Step-by-step recommendations utilizing four-dimensional intracardiac echocardiography in left atrial appendage procedures.

INTRODUCTION: Four-dimensional (4D) intracardiac echocardiography (ICE) is a novel cardiac imaging modality that has been applied to various workflows, including catheter ablation, tricuspid valve repair, and left atrial appendage occlusion (LAAO). The use of this type of advanced ICE imaging may ultimately allow for the replacement of transesophageal echocardiography (TEE) for LAAO, providing comparable imaging quality while eliminating the need for general anesthesia. METHODS: Based on our initial clinical experience with 4D ICE in LAAO, we have developed an optimized workflow for the use of the NUVISION™ 4D ICE Catheter in conjunction with the GE E95 and S70N Ultrasound Systems in LAAO. In this manuscript, we provide a step-by-step guide to using 4D ICE in conjunction with compatible imaging consoles. We have also evaluated the performance of 4D ICE with the NUVISION Ultrasound Catheter versus TEE in one LAAO case and present those results here. RESULTS: In our comparison of 4D ICE using our optimized workflow with TEE in an LAAO case, ICE LAA measurements were similar to those from TEE. The best image resolution was seen via ICE in 2-dimensional and multislice modes (triplane and biplane). The FlexiSlice multiplanar reconstruction tool, which creates an en-face image derived from a 4D volume set, also provided valuable information but yielded slightly lower image quality, as expected for these volume-derived images. For this case, comparable images were obtained with TEE and ICE but with less need to reposition the ICE catheter. CONCLUSION: The use of optimized 4D ICE catheter workflow recommendations allows for efficient LAAO procedures, with higher resolution imaging, comparable to TEE.

Best anticoagulation strategy with and without appendage occlusion for stroke-prophylaxis in postablation atrial fibrillation patients with cardiac amyloidosis.

INTRODUCTION: Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. METHODS: Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke" in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD) NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. RESULTS: A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HD NOAC. At 1-year follow-up, four stroke, one TIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and four GI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. CONCLUSION: In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.

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.

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.

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.

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.

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.

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.

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.

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

BACKGROUND: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. METHODS: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. RESULTS: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. CONCLUSIONS: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.

Leak closure following left atrial appendage exclusion procedures: A multicenter registry.

BACKGROUND: Though infrequent, incomplete left atrial appendage closure (LAAC) may result from residual leaks. Percutaneous closure has been described though data is limited. METHODS: We compiled a registry from four centers of patients undergoing percutaneous closure of residual leaks following LAAC via surgical means or with the Watchman device. Leak severity was classified as none (no leak), mild (1-2 mm), moderate (3-4 mm), or severe (≥5 mm). Procedural and clinical success was defined as the elimination of leak or mild residual leak at the conclusion of the procedure or follow-up, respectively. RESULTS: Of 72 (age 72.2 ± 9.2 years; 67% male) patients, 53 had undergone prior LAAC using the Watchman device and 19 patients surgical LAAC. Mean CHADS2 -VA2 Sc score was 4.0 ± 1.8. The median leak size was 5 mm, range: 2-13). A total of 13 received Amplatzer Vascular Plug-II, 18 received Amplatzer Duct Occluder-II and 40 patients received coils. One underwent closure using a 21 mm-Watchman. Procedural success was 94%. Zero surgical and nine Watchman patients (13%) had a residual leak at procedural-end (five mild, three moderate, and one severe)-only one patient had no reduction in leak size. Overall leak size reduction was 94%. Two (3%) had intraoperative pericardial effusion. There were no device embolizations, device-related thrombi, or procedural deaths. Clinical success was maintained at 94%. Two had cerebrovascular accidents-at 2 days (transient ischemic attack) and 10 months postprocedure. Two had major bleeding outside the 30-day periprocedural window. CONCLUSION: Percutaneous closure of residual leaks following left atrial appendage closure is feasible and associated with good outcomes. The procedural risk appears to be satisfactory.

Amplatzer PFO Occluder for treatment of incomplete LAA closure with AtriClip.

Herein, we describe the use of an Amplatzer PFO Occluder to treat incomplete LAA closure due to a malpositioned AtriClip.

Results from the prospective, multicenter AMBULATE-CAP trial: Reduced use of urinary catheters and protamine with hemostasis via the Mid-Bore Venous Vascular Closure System (VASCADE® MVP) following multi-access cardiac ablation procedures.

INTRODUCTION: Manual compression (MC), historically the most common method to achieve hemostasis after percutaneous vascular procedures, is time consuming, requires prolonged bedrest, and is uncomfortable for patients and clinicians. Recent studies demonstrate the efficacy and safety of vascular closure devices and suggest shorter times to hemostasis and patient ambulation compared with MC. The current study evaluated the feasibility of the VASCADE® venous vascular closure system (VVCS) while allowing for urinary catheter (UC) elimination, and elimination of protamine and/or same calendar day discharge (SCDD). METHODS AND RESULTS: In this prospective, multicenter trial, patients were enrolled and assigned to the following groups: no UC, no protamine, and/or SCDD (no co-enrollment in no protamine and SCDD). After completing the catheter-based cardiac procedure, access sites were closed using the VVCS. Outcomes included final hemostasis (all sites) without major access site-related complications at 30 days, rates of access site closure-related complications, device success, and study group success. All 168 patients had hemostasis without major access site-related complications through 30 days. In the no UC group, 160 out of 164 (97.6%) patients did not receive a UC. Additionally, 39 out of 41 (95.1%) patients received heparin without protamine reversal and no access site bleeding-related ambulation delays, and 18 out of 18 (100%) patients were discharged on the same day. There were no major access site closure-related complications, few minor complications, and adverse events were generally mild and well managed. CONCLUSION: The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed.

Intracardiac echocardiography- versus transesophageal echocardiography-guided left atrial appendage occlusion with Watchman FLX.

INTRODUCTION: Watchman FLX has been recently approved for left atrial appendage occlusion (LAAO) in the US. Intracardiac echocardiography (ICE) - which is already commonly used to guide trans-septal access - can serve as an alternative to TEE, simplifying the procedure and reducing associated costs. Herein, we report our experience with ICE-guided LAAO with Watchman FLX. METHODS AND RESULTS: This cohort study included the first 190 consecutive patients who underwent LAAO with Watchman FLX in our center. LAAO was successful in all patients without significant peri-procedural, device-related complications in either group. Compared to TEE, we observed a significant reduction in procedural times when using ICE. In addition, there was a potentially clinically relevant reduction in fluoroscopy dose, mainly secondary to fewer cine acquisition runs. At follow-up, no cases of device embolism were noted, whereas the rate of device-related thrombosis and peri-device leaks were comparable between groups. CONCLUSION: ICE-guided LAAO with Watchman FLX is safe and feasible, with a significant reduction in procedural time and potential reduction in fluoroscopy dose when compared to TEE.

Half-normal saline versus normal saline for irrigation of open-irrigated radiofrequency catheters in atrial fibrillation ablation.

BACKGROUND: The creation of effective and permanent lesions is a crucial factor in determining the success rate of atrial fibrillation (AF) ablation. By increasing the efficacy of radiofrequency (RF) energy-mediated lesion formation, half-normal saline (HNS) as an irrigant for open-irrigated ablation catheters has the potential to reduce procedural times and improve acute and long-term outcomes. METHODS: This is a double-blind randomized clinical trial of 99 patients undergoing first-time RF catheter ablation for AF. Patients enrolled were randomly assigned in a 1:1 fashion to perform ablation using HNS or normal saline (NS) as an irrigant for the ablation catheter. RESULTS: The use of HNS is associated with shorter RF times (26 vs. 33 min; p = .02) with comparable procedure times (104 vs. 104 min). The rate of acute pulmonary vein reconnections (16% vs. 18%) was comparable, with a median of 1 vein reconnection in the HNS arm versus 2 in the NS arm. There was no difference in procedure-related complications, including the incidence of postprocedural hyponatremia when using HNS. Over the 1-year follow-up, there is no significant difference between the HNS and NS with respect to the recurrence of any atrial arrhythmia (off antiarrhythmic drugs [AAD]: 47% vs. 52%; hazard ratio [HR]: 1.17, 95% confidence interval [CI]: 0.66-2.06; off/on AAD: 66% vs. 66%, HR: 1.06, 95% CI: 0.53-2.12), with a potential benefit of using HNS when considering the paroxysmal AF cohort (on/off AAD 73% vs. 62%, HR: 0.72, 95% CI: 0.19-2.70). CONCLUSIONS: In a mixed cohort of patients undergoing first-time AF ablation, irrigation of open-irrigated RF ablation catheters with HNS is associated with shorter RF times, with a comparably low rate of procedure-related complications. In the long term, there is no significant difference with respect to the recurrence of any atrial arrhythmia. Larger studies with a more homogeneous population are necessary to determine whether HNS improves clinical outcomes.

Clinical presentation, diagnosis, and treatment of atrioesophageal fistula resulting from atrial fibrillation ablation.

BACKGROUND: Atrioesophageal fistula (AEF) is a worrisome complication of atrial fibrillation (AF) ablation. Its clinical manifestations and time course are unpredictable and may contribute to diagnostic and treatment delays. We conducted a systematic review of all available cases of AEF, aiming at characterizing clinical presentation, time course, diagnostic pitfalls, and outcomes. METHODS: The digital search retrieved 150 studies containing 257 cases, 238 (92.6%) of which with a confirmed diagnosis of AEF and 19 (7.4%) of pericardioesophageal fistula. RESULTS: The median time from ablation to symptom onset was 21 days (interquartile range [IQR]: 11-28). Neurological abnormalities were documented in 75% of patients. Compared to patients seen by a specialist, those evaluated at a walk-in clinic or community hospital had a significantly greater delay between symptom onset and hospital admission (median: 2.5 day [IQR: 1-8] vs. 1 day [IQR: 1-5); p = .03). Overall, 198 patients underwent a chest scan (computed tomography [CT]: 192 patients and magnetic resonance imaging [MRI]: 6 patients), 48 (24.2%; 46 CT and 2 MRI) of whom had normal/unremarkable findings. Time from hospital admission to diagnostic confirmation was significantly longer in patients with a first normal/unremarkable chest scan (p < .001). Overall mortality rate was 59.3% and 26.0% survivors had residual neurological deficits at the time of discharge. CONCLUSIONS: Since healthcare professionals of any specialty might be involved in treating AEF patients, awareness of the clinical manifestations, diagnostic pitfalls, and time course, as well as an early contact with the treating electrophysiologist for a coordinated interdisciplinary medical effort, are pivotal to prevent diagnostic delays and reduce mortality.

Targeting non-pulmonary vein triggers in persistent atrial fibrillation: results from a prospective, multicentre, observational registry.

AIMS: We evaluated the efficacy of an ablation strategy empirically targeting pulmonary veins (PVs) and posterior wall (PW) and the prevalence and clinical impact of extrapulmonary trigger inducibility and ablation in a large cohort of patients with persistent atrial fibrillation (PerAF). METHODS AND RESULTS: A total of 1803 PerAF patients were prospectively enrolled. All patients underwent pulmonary vein antrum isolation (PVAI) extended to the entire PW. A standardized protocol was performed to confirm persistent PVAI and elicit any triggers originating from non-PV sites. All non-PV triggers initiating sustained atrial tachyarrhythmias were ablated. Ablation of non-PV sites triggering non-sustained runs (<30 s) of atrial tachyarrhythmias or promoting frequent premature atrial complexes (≥10/min) was left to operator's discretion. Overall, 1319 (73.2%) patients had documented triggers from non-PV areas. After 17.4 ± 8.5 months of follow-up, the cumulative freedom from atrial tachyarrhythmias among patients without inducible non-PV triggers (n = 484) was 70.2%. Patients with ablation of induced non-PV triggers had a significantly higher arrhythmia control than those whose triggers were not ablated (67.9% vs. 39.4%, respectively; P < 0.001). After adjusting for clinically relevant variables, patients in whom non-PV triggers were documented but not ablated had an increased risk of arrhythmia relapse (hazard ratio: 2.39; 95% confidence interval: 2.01-2.83; P < 0.001). CONCLUSION: Pulmonary vein antrum isolation extended to the entire PW might provide acceptable long-term arrhythmia-free survival in PerAF patients without inducible non-PV triggers. In our population of PerAF patients, non-PV triggers could be elicited in ∼70% of PerAF patients and their elimination significantly improved outcomes.

Fluoroless 3D mapping-guided pacemaker implant in a pregnant patient.

We describe a case of pacemaker implant guided by intracardiac echocardiography and three-dimensional anatomical mapping in a pregnant patient, with no peri-procedural use of radiation.

Arrhythmia profile and ablation-outcome in elderly women with atrial fibrillation undergoing first catheter ablation.

BACKGROUND: This study evaluated the arrhythmia profile and ablation outcome in women with atrial fibrillation (AF) aged ≥75 years. METHODS: A total of 573 consecutive female patients undergoing first AF ablation were classified into group 1: ≥75 years (n = 221) and group 2: < 75 years (n = 352). Isolation of PVs, posterior wall and superior vena cava was performed in all. Non-PV triggers from other areas were ablated based on operator's discretion. RESULTS: Group 1 had higher prevalence of hypertension (154 (69.7%) vs. 188 (53.4%), p < .001) and non-paroxysmal AF (136 (61.5%) vs. 126 (35.8%), p < .001). Non-PV triggers were detected in 194 (87.8%) patients from group 1 and 143 (40.6%) from group 2 (p < .001) and were ablated in 152 (68.8%) and 114 (32.4%) from group 1 and 2 respectively. Remaining patients (group 1: 69/221 and group 2: 238/352) received no additional ablation. At 4 years, 109 (49.3%) and 185 (52.6%) from group 1 and 2, respectively, were arrhythmia-free, p = .69. When stratified by ablation-strategy, success-rate was similar across groups in patients receiving non-PV trigger ablation (96 (63.2%) in group 1 and 76 (66.7%) in group 2, p = .61), whereas it was significantly lower in group 1 patients not receiving additional ablation compared to those from group 2 (13 (18.8%) vs. 109 (45.8%), p < .001). CONCLUSION: Non-paroxysmal AF was more common in women aged ≥75 years. Furthermore, significantly higher number of non-PV triggers were detected in elderly women and ablation of those provided similar ablation success as that in women aged < 75 years.