Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation.

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. RESULTS: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. CONCLUSION: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.

TriGuard Embolic Protection Device in percutaneous cardiac interventions with intracavitary cardiac thrombosis: A case series.

Embolic cerebral protection devices are not routinely used in clinical practice during electrophysiological interventions. We report a case series of patients with intracardiac thrombosis undergoing a percutaneous left atrial appendage (LAA) closure and a ventricular tachycardia (VT) catheter ablation supported by TriGuard 3 Cerebral Embolic Protection Device.

Pulsed-field ablation of pulmonary vein and left atrial posterior wall combined with left atrial appendage occlusion as single procedure.

Pulmonary vein isolation and left atrial posterior wall ablation using the Farapulse system, followed by left atrial appendage occlusion, have been achieved as single combined procedure to treat long-standing persistent atrial fibrillation in a patient at high hemorrhagic risk.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.

In vivo Lesion Index (LSI) validation in percutaneous radiofrequency catheter ablation.

INTRODUCTION: Lesion Index (LSI) has been developed to predict lesion efficacy during radiofrequency (RF) catheter ablation. However, its value in predicting lesions size has still to be established. The aim of our study was to assess the lesions size reproducibility for prespecified values of LSI reached during RF delivery in an in vivo beating heart. METHODS: Ablation lesions were created with different values of LSI in seven domestic pigs by means of a contact force-sensing catheter (TactiCathTM , Abbott). Lesions were identified during RF delivery by means of a three-dimensional mapping system (EnSiteTM Precision, Abbott) and measured after heart explantation. Histology was carried out after gross examination on the first three lesions to confirm the accuracy of the macroscopic evaluation. RESULTS: A total of 64 myocardial lesions were created. Thirty-nine lesions were excluded from the analysis for the following reasons: histological confirmation of macroscopic lesion measurement (n = 3), transmurality (n = 24), unfavorable anatomic position (n = 10), not macroscopically identifiable (n = 2). In a final set of 25 nontransmural lesions, injury width and depth were, respectively, 4.6 ± 0.6 and 2.6 ± 0.8 mm for LSI = 4, 7.3 ± 0.8 and 4.7 ± 0.6 mm for LSI = 5, and 8.6 ± 1.2 and 7.2 ± 1.1 mm for LSI = 6. A strong linear correlation was observed between LSI and lesion width (r = .87, p < .00001) and depth (r = .89, p < .00001). Multiple linear regression analysis identified LSI as the only ablation parameter that significantly predicted lesion width (p < .001) and depth (p < .001). CONCLUSION: In our in vivo study, LSI proved highly predictive of lesion size and depth.

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.

AIMS: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. METHODS AND RESULTS: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. CONCLUSION: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.

Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform.

INTRODUCTION: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report. METHODS: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared with a historical cohort of patients submitted to AF cryoablation with the AFAP. RESULTS: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA2 DS2 -VASc 1, left-atrium size 34 ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p = .39). The median total procedural time was longer in the POLARx™ group (90 min vs. 60 min, p < .001), but the overall time-to-isolation (TTI; 44.8 s vs. 39 s, p = .253) and ablation time (15 min vs. 13.7 min, p = .122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57°C vs -47°C, p < .001). CONCLUSION: The novel POLARx™ cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.

High-density mapping validation of antral pulmonary vein isolation and posterior wall isolation created with a new cryoballoon ablation system: The first reported case.

Cryoballoon ablation is a recognized and widespread method for pulmonary vein isolation. For many years the impossibility of using it to create additional lines was considered a drawback of this approach. However, recently, the technique was adapted to allow the creation of rooflines, and potentially also inferior lines. In this article, we present the first reported case of a patient submitted to pulmonary vein isolation plus posterior wall isolation using the novel Boston POLAR X™ cryoballoon exclusively. To confirm the quality of the lesions, the patient underwent pre and postablation high-density mapping.

Cardiac and arrhythmic complications in patients with COVID-19.

In December 2019, the world started to face a new pandemic situation, the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). Although coronavirus disease (COVID-19) clinical manifestations are mainly respiratory, major cardiac complications are being reported. Cardiac manifestations etiology seems to be multifactorial, comprising direct viral myocardial damage, hypoxia, hypotension, enhanced inflammatory status, ACE2-receptors downregulation, drug toxicity, endogenous catecholamine adrenergic status, among others. Studies evaluating patients with COVID-19 presenting cardiac injury markers show that it is associated with poorer outcomes, and arrhythmic events are not uncommon. Besides, drugs currently used to treat the COVID-19 are known to prolong the QT interval and can have a proarrhythmic propensity. This review focus on COVID-19 cardiac and arrhythmic manifestations and, in parallel, makes an appraisal of other virus epidemics as SARS-CoV, Middle East respiratory syndrome coronavirus, and H1N1 influenza.

A left atrial appendage closure combined procedure review: Past, present, and future perspectives.

BACKGROUND AND OBJECTIVE: Atrial fibrillation (AF) represents the most common cardiac arrhythmia worldwide; it poses a great burden in terms of quality of life reduction and yearly stroke risk. Left atrial appendage closure (LAAC) is a stroke prevention strategy that has been proven a viable alternative to antithrombotic regimens in nonvalvular AF patients. LAAC can be performed as a standalone procedure or alongside a concomitant AF transcatheter ablation, in a procedure known as "Combined procedure". Aim of this study is to summarize the scientific evidence backing this combined strategy. METHODS: We reviewed the whole Medline indexed combined procedure literature, to summarize all the combined procedure study data. RESULTS: Nine published studies regarding combined procedure were found. Data, aims, and scientific rationales were reported and commented. CONCLUSION: LAA combined procedure appears to be a safe and effective procedure; a careful patient selection is necessary to maximize its benefit.

Cryoablation of atrial fibrillation with the fourth-generation balloon: The first reported case.

Cryoballoon ablation was developed as a new treatment for pulmonary vein (PV) isolation and has demonstrated high procedural success and comforting long-term clinical outcome. However, some improvements are necessary for real-time visualization of PV signals that appeared important to increase the efficacy and reduce ineffective cryoapplications. We report, for the first time, a cryoablation procedure using the fourth-generation cryoballoon, describing betterment in vein signal recording and acute procedural success.

Acute outcome after a single cryoballoon ablation: Comparison between Arctic Front Advance and Arctic Front Advance PRO.

BACKGROUND: The novel fourth-generation cryoballoon (CB4) potentially allows for enhanced catheter maneuverability and more frequent capture of pulmonary vein (PV) potentials which can be used to monitor real-time PV isolation (PVI). The aim of our study is to compare the acute procedural endpoints between the CB4 and second-generation cryoballoon (CB2). METHODS: A single-center retrospective chart review was used to examine 50 consecutive patients with drug-refractory atrial fibrillation undergoing CB4-based PVI. Procedural data and acute success of these patients were compared to 50 propensity-matched controls who underwent cryoballoon ablation procedure using CB2. RESULTS: Procedures performed with the CB4 showed significant shorter fluoroscopy time (14.8 ± 5.5 vs 18.0 ± 6.5 minutes, P = .04), shorter procedure time (58.3 ± 15.7 vs 65.3 ± 21 minutes, P = .13), and shorter total ablation time (10.8 ± 1.5 vs 13.8 ± 1.9 minutes, P = .42). The real-time PVI visualization rate was 33.3% in the CB2 group and 74.7% in the CB4 group (P < .001). CB4 was correlated to significant increase of acute real-time recordings with regard to all the single PV (left superior PV: 58% vs 84%, P = .02; left inferior PV: 26% vs 71%, P = .001; right superior PV 29% vs 61%, P = .01; and right inferior PV 19% vs 58%, P = .002). CONCLUSION: The CB4 was more often able to capture real-time recordings of PV potentials and the subsequent acute PV isolation.

Contrast Dye ICE Cap Embolization Using the Third-Generation Cryoballoon.

Cryoballoon ablation is a widely diffuse technology to perform paroxysmal atrial fibrillation ablation. The new generation cryoballoon catheters have been redesigned in order to improve the cooling capability. During cryoballoon ablation, it is not unusual to observe the formation of a contrast dye ice cap on top of the balloon itself. The automated balloon deflation before dissolution of the ice cap may increase the risk of embolization of large ice-mixed-contrast crystals in the systemic circulation. In the case hereby reported, we describe an uneventful embolization of this contrast dye ice cap in the systemic circulation.

Left Atrial Appendage Closure Guided by 3D Printed Cardiac Reconstruction: Emerging Directions and Future Trends.

INTRODUCTION: Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative therapeutic approach to medical therapy for stroke prevention in patients with atrial fibrillation. 3D printing is a novel technology able to create a patient specific model of any given anatomical portion of the heart. RESULTS: Herein we report the first 2 cases of LAA occlusion procedure with 2 different systems, the Wave Crest device (Coherex Medical, Inc., USA) and the Amplatzer Amulet device (St. Jude Medical, St. Paul, MN, USA), in which a 3D printed LAA model (Care Tronik, Prato, Italy) was used in a rehearse phase. Both patients had history of paroxysmal AF and previous transient ischemic attack (TIA) occurred during oral anticoagulation with correct INR. In the first patient the occlusive device was positioned within the LAA after a rehearse occlusion using the 3D printed LAA plus a 27 mm Coherex Wavecrest device, demonstrating a good compression and sealing, particularly considering a proximal lobe of the appendage. In the second patient an attempt with the 27 mm Amulet device delivered within the 3D printed LAA, based on angiography and transesophageal echocardiographic (TEE), revealed insufficient covering of the proximal part of LAA vestibule; the device was released only after a second test with the 31 mm Amulet demonstrating a good sealing. CONCLUSION: These 2 cases demonstrated that 3D model could help in finding the correct position within LAA, sizing the device and guiding the choice of the closure device despite the measurements provided by angiography and TEE.

Concomitant cryoballoon ablation and percutaneous closure of left atrial appendage in patients with atrial fibrillation.

AIMS: Pulmonary veins (PVs) isolation is the cornerstone of atrial fibrillation (AF) ablation and can be achieved either by conventional radiofrequency ablation or by cryoenergy. Left atrial appendage (LAA) closure has been proposed as alternative treatment to vitamin K antagonists (VKA). We aimed to evaluate the feasibility of combining cryoballoon (CB) ablation and LAA occlusion in patients with AF and a high thromboembolic risk or contraindication to antithrombotic therapy. METHODS AND RESULTS: Thirty-five patients (28 males, 74 ± 2 years) underwent CB ablation. Left atrial appendage occlusion was carried out by using two occluder devices (Amplatz Cardiac Plug, ACP, St. Jude Medical, MN, USA, in 25 patients; Watchman, Boston Scientific, MA, USA, in 10 patients). Thirty patients (86%) had previous stroke/TIA episodes, 6 patients (17%) had major bleeding while on VKA therapy, and 7 patients (20%) had inherited bleeding disorders. Over the follow-up (24 ± 12 months), atrial arrhythmias recurred in 10 (28%) patients. Thirty patients (86%) had complete sealing; 5 patients (14%) showed a residual flow (<5 mm) at first transoesophageal echocardiography (TEE) check, while at 1-year TEE residual flow was detected in 3 patients. In 13 patients (37%), VKA therapy was immediately discontinued. Six patients (17%) received novel oral anticoagulants treatment and then discontinued 3 months thereafter. No device-related complications or clinical thromboembolic events occurred. CONCLUSION: Combined CB ablation and LAA closure using different devices appears to be feasible in patients with non-valvular AF associated with high risk of stroke or contraindication to antithrombotic treatment.

Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial.

BACKGROUND: Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation (AF). The periprocedural anticoagulation management could play a role in the incidence of these complications. Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk, no randomized study exists. METHODS AND RESULTS: This was a prospective, open-label, randomized, parallel-group, multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation. Patients with CHADS2 score ≥1 were included. Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm. The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study. The study enrolled 1584 patients: 790 assigned to discontinue warfarin (group 1) and 794 assigned to continuous warfarin (group 2). No statistical difference in baseline characteristics was observed. There were 39 thromboembolic events (3.7% strokes [n=29] and 1.3% transient ischemic attacks [n=10]) in group 1: two events (0.87%) in patients with paroxysmal AF, 4 (2.3%) in patients with persistent AF, and 33 (8.5%) in patients with long-standing persistent AF. Only 2 strokes (0.25%) in patients with long-standing persistent AF were observed in group 2 (P<0.001). Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism (odds ratio, 13; 95% confidence interval, 3.1-55.6; P<0.001). CONCLUSION: This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01006876.

An alternative transseptal intracardiac echocardiography strategy to guide left atrial appendage closure: the first described case.

Transesophageal echocardiography (TEE) is the standard imaging technique to guide device implantation for left atrial appendage (LAA) closure. Unfortunately, TEE was contraindicated in this patient due to the high risk of variceal hemorrhage. Critical information about the exact anatomic characteristics of the LAA can be obtained using intracardiac echocardiography (ICE). However, standard right-side views do not allow a complete visualization of the LAA: in particular, a reliable left circumflex coronary artery short axis view, relevant for device positioning, is not always achievable. Transseptal views of the LAA with ICE might be used in planning an appropriate intervention strategy for patients who are not suitable for TEE imaging.

Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study.

(1) Background/Objective Balloon-guided catheter ablation (CA) has emerged as an alternative option for atrial fibrillation (AF) management. The recent introduction of a novel-size adjustable second-generation cryoballoon (CB) system offers innovations, but clinical outcomes remain unexplored. This study aims to assess the acute performance of the POLARx FIT™ CB system in AFCA. (2) Methods: Consecutive patients undergoing AF ablation with the POLARx FIT™ CB system in our center were included. The primary outcome was the rate of 31 mm balloon-size utilization, with secondary outcomes including acute pulmonary vein isolation (PVI) rate, periprocedural complications, and in-hospital AF recurrences. (3) Results: Twenty-four patients with a mean age of 59.5 years, predominantly male (87.5%), and exhibiting paroxysmal AF (91.7%) were enrolled. Procedural characteristics demonstrated a high acute success rate (100% PV isolation) with a favorable safety profile. Notably, the 31 mm CB configuration was utilized in 51% of applications, showcasing its adaptability in challenging anatomies. No major complications occurred, with two patients experiencing in-hospital self-limiting AF recurrences. (4) Conclusions: This study represents the first comprehensive assessment of the POLARx FIT™ CB system in AF ablation. While acknowledging the study's limitations, this novel CB emerges as a promising tool, warranting further exploration in larger studies with extended follow-up periods.

A real-world multicenter study on left atrial appendage occlusion: The Italian multi-device experience.

Background: Transcatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO. Methods: We retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies. Results: Among the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes. Conclusions: Our findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.