Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations: results from the SELENE HF study.

AIMS: We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. METHODS AND RESULTS: The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83-0.95] with 2.73 odds ratio (CI 1.98-3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year. CONCLUSION: With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

Reactive atrial-based antitachycardia pacing therapy reduces atrial tachyarrhythmias.

BACKGROUND: Reactive atrial-based antitachycardia pacing (rATP) aims to terminate atrial tachyarrhythmia/atrial fibrillation (AT/AF) episodes when they spontaneously organize to atrial flutter or atrial tachycardia; however, its effectiveness in the real-world has not been studied. We used a large device database (Medtronic CareLink, Medtronic, Minneapolis, MN, USA) to evaluate the effects of rATP at reducing AT/AF. METHODS: Pacemaker, defibrillator, and resynchronization device transmission data were analyzed. Eligible patients had device detected AT/AF during a baseline period but were not in persistent AT/AF immediately preceding first transmission. Note that 1:1 individual matching between groups was conducted using age, sex, device type, pacing mode, AT/AF, and percent ventricular pacing at baseline. Risks of AT/AF events were compared between patients with rATP-enabled versus control patients with rATP-disabled or not available in the device. For matched patients, AT/AF event rates at 2 years were estimated by Kaplan-Meier method, and hazard ratios (HRs) were calculated by Cox proportional hazard models. RESULTS: Of 43,440 qualifying patients, 4,203 had rATP on. Matching resulted in 4,016 pairs, totaling 8,032 patients for analysis. The rATP group experienced significantly lower risks of AT/AF events lasting ≥1 day (HR 0.81), ≥7 days (HR 0.64), and ≥30 days (HR 0.56) compared to control (P < 0.0001 for all). In subgroup analysis, rATP was associated with reduced risks of AT/AF events across age, sex, device type, baseline AT/AF, and preventive atrial pacing. CONCLUSIONS: Among real-world patients from a large device database, rATP therapy was significantly associated with a reduced risk of AT/AF. This association was independent of whether the patient had a pacemaker, defibrillator, or resynchronization device.

Myocardial 123I-metaiodobenzylguanidine imaging in hypertension and left ventricular hypertrophy.

Sympathetic nervous system plays a pivotal role in essential hypertension and in the development of left ventricular hypertrophy. Moreover, cardiac sympathetic dys-regulation has been demonstrated as a key con-causal factor in the genesis and progression of pathologic conditions such as congestive heart failure and ischemic heart disease to which hypertension predisposes as a risk factor. However, despite its fundamental role in cardiac pathophysiology, the evaluation of cardiac sympathetic nervous system has never gained a wide clinical application, remaining mostly a research tool. In this context, nuclear imaging techniques are the only modalities to allow the direct evaluation of cardiac sympathetic nervous integrity, giving the chance to obtain objective measures of the sympathetic tone. This review, while summarizing the general profile of currently available tests for autonomic evaluation, focuses on 123I-metaiodobenzylguanidine nuclear imaging as a preferential tool to assess cardiac sympathetic status. Specifically, the review discusses the available evidence on cardiac 123I-metaiodobenzylguanidine scintigraphy in arterial hypertension and left ventricular hypertrophy and its diagnostic and prognostic potential in congestive heart failure and ischemic heart disease.

The prognostic benefit of cardiac resynchronization therapy is greater in concordant vs. discordant left bundle branch block in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT).

Aims: Discordant and concordant left bundle branch block (dLBBB/cLBBB) are characterized by negative or positive T waves, respectively, in lateral leads. We assessed if the two morphologies are associated with different clinical status and prognosis in patients with heart failure (HF) and current indication to Cardiac Resynchronization Therapy (CRT)/CRT-Defibrillator (CRT-D). Methods and results: Baseline electrocardiograms of 1270 patients with LBBB in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy cohort were analysed to identify dLBBB and cLBBB. The two groups were compared with respect to baseline clinical characteristics, primary endpoint (HF event or death), and secondary endpoint (ventricular tachycardia, ventricular fibrillation, or death) over a 3.5-year period, and benefit of CRT-D over implantable cardioverter defibrillator (ICD). dLBBB was identified in 909 (72%) patients, and cLBBB in 361 (28%). Patients with dLBBB were older, had more severe symptoms and systolic dysfunction, as well as higher brain natriuretic peptide. CRT-D was superior to ICD in patients with both LBBB morphologies. The occurrence of the primary outcome was significantly more frequent in patients with dLBBB than in those with cLBBB, both in the entire cohort (P = 0.005), and in the CRT-D arm (P = 0.002). There was a trend towards more frequent occurrence of the secondary endpoint in patients with dLBBB than in those with cLBBB, but statistical significance was not reached in the whole population or in the subgroup undergoing CRT-D. Among patients receiving CRT-D, dLBBB was an independent predictor of the primary endpoint. Conclusion: dLBBB morphology is associated with more severe HF clinical status and worse prognosis, even in patients receiving CRT-D, compared with cLBBB morphology.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study.

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

The importance of integrated left atrial evaluation: From hypertension to heart failure with preserved ejection fraction.

AIM: Functional analysis and measurement of left atrium are an integral part of cardiac evaluation, and they represent a key element during non-invasive analysis of diastolic function in patients with hypertension (HT) and/or heart failure with preserved ejection fraction (HFpEF). However, diastolic dysfunction remains quite elusive regarding classification, and atrial size and function are two key factors for left ventricular (LV) filling evaluation. Chronic left atrial (LA) remodelling is the final step of chronic intra-cavitary pressure overload, and it accompanies increased neurohormonal, proarrhythmic and prothrombotic activities. In this systematic review, we aim to purpose a multi-modality approach for LA geometry and function analysis, which integrates diastolic flow with LA characteristics and remodelling through application of both traditional and new diagnostic tools. METHODS: The most important studies published in the literature on LA size, function and diastolic dysfunction in patients with HFpEF, HT and/or atrial fibrillation (AF) are considered and discussed. RESULTS: In HFpEF and HT, pulsed and tissue Doppler assessments are useful tools to estimate LV filling pressure, atrio-ventricular coupling and LV relaxation but they need to be enriched with LA evaluation in terms of morphology and function. An integrated evaluation should be also applied to patients with a high arrhythmic risk, in whom eccentric LA remodelling and higher LA stiffness are associated with a greater AF risk. CONCLUSION: Evaluation of LA size, volume, function and structure are mandatory in the management of patients with HT, HFpEF and AF. A multi-modality approach could provide additional information, identifying subjects with more severe LA remodelling. Left atrium assessment deserves an accurate study inside the cardiac imaging approach and optimised measurement with established cut-offs need to be better recognised through multicenter studies.

Ventricular-arterial coupling in centenarians without cardiovascular diseases.

BACKGROUND: Ventricular-arterial (VA) coupling is a central determinant of cardiovascular system performance and cardiac energetics. This index is expressed by the Ea/Ees ratio, where the effective arterial elastance (Ea) indicates the net arterial load exerted on the left ventricle and the left ventricular end-systolic elastance (Ees) is a load-independent measure of left ventricular chamber performance. METHODS: Thirty-three centenarians (100.6 ± 1.2 years, range 99-105 years, 10 M) without cardiovascular diseases underwent a complete echocardiographic evaluation and an instantaneous arterial blood pressure measurement, to characterize the Ea/Ees ratio and its two determinants indexed to body surface area. RESULTS: VA coupling was markedly reduced (Ea/Ees ratio 0.40 ± 0.1), reflecting a disproportionate increase in Ees index (8.5 ± 2.2 mmHg/ml/m2) compared with Ea index (3.2 ± 0.8 mmHg/ml/m2). Notably, the coupling ratio was significantly lower in women (0.37 ± 0.1) than in men (0.45 ± 0.1, p = 0.0003), due to an increase in Ees index significantly greater in women (9.4 ± 1.9 mmHg/ml/m2) than in men (6.5 ± 1.5 mmHg/ml/m2, p = 0.0002). Using multivariate regression analysis, only female gender (ß coefficient -0.04, p = 0.01) and relative wall thickness (ß coefficient -0.49, p < 0.0001) showed a significant inverse correlation to VA coupling. CONCLUSIONS: Our analysis in a population of centenarians without overt cardiovascular disease revealed very low values of VA coupling, especially in women. Both a LV structural remodeling as well as a high aortic elastance might have contributed to a secondary disproportionate increase in myocardial stiffness.

Arterial stiffness and left ventricular performance in elderly patients with persistent atrial fibrillation.

BACKGROUND: The prevalence of atrial fibrillation (AF) and arterial stiffness (AS) increases with age. AIMS: To evaluate if AS is correlated to longitudinal strain (LS), a marker of left ventricular (LV) function, in elderly AF patients with preserved ejection fraction (EF) undergoing external cardioversion. METHODS: AS was measured using the cardio-ankle vascular index (CAVI), LS was calculated from echocardiographic data of three consecutive cardiac cycles. RESULTS: We enrolled 38 patients (age 76 ± 8 years; men 60.5%; EF 65 ± 7%). LS and CAVI were, respectively, - 17.7 ± 3.7% and 9.7 ± 1.3. Multivariate analysis showed that LV performance was inversely related to height (p < 0.001) and to the presence of AF-related symptoms (p = 0.008). LS grew with increasing values of CAVI (p = 0.038). CONCLUSIONS: In elderly AF patients with preserved systolic function, LV performance is directly associated with AS. This link could influence atrium remodeling and the incidence of arrhythmia relapse.

Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial.

AIMS: Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT. METHODS AND RESULTS: RESPOND-CRT was a prospective, randomized, double-blinded, multicentre, non-inferiority trial. Patients were randomized (2:1, respectively) to receive weekly, automatic CRT optimization with SonR vs. an Echo-guided optimization of AV and VV timings. The primary efficacy endpoint was the rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in New York Heart Association class or quality of life), at 12 months. The study randomized 998 patients. Responder rates were 75.0% in the SonR arm and 70.4% in the Echo arm (mean difference, 4.6%; 95% CI, -1.4% to 10.6%; P < 0.001 for non-inferiority margin -10.0%) (Table 2). At an overall mean follow-up of 548 ± 190 days SonR was associated with a 35% risk reduction in HF hospitalization (hazard ratio, 0.65; 95% CI, 0.46-0.92; log-rank P = 0.01). CONCLUSION: Automatic AV and VV optimization using the contractility sensor was safe and as effective as Echo-guided AV and VV optimization in increasing response to CRT. CLINICALTRIALS.GOV NUMBER: NCT01534234.

Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy.

Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood. METHODS: We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates. RESULTS: In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P<.01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P=.005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P=.028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P=.997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05). CONCLUSIONS: In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device.

Recurrences in the Blanking Period and 12-Month Success Rate by Continuous Cardiac Monitoring After Cryoablation of Paroxysmal and Non-Paroxysmal Atrial Fibrillation.

INTRODUCTION: Recurrences within the blanking period (early recurrences) are common after atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI), but their clinical significance is still controversial. We aimed at evaluating the significance of within-blanking recurrences at 12-month follow-up after cryoballoon (CB) PVI, and to assess the real procedural success rate by continuous monitoring of cardiac rhythm. METHODS AND RESULTS: Sixty consecutive AF patients (34 paroxysmal, 56.7%) underwent their first CB-PVI at one Italian center (May 2013 to April 2015), and subsequent implantation of an implantable loop recorder (ILR). Overall, 12-month success rate after the blanking period was 55%. The shortest detected event was 7 minutes long. Late recurrences were more frequent in non-paroxysmal (19/26, 73.1%) than in paroxysmal AF (8/34, 23.5%; P <0.001). Early recurrences occurred in 17 (28.3%) patients, with 14 also having late recurrences (82.3%), while only 13 out of 43 (30.2%) without within-blanking recurrences experienced post-blanking events (P <0.001). Overall, early recurrences showed 51.8% sensitivity (95% CI 31.9-71.3%) and 90.9% specificity (95% CI 75.7-98.1%) for later recurrences, with 82.3% (95% CI 56.6-96.2%) positive and 69.8% (95% CI 53.9-82.8%) negative predictive value. The positive likelihood ratio was 5.7 (95% CI 1.8-17.8). At multivariable analysis, non-paroxysmal AF (HR: 3.113; 95% CI 1.309-7.403; P = 0.010) and within-blanking recurrences (HR: 3.453; 95% CI 1.544-7.722; P = 0.003) were independent predictors of post-blanking AT/AF. CONCLUSION: CB-PVI for paroxysmal AF shows a 12-month success rate of 76.5% after one single procedure, as assessed by continuous cardiac rhythm monitoring. Within-blanking recurrences predict the ablation failure in more than 80% of patients.

Impact of haemodynamic SonR sensor on monitoring of left ventricular function in patients undergoing cardiac resynchronization therapy.

AIMS: The haemodynamic SonR sensor is able to measure myocardial contractility. The isometric effort is useful in quantifying left ventricular (LV) performance. We investigated the amplitude changes in SonR signal over time and during static exercise according to the recovery of the left ventricle. METHODS AND RESULTS: Twenty five patients [18 male, 70 ± 8 years, LV ejection fraction (LVEF) 29 ± 5%, in sinus rhythm] underwent biventricular SonR implantable cardioverter defibrillator implant. After procedure and at 6 months, each patient underwent detection of SonR signal and continuous measurement of blood pressure, at rest and during isometric effort. During evaluation at baseline device was programmed in VVI at 40 bpm while in DDD at 60 bpm at follow-up. At 6 months, LV reverse remodelling was investigated. Cardiac resynchronization therapy patients were considered responders when an absolute improvement in LV ejection fraction ≥ 5% occurred. At 6 months, 14 (56%) patients were responders and 11 (44%) non-responders (mean LVEF 40 ± 10% vs. 27 ± 6%, respectively). In responders, SonR value did not significantly change at follow-up compared to baseline (P = 0.894). At follow-up, SonR value was not significantly different between two groups (P = 0.651). SonR signal significantly increased during isometric effort in responders (P = 0.002) while it slightly decreased in non-responders at follow-up (P = 0.572). No differences were observed in response to isometric effort between two groups at baseline (P = 0.182, P = 0.069, respectively). CONCLUSIONS: The absolute SonR amplitude provides limited information on the status of LV performance. The variation in SonR signal during static exercise is more likely to identify responders at follow-up.

Use of delayed-enhancement magnetic resonance imaging for fibrosis detection in the atria: a review.

This paper presents a review of the different approaches existing in the literature to detect and quantify fibrosis in contrast-enhanced magnetic resonance images of the left atrial wall. The paper provides a critical analysis of the different methods, stating their advantages and limitations, and providing detailed analysis on the possible sources of variability in the final amount of detected fibrosis coming from the use of different techniques.

The effects of gender on electrical therapies for the heart: physiology, epidemiology, and access to therapies.

The difference between men and women is clear even just by looking at an electrocardiogram: females present higher resting heart rate, a shorter QRS complex length and greater corrected QT interval. The development of these differences from pubertal age onward suggests that sexual hormones play a key role, although their effect is far from being completely understood. Different incidences between sexes have been reported for many arrhythmias, both ventricular and supraventricular, and also for sudden cardiac death. Moreover, arrhythmias are an important issue during pregnancy, both for diagnosis and treatment. Interestingly, cardiovascular structural and electrophysiological remodelling promoted by exercise training enhances this 'gender effect'. Despite all these relevant issues, we lack gender specific recommendations in the current guidelines for electrical therapies for heart rhythm disorders and heart failure. Even more, we continue to see that fewer women are included in clinical trials and are less referred than men for these treatments.

Reduction in unnecessary ventricular pacing fails to affect hard clinical outcomes in patients with preserved left ventricular function: a meta-analysis.

Aims: Several pacing modalities across multiple manufacturers have been introduced to minimize unnecessary right ventricular pacing. We conducted a meta-analysis to assess whether ventricular pacing reduction modalities (VPRM) influence hard clinical outcomes in comparison to standard dual-chamber pacing (DDD). Methods and Results: An electronic search was performed using Cochrane Central Register, PubMed, Embase, and Scopus. Only randomized controlled trials (RCT) were included in this analysis. Outcomes of interest included: frequency of ventricular pacing (VP), incident persistent/permanent atrial fibrillation (PerAF), all-cause hospitalization and all-cause mortality. Odds ratios (OR) were reported for dichotomous variables. Seven RCTs involving 4119 adult patients were identified. Ventricular pacing reduction modalities were employed in 2069 patients: (MVP, Medtronic Inc.) in 1423 and (SafeR, Sorin CRM, Clamart) in 646 patients. Baseline demographics and clinical characteristics were similar between VPRM and DDD groups. The mean follow-up period was 2.5 ± 0.9 years. Ventricular pacing reduction modalities showed uniform reduction in VP in comparison to DDD groups among all individual studies. The incidence of PerAF was similar between both groups {8 vs. 10%, OR 0.84 [95% confidence interval (CI) 0.57; 1.24], P = 0.38}. Ventricular pacing reduction modalities showed no significant differences in comparison to DDD for all-cause hospitalization or all-cause mortality [9 vs. 11%, OR 0.82 (95% CI 0.65; 1.03), P= 0.09; 6 vs. 6%, OR 0.97 (95% CI 0.74; 1.28), P = 0.84, respectively]. Conclusion: Novel VPRM measures effectively reduce VP in comparison to standard DDD. When actively programmed, VPRM did not improve clinical outcomes and were not superior to standard DDD programming in reducing incidence of PerAF, all-cause hospitalization, or all-cause mortality.

The effects of gender on electrical therapies for the heart: procedural considerations, results and complications: A report from the XII Congress of the Italian Association on Arrhythmology and Cardiostimulation (AIAC).

Use of cardiac implantable devices and catheter ablation is steadily increasing in Western countries following the positive results of clinical trials. Despite the advances in scientific knowledge, tools development, and techniques improvement we still have some grey area in the field of electrical therapies for the heart. In particular, several reports highlighted differences both in medical behaviour and procedural outcomes between female and male candidates. Women are referred later for catheter ablation of supraventricular arrhythmias, especially atrial fibrillation, leading to suboptimal results. On the opposite females present greater response to cardiac resynchronization, while the benefit of implantable defibrillator in primary prevention seems to be less pronounced. Differences on aetiology, clinical profile, and development of myocardial scarring are the more plausible causes. This review will discuss all these aspects together with gender-related differences in terms of acute/late complications. We will also provide useful hints on plausible mechanisms and practical procedural aspects.

The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden.

AIMS: To evaluate if the increased thromboembolic risk in female patients may be related to a higher burden of atrial fibrillation (AF). METHODS AND RESULTS: Data collected in a prospective observational research of patients implanted with a cardiac implantable electrical device (CIED) were analysed. We included 2398 patients: 489 (20.4%) were female and 1909 (79.6%) were male (oral anticoagulants treatment in 23.2%, independent of gender). During the follow-up (mean 42.8, median 37.7 months), 26 thromboembolic events occurred in 22 patients, with an incidence rate ratio of both stroke and stroke/transient ischemic attack (TIA) significantly higher in females compared with males [2.00, 95% confidence interval (CI) 1.53-2.61, P< 0.001 for stroke; 1.77 (95% C1.37-2.31, P< 0.001 for stroke/TIA]. An AF burden ≥5 min was a common finding (44% of patients), with no difference between men and women. The maximum daily AF burden and the time to evolution in permanent AF did not differ according to gender. The results of multivariate Cox regression showed that female gender, as well as history of CABG, were significant independent predictors of stroke and female gender was also an independent predictor of stroke/TIA. CONCLUSIONS: Among patients implanted with a CIED, an AF burden of at least 5 min is a common finding, (44% of patients). Female patients have a risk of stroke and TIAs that is around two-fold that of male patients, but this increased risk cannot be ascribed to a higher burden of AF or to differences in the evolution to permanent AF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01007474.

The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not?

AIMS: A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD. METHODS AND RESULTS: The survey 'S-ICD Why Not?' was an independent initiative taken by the Italian Heart Rhythm Society (AIAC). Clinical characteristics, selection criteria, and factors guiding the choice of ICD type were collected in consecutive patients who underwent ICD implantation in 33 Italian centres from September to December 2015. A cardiac resynchronization therapy (CRT) device was implanted in 39% (369 of 947) of patients undergoing de novo ICD implantation. An S-ICD was implanted in 12% of patients with no CRT indication (62 of 510 with available data). S-ICD patients were younger than patients who received transvenous ICD, more often had channelopathies, and more frequently received their device for secondary prevention of sudden death. More frequently, the clinical reason for preferring a transvenous ICD over an S-ICD was the need for pacing (45%) or for antitachycardia pacing (36%). Nonetheless, only 7% of patients fulfilled conditions for recommending permanent pacing, and 4% of patients had a history of monomorphic ventricular tachycardia that might have been treatable with antitachycardia pacing. CONCLUSION: The vast majority of patients needing ICD therapy are suitable candidates for S-ICD implantation. Nevertheless, it currently seems to be preferentially adopted for secondary prevention of sudden death in young patients with channelopathies.

Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project.

BACKGROUND: Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA. METHODS: A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated. RESULTS: Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred. CONCLUSION: This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

ANMCO/AIAC/SICI-GISE/SIC/SICCH Consensus Document: percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation patients: indications, patient selection, staff skills, organisation, and training.

Atrial fibrillation (AF) is the most common arrhythmia and its prevalence is increasing due to the progressive aging of the population. About 20% of strokes are attributable to AF and AF patients are at five-fold increased risk of stroke. The mainstay of treatment of AF is the prevention of thromboembolic complications with oral anticoagulation therapy. Drug treatment for many years has been based on the use of vitamin K antagonists, but recently newer and safer molecules have been introduced (dabigatran etexilate, rivaroxaban, apixaban, and edoxaban). Despite these advances, many patients still do not receive adequate anticoagulation therapy because of contraindications (relative and absolute) to this treatment. Over the last decade, percutaneous closure of left atrial appendage, main site of thrombus formation during AF, proved effective in reducing thromboembolic complications, thus offering a valid medical treatment especially in patients at increased bleeding risk. The aim of this consensus document is to review the main aspects of left atrial appendage occlusion (selection and multidisciplinary assessment of patients, currently available methods and devices, requirements for centres and operators, associated therapies and follow-up modalities) having as a ground the significant evolution of techniques and the available relevant clinical data.