Atrial fibrillation recurrences during the blanking period after catheter ablation with the laser balloon technique.

INTRODUCTION: Regardless of the catheter ablation (CA) for atrial fibrillation (AF) strategy, the role of early recurrences during the blanking period (BP) is still unclear. Our aim was to evaluate atrial tachyarrhythmias (ATAs) recurrences during the BP after CA with the laser-balloon (LB) technique. METHODS: Consecutive patients undergoing LBCA were enrolled. Primary outcome of the study was the overall crude ATA recurrence rate during the BP. ATA recurrences after the BP and in-hospital readmissions during the BP were deemed secondary outcomes. RESULTS: Two hundred and twenty-four patients underwent CA with the LB. Median age was 63.0 (55.5-69.5) years and 74.1% were males. 28.6% were persistent AF patients, and 34.8% of patients were followed up with a loop recorder. 15.6% of patients experienced at least an ATA recurrence during the BP. Male sex, chronic heart failure, persistent AF, and recurrences during the BP were found to be associated with long-term ATA recurrences. Recurrences during the BP remained associated with the outcome of interest at multivariate analysis (hazard ratio [HR] = 12.393, 95% confidence interval [95% CI] = 3.699-41.865, p < .001). An association over time was found between early and late recurrences, with 73.7%, 45.5%, and 10.8% of patients presenting with recurrences at 1-, 2-, and 3-month follow-up being free from recurrences after the BP, respectively. 8.0% of patients were readmitted during the BP: 4.5% for AF electrical cardioversion, and 1.8% for CA of other atrial arrhythmias; no redo CA was performed. CONCLUSION: After adjusting for confounders, ATA recurrences during the BP represent the most significant predictor of ATA recurrences after the BP, regardless of AF pattern.

Cardiac resynchronization therapy: present and future.

Cardiac resynchronization therapy (CRT) via biventricular pacing (BVP) is a well-established therapy for patients with heart failure with reduced ejection fraction and left bundle branch block, who remain symptomatic despite optimal medical therapy. Despite the long-standing clinical evidence, as well as the familiarity of cardiac electrophysiologists with the implantation technique, CRT via BVP cannot be achieved or may result ineffective in up to one-third of the patients. Therefore, new alternative techniques, such as conduction system pacing and left ventricular pacing, are emerging as potential alternatives to this technique, not only in case of BVP failure, but also as a stand-alone first choice due to several potential advantages over traditional CRT. Specifically, due to its procedural characteristics, left bundle branch area pacing appears to be the most convincing technique, showing comparable efficacy outcomes when compared with traditional CRT, not increasing short-term device-related complications, as well as improving procedural times. However, transvenous leads remain a major limitation of all these pacing modalities. To overcome this limit, a leadless left ventricular endocardial pacing has been developed as an additional tool to achieve a left endocardial activation, although being still associated with non-negligible pitfalls, limiting its current use in clinical practice. This article focuses on the current state and latest progresses in cardiac resynchronization therapy.

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry.

Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED−)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED−, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45−80) mins vs. 50 (40−65) mins, p < 0.001), showing higher rates of temporary pacing (94.4% for ED+ vs. 28.9% for ED−, p < 0.001). Emergency LPM implantation was not correlated with an increase in the rate of major complications compared to the control group (6.9% ED+ vs. 4.2% ED−, p = 0.244). Conclusion. LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmia in an urgent setting. Urgent LPM implantation was not correlated with an increase in the rate of major complications compared to the control group, but it was associated with longer procedural times.

Micra-AV leadless pacemaker and atrioventricular (dys)synchrony: A stepwise process.

Leadless pacemakers have become a major breakthrough in the management of bradyarrhythmia as an attractive alternative to the standard transvenous pacemakers, but safety and long-term outcomes of the new Micra-AV, which is capable guarantee atrioventricular (AV) synchrony, have been poorly described. Hence, we describe how we managed a 57-year-old patient who developed pacemaker syndrome due to significant Micra-AV dyssynchrony. This case emphasizes how leadless pacemaker AV synchrony could be overestimated, thereby requiring a stepwise process leading to adequate device reprogramming. Holter-ECG monitoring and exercise test resulted to be valuable tools for an early detection of inadequate AV synchrony, integrating and completing device reports.

Clinical-radiological correlations in COVID-19-related venous thromboembolism: Preliminary results from a multidisciplinary study.

INTRODUCTION: Among the multiple complex pathophysiological mechanisms underlying COVID-19 pneumonia, immunothrombosis has been shown to play a key role. One of the most dangerous consequences of the prothrombotic imbalance is the increased incidence of micro- and macrothrombotic phenomena, especially deep vein thrombosis (DVT) and pulmonary embolism (PE). METHODS: We investigated the correlation between radiological and clinical-biochemical characteristics in a cohort of hospitalised COVID-19 patients. RESULTS: PE was confirmed in 14/61 (23%) patients, five (35.7%) had DVT. The radiographic findings, quantified by Qanadli score calculated on CT angiography, correlated with the clinical score and biochemical markers. The ratio between the right and left ventricle diameter measured at CT angiography correlated with the length of hospital stay. CONCLUSION: In our cohort radiological parameters showed a significant correlation with clinical prognostic indices and scores, thus suggesting that a multidisciplinary approach is advisable in the evaluation of PE in COVID-19 patients.

Early repolarization pattern as a predictor of atrial fibrillation recurrence following radiofrequency pulmonary vein isolation.

BACKGROUND: Early repolarization patterns (ERP) have been found to be associated with poor cardiovascular end points. We aimed to evaluate the ERP prevalence among patients with structurally normal hearts undergoing radiofrequency (RF) pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) ablation and its association with the AF recurrence. METHODS: All consecutive patients who underwent RF-PVI as index procedure for paroxysmal AF in our center were evaluated. EXCLUSION CRITERIA: structural heart disease, ongoing use of Class I/III antiarrhythmics, complete-bundle-branch-block. Lateral (I, aVL, V5 -V6 ), inferior (II, III, aVF), or infero-lateral (both) ERP were defined in baseline ECG as horizontal/downsloping J-point elevation ≥1 mm in two consecutive leads with QRS slurring/notching. Documented episodes of AF lasting ≥30 s were considered recurrence. RESULTS: Of 701 cases, 434 patients (305 males, 58 ± 11 years) were included for analysis. ERP observed in 67 patients (15.4%) (Infero-lateral n = 26, inferior n = 23, lateral n = 18) which were significantly younger, demonstrating longer PR-interval and lower heart rates. At a mean follow-up of 22.1 ± 9.7 months, AF recurrences were found in 107 patients (24.6%). In middle-aged patients (≥40-<60 years; n = 206, 79% male), those with an infero-lateral ERP had higher recurrence compared with the ones without (56.3% vs. 19%; p = 0.002). Infero-lateral ERP was significantly predicting recurrence (HR 2.42, 95% CI 1.21-4.82; p = 0.01). CONCLUSION: Early repolarization patterns was more prevalent in our AF population than in the general population. Infero-lateral ERP in baseline ECG might predict AF recurrence in the follow-up after RF-PVI in middle-aged patients.

High rate of subcutaneous implantable cardioverter-defibrillator sensing screening failure in patients with Brugada syndrome: a comparison with other inherited primary arrhythmia syndromes.

Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) can avoid important complications associated with transvenous leads in patients with inherited primary arrhythmia syndromes, who do not need pacing therapy. Few data are available on the percentage of patients with inherited arrhythmia syndromes eligible for S-ICD implantation. Aim of this study was to analyse the eligibility for S-ICD in a series of patients with Brugada syndrome (BrS), and to compare it with patients with other channelopathies. Methods and results: Patients presenting with BrS, long-QT syndrome (LQTS), early repolarization syndrome (ERS), and idiopathic ventricular fibrillation (IVF) were considered eligible for this study. ECG screening was performed by analysis of QRS complex and T wave morphology recorded in standing and supine position. Eligibility was defined when ≥1 sense vector was acceptable in both supine and standing position. A total of 100 patients (72 males; mean age: 46 ± 17 years) underwent S-ICD sensing screening. Sixty-one patients presented with BrS, 21 with LQTS, 14 with IVF, and 4 with ERS. Thirty-four patients with BrS (56%) presented with spontaneous type 1 ECG. In the other 27 patients (44%), type 1 ECG was unmasked by ajmaline. Overall, rate of screening failure was 13%. Patients with BrS had a higher rate of inappropriate morphology analysis as compared with other channelopathies (18% vs. 5%, P = 0.07) and had a lower number of suitable sensing vectors (49.6% vs. 84.7% vs. P < 0.001). Ajmaline challenge unmasked sensing failure in 14.8% of drug-induced BrS patients previously considered eligible. In all patients, the reason for sensing inappropriateness was due to the presence of high T wave voltages. Conclusion: S-ICD screening failure occurs in up to 13% of patients with inherited primary arrhythmia syndromes. Patients with BrS present a higher rate of screening failure as compared with other cardiac channelopathies.

Second generation cryoballoon ablation for atrial fibrillation in young adults: midterm outcome in patients under 40 years of age.

Aims: Pulmonary vein isolation (PVI) has been demonstrated more effective in young patients, in which the substrate for atrial fibrillation (AF) is probably more confined to pulmonary vein potentials. The present study sought to focus on the midterm outcomes in patients under 40 years having undergone PVI with the Cryoballoon Advance because of drug resistant AF. Methods and results: Between June 2012 and December 2015, 57 patients having undergone Cryoballoon ablation (CB-A) below 40 years of age for AF in our centre were retrospectively analysed and considered for our analysis. All patients underwent this procedure with the 28 mm Cryoballon Advance. All 227 veins were successfully isolated without the need for additional focal tip ablation. Median follow-up was 18 ±10 months. The freedom from AF after a blanking period of 3 months was 88% in our cohort of patients younger than 40 years old. The most frequent periprocedural complication was related to the groin puncture and occurred in 2 patients. After a single procedure, the only univariate predictor of clinical recurrence was the diagnosis of hypertrophic cardiomyopathy. Conclusion: Young patients affected by AF can be effectively and safely treated with CB-A that grants freedom from AF in 88% of the patients at 18 months follow-up following a 3-month blanking period. All veins could be isolated with the large 28 mm Cryoballoon Advance only.

Long-term outcome of pulmonary vein isolation in patients with paroxysmal atrial fibrillation and Brugada syndrome.

Aims: The therapeutical management of atrial fibrillation (AF) in the setting of Brugada syndrome (BS) might be challenging as many antiarrhythmic drugs (AADs) with sodium channel blocking properties might lead to to the development of ventricular arrhythmias. This study sought to evaluate the clinical outcome in a consecutive series of patients with BS having undergone pulmonary vein (PV) isolation by means of radiofrequency (RF) or cryoballoon (CB) ablation and the efficacy of catheter ablation for preventing inappropriate interventions delivered by implantable cardioverter defibrillators (ICD) on a 3-year follow up. Methods and results: Twenty-three consecutive patients with BS (13 males; mean age was 47 ± 18 years) having undergone PV isolation for drug-resistant paroxysmal AF were enrolled. Eleven patients (48%) had an ICD implanted of whom four had inappropriate shocks secondary to rapid AF. Over a mean follow-up period of 35.0 ± 25.4 months (median 36 months) the freedom from AF recurrence after the index PV isolation procedure was 74% without AADs. Patients with inappropriate ICD interventions for AF did not present futher ICD shocks after AF ablation. No major complications occurred. Conclusion: Catheter ablation is a valid therapeutic choice for patients with BS and paroxysmal AF considering the high success rates, the limitations of the AADs and the safety of the procedure, and it should be taken into consideration especially in those patients presenting inappropriate ICD shocks due to rapid AF.

Second-Generation Cryoballoon Ablation in the Setting of Lone Paroxysmal Atrial Fibrillation: Single Procedural Outcome at 12 Months.

BACKGROUND: Lone atrial fibrillation (LAF) develops in younger individuals without cardiovascular or pulmonary disease. As pulmonary vein isolation has been recognized as an optimal treatment for drug-resistant atrial fibrillation, cryoballoon ablation with second-generation balloon (CB-A) may be an ideal solution for LAF patients. OBJECTIVE: The aim of this study was to investigate acute success, periprocedural complications and outcome over a 12-month follow-up period in a cohort of patients having undergone PV isolation (PVI) for LAF using CB-A technology. METHODS: A total of 75 consecutive patients (50 male, mean age 47 ± 12 years) with a diagnosis of lone paroxysmal atrial fibrillation who underwent pulmonary vein isolation (PVI) by CB-A from June 2012 were included. All patients underwent this procedure with the 28 mm CB-A. A total of 299 PVs (100%) could be isolated with CB-A alone. RESULTS: The freedom from AF recurrence after a single procedure was 92% of patients during the entire 13-month follow-up. When considering a blanking period (BP) of 3 months, success rate was 93.3%. Transient phrenic nerve palsy (PNP) was the most frequent complication, occurring in 5.3% of individuals (4 patients); complete recovery was documented for all of these patients prior to hospital discharge. CONCLUSIONS: CB-A is extremely effective in achieving PVI and affords freedom from AF at 13-month follow-up in 93% of young patients affected by drug-resistant LPAF following a 3-month BP. The most frequent complication observed was PNP, which reverted prior to discharge in all patients.

Incidence of real-time recordings of pulmonary vein potentials using the third-generation short-tip cryoballoon.

AIMS: The third-generation Cryoballoon Advance Short-tip (CB-ST) has been designed with a 40% shortened tip length compared with the former second-generation CB Advance device. Ideally, a shorter tip should permit an improved visualization of real-time (RT) recordings in the pulmonary vein (PV) due to a more proximal positioning of the inner lumen mapping catheter. In the present study, we sought to analyse the rate of visualization of RT recordings in our first series of patients with the CB-ST device. METHODS AND RESULTS: All consecutive patients having undergone CB ablation using CB-ST technology were analysed. Exclusion criteria were the presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, and contraindications to general anaesthesia. A total of 60 consecutive patients (60.5 ± 11.2 years, 62% males) were evaluated. Real-time recordings were detected in 209 of 240 PVs (87.1%). Specifically, RT recordings could be visualized in 55 left superior PVs (91.7%), 51 left inferior PVs (85.0%), 53 right superior PVs (88.3%), and 50 right inferior PVs (83.3). CONCLUSION: The rate of visualization of RT recordings is significantly high during third-generation CB-ST ablation. Real-time recordings can be visualized in ∼87.1% of veins with this novel cryoballoon.

Spontaneous ventricular tachyarrhythmias in ß2-adrenoceptor transgenic mice in relation to cardiac interstitial fibrosis.

Myocardial fibrosis is regarded as a pivotal proarrhythmic substrate, but there have been no comprehensive studies showing a correlation between the severity of fibrosis and ventricular tachyarrhythmias (VTAs). Our purpose was to document this relationship in a transgenic (TG) strain of mice with fibrotic cardiomyopathy. TG mice with cardiac overexpression of ß2-adrenoceptors (ß2-AR mice) and non-TG (NTG) littermates were studied at 4-12 mo of age. VTA was quantified by ECG telemetry. The effect of pharmacological blockade of ß2-ARs on VTA was examined. Myocardial collagen content was determined by hydroxyproline assay. NTG and TG mice displayed circadian variation in heart rate, which was higher in TG mice than in NTG mice (P <0.05). Frequent spontaneous ventricular ectopic beats (VEBs) and ventricular tachycardia (VT) were prominent in TG mice but not present in NTG mice. The frequency of VEB and VT episodes in TG mice increased with age (P < 0.01). Ventricular collagen content was greater in TG mice than in NTG mice (P <0.001) and correlated with age (r = 0.71, P < 0.01). The number of VEBs or VT episodes correlated with age (r = 0.83 and r = 0.73) and the content of total or cross-linked collagen (r = 0.62∼0.66, all P <0.01). While having no effect in younger ß2-TG mice, ß2-AR blockade reduced the frequency of VTA in old ß2-TG mice with more severe fibrosis. In conclusion, ß2-TG mice exhibit interstitial fibrosis and spontaneous onset of VTA, becoming more severe with aging. The extent of cardiac fibrosis is a major determinant for both the frequency of VTA and proarrhythmic action of ß2-AR activation.

Venous Thromboembolism Management throughout the COVID-19 Era: Addressing Acute and Long-Term Challenges.

Background: COVID-19 increases the risk of venous thromboembolism (VTE) through a complex interplay of mechanisms collectively referred to as immunothrombosis. Limited data exist on VTE challenges in the acute setting throughout a dynamic long-term follow-up of COVID-19 patients compared to non-COVID-19 patients. The aim of the study was to investigate acute and long-term management and complications in VTE patients with and without COVID-19. Methods: A prospective, observational, single-center cohort study on VTE patients followed from the acute care stage until 24 months post-diagnosis. Results: 157 patients, 30 with COVID-19-associated VTE and 127 unrelated to COVID-19, were enrolled. The mean follow-up was 10.8 (±8.9) months. COVID-19 patients had fewer comorbidities (1.3 ± 1.29 vs. 2.26 ± 1.68, p < 0.001), a higher proportion of pulmonary embolism at baseline (96.7% vs. 76.4%, p = 0.01), and had a lower probability of remaining on anticoagulant therapy after three months (p < 0.003). The most used initial therapy was low-molecular-weight heparin in 130/157 cases, followed by long-term treatment with direct oral anticoagulants in 123/157. Two (6.7%) COVID-19 vs. three (2.4%) non-COVID-19 patients (p = 0.243) had major hemorrhagic events, all of them within the first three months. Four (3.1%) non-COVID-19 patients had VTE recurrence after six months. Three (2.4%) non-COVID-19 patients developed chronic thromboembolic pulmonary hypertension. There were no fatalities among patients with COVID-19, compared to a mortality of 12/127 (9.4%) in the non-COVID-19 subgroup (p = 0.027). Discussion: Our study offers a comprehensive overview of the evolving nature of VTE management, emphasizing the importance of personalized risk-based approaches, including a limited course of anticoagulation for most COVID-19-associated VTE cases and reduced-dose extended therapy for high-risk subsets.

Low-molecular-weight heparin for the prevention of clinical worsening in severe non-critically ill COVID-19 patients: a joint analysis of two randomized controlled trials.

Coronavirus disease 2019 (COVID-19) carries a high risk of vascular thrombosis. However, whether a specific anticoagulation intensity strategy may prevent clinical worsening in severe COVID-19 patients is still debated. We conducted a joint analysis of two randomized controlled trials, COVID-19 HD (NCT044082359) and EMOS-COVID (NCT04646655), to assess the efficacy and safety of two anticoagulant regimens in hospitalized severe COVID-19 patients. Subjects with COVID-19-associated respiratory compromise and/or coagulopathy were randomly assigned to low (4000 IU qd) or high (70 IU Kg-1 every 12 h) enoxaparin dose. The primary efficacy endpoint was clinical worsening within 30 days, defined as the occurrence of at least one of the following events, whichever came first: in-hospital death, evidence of arterial or venous thromboembolism, acute myocardial infarction, need for either continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) in patients receiving standard oxygen therapy or none at randomization, and need for mechanical ventilation in any patient. The safety endpoint was major bleeding. We estimated the relative risk (RR) and its 95% confidence interval (CI) for the outcomes. Among 283 patients included in the study (144 in the low-dose and 139 in the high-dose group), 118 (41.7%) were on NIV or CPAP at randomization. 23/139 (16.5%) patients in the high-dose group reached the primary endpoint compared to 33/144 (22.9%) in the low-dose group (RR 0.72, 95% CI 0.45-1.17). No major bleeding was observed. No significant differences were found in the clinical worsening of hospitalized COVID-19 patients treated with high versus low doses of enoxaparin.

Long-term comparisons of atrial fibrillation ablation outcomes with a cryoballoon or laser-balloon: A propensity-matched analysis based on continuous rhythm monitoring.

OBJECTIVE: Cryoballoon (CB) and laser-balloon (LB) catheter ablation (CA) has been demonstrated to achieve durable and effective pulmonary vein isolation (PVI). Only one head-to-head comparison with an intermittent rhythm monitor strategy is currently available. The aim of this study was to compare acute and long-term outcomes of CB and LB atrial fibrillation ablation procedures, by using a continuous rhythm monitoring strategy. METHODS: This was a prospective two-arm nonrandomized propensity-matched observational trial that compared the outcomes of atrial fibrillation (AF) ablation using LB and CB techniques. To evaluate AF recurrences, an implantable cardiac monitor (ICM) was implanted before hospital discharge to detect atrial tachyarrhythmia (ATA) recurrences. RESULTS: A total of 110 propensity-matched patients undergoing AF ablation with an LB (n = 55) or with a CB system (n = 55) were enrolled (paroxysmal AF 57.3%). Procedural time (LB: 87 [73-104] vs. CB 90 [70-130] min; p = 0.264) and fluoroscopy time did not differ. No differences in ATA recurrences were observed at 12 months (LB-30.9% vs. CB-29.1% and LB-45.5% vs. CB-38.2%; log-rank 0.539). As for AF burden, the 12-month median was 0 [0-1] vs. 0 [0-3]% (p = 0.127) in the LB and CB groups, respectively. When considering only PeAF patients, the median 12-month ATA burden was 26 [18.5-40.5] vs. 29 [26-35]% (p = 0.919) for the LB and CB patients, respectively. CONCLUSION: In a propensity-matched cohort undergoing AF ablation, arrhythmia outcomes assessed by continuous rhythm monitoring did not differ between LB and CB, with an overall low ATA burden. The only predictor of recurrences was persistent AF. There was no difference in procedure or fluoroscopy time.

Early echocardiographic findings in patients hospitalized for COVID-19 pneumonia: a prospective, single center study.

BACKGROUND: Cardiac dysfunction, mainly assessed by biomarker alterations, has been described in COVID-19 infection. However, there are still areas of uncertainty regarding its effective role in disease evolution. Aim of this study was to evaluate early echocardiographic parameters in COVID pneumonia and their association with severity disease and prognosis. METHODS: An echocardiographic examination was performed within 72 h from admission in 64 consecutive patients hospitalized for COVID-19 pneumonia in our medium-intensity care unit, from March 30th to May 15th 2020. Six patients were excluded for inadequate acoustic window. RESULTS: Fifty-eight consecutive patients were finally enrolled, with a median age of 58 years. Twenty-two (38%) were classifiable as severe COVID-19 disease. Eight out of 58 patients experienced adverse evolution (six died, two were admitted to ICU and received mechanical ventilation), all of them in the severe pneumonia group. Severe pneumonia patients showed higher troponin, IL-6 and D-Dimer values. No significant new onset alterations of left and right ventricular systolic function parameters were observed. Patients with severe pneumonia showed higher mean estimated systolic pulmonary artery pressure (sPAP) (30.7 ± 5.2 mmHg vs 26.2 ± 4.3 mmHg, p = 0.006), even if in the normality range values. No differences in echocardiographic parameters were retrieved in patients with adverse events with respect to those with favorable clinical course. CONCLUSION: A mild sPAP increase in severe pneumonia patients with respect to those with milder disease was the only significant finding at early echocardiographic examination, without other signs of new onset major cardiac dysfunction. Future studies are needed to deepen the knowledge regarding minor cardiac functional perturbation in the evolution of a complex systemic disorder, in which the respiratory involvement appears as the main character, at least in non-ICU patients.

Learning curve using the second-generation cryoballoon ablation.

AIMS: To study the learning curve with the second-generation cryoballoon technology focusing on safety, efficacy and procedural characteristics. METHODS: We included 300 patients (men 64.6%, mean age 58.3 ±â€Š12.4 years), 240 of whom were treated by four operators without prior experience in atrial fibrillation ablation and compared them with 60 consecutive patients treated by senior operator. To study the learning curves, we divided the study period into two trimesters and analyzed procedure duration, fluoroscopy times, complications, characteristics of the freeze-thaw cycles and midterm outcomes. RESULTS: Hands-on help from senior operators to achieve pulmonary vein isolation was needed only in the first study trimester (24.1%), most commonly to achieve right inferior pulmonary vein isolation (55.2%). The mean procedure duration shortened from 76.7 ±â€Š17.4 to 65.1 ±â€Š11.4 min (P < 0.0001), and fluoroscopy time decreased from 18.5 ±â€Š7.3 to 12.1 ±â€Š4.3 min (P < 0.0001) for first and second trimester, respectively, and approached senior operator's results (58.2 ±â€Š12.8 and 8.7 ±â€Š4.5 min). Most of the major complications (one stroke, four pseudoaneurysms and one retroperitoneal hematoma) occurred during the first study trimester. Most characteristics of the freeze cycles remained unchanged in both study periods. Compared with junior operators, the senior operator achieved lower nadir temperatures in both inferior veins. However, there was no significant difference in midterm outcomes between junior and senior operators (79.5 vs 83.3%, P = 0.589). CONCLUSION: The learning curve with the second-generation cryoballoon is steep. Inexperienced operators, trained in high-volume centers, can achieve pulmonary vein isolation safely and efficiently with short procedure and fluoroscopy times after having performed 20-30 cases.

Femoral venous pressure waveform as indicator of phrenic nerve injury in the setting of second-generation cryoballoon ablation.

AIMS: Femoral venous pressure waveform (VPW) analysis has been recently described as a novel method to assess phrenic nerve function during atrial fibrillation ablation procedures by means of the cryoballoon technique. In this study, we sought to evaluate the feasibility and effectiveness of this technique, with respect to the incidence of phrenic nerve injury (PNI), in comparison with the traditional abdominal palpation technique alone. METHODS: Consecutive patients undergoing second-generation cryoballoon ablation (CB-A) from June 2014 to June 2015 were retrospectively analyzed. Diagnosis of PNI was made if any reduced motility or paralysis of the hemidiaphragm was detected on fluoroscopy. RESULTS: During the study period, a total of 350 consecutive patients (man 67%, age 57.2 ±â€Š12.9 years) were enrolled (200 using traditional phrenic nerve assessment and 150 using VPW monitoring). The incidence of PNI in the overall population was 8.0% (28/350); of these, eight were impending PNI (2.3%), 14 transient (4.0%), and six persistent (1.7%). Patients having undergone CB-A with traditional assessment experienced 18 phrenic nerve palsies (9.0%) vs two in 'VPW monitoring' group (1.3%; P = 0.002). Specifically, the former presented 12 transient (6.0%) and six persistent (3.0%) phrenic nerve palsies, and the latter exhibited two transient (1.3%; P = 0.03) and no persistent (0%; P = 0.04) phrenic nerve palsies. CONCLUSION: In conclusion, this novel method assessing the VPW for predicting PNI is inexpensive, easily available, with reproducible measurements, and appears to be more effective than traditional assessment methods.

Long-term outcome after second-generation cryoballoon ablation for paroxysmal atrial fibrillation - a 3-years follow-up.

BACKGROUND: The second-generation cryoballoon (cryoballoon Advance; CB-A) offers excellent outcomes on the mid-term follow-up. To the best of our knowledge, little is known regarding the long-term outcome after CB-A ablation for paroxysmal atrial fibrillation (AF). OBJECTIVE: The aim of the study was to evaluate the freedom from recurrence of AF during a 3-year follow-up period, among consecutive patients having undergone pulmonary vein isolation (PVI) with the CB-A for paroxysmal AF (PAF). METHODS: Consecutive patients with drug-resistant PAF who underwent PVI using CB-A as an index procedure formed the study group. Patients were evaluated with holter ECG recordings at 1, 3, 6 and 12 months and subsequent follow-up was biannual or based on the clinical status and at the physician discretion. RESULTS: Seventy-six consecutive patients were enrolled. Of these patients, 6 were excluded because of lack of long-term follow-up. A total of 70 patients [44 male (63%); mean age 57.9 ± 14.5 years] with a mean follow-up of 38.0 ± 7.4 months were finally included. In total, 278 PVs were depicted on the pre-procedural CT scan. All PVs (100%) could be isolated with the CB-A only. The freedom from AF without antiarrhythmic drug (AADs) after a single procedure was 71.5% of patients at a mean 38.0 ± 7.4 months follow-up. If including repeat procedures, 80% of the patients were free from AF recurrence after 1.11 ± 0.32 procedures without AADs. CONCLUSION: The second-generation cryoballoon offers long-term freedom from PAF in 71.5% of treated patients with a single procedure without AADs on a 3-year follow-up period.

Second-generation cryoballoon ablation for paroxysmal atrial fibrillation: Predictive role of atrial arrhythmias occurring in the blanking period on the incidence of late recurrences.

BACKGROUND: Although consensus documents on catheter and surgical ablation of atrial fibrillation (AF) suggest a uniform "blanking period" of 3 months, recent evidence suggested that early recurrences of atrial tachyarrhythmias (ERATs) are strongly associated with late recurrences (LRs), especially if ERATs occurred in the last part of the "blanking period". OBJECTIVE: The present study sought to assess the role of ERATs in predicting LRs in a large cohort of patients with paroxysmal AF who have undergone second-generation cryoballoon ablation. METHODS: Consecutive patients with drug-resistant paroxysmal AF who underwent pulmonary vein isolation using CB-A technology as the index procedure were retrospectively included in our analysis. The exclusion criteria were any contraindications for the procedure, including the presence of an intracavitary thrombus, uncontrolled heart failure, contraindications to general anesthesia, and persistent AF. RESULTS: A total of 331 consecutive patients (104 women [31%]; mean age 56.7 ± 13.3 years) were enrolled. Atrial tachyarrhythmias/AF recurrences were detected in 57 patients (17.2%). The highest prevalence of ERATs was observed in the first 2 weeks (55%) after pulmonary vein isolation. Of note, all the ERATs occurring 1.5 months after AF ablation relapsed after 3 months and were confirmed as definitive recurrences. Late recurrence of AF and atrial tachycardia occurred in 20 of 29 patients with ERATs (69.0%) and 28 of 302 patients without ERATs (9.3%) (P < .0001). A multivariate Cox regression analysis showed that the early recurrence within the blanking period was significantly and independently associated with an increased risk of developing a late recurrence (hazard ratio 6.79; 95% confidence interval 3.52-10.14; P < .0001). CONCLUSION: Our findings reveal that ERATs are strongly associated with an LR after paroxysmal AF ablation using CB-A technology (hazard ratio 6.79; 95% confidence interval 3.52-10.14; P < .0001). Of note, when ERATs occurred later than 1.5 months, patients systematically experienced an LR.