bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association between left atrial wall thickness and residual potential after pulmonary vein antral isolation in patients with atrial fibrillation receiving Ablation Index-guided ablation
Authors: Lee S.R , Lee E.J , Cha M.J , Choi E.K , Oh S 
Published: November 2020

Abstract

Background
For the improvement of efficacy in radiofrequency catheter ablation (RFCA) of pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), fixed target Ablation Index (AI) value has been recommended regardless of individual and regional differences of left atrial wall thickness (LAWT).

Objective
To evaluate the association between LAWT and residual potential (RP) after first pass encirclement of PVI in AF patients receiving AI-guided PVI.

Method
A total of 116 patients (29% persistent AF) undergone AF RFCA using AI-guided PVI were included. Using SmartTouch catheter or SmartTouch SF catheter (Biosense Webster Inc., CA, US), point-by-point ablation was delivered at 30–40W on the anterior/roof segments and 25–30W on the posterior/inferior/carina segments. AI targets were 450 on the anterior/roof segments and 350 on the posterior/inferior/carina segments. After first encirclement of PVI was performed, RP was evaluated. LAWT was evaluated by 3-dimensional wall thickness map using computed tomographic images. LAWT values of ablation regions were graded by LAWT in each segment of PV antrum (Figure).

Results
Among a total of 1564 PV segments, RP was observed in 106 segments (6.8%). Left superior, inferior PV ridges and right superior PV roof segments were the most, second, and third thickest area among 14 PV segments (mean LAWT grade 5.09±1.08, 3.34±1.70, and 2.32±1.11, respectively). Mean LAWT grade was lower in segments with RP than those in without RP (2.74±1.80 vs. 2.07±1.28, p&lt;0.001, Figure). In segments applied AI 450 (anterior/roof), segments with RP showed significantly thicker LAWT than those without RP (mean LAWT grade 3.65±2.01 vs. 2.57±1.56, p&lt;0.001). In posterior/inferior/carina segments applied AI 350, there was no significant difference in mean LAWT between segments with and without RP (1.80±0.77 vs. 1.75±0.83, p=0.744).

Conclusion
Delivering same AI during PVI, thicker LAWT was associated with higher incidence of RP after first pass encirclement of PV in anterior/roof area. Tailored AI should be considered by LAWT to improve acute outcome of PVI.
LAWP RP

Funding Acknowledgement
Type of funding source: None
Stability and performance of the EnSite Precision cardiac mapping system for electrophysiology mapping and ablation procedures: results from the EnSite Precision observational study
Authors: Lin D , Glover B , Colley J , Thibault B , Steinberg C.M , Jewell C , Bernard M , Siddiqui U , Li J , Sarver A , Hsu J , Cooper D 
Published: November 2020

Abstract

Background
The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and dynamic 3-D maps of cardiac chambers.

Objective
The EnSite Precision™ Observational Study was designed to quantify and characterize the use of the EnSite Precision™ Cardiac Mapping System for mapping and ablation of cardiac arrhythmias in a real-world environment and to evaluate procedural and subsequent clinical outcomes.

Methods
1065 patients were enrolled at 38 centers in the U.S. and Canada between 2017–2018. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedures using the EnSite Precision™ System.

Results
Of 989 patients who completed the protocol, a geometry was created in 936 (94.7%). Most initial maps were created using Automap (n=545, 67.0%) or a combination of Automap and manually mapping (n=151, 18.6%). Median time to create an initial map was 9.0 min (IQR 5.0–15.0), with a median number of used mapping points per minute of 92.7 (IQR 30.0–192.0). During ablation, AutoMark was used in 817 (82.6%) of procedures. The most frequent metrics for lesion color were Impedance Drop or Impedance Drop Percent (45.5% combined), time (23.9%) and average force (14.2%). At Canadian sites where LSI was an option, it was used as the color metric in 87 (45.8%) of cases (10.6% overall). The EnSite System was stable throughout 79.7% (n=788 of 989) of procedures. Factors affecting stability were respiratory change (n=88 of 989, 8.9%), patient movement (n=73, 7.4%), CS Positional Reference dislodgement (n=32, 3.2%), and cardioversion (n=19, 1.9%). Conscious sedation was used in 189 (19.1%) of patients. Acute success was reached based on the pre-defined endpoints for the procedure in 97.4% (n=963) of cases.

Conclusion
In a real-world study analysis, the EnSite Precision™ mapping system was associated with a high prevalence of acute procedural success, low mapping times, and high system stability.

Funding Acknowledgement
Type of funding source: None
Guideline-directed medical therapies for comorbidities among patients with atrial fibrillation: results from GARFIELD-AF
Authors: Camm A.J , Steffel J , Virdone S , Bassand J.-P , Fitzmaurice D.A , Fox K.A.A , Goldhaber S.Z , Goto S , Haas S , Turpie A.G.G , Verheugt F.W.A , Misselwitz F , Kayani G , Pieper K.S , Kakkar A.K 
Published: November 2020

Abstract

Introduction
The GARFIELD-AF registry is a prospective, multicentre, observational study of adults with recently diagnosed non-valvular atrial fibrillation (AF) and at least one risk factor for stroke. In GARFIELD-AF the absolute risk reduction of mortality associated with anticoagulation is far greater than the apparent absolute risk reduction in (ischemic) stroke. One potential explanation is improved treatment, with the use of comprehensive guideline-directed medical therapies (GDMT), in patients with AF receiving oral anticoagulant (OAC) therapy. The objectives were to identify the potential relationships between anticoagulation status, GDMT use and clinical outcomes.

Methods
Use of GDMT was determined on the basis of published European Society for Cardiology guidelines operative between 2010 and 2016. We explored the use of GDMT in patients enrolled in GARFIELD-AF (March 2010-Aug 2016) with CHA2DS2-VASc ≥2 and with one or more of five comorbidities–coronary artery disease, diabetes mellitus, heart failure, hypertension and peripheral vascular disease. Association between GDMT use and clinical outcomes events was evaluated with Cox-proportional hazards models. The models included stratification by all possible combinations of the five comorbidities used to define GDMT eligibility.

Results
The study population comprised of 39,946 patients who had one or more comorbidities (3238 [8.1%] received none of the GDMT, 17,398 [43.6%] received some, and 19,310 [48.3%] received all of the GDMT for which they were eligible). Patients on OAC tended to receive all the GDMTs more frequently compared to patients on no OAC (50.2% vs 44.8%, respectively).
Comprehensive GDMT was associated with a lower risk of all-cause mortality (HR: 0.89 [0.80–0.99]) and non-cardiovascular mortality (0.80 [0.68–0.95]) compared to inadequate or no GDMT but was not associated with a lower risk of stroke (HR: 1.04 (0.88–1.24)] (Figure). The effect of OAC was beneficial for mortality and stroke risk whether receiving comprehensive GDMT or not.

Conclusion
OAC therapy is associated with a lower risk of all-cause mortality, non-cardiovascular mortality and stroke/SE in comparison with no OAC, irrespective of GDMT use in patients with CHA2DS2-VASc ≥2. Although the use of GDMT is associated with a significant reduction in mortality, there is little evidence that this explains the decrease in mortality with the use of OAC.
GDMT use at two years of follow-up

Funding Acknowledgement
Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer AG.
The effect of computer decision support on optimizing appropriate dosing of novel oral anticoagulant therapy in the IMPACT-AF study
Authors: Cox J , Hamilton L , Doucette S , Foster G , Thabane L , Parkash R , Xie F , MacKillop J , Ciaccia A , Choudhri S , Nemis-White J 
Published: November 2020

Abstract

Background
Guidelines favour use of the non-vitamin K oral anticoagulants (NOACs) over vitamin-K antagonists for stroke prevention in atrial fibrillation (AF). However, studies have shown these agents are being under-dosed relative to the doses recommended in the product labels.

Purpose
To assess the ability of a CDS tool, employed to support management of patients with AF in primary care, to optimize NOAC prescribing.

Methods
The Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) study was a cluster randomized controlled trial that assessed the ability of a CDS tool to optimize care of community-based AF patients. Between September 2014 and December 2016, 203 primary care providers (104 randomized to CDS use, 99 to usual care [UC]) and 1133 of their patients (n=597 CDS, n=548 UC) were enrolled. Among other functions, 9 CDS program rules provided recommendations on NOAC prescribing based upon a given patient's clinical profile, as per product labels. Appropriate NOAC prescribing within the IMPACT-AF study population was compared between patients managed with the CDS versus UC at baseline and 12-months.

Results
Of those patients prescribed a NOAC, a high proportion (approximately 70%) were managed as per NOAC prescribing recommendations at baseline (Fig. 1). At 12 months, this proportion did not appreciably change in the UC arm (Fig. 1). In the CDS arm, an 8.2% absolute/11.8% relative improvement in appropriate NOAC prescribing over baseline was seen at 12-months (Fig. 1).
A comparison of patients at baseline and 12-months within each arm revealed a non-significant decline in the level of appropriate NOAC prescribing in the UC group (p=0.53). In the CDS arm, a significant improvement was observed in appropriate NOAC prescribing over time (p&lt;0.001).

Conclusion
Even prior to any quality improvement efforts, appropriate NOAC prescribing was higher than anticipated in this contemporary cohort of community-based AF patients. At 12-months, significant further improvements were seen in the CDS but not the UC arm. These findings suggest that physician decision support can help enhance appropriate NOAC prescribing in the primary care setting.
Figure 1. Appropriate NOAC prescribing

Funding Acknowledgement
Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Bayer Inc.
Impact of creatinine clearance on clinical outcomes in elderly atrial fibrillation patients receiving apixaban: J-ELD AF Registry sub-analysis
Authors: Akao M , Yamashita T , Suzuki S , Okumura K 
Published: November 2020

Abstract

Background
Randomized clinical trials demonstrated the efficacy and safety of apixaban in preventing stroke in patients with atrial fibrillation (AF). However, data on patients with low creatinine clearance (CCr), especially CCr 15–29 mL/min, are limited.

Methods
The J-ELD AF Registry is a large-scale, multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75 years taking on-label dose (standard dose of 5 mg bid or reduced dose of 2.5 mg bid) of apixaban. The enrollment period was from September 2015 to August 2016, and the observation period for each patient was 1 year. The entire cohort (3,015 patients from 110 institutions) was divided into three CCr subgroups: CCr ≥50 mL/min (n=1,165, 38.6%), CCr 30–49 mL/min (n=1,395, 46.3%), and CCr 15–29 mL/min (n=455, 15.1%).

Results
Most patients (74.3%) in the CCr ≥50 group received the standard apixaban dose, and most (97.4%) in the CCr 15–29 group received the reduced apixaban dose. The average age was 79.2 years for the CCr ≥50 group, 82.5 years for the CCr 30–49 group, and 85.6 years for the CCr 15–29 group. The lower CCr value group included more female patients, had lower body weight, and less cases of paroxysmal AF, as well as more cases of heart failure, peripheral artery disease, and myocardial infarction as comorbidities. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.2 and 2.4±0.8 for the CCr ≥50 group, 4.5±1.2 and 2.4±0.8 for the CCr 30–49 group, and 4.9±1.2 and 2.4±0.7 for the CCr 15–29 group, respectively. Kaplan Meier curves for cumulative incidence of events are shown in Figure. The event incidence rates (/100 person-years) were 1.76, 1.39, and 1.67 for stroke or systemic embolism (log rank p=0.762), 1.39, 1.93, and 3.13 for bleeding requiring hospitalization (log rank p=0.159), 1.75, 2.76, and 7.87 for total deaths (log rank p&lt;0.001), and 0.46, 0.84, and 2.62 for cardiovascular deaths (log rank p&lt;0.001), in the CCr ≥50 group, CCr 30–49 group, and CCr 15–29 group, respectively. After adjusting for confounders by Cox regression analysis, CCr 15–29 was an independent risk for total death [hazard ratio (HR) 3.22, 95% confidence interval (CI) 1.68–6.17, with reference to the CCr ≥50 group] and cardiovascular death [HR 3.18, 95% CI 1.06–9.56], but not for stroke or systemic embolism [HR 0.94, 95% CI 0.40–2.24], or bleeding requiring hospitalization [HR 2.00, 95% CI 0.93–4.28].

Conclusions
The incidence of events in each CCr value group was comparable for stroke or systemic embolism and bleeding requiring hospitalization, and significantly higher for total deaths and cardiovascular deaths only in the CCr 15–29 group, in Japanese non-valvular AF patients aged ≥75 years.
Cumulative incidence rates of events

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Bristol-Myers Squibb
Oral anticoagulants in extremely high risk very elderly (&gt;90 years) patients with Atrial Fibrillation
Authors: Chao T.F , Lip G.Y.H , Chen S.A 
Published: November 2020

Abstract

Background
The prevalence and incidence of atrial fibrillation (AF) increases with age, resulting in a high mortality and morbidity, especially from stroke and systemic thromboembolism (SSE). Nonetheless, the elderly are often denied oral anticoagulants (OACs), especially if they are “very elderly” (age ≥90 years) and perceived to be “high risk” of bleeding, for example, those with a history of intracranial haemorrhage (ICH), gastrointestinal bleeding or chronic kidney disease. We aimed to investigate the effectiveness and safety of OAC in this “high risk” very elderly group.

Methods
We used the Taiwan National Insurance Database to identify “high risk” very elderly subjects taking OACs, whether warfarin or non-vitamin K antagonist OACs (NOACs), who were compared to non-OAC users for the composite clinical endpoint of “ischemic stroke, ICH, major bleeding or mortality”. Propensity score matching was used for comparisons of the treatment groups.

Results
We studied 7,362 subjects (48.4% males; mean age 92.5 years, SD 2.78), of which 1737 were taking NOACs, 670 warfarin and 4955 were non-OAC users. Using non-OAC users as the reference group, warfarin use in “high risk” very elderly patients was associated with a higher risk of the composite endpoint (adjusted hazard ratio [aHR] 1.163, 95% CI 1.052–1.287), while NOACs were associated with a lower risk (aHR 0.763, 0.702–0.830). After propensity matching, NOACs were associated with a lower risk of events compared to “non-OAC use” or “warfarin”, while warfarin had a similar risk compared to non-OAC use (Figure).

Conclusions
Warfarin was associated with a similar (after propensity matching) or higher (Cox model before matching) risk of the composite clinical outcome compared to non-OAC use. NOACs were associated with a significantly lower risk of the composite clinical outcome compared to warfarin or non-OAC use. NOACs should be considered as the preferred OAC strategy in these “high risk” very elderly AF patients.

Funding Acknowledgement
Type of funding source: None
Impact of treatment strategies for AF on the progression and regression of AF type in the CABANA trial
Authors: Packer D.L , Monahan K.H , Piccini J.P , Al-Khalidi H.R , Silverstein A.P , Poole J.E , Bahnson T.D , Mark D.B 
Published: November 2020

Abstract

Background
The CABANA trial compared drug vs ablation therapy yet did not identify a difference in the primary endpoint of death, stroke, severe bleeding, or cardiac arrest or the secondary endpoint of all-cause mortality by intention to treat (ITT) analysis. Nevertheless, there was evidence of improved outcomes and survival in the as-treated and per-protocol analyses.

Objectives
To determine how the treatment strategies of drug therapy vs ablation impact the atrial fibrillation progression and regression.

Methods
CABANA randomized 2204 pts with AF ≥65 yrs old or &lt;65 with ≥1 risk factor for stroke at 126 sites worldwide to ablation with pulmonary vein isolation vs drug including rate/rhythm control medication. AF type was recorded at the time of enrollment in the CABANA Trial. Following treatment with drug therapy or ablation, the AF type was assessed as recorded at the patient's last follow-up. Comparisons between baseline AF type and last AF type were performed according to ITT.

Results
Following treatment with ablation, 64% maintained sinus rhythm with elimination of AF, 11% experienced AF regression, and only 7% had progression of AF. In contrast, in those randomized to drug therapy, only 48% experienced maintenance of sinus rhythm, 10% experienced AF regression, and 13% had progression of AF. Moreover, in the drug arm there was a 32% increase in long-standing persistent compared with a 49% reduction in the ablation arm.

Conclusion
Catheter ablation significantly alters the natural history of atrial fibrillation. Intention to treat analysis reveals that catheter ablation provides superior elimination of AF, protection against AF progression, and dramatically lower risks of long-standing persistent AF.
Figure 1

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health
Atomoxetine in patients with recurrent vasovagal syncope for preventing vasovagal attacks and improvement of depression and anxiety: a randomized double-blind placebo-controlled clinical trial
Authors: Tajdini M , Aminorroaya A , Tavolinejad H , Tofighi S , Jalali A , Sadeghian S , Akhondzadeh S , Vasheghani-Farahani A , Yadangi S , Shahmansouri N , Bozorgi A 
Published: November 2020

Abstract

Background
Studies showed that sibutramine or reboxetine reduced head-up tilt (HUT)-induced syncope and pre-syncope by 78%. Furthermore, in an open-label series of highly symptomatic patients with vasovagal syncope (VVS), sibutramine reduced frequency of vasovagal spells. In a recent proof of principle study, atomoxetine reduced number of HUT-induced syncopal episodes by about 50% compared to placebo.

Purpose
In this study, we aimed to evaluate the effectiveness of atomoxetine on preventing recurrence of syncopal and pre-syncopal episodes in patients with recurrent VVS after three months of follow-up. Moreover, we determined whether it can improve patients' anxiety and depression.

Methods
In this double-blind placebo-controlled randomized clinical trial, we screened 843 patients with VVS. Patients with 10 &lt; age &lt; 70 years who had ≥3 syncopal episodes in the past three months were included. Eventually, 46 patients were randomized to receive atomoxetine (20 mg daily for two weeks followed by 40 mg daily for two weeks, N=23) or placebo (for four weeks, N=23). The primary endpoint was the number of syncopal and pre-syncopal episodes at one and three months and was analyzed by the repeated measures analysis of variance. Secondary endpoints were decrements of depression and anxiety measured by the Hospital Anxiety and Depression Scale after three months and were analyzed by the Mann-Whitney U test.

Results
The primary endpoint was lower after three months in the atomoxetine arm (2.3±1.3 vs 4.3±1.7), with a significant between-subjects effect by atomoxetine versus placebo (P&lt;0.001). This observation was primarily due to the reduction of pre-syncopal episodes rather than syncopal episodes (P&lt;0.001 vs P=0.944, respectively, Table). In contrast with placebo, atomoxetine significantly improved anxiety (P=0.048 vs P=0.352) and depression (P=0.001 vs P=0.206) after three months; nonetheless, anxiety and depression scores of the patients were not different across the groups after three months (P&gt;0.05, Figure).

Conclusions
In patients with VVS, atomoxetine significantly reduced the recurrence of a composite of syncopal and pre-syncopal episodes, and remarkably improved anxiety and depression at three months.
Anxiety and Depression of the Patients

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): Tehran University of Medical Sciences
Randomized investigation of the left atrial sweet spot for vagal denervation of atrioventricular node during the cardioneuroablation
Authors: Jansova H , Wichterle D , Stiavnicky P , Peichl P , Cihak R , Kautzner J 
Published: November 2020

Abstract

Background
Radiofrequency catheter ablation of inferior atrial ganglionic plexi frequently results in vagal denervation of the atrioventricular (AV) node. The effective sites are, however, considerably variable.

Purpose
We prospectively sought the left atrial (LA) ablation site with the maximum effect on AV nodal modulation.

Methods
The study included 16 patients (age: 46±14 years, 56% males) who underwent cardioneuroablation for recurrent reflex cardioinhibitory syncope in general anesthesia. After targeting the superior paraseptal ganglionic plexi and achieving the denervation of the sinus node, study ablations were performed at the bottom of the LA to accomplish the AV nodal denervation (Figure). Five equidistantly distributed ablation lesions (30W / 30s / 20ml/min) were created on the virtual line connecting inferior ostium of right inferior pulmonary vein (RIPV) and inferior mitral annulus (MA). Lesions were centered symmetrically relative to the posterior mid-left-atrial line. They were numbered in ascending order from #1 (more septal, closer to the RIPV) to #5 (more lateral, closer to the MA). Patients were randomly (1:1) assigned to mutually opposite direction of ablation (from site #1 to #5 or from site #5 to #1). The response of heart rhythm to extracardiac vagal nerve high-frequency stimulation (50Hz/0.05ms/1V/kg [&lt;70V]/5s) were recorded at baseline and after each radiofrequency energy delivery.

Results
Study protocol ablations overall resulted in elimination or attenuation of inducible AV block (maximum R-R interval: 2.9±2.8 vs. 5.2±2.4s, P&lt;0.001). Temporal development of effect with the progression of ablation is shown in the Figure indicating that the most lateral lesion alone produces the maximum effect. The AV nodal denervation was incomplete after per-protocol ablations in 7/16 patients. In the majority of them, the final success was achieved by extension of ablation lesion toward the inferior mitral annulus either endocardially or via the proximal coronary sinus.

Conclusion
Ablation of perimitral region of the inferior LA conveyed the maximum effect in terms of AV nodal denervation.

Funding Acknowledgement
Type of funding source: None