bluuebunny/crossref_metadata_2025 huggingface dataset:
Screening for obstructive sleep apnea in atrial fibrillation patients at their home before catheter ablation using watch peripheral arterial tonometry
Authors: Tanaka N , Inoue K , Tanaka K , Hirao Y , Oka T , Okada M , Yoshimoto I , Onishi T , Iwakura K , Fujii K
Published: November 2020

Background

Catheter ablation of atrial fibrillation (AF) is effective, but certain patients experience AF recurrences. Obstructive sleep apnea (OSA) is a risk factor for AF recurrence. Watch peripheral arterial tonometry (WP) has a good correlation with polysomnography (PSG) in terms of the apnea-hypopnea index (AHI) and is easier to perform than PSG. Patients in AF have a high prevalence of OSA. Whether all patients with AF should be evaluated for OSA before catheter ablation is still controversial.

Purpose

To elucidate the prevalence and predictors of OSA using WP as a home sleep apnea test in AF patients before catheter ablation.

Methods

This study was conducted under a retrospective, single-center, observational design. Patients who received AF ablation without a prior diagnosis of sleep apnea and assessment of their AHI using WP were included in this analysis. The patients were mounted with a WP device by themselves at their own home. Twenty-two patients who were already diagnosed with OSA were excluded.

Results

Seven hundred seventy-four (65±11 years, 567 males, 440 paroxysmal AF) out of 776 patients were successfully mounted with WP devices on their own and underwent an OSA assessment. Their mean body mass index (BMI) was 24.1±3.5 kg/m2. The mean AHI was 20.1±15.6. Only 88 (11.4%) patients had a normal AHI (AHI<5). Mild OSA (5≤AHI<15), moderate OSA (15≤AHI<30), and severe OSA (AHI≥30) were observed in 274 (35.4%), 252 (32.6%), and 160 (20.7%) patients, respectively. A BMI≥25 (odds ratio [OR]; 2.42, 95% confidence interval [CI]; 1.74–3.37, p<0.001), male sex (1.70, 1.19–2.44, p=0.0037), non-paroxysmal AF (1.90, 1.35–2.66, p=0.0002), hypertension (1.70, 1.24–2.33, p=0.009), and left atrial volume index ≥30 (OR=1.51, CI 1.06–2.16, p=0.022) were significant predictors of moderate or severe OSA by a multivariate analysis, while an Epworth sleepiness scale ≥11 was not a predictor of moderate or severe OSA (OR=0.99, CI 0.66–1.49, p=0.95). However, 44.2% of non-obese patients (BMI <25) had moderate-severe OSA.

Conclusion Almost

All patients successfully underwent WP to diagnose OSA. AF patients had a high prevalence of OSA, and screening OSA would be important in AF patients receiving ablation even if patients do not have sleepiness or are obese. We cannot deny OSA in AF patients before catheter ablation without performing screening tests for OSA.

Funding Acknowledgement

Type of funding source: None
Symptom status, clinical subtypes and prognosis in Middle East patients with atrial fibrillation: a report from the Gulf-SAFE registry
Authors: Li Y.G , Bai J , Domek M , Alsheikh-Ali A , Almahmeed W , Shehab A , Sulaiman K , Asaad N , Zubaid M , Lip G.Y
Published: November 2020

Background

Atrial fibrillation (AF) is often asymptomatic. The prognosis of asymptomatic AF is similar or worse than symptomatic AF, but there are no such data from Middle East.

Method

The Gulf survey of AF events (Gulf SAFE) registry is a multi-center prospective survey of AF patients from six countries (23 centers) in the Gulf Region (n=2043). We investigated the prognostic outcomes of asymptomatic AF, in relation to clinical subtypes.

Result

541 (26.5%) AF patients were asymptomatic; they tended to be older, with higher prevalence of hypertension, heart failure (HF), diabetes, stroke, renal dysfunction, and higher CHADS2, CHA2DS2-VASc, and HAS-BLED scores (all p<0.05). After multivariable adjustment, asymptomatic AF was associated with higher risks of stroke/systematic embolism (SE) (odds ratio [OR] 2.18, 95% confidence interval [CI] 1.10–4.34), all cause-mortality (OR 2.85 [1.90–4.28]) and the composite outcome of stroke/SE, bleeding and all-cause mortality (OR 1.74 [1.26–2.41]).

Asymptomatic AF was associated with fewer admissions for AF (OR 0.53 [0.32–0.83]) and HF (OR 0.58 [0.38–0.86]).

The increased risk of stroke/SE in asymptomatic AF was associated with paroxysmal AF (Figure 1; P interaction=0.028).

Conclusion

In this large Middle East cohort, asymptomatic AF was common, less likely hospitalized but associated with unfavorable prognosis. When AF was asymptomatic, the paroxysmal subtype had a greater association with stroke/SE.

Adjusted odds ratio of clinical outcomes

Funding Acknowledgement

Type of funding source: None
Incidence and risk of short episodes of atrial fibrillation detected with 14 days of continuous electrocardiographic monitoring
Authors: McIntyre W.F , Wang J , Connolly S.J , Van Gelder I.C , Lopes R.D , Gold M.R , Hohnloser S.H , Lau C.P , Israel C.W , Benz A.P , Wong J.A , Conen D , Healey J.S
Published: November 2020

Background

There is widespread interest in population-based screening for atrial fibrillation (AF). However, there is debate regarding the optimal screening method and duration.

Objectives

To estimate the incidence of short-duration AF detected by a single continuous 14-day electrocardiographic (ECG) monitor in older individuals without prior AF and to estimate the risk of ischemic stroke or systemic embolism associated with these episodes.

Methods

Pacemaker and defibrillator electrograms were reviewed from a cohort of individuals ≥65 years old, with a history of hypertension, but no prior AF. For each participant, we simulated a continuous 14-day ECG monitor by randomly selecting a 14-day window in the 6 months following enrolment and measured the total AF burden during that period. We repeated random sampling 1000 times to ensure a robust estimate of the likelihood of capturing AF in a single 14-day period. We used Cox proportional hazards models adjusted for CHA2DS2-VASc score to estimate the risk of ischemic stroke or systemic embolism associated with different burdens of AF.

Results

Among 2470 participants with at least 6 months of follow-up, the mean CHA2DS2-VASc score was 4.0±1.3. The proportion of participants with an AF burden of >6 min on a single 14-day monitor was estimated as 3.1%, while the proportion with burdens of >15 min and >30 min were 2.9% and 2.6%, respectively.

Over a mean follow-up of 2.5 years, 44 participants had an ischemic stroke or systemic embolism; the rate among patients with an AF burden ≤6 mins was 0.70%/year. An AF burden >6 min was associated with an increased risk of stroke or systemic embolism (2.2%/year, HR 3.0; 95% CI 1.3–5.7), as were burdens >15 min (2.4%/year; HR 3.3; 95% CI 1.4–6.4) and >30 min (2.6%/year HR 3.5; 95% CI 1.5–6.7).

Conclusion

Approximately 3% of individuals aged 65 years and older and with hypertension may have previously undiagnosed asymptomatic AF detected by a single 14-day continuous ECG monitor. As little as 6 minutes of AF may be associated with an increased risk of stroke. Randomized clinical trials are required to definitively assess screening in this population.

Funding Acknowledgement

Type of funding source: None
Perioperative atrial fibrillation and risk of stroke after cardiac surgery: a systematic review and meta-analysis
Authors: Wang M.K , Chen P , Meyre P , Ali M.Z , Heo R , McIntyre W , Healey J , Whitlock R , Lamy A , Devereaux P.J , Conen D
Published: November 2020

Background

Perioperative atrial fibrillation (POAF) after cardiac surgery has been associated with an increased risk of stroke. However, many previous studies have not systematically excluded patients with pre-existing AF. As such, the association between new-onset POAF and stroke risk has not been well established.

Purpose

To perform a systematic review and meta-analysis on the short and long-term risks of stroke in patients experiencing new-onset POAF after cardiac surgery.

Methods

We searched MEDLINE, EMBASE, and the Cochrane Library databases for studies comparing the risk of stroke in patients with versus without new-onset POAF after cardiac surgery. Studies were included in our review if they enrolled ≥100 patients and defined POAF as new-onset AF in patients with no history of preoperative AF. Data were independently extracted in duplicate. The quality of studies was assessed using the Newcastle Ottawa Scale. Random-effects meta-analysis was used to calculate summary risk ratios. Short-term stroke risk was calculated using events occurring either in-hospital or ≤30 days after surgery, and long-term risk was calculated using events occurring >30 days after surgery.

Results

After reviewing 11,791 citations, 46 studies met the inclusion criteria. These studies included 364,822 patients, of which 76,388 (20.9%) developed new-onset POAF. The incidence of stroke was higher among patients with POAF versus no POAF (n=44 studies; incidence 2.76% vs. 1.53%; relative risk (RR) 1.91, 95% CI 1.65–2.23; I2 = 78%). A sensitivity analysis of high-quality studies alone yielded similar results (n=9 studies; RR 1.74, 95% CI 1.31–2.30; I2 = 88%). Patients with POAF had a higher incidence of stroke both in the short-term (n=35 studies; 2.71% vs. 1.36%; RR 2.13, 95% CI 1.81–2.51; I2 = 69%) and long-term (n=20 studies; 1.6 vs. 1.0 per 100 patient-years; RR 1.39, 95% CI 1.24–1.57; I2 = 27%). The risk of stroke was increased in POAF patients across all types of cardiac surgery performed, including isolated CABG (n=19 studies; RR 1.93, 95% CI 1.60–2.32; I2 = 62%), isolated transcatheter aortic valve implantation (n=7 studies; RR 1.86, 95% CI 1.32–2.63; I2 = 0%), and studies including multiple procedure types (n=16 studies; RR 1.90, 95% CI 1.44–2.51; I2 = 89%).

Conclusion

New-onset POAF after cardiac surgery is associated with an increased risk of stroke, both in the short and long term. The absolute risk difference is small, and randomized trials are needed to assess the efficacy and safety of treatment interventions in this patient population.

Funding Acknowledgement

Type of funding source: None
Risk of ischemic stroke and recurrent ICH in patients with atrial fibrillation presenting with incident ICH: an analysis from the Danish Stroke Registry
Authors: Nielsen P.B , Soegaard M , Skjoeth F , Larsen T.B , Lip G.Y.H
Published: November 2020

Background

Intracerebral haemorrhage (ICH) is a devastating vascular event, and secondary prevention is central to avoid cerebral complications. The PRESTIGE-AF trial is a multinational randomized controlled trial designed to investigate the optimal stroke prevention strategy in atrial fibrillation (AF) patients who have suffered an ICH.

Purpose

To examine one-year risk of cerebrovascular events in a study population similar to the expected PRESTIGE-AF trial.

Methods

We used the Danish nationwide registries to identify all patients presenting with incident ICH and prevalent AF between 2003–2018. The study population was restricted using key inclusion criteria for trial participation: indication for antithrombotic treatment due to AF, and at least two CHA2DS2-VASc score stroke risk factors (three for females). Exclusion criteria were: ICH event occurring as a result of trauma or vascular malformation; other indication for long-term anticoagulant treatment; or use of left atrial appendage occlusion device. Patients were followed up in the Danish Stroke Registry, and outcomes were reported stratified by levels of the CHA2DS2-VASc score (score 2–3; 4–6; and >6 points).

Results

A total of 16,269 ICH patients were identified and after exclusions, 1797 patients were eligible for analysis. The main reason for exclusion was lack of AF diagnosis (81.2%). The study population mean age was 79.5 (SD: 8.7) and 48.1% were females. Among included patients 573 (%) had a CHA2DS2-VASc score of 2–3, 829 (%) had a score of 4–6, and 395 (%) had a score >6. The most prevalent stroke risk factors were hypertension (76.6%) and prior stroke (33.2%).

During one-year follow-up, 56 ischemic stroke events and 43 recurrent ICH were observed at a rate of 4.33 (per 100 person-years) and 3.30, respectively. The Figure depicts risk development over time by means of cumulative incidence function based on the Aalen-Johansen estimator (factoring competing risk of death into the analytic approach). The risk of ischemic stroke was generally similar across strata of the stroke risk categories, while the risk of recurrent ICH was highest among patients with a CHA2DS2-VASc score >6 points.

Conclusion

Using the Danish Stroke Registry, we identified a population mirroring the PRESTIGE-AF trial population. The patients were generally elderly and more than 68% had a CHA2DS2-VASc score of 4 or higher. The observed risk of ischemic stroke was similar across strata, while recurrent ICH was highest among those with a score >6 points. The outputs from the PRESTIGE-AF trial are warranted to determine optimal stroke prevention treatment patients with AF presenting with an ICH.

Figure 1

Funding Acknowledgement

Type of funding source: Public grant(s) – EU funding. Main funding source(s): This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement no. 754517
Real-world effectiveness and the safety of anticoagulant treatment in elderly non-valvular atrial fibrillation in the ANAFIE registry, the largest real-world elderly AF registry
Authors: Yamashita T , Inoue H
Published: November 2020

Background

The optimal anticoagulant regimen for elderly AF has not been well elucidated, because this population, especially the very elderly (≥85 years), have not been sufficiently represented in most randomized controlled clinical trials for stroke prevention in non-valvular AF (NVAF).

Purpose

The ANAFIE registry was designed to evaluate the real-world anticoagulant treatment status of elderly (≥75 years) NVAF patients including >8,000 very elderly patients. In this main analysis of the ANAFIE, the incidence of stroke or systemic embolic events (stroke/SEE), and major bleeding were compared between warfarin (WF) and direct oral anticoagulants (DOACs).

Methods

A total of 33,018 NVAF patients aged ≥75 years was enrolled in the ANAFIE, and followed for 2 years. The incidence of stroke/SEE and major bleeding by type of anticoagulants (WF and all DOACs) was estimated using Kaplan-Meier method. Hazard ratio (HR) and 95% confidence interval (95% CI) were calculated by Cox proportional hazard model.

Results

In the analysis set of 32,099 patients, the mean age was 81.5 years. 23,738 (74%) were <85 years and 8,361 (26.0%) were ≥85 years. 92.5% of the whole population used anticoagulants including WF (27.6%) or DOACs (72.3%). The ratio of each DOAC was dabigatran 7.8%, rivaroxaban 21.5%, apixaban 26.9% and edoxaban 16.1%. Stroke/SEE and major bleeding was observed in 396 patients (1.24/100 patient-years [py]) and 279 patients (0.87/100py). The time in therapeutic range for patients <85 years and ≥85 years in the WF group was 76.7% and 72.2%, respectively. The incidence of stroke/SEE was numerically lower in patients taking any DOAC vs. WF regardless of age group (<85 years [HR 0.83] and ≥85 years [HR 0.71]). Major bleeding was also lower vs. WF in both age groups (<85 years [HR 0.60] and ≥85 years [HR 0.65]).

Conclusion

In elderly NVAF patients enrolled in the ANAFIE registry, the incidence of stroke/SEE and major bleeding was lower in patients taking a DOAC compared with WF for all patients ≥75 years, even for very elderly patients.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.
Atrial fibrillation burden and the risks of ischemic stroke and intracranial hemorrhage: comparisons of catheter ablation, medical therapy, and non-atrial fibrillation population
Authors: Kim M , Yu H.-T , Kim T.-H , Uhm J.-S , Seung J.-H , Joung B.-Y , Lee M.-H , Pak H.-N
Published: November 2020

Background

Although atrial fibrillation (AF) burden was known to be related to the risk of ischemic stroke (IS), clinical evidence regarding intracranial hemorrhage (ICH) or comparison of the patients after AF catheter ablation (AFCA) and the non-AF population are limited.

Objective

We explored the risks of IS and ICH after AFCA or medical therapy (Med) in the AF population and the matched non-AF population.

Methods

We compared 1,629 with AFCA (Yonsei AF cohort), 3,258 with Med (Korean National Health Insurance Sharing Service [KNHISS] database), and 3,258 non-AF population (KNHISS database) after 1:2:2 propensity-score match in terms of clinical characteristics and medications (57±12 years old, 22.1% female). IS and ICH were determined by ICD code, brain imaging, and hospital admission in Med and non-AF groups. All AFCA patients underwent regular rhythm follow-up, and the medications including antithrombotic therapies were evaluated for 52±23 months.

Results

1. Among AFCA group, the annualized IS rate was significantly higher in the patients with sustaining recurrence of AF/atrial tachycardia (AT) after the last ablation procedure than those remaining in sinus rhythm (SR) (0.87% vs. 0.24%, p=0.017; HR 4.87 [1.36–17.49], p=0.015; log rank p=0.003).

2. The annualized ICH rate was 0% in SR group and 0.06% in sustaining recurrent AF/AT group after AFCA (p=0.361, log rank p=0.545).

3. The annualized IS rate was significantly higher in Med group (1.09%) than in AFCA group (0.30%, p<0.001, log rank p<0.001) or non-AF group (0.34%, p<0.001, log rank p<0.001). There was no significant difference in annualized IS rate between AFCA and non-AF groups (p=0.673, log rank p=0.874)

4. The annualized ICH rates were 0.17% in Med group, 0.06% AFCA group (p=0.023, log rank p=0.042 vs. Med; p=0.172, log rank p=0.193 vs. non-AF), and 0.12% in non-AF group (p=0.226, log rank p=0.241 vs. Med), respectively.

Conclusion

Post-procedural AF burden influence the risk of IS. AFCA significantly reduces the risks of both IS and ICH to the extent of non-AF population compared to Med group.

Funding Acknowledgement

Type of funding source: None
Incidence, epidemiology, risk factors and prognosis of atrio-esophageal fistula following percutaneous catheter ablation. An exhaustive natiowide registry
Authors: Mandel F , Rollin A , Galinier M , Carrie D , Maury P , Gandjbakhch E
Published: November 2020

Introduction

A rare but often fatal complication of atrial fibrillation (AF) ablation is the formation of an atrioesophageal fistula (AEF) whose true prevalence and risk factors remain obscure.

Objective

To determine incidence, epidemiology, risk factors and prognosis of AEF using a – as exhaustive as possible – nationwide survey

Method

All French centers performing AF ablation were identified and survey were sent concerning the habits, techniques of AF ablation and eventual cases of AEF.

Results

82 of the 103 centers (80%) performing ablation of AF in France were included in the study performing 129286 ablations from 2006 (93% of the total AF ablation in France). 33 AEF were declared (26 AEF and 4 esopericardial fistula) (0.026% risk per procedure) with a stable annual incidence over time, unchanged after the advent of thermal probe. Sensititvity of CT scan for AEF diagnosis was 81%. Mortality was 60%, significantly lower in case of surgical mangement (31 vs 93%, p=0.001). No case of AEF happened after cryoablation and only two AEF occurred in redo ablation. In multivariate analysis, lack of use of contact force catheters and the realization of posterior/roof ablation lines emerged as independent factors associated with the risk of AEF with OR 23.6 (95% CI [4.5; 21]) p=0.0002 and OR 3.7 (95% CI [1.1, 13]) p=0.04) while the lack of thermal probes remained of borderline significance.

Conclusion

The rate of AEF after AF ablation in a nationwide and well exhaustive survey can be evaluated to 0.026% with an annual incidence remaining stable over time. A normal CT scan does not rule out the diagnosis. Prognosis remains poor with a mortality of 60% and crucially dependant of immediate surgical correction.

Funding Acknowledgement

Type of funding source: None
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

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<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<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

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

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

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<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

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<0.001), and 0.46, 0.84, and 2.62 for cardiovascular deaths (log rank p<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 (>90 years) patients with Atrial Fibrillation
Authors: Chao T.F , Lip G.Y.H , Chen S.A
Published: November 2020

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

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 <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

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 < age < 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<0.001). This observation was primarily due to the reduction of pre-syncopal episodes rather than syncopal episodes (P<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>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

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 [<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<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
Surgical cardiac sympathetic denervation in patients with VT storm: long term follow-up data
Authors: Barwad P , Lokhandwala Y.Y , Kumar B , Vyas A , Shah V , Vichare S , Bachani N
Published: November 2020

Background

Surgical Cardiac Sympathetic Denervation (CSD) is a procedure which involves surgical removal of terminal cervical and thoracic sympathetic ganglion for reducing sympathetic discharge to the heart. CSD is usually performed as a last desperate measure in treatment of ventricular tachycardia (VT). We report here the clinical profile and long-term follow-up of all our patients who underwent CSD (unilateral or bilateral) predominantly upfront prior to considering catheter ablation of VT for VT storm.

Material and methods

We retrospectively collected data of all patients who underwent CSD for VT storm between year 2010 till 2019. Success of CSD was defined as successful discharge of patient from the hospital after the procedure more than 75% decrease in the frequency of VT after two weeks of surgical procedure.

Results

A total of 65 patients underwent CSD in the above-mentioned period and the average duration of follow-up was 28 months. The clinical parameters, demographic data and outcome analysis is provided in details in table 1. Only 14 (21.5%) patients underwent attempt of catheter ablation of VT prior to considering CSD. CSD was successful in 53 (81.5%) of patients. There was a significant decline in the incidence of number of ICD or external shocks before and after CSD (25.2±39.4 vs 1.09±2.9) respectively. There was no significant effect of CSD on ejection fraction. None of the available clinical parameters predicted the success of CSD.

Discussion and conclusion

The current retrospective analysis reemphasize the role of surgical CSD in treatment of patients with VT storm. As in predominant patient's CSD was performed even before the attempting catheter-based ablation, it brings in a new dimension in the treatment of VT. Efficacy of CSD (81.5%) in experienced hand is equivalent or even better than catheter-based ablation in patients with VT storm.

Funding Acknowledgement

Type of funding source: None
First two MRI guided stereotactic body radiation therapy of recurrent sustained ventricular tachycardia
Authors: Kovacs B , Mayinger M , Tanadini-Lang S , Ehrbar S , Wilke L , Chamberlain M , Duru F , Steffel J , Garcia Schueler H.I , Manka R , Ruschitzka F , Guckenberger M , Andratschke N , Saguner A.M
Published: November 2020

Background

Stereotactic body radiation therapy (SBRT) is emerging as a bail-out treatment in patients suffering from therapy resistant ventricular tachyarrhythmias (VT).

Purpose

We report the worldwide first cases of real-time magnetic resonance image guided SBRT (MR-SBRT) in recurrent sustained VT and electrical storm (ES) due to dilated cardiomyopathy (DCM).

Methods

The patients were male, 71- (patient A) and 74-year-old (patients B) suffering from recurrent VT and ES with ICD shocks, despite guideline-directed medical therapy including maximal antiarrhythmic therapy. Patient A had two endocardial radiofrequency catheter ablation (RFA) and one epicardial surgical RFA and patient B had one endocardial RFA prior. An interdisciplinary decision was made to perform MR-SBRT in palliative intent to minimize repetitive ICD shocks.

Results

Areas of VT-substrate were identified to build a volumetric target using the performed EP studies as well as cardiac MRI and CT. A single fraction of 25Gy at isodose 80% was delivered to a planned target volume of 115.1ml and 73ml in the anterior/anteroseptal basal regions in patients A and B, respectively on a dedicated MR linac using real-time MRI tracking. Patient A developed a prolonged ES interpreted as acute radiation-induced inflammation following the treatment, which ceased two days after administration of high-dose dexamethasone. Patient B had no immediate adverse effects from the treatment. Left-ventricular ejection fraction remained stable in both patients at 25%. Both patients had significant improvement of their quality of life. Patient A died 222 days after MR-SBRT due to recurrent ES at another hospital. Patient B is free from VT over six months after treatment.

Conclusion

In these first two cases, we demonstrate feasibility, safety and short-term efficacy of MR-SBRT.

ICD therapies before and after MR-SBRT

Funding Acknowledgement

Type of funding source: None