT in patients after left atrial appendage occlusion (LAAO). The objective of the study is to study the incidence, significance, and factors associated with cTNT elevation after LAAO.Methods: We prospectively included patients who underwent LAAO from January 2019 to July 2020 in Fudan Zhongshan Hospital. Patients were divided into those with elevated cTNT after procedure and those with normal postprocedure cTNT. All individuals were followed up for 1 year. The primary outcome is major adverse cardiovascular events, which include myocardial infarction, heart failure, cardiac death, and stroke. The second outcome is periprocedure complication, including chest pain, tachycardia, cardiac tamponade, change of electrocardiograph, and atrial thrombus.Results: A total of 190 patients were enrolled. Of the patients, 85.3% had elevated cTNT after LAAO, while 14.7% of them did not. Exposure time, dosage of contrast, types of devices, shapes, and sizes of LAA could contribute to elevated postprocedure cTNT. We found that patients with a Watchman device were more likely to have elevated postprocedure cTNT than those with a Lambre device (89.2 vs. 76.7%, p = 0.029). LAAO shapes were associated with cTNT levels in patients with a Watchman device, while the diameter of the outer disc and LAA depth mattered for the Lambre device. There was no significant difference in the primary and second outcome between the two groups (p-value: 0.619, 0.674).Conclusion: LAAO was found to be commonly accompanied with cTNT elevation, which might not to be related to the complications and adverse cardiac outcomes within 1 year of follow-up. Moreover, eGFR at baseline, exposure time, dosage of contrast, types of LAAO device, and LAA morphology could contribute to cTNT elevation.