ABSTRACT
Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Consensus , Predictive Value of Tests , Stroke , Tomography, X-Ray Computed , Humans , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Atrial Fibrillation/physiopathology , Treatment Outcome , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/standards , Stroke/prevention & control , Stroke/etiology , Risk Factors , Echocardiography, TransesophagealABSTRACT
BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Registries , Thrombosis , Humans , Female , Male , Atrial Appendage/surgery , Aged , Thrombosis/etiology , Atrial Fibrillation/surgery , Sex Factors , Anticoagulants/therapeutic use , Risk Factors , Postoperative Complications , Septal Occluder Device , Treatment Outcome , Echocardiography, Transesophageal/methods , Europe/epidemiology , Left Atrial Appendage ClosureABSTRACT
AIMS: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. METHODS AND RESULTS: We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60-125) for the combined procedure, 71 min (25-241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15-162) for individual LAAO. The respective fluoroscopy times were 21 (15-26), 15 (5-44), and 10 (3-50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34-93) and LAAO added 20 min (15-37). CONCLUSION: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Feasibility Studies , Operative Time , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/physiopathology , Atrial Appendage/surgery , Atrial Appendage/diagnostic imaging , Male , Female , Aged , Catheter Ablation/methods , Treatment Outcome , Middle Aged , Time Factors , Electrophysiologic Techniques, Cardiac , Fluoroscopy , Aged, 80 and overABSTRACT
BACKGROUND: Pericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood. OBJECTIVES: This study sought to assess the frequency, timing, predictors and clinical impact of PE after LAAC. METHODS: Data on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE. RESULTS: Of 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE. CONCLUSIONS: In this large LAAC registry, PE was observed in <1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078).
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Pericardial Effusion , Humans , Female , Male , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Time Factors , Aged , Risk Factors , Pericardial Effusion/etiology , Pericardial Effusion/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Treatment Outcome , Aged, 80 and over , Risk Assessment , Septal Occluder Device , Middle Aged , Prospective Studies , Sex Factors , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Left Atrial Appendage ClosureABSTRACT
BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Device Removal , Registries , Humans , Male , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Female , Aged , Retrospective Studies , Treatment Outcome , Time Factors , Aged, 80 and over , Risk Factors , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Atrial Fibrillation/therapy , Atrial Fibrillation/mortality , Device Removal/adverse effects , Embolism/etiology , Embolism/mortality , Middle Aged , Septal Occluder Device , Left Atrial Appendage ClosureABSTRACT
BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Humans , Left Atrial Appendage Closure , Warfarin , Anticoagulants , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/surgery , Treatment Outcome , Stroke/etiology , Stroke/prevention & control , Cardiac Catheterization/adverse effectsABSTRACT
BACKGROUND AND AIMS: The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. METHODS: Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000-21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. RESULTS: At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P < .001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P < .001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016-21. CONCLUSIONS: The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification.
Subject(s)
Cardiovascular System , Transcatheter Aortic Valve Replacement , Humans , Heart , Prostheses and Implants , European UnionABSTRACT
Patients with atrial fibrillation (AF) experiencing ischemic stroke despite oral anticoagulation (OAC), i.e., breakthrough strokes, are not uncommon, and represent an important clinical subgroup in view of the consistently high risk of stroke recurrence and mortality. The understanding of the heterogenous potential mechanism underlying OAC failure is essential in order to implement specific therapeutic measures aimed at reducing the risk of recurrent ischemic stroke. However, due to the incomplete comprehension of this phenomenon and the limited available data, secondary stroke prevention in such high-risk patients represents a clinical dilemma. There are several available strategies to prevent ischemic stroke recurrence in AF patients with breakthrough stroke in the absence of competing causes unrelated to AF, and these include continuation or change in the type of OAC, addition of antiplatelet therapy, left atrial appendage closure, or any combination of the above options. However, due to the limited available data, the latest guidelines do not provide any specific recommendations about which of the above strategies may be preferred. This review describes the incidence, the clinical impact and the potential mechanisms underlying OAC failure in AF patients. Furthermore, the evidence supporting each of the above therapeutic options for secondary stroke prevention and the potential future directions will be discussed.
ABSTRACT
Background The interrelationships between left atrial appendage (LAA) dimensions and device following implantation are unknown. We aimed to analyze the impact of Watchman device implantation on LAA dimensions following its percutaneous closure and potential predictors of remodeling. Methods and Results All consecutive LAA closure procedures performed at 2 centers between November 2017 and December 2020 were included in the WATCH-DUAL (Watchman 2.5 Versus Watchman FLX in a Dual-Center Left Atrial Appendage Closure Cohort) registry. This study included patients who had pre- and postintervention computed tomography scan analysis. The LAA and device dimensions were measured in a centralized core lab by 3-dimensional computed tomography scan reconstruction methods, focusing on the device landing zone. This analysis included 104 patients (age, 76.0 [range, 72.0-83.0] years; 72% men; 53% Watchman FLX; 47% Watchman 2.5). The baseline characteristics were comparable between Watchman 2.5 and Watchman FLX groups, except for the higher use of oversizing in the latter group. The median delay for computed tomography control was 49 (range, 43-64) days. The landing zone area (median, 446 [range, 363-523] versus 290 [222-366] mm2; P<0.001) and minimal diameter (median, 23.0 [range, 20.7-24.8] versus 16.7 [14.7-19.4] mm; P<0.001) significantly increased after implantation. The absolute (median, 157 [range, 98-220] versus 85 [18-148] mm2, P<0.001) and relative (median, 50% [range, 32%-79%] versus 26% [4%-50%]; P<0.001) increases in landing zone area were more pronounced in patients with oversized device. Baseline LAA dimensions were smaller, landing zone eccentricity larger, and oversized device more frequent in patients with significant overexpansion compared with the others. Conclusions LAA dimensions increased at the site of the Watchman prosthesis after implantation, suggesting a local positive remodeling after the procedure. This phenomenon was more pronounced in the case of oversized devices.
Subject(s)
Atrial Appendage , Atrial Remodeling , Male , Humans , Aged , Female , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Prosthesis Implantation , Registries , Tomography, X-Ray ComputedABSTRACT
BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Thrombosis , Humans , Treatment Outcome , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Thrombosis/diagnosis , Thrombosis/epidemiology , Thrombosis/etiology , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiology , Registries , Atrial Appendage/diagnostic imagingABSTRACT
BACKGROUND: The benefit related to the use of preprocedural computed tomography angiography (CCTA) on top of periprocedural echocardiography to plan percutaneous left atrial appendage closure (LAAC) procedures is still unclear. OBJECTIVES: The authors sought to evaluate the impact of preprocedural CCTA on LAAC procedural success. METHODS: In the investigator-initiated SWISS-APERO (Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure) trial, patients undergoing echocardiography-guided LAAC were randomly assigned to receive the Amulet (Abbott) or Watchman 2.5/FLX (Boston Scientific) device across 8 European centers. According to the study protocol ongoing at the time of the procedure, the first operators had (CCTA unblinded group) or did not have (CCTA blinded group) access to preprocedural CCTA images. In this post hoc analysis, we compared blinded vs unblinded procedures in terms of procedural success defined as complete left atrial appendage occlusion as evaluated at the end of LAAC (short-term) or at the 45-day follow-up (long-term) without procedural-related complications. RESULTS: Among 219 LAACs preceded by CCTA, 92 (42.1%) and 127 (57.9%) were assigned to the CCTA unblinded and blinded group, respectively. After adjusting for confounders, operator unblinding to preprocedural CCTA remained associated with a higher rate of short-term procedural success (93.5% vs 81.1%; P = 0.009; adjusted OR: 2.76; 95% CI: 1.05-7.29; P = 0.040) and long-term procedural success (83.7% vs 72.4%; P = 0.050; adjusted OR: 2.12; 95% CI: 1.03-4.35; P = 0.041). CONCLUSIONS: In a prospective multicenter cohort of clinically indicated echocardiography-guided LAACs, unblinding of the first operators to preprocedural CCTA images was independently associated with a higher rate of both short- and long-term procedural success. Further studies are needed to better evaluate the impact of preprocedural CCTA on clinical outcomes.
Subject(s)
Atrial Appendage , Humans , Atrial Appendage/diagnostic imaging , Prospective Studies , Treatment Outcome , Tomography, X-Ray Computed , Computed Tomography AngiographyABSTRACT
Percutaneous left atrial appendage closure (LAAC) has been established in clinical practice as an attractive alternative to oral anticoagulation for preventing stroke in patients with atrial fibrillation and high bleeding risk. The devices approved in Europe and United States (US) for percutaneous LAAC contain metal and antithrombotic therapy is strongly recommended after their implantation to prevent apposition of thrombus on the atrial surface of the device during endothelialization. However, there is still uncertainty regarding the optimal antithrombotic drug regimen following device implantation in view of the incomplete understanding of the LAAC device healing process, the lack of randomized clinical trials comparing different antithrombotic agents after LAAC and the heterogeneous bleeding risk of patients undergoing LAAC. Thus, this review aims to evaluate the available evidence and the remaining challenges related to the post-LAAC antithrombotic regimens. Furthermore, common clinical scenarios associated with challenging management of antithrombotic therapy after LAAC and potential future directions, will be discussed.
ABSTRACT
BACKGROUND: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Ischemic Attack, Transient , Stroke , Thrombosis , Humans , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/complications , Atrial Fibrillation/surgery , Treatment Outcome , Thrombosis/diagnosis , Thrombosis/epidemiology , Thrombosis/etiology , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiology , Risk Factors , Echocardiography , Registries , Anticoagulants/therapeutic useABSTRACT
AIMS: No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). METHODS AND RESULTS: All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160-0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0-36) vs. 40 (6-115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100-0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. CONCLUSIONS: In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Septal Occluder Device , Stroke , Thrombosis , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Cardiac Catheterization/adverse effects , Echocardiography, Transesophageal , Humans , Septal Occluder Device/adverse effects , Stroke/complications , Stroke/prevention & control , Thrombosis/etiology , Thrombosis/prevention & control , Treatment OutcomeABSTRACT
BACKGROUND: Although the presence of a thrombus contraindicates left atrial appendage closure procedure (LAAC), a previous study reported the feasibility of the thrombus trapping procedure (TTP) technique to overcome this limitation. AIMS: This study aimed to analyse the short-term outcomes in a series of patients who underwent LAAC using the TTP (TTP-LAAC). METHODS: This retrospective series included patients who underwent TTP-LAAC between January 2018 and May 2020 in 13 European centres. Device choice, pre-interventional work-up and post-discharge antithrombotic therapy regimens were left to the discretion of the operators. The primary endpoint was the 30-day occurrence of stroke, systemic embolism or cardiovascular death. RESULTS: During the study period, a total of 1,918 patients underwent LAAC. A thrombus was identified in 71 cases but completely disappeared in 24 patients before procedure. TTP-LAAC was finally performed in 53 cases (3%). Thrombi were identified ahead of the actual day of implantation in 47 patients (87%) and were mostly limited in size (50 cases with extension <50% of the LAA surface). The Amplatzer Amulet and WATCHMAN FLX occluders were implanted in 44 and 9 patients, respectively. A single deployment approach was applied in 70% and a cerebral embolic protection system was used in 9% of the patients. The overall success rate was 100%. Small pericardial effusion without tamponade was observed in 6% of the cases. Patients were discharged with 72% under antiplatelet therapy and 10% under short-term oral anticoagulation. The primary endpoint occurred in one patient. CONCLUSIONS: TTP-LAAC might be used in a minority of LAAC procedures but appears to be feasible and safe in the short-term, in select cases.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Thrombosis , Aftercare , Atrial Appendage/surgery , Humans , Patient Discharge , Registries , Retrospective Studies , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control , Thrombosis/surgery , Treatment OutcomeABSTRACT
BACKGROUND: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. METHODS: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. RESULTS: Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. CONCLUSIONS: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03399851.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Surgical Procedures , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Cardiac Catheterization/adverse effects , Cardiac Surgical Procedures/adverse effects , Echocardiography, Transesophageal/methods , Humans , Treatment OutcomeABSTRACT
OBJECTIVES: The aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC). BACKGROUND: Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC. METHODS: Consecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints. RESULTS: Among 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months). CONCLUSIONS: In a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Cardiac Catheterization/adverse effects , Echocardiography , Echocardiography, Transesophageal , Humans , Treatment OutcomeABSTRACT
BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure. AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO. METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure. RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding). CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.