Use of Oral Anticoagulants in Patients with Atrial Fibrillation: Preliminary Data from the Italian Atrial Fibrillation (ITALY-AF) Registry.

BACKGROUND: Atrial fibrillation (AFIB), the most frequent cardiac arrhythmia, is a major risk factor for stroke, heart failure, and death. Because of the recent advances in AFIB management and the availability of new oral anticoagulants (OACs), there is a need for a systematic and predefined collection of contemporary data regarding its management and treatment. METHODS: The objective of the ongoing ITALY-AFIB registry is to evaluate the long-term morbidity and mortality in patients with AFIB and to verify the implementation of the current guidelines for stroke prevention in these patients. The registry includes consecutive in- and out-patients with first diagnosed, paroxysmal, persistent, or permanent AFIB. In patients in sinus rhythm at entry, the qualifying episode of AFIB, confirmed by ECG diagnosis, had to have occurred within 1 year before entry. The clinical record form is web-based and accessible by personal keyword. RESULTS: Enrolment into the registry started in the year 2013. In a current cohort of 2470 patients (mean age 75 ± 11 years, males 56%), the mean CHA2DS2-VASc score was 3.7 ± 1.8, and the mean HAS-BLED was 1.6 ± 0.9. There were no significant sex differences in the AFIB subtypes. At the end of the inclusion visit and after receiving knowledge of the web-based electronic estimate of risk for stroke and bleeding, the proportion of patients discharged with OACs was 80%. After exclusion of patients with first diagnosed AFIB (n = 397), the proportion of patients with prescription of OACs rose from 66% before the visit to 82% on discharge (p < 0.0001). Prescription of aspirin or other antiplatelet drugs fell from 18% before the visit to 10% on discharge (p < 0.0001). CONCLUSIONS: A web-based management of AFIB with automated estimation of risk profiles appears to favorably affect adherence to AFIB guidelines, based on a high proportion of patients treated with OACs and a substantial decline in the use of antiplatelet drugs.

[Barlow's disease with arrhythmic phenotype: a case report]. / Un caso di malattia di Barlow a fenotipo aritmico.

Barlow disease represents the extreme form of the degenerative mitral valve spectrum described by Carpentier. The myxoid degeneration of the mitral valve may result in a billowing leaflet or in a prolapse and myxomatous degeneration of the mitral leaflets. There are increasing evidences of the association between Barlow disease and sudden cardiac death. It is common in young women. Symptoms include anxiety, chest pain and palpitation. In this case report, the markers of risk for sudden death such as typical ECG changes, complex ventricular ectopy, a spiked configuration of the lateral annular velocities, mitral annular disjunction and evidence of myocardial fibrosis were assessed.

Rationale and study design of the Italian Registry in the setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS.

BACKGROUND: Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhythm control. There is mounting evidence that CA procedures should be performed during continuous oral anticoagulation and direct oral anticoagulants (DOACs) are considered the first anticoagulation strategy. Few real-life data are now available and even less in the Italian panorama. METHODS: IRIS is an Italian multicenter, non-interventional, prospective study which will be enrolled consecutive AF patients eligible for CA and treated with Rivaroxaban; patients in treatment with Rivaroxaban proceeded directly to CA while Rivaroxaban-naive patients were scheduled for CA after 4 weeks of uninterrupted anticoagulation unless the exclusion of atrial thrombi. Rivaroxaban was uninterrupted or shortly uninterrupted (<24 hours) prior CA, in line with routinely practice of each operator. Patients will be followed on continuous anticoagulation for 1 month after the ablation. The primary efficacy outcome is the cumulative incidence of all-cause death and systemic embolism while the primary safety outcome is the incidence of major bleeding events. The secondary outcomes are represented by non-major bleeding events. All events must be occurred within the first 30 days after the procedure. RESULTS: Two hundred fifty patients are expected to be enrolled and the study is estimated to be completed by the end of 2022. Up to now 56 patients have been enrolled. CONCLUSIONS: This study is the first large Italian prospective study on the management of Rivaroxaban in patients undergoing CA of AF. It aims to depict a comprehensive view of anticoagulation strategy prior CA in several Italian electrophysiology labs.

Patient acceptance of subcutaneous versus transvenous defibrillator systems: A multi-center experience.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome. OBJECTIVE: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD. METHODS: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation. RESULTS: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02). CONCLUSIONS: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.

Ablation therapy for ventricular arrhythmias in patients with LVAD: Multiple faces of an electrophysiological challenge.

Left ventricular assist device implantation is a recognized treatment option for patients with advanced heart failure refractory to medical therapy and can be used both as bridge to transplantation and as destination therapy. The risk of ventricular arrhythmias is common after left ventricular assist device implantation and is influenced by pre-, peri and post-operative determinants. The management of ventricular arrhythmias can be a challenge when they become refractory to medication or to device therapy and their impact on prognosis can be detrimental despite the mechanical support. In this setting, catheter ablation is being increasingly recognized as a feasible option for patients in which standard therapeutic strategies fail, but also with preventive purpose. Catheter ablation is being increasingly considered for the management of ventricular arrhythmias in patients with left ventricular assist device despite complex clinical and technical peculiarities due to the characteristics of the mechanical support. Much conflicting data exist regarding the predictors of success of the procedure and the rate of recurrence. In this review we discuss the latest evidences regarding catheter ablation of ventricular arrhythmias in this subset of patients, focusing on clinical characteristics, arrhythmia etiology, technical aspects and postprocedural features which must be considered by the electrophysiologist.

Challenging Cases of Wide Complex Tachycardias: Use and Limits of Algorithms.

Electrocardiographic algorithms are particularly useful to differentiate, in the presence of a wide complex tachycardia, between supraventricular aberrancy and ventricular tachycardias (VT). There are numerous limitations to the sensitivity and specificity of these algorithms including the presence of accessory pathways, use of antiarrhythmic drugs, congenital heart diseases, electrolytes impairments, and artificial pacing. Once the diagnosis of VT has been reached, other algorithms can help in localizing the origin of the ventricular arrhythmia. These approaches are also limited by the anatomic structure of where the arrhythmia originates. This article illustrates the difficulties in applying common algorithms in many clinical circumstances.

A case of arrhythmogenic right ventricular cardiomyopathy with biventricular involvement.

We reported a case of a young adult male aged 18 years admitted in our institution for syncope during a basketball match. No previous symptoms were reported. Electrocardiogram (ECG) showed T-wave inversion in the anterior leads and an incomplete right bundle branch block. Surprisingly, a complete echocardiographic evaluation demonstrated the presence of severe right ventricular enlargement with significant wall motion abnormalities, apical aneurysm and reduced systolic function. Cardiac Magnetic Resonance was pathognomonic for a fibro-fatty replacement of both ventricles. We decided for a subcutaneous defibrillator implantation and, after inducing a ventricular fibrillation to test the device status, epsilon wave appeared on the ECG. This clinical scenario depicted an advanced arrhythmogenic right ventricular cardiomyopathy at its first clinical manifestation.

Long-term monitoring of respiratory rate in patients with heart failure: the Multiparametric Heart Failure Evaluation in Implantable Cardioverter-Defibrillator Patients (MULTITUDE-HF) study.

BACKGROUND: Monitoring respiratory rate (RR) is recommended at the time of hospital presentation for acute decompensation in heart failure (HF). Device-based continuous monitoring of RR may be helpful for diagnostic and prognostic stratification after implantable cardioverter-defibrillator (ICD) implantation. This study was undertaken to analyze short- and long-term changes in ICD-measured RR and to relate RR with the patient's clinical status and the occurrence of HF events. METHODS: One hundred twenty-four consecutive HF patients who received ICD endowed with this diagnostic capability (Boston Scientific Inc., Natick, MA, USA) were prospectively enrolled. Patients were followed up for 12 months. RESULTS: At the baseline, the proportion of New York Heart Association (NYHA) class III-IV was higher among patients with daily maximum RR >27 breaths/min (third tertile) than those with <24 breaths/min (first tertile) (43 vs. 23%, p < 0.05). Moreover, the ejection fraction was lower (27 ± 7 vs. 34 ± 8%, p < 0.05). In patients with HF hospitalizations (33 events) and urgent visits for HF (15 events), the weekly average of RR calculated over the 7 days preceding hospital accesses did not differ from values recorded at the baseline and before scheduled follow-up visits. However, the weekly variation in RR (i.e., the difference between maximum and minimum values collected over the week) was significantly higher prior to hospitalization (p < 0.05). A weekly variation >3 breaths/min in maximum RR predicted an impending hospital admission for HF with sensitivity of 73 % and specificity of 57%. CONCLUSIONS: In this study, elevated values of ICD-monitored RR identified patients with worse functional status and lower systolic function. The weekly variation in RR increased before HF exacerbation. This monitoring technology may represent a useful tool in the clinical management of patients with HF.

Metabolic syndrome is associated with a poor outcome in patients affected by outflow tract premature ventricular contractions treated by catheter ablation.

BACKGROUND: The purpose of this study was to investigate the impact of metabolic syndrome (MS) on outcome of catheter ablation (CA) for treatment of frequent premature ventricular contraction beats (PVCs) originating from right ventricular outflow tract (RVOT), left ventricular outflow tract (LVOT) or coronary cusps (CUSPs), in patients with normal ventricular systolic function and absence of cardiac structural disease. METHODS: In this multicentre prospective study we evaluated 90 patients with frequent PVCs originating from RVOT (n = 68), LVOT (n = 19) or CUSPs (n = 3), treated with CA. According to baseline diagnosis they were divided in patients with MS (n = 24) or without MS (n = 66). The study endpoint was a composite of recurrence of acute or delayed outflow tract ventricular arrhythmia: acute spontaneous or inducible outflow tract ventricular arrhythmia recurrence or recurrence of outflow tract PVCs in holter monitoring at follow up. RESULTS: Patients with MS compared to patients without MS showed a higher acute post-procedural recurrence of outflow tract PVCs (n = 8, 66.6%, vs. n = 6, 9.0%, p = 0.005). At a mean follow up of 35 (17-43) months survival free of recurrence of outflow tract PVCs was lower in patients with baseline MS compared to patients without MS diagnosis (log-rank test, p < 0.001). In cox regression analysis, only MS was independently associated with study endpoint (HR = 9.655 , 95% CI 3.000-31.0.68 , p < 0.001). CONCLUSIONS: MS is associated with a higher recurrence rate of outflow tract PVCs after CA in patients without structural heart disease.

Clinical impact of catheter ablation in patients with asymptomatic atrial fibrillation: the IRON-AF (Italian registry on NavX atrial fibrillation ablation procedures) study.

Whether and to what extent patients with asymptomatic atrial fibrillation (AF) would benefit from catheter ablation has not been investigated. This is the first multicenter prospective study reporting on the outcome of catheter ablation in patients with asymptomatic AF. Consecutive patients (n = 545) referred for AF ablation were prospectively enrolled in a multicenter Italian registry. Of these patients, 54 have asymptomatic AF and composed our patient population. At 24 month follow-up, catheter ablation in asymptomatic AF patients resulted to be as safe and effective as in patients with drug refractory symptomatic AF. Our study provides significant insights on the role of AF ablation in asymptomatic patients. Further studies in much larger cohorts are needed to validate our conclusions.

Effect of right ventricular apical pacing in survivors of myocardial infarction.

BACKGROUND: Much information is available regarding the possible negative effects of long-term right ventricular (RV) apical pacing, which may cause worsening of heart failure. However, very limited data are available regarding the effects of RV pacing in patients with a previous myocardial infarction (MI). METHODS AND RESULTS: We screened 115 consecutive post-MI patients and matched a group of 29 pacemaker (PM) recipients with a group of 49 unpaced patients, for age, left ventricular (LV) ejection fraction, and site of MI. During a median follow-up of 54 months, echocardiograms showed a decrease in LV ejection fraction in the paced group, from 51 +/- 10 to 39 +/- 11 (P < 0.01), and a minimal change in the unpaced group, from 57 +/- 8 to 56 +/- 7 (P = 0.98). Similar change was observed in systolic and diastolic diameters and volumes. CONCLUSIONS: The study showed that, in post-MI patients, RV apical pacing was associated with a worsening of LV function, suggesting that, among MI survivors, the need for a PM is a marker of worse outcome.

A radial global dyssynchrony index as predictor of left ventricular reverse remodeling after cardiac resynchronization therapy.

BACKGROUND: Cardiac mechanical efficiency requires that opposing left ventricular regions are coupled both in shortening and lengthening during the same phase of cardiac cycle. Aim of this study was to evaluate whether global measures of mechanical dyssynchrony are able to predict reverse remodeling of the left ventricle in patients receiving cardiac resynchronization therapy (CRT). METHODS: Sixty-two patients underwent a clinical examination, including New York Heart Association class evaluation and 6-minute walking distance and both echocardiographic study before and 6 months after CRT. Intraventricular dyssynchrony was evaluated by two-dimensional strain echocardiography, measuring the amount of uncoordinated contraction and relaxation between septum and free wall for both longitudinal and radial function and was presented as the longitudinal global dyssynchrony index (LGDI) and the radial global dyssynchrony index (RGDI). Reverse remodeling was defined by a left ventricular end systolic volume reduction >or= 15%. RESULTS: After CRT 39 patients showed reverse remodeling. In this group, RGDI (0.74 +/- 0.26 vs 0.32 +/- 0.30; P = 0.0001) and LGDI (0.52 +/- 0.28 vs 0.30 +/- 0.24; P = 0.002) were significantly higher than in nonresponders. A receiver-operating characteristic curve analysis showed that RGDI >0.47 and LGDI >0.34 had a sensitivity and a specificity to predict reverse remodeling of 87% and 74%, 82%, and 74%, respectively. Stepwise forward multiple logistic regression analysis showed that RGDI (O.R.:13.4; 95%C.I.:4.2-120.5; P < 0.0001) was an independent determinant of a positive response to CRT. CONCLUSION: A radial global dyssynchrony index predicts left ventricular reverse remodeling after CRT.

High prevalence of cooled tip use as compared with 8-mm tip in a multicenter Italian registry on atrial fibrillation ablation: focus on procedural safety.

BACKGROUND: Whether cooling catheters should be preferred for atrial fibrillation (AF) ablation is not yet clear. METHODS: From April 2005 to October 2006, 991 (74% men) consecutive patients who underwent AF ablation were prospectively enrolled in 10 Italian centers. For the present subanalysis, patients were ranked in the two study groups on the basis of the catheter system chosen: 8-mm tip was used in 86 patients (9% conventional group) and open-irrigated tip in 905 patients (91% cooled group). RESULTS: The registry clinical data of both groups showed marked heterogeneity due to the fact that the higher number of patients of the cooled group had longer AF history (4.9+/-4.1 versus 1.2+/-1.8 years; P=0.0001), permanent/persistent AF (41.2 versus 27.9%; P=0.01), and larger left atrium (LA) size (44.1+/-6.2 versus 33.4+/-10.5 mm; P

End-diastolic wall thickness as a predictor of reverse remodelling after cardiac resynchronization therapy: a two-dimensional echocardiographic study.

BACKGROUND: The aim of this study was to evaluate whether in patients with ischemic heart failure (HF) with mechanical dyssynchrony the echocardiographic assessment of the extent of scarred ventricular tissue by end-diastolic wall thickness (EDWT) could predict reverse remodeling (RR) after cardiac resynchronization therapy (CRT). Recent studies using cardiac magnetic resonance imaging have shown that the burden of myocardial scar is an important factor influencing response to CRT, despite documented mechanical dyssynchrony. EDWT assessed by two-dimensional (2D) resting echocardiography is a simple and reliable marker to identify scar tissue in patients with ischemic left ventricular dysfunction. METHODS: Seventy-four patients with ischemic HF were evaluated 1 week before and 6 months after CRT. Inclusion criteria were New York Heart Association class III or IV, ejection fraction < 35%, QRS duration > 120 ms, and mechanical intraventricular dyssynchrony >/= 65 ms. The left ventricle was divided into 16 segments; left ventricular (LV) segments with EDWT < 6 mm were considered scarred. Percentage global scar area (GSA) was calculated by dividing the number of scarred LV segments by 16. RESULTS: RR, defined as a reduction of LV end-systolic volume >/= 15%, was found in 38 patients (51.4%) with ischemic HF. A significant inverse linear relationship was found between GSA and RR (r = -0.57; P = .0001). Mean percentage GSA was significantly higher in nonresponders (31.6 +/- 18% vs 6.4 +/- 11%; P < .001). GSA

Presence of left ventricular contractile reserve, evaluated by means of dobutamine stress-echo test, is able to predict response to cardiac resynchronization therapy.

INTRODUCTION: We evaluated whether the dobutamine stress-echo test can select responders to cardiac resynchronization therapy (CRT). Up to 50% of patients do not respond to CRT. Lack of response may be due to a significant amount of scar or fibrotic tissue at myocardial level. METHODS AND RESULTS: We studied 42 CRT patients. After clinical and echocardiographic evaluation, all patients underwent a dobutamine stress-echo test to assess contractile reserve. Cut-off for the test was an increase of 25% of the left ventricular ejection fraction. Patients were implanted with a CRT-defibrillator and followed up at 6 months. Cut-off for CRT response was a reduction of 15% of left ventricular end-systolic volume. Twenty-five patients responded to CRT; all of them showed presence of contractile reserve. The test showed a sensitivity of 100% and a specificity of 88%. CONCLUSION: Contractile reserve was a strong predictive factor of response to CRT in the studied population.

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety.

BACKGROUND: Data on the procedural safety of pulmonary vein radiofrequency catheter ablation for atrial fibrillation (AF) are as yet scant. OBJECTIVE: The aims of the present study were to prospectively evaluate the incidence of early complications of pulmonary vein ablation for AF in an unselected population of consecutive patients, and to identify possible predictors. METHODS: From April 2005 to October 2006, data from 1,011 consecutive patients who were undergoing radiofrequency catheter ablation for every type of AF in 10 Italian centers were collected. All complications occurring from the admission of the patient up to the 30th day were considered. RESULTS: No procedure-related death was observed. Complications occurred in 40 patients (3.9%): 12 (1.2%) had peripheral vascular complications, 8 (0.8%) had conservatively treated pericardial effusion, 6 (0.6%) had cardiac tamponade (successfully drained), 5 (0.5%) had cerebral embolisms, 4 (0.4%) presented pulmonary vein stenosis >50%, and 5 (0.5%) presented other isolated adverse events. History of coronary artery disease (odds ratio 5,603, 95% confidence interval 1,559 to 20,139, P < .008) characterized patients who presented with hemorrhagic complications. CONCLUSION: Early complications of pulmonary vein catheter ablation seem to be fewer than in the early years of AF ablation, but still occur in 3.9% of procedures.

Effect of pacing the right ventricular mid-septum tract in patients with permanent atrial fibrillation and low ejection fraction.

INTRODUCTION: Permanent right ventricular (RV) pacing leads have been traditionally implanted in the right ventricular apex (RVA). Nowadays, some deleterious effects of RVA pacing have been recognized. The aim of this study was to evaluate the effect of different sites of RV pacing in patients with permanent atrial fibrillation (AF) and low ejection fraction (LEF) needing a pacemaker (PM) implantation. METHODS: Two hundred seventy-three patients with permanent AF and EF <30% underwent a one-chamber rate responsive (VVIR) PM implant procedure. Patients were divided into two groups: Group A, including 113 patients with the pacing lead tip placed in the RV mid-septum, and Group B of 120 patients with the pacing lead tip placed at the apex of RV. All patients had clinical and Echo control after 1, 3, 6, 12, and 18 months after PM implantation to assess New York Heart Association (NYHA) class and EF. RESULTS: After 18 months, NYHA class changed in Group A from 2.9 +/- 0.4 at implant to 1.7 +/- 0.3 at 18 months (P = 0.01), and in Group B from 3.0 +/- 0.5 at implant to 3.3 +/- 0.6 at 18 months (P = n.s.). EF increased in Group A: 28 +/- 2% at implant, 33 +/- 1% at 18 months (P = 0.0125), while no significant changes were observed in Group B: at implant 27 +/- 2%, 26 +/- 2% at 18 months (P = n.s.). CONCLUSION: The present study suggests that more physiological pacing from the RV sept can improve EF and quality of life (QoL) in patients with permanent AF and low EF needing a PM.

Is it possible to create a linear lesion with no local electrograms? Comparison between a three-dimensional mapping system and conventional fluoroscopy for cavotricuspid isthmus ablation of typical atrial flutter.

OBJECTIVE: The aim of this prospective, randomised study was to evaluate the efficacy, safety and long-term outcomes of the complete disappearance of local electrograms along the linear lesion using the EnSite NavX three-dimensional mapping system as compared with conventional fluoroscopy for ablation of typical atrial flutter (AFL). METHODS: Seventy-three patients with spontaneous AFL episodes were randomised to undergo fluoroscopy-guided (group I, n=35) or EnSite NavX-guided (group II, n=38) ablation. When bidirectional isthmus block was achieved, the catheter was navigated back along the ablation line to assess the presence of local potentials along the lesion line. RESULTS: Bidirectional isthmus block was achieved in all patients. Mean total fluoroscopy time was 19.8 +/- 4.1 min in group I and 9.1 +/- 3.5 min in group II (P<0.001); mean fluoroscopy time required for radiofrequency ablation was 6.9 +/- 1.4 min in group I and 0.6 +/- 0.3 min in group II (P<0.001). During a follow-up of 16 +/- 9 months, three patients in group I (10%) experienced recurrence of AFL as opposed to none in group II (P<0.005). CONCLUSIONS: NavX technology allows accurate re-navigation of the lesion line to assess the presence of local potentials during an ablation procedure for typical AFL. Electroanatomic activation mapping can accurately identify gaps in the linear radiofrequency lesion with no AFL recurrence compared with 20% of recurrences after a standard procedure.

Is it possible to perform a linear lesion with no local electrograms using a three-dimensional mapping system for the ablation of typical atrial flutter?

AIMS: A randomized prospective study to evaluate the efficacy, safety and long-term outcomes of the complete disappearance of local electrograms along the linear lesion using the EnSite NavX three-dimensional mapping system compared to the conventional fluoroscopy-based mapping for the ablation of typical atrial flutter (AFL). METHODS: 83 patients with spontaneous AFL episodes were randomized to the conventional procedure (group I, 41 patients) or to the EnSite NavX three-dimensional mapping system (group II, 42 patients). When bidirectional block was achieved, a renavigation of the ablation line was performed to verify the absence of local potentials along the line. RESULTS: In all patients, bidirectional isthmus block was achieved. Total mean fluoroscopy time was 19.8 +/- 4.1 min and 9.1 +/- 3.5 min (p < 0.001) and radiofrequency (RF) mean fluoroscopy time was 6.9 +/- 1.4 min and 0.6 +/- 0.3 min (p < 0.001), respectively, in group I and II. During long-term follow-up of 16 +/- 9 months, there were 4 (10%) AFL recurrences in group I and 0 in group II (p < 0.005). CONCLUSION: NavX accurately renavigates the lesion line and verifies local potentials. The electro-anatomic activation map accurately identifies gaps in the RF lesion line and no recurrences were found compared with 10% recurrences after standard procedures for typical AFL.