Clin Res Cardiol (2021)
DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Long-term outcome following LAA closure therapy in patients with atrial fibrillation- a real world registry of 5 German high volume centers
S. Möbius-Winkler1, F. Meincke2, J. Yu3, M. W. Bergmann4, C. Paitazoglou4, F. Härtel1, A. Hamadanchi1, T. Pörner5, C. Schulze1, M. Sandri6
1Klinik für Innere Medizin I - Kardiologie, Universitätsklinikum Jena, Jena; 2Kardiologie, Asklepios Klinik St. Georg, Hamburg; 3Klinik für Allg. Innere Medizin/Kardiologie, Katholisches Klinikum Koblenz-Montabaur gGmbH, Koblenz; 4Cardiologicum Hamburg, Hamburg; 5Innere Medizin II - Kardiologie, Katholische Stiftung Marienhospital Aachen, Aachen; 6Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig;

Introduction

Left atrial appendage closure has been introduced into clinical routine in Germany in 2009, especially in patients with contraindications to long-term anticoagulation therapy. Data from two randomized trials were able to show efficacy and safety of the therapy, however long term follow up data in the real world setting are lacking

Methods

We combined real world registries from 5 high volume centers to analyze long term outcome of the patients regarding periprocedural complications, short term outcome and long-term outcome for death, cardiovascular death, stroke / TIA and bleeding events. Here we report on the long-term follow-up

Results

We included data from 1591 patients from 5 German centers: Age: 73.8 ± 9.4 years; 606 women (38.1 %) and 985 men (61. 9 %); CHA2DS2VASC score:  4.2 ± 1.5; 847 (53.2%) > 75 years. Type of AF: 32.9% paroxysmal (524 patients), 36.8% permanent (586 patients), 24.9% persistent (396 patients), 5.3% unknown (85 patients). A Watchman device was implanted in 80.9% (1287 pts.) a Amulet or ACP device was implanted in 65 patients, other device (Coherex, Lambre, Occlutech, Watchman Flx) were implanted in the other pts.

After a mean follow up of 907 days (from 321 to 1640 days), we observed 221 deaths (13.9%), 33 cardiovascular deaths (2.1%), 88 strokes/ TIA (5.5%), 138 bleeding events (8.7%). Between the centers, there were significant differences regarding death (from 27.3 to 7.0%), CV death (from 6.1 to 0 %) and bleeding events (from 25.8 to 0.9%) whereas stroke/ TIA rate was comparable between the centers.  We observed a reduction in stroke rate by 60.03 % from expected  (5.03 to 2,01%/ year)

Conclusion

In this current long-term analysis of real world data from 5 German high volume centers, LAA closure in patients with AF and contraindications for therapeutic anticoagulation showed a higher rate of mortality (total and CV mortality), strokes and bleeding events compared to the long-term analysis of the two published randomized trials (Protect AF and Prevail). However, patient cohorts were different (contraindicated patients in the current analysis, not contraindicated patients in the randomized trials). Stroke rate in the real world registries showed a reduction of 60% compared to the estimated stroke rate. More prospective data on all comer data are necessary. 
https://dgk.org/kongress_programme/jt2021/aP1485.html