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Published in: BMC Cardiovascular Disorders 1/2018

Open Access 01-12-2018 | Research article

Real-world experience comparing two common left atrial appendage closure devices

Authors: Christian Fastner, Lea Hoffmann, Mohamed Aboukoura, Michael Behnes, Siegfried Lang, Martin Borggrefe, Ibrahim Akin, Christoph A. Nienaber

Published in: BMC Cardiovascular Disorders | Issue 1/2018

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Abstract

Background

The interventional left atrial appendage closure (LAAC) is a guideline-conform alternative to oral anticoagulation (OAC) in non-valvular atrial fibrillation patients with OAC ineligibility. It was aimed to directly compare two contemporary devices in a real-world patient population.

Methods

LAAC was conducted in two centres between 2010 and 2014 as well as between 2014 and 2017, respectively, in a standard fashion based on the specific manufacturer’s recommendations. Baseline characteristics, procedural data and event rates during intra-hospital and 6 months follow-up were registered in a retrospective approach, and analysed in device-related groups.

Results

A total of 189 patients presented for LAAC device implantation. Baseline characteristics were mostly evenly distributed. In 148 patients, a Watchman™ device (Boston Scientific, Natick, MA, USA) was successfully implanted, an Amplatzer™ Amulet™ (St. Jude Medical, St. Paul, MN, USA) in 34 patients (96.1 and 97.1%, respectively; p = 1.00). Major access site bleedings were more frequent in the Amplatzer™ Amulet™ group (8.9 versus 1.4%; p = 0.046). No intra-hospital thromboembolic event was present. During 6 months follow-up, peri-device leaks > 5 mm and thromboembolic events were uncommon (each p = n.s.).

Conclusions

While procedural success was equally high with both contemporary devices, complications during follow-up were rare, and evenly distributed.
Literature
1.
go back to reference Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and risk factors in atrial fibrillation (ATRIA) study. JAMA. 2001;285(18):2370–5.CrossRefPubMed Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and risk factors in atrial fibrillation (ATRIA) study. JAMA. 2001;285(18):2370–5.CrossRefPubMed
3.
go back to reference Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893–962.CrossRefPubMed Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893–962.CrossRefPubMed
4.
go back to reference Waldo AL, Becker RC, Tapson VF, Colgan KJ, Committee NS. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol. 2005;46(9):1729–36.CrossRefPubMed Waldo AL, Becker RC, Tapson VF, Colgan KJ, Committee NS. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol. 2005;46(9):1729–36.CrossRefPubMed
5.
go back to reference Vedovati MC, Verdecchia P, Giustozzi M, Molini G, Conti S, Pierpaoli L, Valecchi F, Aita A, Agnelli G, Becattini C. Permanent discontinuation of non vitamin K oral anticoagulants in real life patients with non-valvular atrial fibrillation. Int J Cardiol. 2017;236:363–9.CrossRefPubMed Vedovati MC, Verdecchia P, Giustozzi M, Molini G, Conti S, Pierpaoli L, Valecchi F, Aita A, Agnelli G, Becattini C. Permanent discontinuation of non vitamin K oral anticoagulants in real life patients with non-valvular atrial fibrillation. Int J Cardiol. 2017;236:363–9.CrossRefPubMed
6.
go back to reference Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013;8(5):e63479.CrossRefPubMedPubMedCentral Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013;8(5):e63479.CrossRefPubMedPubMedCentral
7.
go back to reference O'Brien EC, Holmes DN, Ansell JE, Allen LA, Hylek E, Kowey PR, Gersh BJ, Fonarow GC, Koller CR, Ezekowitz MD, et al. Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation: findings from the outcomes registry for better informed treatment of atrial fibrillation (ORBIT-AF) registry. Am Heart J. 2014;167(4):601–9. e601CrossRefPubMed O'Brien EC, Holmes DN, Ansell JE, Allen LA, Hylek E, Kowey PR, Gersh BJ, Fonarow GC, Koller CR, Ezekowitz MD, et al. Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation: findings from the outcomes registry for better informed treatment of atrial fibrillation (ORBIT-AF) registry. Am Heart J. 2014;167(4):601–9. e601CrossRefPubMed
8.
go back to reference Okumura Y, Yokoyama K, Matsumoto N, Tachibana E, Kuronuma K, Oiwa K, Matsumoto M, Kojima T, Hanada S, Nomoto K, et al. Current use of direct oral anticoagulants for atrial fibrillation in Japan: findings from the SAKURA AF registry. J Arrhythm. 2017;33(4):289–96.CrossRefPubMedPubMedCentral Okumura Y, Yokoyama K, Matsumoto N, Tachibana E, Kuronuma K, Oiwa K, Matsumoto M, Kojima T, Hanada S, Nomoto K, et al. Current use of direct oral anticoagulants for atrial fibrillation in Japan: findings from the SAKURA AF registry. J Arrhythm. 2017;33(4):289–96.CrossRefPubMedPubMedCentral
9.
go back to reference Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61(2):755–9.CrossRefPubMed Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61(2):755–9.CrossRefPubMed
10.
go back to reference Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P, Investigators PA. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534–42.CrossRefPubMed Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P, Investigators PA. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534–42.CrossRefPubMed
11.
go back to reference Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988–98.CrossRefPubMed Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988–98.CrossRefPubMed
12.
go back to reference Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix feasibility study with Watchman left atrial appendage closure technology). J Am Coll Cardiol. 2013;61(25):2551–6.CrossRefPubMed Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix feasibility study with Watchman left atrial appendage closure technology). J Am Coll Cardiol. 2013;61(25):2551–6.CrossRefPubMed
13.
go back to reference Urena M, Rodes-Cabau J, Freixa X, Saw J, Webb JG, Freeman M, Horlick E, Osten M, Chan A, Marquis JF, 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(2):96–102.CrossRefPubMed Urena M, Rodes-Cabau J, Freixa X, Saw J, Webb JG, Freeman M, Horlick E, Osten M, Chan A, Marquis JF, 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(2):96–102.CrossRefPubMed
14.
go back to reference 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(10):1170–9.CrossRefPubMed 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(10):1170–9.CrossRefPubMed
15.
go back to reference Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, et al. Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017;14(9):1302–8.CrossRefPubMed Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, et al. Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017;14(9):1302–8.CrossRefPubMed
16.
go back to reference Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, 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(31):2465–74.CrossRefPubMedPubMedCentral Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, 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(31):2465–74.CrossRefPubMedPubMedCentral
17.
go back to reference Fastner C, Nienaber CA, Park JW, Brachmann J, Zeymer U, Goedde M, Sievert H, Geist V, Lewalter T, Krapivsky A, et al. Impact of left atrial appendage morphology on indication and procedural outcome after interventional occlusion - results from the prospective multicenter German LAARGE registry. EuroIntervention. 2018;14(2):151–7.CrossRefPubMed Fastner C, Nienaber CA, Park JW, Brachmann J, Zeymer U, Goedde M, Sievert H, Geist V, Lewalter T, Krapivsky A, et al. Impact of left atrial appendage morphology on indication and procedural outcome after interventional occlusion - results from the prospective multicenter German LAARGE registry. EuroIntervention. 2018;14(2):151–7.CrossRefPubMed
18.
go back to reference Figini F, Mazzone P, Regazzoli D, Porata G, Ruparelia N, Giannini F, Stella S, Ancona F, Agricola E, Sora N, et al. Left atrial appendage closure: a single center experience and comparison of two contemporary devices. Catheter Cardiovasc Interv. 2017;89(4):763–72.CrossRefPubMed Figini F, Mazzone P, Regazzoli D, Porata G, Ruparelia N, Giannini F, Stella S, Ancona F, Agricola E, Sora N, et al. Left atrial appendage closure: a single center experience and comparison of two contemporary devices. Catheter Cardiovasc Interv. 2017;89(4):763–72.CrossRefPubMed
19.
go back to reference Fastner C, Lehmann R, Behnes M, Sartorius B, Borggrefe M, Akin I. Veno-venous double lasso pull-and-push technique for transseptal retrieval of an embolized Watchman occluder. Cardiovasc Revasc Med. 2016;17(3):206–8.CrossRefPubMed Fastner C, Lehmann R, Behnes M, Sartorius B, Borggrefe M, Akin I. Veno-venous double lasso pull-and-push technique for transseptal retrieval of an embolized Watchman occluder. Cardiovasc Revasc Med. 2016;17(3):206–8.CrossRefPubMed
20.
go back to reference Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. 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):1–12.CrossRefPubMed Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. 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):1–12.CrossRefPubMed
21.
go back to reference Tzikas A, Bergmann MW. Left atrial appendage closure: patient, device and post-procedure drug selection. EuroIntervention. 2016;12(Suppl X):X48–54.CrossRefPubMed Tzikas A, Bergmann MW. Left atrial appendage closure: patient, device and post-procedure drug selection. EuroIntervention. 2016;12(Suppl X):X48–54.CrossRefPubMed
22.
go back to reference Shah M, Avgil Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Behlouli H, Guo H, et al. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation. 2014;129(11):1196–203.CrossRefPubMed Shah M, Avgil Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Behlouli H, Guo H, et al. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation. 2014;129(11):1196–203.CrossRefPubMed
23.
go back to reference Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, Holmes D, Reddy VY. The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J Am Coll Cardiol. 2012;59(10):923–9.CrossRefPubMed Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, Holmes D, Reddy VY. The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J Am Coll Cardiol. 2012;59(10):923–9.CrossRefPubMed
24.
go back to reference Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet. 2009;373(9658):155–66.CrossRefPubMed Watson T, Shantsila E, Lip GY. Mechanisms of thrombogenesis in atrial fibrillation: Virchow's triad revisited. Lancet. 2009;373(9658):155–66.CrossRefPubMed
25.
go back to reference Gloekler S, Shakir S, Doblies J, Khattab AA, Praz F, Guerios E, Koermendy D, Stortecky S, Pilgrim T, Buellesfeld L, et al. Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol. 2015;104(8):656–65.CrossRefPubMed Gloekler S, Shakir S, Doblies J, Khattab AA, Praz F, Guerios E, Koermendy D, Stortecky S, Pilgrim T, Buellesfeld L, et al. Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol. 2015;104(8):656–65.CrossRefPubMed
26.
go back to reference Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ, Investigators AW. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W substudy. J Am Coll Cardiol. 2007;50(22):2156–61.CrossRefPubMed Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ, Investigators AW. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W substudy. J Am Coll Cardiol. 2007;50(22):2156–61.CrossRefPubMed
Metadata
Title
Real-world experience comparing two common left atrial appendage closure devices
Authors
Christian Fastner
Lea Hoffmann
Mohamed Aboukoura
Michael Behnes
Siegfried Lang
Martin Borggrefe
Ibrahim Akin
Christoph A. Nienaber
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2018
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-018-0899-9

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