The healing response of LAMax LAAC™ left atrial appendage occluder in a canine model: the potential influence of the implantation technique on the healing response
Tóm tắt
Device-associated thrombus are potential causes for thromboembolic events post left atrial appendage closure (LAAC), and correlated with the complete endothelialization of the device surface. Our aim was to evaluate the endothelialization of LAMax LAAC™ occluder surface and analyze the potential influence of the implantation technique on the healing response. A total of 29 healthy dogs (28.0 ± 3.7 kg) were implanted with the devices successfully after ensuring COVER signs was met (Concavity of the disc, Oversizing by 20–50%, Verifying position, Ensuring stability, Residual flow < 5 mm by transesophageal echocardiographic (TEE) examination), and sacrificed at < 24 h, 1-, 2-, 3-, and 6-months. Gross examinations were conducted to evaluate healing response.
The mean diameters of LAA orifice measured by angiography and TEE were 19.0 ± 2.9 mm and 16.6 ± 2.9 mm (P < 0.05), respectively. TEE found that the discs in 18 dogs (62.1%) were completely pulled into the LAA with concavity and in 11 dogs incompletely pulled into the LAA with suboptimally concavity, while 5 of them had residual flow. Gross examinations showed that the complete endothelialization on the device surface with concaved disc was found at 1-month after LAAC. Microscopic examinations confirmed complete healing on the device with optimal closure effect. The good healing response and the optimal closure effect were observed using the LAMax device in a canine model by following the COVER implantation technique.
Tài liệu tham khảo
Hobohm L, von Bardeleben RS, Ostad MA, Wenzel P, Münzel T, Gori T, Keller K. 5-year experience of in-hospital outcomes after percutaneous left atrial appendage closure in Germany. JACC Cardiovasc Interv. 2019;10(12):1044–52.
Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr. PREVAIL and PROTECTAF Investigators. 5-year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials. J Am Coll Cardiol. 2017;70:2964–75.
Kabra R, Girotra S, Vaughan SM. Clinical outcomes of mortality, readmissions, and ischemic stroke among medicare patients undergoing left atrial appendage closure via implanted device. JAMA Netw Open. 2019;2(2): e1914268.
Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Foley D, Sievert H, Mazzone P, De Potter T, Vireca E, Stein K, Bergmann MW. EWOLUTION investigators. 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;14:1302–8.
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. 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. 2017;10:391–9.
Lempereur M, Aminian A, Freixa X, Gafoor S, Kefer J, Tzikas A, Legrand V, Saw J. 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. 2017;90:E111–21.
Dukkipati SR, Kar S, Holmes DR, Doshi SK, Swarup V, Gibson DN, Maini B, Gordon NT, Main ML, Reddy VY. Device-related thrombus after left atrial appendage closure: incidence, predictors, and outcomes. Circulation. 2018;138:874–85.
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;8:1094–8.
Lam SC, Bertog S, Sievert H. Incomplete left atrial appendage occlusion and thrombus formation after watchman implantation treated with anticoagulation followed by further transcatheter closure with a second-generation amplatzer cardiac plug (Amulet device). Catheter Cardiovasc Interv. 2015;85:321–7.
Cruz-González I, Korsholm K, Trejo-Velasco B, Thambo JB, Mazzone P, Rioufol G, Grygier M, Möbius-Winkler S, Betts T, Meincke F, Sandri M, Schmidt B, Schmitz T, Nielsen-Kudsk JE. Procedural and short-term results with the new watchman FLX left atrial appendage occlusion device. JACC Cardiovasc Interv. 2020;14(13):2732–41.
Schwartz RS, Holmes DR, Van Tassel RA, Hauser R, Henry TD, Mooney M, Matthews R, Doshi S, Jones RM, Virmani R. Left atrial appendage obliteration: mechanisms of healing and intracardiac integration. JACC Cardiovasc Interv. 2010;3:870–7.
Kar S, Hou D, Jones R, Werner D, Swanson L, Tischler B, Stein K, Huibregtse B, Ladich E, Kutys R, Virmani R. Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model. JACC CardiovascInterv. 2014;7:801–9.
Wu X, Fan D, Huang W, Meng Y, Wan T, Amsterdam EA, Shen Y, Chen Y, Ma D. Contrast-enhanced transesophageal echocardiography predicts neo-intimal coverage of device post-left atrial appendage closure. Cardiol J. 2022;29(3):489–98. https://doi.org/10.5603/CJ.a2020.0125.
Beigel R, Wunderlich NC, Ho SY, Arsanjani R, Siegel RJ. The left atrial appendage: anatomy, function, and noninvasive evaluation. JACC. 2014;7:1251–65.
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. 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. 2016;117:1127–34.
Rodes-Cabau J, Champagne J, Bernier M. Transcatheter closure of the left atrial appendage: initial experience with the amplatzer cardiac plug device. Catheter Cardiovasc Interv. 2010;76:186–92.