Abstract
This study aimed to estimate the incidence and risk factors of device-related thrombus (DRT) following percutaneous left atrial appendage closure (LAAC) in real-world practices. Between February 2012 and December 2016, 319 consecutive patients with atrial fibrillation underwent percutaneous LAAC using WATCHMAN, WATCHMAN Flx, Amplatzer cardiac plug, and Amulet devices. All patients underwent transesophageal echocardiography (TEE) at a minimum of three time points; periprocedurally, at 45 days, and at 6 months. Other clinical parameters were also evaluated, and a comparison between patients with DRT and those not suffering from DRT was done. The percutaneous LAAC was successfully performed in 97.8% of the patients. DRT was detected in 14 (4.49%) patients; of the 14 patients, DRT was detected in 3 patients at acute phase, 8 patients at subacute phase, 2 patients at late phase and 1 patient at very late phase. Most of the DRT originated from the central screw of device. In 6 out of 14 patients, DRT was successfully resolved by oral anticoagulation. Higher HAS-BLED score (4.1 ± 1.2 vs. 3.5 ± 1.1, p = 0.042) was more frequent in patients with DRT. Multivariable analysis showed that residual peri-device leak may result in a predisposition to DRT (p = 0.023). The incidence of DRT after percutaneous LAAC was acceptable, as a part of the DRT was resolved with oral anticoagulation. Residual peri-device leak was associated with DRT. Optimal implantation without peri-device gap, individual antithrombotic regimens, and careful monitoring with TEE follow-up could be conducive to the prevention of DRT.
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References
Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P, PROTECT AF Investigators (2009) 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 374:534–542
Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S (2011) 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 123:417–424
Ledwoch J, Franke J, Gonzaga M, Bertog S, Braut A, Hofmann I, Vaskelyte L, Gafoor S, Reddy V, Sievert H (2016) Left atrial appendage closure: first in man with the 4th generation WATCHMAN device. Catheter Cardiovasc Interv 87:787–794
Landmesser U, Schmidt B, Nielsen-Kudsk JE, Lam SCC, Park JW, Tarantini G, Cruz-Gonzalez I, Geist V, Della Bella P, Colombo A, Zeus T, Omran H, Piorkowski C, Lund J, Tondo C, Hildick-Smith D (2017) Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention 13:867–876
Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbäcker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW (2016) Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention 11:1170–1179
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, ESC Scientific Document Group (2016) 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 37:2893–2962
Gangireddy SR, Halperin JL, Fuster V, Reddy VY (2012) Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit. Eur Heart J 33:2700–2708
Ayirala S, Kumar S, O’Sullivan DM, Silverman DI (2011) Echocardiographic predictors of left atrial appendage thrombus formation. J Am Soc Echocardiogr 24:499–505
Plicht B, Konorza TF, Kahlert P, Al-Rashid F, Kaelsch H, Jánosi RA, Buck T, Bachmann HS, Siffert W, Heusch G, Erbel R (2013) Risk factors for thrombus formation on the Amplatzer Cardiac Plug after left atrial appendage occlusion. JACC Cardiovasc Interv 6:606–613
Main ML, Fan D, Reddy VY, Holmes DR, Gordon NT, Coggins TR, House JA, Liao L, Rabineau D, Latus GG, Huber KC, Sievert H, Wright RF, Doshi SK, Douglas PS (2016) Assessment of device-related thrombus and associated clinical outcomes with the WATCHMAN left atrial appendage closure device for embolic protection in patients with atrial fibrillation (from the PROTECT-AF Trial). Am J Cardiol 117:1127–1134
Saw J, Tzikas A, Shakir S, Gafoor S, Omran H, Nielsen-Kudsk JE, Kefer J, Aminian A, Berti S, Santoro G, Nietlispach F, Moschovitis A, Cruz-Gonzalez I, Stammen F, Tichelbäcker T, Freixa X, Ibrahim R, Schillinger W, Meier B, Sievert H, Gloekler S (2017) Incidence and clinical impact of device-associated thrombus and peri-device leak following left atrial appendage closure with the amplatzer cardiac plug. JACC Cardiovasc Interv 10:391–399
Dukkipati SR, Kar S, Holmes DR Jr, Doshi SK, Swarup V, Gibson DN, Maini B, Gordon NT, Main ML, Reddy VY (2018) Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. https://doi.org/10.1161/circulationaha.118.035090
Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P (2018) Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation. J Am Coll Cardiol 71:1528–1536
Kaneko H, Neuss M, Weissenborn J, Butter C (2017) Predictors of thrombus formation after percutaneous left atrial appendage closure using the WATCHMAN device. Heart Vessels 32(9):1137–1143
Peyrol M, Cautela J, Salaun E, Miola C, Franceschi F, Thuny F, Pinto J, Laine M, Maximovitch A, Paganelli F, Armero S, Bonello L (2018) Device-related thrombus after left atrial appendage occlusion with the amulet device. Heart Lung Circ 2:22. https://doi.org/10.1016/j.hlc.2018.08.022
Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomström-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T (2017) Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace 19:4–15
Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 60:1438–1454
Fatkin D, Loupas T, Jacobs N, Feneley MP (1995) Quantification of blood echogenicity: evaluation of a semiquantitative method of grading spontaneous echo contrast. Ultrasound Med Biol 21:1191–1198
Lempereur M, Aminian A, Freixa X, Gafoor S, Kefer J, Tzikas A, Legrand V, Saw J (2017) Device-associated thrombus formation after left atrial appendage occlusion: a systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet. Catheter Cardiovasc Interv 90:E111–E121
Enomoto Y, Gadiyaram VK, Gianni C, Horton RP, Trivedi C, Mohanty S, Di Biase L, Al-Ahmad A, Burkhardt JD, Narula A, Janczyk G, Price MJ, Afzal MR, Atoui M, Earnest M, Swarup V, Doshi SK, van der Zee S, Fisher R, Lakkireddy DR, Gibson DN, Natale A, Reddy VY (2017) Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device. Heart Rhythm 14:19–24
Kar S, Hou D, Jones R, Werner D, Swanson L, Tischler B, Stein K, Huibregtse B, Ladich E, Kutys R, Virmani R (2014) Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model. JACC Cardiovasc Interv 7:801–809
Massarenti L, Yilmaz A (2012) Incomplete endothelialization of left atrial appendage occlusion device 10 months after implantation. J Cardiovasc Electrophysiol 23:1384–1385
Sedaghat A, Schrickel JW, Andrié R, Schueler R, Nickenig G, Hammerstingl C (2017) Thrombus formation after left atrial appendage occlusion with the amplatzer amulet device. JACC Clin Electrophysiol 3:71–75
Viles-Gonzalez JF, Kar S, Douglas P, Dukkipati S, Feldman T, Horton R, Holmes D, Reddy VY (2012) 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 59:923–929
Ketterer U, D’Ancona G, Siegel I, Ortak J, Ince H, Kische S (2016) Percutaneous left atrial appendage occlusion: device thrombosis in clopidogrel non-responders. Int J Cardiol 204:196–197
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The authors thank Cody R. Hou and Joseph Donnelly for their assistance in manuscript preparation.
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Bai, Y., Xue, X., Duenninger, E. et al. Real-world survival data of device-related thrombus following left atrial appendage closure: 4-year experience from a single center. Heart Vessels 34, 1360–1369 (2019). https://doi.org/10.1007/s00380-019-01364-7
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DOI: https://doi.org/10.1007/s00380-019-01364-7