Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Esophageal temperature management during cryoballoon ablation for atrial fibrillation.

INTRODUCTION: Esophageal thermal injury (ETI) is a well-recognized complication of atrial fibrillation (AF) ablation. Previous studies have demonstrated that direct esophageal cooling reduces ETI during radiofrequency AF ablation. The purpose of this study was to evaluate the use of an esophageal warming device to prevent ETI during cryoballoon ablation (CBA) for AF. METHODS: This prospective, double-blinded study enrolled 42 patients with symptomatic AF undergoing CBA. Patients were randomized to the treatment group with esophageal warming (42°C) using recirculated water through a multilumen, silicone tube inserted into the esophagus (EnsoETM®; Attune Medical) (WRM) or the control group with a luminal single-electrode esophageal temperature monitoring probe (LET). Patients underwent upper endoscopy esophagogastroduodenoscopy (EGD) the following day. ETI was classified into four grades. RESULTS: Baseline patient characteristics were similar between groups. Procedural characteristics including number of freezes, total freeze time, early freeze terminations, coldest balloon temperature, procedure duration, posterior wall ablation, and proton pump inhibitor and transesophageal echocardiogram use before procedure were not different between groups. The EGD was completed in 40/42 patients. There was significantly more ETI in the WRM group compared to the LET group (n = 8 [38%] vs. n = 1 [5%], p = 0.02). All ETI lesions were grade 1 (erythema) or 2 (superficial ulceration). Total freeze time in the left inferior pulmonary vein was predictive of ETI (360 vs. 300 s, p = 0.03). CONCLUSION: Use of a luminal heat exchange tube for esophageal warming during CBA for AF was paradoxically associated with a higher risk of ETI.

Transseptal access: A review of contemporary tools.

Transseptal left atrial catheterization is routinely used for many common catheter-based interventions. Tools for transseptal catheterization have advanced over the recent years. Such tools include imaging advances with intracardiac echocardiology as well as an array of needles, wires, and dilators to achieve transseptal access with greater ease and safety. This study will discuss the contemporary tools for transseptal catheterization and guidance for difficult cases.

Use of a novel 4D intracardiac echocardiography catheter to guide interventional electrophysiology procedures.

INTRODUCTION: Standard two-dimensional (2D), phased-array intracardiac echocardiography (ICE) is routinely used to guide interventional electrophysiology (EP) procedures. A novel four-dimensional (4D) ICE catheter (VeriSight Pro, Philips) can obtain 2D and three-dimensional (3D) volumetric images and cine-videos in real-time (4D). The purpose of this study was to determine the early feasibility and safety of this 4D ICE catheter during EP procedures. METHODS: The 4D ICE catheter was placed from the femoral vein in ten patients into various cardiac chambers to guide EP procedures requiring transseptal catheterization, including ablation for atrial fibrillation and left atrial appendage closure. 2D- and 3D-ICE images were acquired in real-time by the electrophysiologist. A dedicated imaging expert performed digital steering to optimize and postprocess 4D images. RESULTS: Eight patients underwent pulmonary vein isolation (cryoballoon in seven patients, pulsed field ablation in one, additional radiofrequency left atrial ablation in one). Two patients underwent left atrial appendage closure. High quality images of cardiac structures, transseptal catheterization equipment, guide sheaths, ablation tools, and closure devices were acquired with the ICE catheter tip positioned in the right atrium, left atrium, pulmonary vein, coronary sinus, right ventricle, and pulmonary artery. There were no complications. CONCLUSION: This is the first experience of a novel deflectable 4D ICE catheter used to guide EP procedures. 4D ICE imaging is safe and allows for acquisition of high-quality 2D and 3D images in real-time. Further use of 4D ICE will be needed to determine its added value for each EP procedure type.

Covariance Between Parent and Child Symptoms Before and During the COVID-19 Pandemic.

OBJECTIVE: COVID-19 has had unprecedented effects on American families, including increases in depression, anxiety, and irritability for both parents and children. While parents and children influence each other's psychological functioning during non-disaster times, this effect may be amplified during times of disaster. The current study investigated how COVID-19 influenced covariance of depressive symptoms and irritability in children and their parents. METHODS: Three hundred and ninety-one parents and their 8- to 17-year-old children (Mage = 10.68 years old, 70% male, 86% White) from a large sample of children and parents, primarily from Southeastern Louisiana, completed self-report measures of depression and irritability approximately 6 weeks into the COVID-19 pandemic, as well as providing retrospective reports of their symptoms prior to the pandemic. Actor-partner interdependence models were used to measure the reciprocal effects of parent symptoms on children and vice versa, both before and during the pandemic. RESULTS: Actor effects in both the depressive symptoms and irritability models suggested that pre-COVID-19 depressive symptoms and irritability were robust predictors of early-COVID-19 depressive symptoms and irritability for both parents and children. Partner effects were also detected in the irritability model, in that parental irritability prior to COVID-19 was associated with decreased child irritability during the pandemic. Both before and during the pandemic, associations between parent and child depressive symptoms and irritability scores were weaker in families evidencing greater dysfunction. CONCLUSIONS: Results suggest that COVID-19-related stress is associated with increases in both parent and child symptomatology, and that family relationships likely influence associations between these symptoms.

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

Impact of pre-ablation weight loss on the success of catheter ablation for atrial fibrillation.

INTRODUCTION: Obesity is an established risk factor for recurrent atrial fibrillation (AF) after ablation. The impact of pre-procedure weight changes on freedom from AF (FFAF) after ablation in obese and nonobese patients is unknown. METHODS: A single-center retrospective cohort study of patients undergoing pulmonary vein isolation was performed. Before ablation, all candidates were encouraged to adopt healthy lifestyle habits according to American Heart Association guidelines, including weight loss, by their physician. The primary endpoint was FFAF through 1-year after completion of the 3-month blanking period. RESULTS: Of the 601 patients (68% male; average age 62.1 ± 10.3 years) included in analysis, 234 patients (38.9%) were obese (body mass index ≥ 30) and 315 (52.4%) had paroxysmal AF. FFAF was observed in 420 patients (69.9%) at 15 months. Percent change in weight that occurred during the year before ablation independently predicted FFAF through 15-months in all patients (adjusted odds ratio = 1.17, 95% confidence interval: 1.11-1.23). Subgroup analyses based on paroxysmal vs persistent AF, presence of obesity, and history of prior ablation were performed. Percent change in weight over the year before ablation was independently associated with FFAF in all subgroups except nonobese patients with persistent AF. CONCLUSION: Pre-ablation weight loss was associated with FFAF in both obese and nonobese patients. Further studies are needed to define the optimal approach to weight loss before AF ablation.

Improvement in renal function following cryoballoon ablation for atrial fibrillation.

PURPOSE: Patients with chronic kidney disease are predisposed to heart rhythm disorders including atrial fibrillation (AF). Several studies have suggested that radiofrequency catheter ablation of AF improves renal function. However, little data exists for pulmonary vein isolation with cryoballoon ablation (CBA). The purpose of this study is to assess change in renal function following CBA for AF. METHOD: This is a single-center retrospective study that included patients who underwent CBA for AF between 2011 and 2016. Patients were grouped by baseline-estimated glomerular filtration rate (eGFR): ≥ 90 (Stage G1), 60-89.9 (Stage G2), and 30-59.9 mL/min/1.73 m2 (Stage G3). Change in eGFR was assessed > 3 months post-ablation. RESULTS: A total of 306 patients with both pre- and post-ablation serum creatinine measurements available were included. Baseline eGFRs for Stages G1, G2, and G3 patients were 103.5 ± 12.9 (n = 82), 74.7 ± 8.2 (n = 184), and 52.6 ± 6.6 mL/min/1.73 m2 (n = 40), respectively. Renal function was assessed 310.8 ± 104.2 days post-ablation. Average intra-procedural contrast use was 58.4 ± 23.8 mL. There was no significant change in eGFR following CBA in Stage G1 patients (p = 0.10). For those with Stages G2 and G3 renal function, eGFR improved by 6.1% (4.2 mL/min/1.73 m2, p < 0.01) and 13.8% (7.2 mL/min/1.73 m2, p < 0.01), respectively. This improvement was seen regardless of the presence or absence of recurrent atrial arrhythmias. CONCLUSIONS: CBA for AF may be associated with an improvement in renal function, particularly among those with a reduced baseline eGFR despite recurrence of atrial arrhythmias and intra-procedural contrast use.

Efficacy and Safety of Direct Oral Anticoagulants for Atrial Fibrillation Across Body Mass Index Categories.

Background Direct-acting oral anticoagulants are now the preferred method of anticoagulation in patients with atrial fibrillation. Limited data on efficacy and safety of these fixed-dose regimens are available in severe obesity where drug pharmacokinetics and pharmacodynamics may be altered. The objectives of this study were to evaluate efficacy and safety in patients with atrial fibrillation taking direct-acting oral anticoagulants across body mass index (BMI) categories in a contemporary, real-world population. Methods and Results We performed a retrospective study of patients with atrial fibrillation at an integrated multisite healthcare system. Patients receiving a direct-acting oral anticoagulant prescription and ≥12 months of follow-up between 2010 and 2017 were included. The primary efficacy and safety outcomes were ischemic stroke or systemic embolism and intracranial hemorrhage. We performed Cox proportional hazards modeling to compute hazard ratios (HRs) adjusted for CHA2DS2-VASc score to examine differences by excess BMI categories relative to normal BMI. Of 7642 patients, mean±SD age was 69±12 years with a median (interquartile range) follow-up of 3.8 (2.2-6.0) years. Approximately 22% had class 1 obesity and 19% had class 2 or 3 obesity. Stroke risks were similar in patients with and without obesity (HR, 1.2; 95% CI, 0.5-2.9; and HR, 0.68; 95% CI, 0.23-2.0 for class 1 and class 2 or 3 obesity compared with normal BMI, respectively). Risk of intracranial hemorrhage was also similar in class 1 and class 2 or 3 obesity compared with normal BMI (HR, 0.64; 95% CI, 0.35-1.2; and HR, 0.66; 95% CI, 0.35-1.2, respectively). Conclusions Direct-acting oral anticoagulants demonstrated similar efficacy and safety across all BMI categories, even at high weight values.

Use of Oral Anticoagulation in a Real-World Population With Device Detected Atrial Fibrillation.

Background Guideline recommendations for oral anticoagulation (OAC) in patients with atrial fibrillation (AF) are based on CHA2DS2-VASc score alone. Patients with cardiac implantable electronic devices provide an opportunity to assess how the interaction between AF duration and CHA2DS2-VASc score influences OAC prescription rates. Methods and Results Data from the Optum de-identified Electronic Health Record data set were linked to the Medtronic CareLink database of cardiac implantable electronic devices. An index date was assigned as the later of 6 months after device implant or 1 year after Electronic Health Record data availability. Maximum daily AF duration (no AF, 6 minutes-23.5 hours, and >23.5 hours) was assessed for 6 months before index date. OAC prescription rates were computed as a function of both AF duration and CHA2DS2-VASc score. A total of 35 779 patients with CHA2DS2-VASc scores ≥1 were identified, including 27 198 not prescribed OAC. Overall OAC prescription rate among the 12 938 patients with device-detected AF >6 minutes was 36.7% and significantly higher in those with a maximum daily AF duration >23.5 hours (45.4%) compared with those with 6 minutes to 23.5 hours (28.7%). OAC prescription rates increased monotonically with both increasing AF duration and CHA2DS2-VASc score, reaching a maximum of 67.2% for patients with AF >23.5 hours and a CHA2DS2-VASc score ≥5. Conclusions Real-world prescription of OAC increased with both increasing duration of AF and CHA2DS2-VASc score. This highlights the need for further research into the role of AF duration, stroke risk, and the need for anticoagulation in patients with devices capable of long-term AF monitoring.

Vasospastic Arrest:: A Heart-Stopping Case of Prinzmetal Angina.

Vasospastic angina is an uncommon cause of cardiac arrest. We describe a patient who presented with sudden cardiac arrest due to severe coronary vasospasm. Telemetry during the event revealed ventricular arrhythmias and asystole followed by spontaneous self-conversion back to normal sinus rhythm. The patient underwent implantable cardioverter-defibrillator therapy. (Level of Difficulty: Beginner.).

Patient-reported outcomes after cryoballoon ablation are equivalent between moderate sedation and general anesthesia.

INTRODUCTION: Moderate sedation (MS) during cryoballoon ablation (CBA) avoids risks of general anesthesia (GA) and improves electrophysiology (EP) lab throughput. However, one barrier to the use of MS is the potential for patient discomfort. The objective of this study was to compare patient-reported outcome measures following CBA for paroxysmal atrial fibrillation (pAF) under MS and GA. METHODS AND RESULTS: Consecutive patients undergoing a first CBA for pAF under GA or MS were prospectively enrolled. The sedation method was assigned based on patient and provider preference, and perceived airway risk. The primary outcomes were quality of recovery (measured using a validated 40 question survey; QoR-40) and likelihood to recommend (LTR) the procedure and sedation method (measured by Likert scale). Secondary outcomes were acute pulmonary vein (PV) isolation rate, procedure, fluoroscopy and ablation times, and complication rates. Forty-seven GA and 53 MS patients were included. The mean age was 64.9 ± 9.4 years and mean CHA2 DS2 -VASc score was 2.0 ± 1.4. QoR-40 scores were 184.6 ± 16.4 for GA and 187.6 ± 10.2 for MS (P = .28). LTR responses were similar between groups. Mean procedure times were 148.2 ± 56.0 minutes for GA and 129.4 ± 31.4 minutes for MS (P = .038). Fluoroscopy and ablation times were similar between groups. A total of 100% (409/409) of PVs were acutely isolated. One hemopericardium occurred in the MS group requiring pericardiocentesis. CONCLUSION: MS for CBA offers an alternative to GA that is safe and well-tolerated by patients with comparable success rates and improved EP lab throughput.

Repeat pulmonary vein isolation with or without FIRM-guided ablation for recurrent atrial fibrillation with pulmonary vein reconnection.

INTRODUCTION: Focal impulse and rotor modulation (FIRM) ablation can be used to target nonpulmonary vein (PV) sources of atrial fibrillation (AF). No published studies have compared freedom from atrial fibrillation (FFAF) after pulmonary vein reisolation (PVRI) plus FIRM to PVRI alone in patients with reconnected PVs undergoing repeat ablation. METHODS: A 3:1 matched retrospective cohort study was performed on 21 patients with recurrent AF and PV reconnection who underwent PVRI plus FIRM-guided ablation and 63 patients with recurrent AF treated with PVRI alone at a single institution. All patients in the PVRI-alone cohort had cryoballoon PVRI at the time of repeat ablation without additional lesion sets for AF. Cases were matched based on the type of AF (paroxysmal vs nonparoxysmal), left atrial diameter (±4 mm), left ventricular ejection fraction (±10%), duration of AF (±18 months), and age (±5 years). The primary endpoint was FFAF after a 3-month blanking period. RESULTS: Out of 53 total FIRM cases performed at Northwestern Memorial Hospital between 2015 and 2017, 21 patients had PVRI plus FIRM for recurrent AF with PV reconnection. These patients had an average of 3.3 ± 2.1 rotors (60% left atrial) ablated. Over a median follow-up time of 24.7 months (interquartile range, 13-36 months), patients in the PVRI-alone cohort demonstrated a higher rate of FFAF (n = 35; 55.6%) than patients in the PVRI plus FIRM-guided ablation cohort (n = 7; 33.3%) (logrank P = .049). CONCLUSION: In patients undergoing repeat ablation for AF with PV reconnection, PVRI plus FIRM did not increase FFAF compared to PVRI alone.

Characterization of atrial flutter after pulmonary vein isolation by cryoballoon ablation.

PURPOSE: Pulmonary vein isolation (PVI) by cryoballoon ablation (CBA) has emerged as a commonly used technique for the treatment of atrial fibrillation. We sought to explore the incidence, risk factors for, and characterization of post-CBA-PVI atrial flutter. METHODS: We analyzed a prospective registry of patients who underwent CBA-PVI at a single institution. We included patients with more than 3 months of follow-up data and excluded those with a history of cavotricuspid isthmus (CTI) ablation. Locations of post-CBA-PVI atrial flutters were determined by analysis of intracardiac electrograms and electroanatomic maps. RESULTS: There were 556 patients included in the analysis. The mean age was 61.0 ± 10.6 years, 67.4% were male, the number of failed anti-arrhythmic medication trials was 1.2 ± 0.8, and the duration of atrial fibrillation pre-CBA was 54.3 ± 69.1 months. The 28-mm second-generation cryoballoon was used almost exclusively. Over a median follow-up time of 22.7 ± 17.9 months, 25 (4.5%) patients developed post-CBA-PVI atrial flutter after the 3-month blanking period. Of those 25 patients, 15 (60%) underwent subsequent ablation to eliminate the atrial flutter circuit, with 60% being CTI-dependent and the remainder left-sided (p value not significant). Risk factors for the development of atrial flutter included NYHA class ≥ 2 (OR 5.02, p < 0.001), presence of baseline bundle branch block (OR 4.33, p = 0.006), and left ventricular ejection fraction < 50% (OR 3.36, p = 0.007). CONCLUSIONS: The rate of post-CBA-PVI atrial flutter is low after the blanking period even with medium-term follow-up. The origin of atrial flutter is equally divided between the right and left atria.