Lucas V Boersma1, Hueseyin Ince2, Stephan Kische3, Evgeny Pokushalov4, Thomas Schmitz5, Boris Schmidt6, Tommaso Gori7, Felix Meincke8, Alexey Vladimir Protopopov9, Timothy Betts10, David Foley11, Horst Sievert12, Patrizio Mazzone13, Tom De Potter14, Elisa Vireca15, Kenneth Stein16, Martin W Bergmann17. 1. St. Antonius Ziekenhuis Nieuwegein/AMC, Amsterdam, The Netherlands. Electronic address: l.boersma@antoniusziekenhuis.nl. 2. Vivantes Klinikum Urban, Berlin, Germany. 3. Vivantes Klinikum im Friedrichshain, Berlin, Germany. 4. State Research Institute of Circulation Pathology, Novosibirsk, Russia. 5. Elisabeth Krankenhaus Essen, Essen, Germany. 6. Cardioangiologisches Centrum Bethanien, Frankfurt/Main, Germany. 7. Universitätsmedizin Mainz und DZHK Standort Rhein-Main, Mainz, Germany. 8. Asklepios Klinik St Georg, Cardiology, Hamburg, Germany. 9. Cardiovascular Center of Regional State Hospital, Krasnoyarsk, Russia. 10. Oxford University Hospitals NHS Trust, Oxford, United Kingdom. 11. Beaumont Hospital, Dublin, Ireland. 12. CardioVascular Center Frankfurt, Frankfurt, Germany. 13. Ospedale San Raffaele, Milan, Italy. 14. Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium. 15. Boston Scientific, Diegem, Belgium. 16. Boston Scientific, St. Paul, Minnesota. 17. Cardiologicum, Hamburg, Germany.
Abstract
BACKGROUND: Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. OBJECTIVE: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. METHODS: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice. RESULTS: The baseline CHA2DS2-VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related. CONCLUSION: 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 (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. OBJECTIVE: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. METHODS: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice. RESULTS: The baseline CHA2DS2-VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related. CONCLUSION: 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.
Authors: Robert C Ward; Trevon McGill; Fadi Adel; Shiva Ponamgi; Samuel J Asirvatham; Larry M Baddour; David R Holmes; Daniel C DeSimone; Christopher V DeSimone Journal: Biomed Hub Date: 2021-06-03