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.

A significant proportion of patients who suffer from atrial fibrillation and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well-known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with atrial fibrillation. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.

The study aimed to confirm the efficacy and safety of WATCHMAN LAA closure in atrial fibrillation patients unsuitable for oral anticoagulation. The EWOLUTION registry prospectively collects all clinical data on 1,005 European patients implanted with a WATCHMAN device. Following the procedure, 605 patients (60.2%) received dual antiplatelet therapy according to the local standard; DAPT was discontinued in 85% of patients within one year. CHA2DS2-VASc and HAS-BLED scores were 4.61.6 and 2.41.2, respectively. The periprocedural SAE rate was 3.3% (2.0% major adverse cardiac events), mostly resolving without sequelae. Device embolisation or pericardial effusion occurred in one (0.2%) and two (0.3%) patients, respectively. TEE (median 62 days post implant, IQR: 47-97) confirmed effective sealing (no leak >5 mm) in 99.2% of patients. Device thrombus was present in 22 patients (4.0%), one patient developed a stroke. One-year mortality in the DAPT group was 9.6% (N=58) reflecting the advanced age and comorbidities in this population. The ischaemic stroke rate at one year was 1.4% (expected based on CHA2DS2-VASc: 7.5%), none fatal. The major bleeding rate was 2.5%, or 2.1% excluding periprocedural events (expected rate on VKA based on HAS-BLED: 5.1%). 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.

Aims: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting.Methods and results: Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak 5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295).Conclusion: The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.

Background: The impact of acute total occlusion (TO) of the culprit artery in non-ST-segment elevation myocardial infarction (NSTEMI) is not fully established. We aimed to evaluate the clinical and angiographic phenotype and outcome of NSTEMI patients with TO (NSTEMI_TO) compared to NSTEMI patients without TO (NSTEMI_NTO) and those with ST-segment elevation and TO (STEMI_TO). Methods: Demographic, clinical and procedure-related data of patients with acute myocardial infarction who underwent percutaneous coronary intervention (PCI) between 2014 and 2017 from the Polish National Registry were analysed. Results: We evaluated 131,729 patients: NSTEMI_NTO (n = 65,206), NSTEMI_TO (n = 16,209) and STEMI_TO (n = 50,314). The NSTEMI_TO group had intermediate results compared to the NSTEMI_NTO and STEMI_TO groups regarding mean age (68.78 ± 11.39 vs 65.98 ± 11.61 vs 64.86 ± 12.04 (years), p < 0.0001), Killip class IV on admission (1.69 vs 2.48 vs 5.03 (%), p < 0.0001), cardiac arrest before admission (2.19 vs 3.09 vs 6.02 (%), p < 0.0001) and death during PCI (0.43 vs 0.97 vs 1.76 (%), p < 0.0001)—for NSTEMI_NTO, NSTEMI_TO and STEMI_TO, respectively. However, we noticed that the NSTEMI_TO group had the longest time from pain to first medical contact (median 4.0 vs 5.0 vs 2.0 (hours), p < 0.0001) and the lowest frequency of TIMI flow grade 3 after PCI (88.61 vs 83.36 vs 95.57 (%), p < 0.0001) and that the left circumflex artery (LCx) was most often the culprit lesion (14.09 vs 35.86 vs 25.42 (%), p < 0.0001). Conclusions: The NSTEMI_TO group clearly differed from the NSTEMI_NTO group. NSTEMI_TO appears to be an intermediate condition between NSTEMI_NTO and STEMI_TO, although NSTEMI_TO patients have the longest time delay to and the worst result of PCI, which can be explained by the location of the culprit lesion in the LCx.