Left atrial appendage occlusion in patients with atrial fibrillation and large prevalence of prior intracranial bleeding.


Journal

Journal of cardiovascular medicine (Hagerstown, Md.)
ISSN: 1558-2035
Titre abrégé: J Cardiovasc Med (Hagerstown)
Pays: United States
ID NLM: 101259752

Informations de publication

Date de publication:
Aug 2020
Historique:
pubmed: 23 5 2020
medline: 7 4 2021
entrez: 23 5 2020
Statut: ppublish

Résumé

Left atrial appendage occlusion (LAAO) represents an alternative approach for the prevention of cardioembolic stroke in patients with nonvalvular atrial fibrillation (NVAF) and contraindication for oral anticoagulation (OAC). The aim of our study was to analyse the outcomes in patients treated with LAAO, with a focus on cases with previous intracranial bleeding. Sixty patients with NVAF underwent LAAO (75.4 ± 9 years); mean CHA2DS2-VASc was 4.4 ± 1.7, mean HAS-BLED 3.2 ± 0.9. Thirty-two patients (53.3%) reported previous intracranial bleeding. Ischaemic and bleeding events recorded during follow-up were compared with expected event rates according to CHA2DS2-VASc and HAS-BLED scores. Device implantation was successful in 58 patients (96.7%). The antiplatelet therapy was tailored according to patients' bleeding risk. During follow-up (2.32 ± 1.5 years) 3 ischaemic strokes and 1 transient ischaemic attack occurred, versus 13 total expected thromboembolic events (P = 0.033); 5 major bleedings were observed, versus 7 expected ones, if the patients were under OAC. Considering the combined endpoint (thromboembolic and major bleeding events) 9 events were observed versus 20 expected major events (P = 0.031). In the prespecified subgroup of patients with previous intracranial bleeding, two ischaemic strokes and one transient ischaemic attack were observed during follow-up versus six total expected thromboembolic events; no intracranial bleeding recurrence was recorded. Regarding the combined endpoint four major events were recorded versus nine expected ones. LAAO is an efficient and safe option for the prevention of cardioembolic stroke in patients with NVAF, high thromboembolic risk and contraindication to OAC, particularly in patients with previous intracranial bleeding.

Sections du résumé

BACKGROUND BACKGROUND
Left atrial appendage occlusion (LAAO) represents an alternative approach for the prevention of cardioembolic stroke in patients with nonvalvular atrial fibrillation (NVAF) and contraindication for oral anticoagulation (OAC). The aim of our study was to analyse the outcomes in patients treated with LAAO, with a focus on cases with previous intracranial bleeding.
METHODS METHODS
Sixty patients with NVAF underwent LAAO (75.4 ± 9 years); mean CHA2DS2-VASc was 4.4 ± 1.7, mean HAS-BLED 3.2 ± 0.9. Thirty-two patients (53.3%) reported previous intracranial bleeding. Ischaemic and bleeding events recorded during follow-up were compared with expected event rates according to CHA2DS2-VASc and HAS-BLED scores.
RESULTS RESULTS
Device implantation was successful in 58 patients (96.7%). The antiplatelet therapy was tailored according to patients' bleeding risk. During follow-up (2.32 ± 1.5 years) 3 ischaemic strokes and 1 transient ischaemic attack occurred, versus 13 total expected thromboembolic events (P = 0.033); 5 major bleedings were observed, versus 7 expected ones, if the patients were under OAC. Considering the combined endpoint (thromboembolic and major bleeding events) 9 events were observed versus 20 expected major events (P = 0.031). In the prespecified subgroup of patients with previous intracranial bleeding, two ischaemic strokes and one transient ischaemic attack were observed during follow-up versus six total expected thromboembolic events; no intracranial bleeding recurrence was recorded. Regarding the combined endpoint four major events were recorded versus nine expected ones.
CONCLUSION CONCLUSIONS
LAAO is an efficient and safe option for the prevention of cardioembolic stroke in patients with NVAF, high thromboembolic risk and contraindication to OAC, particularly in patients with previous intracranial bleeding.

Identifiants

pubmed: 32443136
doi: 10.2459/JCM.0000000000000976
pii: 01244665-202008000-00009
doi:

Types de publication

Journal Article Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

583-591

Commentaires et corrections

Type : CommentIn

Références

Krijthe BP, Kunst A, Benjamin EJ, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J 2013; 34:2746–2751.
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham study. Stroke 1991; 22:983–988.
Sjogren V, Grzymala-Lubanski B, Renlund H, Friberg L, Lip GY, Svensson PJ. Safety and efficacy of well managed warfarin: a report from the Swedish quality register Auricula. Thromb Haemost 2015; 113:1370–1377.
Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel userfriendly score (has-bled) to assess one-year risk of major bleeding in atrial fibrillation patients: the Euro Heart Survey. Chest 2010; 138:1093–1100.
Dentali F, Riva N, Crowther M, Turpie AG, Lip GY, Ageno W. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of the literature. Circulation 2012; 126:2381–2391.
Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016; 37:2893–2962.
Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010; 137:263–272.
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.
Olesen JB, Sorensen R, Hansen ML, et al. Nonvitamin K antagonist oral anticoagulation agents in anticoagulant naive atrial fibrillation patients: Danish nationwide descriptive data 2011–2013. Europace 2015; 17:187–193.
Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet 2009; 373:155–166.
Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 1996; 62:755–759.
Tsai L, Lin L, Teng J, Chen J. Prevalence and clinical significance of left atrial thrombus in nonrheumatic atrial fibrillation. Int J Cardiol 1997; 58:163–169.
Stoddard M, Singh P, Dawn B, Longaker R. Left atrial thrombus predicts transient ischemic attack in patients with atrial fibrillation. Am Heart J 2003; 145:676–682.
Yan BP, Kiernan TJ, Gonzales-Cruz I, Lam YY. Left atrial appendage-occluding devices for stroke prevention in patients with nonvalvular atrial fibrillation. Expert Rev Med Devices 2009; 6:611–620.
Meier B, Blaauw Y, Khattab A, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. Europace 2014; 16:1397–1416.
Onalan O, Crystal E. Left atrial appendage exclusion for stroke prevention in patients with nonrheumatic atrial fibrillation. Stroke 2007; 38:624–630.
Holmes D, Reddy V, Turi Z, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised noninferiority trial. Lancet 2009; 374:534–542.
Fountain RB, Holmes DR, Chandrasekaran K, et al. The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients with Atrial Fibrillation) trial. Am Heart J 2006; 151:956–961.
Reddy VY, Sievert H, Halperin J, et al. PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. J Am Coll Cardiol 2014; 312:1988–1998.
Holmes D, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 2014; 64:1–12.
Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry (CAP). Circulation 2011; 123:417–424.
Boersma LV, Schmidt B, Betts TR, et al. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J 2016; 37:2465–2474.
Meier B, Palacios I, Windecker S, et al. Transcatheter left atrial appendage occlusion with Amplatzer devices to obviate anticoagulation in patients with atrial fibrillation. Catheter Cardiovasc Interv 2003; 60:417–422.
Urena M, Rodés-Cabau J, Freixa X, et al. Percutaneous left atrial appendage closure with the AMPLATZER cardiac plug device in patients with nonvalvular atrial fibrillation and contraindications to anticoagulation therapy. J Am Coll Cardiol 2013; 62:96–102.
Freixa X, Chan JL, Tzikas A, Garceau P, Basmadjian A, Ibrahim R. The Amplatzer Cardiac Plug 2 for left atrial appendage occlusion: novel features and first-in-man experience. EuroIntervention 2013; 8:1094–1098.
Osmancik P, Tousek P, Herman D, et al. Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study), trial design. Am Heart J 2017; 183:108–114. Presented by Dr Osmancik P. at the European Society of Cardiology Congress, Paris, France in 2 September 2019.
Alkhouli M, Noseworthy PA, Rihal CS, Holmes DR Jr. Stroke prevention in nonvalvular atrial fibrillation: a stakeholder perspective. J Am Coll Cardiol 2018; 71:2790–2801.
Saw J, Lempereur M. Percutaneous left atrial appendage closure procedural techniques and outcomes. JACC Cardiovasc Interv 2014; 7:1205–1220.
Yeow WL, Kar S. Device- and LAA-specific characteristics for successful LAA closure: tips and tricks. Interv Cardiol Clin 2014; 3:239–254.
Tzikas A, Holmes DR, Gafoor S, et al. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. EuroIntervention 2016; 12:103–111.
Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011; 123:2736–2747.
Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J 1957; 2:200–215. van Swieten J, Koudstaal P, Visser M, et al. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988;19:604–7.
Wilson JL, Hareendran A, Grant M, et al. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin scale. Stroke 2002; 33:2243–2246.
Adam SS, McDuffie JR, Ortel TL, Williams JW Jr. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review. Ann Intern Med 2012; 157:796–807.
Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013; 369:1206–1214.
Tzikas A, Shakir S, Gafoor S, et al. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention 2015; 11:1170–1179.
Berti S, Pastormerlo LE, Rezzaghi M, et al. Left atrial appendage occlusion in high-risk patients with nonvalvular atrial fibrillation. Heart 2016; 102:1969–1973.
Jalala Z, Dineta ML, Combesb N, et al. Percutaneous left atrial appendage closure followed by single antiplatelet therapy: short- and mid-term outcomes. Arch Cardiovasc Dis 2017; 16:1875–1883.
Nielsen PB, Larsen TB, Skjoth FS, et al. Restarting anticoagulant treatment after intracranial hemorrhage in patients with atrial fibrillation and the impact on recurrent stroke, mortality and bleeding. Circulation 2015; 132:517–525.

Auteurs

Federico Barocelli (F)

Dipartimento di Medicina e Chirurgia, Università degli Studi di Parma.

Stefano Coli (S)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Antonio Crocamo (A)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Angela Guidorossi (A)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Maria A Cattabiani (MA)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Francesca Preti (F)

Dipartimento di Medicina e Chirurgia, Università degli Studi di Parma.

Davide Bosi (D)

Dipartimento di Medicina e Chirurgia, Università degli Studi di Parma.

Cristina Spaziani (C)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Daniela Lina (D)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Alberto Menozzi (A)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Emilia Solinas (E)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Giovanna Pelà (G)

Dipartimento di Medicina e Chirurgia, Università degli Studi di Parma.

Luigi Vignali (L)

Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

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