bluuebunny/crossref_metadata_2025_split huggingface dataset:
Baseline demographic and clinical characteristics as predictors of adverse outcomes to improve management of patients with AF receiving edoxaban: a subanalysis of the ETNA-AF registry
Authors: Morrone D , Chao T , Chen C , Choi E , De Groot J , Kirchhof P , Pecen L , Tse H , Unverdorben M , De Caterina R 
Published: November 2023

Abstract

Background/Introduction
Atrial fibrillation (AF) is associated with substantial morbidity and mortality for patients, and significant burden for societal health and health economy. Even optimal oral anticoagulation and treatment of concomitant conditions leave an unacceptable remaining morbidity and mortality.

Aim
The purpose of this analysis was to identify clinical parameters associated with cardiovascular events in patients with AF receiving adequate anticoagulation.

Methods
The Global Edoxaban Treatment in routiNe clinical prActice (ETNA)-AF observational, non-interventional programme prospectively collects data on characteristics and clinical outcomes in patients treated with the direct oral factor Xa inhibitor edoxaban for stroke prevention in AF from Europe, Japan, and other Asian countries. A risk prediction model was built and evaluated for two dependent variables: composite endpoint 1, consisting of cardiovascular (CV) death, all stroke or systemic embolism or transient ischaemic attack (TIA), myocardial infarction (MI), and venous thromboembolism (VTE); and composite endpoint 2, consisting of CV death, all stroke, and MI. Independent variables used to identify predictors of the composite endpoints included the following parameters at baseline: age, history of any stroke/TIA, peripheral arterial disease (PAD), heart failure (HF), coronary artery disease (CAD), major or clinically relevant non-major gastrointestinal bleeding, chronic obstructive pulmonary disease, body mass index &lt;18.5 kg/m2, weight, creatinine clearance (CrCl), history of valvular disease, history of diabetes mellitus, smoking history, age ≥85 years, and hepatic impairment. Multivariable Cox analysis with stepwise selection was used to identify baseline predictors of the composite endpoints.

Results
Overall, 26,580 edoxaban patients were included in the analysis. At baseline, 3034 (11.4%) patients were ≥85 years. Additional baseline demographics and clinical characteristics are reported in Table 1. All clinical variables were significant predictors (P &lt;0.05) of both composite endpoints. Stronger predictors of composite endpoint 1 included history of any stroke/TIA, PAD, HF, higher weight, and lower CrCl (all P &lt;0.0001; Figure 1). Most significant predictors of composite endpoint 2 included a history of ischaemic stroke, PAD, HF, and weight (P &lt;0.0001; Figure 1).

Conclusion
A history of ischemic stroke, peripheral artery disease, heart failure, and weight identify patients with atrial fibrillation at risk of cardiovascular events on optimal current therapy. These patients may benefit from targeted interventions including early rhythm control and intensified, integrated management. Additional external validation will be performed to further the additive value of the analysis presented here.Table 1Figure 1
Persistence to edoxaban treatment in patients with atrial fibrillation: Analysis from the Global ETNA-AF program
Authors: Diemberger I , Chen C , Choi J , De Groot J , Kirchhof P , Pecen L , Unverdorben M , Wang C , Yamashita T , De Caterina R 
Published: November 2023

Abstract

Background/Introduction
Direct oral anticoagulants (DOACs) are now the standard treatment for stroke prevention in most patients with atrial fibrillation (AF). However, many studies have reported suboptimal adherence and persistence to DOAC treatment. Data collected in routine care, such as in the Global Edoxaban Treatment in routiNe clinical prActice (ETNA)-AF program, may provide insight into factors associated with treatment persistence.

Purpose
Evaluate the persistence to edoxaban treatment in a large, unselected, real-world population using 2-year data from the Global ETNA-AF study.

Methods
The Global ETNA-AF program is a predefined integration of prospective, observational, non-interventional regional studies from Europe, Japan, and other Asian countries to evaluate the safety and effectiveness of edoxaban in patients with AF. Demographic and clinical characteristics were collected at baseline. In this analysis, patients were stratified by persistence to edoxaban treatment during a 2-year follow-up period (ie, persistence [PERS], suspension [SUS], permanent discontinuation [PERD], and suspension with later permanent discontinuation [SUS+PERD]).

Results
Overall persistence was high, with 87.1% of patients under edoxaban treatment at 2 years considering both groups that discontinued edoxaban at any time (PERD and SUS+PERD). Mean patient age, creatinine clearance, CHA2DS2-VASc, and HAS-BLED score were similar between the PERS (n = 20,053), SUS (n = 3088), PERD (n = 2936), and SUS+PERD (n = 503) groups (Table). In the PERS group, there were slightly fewer patients who received previous anticoagulation (vitamin K antagonist or DOAC) and were concomitantly using anti-platelet drugs at baseline. A larger proportion of SUS+PERD vs all other patients had a history of ischaemic stroke and/or major bleeding. Overall mortality was lower in patients in the PERS and SUS groups (0.79% [95% confidence interval {CI} 0.70–0.89] and 1.85% [95% CI 1.53–2.24], respectively) compared with patients who discontinued the treatment (PERD: 22.50% [95% CI 21.12–23.98]; SUS+PERD: 13.05% [95% CI 10.73–15.88]). Notably, persistence in the Global ETNA-AF program was generally higher than reported in GLORIA-AF at 2 years (70.9%) and XANTUS at 1 year (77.4%), despite a more compromised health profile especially considering the advanced patient age.

Conclusions
Treatment with edoxaban in routine clinical practice is associated with high persistence (87%) at 2 years in elderly patients with AF and multiple comorbidities. Persistence to edoxaban treatment was associated with better survival during the 2-year follow-up period. Further investigation is ongoing to determine the specific causes and consequences of edoxaban suspension and discontinuation to improve personalization of thromboembolic prophylaxis in patients with AF.Table 1
Has the use of concomitant cardiac medications improved over time in primary prevention ICD patients? Insights from the APPRAISE ATP study
Authors: Mont L , Daubert J , Kutyifa V , Zareba W , Ando K , Wold N , Yong P , Schuger C 
Published: November 2023

Abstract

Introduction
Patients (pts) implanted with an ICD for a primary prevention (PP) typically receive concomitant medications (meds) to treat LV dysfunction. However, It is not well established whether compliance with guideline-directed medical therapy (GDMT) has improved over time in this population.

Methods
Data were drawn from the MADIT-RIT (2009-2012) and APPRAISE ATP (2016-present) studies. Both studies were global in scope and enrolled pts who were implanted with an ICD for PP indications. Meds prescribed at baseline were compared between the two studies. Meds of interest included: evidence-based beta blockers [(BB-EV) defined as carvedilol, metoprolol, and bisoprolol], ACE inhibitors, ARBs, ARNIs, and mineralocorticoid receptor antagonists (MRA). SGLT2i were introduced into GDMT after the study APPRAISE ATP started and were not included. Meds were analyzed both individually and in combination as GDMT, defined as joint use of BB-EV, ACE/ARB/ARNI, and MRA. Differences were compared with a t-test for continuous variables, a Chi-square test for categorical data and a Cochran-Armitage trend test for ordinal categorical data.

Results
Demographics for the two studies were compared for pts who received ICDs in MADIT-RIT (n=742) and APPRAISE ATP (n=2627 enrolled with n=2596 randomized) and are shown in the table below. When compared to MADIT-RIT, APPRAISE ATP pts were significantly older with a greater prevalence of diabetes. Comparison of baseline meds are shown in both the table and in the figure. Although BB-EV and ACE/ARB use was slightly but significantly lower in APPRAISE ATP, these declines were offset by a significant increase in MRA use in APPRAISE ATP. A marked shift was seen over time with significant decline in use of ACE-I that was matched by a significant increase in use of ARBs, either alone or in combination with ARNIs. When considering meds used in combination for GDMT, pts in APPRAISE ATP were significantly more likely to meet GDMT recommendations than pts who were enrolled in MADIT-RIT (36.7% vs 27.2%, respectively, p&lt;0.001).

Conclusions
In the APPRAISE ATP study, compliance with GDMT in PP ICD pts has significantly improved when compared to the MADIT-RIT study conducted 10 years previously. These changes have been characterized by greater use of MRAs as well as a shift away from ACE inhibitors towards use of ARBs and ARNIs. Although there was considerably greater compliance with GDMT, with approximately one third of pts fulfilling GMDT, opportunities still remain for improvement. Further investigation is needed to determine what influence greater compliance with GDMT may have on improved clinical outcomes such as reductions in VT/VF event rates and all-cause mortality.
Left atrial functional changes and its predictive value in the early period after cryoballoon ablation for paroxysmal atrial fibrillation
Authors: Soysal A , Golcuk E , Ozturk S , Atici A , Gulfidan A , Yalman H , Ceviker A , Tokdil H , Raimoglu U , Cimci M , Durmaz E , Ikitimur B , Yalin K 
Published: November 2023

Abstract

Introduction/Purpose
In patients with paroxysmal atrial fibrillation (PAF), functional changes are observed in the left atrium (LA) after the pulmonary vein isolation (PVI) procedure. Although previous studies have investigated the altered mechanical functions of the LA with radiofrequency (RF) ablation, changes in the LA functions in the early period after cryoablation (CB-2) and the relationship between early period serial echocardiographic follow-ups after cryoablation and recurrence of atrial fibrillation/atrial tachycardia (AF/AT) have not been clearly demonstrated. This study aims to determine changes in the mechanical functions of LA in patients with PAF during the early period after cryoablation and whether these changes are effective in predicting the risk of recurrence by using echocardiographic parameters including Doppler and strain parameters.

Methods
Consecutive seventy-seven patients (mean age: 57.5±11.2 years; 57% men) with PAF underwent CB-2 and were prospectively analyzed. All patients were in sinus rhythm before and after the procedure. The LA dimensions, the LA reservoir strain (LASr), the LA atrial contractile strain (LASct), the LA conduit strain (LAScd) and left ventricular diastolic function parameters were evaluated by Doppler echocardiography before and 3 months after the procedure. Patients were monitored with 48-hour Holter at 1-3-6-12th months after the procedure to evaluate for recurrence.

Results
Acute procedural success was achieved in all cases. No major complications were observed. LASr and LASct showed significant recovery after the procedure (28.3±12.8% vs 34.6±13.8%, p&lt;0.001 and -10.8±7.9% vs -13.9±9.3%, p=0.014 respectively). No significant change was demonstrated in other echocardiographic parameters. During the one-year follow-up after the procedure late recurrence (&gt;3 months) of AF/AT was observed in 9 (11.7%) patients. Although the power of echocardiographic parameters in predicting recurrence was found to be not statistically significant, a downward trend especially in the values of LASr (p=0.068) and LASct (p=0.058) was observed at the 3rd month control echocardiographic results in patients with recurrence.

Conclusion
Significant improvement in mechanical functions may occur even in the early period after cryoballoon ablation in patients with PAF. In addition, as our study points out strain parameters, indicators of mechanical function tend to decline in patients with late term recurrence.
Comparison of ultralow temperature cryoablation and classical cryoballoon ablation for pulmonary vein isolation in patients with atrial fibrillation
Authors: Rudolph I , Bohnen J , Siebermair J , Rattka M , Rassaf T , Wakili R 
Published: November 2023

Abstract

Introduction
Pulmonary vein isolation (PVI) has become the standard-of-care in the treatment of atrial fibrillation (AF). In cryoablation cell damage is caused by freezing using predominantly nitrous oxide gas allowing temperature drops down to -60°C usually using a cryoballoon-based catheter (CB). Ultralow temperature cryoablation (ULTC) represents a novel ablation technique promising higher efficacy rates by achieving better transmurality of generated lesions. By using Nitrogen near it’s liquid vapor critical point (Near-critical nitrogen) in a linear catheter, ULTC achieves cooling temperatures as low as -196 °C. First studies using ULTC for PVI reported promising success rates. However, to date there is only limited data on outcomes of patients undergoing cryoablation with ULTC compared to CB.

Material and Methods
Our study aimed to compare the efficacy and safety of CB and ULTC ablation for PVI in AF patients. 90 consecutive patients with AF undergoing PVI by cryoablation at our university hospital between July 2020 and November 2022 were included in the analysis. The primary outcome was freedom from atrial arrythmia after 12 months. Furthermore, procedural parameters and periprocedural complications were compared.

Results
In total 90 patients, n=72 treated by CB ablation and n=18 by ULTC, were included in our study. Median age was 64yrs in CB and 70yrs in ULTC patients. Majority of patients of the CB (64%) and of the ULTC group (72%) were male. Paroxysmal AF was present in 57% of CB and 55% in the ULTC group. Median follow up was 365d for the CB and 232d for the ULTC group, respectively. The primary endpoint (Atrial arrythmia recurrence) occurred in 24/72 patients in the CB and in 10/18 patients in the ULCT group (HR: 0.47; 95% CI: 0.19-1.16; p=0.037).
There were no differences in periprocedural complications (CB: 12,5% vs. ULCA: 17%). Analysis of procedural parameters showed that the total procedure time was longer in the ULTC group (CB: 135 [124, 167] min, ULTC: 198 [168, 242] min; p=&lt;0.0001). Fluoroscopy time was increased (CB: 23 min [16, 28] min, ULTC: 44 [38, 48] min; p=&lt;0.0001) as was the median number of required freezes per vein in the ULTC group (ULTC: 4 [3, 6] vs CB: 1 [1, 2], p=&lt; 0.0001).

Conclusion
The findings of this retrospective analysis comparing cryoablation by ULTC vs. CB for PVI in AF patients suggests that ULTC is not yet equivalent to CB ablation with respect to procedural parameters and freedom from AF. Nevertheless, learning curve and limited device handling experience has to be taken into account. Future controlled studies and randomized trials are required to further elucidate the value of ULTC in AF ablation procedures, especially in the context of the novel Pulsed field ablation technology.
Optimal cutoff duration of history or persistence of atrial fibrillation to undergo radiofrequency catheter ablation of longstanding atrial fibrillation
Authors: Matsunaga Y , Egami Y , Ukita K , Yasumoto K , Okamoto N , Yano M , Tanaka N , Masuda M , Watanabe T , Inoue K , Sunaga A , Hikoso S , Sakata Y , Nishino M , Tanouchi J 
Published: November 2023

Abstract

Background
The limitations of catheter ablation for longstanding atrial fibrillation (LsAF) are beginning to emerge and appropriate patient selection are needed. It is well known that the longer the duration of atrial fibrillation (AF), the less likely it is to be cured by catheter ablation.

Purpose
To identify the optimal cutoff duration of AF to predict outcomes after catheter ablation in patients with LsAF in the contact force sensing catheter (CF) era.

Methods
From the EARNEST-PVI (Effect of Extensive Ablation on Recurrence in Patients with Persistent AF Treated with Pulmonary Vein Isolation) trial, which was a prospective, multicenter, randomized, open-label trial, comparing the pulmonary vein isolation (PVI) alone and PVI plus additional substrate ablation, factors associated with arrhythmia-free survival after a 3-month blank period were evaluated in patients with LsAF.

Results
Among 124 patients, CF was used in 114 (92%). Duration of AF history and persistence were related to recurrences. Other factors, including age, gender, left atrial diameter, chronic kidney disease and substrate ablation, were not related to recurrences (Table). Receiver operating characteristic analysis detected suitable cutoff duration of AF history and AD persistence as both 2.4 years (area under curve; 0.654 and 0.609, respectively)). The arrhythmia-free survival was significantly better in patients with AF history ≤ 2.4 years than the others (p=0.001, HR 2.69, 95% CI: 1.47-4.89) and better in patients with AF persistence ≤ 2.4 years than the others (p=0.008, HR 2.04, 95% CI: 1.19-3.48) (Figure).

Conclusion
Duration of AF history or persistence ≤ 2.4 years were suitable to undergo radiofrequency ablation of LsAF.TableFigure
Acute termination as an endpoint in individualised electrophysiological substrate ablation in persistent atrial fibrillation
Authors: Sharp A J , Gala A , Pope M T B , Betts T R 
Published: November 2023

Abstract

Background
Individualised electrophysiological substrate ablation in persistent atrial fibrillation (perAF) is complicated by the lack of a clearly defined procedural endpoint. The frequency of acute termination and its association with long-term outcomes is not well described.

Purpose
To define the frequency of acute termination with ablation in a cohort of patients with perAF undergoing catheter ablation with a non-contact charge density mapping (CDM) system and assess its correlation with long term outcomes.

Methods
The DISCOVER registry (NCT03893331) contains patients recruited to an ongoing multicenter, observational study of CDM guided endocardial ablation procedures. We searched the U.K. component of this registry for all patients presenting for perAF ablations to extract the necessary data for analysis.
Termination was considered secondary to ablation whether occurring directly from AF, or via an organized atrial tachycardia (AT). Follow up was performed at 6 and 12 months, and included patient reported recurrence, standard 12-lead ECG, and 7-day ambulatory ECG.

Results
Eighty-six patients were analysed. All presented in AF at the start of their procedure. Termination was with ablation in 18 (21%).
Six-month follow up data was available in 80 (93%), and 12-month in 71 (83%) patients. Freedom from AF was significantly higher in patients ablated to termination; at 6-months 82% vs 51% (p=0.02), at 12-months 69% vs 40% (p=0.04) [figure 1].
Rates of AT during follow up were similar between both groups; at 6-months 24% vs 25% (p=0.93), at 12-months 46% vs 33% (p=0.38) in ablation to termination vs no acute termination groups respectively.

Conclusion
Occurring in approximately 1/5th of our cohort, the value of ablation to termination as a marker of procedural endpoint may be limited; however, it is a predictor of favorable outcomes. Furthermore, there is no indication from our analysis of a hypothetical association with larger volumes of substrate modification and subsequently development of AT.Freedom from AF at 6 and 12 months
High-density open window mapping vs conventional mapping in accessory pathways ablation
Authors: Martinez Sande J L , Minguito-Carazo C , Gonzalez-Melchor L , Garcia-Seara J , Rodriguez-Manero M , Martinon-Martinez J , Garcia-Rodeja F , Jimenez-Ramos V , Fernandez-Lopez X A , Gonzalez-Ferrero T , Gonzalez-Juanatey J R 
Published: November 2023

Abstract

Background and purpose
High density (HD) mapping is associated with a reduction in fluoroscopy time compared to conventional mapping in accessory pathway (AP) ablation. The Open Window (OW) technique (CARTO 3, Biosense Webster) is a new tool that automatically uses conventional electrophysiology criteria for AP location, as shorter local EGM AV interval (extended early meets late tool), earliest local activation time (LAT) and annotation at unipolar signal (wavefront annotation). However, no studies comparing its feasibility to conventional mapping have been conducted. Therefore, the aim of the present study was to assess the feasibility and the clinical implications of high-density OW mapping when compared to conventional HD mapping.

Methods
A prospective, unicentric cohort study was conducted that included consecutive patients which were referred to our institution for AP ablation with OW mapping technique and compared to a recent retrospective cohort of patients who underwent conventional HD mapping. Total fluoroscopy time, total mapping time and the rate of recurrence of the AP were compared between groups. A schematic step by step graphic of the workflow procedure is represented in figure 1.

Results
A total of 33 consecutive patients (32.28 ± 18 years, 58% males) were included in the OW group and compared with a cohort of 29 patients (29.6 ± 18 years, 52% males) who underwent conventional HD mapping. An example of Right Superior AP ablation is showed in figure 2. No differences in the location of the AP were observed (p=NS). OW mapping was associated to a lower mapping time (29.3 vs 37.8 min; p=0.04), lower fluoroscopy time (14.3 vs 21.3 min; p= 0.04) and lower radiofrequency time (p=0.007). After a median follow up of6 months, there were no differences in the rate of recurrence of the AP conduction between groups (p=NS).

Conclusions
In our experience, OW mapping was a feasible tool for AP location associated to a lower mapping time, lower radiofrequency time and lower X-ray exposure time with no differences in recurrence rate when compared to conventional HD mapping. However, more studies should be performed to corroborate these conclusions.Step by Step WorkflowRight Superior AP ablation