Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation: The aMAZE Randomized Clinical Trial.

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021. Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone. Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation. Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients. Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.

Bailout Deep Septal LV Pacing to Treat Inadvertent Complete AV Block During Complex Ablation Procedure.

We present a case of persistent complete atrioventricular block that occurred during the diagnostic portion of a premature ventricular contractions' radiofrequency ablation in a complex heart failure patient. The case was managed by bailout deep left ventricular septal pacing after bipolar radiofrequency elimination of premature ventricular contractions.

Acute Kidney Injury Resulting From Hemoglobinuria After Pulsed-Field Ablation in Atrial Fibrillation: Is it Preventable?

BACKGROUND: High-voltage pulses can cause hemolysis. OBJECTIVES: The authors evaluated the occurrence of hemoglobinuria after pulsed-field ablation (PFA) and its impact on renal function in patients with atrial fibrillation (AF). METHODS: A consecutive series of patients with AF undergoing PFA were included in this analysis. The initial patients who did not receive postablation hydration immediately after the procedure were classified as group 1 (n = 28), and the rest of the study patients who received planned fluid infusion (0.9% sodium chloride ≥2 L) after the procedure were categorized as group 2 (n = 75). RESULTS: Of the 28 patients in group 1, 21 (75%) experienced hemoglobinuria during the 24 hours after catheter ablation. The mean postablation serum creatinine (S-Cr) was significantly higher than the baseline value in those 21 patients (1.46 ± 0.28 mg/dL vs 0.86 ± 0.24 mg/dL, P < 0.001). Of those 21 patients, 4 (19%) had S-Cr. >2.5 mg/dL (mean: 2.95 ± 0.21 mg/dL). The mean number of PF applications was significantly higher in those 4 patients than in the other 17 patients experiencing hemoglobinuria (94.63 ± 3.20 vs 46.75 ± 9.10, P < 0.001). In group 2 patients, no significant changes in S-Cr were noted. The group 2 patients received significantly higher amounts of fluid infusion after catheter ablation than did those in group 1 (2,082.50 ± 258.08 mL vs 494.01 ± 71.65 mL, P < 0.001). In multivariable analysis, both hydration (R2 = 0.63, P < 0.01) and number of PFA applications (R2 = 0.33, P < 0.01) were independent predictors of postprocedure acute kidney injury. CONCLUSIONS: On the basis of our findings, both the number of PFA applications and postablation hydration were independent predictors of renal insult that could be prevented using planned fluid infusion immediately after the procedure.

Lower rate of major bleeding in very high risk patients undergoing left atrial appendage occlusion: A propensity score-matched comparison with direct oral anticoagulation.

BACKGROUND: Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation. However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high TE risk profile. OBJECTIVE: The purpose of this study was to compare the safety and efficacy of LAAO vs DOACs in patients with atrial fibrillation at very high stroke risk (CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score ≥ 5). METHODS: Data from patients with CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (covariates: CHA2DS2-VASc and HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] scores), which resulted in a matched population of 277 patients per group. The primary end point was a composite of cardiovascular death, TE events, and clinically relevant bleeding during follow-up. RESULTS: Of 2381 patients, 554 very high risk patients were included in the study (mean age 79 ± 7 years; CHA2DS2-VASc score 5.8 ± 0.9; HAS-BLED score 3.0 ± 0.9). The mean follow-up duration was 25 ± 11 months. A higher incidence of the composite end point was documented with DOACs compared with LAAO (14.9 events per 100 patient-years in the DOAC group vs 9.4 events per 100 patient-years in the LAAO group; P = .03). The annualized clinically relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; P = .04), while the risk of TE events was not different between groups (4.1% vs 3.2%; P = .63). CONCLUSION: In high-risk patients, LAAO had a similar stroke prevention efficacy but a significantly lower risk of clinically relevant bleeding when compared with DOACs. The clinical benefit of LAAO became significant after 18 months of follow-up.

Pulsed-Field Ablation Does Not Worsen Baseline Pulmonary Hypertension Following Prior Radiofrequency Ablations.

BACKGROUND: Studies have reported development of pulmonary hypertension (PH) secondary to reduced LA compliance following AF ablation. OBJECTIVES: We aimed to compare the risk of worsening of baseline PH between non-paroxysmal AF patients undergoing pulsed-field ablation (PFA) and standard radiofrequency ablation (RFA). METHODS: This multicenter study included 28 nonparoxysmal AF patients with PH undergoing a PFA-based ablation procedure after >1 failed RFA. A cohort of 28 AF patients with PH, scheduled for repeat RFA, 1:1 propensity-score matched using a multivariable logistic model, were used as the comparator group. Right heart catheterization and echocardiography were performed before and after the procedure to assess the pulmonary artery pressure (PAP). PH was defined as resting mean PAP of >20 mm Hg. RESULTS: The baseline characteristics of the PFA and propensity-matched RFA groups were comparable. The mean PAP assessments at baseline, follow-up, and change from baseline were analyzed. The groups had comparable baseline mean pulmonary artery pressures (mPAP) (P = 0.177). After adjustment for baseline mPAP in an analysis of covariance model, the least-squares means change at 3 months after ablation was -1.71 ± 1.03 mm Hg and 19.67 ± 1.03 mm Hg in PFA and RFA, respectively (P <0.001). CONCLUSIONS: In this propensity-matched population, no worsening of mPAP was detected following pulsed-field ablation in patients with pre-existing PH undergoing a repeat procedure for recurrence.

Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.

AIMS: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. CONCLUSION: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

Catheter ablation approach and outcome in HIV+ patients with recurrent atrial fibrillation.

INTRODUCTION: Earlier studies have shown a clear association between severity of human immunodeficiency virus (HIV) infection and incident atrial fibrillation (AF). We present the long-term outcome of catheter ablation (CA) and electrophysiological characteristics in HIV+ AF patients. METHODS: This study evaluated 1438 consecutive AF patients [31 (2.15%) with HIV and 1407 (97.8%) without HIV diagnosis] undergoing their first CA at our center. A total of 31 HIV patients and 31 controls were generated by propensity matching, based on calculated risk factor scores, using a logistic model. During first procedure, all received isolation of pulmonary vein (PV) + posterior wall and superior vena cava. Non-PV triggers, defined as ectopic triggers originating from sites other than PVs, were identified at the redo ablation with high-dose isoproterenol challenge. RESULTS: Clinical characteristics were not different between the groups. When compared to the control, by the end of 5 years after the first procedure, recurrence was significantly greater in HIV group [100% vs. 54%, p < .001]. Among patients that underwent redo ablation non-PV triggers were higher in HIV group [93.5% vs. 54%, p < .001], and most frequently originated from the coronary sinus [67.7% vs. 45.2%, p < .001] and left atrial appendage [41.9% vs. 25.8%, p < .001]. After focal ablation of non-PV trigger, no difference in arrhythmia recurrence between two groups [80.6% vs. 87.1%, p = .753] at 1-year follow up was found. CONCLUSION: Our findings suggest that non-PV triggers are highly prevalent in HIV+ AF patients resulting in higher rate of the mid- and long-term arrhythmia recurrence.

3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE).

BACKGROUND: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years. OBJECTIVES: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial. METHODS: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death. RESULTS: A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients. CONCLUSIONS: The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial [Amulet IDE]; NCT02879448).

Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system.

INTRODUCTION: Transseptal puncture (TSP) to allow for large delivery sheath left atrial (LA) access remains a challenging aspect of LA appendage closure (LAAC) in patients with prior history of TSP, thick or lipomatous septum, atrial septal aneurysms, or other complex cardiac anatomies. This study investigates the use of the VersaCross large access (VLA) system (Baylis Medical/Boston Scientific) to improve procedural efficiency of LAAC compared to the standard needle workflow. METHODS AND RESULTS: Fifty LAAC procedures using WATCHMAN FLX between November 2021 and September 2022 were retrospectively analyzed comparing the VLA workflow (n = 25) to the standard needle workflow (n = 25). Study primary endpoint was time to procedural efficiency, and secondary endpoints included TSP time, acute LAAC success, fluoroscopy use, device recaptures, and periprocedural complications. Acute LAAC was successfully completed in all cases with no intraprocedural complications. TSP time was faster, but not significant, using the VLA workflow compared to the standard RF needle workflow (2.6 ± 1.1 min vs. 3.0 ± 1.8 min, p = 0.38). Time to WATCHMAN sheath in LA from TSP was 27% faster (1.5 ± 0.8 min vs. 2.1 ± 0.9 min; p = 0.03), and time to WATCHMAN release from TSP was 19% faster (10.5. ± 2.5 min vs. 13.0 ± 3.7 min; p = 0.01) with the VLA workflow. Overall procedure time was 15% faster (30.4 ± 5.1 min vs. 36.0 ± 6.6 min; p = 0.003) using VLA. Fluoroscopy time was 25% lower (4.0 ± 2.2 min vs. 5.5 ± 2.3 min; p = 0.003) and fluoroscopy dose was 60% lower (97.0 ± 91.7 mGy vs. 241.8 ± 240.6 mGy; p = 0.01) and more consistent [F-test, p ˂ 0.0001] using the VLA workflow compared to the needle workflow. CONCLUSION: The VLA system streamlines LAAC procedures, improving LAAC efficiency and reducing fluoroscopy use by allowing for de novo dilation of the septum for large-bore delivery sheaths, and reducing device exchanges and delivery sheath manipulation.

Impact of Colchicine Monotherapy on the Risk of Acute Pericarditis Following Atrial Fibrillation Ablation.

BACKGROUND: Acute pericarditis is a known complication of ablation procedures for atrial fibrillation (AF). OBJECTIVES: This study aimed to evaluate the benefits of colchicine monotherapy in terms of reducing the risk of pericarditis and related hospitalization rate in AF patients undergoing catheter ablation. METHODS: Consecutive AF patients undergoing first catheter ablation were classified into 3 groups based on their colchicine use: Group 1: no colchicine; group 2: colchicine from 7 days before to 1 month after ablation; and group 3: colchicine from the day of the procedure to 1 month after. Standard institutional protocol was used to follow all patients for 1 year. RESULTS: A total of 1,075 patients were classified into groups 1 (n = 607), 2 (n = 213), and 3 (n = 255). Symptoms of acute pericarditis were reported in 129 patients (12%): group 1: n = 106 (17.5%); group 2: n = 4 (1.9%); and group 3: n = 19 (7.5%); P < 0.001. Rate of mild-moderate as well as severe pericarditis were significantly lower in group 2. In the multivariable regression analysis, pre- and post-ablation colchicine use was seen to be associated with significantly lower risk of acute pericarditis and related hospitalization compared with the other 2 groups. In addition, at 1-year follow-up, arrhythmia-free survival rate was significantly higher in paroxysmal AF patients receiving colchicine compared with the no-colchicine population. CONCLUSIONS: Colchicine therapy starting 7 days before to 1 month after the ablation procedure was associated with significantly lower risk of acute pericarditis and related hospitalization. In addition, paroxysmal AF patients receiving colchicine had a higher arrhythmia-free survival rate compared with those not receiving colchicine.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

AIMS: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding. METHODS: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month. RESULTS: Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047). CONCLUSIONS: Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

Best ablation strategy in patients with premature ventricular contractions with multiple morphology: a single-centre experience.

AIMS: This study aimed to examine the clinical benefits of targeted ablation of all Premature ventricular complex (PVC) morphologies vs. predominant PVC only. METHODS AND RESULTS: A total of 171 consecutive patients with reduced left ventricular ejection fraction (LVEF) and ≥2 PVC morphology with high burden (>10%/day) undergoing their first ablation procedure were included in the analysis. At the initial procedure, prevalent PVC alone was ablated in the majority. However, at the redo, all PVC morphologies were targeted for ablation. : At the first procedure, 152 (89%) patients received ablation of the dominant PVC only. In the remaining 19 (11%) patients, all PVC morphologies were ablated. At two years, high PVC burden was detected in 89 (52%) patients. Repeat procedure was performed in 78 of 89, where all PVC morphologies were ablated. At 5 years after the repeat procedure, 71 (91%) had PVC burden of <5% [3.8 ± 1.1% vs. 15.4 ± 4.3% in successful vs. failed subjects (P < 0.001)]. In patients with low PVC burden after the initial procedure, LVEF improved from 37.5% to 41.6% [mean difference (MD): 3.39 ± 2.9%, P < 0.001], whereas a reduction in LVEF from 39.8% to 34.5% (MD: 6.45 ± 4.7%, P < 0.001) was recorded in patients with high PVC burden. One year after the repeat procedure, LVEF improved from 36.2% to 41.7% (MD: 5.5 ± 4.3%, P < 0.001) in patients with successful ablation. CONCLUSION: In this observational series, ablation of all PVC morphologies was associated with significantly lower PVC burden and improvement of LVEF at long-term follow-up, compared with ablation of the dominant morphology only.

Two-Year Outcomes With a Next-Generation Left Atrial Appendage Device: Final Results of the PINNACLE FLX Trial.

Background The PINNACLE FLX (Protection Against Embolism for Non-valvular AF [Atrial Fibrillation] Patients: Investigational Device Evaluation of the Watchman FLX LAA [Left Atrial Appendage] Closure Technology) trial evaluated the safety and efficacy of a next-generation left atrial appendage closure device (WATCHMAN FLX; Boston Scientific, Marlborough, MA). At 1 year, the study met the primary end points of safety and anatomical efficacy/appendage closure. This final report of the PINNACLE FLX trial includes the prespecified secondary end point of ischemic stroke or systemic embolism at 2 years, also making it the first report of 2-year outcomes with this next-generation left atrial appendage closure device. Methods and Results Patients with nonvalvular atrial fibrillation with CHA2DS2-VASc score ≥2 (men) or ≥3 (women), with an appropriate rationale for left atrial appendage closure, were enrolled to receive the left atrial appendage closure device at 29 US centers. Adverse events were assessed by an independent clinical events committee, and imaging was assessed by independent core laboratories. Among 395 implanted patients (36% women; mean age, 74 years; CHA2DS2-VASc, 4.2±1.5), the secondary efficacy end point of 2-year ischemic stroke or systemic embolism was met, with an absolute rate of 3.4% (annualized rate, 1.7%) and an upper 1-sided 95% confidence bound of 5.3%, which was superior to the 8.7% performance goal. Two-year rates of adverse events were as follows: 9.3% all-cause mortality, 5.5% cardiovascular death, 3.4% all stroke, and 10.1% major bleeding (Bleeding Academic Research Consortium 3 or 5). There were no additional systemic embolisms, device embolizations, pericardial effusions, or symptomatic device-related thrombi after 1 year. Conclusions The secondary end point of 2-year stroke or systemic embolism was met at 3.4%. In these final results of the PINNACLE FLX trial, the next-generation WATCHMAN FLX device demonstrated favorable safety and efficacy outcomes.

Prevalence of atrial fibrillation and procedural outcome in patients undergoing catheter ablation for premature ventricular complexes.

INTRODUCTION: Atrial fibrillation (AF) and premature ventricular complexes (PVC) are common arrhythmias. We aimed to investigate AF prevalence in patients with PVC and its impact on PVC ablation outcomes. METHODS: Consecutive patients undergoing PVC ablation at a single institution between 2016 and 2019 were included and prospectively followed for 2 years. Patients with severe valvular heart disease, hyperthyroidism, malignancy, alcohol use disorder and advanced renal/hepatic diseases were excluded. Twelve-lead electrocardiograms were used to diagnose AF and assess PVC morphology. All PVCs were targeted for ablation using 4-mm irrigated-tip catheters at standardized radiofrequency power guided by 3-D mapping and intracardiac echocardiography. Patients were followed with remote monitoring, device interrogations and office visits every 6 months for 2 years. Detection of any PVCs in follow-up was considered as recurrence. RESULTS: A total of 394 patients underwent PVC ablation and 96 (24%) had concurrent AF. Patients with PVC and AF were significantly older (68.2 ± 10.8 vs. 58.3 ± 15.8 years, p < .001), had lower LV ejection fraction (43.3 ± 13.3% vs. 49.6 ± 12.4%, p < .001), higher CHA2 DS2 -VASc (2.8 ± 1.3 vs. 2.0 ± 1.3, p < .001) than those without. PVCs with ≥2 morphologies were detected in 60.4% and 13.7% patients with vs without AF (p < .001). At 2-year follow-up, PVC recurrence rate was significantly higher in patients with vs without AF (17.7% vs. 9.4%, p = .02). CONCLUSION: AF was documented in 1/4 of patients undergoing PVC ablation and was associated with lower procedural success at long-term follow-up. This was likely attributed to older age, worse LV function and higher prevalence of multiple PVC morphologies in patients with concurrent AF.

Cardiac computed tomography following Watchman FLX implantation: device-related thrombus or device healing?

AIMS: Cardiac computed tomography (CT) is increasingly utilized during follow-up after left atrial appendage closure (LAAC). Hypoattenuated thickening (HAT) is a common finding and might represent either benign device healing or device-related thrombosis (DRT). The appearance and characteristics of HAT associated with the Watchman FLX have not been previously described. Therefore, we sought to investigate cardiac CT findings during follow-up after Watchman FLX implantation with a focus on HAT and DRT. METHODS AND RESULTS: Retrospective single-centre, observational study including all patients with successful Watchman FLX implantation and follow-up cardiac CT between March 2019 and September 2021 (n = 244). Blinded analysis of CT images was performed describing the localization, extent, and morphology of HAT and correlated to imaging and histology findings in a canine model. Relevant clinical and preclinical ethical approvals were obtained.Overall, HAT was present in 156 cases (64%) and could be classified as either subfabric hypoattenuation (n = 59), flat sessile HAT (n = 78), protruding sessile HAT (n = 16), or pedunculated HAT (n = 3). All cases of pedunculated HAT and five cases of protruding sessile HAT were considered as high-grade HAT (n = 7). Subfabric hypoattenuation and flat sessile HAT correlated with device healing and endothelialization in histological analysis of explanted devices. CONCLUSION: Subfabric hypoattenuation and flat sessile HAT are frequent CT findings for Watchman FLX, likely representing benign device healing and endothelialization. Pedunculated HAT and protruding HAT are infrequent CT findings that might represent DRT.

Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance.

AIMS: Left atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. We aimed at reporting procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transoesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing. METHODS AND RESULTS: Among 274 patients undergoing left atrial appendage occlusion (LAAO) with a Watchman FLX, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel (NUVISION™) 3D-ICE one (54 patients). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks ≥ 3 mm at follow-up TEE. 3D-ICE measurements of maximum landing zone correlated highly with pre-procedural TEE reference values [Pearson's: 0.94; P < 0.001; bias: -0.06 (-2.39, 2.27)]. The agreement between 3D-ICE-based device selection and final device size was 96.3% vs. 79.1% with 2D-ICE (P = 0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (P = 0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs. 44.5%; P = 0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients vs. 45.9% of 2D-ICE ones (P = 0.065). CONCLUSION: Intracardiac echocardiography-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for FLX size selection and may provide better guidance during device deployment.

Evaluation of Multimodality LAA Leak Closure Methods Following Incomplete Occlusion: The LAA Leak Study.

BACKGROUND: Incomplete left atrial appendage (LAA) closure is an evolving topic of clinical significance and thromboembolic potential, with recent long-term studies suggesting lower cutoffs for relevant leak size. OBJECTIVES: The aim of this prospective observational study was to assess 3 different closure techniques for persistent peridevice leaks after incomplete LAA closure and compare their efficacy and safety outcomes. METHODS: We studied 160 patients (mean age 72 ± 9 years; 71% men) who underwent 1 of the 3 available modalities (detachable embolization coils, vascular plugs or septal occluders, and radiofrequency ablation) for residual central or eccentric leak closure. Both acute postprocedural success (closure or <1-mm leak at the end of the procedure) and closure at 1-year follow-up transesophageal echocardiography imaging were evaluated. RESULTS: Of 160 patients, 0.6%, 41.3%, and 58.1% had mild (1-2 mm), moderate (3-5 mm), and severe (≥5 mm) leaks, respectively. Baseline LAA closure type was 72.5% Watchman FLX, 16.3% Lariat, 5.6% surgical ligation, 1.9% AtriClip, and 1.9% Amulet. Successful closure (0- or <1-mm leak) was seen in 100% of patients in all cohorts following intervention, with overall complete closure (0-1 mm) or mild or minimal leaks (1-2 mm) on 1-year follow-up transesophageal echocardiography seen in 100% of the atrial septal occluder or vascular plug cohort, 85.9% of the coil cohort, and 83.3% of the radiofrequency ablation cohort (P < 0.001). Two patients (1.3%) experienced cardiac tamponade, and there were no deaths or other complications. CONCLUSIONS: Peridevice leaks can safely and effectively be closed using 3 different modalities depending on size and location.