Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

Sex Differences in Epidemiology, Morphology, Mechanisms, and Treatment of Mitral Valve Regurgitation.

Sex-related disparities have been recognized in incidence, pathological findings, pathophysiological mechanisms, and diagnostic pathways of non-rheumatic mitral regurgitation. Furthermore, access to treatments and outcomes for surgical and interventional therapies among women and men appears to be different. Despite this, current European and US guidelines have identified common diagnostic and therapeutic pathways that do not consider patient sex in decision-making. The aim of this review is to summarize the current evidence on sex-related differences in non-rheumatic mitral regurgitation, particularly regarding incidence, imaging modalities, surgical-derived evidence, and outcomes of transcatheter edge-to-edge repair, with the goal of informing clinicians about sex-specific challenges to consider when making treatment decisions for patients with mitral regurgitation.

Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy in Women: A Propensity Score-Matched Analysis.

BACKGROUND: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood. OBJECTIVES: This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS). METHODS: We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup. RESULTS: In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P < 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P < 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction <30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31). CONCLUSIONS: After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction <30%.

Association among myocardial injury and mortality in Influenza: A prospective cohort study.

BACKGROUND: Myocardial injury (MINJ) is a well-recognized prognostic marker in different acute cardio-respiratory illnesses, nonetheless, its relevance in Influenza remains poorly defined. Our aim was to assess incidence, correlates, short and mid-term prognostic role of MINJ in Influenza. METHODS: Hospitalized patients (pts) with laboratory confirmed Influenza A or B underwent highly sensitive cardiac T Troponin (hs-cTnT) measurement at admission in four regional Swiss hospitals during the 2018-2019 epidemic. MINJ was defined as hs-cTnT >14 ng/L. Clinical, laboratory and outcome data were prospectively collected. The primary endpoint was mortality at 28 days while the composite of mortality, admission to intensive care unit (ICU) or need for mechanical ventilation at 28-days and mortality at 30-months were set as secondary endpoints. RESULTS: The presence of MINJ was assessed within 48 h from admission in 145 consecutive hospitalized pts, being evident in 94 (65.5%) pts and associated with older age, higher C-reactive protein levels, renal impairment or chronic obstructive pulmonary disease. At a 28-days follow-up, 7 deaths (4.8%) occurred, all in patients with MINJ at admission (log-rank p = 0.048). MINJ was strongly associated with occurrence of death, ICU admission or mechanical ventilation (OR 5.74, 95% CI 1.28-53.29; p = 0.015). After a median follow-up of 32.7 months (IQR 32.2-33.4), 15 (10.3%) deaths occurred, all among pts with MINJ at index hospitalization leading to a higher mortality at follow-up among patients with MINJ (log-rank p = 0.003). CONCLUSIONS: MINJ is common in patients hospitalized for Influenza and is able to stratify the risk of short-term adverse events and mid-term mortality.

One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?

PURPOSE: The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients. METHODS: We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry. RESULTS: We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models. CONCLUSION: In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.

Cardiac resynchronization therapy defibrillators in patients with permanent atrial fibrillation.

AIMS: There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. METHODS AND RESULTS: We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse-probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P < 0.001), more frequently male (82.5% vs. 75.5%, P = 0.02), and had higher heart rate (75.7 vs. 71.0 b.p.m., P < 0.001). Of the 229 AF patients, 162 (70.7%) received suboptimal CRT (<98%) and 67 (29.3%) had adequate CRT (≥98%). During a median follow-up of 24 months, total mortality did not differ between AF and SR groups (propensity-score-weighted hazard ratio, HR 1.32 [95% confidence interval, 0.82-2.15], P = 0.25). The risk of appropriate shocks was significantly higher in the AF group with <98% CRT than in the SR group (weighted-HR, 1.99 [1.21-3.26], P = 0.006) and was similar in the AF group with ≥98% CRT versus the SR group (1.29 [0.66-2.53], P = 0.45). During follow-up, sinus rhythm was recovered in 23 patients in the AF group (10%) after a median time of 106 (42-256) days. The rate of sinus rhythm recovery in the AF group was 4.5 (95% CI, 2.8-6.7) per 100 patient-years; the rate of permanent AF occurrence in the SR group was 2.5 (95% CI, 1.9-3.3) per 100 patient-years. CONCLUSIONS: Although mortality was similar across patient groups, patients with permanent AF and suboptimal CRT had twofold higher risk of appropriate shocks than SR patients or AF patients with CRT ≥ 98%.

Circadian periodicity affects the type of ventricular arrhythmias and efficacy of implantable defibrillator therapies.

INTRODUCTION: Factors influencing malignant arrhythmia onset are not fully understood. We explored the circadian periodicity of ventricular arrhythmias (VAs) in patients with implantable cardioverter and cardiac resynchronization defibrillators (ICD/CRT-D). METHODS: Time, morphology (monomorphic/polymorphic), and mode of termination (anti-tachycardia pacing [ATP] or shock) of VAs stored in a database of remote monitoring data were adjudicated. Episodes were grouped in six 4-h timeslots from 00:00 to 24:00. Circadian distributions and adjusted marginal odds ratios (ORs), with 95% confidence interval (CI), were analyzed using mixed-effect models and logit generalized estimating equations, respectively, to account for within-subject correlation of multiple episodes. RESULTS: Among 1303 VA episodes from 446 patients (63% ICD and 37% CRT-D), 120 (9%) self-extinguished, and 842 (65%) were terminated by ATP, 343 (26%) by shock. VAs clustered from 08:00 to 16:00 with 44% of episodes, as compared with 22% from 00:00 to 08:00 (p < .001) and 34% from 16:00 to 24:00 (p = .005). Episodes were more likely to be polymorphic at night with an adjusted marginal OR of 1.66 (CI, 1.15-2.40; p = .007) at 00:00-04:00 versus other timeslots. Episodes were less likely to be terminated by ATP in the 00:00-04:00 (success-to-failure ratio, 0.67; CI, 0.46-0.98; p = .039) and 08:00-12:00 (0.70; CI, 0.51-0.96; p = .02) timeslots, and most likely to be terminated by ATP between 12:00 and 16:00 (success-to-failure ratio 1.42; CI, 1.06-1.91; p = .02). CONCLUSION: VAs did not distribute uniformly over the 24 h, with a majority of episodes occurring from 08:00 to 16:00. Nocturnal episodes were more likely to be polymorphic. The efficacy of ATP depended on the time of delivery.

Comparative frequency and prognostic impact of myocardial injury in hospitalized patients with COVID-19 and Influenza.

Aims: Myocardial injury (MINJ) in Coronavirus disease 2019 (COVID-19) identifies individuals at high mortality risk but its clinical relevance is less well established for Influenza and no comparative analyses evaluating frequency and clinical implications of MINJ among hospitalized patients with Influenza or COVID-19 are available. Methods and results: Hospitalized adults with laboratory confirmed Influenza A or B or COVID-19 underwent highly sensitive cardiac T Troponin (hs-cTnT) measurement at admission in four regional hospitals in Canton Ticino, Switzerland. MINJ was defined as hs-cTnT >14 ng/L. Clinical, laboratory and outcome data were retrospectively collected. The primary outcome was mortality up to 28 days. Cox regression models were used to assess correlations between admission diagnosis, MINJ, and mortality. Clinical correlates of MINJ in both viral diseases were also identified. MINJ occurred in 94 (65.5%) out of 145 patients hospitalized for Influenza and 216 (47.8%) out of 452 patients hospitalized for COVID-19. Advanced age and renal impairment were factors associated with MINJ in both diseases. At 28 days, 7 (4.8%) deaths occurred among Influenza and 76 deaths (16.8%) among COVID-19 patients with a hazard ratio (HR) of 3.69 [95% confidence interval (CI) 1.70-8.00]. Adjusted Cox regression models showed admission diagnosis of COVID-19 [HR 6.41 (95% CI 4.05-10.14)] and MINJ [HR 8.01 (95% CI 4.64-13.82)] to be associated with mortality. Conclusions: Myocardial injury is frequent among both viral diseases and increases the risk of death in both COVID-19 and Influenza. The absolute risk of death is considerably higher in patients admitted for COVID-19 when compared with Influenza.

Transcatheter Aortic Valve Replacement in Young Low-Risk Patients With Severe Aortic Stenosis: A Review.

In the last decades, transcatheter aortic valve replacement (TAVR) revolutionized the treatment of symptomatic severe aortic stenosis. The efficacy and safety of TAVR were first proven in inoperable and high-risk patients. Then, subsequent randomized clinical trials showed non-inferiority of TAVR as compared to surgical aortic valve replacement also in intermediate- and low-risk populations. As TAVR was progressively studied and clinically used in lower-risk patients, issues were raised questioning its opportunity in a younger population with a longer life-expectancy. As long-term follow-up data mainly derive from old studies with early generation devices on high or intermediate surgical risk patients, results can hardly be extended to most of currently treated patients who often show a low surgical risk and are treated with newer generation prostheses. Thus, in this low-risk younger population, decision making is difficult due to the lack of supporting data. The aim of the present review is to revise current literature regarding TAVR in younger patients.

[Care path for non-deferred elective hospitalizations in cardiology in the Covid-19 period]. / Percorso assistenziale per i ricoveri elettivi non differibili in cardiologia in periodo di Covid-19.

. Care path for non-deferred elective hospitalizations in cardiology in the Covid-19 period. INTRODUCTION: The novel coronavirus-19 (Covid-19) has rapidly resulted in a global pandemic. Our hospital had to postpone all elective admissions to increase capacity for COVID-19 patients. Therefore, a rearrangement of the elective admissions was necessary to guarantee a restart of ordinary procedures. AIM: To describe the organizational model adopted for elective procedures during the Covid-19 pandemic, to guarantee maximum safety for patients and healthcare workers. METHODS: Patients on waiting list for cardiac procedures were rearranged based on risks prioritization. Procedure of coronary angiography and cardiac devices (PM and ICD) implants or replacement took priority upon other cardiac procedures. Each patient underwent a telephone nurse triage to assess for any covid-19 symptoms. The hospital admissions were organized in accordance with health and safety measures declared by the National Institute of Health, with different paths according to the swab results. RESULTS: A total of 66 patients were contacted and 40 accepted the hospital admission (26 refused it, for fear of infection or covid-19 related family problems). No patient resulted positive to the nasal swab. CONCLUSIONS: In view of the impact on the health care system of this new pandemic, the choice of an appropriate pathway which can preserve patients' safety is essential, while guaranteeing the treatment of problems, such as cardiovascular diseases, with a high mortality rate.

Incomplete Left Atrial Appendage Closure Successfully Treated With a Redo Procedure.

A 68 year's old man with permanent atrial fibrillation, underwent a left atrial appendage closure because of high bleeding risk. However, after one month, an incomplete occlusion of the left atrial appendage due to a too deep position of the device, was detected by a transesophageal echocardiogram. Considering the residual high risk of thrombi formation, a new different device was successfully implanted with a correct closure of the appendage.

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses.

BACKGROUND: Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far. METHODS: We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality. RESULTS: From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization. CONCLUSION: In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES.

WorldwIde SurvEy on Clinical and Anatomical Factors Driving the Choice of Transcatheter Aortic Valve pRostheses.

Background: Following the success of the first human transcatheter aortic valve replacement (TAVR) in 2002, multiple transcatheter heart valves (THVs) have become available. However, guidelines or expert consensus on how to optimize THV choice according to patients' anatomical and clinical characteristics is missing. This survey-based study aimed to identify patient-specific characteristics deemed important in the choice of THV type. Methods and results: A web-based survey including 39 questions was completed by 71 experienced TAVR operators from 23 countries with a median TAVR volume of 88 procedures in the year prior to survey completion (IQR 61-180). The survey covered five topics: access, aortic annulus/leaflets, aortic root, left ventricular function and clinical characteristics. Factors with the most impact on THV choice were reported to be a calcified sinotubular junction, valve-in-valve procedure, annular dimension >575 mm2, femoral diameter ≤ 5.0 mm, low coronary ostia, calcification at the annular level and/or protruding into the left ventricular outflow tract, and need for post TAVR PCI. Also, in case of off-label use of THVs to treat bicuspid aortic valve disease and isolated aortic regurgitation, the choice of THV type was reported to be important. Conclusions: This survey-based study identifies key patient characteristics that impact THV selection. As such, we present a guide, based on current practice, of which THV types are best suited to these different patient-specific characteristics. A patient-tailored THV choice is likely to optimize TAVR outcomes.

Atrial signal amplitude predicts atrial high-rate episodes in implantable cardioverter defibrillator patients: Insights from a large database of remote monitoring transmissions.

BACKGROUND: Parameters measured during implantable cardioverter defibrillator (ICD) implant also depend on bioelectrical properties of the myocardium. We aimed to explore their potential association with clinical outcomes in patients with single/dual-chamber ICD and cardiac resynchronization therapy defibrillator (CRT-D). METHODS: In the framework of the Home Monitoring Expert Alliance, baseline electrical parameters for all implanted leads were compared by the occurrence of all-cause mortality, adjudicated ventricular arrhythmia (VA), and atrial high-rate episode lasting ≥24 hours (24 h AHRE). RESULTS: In a cohort of 2976 patients (58.1% ICD) with a median follow-up of 25 months, event rates were 3.1/100 patient-years for all-cause mortality, 18.1/100 patient-years for VA, and 9.3/100 patient-years for 24 h AHRE. At univariate analysis, baseline shock impedance was consistently lower in groups with events than without, with a 40 Ω cutoff that better identified high-risk patients. However, at multivariable analysis, the adjusted-hazard ratios (HRs) lost statistical significance for any endpoint. Baseline atrial sensing amplitude during sinus rhythm was lower in patients with 24 h AHRE than in those without (2.45 [IQR: 1.65-3.85] vs 3.51 [IQR: 2.37-4.67] mV, P < .01). The adjusted HR for 24 h AHRE in patients with atrial sensing >1.5 mV vs those with values ≤1.5 mV was 0.52 (95% CI: 0.33-0.83), P = .006. CONCLUSIONS: Although lower baseline shock impedance was observed in patients with events, the association lost statistical significance at multivariable analysis. Conversely, low sinus rhythm atrial sensing (≤1.5 mV) measured with standard transvenous leads could identify subjects at high risk of atrial arrhythmia.

Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Combining left atrial appendage closure and catheter ablation for atrial fibrillation: 2-year outcomes from a multinational registry.

AIMS: Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries. METHODS AND RESULTS: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores. CONCLUSION: The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.

Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: An Evaluation of Cohorts With and Without Structural Heart Disease.

BACKGROUND: Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD. METHOD: From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. RESULTS: Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p < 0.001), was more frequently male (79.1% vs 69.8%; p < 0.002), had a higher thrombo-embolic risk (CHA2DS2VASc ≥2: 63.4% vs 40.2%; p < 0.001), had a higher body mass index (27.7 ± 3.9 vs 26.4 ± 3.9 kg/m2; p < 0.001), had a larger atrial diameter (43.8 ± 7.0 vs 40.2 ± 5.8 mm; p < 0.001), and had a lower LV ejection fraction (57.2 ± 7.7% vs 60.7 ± 6.0%; p < 0.001). At the time of ablation, 73% of patients were on class Ic or III anti-arrhythmic drugs. Procedure time (106.9 ± 41.5 vs 112.1 ± 46.8 min; p = 0.248), fluoroscopic time (28.7 ± 14.7 vs 28.6 ± 15.2 min; p = 0.819), and complication rate (3.9% vs 4.8%; p = 0.525) were not different between the SHD and non-SHD cohorts. However, the acute success rate (98.9% vs 97.7%; p = 0.016) was higher in patients with SHD. After a follow-up of 13.4 ± 12.8 months, freedom from symptomatic recurrence was 78.0% for SHD and 78.4% for non-SHD (p = 0.895). Recurrence rate was not related to either left atrial size or LVEF. In the SHD cohort, Class Ic or III anti-arrhythmic drugs treatment decreased from 70.7% of patients before ablation to 28.7% of patients after CB-PVI (p = 0.001). CONCLUSIONS: CB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population.

Are Atrial High-Rate Episodes Associated With Increased Risk of Ventricular Arrhythmias and Mortality?

OBJECTIVES: This study evaluated the temporal association between atrial high-rate episodes (AHREs) and sustained ventricular arrhythmias (VAs) in a remotely monitored cohort with implantable cardioverter-defibrillators (ICD) with and/or without cardiac resynchronization therapy with a defibrillator (CRT-D). BACKGROUND: Clinical relevance of AHREs in terms of VA rate and survival has not been outlined yet. METHODS: This study analyzed data of patients with ICDs and CRT-Ds from the nationwide Home Monitoring Expert Alliance network. The cohort included 2,435 patients with a median follow-up of 25 months (interquartile range: 13 to 42 months) and age 70 years (range 61 to 77 years); 19.7% were women, 51.4% had coronary artery disease, and 45.2% had a CRT-D. There were 3,410 appropriate VA episodes; 498 (14.6%) were preceded by AHREs within 48 h; in 85.5% of this group, AHREs were still ongoing at episode onset. RESULTS: In a longitudinal analysis, the odds ratios (ORs) of experiencing any VA in a 30-day interval with AHREs versus intervals without AHREs were 2.35 (95% confidence interval [CI]: 1.86 to 2.97; p < 0.001) for ventricular tachycardia (VT), 3.06 (95% CI: 2.35 to 3.99; p < 0.001) for fast VT, 1.84 (95% CI: 1.36 to 2.48; p < 0.001) for self-extinguishing ventricular fibrillation (VF), and 2.31 (95% CI: 1.17 to 4.57; p = 0.01) for VF. ORs decreased with increasing AHRE burden. Patients with AHREs 48 h before VAs were more likely to experience VA recurrences (adjusted hazard ratio [HR]: 1.78; 95% CI: 1.41 to 2.24; p < 0.001) and had higher overall mortality (HR: 2.67; 95% CI: 1.68 to 4.23; p < 0.001). CONCLUSIONS: AHREs were not uncommon 48 h before VAs, which tended to be distributed around intervals with AHREs. Temporal connection between AHREs and VAs was a marker of increased risk of VA recurrence and a poorer prognosis.

Rate-responsive pacing and atrial high rate episodes in cardiac resynchronization therapy patients: Is low heart rate the key?

BACKGROUND: The role of atrial rate-responsive (RR) pacing in cardiac resynchronization therapy (CRT) is unclear due to the favorable effect of rate lowering in systolic heart failure. Atrial high rate episodes (AHREs) in CRT recipients are particularly worrisome since they cause loss of CRT, beyond representing a stroke risk factor. HYPOTHESIS: The presence of an association between RR and the incidence of AHREs. METHODS: Daily remote transmissions from 836 CRT recipients were analyzed. AHREs were classified by duration: ≥15 minutes, ≥5 hours, and ≥ 24 hours. Variables possibly associated to AHREs were included in time-dependent proportional-hazard models, averaging over 30-day periods and adjusting for main baseline variables. RESULTS: After a median follow-up of 23.9 (12.2-36.0) months, 507 (60.6%) patients experienced at least one 15-minute AHRE. RR function was programmed in 166 (19.8%) patients and was associated with an increased AHRE occurrence rate with hazard ratio (HR) ranging from 1.45 to 1.78 for the 3 cutoffs of episode duration. The negative effect of RR function was not observed in the subset of patients with low mean heart rate (<68 bpm). Higher mean heart rates increased AHRE risk (HR:1.02, P = .01), while CRT amount decreased it (HR:0.98, P < .01). The extent of atrial pacing did not predict AHRE occurrence. CONCLUSIONS: RR pacing in CRT recipients is associated with increased AHRE occurrence, especially when an average heart rate > 68 bpm is attained.