Patients who have experienced a myocardial infarction (MI) are at increased risk of sudden cardiac death (SCD). With the advent of implantable cardioverter-defibrillators (ICDs), accurate risk ...stratification has become very relevant. Numerous investigations have proven that a reduced left ventricular ejection fraction (LVEF) significantly increases the SCD risk. Furthermore, ICD implantation in patients with reduced LVEF confers significant survival benefit. As a result, LVEF is the cornerstone of current decision making for prophylactic ICD implantation after MI. However, LVEF as standalone risk stratifier has major limitations: (i) the majority of SCD cases occur in patients with preserved or moderately reduced LVEF, (ii) only relatively few patients with reduced LVEF will benefit from an ICD (most will never experience a threatening arrhythmic event, others have a high risk for non-sudden death), (iii) a reduced LVEF is a risk factor for both sudden and non-sudden death. Several other non-invasive and invasive risk stratifiers, such as ventricular ectopy, QRS duration, signal-averaged electrocardiogram, microvolt T-wave alternans, markers of autonomic tone as well as programmed ventricular stimulation, have been evaluated. However, none of these techniques has unequivocally demonstrated the efficacy when applied alone or in combination with LVEF. Apart from their limited sensitivity, most of them are risk factors for both sudden and non-sudden death. Considering the multiple mechanisms involved in SCD, it seems unlikely that a single test will prove adequate for all patients. A combination of clinical characteristics with selected stratification tools may significantly improve risk stratification in the future.
In this trial, patients with symptomatic paroxysmal atrial fibrillation were assigned to either radiofrequency ablation or antiarrhythmic drug therapy as first-line treatment. There was no ...significant difference between the groups in the cumulative burden of AF over a 2-year period.
Radiofrequency catheter ablation has emerged as an effective therapy for patients with paroxysmal atrial fibrillation who have recurrent episodes of arrhythmia despite antiarrhythmic drug therapy.
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It has been suggested that pulmonary-vein isolation can also be used as first-line treatment in selected patients with paroxysmal atrial fibrillation,
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and there are physiological reasons to assume that ablation as first-line therapy might be more effective than later intervention. Irreversible structural changes such as fibrosis and myolysis are commonly detected in the atria when atrial fibrillation has become persistent,
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and extensive atrial fibrosis detected by magnetic resonance imaging predicts a poor outcome . . .
In this multicenter, randomized trial comparing early rhythm control with usual care in patients with early atrial fibrillation and cardiovascular conditions, early rhythm control reduced the rate of ...death from cardiovascular causes and cardiovascular complications and did not affect the number of nights in the hospital.
Abstract
Atrial fibrillation (AF) is a complex condition requiring holistic management with multiple treatment decisions about optimal thromboprophylaxis, symptom control (and prevention of AF ...progression), and identification and management of concomitant cardiovascular risk factors and comorbidity. Sometimes the information needed for treatment decisions is incomplete, as available classifications of AF mostly address a single domain of AF (or patient)-related characteristics. The most widely used classification of AF based on AF episode duration and temporal patterns (that is, the classification to first-diagnosed, paroxysmal, persistent/long-standing persistent, and permanent AF) has contributed to a better understanding of AF prevention and treatment but its limitations and the need for a multidimensional AF classification have been recognized as more complex treatment options became available. We propose a paradigm shift from classification toward a structured
characterization
of AF, addressing specific domains having treatment and prognostic implications to become a standard in clinical practice, thus aiming to streamline the assessment of AF patients at all health care levels facilitating communication among physicians, treatment decision-making, and optimal risk evaluation and management of AF patients. Specifically, we propose the 4S-AF structured pathophysiology-based
characterization
(rather than classification) scheme that includes four AF- and patient-related domains—Stroke risk, Symptoms, Severity of AF burden, and Substrate severity—and provide a hypothetical model for the use of 4S-AF characterization scheme to aid treatment decision making concerning the management of patients with AF in clinical practice.
Anticoagulation in patients with atrial fibrillation (AF) should be guided by considerations of the risk of thromboembolism, stroke, and bleeding as well as the patient’s preference. Well-recognized ...scores have been developed to help the clinician in daily risk assessment, but there are several special patient populations for whom scores are not developed or validated. Furthermore, these patients were not adequately represented in the pivotal randomized trials for non-vitamin K antagonist oral anticoagulants (NOACs). In patients with cancer, the intrinsic hypercoagulable state has to be balanced against an increased risk of bleeding, and a dynamic concept should be applied, taking into account the cancer type, current disease state, therapeutic strategy, and patient-related factors, with NOACs playing an increasingly larger role. In women with planned pregnancy or already pregnant, NOACs should be avoided. However, accidental exposure during pregnancy should not lead to recommendations for pregnancy termination in view of current observational data. Whether patients on dialysis with AF benefit from anticoagulation at all is questionable. But if the decision for anticoagulation is made, NOACs may contribute to a more favorable risk–benefit profile than vitamin- K antagonists. Finally, patients on the ward deserve special considerations regarding periprocedural management of anticoagulation. Although for the majority of procedures a short discontinuation of oral anticoagulation seems appropriate, there are some low-bleeding-risk procedures that do not require cessation. The aim of the present review is to discuss the major particularities of these four patient subgroups and thus to facilitate the clinical decision-making.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional ...catheter ablation while preventing thermally mediated complications.
The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.
Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.
PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.
URL: https://www.
gov; Unique identifier: NCT04198701.
Summary Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring ...function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. Methods We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II–III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov , number NCT00538356. Findings We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43–0·90). Ten versus 27 patients died during follow-up. Interpretation Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. Funding Biotronik SE & Co. KG.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
The aim of this analysis was to provide comprehensive information on invasive cardiac arrhythmia therapies in the European Society of Cardiology (ESC) area over the past 10 years.
The European Heart ...Rhythm Association (EHRA) has collected data on invasive arrhythmia therapies since 2008. This year 53 of the 56 ESC member countries provided data for the EHRA White Book. Here we present updated data on procedure rates together with information on demographics, economy, vital statistics, local healthcare systems and training activities. Considerable heterogeneity in the access to invasive arrhythmia therapies still exists across the five geographical ESC regions. In 2016, the device implantation rates per million population were 3-6 times higher in the Western region than in the non-European and Eastern ESC member countries. Catheter ablation activity was highest in the Western countries followed by the Northern and Southern areas. In the non-European countries, atrial fibrillation ablation rate was more than tenfold lower than in the European countries. On the other hand, the growth rate over the past ten years was highest in the non-European and Eastern countries. In some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values.
It was encouraging to note that during the past decade the growth in invasive arrhythmia therapies was greatest in the areas historically with relatively low activity. Nevertheless, there is substantial disparity and continued efforts are needed to improve harmonization of cardiac arrhythmia therapies in the ESC area.
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