Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology

Abstract

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.

Indications and Outcome in Patients Undergoing Left Atrial Appendage Closure—The Austrian LAAC Registry

“…The bleeding rate (5.3%) was also higher than existing analyses or registries, which reported rates of 0.0–4.8% [ 9 , 13 , 14 , 15 , 16 , 18 , 26 ], possibly because of the excessively high prevalence of previous bleeding in this cohort. The reduction of bleeding and embolic events compared to historic controls has been confirmed in other studies [ 12 , 26 ], which reported a bleeding rate reduction of 46% [ 26 ] and a reduction of thromboembolic events of 77–83% [ 12 , 26 ]. Concerning mortality, the results of this analysis (annual death rate = 8.6%) were similar to other studies (3.7 to 10.8%) [ 9 , 11 , 12 , 13 , 14 , 15 , 16 , 18 , 26 ].…”

“…Because of the higher risk profile of our patient cohort, the thromboembolic rate of 3.7% was higher than in other studies, which reported events in 1.3 to 3.4% of patients [ 9 , 11 , 12 , 13 , 14 , 15 , 16 , 18 , 26 ]. The bleeding rate (5.3%) was also higher than existing analyses or registries, which reported rates of 0.0–4.8% [ 9 , 13 , 14 , 15 , 16 , 18 , 26 ], possibly because of the excessively high prevalence of previous bleeding in this cohort. The reduction of bleeding and embolic events compared to historic controls has been confirmed in other studies [ 12 , 26 ], which reported a bleeding rate reduction of 46% [ 26 ] and a reduction of thromboembolic events of 77–83% [ 12 , 26 ].…”

LAA-Okkluder versus orale Antikoagulation bei nonvalvulärem Vorhofflimmern in klinischen Studien: Wie ist die Evidenz?

“…In der Prevail-Studie war in der Warfarin-Gruppe eine geringe Rate ischämischer Insulte (1,68 Watchman vs. 0,73 Warfarin, Ereignisraten pro 100 Patientenjahre) nach 5 Jahren [27] bei einem mittleren CHA2DS2-VASc score von 4,0 ± 1,2 (m u. s) auffällig [17,27]. Die Mortalität (kardiovaskular/ungeklärt nach 5 Jahren) war in der Watchman-Gruppe geringfügig niedriger als in der Warfarin-Gruppe ( ten mit Insult (und LAA-Bildgebung) lag ein MP-Thrombus vor [10]. Ein Zusammenhang zwischen der Intensität der Antikoagulation während der ersten 3 bis 6 Monate und der Präsenz von MP-Thromben wurde nicht festgestellt [10].…”

“…Die Mortalität (kardiovaskular/ungeklärt nach 5 Jahren) war in der Watchman-Gruppe geringfügig niedriger als in der Warfarin-Gruppe ( ten mit Insult (und LAA-Bildgebung) lag ein MP-Thrombus vor [10]. Ein Zusammenhang zwischen der Intensität der Antikoagulation während der ersten 3 bis 6 Monate und der Präsenz von MP-Thromben wurde nicht festgestellt [10]. [12]).…”

Application of transesophageal echocardiography, left atrial appendage angiography, cardiac computed tomography angiography, and three-dimensional reconstruction model in left atrial appendage occlusion

“…Its clinical benefits and safety have also been confirmed by many clinical studies. [9][10][11] However, due to the changeable morphology and irregular opening of the LAA, the success rate and occlusion effect of the LAA occlusion often vary. However, full assessment of the morphology and size of the LAA before surgery can improve the success rate and effectiveness of such occlusion.…”