Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study

Christian Fastner, Michael Behnes, Benjamin Sartorius, Mustafa Yildiz, Kambis Mashayekhi, Ibrahim El-Battrawy, Ralf Lehmann, Stefan Baumann, Tobias Becher, Martin Borggrefe, Ibrahim Akin, Christian Fastner, Michael Behnes, Benjamin Sartorius, Mustafa Yildiz, Kambis Mashayekhi, Ibrahim El-Battrawy, Ralf Lehmann, Stefan Baumann, Tobias Becher, Martin Borggrefe, Ibrahim Akin

Abstract

Background: Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices.

Methods: This single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm).

Results: In total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9% of patients (90.9% for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7% of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3% of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0% of all access-site complications). One patient died due to septic shock (non-procedure related).

Conclusions: In daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe.

References

    1. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, et al. 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. doi: 10.1001/jama.285.18.2370.
    1. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285(22):2864–70. doi: 10.1001/jama.285.22.2864.
    1. Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005;36(6):1115–9. doi: 10.1161/01.STR.0000166053.83476.4a.
    1. European Heart Rhythm Association. European Association for Cardio-Thoracic Surgery. Camm AJ, Kirchhof P, Lip GY, Schotten U, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Eur Heart J. 2010;31:2369–429. doi: 10.1093/eurheartj/ehq278.
    1. Lane DA, Lip GY. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126(7):860–5. doi: 10.1161/CIRCULATIONAHA.111.060061.
    1. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, et al. Guidelines ESCCfP: 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012;33(21):2719–47. doi: 10.1093/eurheartj/ehs253.
    1. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–62. doi: 10.1016/S0140-6736(13)62343-0.
    1. 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. doi: 10.1016/j.jacc.2005.06.077.
    1. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, et al. 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. doi: 10.1016/S0140-6736(09)61343-X.
    1. Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, et al. 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. doi: 10.1016/j.jacc.2013.03.035.
    1. Urena M, Rodes-Cabau J, Freixa X, Saw J, Webb JG, Freeman M, 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. doi: 10.1016/j.jacc.2013.02.089.
    1. Gloekler S, Shakir S, Doblies J, Khattab AA, Praz F, Guerios E, 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.
    1. Pison L, Potpara TS, Chen J, Larsen TB, Bongiorni MG, Blomstrom-Lundqvist C. Scientific Initiative Committee EHRA: Left atrial appendage closure-indications, techniques, and outcomes: results of the European Heart Rhythm Association Survey. Europace. 2015;17(4):642–6. doi: 10.1093/europace/euv069.
    1. Freixa X, Abualsaud A, Chan J, Nosair M, Tzikas A, Garceau P, et al. Left atrial appendage occlusion: initial experience with the Amplatzer Amulet. Int J Cardiol. 2014;174(3):492–6. doi: 10.1016/j.ijcard.2014.03.154.
    1. Meerkin D, Butnaru A, Dratva D, Bertrand OF, Tzivoni D. Early safety of the Amplatzer Cardiac Plug for left atrial appendage occlusion. Int J Cardiol. 2013;168(4):3920–5. doi: 10.1016/j.ijcard.2013.06.062.
    1. Streb W, Szymala M, Kukulski T, Nowak J, Lekston A, Sokal A, et al. Percutaneous closure of the left atrial appendage using the Amplatzer Cardiac Plug in patients with atrial fibrillation: evaluation of safety and feasibility. Kardiol Pol. 2013;71(1):8–16.
    1. Lam YY, Yip GW, Yu CM, Chan WW, Cheng BC, Yan BP, et al. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012;79(5):794–800. doi: 10.1002/ccd.23136.
    1. Chun KR, Bordignon S, Urban V, Perrotta L, Dugo D, Furnkranz A, et al. Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. Heart Rhythm. 2013;10(12):1792–9. doi: 10.1016/j.hrthm.2013.08.025.
    1. Gafoor S, Franke J, Bertog S, Boehm P, Heuer L, Gonzaga M, et al. Left atrial appendage occlusion in octogenarians: short-term and 1-year follow-up. Catheter Cardiovasc Interv. 2014;83(5):805–10. doi: 10.1002/ccd.25297.
    1. 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. Circulation. 2011;123(4):417–24. doi: 10.1161/CIRCULATIONAHA.110.976449.
    1. Meier B, Blaauw Y, Khattab AA, Lewalter T, Sievert H, Tondo C, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. EuroIntervention. 2015;10(9):1109–25. doi: 10.4244/EIJY14M09_18.
    1. Wunderlich NC, Beigel R, Swaans MJ, Ho SY, Siegel RJ. Percutaneous Interventions for left atrial appendage exclusion: options, assessment, and imaging Using 2D and 3D Echocardiography. JACC Cardiovasc Imaging. 2015;8(4):472–88. doi: 10.1016/j.jcmg.2015.02.002.
    1. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–47. doi: 10.1161/CIRCULATIONAHA.110.009449.
    1. Greenspon AJ. A review of oral anticoagulants in patients with atrial fibrillation. Postgrad Med. 2012;124(6):7–16. doi: 10.3810/pgm.2012.11.2608.
    1. O’Brien EC, Holmes DN, Ansell JE, Allen LA, Hylek E, Kowey PR, 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. doi: 10.1016/j.ahj.2013.12.014.
    1. Bradley BC, Perdue KS, Tisdel KA, Gilligan DM. Frequency of anticoagulation for atrial fibrillation and reasons for its non-use at a Veterans Affairs medical center. Am J Cardiol. 2000;85(5):568–72. doi: 10.1016/S0002-9149(99)00813-9.
    1. Jorge E, Pereira FS, Baptista R, Monteiro P, Santos L, Fonseca I, et al. Anticoagulation in elderly patients with atrial fibrillation: from the guidelines to the daily medical practice. Acta Med Port. 2011;24(Suppl 2):293–300.
    1. Diez-Manglano J, Gomes-Martin J, Al-Cheikh-Felices P, Perez SI, Diez-Angulo R, Clemente-Sarasa C. Adherence to guidelines and mortality in atrial fibrillation. Int J Cardiol. 2014;176(2):430–6. doi: 10.1016/j.ijcard.2014.07.098.
    1. Madden JL. Resection of the left auricular appendix; a prophylaxis for recurrent arterial emboli. JAMA. 1949;140(9):769–72. doi: 10.1001/jama.1949.02900440011003.
    1. Bayard YL, Omran H, Neuzil P, Thuesen L, Pichler M, Rowland E, et al. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study. EuroIntervention. 2010;6(2):220–6. doi: 10.4244/EIJV6I2A35.
    1. Chan SK, Kannam JP, Douglas PS, Manning WJ. Multiplane transesophageal echocardiographic assessment of left atrial appendage anatomy and function. Am J Cardiol. 1995;76(7):528–30. doi: 10.1016/S0002-9149(99)80147-7.
    1. Freixa X, Tzikas A, Basmadjian A, Garceau P, Ibrahim R. The chicken-wing morphology: an anatomical challenge for left atrial appendage occlusion. J Interv Cardiol. 2013;26(5):509–14.
    1. Kretzschmar D, Lauten A, Goebel B, Doenst T, Poerner TC, Ferrari M, et al. Optimal prosthesis sizing in transcatheter aortic valve implantation by exclusive use of three-dimensional transoesophageal echocardiography. Clin Physiol Funct Imaging. 2014.
    1. Cruz-Gonzalez I, Perez-Rivera A, Lopez-Jimenez R, Rodriguez-Collado J, Martin-Moreiras J, Cascon M, et al. Significance of the learning curve in left atrial appendage occlusion with two different devices. Catheter Cardiovasc Interv. 2014;83(4):642–6. doi: 10.1002/ccd.25230.
    1. Mobius-Winkler S, Majunke N, Sandri M, Mangner N, Linke A, Stone GW, et al. Percutaneous left atrial appendage closure: Technical aspects and prevention of periprocedural complications with the watchman device. World J Cardiol. 2015;7(2):65–75. doi: 10.4330/wjc.v7.i2.65.

Source: PubMed

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