Publications

Reliable prediction of very late recurrence of atrial fibrillation (VLRAF) occuring >12 months after catheter ablation (CA) in apparently "cured" patients could optimize long-term follow-up and modify decision-making regarding the discontinuation of oral anticoagulant therapy. In a single-centre cohort of consecutive patients post radiofrequency AFCA, we retrospectively derived a novel score for VLRAF prediction. Of 133 consecutive post AFCA patients (mean age 56.9 ± 11.8 years, 63.9% male, 69.2% with paroxysmal AF) who were arrhythmia-free at 12 months (excluding 3-month "blanking period"), 20 patients expirienced a VLRAF during a 29.1 ± 10.1-month follow-up, with a 3-year cumulative VLRAF rate of 31.1%. The MB-LATER score (Male, Bundle brunch block, Left atrium ≥47 mm, Type of AF [paroxysmal, persistent or long-standing persistent], and ER-AF = early recurrent AF), had better predictive ability for VLRAF (AUC 0.782) than the APPLE, ALARMc, BASE-AF2, CHADS₂, CHA₂DS₂VASc or HATCH score (AUC 0.716, 0.671, 0.648, 0.552, 0.519 and 0.583, respectively), resulted in an improved net reclassification index (NRI) of 48.6-95.1% and better identified patients with subsequent VLRAF using decision-curve analysis (DCA). The MB-LATER score provides a readily available VLRAF risk assessment, and performs better than other scores. Validation of the MB-LATER score in other cohorts is underway.

The incidence of cardiometabolic diseases, such as obesity, diabetes, and cardiovascular diseases, is constantly rising. Successful lifestyle changes may limit their incidence, which is why researchers focus on the role of nutrition in this context. The outcomes of studies carried out in past decades have influenced dietary guidelines, which primarily recommend reducing saturated fat as a therapeutic approach for cardiovascular disease prevention, while limiting the role of sugar due to its harmful effects. On the other hand, a low-carbohydrate diet (LCD) as a method of treatment remains controversial. A number of studies on the effect of LCDs on patients with type 2 diabetes mellitus proved that it is a safe and effective method of dietary management. As for the risk of cardiovascular diseases, the source of carbohydrates and fats corresponds with the mortality rate and protective effect of plant-derived components. Additionally, some recent studies have focused on the gut microbiota in relation to cardiometabolic diseases and diet as one of the leading factors affecting microbiota composition. Unfortunately, there is still no precise answer to the question of which a single nutrient plays the most important role in reducing cardiometabolic risk, and this review article presents the current state of the knowledge in this field.

There are few head-to-head trials directly comparing non-vitamin K antagonist oral anticoagulants (NOACs) against one other. A network meta-analysis (NMA) was performed to examine the indirect comparisons among NOACs in Asians with nonvalvular atrial fibrillation (NVAF). STATA 15.0 and ADDIS 1.16.8 softwares were used to perform the statistical analysis. Odds ratios with 95% credible intervals were applied to evaluate the end points. The probabilities of treatment rank were used to understand which interventions are more effective and safe, and the total rank probability was 1. In our NMA, the rank probabilities of apixaban in the case of stroke or systemic embolism, death from any cause, major bleeding, and intracranial hemorrhage (ICH) were 0.47, 0.49, 0.42, and 0.51, respectively. For cases of myocardial infarction, the rank probabilities of rivaroxaban were 0.40. This NMA indirectly compares the main efficacy and safety end points among NOACs in Asians with NVAF, and the rank probability analysis showed that apixaban likely performs best in cases of stroke or systemic embolism, death from any cause, and ICH; rivaroxaban may have the best performance for myocardial infarction.

Systematic review registration: PROSPERO registration number is CRD42021290542. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021290542.

<h3>Introduction</h3> Outpatient based management of heart failure is gaining popularity in the UK. Observation data and a small pilot randomised controlled trial suggested it is safe and clinically effective. However, the cost-effectiveness of this novel treatment approach is not known. Patient level costing is thought to be more accurate providing extra granularity when reviewing the cost of patient pathways. <h3>Methods</h3> We used the Trust’s patient level costing models from financial years 2018/19 and 2019/20 to calculate total treatment costs for the patients in the pilot prospective trial which randomised acute heart failure patients to receive inpatient vs outpatient based therapy. Patient level costing for inpatients would include hospital bed, nursing cost, consultant /ward doctor cost, non-pay costs (pharmacy including iv drugs, diagnostics e.g. pathology, radiology, ECG, echocardiography). Where patient level costs are unavailable, for example Community contacts, we have used a national average cost. Community centre visit - HRG code of N29AF 2018/19 National average cost £71 Home visit - HRG code of N29AF 2018/19 National average cost £71 GP visit - National average cost of £30 [1] All other costs used are from the Trust costing model. We also tested the feasibility of collecting quality of life data using EQ5D-5L and the visual analogue scale (VAS) where 100 means the ‘best health you can imagine’ and 0 is the worst. EQ-5D-5L 5 items each with a different domain: mobility, self-care, activities, pain and depression. Each is scored from 1-5 where 5 is the worst (severe limitation/unable to do). Value sets are used to transform the health profile into an index value that can be interpreted as a health utility; these range from -0.594 to 1.000 where a value below zero is taken to describe a health state whose quality is ‘worse than death’. <h3>Results</h3> 24 patients were randomised to 13 outpatients and 11 inpatients between July 2018 and June 2019: Inpatients received 5.8 ± 2.8 days of treatment, outpatients received 8.5 ± 5.2 (p=0.12). No patient was in CCU, HDU or ITU or received dialysis/haemofiltration. 1 patient randomised to inpatient care died during the index episode, but none died in the outpatient group. There was one extra A&amp;E visit. There were no extra GP visits during the index episode for outpatients, and the cost of extra visit for consultant /HF clinic (12 extra visits) has been factored into the equation (£1536). Inpatients costed £55892 (i.e. mean £5081 per patient); Outpatients costed £31435 (£2418 on average). Therefore total average saving was £2663 per patient. Treatment groups varied little in their quality of life. EQ-5D-5L VAS scores are significantly higher for outpatient. [Figure 1] Indeed a linear mixed model confirms that treatment arm is significantly associated with higher VAS scores; an outpatient reports a VAS score 13 points higher on average than an inpatient, and there is evidence that the score increases slightly over time (0.18 points per day, equivalent to ≈ 11 points over the 60 day period) for all patients. [Table 1] This is not true of EQ-5D utility indices; estimates for treatment and time are non-significant (p=0.78 and p=0.88 respectively). <h3>Conclusion</h3> Outpatient based AHF management appears cost-effective. Total average saving was £2663 per patient. Treatment groups varied little in their quality of life. EQ-5D-5L VAS scores are significantly higher for outpatient. <h3>Conflict of Interest</h3> No conflict of interest

Stroke risk stratification in HF patients remains an important issue. Recently, the CHA₂DS₂-VASc score, originally developed to predict stroke risk in AF patients, had been reported to be a predictive for strokes in HF patients regardless of AF being present. Furthermore, there are several independent risk factors (e.g., hypertension, diabetes mellitus, prior stroke) described. Based on the current evidence, HF should be considered as an independent risk factor for stroke. The CHA₂DS₂-VASc score might be useful to predict stroke risk in HF patients with or without AF in clinical routine. However, there is only a recommendation for the oral anticoagulation use in patients with concomitant HF and AF, while in patients with HF and no AF, individualized risk stratification is preferred. Current guidelines recommend to prefer non-vitamin Kantagonist anticoagulants over warfarin.

Hypertension is the most common cardiovascular disorder and atrial fibrillation is the most common clinically significant arrhythmia. Both these conditions frequently coexist and their prevalence increases rapidly with aging. There are different risk factors and clinical conditions predisposing to the development of atrial fibrillation, but due its high prevalence, hypertension is still the main risk factor for the development of atrial fibrillation. Several pathophysiologic mechanisms (such as structural changes, neurohormonal activation, fibrosis, atherosclerosis, etc.) have been advocated to explain the onset of atrial fibrillation. The presence of atrial fibrillation per se increases the risk of stroke but its coexistence with high blood pressure leads to an abrupt increase of cardiovascular complications. Different risk models are available for the risk stratification and the prevention of thromboembolism in patients with atrial fibrillation. In all of them hypertension is present and is an important risk factor. Antihypertensive treatment may contribute to reduce this risk, and it seems some classes are superior to others in the prevention of new-onset atrial fibrillation and prevention of stroke. Antithrombotic treatment with warfarin is effective in the prevention of thromboembolic events, although quite recently, new classes of anticoagulants that do not require international normalized ratio monitoring have been introduced with promising results.

British Heart Foundation and UK Stroke Association.

Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design). Under this framework, RWD refers only to data source, and a study incorporates RWD when it primarily uses data collected for non-research purposes, such as insurance claims data or the electronic health record, regardless of study design. Separation of study design, data source, and context enables parallel evaluation of two critical elements: (i) whether a study can support claims of causal inference, which can be assured with a high degree of confidence only in studies where patients are assigned treatments by protocol; and (ii) whether the study population and clinical context mirror clinical practice, a strength of observational studies using data from clinical practice or administrative claims. In this review, we describe the strengths and weaknesses of observational and non-observational studies, and studies involving RWD and non-RWD, through the lens of anticoagulation for atrial fibrillation (AF). Observational studies employing RWD are useful for describing how oral anticoagulants are used in clinical practice, but generally cannot be used to make claims regarding comparative treatment effects. Questions regarding treatment effect generally are best answered through an RCT, and additional pragmatic RCTs are needed to compare different antithrombotic agents for the prevention of thrombotic events in AF.