Ten-Year Outcomes Following Percutaneous Left Atrial Appendage Closure In Patients With Atrial Fibrillation And Absolute Or Relative Contraindications To Chronic Anticoagulation

HomeCirculation: Cardiovascular InterventionsVol. 14, No. 8Ten-Year Outcomes Following Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Absolute or Relative Contraindications to Chronic Anticoagulation Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBTen-Year Outcomes Following Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Absolute or Relative Contraindications to Chronic Anticoagulation Jules Mesnier, MD Ignacio Cruz-González, MD, PhD Vicente Peral, MD, PhD Luis Nombela-Franco, MD, PhD Xavier Freixa, MD, PhD Ana E. Laffond, MD Caterina Mas-Lladó, MD Angela McInerney, MD Ander Regueiro, MD, PhD Gilles O’Hara, MD Josep Rodés-CabauMD, PhD Jules MesnierJules Mesnier Quebec Heart and Lung Institute, Laval University, Québec City, Canada (J.M., G.O., J.R.-C.). Search for more papers by this author , Ignacio Cruz-GonzálezIgnacio Cruz-González University Hospital Salamanca, IBSAL, CIBER-CV, Spain (I.C.-G., A.A.E.L.). Search for more papers by this author , Vicente PeralVicente Peral Department of Cardiology, Health Research Institute of the Balearic Islands (IdISBa), Hospital Universitari Son Espases, Palma, Spain (V.P., C.M.-L.). Search for more papers by this author , Luis Nombela-FrancoLuis Nombela-Franco https://orcid.org/0000-0003-3438-8907 Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (L.N.-F., A.M.). Search for more papers by this author , Xavier FreixaXavier Freixa Institut Clínic Cardiovascular, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (X.F., A.R., J.R.-C.). Search for more papers by this author , Ana E. LaffondAna E. Laffond University Hospital Salamanca, IBSAL, CIBER-CV, Spain (I.C.-G., A.A.E.L.). Search for more papers by this author , Caterina Mas-LladóCaterina Mas-Lladó https://orcid.org/0000-0002-3763-3632 Department of Cardiology, Health Research Institute of the Balearic Islands (IdISBa), Hospital Universitari Son Espases, Palma, Spain (V.P., C.M.-L.). Search for more papers by this author , Angela McInerneyAngela McInerney https://orcid.org/0000-0002-1160-7735 Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (L.N.-F., A.M.). Search for more papers by this author , Ander RegueiroAnder Regueiro Institut Clínic Cardiovascular, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (X.F., A.R., J.R.-C.). Search for more papers by this author , Gilles O’HaraGilles O’Hara Quebec Heart and Lung Institute, Laval University, Québec City, Canada (J.M., G.O., J.R.-C.). Search for more papers by this author , and Josep Rodés-CabauJosep Rodés-Cabau Correspondence to: Josep Rodés-Cabau, MD, Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V 4GS, Quebec City, Quebec, Canada. Email E-mail Address: [email protected] https://orcid.org/0000-0001-8237-7095 Quebec Heart and Lung Institute, Laval University, Québec City, Canada (J.M., G.O., J.R.-C.). Institut Clínic Cardiovascular, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (X.F., A.R., J.R.-C.). Search for more papers by this author Originally published16 Jul 2021https://doi.org/10.1161/CIRCINTERVENTIONS.121.010821Circulation: Cardiovascular Interventions. 2021;14:e010821Percutaneous left atrial appendage closure (LAAC) is an alternative to anticoagulant treatment for stroke prevention in patients with nonvalvular atrial fibrillation. Convincing evidence has been gathered supporting its early efficacy and safety.1 As a preventive procedure, long-term efficacy and safety of LAAC is critical and current reports are limited to 5-year follow-up.2,3 The objective of this study was to evaluate the 10-year clinical outcomes following percutaneous LAAC in patients with atrial fibrillation.We included 66 consecutive patients with atrial fibrillation and contraindications to chronic anticoagulation that underwent percutaneous LAAC from 2009 to 2011 in 5 centers. Details of procedure have previously been reported,1 and the study was performed in accordance with the Ethics Committee of each participating center, and the patients provided signed informed consent for the procedures. The data that support the findings of this study are available from the corresponding author and the authors from different participating centers upon reasonable request. Mean age (at procedure) was 74±9 years, with 31 (47.0%) women, and mean CHA2DS2-VASc and HAS-BLED bleeding risk scores of 5.0±1.5 and 4.0±1.0, respectively. All patients had LAAC with the Amplatzer Cardiac Plug device (Abbott, St Paul, MN). Procedural success was achieved in all but 4 patients (93.9%). One patient died of tamponade and 3 protheses embolized during or shortly after the procedure. Two were successfully re-implanted in a second procedure. At discharge, 40 (61.5%) patients were treated with dual antiplatelet therapy, 22 (33.8%) with a single antiplatelet agent, and 3 (4.6%) patients received oral anticoagulation. After the first year, 54 of the 60 patients alive (90.0%) were treated with either single antiplatelet treatment or no antithrombotic treatment.Follow-up was complete in all but 5 patients (92.4%), who were lost after the 5-year follow-up. The 10-year Kaplan-Meier curves for the main clinical events are shown in the Figure [A]. Thirty-five patients died during follow-up (53.0%, 8.6 per 100 patient-years). Proportion of patients alive at 1 and 5 years were 92.4% and 56.9%, respectively. Most deaths were from unknown cause (n=8, 22.9%), followed by heart failure (n=7, 20.0%), cancer-related death (n=4, 11.4%), infections (n=5, 14.3%), and major bleeding (n=3, 8.6%). A total of 4 patients had an ischemic stroke (6.1%, 1.0 per 100 patient-years), 1 early (9 days after the procedure), and 3 late (at 0.6, 4.1, and 5.5 years after LAAC). One late ischemic stroke was fatal, and none were related to device thrombosis. Two patients had a hemorrhagic stroke, one fatal at 20 days postprocedure and one nonfatal at 212 days. LAAC was associated with a significant reduction in long-term ischemic stroke compared with the expected incidence based on the CHA2DS2-VASc score (7.2 versus 1.0 per 100 patient-years for no treatment and LAAC, respectively, P<0.001)4 (Figure [B]). Similar findings were observed even when every death of unknown cause was considered as an ischemic event (7.2 versus 3.1 per 100 patient-years for no treatment and LAAC, respectively, P=0.001).Download figureDownload PowerPointFigure. Survival curves and expected rate of thromboembolic and hemorrhagic events 10 y after left atrial appendage closure (LAAC).A, Kaplan-Meier survival curves for all-cause death, ischemic stroke, major bleeding, and major clinical events (composite of death, ischemic stroke, and major bleeding events). B, Comparison between expected and observed annual event rate 10 y after LAAC. P value from binomial test.Major bleeding, defined as Bleeding Academic Research Consoritum bleeding type 3 or 5, occurred in 17 patients (25.8%, 4.7 per 100 patient-years), 2 of which were procedure-related, one leading to death. Two additional major bleeding events occurred in the early phase with intensive antithrombotic therapy in patients treated with dual antiplatelet therapy, one of which was fatal. At 1 and 5 years, 91.7%, 50.8% of patients were alive and free from major bleeding events. Based on the mean HAS-BLED score, LAAC patients had a tendency towards a lower rate of major bleeding (8.7 versus 4.7 per 100 patient-years, P=0.049).5 Patients who experienced late major bleeding events (after 6 months) were receiving at the time of the event single antiplatelet therapy, dual antiplatelet therapy, no antithrombotic treatment, and oral anticoagulation in 8, 2, 2, and 1 of cases, respectively. Of note, adverse events and cause of death were not adjudicated and were reported based on available medical or administrative evidence.In conclusion, long-term mortality in patients treated with LAAC was high (>50%), underlining the high-risk profile of LAAC recipients. In survivors, the preventive effects of LAAC regarding ischemic stroke were maintained, with a very low incidence over time (1.0 per 100 patient-years), much lower than the expected event rate in this population. However, while a tendency towards a reduction of bleeding events was observed, the incidence of major bleeding episodes remained relatively high (close to 5 per 100 patient-years), despite decreasing the intensity of antithrombotic therapy during follow-up. These findings further highlight the importance of future studies to identify patients at the highest risk for both mortality and bleeding to improve patient selection and provide a tailored post-procedural antithrombotic management strategy.Nonstandard Abbreviations and AcronymsLAACleft atrial appendage closureSources of FundingDr Mesnier is supported by a grant from the Fédération Française de Cardiologie. Dr Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. Dr Cruz-González was supported by Instituto de Salud Carlos III (PI19/00658), co-funded by European Regional Development Fund, A way to make Europe and Gerencia Regional Salud de CyL (GRS 3031/A/19).Disclosures Dr Cruz-González is a proctor for Boston Scientific, Abbott, Lifetech. Dr Nombela-Franco is a proctor for Abbott. Dr Rodés-Cabau has received institutional research grants from Boston Scientific. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 875.Correspondence to: Josep Rodés-Cabau, MD, Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V 4GS, Quebec City, Quebec, Canada. Email josep.[email protected]ulaval.caReferences1. Asmarats L, Rodés-Cabau J. Percutaneous left atrial appendage closure: current devices and clinical outcomes.Circ Cardiovasc Interv. 2017; 10:e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359LinkGoogle Scholar2. Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, et al.. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER cardiac plug.EuroIntervention. 2016; 11:1170–1179. doi: 10.4244/EIJY15M01_06CrossrefMedlineGoogle Scholar3. Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, et al.; PREVAIL and PROTECT AF Investigators. 5-year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials.J Am Coll Cardiol. 2017; 70:2964–2975. doi: 10.1016/j.jacc.2017.10.021CrossrefMedlineGoogle Scholar4. Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study.Eur Heart J. 2012; 33:1500–1510. doi: 10.1093/eurheartj/ehr488CrossrefMedlineGoogle Scholar5. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey.Chest. 2010; 138:1093–1100. doi: 10.1378/chest.10-0134CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails August 2021Vol 14, Issue 8Article InformationMetrics Download: 117 © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.121.010821PMID: 34266312 Originally publishedJuly 16, 2021 Keywordsstrokeatrial appendageatrial fibrillationsafetyanticoagulantsPDF download SubjectsIschemic StrokeAtrial FibrillationAnticoagulants