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Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device

Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 6613683, 6 pages https://doi.org/10.1155/2020/6613683 Research Article Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device 1,2,3 1,2,3 1,2,3 1,2,3 Guangji Wang , Bin Kong, Yu Liu, and He Huang Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China Cardiovascular Research Institute of Wuhan University, Wuhan, Hubei, China Hubei Key Laboratory of Cardiology, Wuhan, Hubei, China Correspondence should be addressed to He Huang; huanghe1977@whu.edu.cn Received 14 October 2020; Revised 28 November 2020; Accepted 13 December 2020; Published 21 December 2020 Academic Editor: Amit Segev Copyright © 2020 Guangji Wang et al. .is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Left atrial appendage closure (LAAC) using the LAmbre device has been associated with prevention of stroke in patients with nonvalvular atrial fibrillation (AF). Here, we interrogated the long-term safety and efficacy of using the LAmbre device in percutaneous LAAC. Methods. We analyzed 56 records of patients with nonvalvular AF undergoing LAAC procedures with the LAmbre device. We collected and analyzed the data to define the safety and efficacy of the LAmbre device implantation. Result. .e LAAC was successfully occluded in the 56 patients. Our data showed no serious residual leak or pericardial effusion occurred during the perioperative period. At a mean follow-up of 37.8± 23.5 months, there were 7.1%, 3.6%, and 3.6% rates of death, stroke, and device-related thrombus, respectively. .ere were no cases of severe residual leak or systemic embolism. Conclusion. Taken together, we demonstrate that execution of LAAC with the LAmbre device has high procedural success and prevents AF-related stroke. However, further large-scale trials might be required to confirm our findings. most of the clinical studies on the LAmbre LAA occluder were 1. Introduction followed up for 1 year. To date, there are no data on the long- Atrial fibrillation (AF) is the most common sustained ar- term safety and efficacy of LAAC with the LAmbre occluder rhythmia, which is associated with an increased risk of stroke in patients with AF. Here, we aimed to evaluate the long-term [1]. AF-induced stroke events are more severe than non-AF effect of the LAmbre LAA occluder in patients with AF. stroke events and are associated with a higher risk of morbidity and mortality [2]. Currently, oral anticoagulation (OAC) 2. Method remains the most effective way to prevent stroke in patients with AF. However, for patients contraindicated with OAC or 2.1. Study Population. A retrospective, single-center study those who refuse OAC therapy, left atrial appendage closure was performed in 56 patients with nonvalvular AF, who (LAAC) with Watchman (Boston Scientific, Natick, Massa- underwent LAAC with the LAmbre device between March chusetts) or Amplatzer Cardiac Plug (ACP; St. Jude Medical, 2014 and June 2020. We included patients with nonvalvular Saint Paul, Minnesota) presents feasible alternatives [3–9]. AF, aged 18 years and above, and a CHA DS -VASc Score 2 2 .e LAmbre (Lifetech Scientific, Shenzhen, China) left ≥2. .e patients were contraindicated to long-term oral atrial appendage (LAA) occluder is a novel system, especially anticoagulants (OACs) or refused OAC therapy. We ex- designed for LAA closure in cases that present morphological cluded those with severe valvular disease or abnormal difficulties [10]. Previous studies have confirmed that LAAC cardiac structure, left atrial or LAA thrombosis confirmed by with the LAmbre is safe and effective in the prevention of transesophageal echocardiogram (TEE), pregnancy or thromboembolic events [11–13], but the effectiveness and the breastfeeding, and left ventricular ejection fraction (LVEF) safety were similar to Watchman and ACP [14]. However, < 30%, as well as significant pericardial effusion. .is study 2 Journal of Interventional Cardiology was approved by the Human Subject Ethics Committee of length was 29.2± 6.5 mm, LAA orifice diameter was Renmin Hospital, Wuhan University. All patients gave 27.6± 5.2 mm, and the LAA landing zone diameter was signed informed consent. 22.6± 4.4 mm. Our TEE analysis showed that there was 1 (1.8%) patient with <1 mm residual flow and there were 5 (8.9%) patients with 1–3 mm residual flow. .ere were 3 2.2. LAmbre LAAC. .e LAmbre LAAC was performed cases of periprocedural complications associated with slight either under local or general anesthesia, aided by the TEE pericardial effusion. .ere was however no cases of death, and X-ray fluoroscope. Besides, transseptal puncture was stroke, major bleeding, major vascular complication, performed under the guidance of the TEE. Selective LAA thrombosis with device, and device dislocation (Table 2). angiogram was performed to understand the shape, size, and adjacent relationships, and the TEE was used to measure the diameter and depth of the LAA. .e size of the LAA occluder 3.3. Patient Follow-Up Data. As shown in Table 3, the mean was chosen based on the data from the LAA angiogram and follow-up time was 37.8± 23.5 months. During the follow- TEE measurements. LAA angiogram and TEE were also up period, there were 4 (7.1%) deaths. 3 cases were non- performed to determine the location and placement of the cardiac death at 3 months, 36 months, and 49 months after occluder. In addition, a gentle tug test was performed under the procedure, while the other was cardiac arrest at 46 fluoroscopy to ensure device stability. .e occluder was months after the procedure. .ere were 2 (3.6%) cases of completely retrieved if the position, sealing effect, and ischemic stroke during the follow-up period. .e TEE stability were not satisfying (Figure 1). analysis showed that device thrombosis occurred in 2 (3.6%) patients. Besides, TEE reexamination revealed thrombotic 2.3. Postsurgical Anticoagulation. .e double antiplatelet dissolution after anticoagulant therapy. Two (3.6%) patients therapy (aspirin plus clopidogrel) was performed for 3 had <1 mm residual flow, while 1 (1.8%) had 1–3 mm re- months after LAAC, followed by TEE examination 3 months sidual flow. later. In cases where there was no significant residual shunt, the double antiplatelet treatment was changed to either aspirin or clopidogrel for long-term treatment. 4. Discussion Here, we demonstrate that LAAC with the LAmbre device 2.4. Follow-Up. In the first year, the patients were monitored has a high success rate. In addition, long-term follow-up at 1, 3, 6, and 12 months after LAAC. Long-term follow-up results robustly associate the LAmbre LAAC with good was performed using phone or mail survey assessment. clinical outcomes in the prevention of stroke. Many clinical studies have associated LAAC with re- duction in stroke [3–13]. While the LAAC device therapy 2.5. Endpoints. .e study endpoints included severe peri- seems promising, the incidence of treatment-related com- operative complications and serious adverse events (SAE) plications remains undefined. For instance, the PROTECT- during the follow-up. .e severe perioperative complications AF and CAP and PREVAIL studies showed that the success and SAE were defined as death, stroke, cardiac effusion, major rate for the Watchman device implantation was 91.3% and bleeding, severe vascular complications, thrombosis with 95%, respectively [3–5]. With the improvement in the im- device, systemic thromboembolism, and device dislocation. plantation techniques, the Watchman device implantation success rate increased to 98.5% in the EWOLUTION study 2.6. Statistical Analysis. Categorical variables were expressed [7]. On the other hand, initial European and Asia-Pacific as frequencies and percentages. On the other hand, con- experience suggested that the ACP device implantation tinuous variables were presented as mean± SD. success rate was 96% (132/137) and 95% (19/20), respectively [8, 15]. A multicenter study associated the use of the ACP 3. Results device with 97.3% success rate [9]. In this study, unlike the Watchman and ACP devices, we show 100% success with the 3.1. Base Characteristics. A total of 56 patients (66.6± 8.4 use of the LAmbre device. Similarly, the initial European years; 23 females) were enrolled in this study (Table 1). .e registration studies reported 100% success rate with the mean CHA DS -VASc Score was 3.7± 1.3, while the mean 2 2 LAmbre device implantation [11]. In addition, a prospective, score for HAS-BLED was 2.3± 0.9. Our analysis revealed multicenter clinical study suggested that the LAmbre device that 26 (46.4%) patients had a history of prior stroke/TIA, implantation success rate was 99.4% [13]. .e high im- while 21 (37.5%) had a previous coronary artery disease. In plantation success rate demonstrated with the use of the addition, 46 (82%) patients had previous hypertension and 8 LAmbre device may be due to its unique design. .e LAmbre (14.3%) had a history of diabetes while 10 (17.9%) and 46 device is shorter in size and requires less depth for the LAA. (82.1%) patients had a paroxysmal and a nonparoxysmal AF, In addition, there are diverse sizes in the LAmbre device, respectively. which makes it more suitable for the special shape of the LAA. 3.2. Procedural Characteristics. .e success rate for the Pericardial effusion is the most common peri- LAmbre device implantation was 100%. .e mean LAA operative complication of LAAC with the Watchman Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: .e procedure of LAA closure with the LAmbre device. (a) LAA angiogram assessment of the left auricle size. (b) .e deployment of the umbrella. (c) .e deployment of the cover. (d) Left atrial angiogram was performed after the release of the device to check for LAA sealing. incidence of serious pericardial effusion in patients with Table 1: Baseline characteristics. Watchman occluder implantation was only 2.2% (10/460) n � 56 [4]. .e EWOLUTION registry reported that the peri- Age (years) 66.6± 8.4 cardial effusion only occurred in 5 patients (0.5%, 5/1004) Female, n (%) 23 (41.1) [7]. Initial European experience reported 3.5% (5/143) BMI (kg/m ) 25.1± 3.2 cases of serious pericardial effusion after ACP implants Hypertension 46 (82.0) [8]. However, the severe pericardial effusion with ACP Diabetes 8 (14.3) occluder implantation was dependent on the operator’s Previous stroke/TIA 26 (46.4) experience. In other ACP registries, no serious pericar- Coronary artery disease 21 (37.5) dial effusion was observed [8, 9, 15]. .e occurrence of Paroxysmal AF 10 (17.9) pericardial effusion was lower in LAmbre registries Nonparoxysmal AF 46 (82.1) compared to either the ACP or Watchman registries. In CHA DS -VASc Score 3.7± 1.3 2 2 HAS-BLED Score 2.3± 0.9 the LAmbre series of 153 patients, serious pericardial effusion occurred only in 3 patients (2.0%) [13]. Peri- BMI � body mass index; AF � atrial fibrillation. operative pericardial incidences were neither reported in the LAmbre series of 60 patients nor in the series of 30 device, whose severity harbors fatal risks [3]. In the patients [11, 12]. However, 2 late pericardial effusions PROTECT-AF study, the incidence of serious pericardial were reported in the series of 60 patients [12]. In our effusion was 4.8% (22/463), of which 15 were treated with study, no serious pericardial effusion occurred. Other typical LAAC perioperative complications, such pericardiocentesis, while the rest underwent surgical intervention [3]. On the other hand, in the CAP study, the as air embolization, cardiac perforation, major bleeding, 4 Journal of Interventional Cardiology Table 2: Periprocedural data. studied 52 patients enrolled in 7 centers and found that the incidence of <3 mm residual flow immediately and at n � 56 6-month follow-up was 13.5% and 16.2%, respectively, LAA diameters following ACP device implantation. .e rate of residual LAA length (mm) 29.2± 6.5 flow in the LAmbre device appears to be higher than the LAA orifice diameter (mm) 27.6± 5.2 ones reported for the ACP and Watchman devices. For LAA landing zone diameter (mm) 22.6± 4.4 instance, Chen et al. [11] reported that there were 5 (20%) Number of LAA lobes patients with a residual flow of 2 mm, 3 (12%) patients Single lobe 42 (75) Two lobes 12 (21.4) with a residual flow of 3 mm, and 1 (4%) patient with a Multiple lobes 2 (3.6) residual flow of 4 mm, during the follow-up period. On Successful implantation 56 (100) the other hand, Park et al. [12] showed that the rate of LAA leak <5 mm residual flow was 14/57 (24.6%), 11/54 (20.4%), or Residual flow <1 mm 1 (1.8) 15/36 (41.7%), at 1, 6, and 12 months of follow-up, re- Residual flow 1–3 mm 5 (8.9) spectively. Besides, a residual flow of ≧5 mm was observed Residual flow >3 mm 0 in 3/60 (5%) patients at the first month of follow-up. In a Procedure time (min) 60.1± 13.0 multicenter study, the residual flow of <1 mm was 1.3% (2 Contrast media (ml) 44.5± 13.7 cases), while the residual flow of 1–3 mm and >3 mm was Complications 13.3% and 0.7%, respectively, immediately after the Death 0 Stroke 0 procedure [13]. .e reason of high incidence of residual Pericardial effusion 0 flow after LAAC with the LAmbre device may be related Major bleeding 0 to the operator’s operating experience. Compared with Major vascular complication 0 Watchman and ACP occluders, the LAmbre occluder is in .rombosis with device 0 less clinical use. .e incidence of residual flow may de- Device dislocation 0 crease with the accumulation of operator experience. LAA � left atrial appendage. Compared to these studies, the incidence of residual flow in our study was relatively lower. In our study, a residual flow of <1 mm or 1–3 mm was observed in 1.8% or 8.9% Table 3: Clinical outcomes during follow-up. patients, respectively, immediately after the procedure with the LAmbre device. During the follow-up, 2 (3.6%) n � 56 patients had a <1 mm residual flow, while 1 (1.8%) patient Follow-up time (months) 37.8± 23.5 had residual flow of 1–3 mm. However, to date, the re- Death 4 (7.1) Noncardiac death 3 (5.4) lationship between residual flow and stroke remains Cardiac death 1 (1.8) controversial. Ischemic stroke 2 (3.6) Device-related thrombus (DRT) is a common medium- and Hemorrhagic stroke 0 long-term complication after LAAC. A previous study dem- Device thrombosis 2 (3.6) onstrated that the DRT is associated with a higher rate of stroke Systemic thromboembolism 0 and systemic embolism [21, 22]. A 1-year follow-up data of the LAA sealing by TEE examination EWOLUTION trial reported that the incidence of DRT with Residual flow <1 mm 2 (3.6) the Watchman device was 3.7% [23]. In the ASAP study (ASA Residual flow 1–3 mm 1 (1.8) plavix feasibility study with Watchman left atrial appendage Residual flow >3 mm 0 closure technology), there were 6 cases (4%) of DRT [24]. In LAA � left atrial appendage; TEE � transesophageal ultrasound. addition, Saw et al. [25] reported the incidence of DRT in the ACP device trial to be 3.2%. .e multicenter experience of device dislocation, or device embolization, were not ob- LAAC with the ACP also reported a 4.4% (28/632 patients) served. .is might be attributed to the fact that the LAmbre DRT incidence [9]. However, the frequency of DRTafter LAAC device includes a specially designed hook umbrella with the with LAmbre is marginal [8, 9]. A multicenter clinical study ability to recapture, retrieve, redeploy, and remain stable reported 2 patients (1.3%) with DRT following LAAC with during deployment. In addition, the transport sheath of the LAmbre. Our present data showed 2 patients (3.6%) with DRT. LAmbre occluder is smaller (8–10 French) than that of However, the observed rate of ischemic stroke in our study was Watchman or ACP occluders (14 French). higher than those reported in other LAAC trials [9, 13, 23]. Residual flow is a common complication in LAAC. Lucas et al. observed a 1.1% rate of ischemic stroke at a 1-year .e factors influencing the occurrence of residual flow follow-up in a Watchman device trial [23]. Similar data were following LAAC are still unclear. Some studies suggested obtained in the ACP device trial [9]. A multicenter clinical study that it may be related to the morphology and type of the with the LAmbre device showed 1.3% ischemic stroke cases LAA, the surrounding structure, and the compression [13]. Here, we reported 2 patients (3.6%) with ischemic stroke, 1 ratio of the occluder [16–19]. EWOLUTION registry of which terminated the use of oral antiplatelet drugs one year showed >5 mm residual flow in 7 patients (0.7%) and after the procedure. .erefore, adequate antithrombotic therapy ≦5 mm residual flow in 78 patients (7.9%) following with aspirin and clopidogrel is important to prevent thrombus Watchman device implantation [7]. Urena et al. [20] formation after LAAC. Journal of Interventional Cardiology 5 .e mortality rate after LAAC varies greatly in different References studies. A 1-year follow-up outcome data in the EWOLU- [1] P. A. Wolf, R. D. Abbott, and W. B. Kannel, “Atrial fibrillation TION trial reported a 9.8% mortality rate after LAAC with as an independent risk factor for stroke: the Framingham the Watchman device [23]. A 5-year mortality rate was 3.6% Study,” Stroke, vol. 22, no. 8, pp. 983–988, 1991. in the PREVAIL and PROTECT-AF trials following LAAC [2] N. Henninger, R. P. Goddeau Jr., A. Karmarkar, J. Helenius, with the Watchman device [26]. In addition, a one-year all- and D. D. McManus, “Atrial fibrillation is associated with a cause mortality from multicenter data with the ACP was worse 90-day outcome than other cardioembolic stroke 4.2% [9]. Besides, a global prospective observational study subtypes,” Stroke, vol. 47, no. 6, pp. 1486–1492, 2016. reported a 2.1% mortality rate after LAAC with the ACP [3] D. R. Holmes, V. Y. Reddy, Z. G. Turi et al., “Percutaneous device [27]. Marian et al. observed a 16.6% mortality rate in a closure of the left atrial appendage versus warfarin therapy for LAmbre device trial. 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Reddy, H. Sievert, J. Halperin et al., “Percutaneous left .is study was conducted retrospectively, was based on a atrial appendage closure vs warfarin for atrial fibrillation,” single center, and has a small sample size. Besides, the JAMA, vol. 312, no. 19, pp. 1988–1998, 2014. follow-up assessments for embolic events were detected [7] L. V. A. Boersma, B. Schmidt, T. R. Betts et al., “Implant based on the description of patients; therefore, the occur- success and safety of left atrial appendage closure with the rence rate might be underestimated. Prospective, multi- WATCHMAN device: peri-procedural outcomes from the center, randomized, and controlled clinical trials are EWOLUTION registry,” European Heart Journal, vol. 37, therefore needed to further confirm the efficacy and safety of no. 31, pp. 2465–2474, 2016. the use of the LAmbre device. [8] J.-W. Park, A. Bethencourt, H. Sievert et al., “Left atrial ap- pendage closure with amplatzer cardiac plug in atrial fibril- lation: initial european experience,” Catheterization and 6. Conclusion Cardiovascular Interventions, vol. 77, no. 5, pp. 700–706, 2011. [9] A. Tzikas, S. Shakir, S. Gafoor et al., “Left atrial appendage Taken together, we deduce that LAAC with the LAmbre occlusion for stroke prevention in atrial fibrillation: multi- device is associated with a low rate of stroke and bleeding centre experience with the AMPLATZER Cardiac Plug,” events. Multicenter, large-scale, randomized, and controlled EuroIntervention, vol. 11, no. 10, pp. 1170–1179, 2016. studies are needed to further verify the long-term safety and [10] Y.-Y. Lam, “A new left atrial appendage occluder (lifetech efficacy of the LAmbre device. LAmbreTM device) for stroke prevention in atrial fibrilla- tion,” Cardiovascular Revascularization Medicine, vol. 14, no. 3, pp. 134–136, 2013. Data Availability [11] S. Chen, B. Schmidt, S. Bordignon et al., “Feasibility of percutaneous left atrial appendage closure using a novel .e data used to support the findings of this study are LAmbre occluder in patients with atrial fibrillation: initial available from the corresponding author upon request. results from a prospective cohort registry study,” Journal of Cardiovascular Electrophysiology, vol. 29, no. 2, pp. 291–297, Conflicts of Interest [12] J.-W. Park, H. Sievert, C. Kleinecke et al., “Left atrial ap- pendage occlusion with lambre in atrial fibrillation: initial .e authors declare that they have no conflicts of interest. European experience,” International Journal of Cardiology, vol. 265, pp. 97–102, 2018. [13] H. Huang, Y. Liu, Y. Xu et al., “Percutaneous left atrial ap- Authors’ Contributions pendage closure with the LAmbre device for stroke preven- tion in atrial fibrillation,” JACC: Cardiovascular Interventions, Guangji Wang and Bin Kong contributed equally to this vol. 10, no. 21, pp. 2188–2194, 2017. work. [14] S. Chen, K. R. J. Chun, S. Bordignon et al., “Left atrial ap- pendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation,” Journal of Cardiology, vol. 73, no. 4, pp. 299–306, 2019. Acknowledgments [15] Y.-Y. Lam, G. W. K. Yip, C.-M. Yu et al., “Left atrial ap- .is study was supported by the National Key R&D Program pendage closure with AMPLATZER cardiac plug for stroke of China (2017YFC1700504). prevention in atrial fibrillation: initial Asia-Pacific 6 Journal of Interventional Cardiology experience,” Catheterization and Cardiovascular Interven- tions, vol. 79, no. 5, pp. 794–800, 2012. [16] Y. Wang, L. Di Biase, R. P. Horton, T. Nguyen, P. Morhanty, and A. Natale, “Left atrial appendage studied by computed tomography to help planning for appendage closure device placement,” Journal of Cardiovascular Electrophysiology, vol. 21, no. 9, pp. 973–982, 2010. [17] F. Figini, P. Mazzone, D. Regazzoli et al., “Left atrial ap- pendage closure: a single center experience and comparison of two contemporary devices,” Catheterization and Cardiovas- cular Interventions, vol. 89, no. 4, pp. 763–772, 2017. [18] S. Kar, D. Hou, R. Jones et al., “Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model,” JACC: Cardiovas- cular Interventions, vol. 7, no. 7, pp. 801–809, 2014. [19] B. Meier, Y. Blaauw, A. A. Khattab et al., “EHRA/EAPCI expert consensus statement on catheter-based left atrial ap- pendage occlusion,” EuroIntervention, vol. 10, no. 9, pp. 1109–1125, 2015. [20] M. Urena, J. Rodes-Cabau, ´ X. Freixa et al., “Percutaneous left atrial appendage closure with the AMPLATZER cardiac plug device in patients with nonvalvular atrial fibrillation and contraindications to anticoagulation therapy,” Journal of the American College of Cardiology, vol. 62, no. 2, pp. 96–102, [21] L. Fauchier, A. Cinaud, F. Brigadeau et al., “Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation,” Journal of the American College of Cardiology, vol. 71, no. 14, pp. 1528–1536, 2018. [22] P. Garot, B. Cormier, and J. Horvilleur, “Device-related thrombus after left atrial appendage closure,” Interventional Cardiology Review, vol. 14, no. 1, pp. 42–44, 2019. [23] L. V. Boersma, H. Ince, S. Kische 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, vol. 14, no. 9, pp. 1302–1308, 2017. [24] V. Y. Reddy, S. Mobius-Winkler, ¨ M. A. Miller et al., “Left atrial appendage closure with the Watchman device in pa- tients with a contraindication for oral anticoagulation,” Journal of the American College of Cardiology, vol. 61, no. 25, pp. 2551–2556, 2013. [25] J. Saw, A. Tzikas, S. Shakir et al., “Incidence and clinical impact of device-associated thrombus and peri-device leak following left atrial appendage closure with the amplatzer cardiac plug,” JACC: Cardiovascular Interventions, vol. 10, no. 4, pp. 391–399, 2017. [26] V. Y. Reddy, S. K. Doshi, S. Kar et al., “5-Year outcomes after left atrial appendage closure,” Journal of the American College of Cardiology, vol. 70, no. 24, pp. 2964–2975, 2017. [27] U. Landmesser, B. Schmidt, J. E. Nielsen-Kudsk et al., “Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study,” Euro- Intervention, vol. 13, no. 7, pp. 867–876, 2017. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Interventional Cardiology Hindawi Publishing Corporation

Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device

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Hindawi Journal of Interventional Cardiology Volume 2020, Article ID 6613683, 6 pages https://doi.org/10.1155/2020/6613683 Research Article Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device 1,2,3 1,2,3 1,2,3 1,2,3 Guangji Wang , Bin Kong, Yu Liu, and He Huang Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China Cardiovascular Research Institute of Wuhan University, Wuhan, Hubei, China Hubei Key Laboratory of Cardiology, Wuhan, Hubei, China Correspondence should be addressed to He Huang; huanghe1977@whu.edu.cn Received 14 October 2020; Revised 28 November 2020; Accepted 13 December 2020; Published 21 December 2020 Academic Editor: Amit Segev Copyright © 2020 Guangji Wang et al. .is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. Left atrial appendage closure (LAAC) using the LAmbre device has been associated with prevention of stroke in patients with nonvalvular atrial fibrillation (AF). Here, we interrogated the long-term safety and efficacy of using the LAmbre device in percutaneous LAAC. Methods. We analyzed 56 records of patients with nonvalvular AF undergoing LAAC procedures with the LAmbre device. We collected and analyzed the data to define the safety and efficacy of the LAmbre device implantation. Result. .e LAAC was successfully occluded in the 56 patients. Our data showed no serious residual leak or pericardial effusion occurred during the perioperative period. At a mean follow-up of 37.8± 23.5 months, there were 7.1%, 3.6%, and 3.6% rates of death, stroke, and device-related thrombus, respectively. .ere were no cases of severe residual leak or systemic embolism. Conclusion. Taken together, we demonstrate that execution of LAAC with the LAmbre device has high procedural success and prevents AF-related stroke. However, further large-scale trials might be required to confirm our findings. most of the clinical studies on the LAmbre LAA occluder were 1. Introduction followed up for 1 year. To date, there are no data on the long- Atrial fibrillation (AF) is the most common sustained ar- term safety and efficacy of LAAC with the LAmbre occluder rhythmia, which is associated with an increased risk of stroke in patients with AF. Here, we aimed to evaluate the long-term [1]. AF-induced stroke events are more severe than non-AF effect of the LAmbre LAA occluder in patients with AF. stroke events and are associated with a higher risk of morbidity and mortality [2]. Currently, oral anticoagulation (OAC) 2. Method remains the most effective way to prevent stroke in patients with AF. However, for patients contraindicated with OAC or 2.1. Study Population. A retrospective, single-center study those who refuse OAC therapy, left atrial appendage closure was performed in 56 patients with nonvalvular AF, who (LAAC) with Watchman (Boston Scientific, Natick, Massa- underwent LAAC with the LAmbre device between March chusetts) or Amplatzer Cardiac Plug (ACP; St. Jude Medical, 2014 and June 2020. We included patients with nonvalvular Saint Paul, Minnesota) presents feasible alternatives [3–9]. AF, aged 18 years and above, and a CHA DS -VASc Score 2 2 .e LAmbre (Lifetech Scientific, Shenzhen, China) left ≥2. .e patients were contraindicated to long-term oral atrial appendage (LAA) occluder is a novel system, especially anticoagulants (OACs) or refused OAC therapy. We ex- designed for LAA closure in cases that present morphological cluded those with severe valvular disease or abnormal difficulties [10]. Previous studies have confirmed that LAAC cardiac structure, left atrial or LAA thrombosis confirmed by with the LAmbre is safe and effective in the prevention of transesophageal echocardiogram (TEE), pregnancy or thromboembolic events [11–13], but the effectiveness and the breastfeeding, and left ventricular ejection fraction (LVEF) safety were similar to Watchman and ACP [14]. However, < 30%, as well as significant pericardial effusion. .is study 2 Journal of Interventional Cardiology was approved by the Human Subject Ethics Committee of length was 29.2± 6.5 mm, LAA orifice diameter was Renmin Hospital, Wuhan University. All patients gave 27.6± 5.2 mm, and the LAA landing zone diameter was signed informed consent. 22.6± 4.4 mm. Our TEE analysis showed that there was 1 (1.8%) patient with <1 mm residual flow and there were 5 (8.9%) patients with 1–3 mm residual flow. .ere were 3 2.2. LAmbre LAAC. .e LAmbre LAAC was performed cases of periprocedural complications associated with slight either under local or general anesthesia, aided by the TEE pericardial effusion. .ere was however no cases of death, and X-ray fluoroscope. Besides, transseptal puncture was stroke, major bleeding, major vascular complication, performed under the guidance of the TEE. Selective LAA thrombosis with device, and device dislocation (Table 2). angiogram was performed to understand the shape, size, and adjacent relationships, and the TEE was used to measure the diameter and depth of the LAA. .e size of the LAA occluder 3.3. Patient Follow-Up Data. As shown in Table 3, the mean was chosen based on the data from the LAA angiogram and follow-up time was 37.8± 23.5 months. During the follow- TEE measurements. LAA angiogram and TEE were also up period, there were 4 (7.1%) deaths. 3 cases were non- performed to determine the location and placement of the cardiac death at 3 months, 36 months, and 49 months after occluder. In addition, a gentle tug test was performed under the procedure, while the other was cardiac arrest at 46 fluoroscopy to ensure device stability. .e occluder was months after the procedure. .ere were 2 (3.6%) cases of completely retrieved if the position, sealing effect, and ischemic stroke during the follow-up period. .e TEE stability were not satisfying (Figure 1). analysis showed that device thrombosis occurred in 2 (3.6%) patients. Besides, TEE reexamination revealed thrombotic 2.3. Postsurgical Anticoagulation. .e double antiplatelet dissolution after anticoagulant therapy. Two (3.6%) patients therapy (aspirin plus clopidogrel) was performed for 3 had <1 mm residual flow, while 1 (1.8%) had 1–3 mm re- months after LAAC, followed by TEE examination 3 months sidual flow. later. In cases where there was no significant residual shunt, the double antiplatelet treatment was changed to either aspirin or clopidogrel for long-term treatment. 4. Discussion Here, we demonstrate that LAAC with the LAmbre device 2.4. Follow-Up. In the first year, the patients were monitored has a high success rate. In addition, long-term follow-up at 1, 3, 6, and 12 months after LAAC. Long-term follow-up results robustly associate the LAmbre LAAC with good was performed using phone or mail survey assessment. clinical outcomes in the prevention of stroke. Many clinical studies have associated LAAC with re- duction in stroke [3–13]. While the LAAC device therapy 2.5. Endpoints. .e study endpoints included severe peri- seems promising, the incidence of treatment-related com- operative complications and serious adverse events (SAE) plications remains undefined. For instance, the PROTECT- during the follow-up. .e severe perioperative complications AF and CAP and PREVAIL studies showed that the success and SAE were defined as death, stroke, cardiac effusion, major rate for the Watchman device implantation was 91.3% and bleeding, severe vascular complications, thrombosis with 95%, respectively [3–5]. With the improvement in the im- device, systemic thromboembolism, and device dislocation. plantation techniques, the Watchman device implantation success rate increased to 98.5% in the EWOLUTION study 2.6. Statistical Analysis. Categorical variables were expressed [7]. On the other hand, initial European and Asia-Pacific as frequencies and percentages. On the other hand, con- experience suggested that the ACP device implantation tinuous variables were presented as mean± SD. success rate was 96% (132/137) and 95% (19/20), respectively [8, 15]. A multicenter study associated the use of the ACP 3. Results device with 97.3% success rate [9]. In this study, unlike the Watchman and ACP devices, we show 100% success with the 3.1. Base Characteristics. A total of 56 patients (66.6± 8.4 use of the LAmbre device. Similarly, the initial European years; 23 females) were enrolled in this study (Table 1). .e registration studies reported 100% success rate with the mean CHA DS -VASc Score was 3.7± 1.3, while the mean 2 2 LAmbre device implantation [11]. In addition, a prospective, score for HAS-BLED was 2.3± 0.9. Our analysis revealed multicenter clinical study suggested that the LAmbre device that 26 (46.4%) patients had a history of prior stroke/TIA, implantation success rate was 99.4% [13]. .e high im- while 21 (37.5%) had a previous coronary artery disease. In plantation success rate demonstrated with the use of the addition, 46 (82%) patients had previous hypertension and 8 LAmbre device may be due to its unique design. .e LAmbre (14.3%) had a history of diabetes while 10 (17.9%) and 46 device is shorter in size and requires less depth for the LAA. (82.1%) patients had a paroxysmal and a nonparoxysmal AF, In addition, there are diverse sizes in the LAmbre device, respectively. which makes it more suitable for the special shape of the LAA. 3.2. Procedural Characteristics. .e success rate for the Pericardial effusion is the most common peri- LAmbre device implantation was 100%. .e mean LAA operative complication of LAAC with the Watchman Journal of Interventional Cardiology 3 (a) (b) (c) (d) Figure 1: .e procedure of LAA closure with the LAmbre device. (a) LAA angiogram assessment of the left auricle size. (b) .e deployment of the umbrella. (c) .e deployment of the cover. (d) Left atrial angiogram was performed after the release of the device to check for LAA sealing. incidence of serious pericardial effusion in patients with Table 1: Baseline characteristics. Watchman occluder implantation was only 2.2% (10/460) n � 56 [4]. .e EWOLUTION registry reported that the peri- Age (years) 66.6± 8.4 cardial effusion only occurred in 5 patients (0.5%, 5/1004) Female, n (%) 23 (41.1) [7]. Initial European experience reported 3.5% (5/143) BMI (kg/m ) 25.1± 3.2 cases of serious pericardial effusion after ACP implants Hypertension 46 (82.0) [8]. However, the severe pericardial effusion with ACP Diabetes 8 (14.3) occluder implantation was dependent on the operator’s Previous stroke/TIA 26 (46.4) experience. In other ACP registries, no serious pericar- Coronary artery disease 21 (37.5) dial effusion was observed [8, 9, 15]. .e occurrence of Paroxysmal AF 10 (17.9) pericardial effusion was lower in LAmbre registries Nonparoxysmal AF 46 (82.1) compared to either the ACP or Watchman registries. In CHA DS -VASc Score 3.7± 1.3 2 2 HAS-BLED Score 2.3± 0.9 the LAmbre series of 153 patients, serious pericardial effusion occurred only in 3 patients (2.0%) [13]. Peri- BMI � body mass index; AF � atrial fibrillation. operative pericardial incidences were neither reported in the LAmbre series of 60 patients nor in the series of 30 device, whose severity harbors fatal risks [3]. In the patients [11, 12]. However, 2 late pericardial effusions PROTECT-AF study, the incidence of serious pericardial were reported in the series of 60 patients [12]. In our effusion was 4.8% (22/463), of which 15 were treated with study, no serious pericardial effusion occurred. Other typical LAAC perioperative complications, such pericardiocentesis, while the rest underwent surgical intervention [3]. On the other hand, in the CAP study, the as air embolization, cardiac perforation, major bleeding, 4 Journal of Interventional Cardiology Table 2: Periprocedural data. studied 52 patients enrolled in 7 centers and found that the incidence of <3 mm residual flow immediately and at n � 56 6-month follow-up was 13.5% and 16.2%, respectively, LAA diameters following ACP device implantation. .e rate of residual LAA length (mm) 29.2± 6.5 flow in the LAmbre device appears to be higher than the LAA orifice diameter (mm) 27.6± 5.2 ones reported for the ACP and Watchman devices. For LAA landing zone diameter (mm) 22.6± 4.4 instance, Chen et al. [11] reported that there were 5 (20%) Number of LAA lobes patients with a residual flow of 2 mm, 3 (12%) patients Single lobe 42 (75) Two lobes 12 (21.4) with a residual flow of 3 mm, and 1 (4%) patient with a Multiple lobes 2 (3.6) residual flow of 4 mm, during the follow-up period. On Successful implantation 56 (100) the other hand, Park et al. [12] showed that the rate of LAA leak <5 mm residual flow was 14/57 (24.6%), 11/54 (20.4%), or Residual flow <1 mm 1 (1.8) 15/36 (41.7%), at 1, 6, and 12 months of follow-up, re- Residual flow 1–3 mm 5 (8.9) spectively. Besides, a residual flow of ≧5 mm was observed Residual flow >3 mm 0 in 3/60 (5%) patients at the first month of follow-up. In a Procedure time (min) 60.1± 13.0 multicenter study, the residual flow of <1 mm was 1.3% (2 Contrast media (ml) 44.5± 13.7 cases), while the residual flow of 1–3 mm and >3 mm was Complications 13.3% and 0.7%, respectively, immediately after the Death 0 Stroke 0 procedure [13]. .e reason of high incidence of residual Pericardial effusion 0 flow after LAAC with the LAmbre device may be related Major bleeding 0 to the operator’s operating experience. Compared with Major vascular complication 0 Watchman and ACP occluders, the LAmbre occluder is in .rombosis with device 0 less clinical use. .e incidence of residual flow may de- Device dislocation 0 crease with the accumulation of operator experience. LAA � left atrial appendage. Compared to these studies, the incidence of residual flow in our study was relatively lower. In our study, a residual flow of <1 mm or 1–3 mm was observed in 1.8% or 8.9% Table 3: Clinical outcomes during follow-up. patients, respectively, immediately after the procedure with the LAmbre device. During the follow-up, 2 (3.6%) n � 56 patients had a <1 mm residual flow, while 1 (1.8%) patient Follow-up time (months) 37.8± 23.5 had residual flow of 1–3 mm. However, to date, the re- Death 4 (7.1) Noncardiac death 3 (5.4) lationship between residual flow and stroke remains Cardiac death 1 (1.8) controversial. Ischemic stroke 2 (3.6) Device-related thrombus (DRT) is a common medium- and Hemorrhagic stroke 0 long-term complication after LAAC. A previous study dem- Device thrombosis 2 (3.6) onstrated that the DRT is associated with a higher rate of stroke Systemic thromboembolism 0 and systemic embolism [21, 22]. A 1-year follow-up data of the LAA sealing by TEE examination EWOLUTION trial reported that the incidence of DRT with Residual flow <1 mm 2 (3.6) the Watchman device was 3.7% [23]. In the ASAP study (ASA Residual flow 1–3 mm 1 (1.8) plavix feasibility study with Watchman left atrial appendage Residual flow >3 mm 0 closure technology), there were 6 cases (4%) of DRT [24]. In LAA � left atrial appendage; TEE � transesophageal ultrasound. addition, Saw et al. [25] reported the incidence of DRT in the ACP device trial to be 3.2%. .e multicenter experience of device dislocation, or device embolization, were not ob- LAAC with the ACP also reported a 4.4% (28/632 patients) served. .is might be attributed to the fact that the LAmbre DRT incidence [9]. However, the frequency of DRTafter LAAC device includes a specially designed hook umbrella with the with LAmbre is marginal [8, 9]. A multicenter clinical study ability to recapture, retrieve, redeploy, and remain stable reported 2 patients (1.3%) with DRT following LAAC with during deployment. In addition, the transport sheath of the LAmbre. Our present data showed 2 patients (3.6%) with DRT. LAmbre occluder is smaller (8–10 French) than that of However, the observed rate of ischemic stroke in our study was Watchman or ACP occluders (14 French). higher than those reported in other LAAC trials [9, 13, 23]. Residual flow is a common complication in LAAC. Lucas et al. observed a 1.1% rate of ischemic stroke at a 1-year .e factors influencing the occurrence of residual flow follow-up in a Watchman device trial [23]. Similar data were following LAAC are still unclear. Some studies suggested obtained in the ACP device trial [9]. A multicenter clinical study that it may be related to the morphology and type of the with the LAmbre device showed 1.3% ischemic stroke cases LAA, the surrounding structure, and the compression [13]. Here, we reported 2 patients (3.6%) with ischemic stroke, 1 ratio of the occluder [16–19]. EWOLUTION registry of which terminated the use of oral antiplatelet drugs one year showed >5 mm residual flow in 7 patients (0.7%) and after the procedure. .erefore, adequate antithrombotic therapy ≦5 mm residual flow in 78 patients (7.9%) following with aspirin and clopidogrel is important to prevent thrombus Watchman device implantation [7]. Urena et al. [20] formation after LAAC. Journal of Interventional Cardiology 5 .e mortality rate after LAAC varies greatly in different References studies. A 1-year follow-up outcome data in the EWOLU- [1] P. A. Wolf, R. D. Abbott, and W. B. 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Published: Dec 21, 2020

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