Stand-alone Left Atrial Appendage Clipping For Stroke Prevention: Thoracs-laao Registry
Piotr Suwalski, PhD1, Grzegorz Suwalski2, Maciej Bartczak1, Sebastian Stec, PhD3, Marek Deja, PhD4, Jaroslaw Bis4, Krzysztof Bartus, PhD5, Robert Sobczynski5, Dariusz Kosior, PhD1, Anna Witkowska1.
1Central Clinical Hospital of the Ministry of Interior in Warsaw, Warsaw, Poland, 2Military Institute of Medicin in Warsaw, Warsaw, Poland, 3MediNice, Rzeszow, Poland, 4Upper-Silesian Medical Centre of the Silesian Medical University, Katowice, Poland, 5Krakowski Szpital Specjalistyczny im. Jana Pawła II, Cracow, Poland.
Background: Atrial fibrillation is associated with a 5-fold increase in stroke rate. The main source of thrombotic material is left atrial appendage (LAA). The standard of care remains oral anticoagulation, however, in elderly patients it is connected with a high risk of bleeding and no compliance. Left atrial appendage occlusion (LAAO) showed non-inferiority to oral anticoagulation. Stand-alone thoracoscopic LAAO is a new procedure in cardiosurgery and no data describing its results in a bigger cohort have been published.
Aim: To evaluate the safety and long-term efficacy of the totally thoracoscopic LAAO using AtriClip® device for stroke prevention in high-risk patients with nonvalvular atrial fibrillation in terms of the first registry in the world - THORACS-LAAO Registry.
Methods: It is an open Polish nationwide multi-institutional registry. Patients have been followed up with transoesophageal echocardiography or computed tomography at 6-12 months to assess the durability of the occlusion and collect the data on adverse events, especially thromboembolism and bleeding.
Results: In the registry are data of 66 patients from 5 centers. The mean age is 71(+/-9) years. Mean CHA2DS2-VASc Score is 4. Mean left atrium dimension is 44(+/-7)mm. Prior to operation 38(56%) patients underwent bleeding episodes, 15(22%) had stroke, 5(7%) had remittent thrombus in LAA. There was no conversion to sternotomy, mean skin to skin time was 58 (+/-17) minutes. We observed one perioperative hemorrhagic stroke, one bleeding from adhesions requiring revision. Mean hospitalization time was 5(+/-4) days. In mean follow-up of 18(+/-6) months there were no strokes/TIA, one gastrointestinal bleeding without further morbidity. There were 4(5%) deaths not related to the clip. 52(78%) patientes were off oral anticoagulation. Stable clip position without stump over 10mm or leakage was confirmed in 92% of patients who reached follow-up examination.
Conclusions: The THORACS-LAAO is the first prospective registry designed to evaluate the safety and effectiveness of the stand-alone totally thoracoscopic epicardial left atrial appendage occlusion. The primary results are encouraging both for early and long-term results. (ClinicalTrials.gov ID: NCT03838341)
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