LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation.

Background: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice. Methods: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years. Results: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA 2 DS 2 -VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (−76% and −41%) or hemorrhagic (−81% and 67%) stroke and prior bleeding (−85% and −30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up ( P =0.28). Conclusions: During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01972282.

Background: There are no randomized trials described outcomes of multivessel percutaneous coronary interventions (PCI) (in primary and staged revascularization) with second generation drug eluting stents (DES) in patients with ST-elevation myocardial infarction (STEMI). We are presenting preliminary results of randomized trial (NCT01781715). Methods: Six-month outcomes of 89 consecutive patients with STEMI and multivessel coronary artery disease (CAD) (SYNTAX 18.6±7.9 points) undergoing primary PCI with zotarolimus-eluting stents (Resolute Integrity; Medtronic) were studied. We used two strategies of multivessel stenting: in primary PCI (MS primary, n=46) (the IRA was opened followed by dilatation of other significantly narrowed arteries during the same procedure) and multivessel stenting in staged revascularisation (MS staged, n=43) (the IRA only was treated during the primary intervention while the complete revascularization was planned in a second procedure (8.5±4.2 days)) in our prospective randomized study. Results: During follow-up of 6 months there was no cardiac death in overall group. We observed 1 (2.3%) non-cardiac death in MS staged group vs 0 in MS primary (p=0.9), 0 non-fatal myocardial infarction (MI) in MS staged group vs 3 (6.5%) in MS primary (p=0.3) due to definite stent thromboses (ST) (2.5% on the number of stents). There was no target vessel revascularization (TVR) in MS staged group, but it was performed in 2 cases (4.3%) in MS primary group (p=0.5). Major adverse cardiac event (MACE) (cardiac death, MI, TVR) was diagnosed in 2.3% and 6.5% in MS staged and MS primary group (p=0.7). Conclusions: second generation DES in STEMI patients with multivessel CAD are satisfactory safely and effectively as part of the strategy of multivessel stenting in primary PCI and multivessel staged PCI (8.5±4.2 days). Multivessel stenting in primary PCI was associated with higher risk of stent thrombosis (ST) compared with multivessel staged PCI in six month follow-up period.

LAA closure with the WATCHMAN device followed by DAPT therapy in a high-risk patient population is safe. At one year, the intervention is associated with a substantial risk reduction regarding ischaemic stroke and major bleeding compared to the expected rate based on CHA2DS2-VASc and HAS-BLED scores.

Background In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device‐related thrombus in a large multi‐center real‐world cohort undergoing LAAc with the WATCHMAN device. Methods and Results We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2‐VASC‐Score 4.3 ± 1.7; HAS‐BLED‐Score 2.3 ± 1.2). Device‐related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42–111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long‐standing, non‐paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non‐paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No‐DRT 2.2%/year, p = .8). Conclusions In real‐world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post‐procedural regimen and was not associated with an increased risk of stroke or SE. While long‐standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.