Retrieval of a left appendage device from the left ventricle using a large bore steerable catheter.

Left atrium appendage closure is a safe and effective therapy for patients with atrial fibrillation and high thromboembolic and hemorrhagic risks. Prosthesis embolization is a potential major complication with an incidence of 0.07%. We report a case of migration of an Amplatzer Amulet (Abbott) device that was successfully retrieved in an innovative way (4).

Case report: three ways to mitigate the risk of embolization during left atrial appendage closure in a patient with a massive and proximal left atrial appendage thrombus.

Background: Left atrial appendage (LAA) thrombus is a contraindication for LAA closure (LAAC). However, in selected cases, oral anticoagulants are strictly contraindicated because of a history of life-threatening bleeding, and LAAC remains the only possible therapy to avoid systemic and especially cerebral embolization. Case summary: We report a case of LAAC despite a massive proximal thrombus in a patient who had an absolute contraindication to anticoagulant therapy, with thorough pre-planning using CT scan, device modelling and thrombus trapping techniques to reduce the risk of systemic embolic events and perform LAAC safely. Discussion: Although LAAC remains at high risk in this setting, the use of cautious techniques and tools, from pre-procedure planning to systemic embolization prevention systems associated to a precise transoesopheageal echocardiography guiding throughout the procedure, allows it to be performed as safely as possible when no other option is available.

Left atrial appendage closure guided by fusion of 3D computational modelling on real-time fluoroscopy: A multicenter experience.

BACKGROUND: Patient-specific 3-dimensional (3D) computational modelling offers a tailored approach with promising results, but experience using digital-twin fusion on real-time fluoroscopy to guide left atrial appendage closure (LAAC) is unreported. OBJECTIVES: To assess whether LAAC guided by fusion of a 3D computational model on real-time fluoroscopy is safe and effective. METHODS: We included retrospectively through a multicenter registry all consecutive patients with non-valvular atrial fibrillation (AF) who underwent LAAC guided by artificial intelligence (AI)-enabled computer simulations (FEops, Gent, Belgium) fusion with real-time fluoroscopy. Operators selected the appropriate device size and position in relation to the LAA using FEops HEARTguide™, and a digital twin was provided for image fusion. The primary efficacy endpoint was successful LAAC with the use of a single device, without moderate or greater peri-device leak and/or device related thrombus (DRT) on follow-up imaging. The primary safety endpoint was a composite of major procedural complications including tamponade, stroke, systemic embolism, major bleeding, and device embolization. RESULTS: A total of 106 patients underwent LAAC with an Amulet™ or Watchman FLX™ device using CT-model-fluoroscopy fusion imaging. Device implantation was successful in 100 % of cases. The primary efficacy endpoint was met in 82 patients (89 %). A single-device SINGLE-deployment LAAC procedure was observed in 49 cases (46 %). The primary safety endpoint occurred in 2 patients (1.9 %). After a median follow-up of 405 days, two patients suffered an ischemic stroke and four expired. CONCLUSIONS: Fusion of a CT-based 3D computational model on real-time fluoroscopy is a safe and effective approach that may optimize transcatheter LAAC outcomes.

Artificial intelligence-based electrocardiogram analysis improves atrial arrhythmia detection from a smartwatch electrocardiogram.

Aims: Smartwatch electrocardiograms (SW ECGs) have been identified as a non-invasive solution to assess abnormal heart rhythm, especially atrial arrhythmias (AAs) that are related to stroke risk. However, the performance of these tools is limited and could be improved with the use of deep neural network (DNN) algorithms, particularly for specific populations encountered in clinical cardiology practice. Methods and results: A total of 400 patients from the electrophysiology department of one tertiary care hospital were included in two similar clinical trials (respectively, 200 patients per study). Simultaneous ECGs were recorded with the watch and a 12-lead recording system during consultation or before and after an electrophysiology procedure if any. The SW ECGs were processed by using the DNN and with the Apple watch ECG software (Apple app). Corresponding 12-lead ECGs (12L ECGs) were adjudicated by an expert electrophysiologist. The performance of the DNN was assessed vs. the expert interpretation of the 12L ECG, and inconclusive rates were reported. Overall, the DNN and the Apple app presented, respectively, a sensitivity of 91% [95% confidence interval (CI) 85-95%] and 61% (95% CI 44-75%) with a specificity of 95% (95% CI 91-97%) and 97% (95% CI 93-99%) when compared with the physician 12L ECG interpretation. The DNN was able to provide a diagnosis on 99% of ECGs, while the Apple app was able to classify only 78% of strips (22% of inconclusive diagnosis). Conclusion: In this study, by including patients from a cardiology department, a DNN-based algorithm applied to an SW ECG provided an accurate diagnosis for AA detection on virtually all tracings, outperforming the SW algorithm.

Safety, feasibility, and prognostic value of stress perfusion CMR in patients with MR-conditional pacemaker.

AIMS: To assess the safety, feasibility, and prognostic value of stress cardiovascular magnetic resonance (CMR) in patients with pacemaker (PM). METHODS AND RESULTS: Between 2008 and 2021, we conducted a bi-centre longitudinal study with all consecutive patients with MR-conditional PM referred for vasodilator stress CMR at 1.5 T in the Institut Cardiovasculaire Paris Sud and Lariboisiere University Hospital. They were followed for the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death or non-fatal myocardial infarction. Cox regression analyses were performed to determine the prognostic value of CMR parameters. The quality of CMR was rated by two observers blinded to clinical details. Of 304 patients who completed the CMR protocol, 273 patients (70% male, mean age 71 ± 9 years) completed the follow-up (median [interquartile range], 7.1 [5.4-7.5] years). Among those, 32 experienced a MACE (11.7%). Stress CMR was well tolerated with no significant change in lead thresholds or pacing parameters. Overall, the image quality was rated good or excellent in 84.9% of segments. Ischaemia and late gadolinium enhancement (LGE) were significantly associated with the occurrence of MACE (hazard ratio, HR: 11.71 [95% CI: 4.60-28.2]; and HR: 5.62 [95% CI: 2.02-16.21], both P < 0.001). After adjustment for traditional risk factors, ischaemia and LGE were independent predictors of MACE (HR: 5.08 [95% CI: 2.58-14.0]; and HR: 2.28 [95% CI: 2.05-3.76]; both P < 0.001). CONCLUSION: Stress CMR is safe, feasible and has a good discriminative prognostic value in consecutive patients with PM.

Correlation between AF substrate ablation difficulty and left atrial fibrosis quantified by delayed-enhancement cardiac magnetic resonance.

BACKGROUND: Studies have shown that the presence of left atrial (LA) fibrosis can be assessed by LA delayed-enhancement cardiac magnetic resonance (LA DE-CMR) and may be predictive of outcome after ablation for atrial fibrillation (AF). We sought to test the hypothesis that the amount of LA fibrosis evaluated by DE-CMR correlates with the difficulty of complex fractionated atrial electrograms (CFAE) ablation. METHODS: Twenty-two consecutive patients (86.4% nonparoxysmal AF) underwent substrate CFAE radiofrequency (RF) ablation (±Pulmonary veins isolation) with AF termination as the endpoint. LA DE-CMR was performed prior to ablation. A global index of DE was defined by an average of six LA segmental scores based on a four-grade scale (no enhancement to maximum enhancement). Time between first RF application and AF termination, and RF duration until AF termination, was recorded. CFAE area/total LA surface was also measured on CARTO maps (Biosense Webster, Diamond Bar, CA, USA). These measures served to evaluate ablation difficulty, and were correlated with CMR images by double-blinded analysis. RESULTS: Ablation restored sinus rhythm in 20 of 22 patients (91%), with a time to terminate AF of 140 ± 91 minutes. There was a significant correlation between the global averaged DE-CMR fibrosis grade and the electrophysiological substrate indexes such as "time to terminate AF" (Rho = 0.70, P = 0.0003), "RF duration until AF termination" (Rho = 0.65, P = 0.001), and a trend toward correlation with "CFAE area/LA surface" (Rho = 0.47, P = 0.03). CONCLUSIONS: LA DE-CMR can predict increased difficulty of CFAE ablation in AF. This tool may be beneficial in both selection of patients and ablation strategy.

Left Atrial Appendage Closure in Patients With Atrial Fibrillation at Very High Bleeding Risk Without Postimplantation Antithrombotic Therapy.

OBJECTIVES: We assess the proportion, baseline characteristics, and outcomes of a cohort of very high bleeding risk (HBR) patients discharged with no antithrombotic therapy after left atrial appendage closure (LAAC). BACKGROUND: The optimal antithrombotic therapy after LAAC remains controversial. However, a substantial proportion of patients have HBR and are contraindicated to any antithrombotic therapy. Data regarding the feasibility and safety of such a strategy are scarce. METHODS: All patients who underwent LAAC at our institution between October 2013 and December 2018 were included. Clinical, procedural, and imaging data were collected prospectively, and patients receiving no antithrombotic therapy were compared with those receiving at least 1 agent. RESULTS: A total of 152 patients were included. At discharge, 72 (47.3%) received single-antiplatelet therapy (SAPT), 57 (37.5%) received dual-antiplatelet therapy (DAPT), and 22 (14.5%) received no antithrombotic therapy (NATT). One patient received a combination of aspirin and vitamin K antagonist. There were no differences regarding baseline characteristics between NATT patients and the others. At a median follow-up of 16 months, 25 patients died. There were no differences between NATT patients and others regarding all-cause mortality (9.1% vs 18.8%, respectively; P=.07) or ischemic stroke (0.0% vs 4.2%, respectively; P=.20). There were 4 episodes of major bleeding, but none occurred in the NATT group, and no device-related thrombosis was seen on computed tomography scan performed within 12 weeks after LAAC. CONCLUSIONS: In highly selected patients at very HBR, discontinuation of any antithrombotic therapy after LAAC appears safe and feasible.

Device-Related Thrombus After Left Atrial Appendage Closure.

Although left atrial appendage closure (LAAC) has proved non-inferior to oral anticoagulants in patients with AF, there has been recent concern about the occurrence of late complications, especially device-related thrombus (DRT), which was associated with increased risk of stroke. In this article, the incidence, risk factors and time course of DRT after LAAC are discussed, as well as the potential benefits of dedicated strategies in the management of DRT, which remain speculative, especially in patients with a contraindication to oral anticoagulants. In these patients, decision-making should be based on a multidisciplinary evaluation of the ischaemic/bleeding balance on an individual basis.

Procedure planning and device positioning for left atrial appendage occlusion: insights from multi detector-row computed tomography with 3D fusion.

To compare planned and achieved device position in patients undergoing left atrial appendage occlusion (LAAO). It is unclear how devices used for LAAO position themselves compared to what is planned. All patients undergoing LAAO at our institution had pre- and post-procedural multi detector-row computed tomography (MDCT) at 3 months (N = 52). Using dedicated software, both datasets were fused to superimpose the left atria in all planes. The effective device position was traced on the post-procedural MDCT and then imported in the pre-procedural dataset to allow comparisons. Planned and effective landing zones were compared with respect to size, location and orientation. The device's final position was in a significantly larger landing zone than planned (452 ± 174 vs. 351 ± 112 mm2 for effective and planned landing zones, respectively, paired t-test: p < 0.0001), resulting in significantly less-than-intended area oversizing (41 ± 31 vs. 12 ± 28%, p < 0.0001). In terms of device orientation, there was a difference of 19.7° between the planned and effective landing zones (p < 0.0001). The Amplatzer device had a shallower-than-planned position in 70% of cases, whereas the Watchman device had a deeper-than-planned position in 75% of cases (p = 0.04). Incomplete occlusion was found in 17 patients (33%). In a multivariable model, oversizing at the effective landing zone was the only MDCT independent predictor of incomplete occlusion (OR: 0.96 per 1% increment, 95% CI 0.95-0.98, p = 0.009). MDCT fusion showed that LAAO device position and orientation are different than planned, and this is associated with incomplete occlusion of the LAA.

The European Society of Cardiology Cardiac Resynchronization Therapy Survey II: A comparison of cardiac resynchronization therapy implantation practice in Europe and France.

BACKGROUND: The first European Cardiac Resynchronization Therapy (CRT) Survey, conducted in 2008-2009, showed considerable variations in guideline adherence and implantation practice. A second prospective survey (CRT Survey II) was then performed to describe contemporary clinical practice regarding CRT among 42 European countries. AIM: To compare the characteristics of French CRT recipients with the overall European population of CRT Survey II. METHODS: Demographic and procedural data from French centres recruiting all consecutive patients undergoing either de novo CRT implantation or an upgrade to a CRT system were collected and compared with data from the European population. RESULTS: A total of 11,088 patients were enrolled in CRT Survey II, 754 of whom were recruited in France. French patients were older (44.7% aged≥75 years vs 31.1% in the European group), had less severe heart failure symptoms, a higher baseline left ventricular ejection fraction and fewer co-morbidities. Additionally, French patients had a shorter intrinsic QRS duration (19.1% had a QRS<130ms vs 12.3% in the European cohort). Successful implantation rates were similar, but procedural and fluoroscopy times were shorter in France. French patients were more likely to receive a CRT pacemaker than European patients overall. Of note, antibiotic prophylaxis was reported to be administered less frequently in France, and a higher rate of early device-related infection was observed. Importantly, French patients were less likely to receive optimal drugs for treating heart failure at hospital discharge. CONCLUSION: This study highlights contemporary clinical practice in France, and describes substantial differences in patient selection, implantation procedure and outcomes compared with the other European countries participating in CRT Survey II.

Preventing the risk of coronary injury in posteroseptal accessory pathway ablation in children: different strategies and advantages of fluoroscopy integrated 3D-mapping system (CARTO-UNIVU™).

PURPOSE: To evaluate various strategies in order to minimize the risk of coronary injury during posteroseptal accessory pathways ablation in children. METHODS: We retrospectively reviewed 68 posteroseptal accessory pathways ablation procedures (20 decremental and 48 typical accessory pathways) performed in 62 pediatric patients at our institution between July 2009 and December 2016. Only posteroseptal accessory pathways targeted near or within the coronary sinus were included and ablation was mostly performed using irrigated tip radiofrequency. RESULTS: Median patient age was 11 years with a median body weight of 39 kg. Thirty patients underwent a coronary angiogram, 21 were coupled to the 3D navigation system CARTO-UNIVU™. The coronary angiogram showed a distance of less than 5 mm between the coronary artery and the ablation site in 40% of our cases; 3 patients had a coronary injury related to RF ablation, 6 patients were switched for cryoablation, 3 patients received limited RF energy (20 W). There were no demographic data predicting the proximity of the coronary artery to the ablation site. CONCLUSION: Ablation of posteroseptal accessory pathways specifically in children carries a risk of coronary artery injury which is probably underestimated. The use of merged 3D images and coronary angiograms, the reduction of RF energy or the switch to cryoablation are possible alternatives to limit the risk of coronary injury.

Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events.

BACKGROUND: Percutaneous left atrial appendage (LAA) closure is an emerging option for patients with atrial fibrillation at high risk for cerebrovascular events. The multicenter FLAAC registry (French Nationwide Observational LAA Closure Registry) was established to assess LAA closure outcomes in everyday practice. METHODS AND RESULTS: Four hundred thirty-six patients referred from April 2013 to September 2015 to 33 French interventional cardiology centers for percutaneous LAA closure were included prospectively in the FLAAC registry. Mean age was 75.4±0.4 years. The stroke risk was high (mean CHA2DS2-VASc score, 4.5±0.1) and most patients had experienced clinically significant bleeding (HAS-BLED score, 3.1±0.05). The device used was Amplatzer LAA occluder in 58% and the Watchman device in 42% of the patients. The procedural success rate was 98.4%. Median postprocedure follow-up was 12.0 (11.8-12.0) months and a single patient was lost to follow-up. During the periprocedural and subsequent follow-up period, procedure-related severe adverse events occurred in 21 (4.9%) and 10 (2.3%) patients, respectively. One-year cumulative incidences of ischemic stroke and cerebral hemorrhage were 2.9% (1.6-5.0) and 1.5% (0.7-3.2), respectively. Overall, 1-year mortality was 9.3% (6.9-12.5) with 7 of the 39 deaths related or possibly related to the device or procedure. CONCLUSIONS: This nationwide prospective registry shows that, in the French population, LAA closure is mainly used in patients with high comorbidity rates and a poor prognosis. LAA closure in such patients seems reasonable to decrease the stroke rate. The overall health status of these patients should be taken into account during the preprocedural evaluation process. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02252861.

Active or passive pulmonary vein in atrial fibrillation: is pulmonary vein isolation always essential?

BACKGROUND: The role of pulmonary veins (PVs) in persistent atrial fibrillation (AF) perpetuation appears less important than in paroxysmal AF. Electrogram-based substrate ablation is not widely performed as a stand-alone strategy. OBJECTIVE: To evaluate PV activity in AF perpetuation and efficacy of our patient-tailored ablation strategy (electrogram-based substrate ablation with or without pulmonary vein isolation [PVI]). METHODS: One hundred twenty-one patients with paroxysmal (n = 19; 15.7%), persistent (n = 77; 63.6%), or long-standing persistent (n = 25; 20.7%) AF underwent electrogram-based substrate ablation with AF termination end point: sinus rhythm or atrial tachycardia conversion. Before ablation, we classified PVs as "passive" if silent PV or if PV cycle length is greater than left atrial appendage cycle length. No PVI was performed in such cases. RESULTS: Passive PVs were observed in 52 of 121 patients (paroxysmal AF = 0%, persistent AF = 40%, and long-standing persistent AF = 76%; P < .0001]). Substrate ablation terminated AF in 95.6% (sinus rhythm conversion in 80.2%). Compared with patients with active PVs, patients with passive PVs had longer AF sustained duration (19.1 ± 29.7 months vs 4.9 ± 11.1 months; P < .0001), larger left atrial diameter (46.9 ± 7.3 mm vs 41.9 ± 6.0 mm; P = .0014), lower left ventricular ejection fraction (45.4% ± 13.5% vs 55.1% ± 9.4%; P < .0001), and more often structural heart disease (57% vs 33%; P = .02). After a follow-up of 20.39 ± 11.23 months (1.6 procedures per patient), 82% were arrhythmia free with this strategy. CONCLUSIONS: PV activity during AF decreases with AF chronicity, left atrial dilatation, and left ventricular ejection fraction. Our patient-tailored ablation strategy without systematic PVI provides good results.

Automated Detection of Complex Fractionated Atrial Electrograms In Substrate-Based Atrial Fibrillation Ablation: Better Discrimination with a New Setting of CARTO® Algorithm.

Background and purpose: Up until recently complex fractionated atrial electrogram (CFAE) ablation has been considered as time consuming and its achievement as challenging, especially for non experimented operators. Moreover, results of substrate ablation based on CFAE detection in atrial fibrillation (AF) are very disparate, mainly because of the operator's subjective electrogram visual analysis and the difficult distinction between CFAEs really involved in AF perpetuation from other CFAE. Automatic detection provided by 3D mapping system (CARTO® algorithm) can be helpful but is not selective enough, drawing too wide CFAE areas. We sought to demonstrate a better selectivity of a new CFAE algorithm setting in order to better discriminate CFAEs really involved in AF perpetuation from other CFAE. Methods and subjects: A population of 32 patients (60.4±12.7 years) with paroxysmal (n=3) AF (PAF), persistent (n=16) AF (PeAF) or long-standing persistent (n=13) AF (LSPeAF), and AF history =56±65 months, underwent CFAE ablation based on visual analysis. Before ablation, left atrium CFAE mapping was performed on CARTO® shortest complex interval (SCI) algorithm and reanalyzed after ablation with the two different settings: nominal (SCI 60-120ms/0.05-0.15mV) vs. customized setting (SCI 30-40ms/0,04-0.15mV). CFAE areas automatically detected by both settings (CFAE-CARTO® areas) were respectively measured. The decision to ablate CFAE was only based upon the operator's electrogram visual analysis taken as reference because of high AF termination rate (93.7%) due to operator's CFAE selection experience. These ablation points drawn reference-CFAE areas involved in AF perpetuation (ablation point=60mm2) allowing to compare the selectivity of the two previous automatic maps. Results: With the customized CARTO® SCI setting, we observed a significant reduction of CFAE areas detected by CARTO® (CFAE-CARTO® areas) and of the ablated CFAE surface inside non-CFAE CARTO® areas, (30.6±20.5cm2 vs. 68.8±24.5cm2, p<0.0001, and 1.86±1.82% vs. 3±3%, p=0.003). Furthermore the proportion of ablated areas/detected CFAE-CARTO® areas were higher with customized setting (38.2±19.6% vs. 20.4±17.5%, p=0.008). Conclusions: This new customized CFAE algorithm setting is significantly more selective than the nominal one and allows an automated detection of CFAE really involved in AF perpetuation truer to an efficient experienced operator's electrogram visual analysis.