Editorial: Epicardial-only left atrial appendage closure: Insights from seven years of first-in-human experience.

Combined atrial fibrillation (AF) ablation and left atrial (LA) appendage (LAA) closure (LAAC) has been practiced for management of both the symptoms and the high stroke risk of AF. The purpose of this review is to review recent evidence regarding the combined procedure. Newly acquired long-term data of combined AF ablation and LAAC supplied satisfactory evidence on the safety and efficacy of the combined procedure. Studies also showed LA structural remodeling following combined procedure was mainly affected by sinus rhythm status post catheter ablation, not by LAAC. A cost-effectiveness study revealed that combined procedure was a cost-effective therapeutic option in symptomatic AF patients with high stroke and bleeding risk. Due to recent evidence of high incidences of LAA thrombus formation after LAA electrical isolation (LAAEI) and benefit of LAAC after LAAEI, an extended combined procedure of standard AF ablation plus LAAEI and LAAC was considered as a potential therapeutic option for persistent AF patients with high stroke risk. In conclusion, combined AF ablation and LAAC serve as a promising option for patients with symptomatic AF and high risk of stroke and/or bleeding.

Although the safety and efficacy of left atrial (LA) appendage (LAA) closure (LAAC) in nonvalvular atrial fibrillation (NVAF) patients have been well documented in randomized controlled trials and real-world experience, there are limited data in the literature about the impact of LAAC on cardiac remodeling. The aim of the study was to examine the impact of LAAC on cardiac functional and structural remodeling in NVAF patients. Between March 2014 and November 2016, 47 NVAF patients who underwent LAAC were included in this study (LAAC group). A control group (non-LAAC group) was formed from 141 NVAF patients without LAAC using propensity score matching. The difference-in-difference analysis was used to evaluate the difference in cardiac remodeling between the two groups at baseline and follow-up evaluations. The LAAC group had a larger increase in LA dimension, volume and volume index than the non-LAAC group (+3.9 mm, p = 0.001; +9.7 mL, p = 0.006 and +5.9 mL/m2, p = 0.011, respectively). Besides, a significant increase in E and E/e' ratio was also observed in the LAAC group (+14.6 cm/s, p = 0.002 and +2.3, p = 0.028, respectively). Compared with the non-LAAC group, left ventricular (LV) ejection fraction and fractional shortening decreased in LAAC patients, but were statistically insignificant (-3.5%, p = 0.109 and -2.0%, p = 0.167, respectively). There were significant increases in LA size and LV filling pressure among NVAF patients after LAAC. These impacts of LAAC on cardiac functional and structural remodeling may have some clinical implications that need to be addressed in future studies.

Key Findings▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups. ▪Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative strategy to oral anticoagulants in selected patients with atrial fibrillation.▪The landmark trials comparing LAA occlusion to an oral anticoagulation strategy enrolled patients with no apparent contraindications to the use of warfarin.▪LAA occlusion has limited head-to-head comparison against the direct-acting oral anticoagulants.▪Observational data to date have generally shown specific adverse events after LAA occlusion in specific subgroups of patients (women, patients with kidney disease and heart failure, patients belonging to racial/ethnic subgroups and with advanced age), but further large-scale studies are necessary to elucidate reasons for increased adverse events associated with LAA occlusion in these subgroups of patients before recommending this modality as first-line therapy in all patient groups.

Background Percutaneous left atrial (LA) appendage closure is increasingly used to prevent strokes in patients with atrial fibrillation (AF). While LA appendage plays a key role in LA physiology, data regarding the impact of LA appendage occlusion on LA hemodynamics are lacking. The alteration of LA compliance by LA appendage occlusion may represent a clinical issue in AF patients which are at high risk of heart failure. Purpose To describe the impact of LA appendage occlusion on LA hemodynamics. Material and methods From july 2015 to january 2020, all patients undergoing LA occlusion procedure at Pitié-Salpêtrière Hospital (Paris, France) in whom LA pressure curves were recorded, before and immediately after device implantation, were included. The LA mean pressure was measured at baseline and after LA appendage occlusion during the same procedure. Abnormal LA mean pressure was defined as >15mmHg. We also recorded cardiovascular death and hospitalization for congestive heart failure at longest follow-up. Results We enrolled 85 patients (78±8 years, 46 men), the CHA2DS2-VASc score was 5±1 and the HAS-BLED score was 4±1. The mean LA volume index was 51±15mL/m2, the left ventricular ejection fraction was 60±7%. The LA mean pressure increased significatively after LA appendage closure from 12.6±3.9mmHg to 15.5±5.2mmHg (p<0.0001, Figure). The prevalence of abnormal LA pressure was 20% (17/85) at baseline and 45% (38/85) after LA appendage closure (p=0.005). Post procedural LA pressure elevation was not related to procedure duration nor to fluid expansion volume. During a median follow-up of 364 [124–726] days, 3 (3.5%) patients died from a cardiovascular cause. Hospitalization for heart failure occurred in 6 (16%) of the 38 patients with abnormal postprocedural LA pressure, whereas no congestive episode was observed in the rest of the study population (p=0.006). Conclusion Catheter-based LA appendage occlusion induces an acute alteration of LA hemodynamics. Post procedural abnormal LA pressure may be linked to heart failure episodes in some patients. Further studies are warranted to investigate heart failure as a potential late complication of LA appendage closure. Variations of mean LA pressure Funding Acknowledgement Type of funding source: None

Percutaneous left atrial appendage closure with an epicardial suture ligation approach: A prospective randomized pre-clinical feasibility study

Pulmonary Artery Perforation by Plug Anchoring System After Percutaneous Closure of Left Appendage

As an alternative to oral anticoagulation, percutaneous left atrial appendage (LAA) closure is an increasingly performed procedure to prevent arterial embolism in patients with non‐valvular atrial fibrillation. Besides procedure‐related complications, residual leaks, device‐related thrombus formation, and dislocation of the LAA occluder have been observed during follow‐up. Heart failure as a consequence of interventional LAA closure has not been reported so far. This case report describes a 79‐year‐old lady with permanent non‐valvular atrial fibrillation presenting with New York Heart Association Class IV heart failure. Symptoms had started immediately after attempted LAA closure 11 months before. Transoesophageal echocardiography demonstrated two devices in the LAA, a large peri‐device leak, a mobile LAA thrombus, a right atrial appendage thrombus, and shunting via a patent foramen ovale. Under a maximally tolerated dose of heart failure medication and edoxaban, the patient remains without bleeding or embolism in New York Heart Association Class II. Because of its unique anatomical and endocrine properties, the LAA plays an important role in situations of pressure and volume overload. Interventional LAA closure interacts unfavourably with left atrial compliance and reservoir function. Atrial and brain natriuretic peptide secretion is known to be significantly reduced after LAA closure. Both mechanisms may result in the development of heart failure. Attempted LAA closure—instead of being the solution—may create new serious problems. Development of heart failure should be assessed, and a systematic search for late leaks after LAA closure should be performed in trials investigating safety and efficacy of this intervention.

Left atrial appendage (LAA) closure (LAAC) has emerged as an alternative therapeutic approach to medical therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, complex LAA anatomy may preclude its use. LAmbre is a new, self-expanding LAA occluder, and is highly adaptable to different LAA morphologies. We explored the feasibility, safety, and efficacy of LAAC using LAmbre device in NVAF patients with or without prior catheter ablation (CA). LAAC using LAmbre device was applied in NVAF patients with (group C) or without (group N) prior CA. Transesophageal echocardiography (TEE) was performed at 3, and 12 months post-LAAC. Among 17 LAAC patients (group C, 6 & group N, 11), 4 cases were implanted with special type devices, 5 were implanted with large devices. Besides one case of cardiac tamponade (N group), there were two minor peri-procedural complications only. Successful sealing of the LAA was documented in all the patients (100%) by TEE both post LAAC and at 3 months. At 3 months, no residual flow was achieved in 11 patients (64.7%); six patients (35.3%) had residual flow < 5 mm. There was no device dislocation or leakage during the mean of 30 months follow up. At 545 days after LAAC, one patient in group C experienced sudden death. Baseline, peri-procedural, and follow-up characteristics were similar between two groups (P > 0.05). LAAC with LAmbre device, subsequent to prior CA for AF, can be performed successfully and safely. The design and distinguishing features of this device could be of help in patients with complex anatomy of LAA.

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width<17mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width<17mm. Thirty-two consecutive patients with a maximal LAA ostial width<17mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA2 DS2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5kg/m2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6mm (range 14-16) and 23.2 ± 4.5mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak>5mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width<17mm.

Subxiphoid Minimally Invasive Epicardial Ablation (Convergent Procedure) With Left Thoracoscopic Closure of the Left Atrial Appendage

Background To prevent stroke in patients with atrial fibrillation (AF), oral anticoagulation (OAC) is often prescribed especially for those with high risk (CHADS2–VASC score ≥ 2), however some patients present contraindications to OAC or they have persistent thrombosis. Left atrial appendage (LAA) closure (LAAc) has emerged as a safe and effective alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). Case Description A 61–year–old woman was referred to our cardiology department for left atrial appendage (LAA) closure (LAAc). She had history of previous mitral valve surgery and replacement with mechanical prothesis (On–X 25/33 mm) and permanent atrial fibrillation (AF) with CHADS2–VASC score 4 and HAS–BLED score 2. The patient presented after a third episode of cardioembolic stroke and transesophageal echocardiography (TEE) revealed a thrombus within the LAA despite anticoagulation treatment. Due to multiple episodes of embolic stroke despite adequate oral anticoagulation, the patient was candidate for LAAc. In preparation for the procedure, TEE and computed tomography (CT) scan were performed to evaluate the anatomy, the size and the potential interference of the prosteshis ring with the LAA. Spontaneous echocontrast was present, the morphology was cauliflower with the ostium close to the mitral prosthesis ring. The anomalous anatomy of the patient increased the technical complexity of the intervention: thus, the procedure’s simulation on a 3D printed model resulted of great help in the choice of the most suitable device. The model was printed in deformable material mimicking the atrial wall mechanical behaviour. After written informed consent, the procedure was performed using a standard transvenous approach. Transseptal puncture was performed postero–inferiorly under TEE guidance and Watchman FLX 35 mm was successfully implanted without residual leak. No complications occurred during the procedure. At 1–month follow–up visit, imaging demonstrated complete LAA occlusion and correct placement of the device with an adequate compression and no residual leak. Conclusion This is a clinical case that describes complex LAAc in a patient with mechanical prosthetic mitral valve. Simulating the patient’s anatomy with a 3D–printed model can be useful in complex LAAc procedures to guide prosthesis selection and device sizing reducing procedure time and the risk of failure.

Contemporary left atrial appendage management during adult cardiac surgery

BackgroundPercutaneous left atrial appendage (LAA) closure is an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients with high thromboembolism risk, particularly with contraindications to OAC. The LAA itself could possess proarrhythmogenic properties. As patients undergoing LAA closure could be candidates for cardioversion or ablation, we aimed to evaluate AF disease progression following LAA closure and the outcome of patients undergoing a rhythm control strategy after the procedure.MethodsThe prospective multicenter French Nationwide Observational LAA Closure Registry (FLAAC) comprises 33 French interventional cardiology departments. Patients were included if they fulfilled the following criteria: history of non-valvular AF, successful LAA closure and long-term ECG follow-up.ResultsA total of 331 patients with successful LAA closure were enrolled in the study. Patients mean age was 75.4 ± 0.5 years. The study population was characterized by a high thromboembolic risk (CHA2DS2-VASc score: 4.5 ± 0.1) and frequent comorbidities. The median follow-up was 11.9 months. One hundred and nineteen (36.0%) patients were in sinus rhythm (SR) at baseline. Among SR patients, documented AF was observed in 16 (13.4%) patients whereas 15 (7.1%) patients in AF at baseline restored SR, at the end of follow up. Finally, only 13 patients (4%) underwent procedures to restore SR without complications during the follow-up.ConclusionsThe vast majority of patients undergoing LAA closure have the same AF status at baseline and one year after the index procedure. During the follow-up, a very small proportion (4%) of our population underwent procedures to restore SR without complications whatever the post-procedural antithrombotic strategy was.

To investigate the role of left atrial appendage (LAA) closure for cerebral ischemic stroke prevention following mitral valve replacement. Retrospective data on 860 consecutive adult patients undergoing mitral valve replacement between January 2008 and January 2013 were analyzed. There were 414 male and 446 female patients, with a mean age of (53 ± 12) years. The patients were divided into two groups according to whether the left atrial appendage was closed during operation: LAA closure group (n = 521) and non-LAA closure group (n = 339).Early mortality, postoperative cerebral ischemic stroke and the risk factors for cerebral ischemic stroke were assessed. Multivariate analysis was performed using logistic regression analysis. Compared with non-LAA closure group, LAA closure group had higher proportion of female gender, higher percentage of patients with cardiac insufficiency, pulmonary hypertension and left atrial thrombus, higher incidence of mechanical valve implantation and concurrent tricuspid surgery, and larger preoperative diameter of left atrium, but lower proportion of hypertension and patients undergoing coronary artery bypass surgery, and shorter aorta cross clamping time (χ² = 6.807 to 122.576, t = -2.818 and 3.756, all P < 0.05). There were no differences in exploratory thoracotomy for bleeding and in-hospital mortality between the two groups. Postoperative cerebral ischemic stroke occurred in 12 patients (1.4%). The incidence of cerebral ischemic stroke in LAA closure group was significantly lower than in non-LAA closure group (0.6% vs.2.7%, χ² = 6.452, P = 0.011).Logistic regression analysis showed that LAA closure was a significant protective factor for postoperative cerebral ischemic stroke (OR = 0.189, 95% CI: 0.039 to 0.902, P = 0.037) while history of cerebrovascular disease (OR = 4.326, 95% CI:1.074 to 17.418, P = 0.039) and preoperative diameter of left atrium (OR = 1.509, 95% CI: 1.022 to 1.098, P = 0.002) being the independent risk factors for postoperative cerebral ischemic stroke. The subgroup analysis showed that, for atrial fibrillation patients, LAA closure was a strong protective factor (OR = 0.064, 95% CI: 0.006 to 0.705, P = 0.025), but LAA closure was not a significant predictive factor (OR = 1.902, 95% CI: 0.171 to 21.191, P = 0.601) in non-atrial fibrillation patients. Concurrent LAA closure during mitral valve replacement is safe and effective to reduce the early postoperative risk of cerebral ischemic stroke in atrial fibrillation patients.

Commentary: The appendage strikes back: The last surgeon