scholarly journals TCT-26 Long-Term Event Rates for Left Atrial Appendage Closure with WATCHMAN: PROTECT AF 5 Year and PREVAIL 3 Year Follow-up

2016 ◽  
Vol 68 (18) ◽  
pp. B11 ◽  
Author(s):  
Vivek Reddy ◽  
Matthew Price ◽  
Miguel valderrabano ◽  
Jose Sanchez ◽  
Shephal Doshi ◽  
...  
EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted grant from Boston Scientific. Boston Scientific was not involved in the design/conduct of the study, data collection/analysis and interpretation of the data and preparation of the manuscript. Background Percutaneous left atrial appendage occlusion is an emerging alternative to anticoagulation in the prevention for stroke in patients with atrial fibrillation, especially in patients with a contra-indication for oral anticoagulation therapy. Long-term results on the efficacy and safety of this treatment remain scarce. Methods In this single-center prospective registry, data of all consecutive patients that underwent percutaneous left atrial appendage closure between 2009 and 2019 were collected. Patients with successful left atrial appendage closure (peri-device leakage ≤5mm) and at least one year of follow-up data were analyzed. The occurrence of thrombo-embolic events (ischemic stroke, TIA and systemic embolism), major bleeding events (BARC >2) and anticoagulation use during long-term follow-up were evaluated. Results A total of 192 patients after left atrial appendage occlusion were included (61 % male, age 69.0 ± 8.4 years, CHA2DS2-VASc 4.0[3.0-5.0], HAS-BLED 3.0[2.0-3.25]) with a mean follow-up duration of 5.7 ± 2.8 years (in total 1087 patient-years). During follow-up 36 patients (19%) died. 49 thrombo-embolic complications were observed in 38 patients. The ischemic stroke rate was 1.9 events per 100 patient-years, accounting for a 70% reduction compared to CHA2DS2-VASc predicted rate. Device-related thrombus (DRT) occurred in 5 patients (2.6%), 3 were observed during routine follow-up and were not associated with thrombo-embolic complications. The other 2 DRT were observed in patients presenting with ischemic stroke more than 3 years after device implantation. Furthermore, 38 non-procedural major bleeding complications occurred in 19 patients, resulting in 3.5 events per 100-patients years, accounting for a reduction of 43% compared to estimated bleeding rates under OAC use. At the end of the study 71% of all patients were on single antiplatelet or no antiplatelet/anticoagulation treatment at all. Conclusions During long-term follow-up thrombo-embolic event rates and non-procedural major bleeding rates were consistently low (ischemic stroke rate reduction 70% and non-procedural major bleeding rate reduction 40% compared to predicted rates). These results confirm the efficacy of left atrial appendage occlusion. Abstract Figure. Ischemic stroke rates


EP Europace ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. 1502-1508 ◽  
Author(s):  
Niklas Zender ◽  
Felix K Weise ◽  
Stefano Bordignon ◽  
Eva Herrmann ◽  
Athanasios Konstantinou ◽  
...  

Abstract Aims Left atrial appendage electrical isolation (LAAI) may improve the rhythm outcome in selected patients with atrial fibrillation (AF). Controversy exists if LAAI is associated with an increased rate of thromboembolic complications. We sought to assess the feasibility, efficacy, and safety of interventional left atrial appendage closure (LAAC) in comparison to oral anticoagulation (OAC) after electrical LAAI. Methods and results Weeks after index LAAI using the cryoballoon or a linear maze like ablation strategy patients’ left atrial appendage was invasively remapped. In case of persistent LAAI, LAAC was performed. Patients who refused invasive remapping continued OAC. The primary endpoint was composed of any stroke or systemic embolism (SE) and the occurrence of intracardiac thrombus. Secondary endpoints included stroke/SE, major bleeding, and all-cause death. Of 166 patients (51% female; mean age 70 ± 8 years; mean CHAD2S2VASc score 3.4 ± 1.8) after LAAI, 94 patients received LAAC (LAAC group) and 72 continued OAC (no LAAC). After LAAC, 83% of patients received dual antiplatelet therapy for 6 weeks and aspirin thereafter. During a mean follow-up of 778 ± 630 days, 5 and 11 primary endpoint events were observed in the LAAC and no LAAC group, respectively [hazard ratio (HR) 0.27, 95% confidence interval (CI) 0.10–0.75; P = 0.010]. The calculated annual thromboembolic event rates were 6.9% (no LAAC) and 2.3% (LAAC), respectively. Left atrial appendage closure significantly reduced the incidence of stroke and SE (HR 0.31, CI 0.1–0.98; P = 0.04). Conclusion After electrical LAAI for rhythm control in AF patients, interventional LAAC was associated with fewer thromboembolic complications when compared with OAC.


Heart Rhythm ◽  
2020 ◽  
Vol 17 (5) ◽  
pp. 728-733 ◽  
Author(s):  
Stephan Staubach ◽  
Leonhard Schlatterbeck ◽  
Moritz Mörtl ◽  
Henning Strohm ◽  
Petra Hoppmann ◽  
...  

2018 ◽  
Vol 92 (2) ◽  
pp. 327-333 ◽  
Author(s):  
Barbara Bellmann ◽  
Andreas Rillig ◽  
Carsten Skurk ◽  
David Manuel Leistner ◽  
Karl Georg Haeusler ◽  
...  

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208710 ◽  
Author(s):  
Radoslaw Litwinowicz ◽  
Magdalena Bartus ◽  
Marian Burysz ◽  
Maciej Brzeziński ◽  
Piotr Suwalski ◽  
...  

2013 ◽  
Vol 62 (18) ◽  
pp. B31
Author(s):  
Saibal Kar ◽  
Shephal Doshi ◽  
Vjendra Swarup ◽  
K. Tucker ◽  
Brian Whisenant ◽  
...  

Heart Rhythm ◽  
2019 ◽  
Vol 16 (9) ◽  
pp. 1320-1326 ◽  
Author(s):  
Gaetano Fassini ◽  
Alessio Gasperetti ◽  
Gianpiero Italiano ◽  
Stefania Riva ◽  
Massimo Moltrasio ◽  
...  

EP Europace ◽  
2018 ◽  
Vol 20 (11) ◽  
pp. 1783-1789 ◽  
Author(s):  
Lisette Wintgens ◽  
Aleksandr Romanov ◽  
Karen Phillips ◽  
Gabriel Ballesteros ◽  
Martin Swaans ◽  
...  

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage occlusion (LAAO) is a well-established stroke prevention strategy in patients with non-valvular atrial fibrillation (AF) and high risk of bleeding or contra-indication to oral anticoagulation (OAC). Despite encouraging randomised control trial and international registry safety and efficacy data, long-term outcome data remains sparce. Purpose This study sought to evaluate the long-term outcomes in ‘real-world’ AF patients undergoing left atrial appendage occlusion in a large UK tertiary centre. Methods This retrospective study included all patients that had a LAAO device implanted in our institution from January 2010 to December 2020. Medical notes, electronic patient records, procedural and imaging reports were reviewed. Annual bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score. Results During the study period a total of 225 patients underwent LAAO device implant. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 life-threatening bleeding episodes). Three different LAAO devices were used: 136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac plugs. Three patients (1.3%) had fatal complications related to the procedure. At discharge, 10% were taking single antiplatelet (ATP), 79% dual-antiplatelet (DAPT), 1.4% OAC, 3.6% ATP and OAC, 3.1% DAPT and OAC, 1.3% were not taking any anti-thrombotic. Nine (4%) patients had device-related thrombus on follow-up transoesophageal echocardiography with no significant difference between devices (5.0%, 2.8% and 6.7% p = 0.8, respectively) and anticoagulation strategy (p = 0.7). Over a total follow-up of 889 patient-years (mean follow-up 3.9 ± 3.7 years), 24 (10.4%) patients died, 55 patients (6.2/100 patient-years) suffered an adverse event, 15 ischaemic strokes (1.7/100 patient-years) and 20 non-procedural major bleeding episodes (2.3/100 patient-years) occurred. Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, our cohort had a 79% and 65% relative risk reduction in ischaemic stroke and major bleeding, respectively. Conclusion In this cohort of "real-world" high-risk patients, major bleeding and thromboembolic rate remained low on long-term follow-up. Abstract Figure 1


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