scholarly journals 349 Left atrial appendage closure with the II generation ultraseal device: an international registry. The ligate study

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gaetano Liccardo ◽  
Carlo A Pivato ◽  
Jorge Sanz-sanchez ◽  
Elisa Pelloni ◽  
Krzysztof Pudjak ◽  
...  
Keyword(s):  
Left Atrial ◽  
Second Generation ◽  
Left Atrial Appendage ◽  
Therapeutic Option ◽  
Atrial Appendage ◽  
Technical Success ◽  
Post Discharge ◽  
Device Implantation ◽  
International Registry

Abstract Aims Left atrial appendage (LAA) occlusion with first generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with non-valvular atrial fibrillation (NVAF). However, there is a paucity of data regarding the novel Ultraseal device. To assess feasibility and safety of second generation LAA closure Ultraseal device in patients with NVAF. Methods and results All patients with NVAF undergoing second generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicentre international registry. Periprocedural and post-discharge events were collected up to 6-months follow-up. Primary efficacy endpoints of interest were device success and technical success; primary safety endpoint was in-hospital major adverse events occurrence. A total of 52 patients were included: mean age 75 ± 8, 69.2% male, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 51 patients (98.0%). In-hospital major adverse event occurred in three patients (5.8%). The incidence of 6-months all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischaemic attacks, systemic embolisms or device embolization were reported. Conclusions Second generation Ultraseal Device implantation was associated with high procedural success rate and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to evaluate the safety and the efficacy of this device, especially at medium and long term follow-up.

scholarly journals Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance

2021 ◽  
Vol 10 (7) ◽  
pp. 1421
Author(s):  
Marc Llagostera-Martín ◽  
Hector Cubero-Gallego ◽  
Aleksandra Mas-Stachurska ◽  
Neus Salvatella ◽  
Andrea Sánchez-Carpintero ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Previous History ◽  
Atrial Appendage ◽  
High Risk Population ◽  
Left Atrial Appendage Closure ◽  
Device Implantation ◽  
Term Performance

The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 ± 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 ± 1.6 and 3.9 ± 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (≥5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.

scholarly journals Heart Team for Left Atrial Appendage Occlusion: A Patient-Tailored Approach

2021 ◽  
Vol 11 (1) ◽  
pp. 176
Author(s):  
Stefano Branzoli ◽  
Fabrizio Guarracini ◽  
Massimiliano Marini ◽  
Giovanni D’Onghia ◽  
Daniele Penzo ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Therapeutic Option ◽  
Atrial Appendage ◽  
Decision Making Process ◽  
Team Approach ◽  
Heart Team ◽  
Left Atrial Appendage Occlusion

Background and Purpose: Left atrial appendage occlusion (LAAO) is an accepted therapeutic option for stroke prevention; however, the ideal technique and device have not yet been identified. In this study we evaluate the potential role of a heart team approach for patients contraindicated for oral anticoagulants and indicated for left atrial appendage closure, to minimize risk and optimize benefit in a patient-centered decision-making process. Methods: Forty patients were evaluated by the heart team for appendage occlusion. Variables considered were CHA2DS2VASc, HASBLED, documented blood transfusions, comorbidities, event forcing anticoagulant interruption, past medical history, anatomy of the left atrial appendage, and patient quality of life. Twenty patients had their appendage occluded percutaneously (65% male, mean age 72.3 ± 7.5, mean CHA2DS2VASc 4.2 ± 1.5, mean HASBLED 3.5 ± 1.1). The other twenty underwent thoracoscopic occlusion (65% male, mean age of 74.9 ± 8, mean CHA2DS2VASc 6.0 ± 1.5, HASBLED mean 5.4 ± 1.4). Percutaneous patients were on dual antiplatelet therapy for the first three months and aspirin thereafter, whereas the others received no anticoagulant/antiplatelet therapy from the day of surgery. Follow up included TEE, CT scan, and periodical clinical evaluation. Results: Mean duration of procedures and hospital stay were comparable. All patients had complete exclusion of the appendage; at a mean follow up of 33.1 ± 14.1 months, no neurological or hemorrhagic events were reported. Conclusions: A heart team approach may improve the decision-making process for stroke and hemorrhage prevention, where LAAO is a therapeutic option. Percutaneous and thoracoscopic appendage occlusion seem to be comparably safe and effective. An epicardial LAAO could be advisable in patients for whom the risk of bleeding is estimated as being too high for post-procedural antiplatelet therapy.

scholarly journals Additive Value of Preprocedural Computed Tomography Planning Versus Stand‐Alone Transesophageal Echocardiogram Guidance to Left Atrial Appendage Occlusion: Comparison of Real‐World Practice

2021 ◽  
Author(s):  
Chak‐yu So ◽  
Guson Kang ◽  
Pedro A. Villablanca ◽  
Abel Ignatius ◽  
Saleha Asghar ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Implantation Rate ◽  
Atrial Appendage ◽  
Transesophageal Echocardiogram ◽  
Frequent Change ◽  
Left Atrial Appendage Occlusion ◽  
Device Implantation ◽  
Procedural Time

Background Transesophageal echocardiogram is currently the standard preprocedural imaging for left atrial appendage occlusion. This study aimed to assess the additive value of preprocedural computed tomography (CT) planning versus stand‐alone transesophageal echocardiogram imaging guidance to left atrial appendage occlusion. Methods and Results We retrospectively reviewed 485 Watchman implantations at a single center to compare the outcomes of using additional CT preprocedural planning (n=328, 67.6%) versus stand‐alone transesophageal echocardiogram guidance (n=157, 32.4%) for left atrial appendage occlusion. The primary end point was the rate of successful device implantation without major peri‐device leak (>5 mm). Secondary end points included major adverse events, total procedural time, delivery sheath and devices used, risk of major peri‐device leak and device‐related thrombus at follow‐up imaging. A single/anterior‐curve delivery sheath was used more commonly in those who underwent CT imaging (35.9% versus 18.8%; P <0.001). Additional preprocedural CT planning was associated with a significantly higher successful device implantation rate (98.5% versus 94.9%; P =0.02), a shorter procedural time (median, 45.5 minutes versus 51.0 minutes; P =0.03) and a less frequent change of device size (5.6% versus 12.1%; P =0.01), particularly device upsize (4% versus 9.4%; P =0.02). However, there was no significant difference in the risk of major adverse events (2.1% versus 1.9%; P =0.87). Only 1 significant peri‐device leak (0.2%) and 5 device‐related thrombi were detected in follow‐up (1.2%) with no intergroup difference. Conclusions Additional preprocedural planning using CT in Watchman implantation was associated with a higher successful device implantation rate, a shorter total procedural time, and a less frequent change of device sizes.

scholarly journals 475 Is left atrial appendage device compression rate a predictor of incomplete occlusion in patients undergoing watchman device implantation?

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Michele Magnocavallo ◽  
Domenico Giovanni Della Rocca ◽  
Carlo Lavalle ◽  
Cristina Chimenti ◽  
Gianni Carola ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Imaging Modality ◽  
Accurate Method ◽  
Atrial Appendage ◽  
Device Implantation ◽  
Watchman Device ◽  
Device Size ◽  
Original Device

Abstract Aims Transesophageal echocardiography (TEE) is a standard peri-procedural imaging modality in patients undergoing percutaneous left atrial appendage (LAA) occlusion. An accurate device sizing is pivotal to assess stability and achieve successful closure. In this prospective study, we sought to evaluate the correlation between Watchman device compression rates (DCRs) and risk of incomplete LAA occlusion at follow-up in patients undergoing Watchman device implantation. Methods and results Two-dimensional TEE via a commercially available transducer (Vivid, Philips) was performed during the procedure and within 3 months after the procedure. LAA size, morphology, and DCRs [(original device size—size after deployment)/original device size; %] were assessed in a mid-oesophageal view at 0°, 45°, 90° and 135°, according to company recommendations. Residual leaks ≥ 3 mm were classified as significant. Between 2016 and 2018, 116 patients underwent LAA occlusion with a Watchman device at our institution. The mean age was 74 ± 9 years and 60.4% (n = 70) were males. The average CHA2DS2-VASc and HAS-BLED scores were 4.7 ± 1.7 and 2.5 ± 1.1, respectively. The final device size was 21 mm in 11 (9.5%) patients, 24 mm in 28 (24.1), 27 mm in 27 (23.3%), 30 mm in 26 (22.4%), and 33 mm in 24 (20.7). At follow-up TEE, 16 (13.8%) patients were found to have a significant (≥3 mm) residual leak. The average DCRs measured at different angles in patients with and without leak were not significantly different (24 ± 8% vs. 26 ± 7% at 0°, P = 0.47; 23 ± 9% vs. 25 ± 7% at 45°, P = 0.58; 23 ± 8% vs. 23 ± 6% at 90°, P = 0.61; 22 ± 8% vs. 21 ± 7% at 135°, P = 0.61). At receiver operating characteristic (ROC) analysis, the areas under the curve to discriminate between patients with/without leak were 0.58, 0.57, 0.55, and 0.46 for DCRs measured at 0°, 45°, 90°, and 135° angles. Conclusions Peri-procedural assessment of DCRs does not appear to be an accurate method to predict LAA complete occlusion in patients undergoing Watchman device implantation.

scholarly journals Left atrial appendage closure device complicated by late-onset pericardial effusion and tamponade: a case report

2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Stefano Albani ◽  
Nicola Berlier ◽  
Francesco Pisano ◽  
Paolo Scacciatella
Keyword(s):  
Pericardial Effusion ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Late Onset ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Closure Device ◽  
Device Implantation ◽  
First Case

Abstract Background Late-onset complications of left atrial appendage occlusion (LAAO) device procedure are anecdotal and there are no such complications reported in literature using Cardia Ultraseal (Cardia, Inc., Eagan, MN, USA). Case summary We report the case of a 74-year-old Caucasian man affected by paroxysmal atrial fibrillation with significant bleeding risk (familiar thrombocytopenia, macroscopic haematuria episodes during therapy with direct oral anticoagulants, HAS-BLED risk score: 4) and ischaemic risk as well (CHADSVASC score: 3). The patient was treated with LAAO device implantation for high bleeding risk. Subsequently, after 26 days from LAAO procedure, he was admitted to the emergency department for haematic cardiac tamponade. The patient was successfully treated with subxyphoidal pericardiocentesis in the acute phase, unfortunately cardiac arrest occurred during the transfer to the referral hospital for urgent cardiac surgery. Permanent neurological damage was reported and the patient died on day 28. Discussion LAAO late-onset complications are very rare and the case presented is the first case described of late-onset pericardial effusion and tamponade secondary to the Cardia Ultraseal LAAO device implantation. We present a revision of the literature regarding the occurrence of similar adverse events and discuss the hypothetical mechanism of this major complication.

Long-term outcomes in patients with non-valvular atrial fibrillation and left atrial appendage closure in a large UK tertiary centre: 10-year experience

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts
Keyword(s):  
High Risk ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Tertiary Centre ◽  
Left Atrial Appendage Occlusion

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage occlusion (LAAO) is a well-established stroke prevention strategy in patients with non-valvular atrial fibrillation (AF) and high risk of bleeding or contra-indication to oral anticoagulation (OAC). Despite encouraging randomised control trial and international registry safety and efficacy data, long-term outcome data remains sparce. Purpose This study sought to evaluate the long-term outcomes in ‘real-world’ AF patients undergoing left atrial appendage occlusion in a large UK tertiary centre. Methods This retrospective study included all patients that had a LAAO device implanted in our institution from January 2010 to December 2020. Medical notes, electronic patient records, procedural and imaging reports were reviewed. Annual bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score. Results During the study period a total of 225 patients underwent LAAO device implant. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 life-threatening bleeding episodes). Three different LAAO devices were used: 136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac plugs. Three patients (1.3%) had fatal complications related to the procedure. At discharge, 10% were taking single antiplatelet (ATP), 79% dual-antiplatelet (DAPT), 1.4% OAC, 3.6% ATP and OAC, 3.1% DAPT and OAC, 1.3% were not taking any anti-thrombotic. Nine (4%) patients had device-related thrombus on follow-up transoesophageal echocardiography with no significant difference between devices (5.0%, 2.8% and 6.7% p = 0.8, respectively) and anticoagulation strategy (p = 0.7). Over a total follow-up of 889 patient-years (mean follow-up 3.9 ± 3.7 years), 24 (10.4%) patients died, 55 patients (6.2/100 patient-years) suffered an adverse event, 15 ischaemic strokes (1.7/100 patient-years) and 20 non-procedural major bleeding episodes (2.3/100 patient-years) occurred. Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, our cohort had a 79% and 65% relative risk reduction in ischaemic stroke and major bleeding, respectively. Conclusion In this cohort of "real-world" high-risk patients, major bleeding and thromboembolic rate remained low on long-term follow-up. Abstract Figure 1

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