Topic: Electrophysiology

Abstract

Accelerometer-derived physical activity and risk of atrial fibrillation.

Khurshid S, Weng LC, Al-Alusi MA, Halford JL, ... McManus DD, Lubitz SA
Aims
Physical activity may be an important modifiable risk factor for atrial fibrillation (AF), but associations have been variable and generally based on self-reported activity.
Methods and results
We analysed 93 669 participants of the UK Biobank prospective cohort study without prevalent AF who wore a wrist-based accelerometer for 1 week. We categorized whether measured activity met the standard recommendations of the European Society of Cardiology, American Heart Association, and World Health Organization [moderate-to-vigorous physical activity (MVPA) ≥150 min/week]. We tested associations between guideline-adherent activity and incident AF (primary) and stroke (secondary) using Cox proportional hazards models adjusted for age, sex, and each component of the Cohorts for Heart and Aging Research in Genomic Epidemiology AF (CHARGE-AF) risk score. We also assessed correlation between accelerometer-derived and self-reported activity. The mean age was 62 ± 8 years and 57% were women. Over a median of 5.2 years, 2338 incident AF events occurred. In multivariable adjusted models, guideline-adherent activity was associated with lower risks of AF [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75-0.89; incidence 3.5/1000 person-years, 95% CI 3.3-3.8 vs. 6.5/1000 person-years, 95% CI 6.1-6.8] and stroke (HR 0.76, 95% CI 0.64-0.90; incidence 1.0/1000 person-years, 95% CI 0.9-1.1 vs. 1.8/1000 person-years, 95% CI 1.6-2.0). Correlation between accelerometer-derived and self-reported MVPA was weak (Spearman r = 0.16, 95% CI 0.16-0.17). Self-reported activity was not associated with incident AF or stroke.
Conclusions
Greater accelerometer-derived physical activity is associated with lower risks of AF and stroke. Future preventive efforts to reduce AF risk may be most effective when targeting adherence to objective activity thresholds.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Eur Heart J: 30 Jun 2021; 42:2472-2483
Khurshid S, Weng LC, Al-Alusi MA, Halford JL, ... McManus DD, Lubitz SA
Eur Heart J: 30 Jun 2021; 42:2472-2483 | PMID: 34037209
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Impact:
Abstract

Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes.

Filippatos G, Bakris GL, Pitt B, Agarwal R, ... Anker SD, FIDELIO-DKD Investigators
Background
Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are at risk of atrial fibrillation or flutter (AFF) due to cardiac remodeling and kidney complications. Finerenone, a novel, selective, nonsteroidal mineralocorticoid receptor antagonist, inhibited cardiac remodeling in preclinical models.
Objectives
This work aims to examine the effect of finerenone on new-onset AFF and cardiorenal effects by history of AFF in the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) study.
Methods
Patients with CKD and T2D were randomized (1:1) to finerenone or placebo. Eligible patients had a urine albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g, an estimated glomerular filtration rate (eGFR) ≥25 to <75 ml/min/1.73 m2 and received optimized doses of renin-angiotensin system blockade. Effect on new-onset AFF was evaluated as a pre-specified outcome adjudicated by an independent cardiologist committee. The primary composite outcome (time to first onset of kidney failure, a sustained decrease of ≥40% in eGFR from baseline, or death from renal causes) and key secondary outcome (time to first onset of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) were analyzed by history of AFF.
Results
Of 5,674 patients, 461 (8.1%) had a history of AFF. New-onset AFF occurred in 82 (3.2%) patients on finerenone and 117 (4.5%) patients on placebo (hazard ratio: 0.71; 95% confidence interval: 0.53-0.94; p = 0.016). The effect of finerenone on primary and key secondary kidney and cardiovascular outcomes was not significantly impacted by baseline AFF (interaction p value: 0.16 and 0.85, respectively).
Conclusions
In patients with CKD and T2D, finerenone reduced the risk of new-onset AFF. The risk of kidney or cardiovascular events was reduced irrespective of history of AFF at baseline. (EudraCT 2015-000990-11 [A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease]; Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease [FIDELIO-DKD]; NCT02540993).

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 12 Jul 2021; 78:142-152
Filippatos G, Bakris GL, Pitt B, Agarwal R, ... Anker SD, FIDELIO-DKD Investigators
J Am Coll Cardiol: 12 Jul 2021; 78:142-152 | PMID: 34015478
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Abstract

Predictors, time course, and outcomes of persistence patterns in oral anticoagulation for non-valvular atrial fibrillation: a Dutch Nationwide Cohort Study.

Toorop MMA, Chen Q, Tichelaar VYIG, Cannegieter SC, Lijfering WM
Aims 
Persistence with direct oral anticoagulants (DOACs) has become a concern in non-valvular atrial fibrillation (NVAF) patients, but whether this affects prognosis is rarely studied. We investigated the persistence with oral anticoagulants (OACs) and its association with prognosis among a nationwide cohort of NVAF patients.
Methods and results 
DOAC-naive NVAF patients who started to use DOACs for ischaemic stroke prevention between 2013 and 2018 were included using Dutch national statistics. Persistence with OACs was determined based on the presence of a 100-day gap between the last prescription and the end of study period. In 93 048 patients, 75.7% had a baseline CHA2DS2-VASc score of ≥2. The cumulative incidence of persistence with OACs was 88.1% [95% confidence interval (CI) 87.9-88.3%], 82.6% (95% CI 82.3-82.9%), 77.7% (95% CI 77.3-78.1%), and 72.0% (95% CI 71.5-72.5%) at 1, 2, 3, and 4 years after receiving DOACs, respectively. Baseline characteristics associated with better persistence with OACs included female sex, age range 65-74 years, permanent atrial fibrillation, previous exposure to vitamin K antagonists, stroke history (including transient ischaemic attack), and a CHA2DS2-VASc score ≥2. Non-persistence with OACs was associated with an increased risk of the composite outcome of ischaemic stroke and ischaemic stroke-related death [adjusted hazard ratio (aHR) 1.79, 95% CI 1.49-2.15] and ischaemic stroke (aHR 1.58, 95% CI 1.29-1.93) compared with being persistent with OACs.
Conclusion 
At least a quarter of NVAF patients were non-persistent with OACs within 4 years, which was associated with poor efficacy of ischaemic stroke prevention. The identified baseline characteristics may help identify patients at risk of non-persistence.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J: 15 Jul 2021; epub ahead of print
Toorop MMA, Chen Q, Tichelaar VYIG, Cannegieter SC, Lijfering WM
Eur Heart J: 15 Jul 2021; epub ahead of print | PMID: 34269375
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Abstract

Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities.

Thomas KL, Al-Khalidi HR, Silverstein AP, Monahan KH, ... Packer DL, CABANA Investigators
Background
Rhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America.
Objectives
This study sought to describe outcomes in the CABANA trial as a function of race/ethnicity.
Methods
CABANA randomized 2,204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in the present analysis, and participants were subgrouped as racial/ethnic minority or nonminority with the use of National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest.
Results
Of 1,280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with nonminorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, respectively, and had more symptomatic heart failure (37.0% vs 22.0%), hypertension (92.1% vs 76.8%, respectively), and ejection fraction <40% (20.8% vs 7.1%). Racial/ethnic minorities treated with ablation had a 68% relative reduction in the primary endpoint (adjusted hazard ratio [aHR]: 0.32; 95% confidence interval [CI]: 0.13-0.78) and a 72% relative reduction in all-cause mortality (aHR: 0.28; 95% CI: 0.10-0.79). Primary event rates in racial/ethnic minority and nonminority participants were similar in the ablation arm (4-year Kaplan-Meier event rates 12.3% vs 9.9%); however, racial and ethnic minorities randomized to drug therapy had a much higher event rate than nonminority participants (27.4% vs. 9.4%).
Conclusion
Among racial or ethnic minorities enrolled in the North American CABANA cohort, catheter ablation significantly improved major clinical outcomes compared with drug therapy. These benefits, which were not seen in nonminority participants, appear to be due to worse outcomes with drug therapy. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

J Am Coll Cardiol: 12 Jul 2021; 78:126-138
Thomas KL, Al-Khalidi HR, Silverstein AP, Monahan KH, ... Packer DL, CABANA Investigators
J Am Coll Cardiol: 12 Jul 2021; 78:126-138 | PMID: 34238436
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Impact:
Abstract

Effectiveness and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Valvular Atrial Fibrillation : A Population-Based Cohort Study.

Dawwas GK, Dietrich E, Cuker A, Barnes GD, Leonard CE, Lewis JD
Background
Direct oral anticoagulants (DOACs) are increasingly used in place of warfarin, but evidence about their effectiveness and safety in patients with valvular atrial fibrillation (AF) remains limited.
Objective
To assess the effectiveness and safety of DOACs compared with warfarin in patients with valvular AF.
Design
New-user retrospective propensity score-matched cohort study.
Setting
U.S.-based commercial health care database from 1 January 2010 to 30 June 2019.
Participants
Adults with valvular AF who were newly prescribed DOACs or warfarin.
Measurements
The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial or gastrointestinal bleeding.
Results
Among a total of 56 336 patients with valvular AF matched on propensity score, use of DOACs (vs. warfarin) was associated with lower risk for ischemic stroke or systemic embolism (hazard ratio [HR], 0.64 [95% CI, 0.59 to 0.70]) and major bleeding events (HR, 0.67 [CI, 0.63 to 0.72]). The results for the effectiveness and safety outcomes remained consistent for apixaban (HRs, 0.54 [CI, 0.47 to 0.61] and 0.52 [CI, 0.47 to 0.57], respectively) and rivaroxaban (HRs, 0.74 [CI, 0.64 to 0.86] and 0.87 [CI, 0.79 to 0.96], respectively); with dabigatran, results were consistent for the major bleeding outcome (HR, 0.81 [CI, 0.68 to 0.97]) but not for effectiveness (HR, 1.03 [CI, 0.81 to 1.31]).
Limitation
Relatively short follow-up; inability to ascertain disease severity.
Conclusion
In this comparative effectiveness study using practice-based claims data, patients with valvular AF who were new users of DOACs had lower risks for ischemic stroke or systemic embolism and major bleeding than new users of warfarin. These data may be used to guide risk-benefit discussions regarding anticoagulant choices for patients with valvular AF.
Primary funding source
None.



Ann Intern Med: 29 Jun 2021; 174:910-919
Dawwas GK, Dietrich E, Cuker A, Barnes GD, Leonard CE, Lewis JD
Ann Intern Med: 29 Jun 2021; 174:910-919 | PMID: 33780291
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Impact:
Abstract

Frailty and Clinical Outcomes of Direct Oral Anticoagulants Versus Warfarin in Older Adults With Atrial Fibrillation : A Cohort Study.

Kim DH, Pawar A, Gagne JJ, Bessette LG, ... Glynn RJ, Schneeweiss S
Background
The role of differing levels of frailty in the choice of oral anticoagulants for older adults with atrial fibrillation (AF) is unclear.
Objective
To examine the outcomes of direct oral anticoagulants (DOACs) versus warfarin by frailty levels.
Design
1:1 propensity score-matched analysis of Medicare data, 2010 to 2017.
Setting
Community.
Patients
Medicare beneficiaries with AF who initiated use of dabigatran, rivaroxaban, apixaban, or warfarin.
Measurements
Composite end point of death, ischemic stroke, or major bleeding by frailty levels, defined by a claims-based frailty index.
Results
In the dabigatran-warfarin cohort (n = 158 730; median follow-up, 72 days), the event rate per 1000 person-years was 63.5 for dabigatran initiators and 65.6 for warfarin initiators (hazard ratio [HR], 0.98 [95% CI, 0.92 to 1.05]; rate difference [RD], -2.2 [CI, -6.5 to 2.1]). For nonfrail, prefrail, and frail persons, HRs were 0.81 (CI, 0.68 to 0.97), 0.98 (CI, 0.90 to 1.08), and 1.09 (CI, 0.96 to 1.23), respectively. In the rivaroxaban-warfarin cohort (n = 275 944; median follow-up, 82 days), the event rate per 1000 person-years was 77.8 for rivaroxaban initiators and 83.7 for warfarin initiators (HR, 0.98 [CI, 0.94 to 1.02]; RD, -5.9 [CI, -9.4 to -2.4]). For nonfrail, prefrail, and frail persons, HRs were 0.88 (CI, 0.77 to 0.99), 1.04 (CI, 0.98 to 1.10), and 0.96 (CI, 0.89 to 1.04), respectively. In the apixaban-warfarin cohort (n = 218 738; median follow-up, 84 days), the event rate per 1000 person-years was 60.1 for apixaban initiators and 92.3 for warfarin initiators (HR, 0.68 [CI, 0.65 to 0.72]; RD, -32.2 [CI, -36.1 to -28.3]). For nonfrail, prefrail, and frail persons, HRs were 0.61 (CI, 0.52 to 0.71), 0.66 (CI, 0.61 to 0.70), and 0.73 (CI, 0.67 to 0.80), respectively.
Limitations
Residual confounding and lack of clinical frailty assessment.
Conclusion
For older adults with AF, apixaban was associated with lower rates of adverse events across all frailty levels. Dabigatran and rivaroxaban were associated with lower event rates only among nonfrail patients.
Primary funding source
National Institute on Aging.



Ann Intern Med: 19 Jul 2021; epub ahead of print
Kim DH, Pawar A, Gagne JJ, Bessette LG, ... Glynn RJ, Schneeweiss S
Ann Intern Med: 19 Jul 2021; epub ahead of print | PMID: 34280330
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Abstract

Trends in the pharmacological management of atrial fibrillation in UK general practice 2008-2018.

Phillips K, Subramanian A, Thomas GN, Khan N, ... Fabritz L, Adderley NJ
Objective
The pharmacological management of atrial fibrillation (AF) comprises anticoagulation, for stroke prophylaxis, and rate or rhythm control drugs to alleviate symptoms and prevent heart failure. The aim of this study was to investigate trends in the proportion of patients with AF prescribed pharmacological therapies in the UK between 2008 and 2018.
Methods
Eleven sequential cross-sectional analyses were performed yearly from 2008 to 2018. Data were derived from an anonymised UK primary care database. Outcomes were the proportion of patients with AF prescribed anticoagulants, rhythm and rate control drugs in the whole cohort, those at high risk of stroke and those with coexisting heart failure.
Results
Between 2008 and 2018, the proportion of patients prescribed anticoagulants increased from 45.3% (95% CI 45.0% to 45.7%) to 71.1% (95% CI 70.7% to 71.5%) driven by increased prescription of non-vitamin K antagonist anticoagulants. The proportion of patients prescribed rate control drugs remained constant between 2008 and 2018 (69.3% (95% CI 68.9% to 69.6%) to 71.6% (95% CI 71.2% to 71.9%)). The proportion of patients prescribed rhythm control therapy by general practitioners (GPs) decreased from 9.5% (95% CI 9.3% to 9.7%) to 5.4% (95% CI 5.2% to 5.6%).
Conclusions
There has been an increase in the proportion of patients with AF appropriately prescribed anticoagulants following National Institute for Health and Care Excellence and European Society of Cardiology guidelines, which correlates with improvements in mortality and stroke outcomes. Beta-blockers appear increasingly favoured over digoxin for rate control. There has been a steady decline in GP prescribing rates for rhythm control drugs, possibly related to concerns over efficacy and safety and increased availability of AF ablation.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 04 Jul 2021; epub ahead of print
Phillips K, Subramanian A, Thomas GN, Khan N, ... Fabritz L, Adderley NJ
Heart: 04 Jul 2021; epub ahead of print | PMID: 34226195
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Impact:
Abstract

Associations of atrial fibrillation with renal function decline in patients with chronic kidney disease.

Chen TH, Chu YC, Ou SM, Tarng DC
Background
Chronic kidney disease (CKD) is known to increase the risk of atrial fibrillation (AF) development, but the relationship between AF and subsequent renal function decline in patients with CKD is not well understood. In this study, we explored the role of AF on renal outcomes among patients with CKD.
Methods
In a retrospective hospital-based cohort study, we identified patients with CKD aged ≥20 years from 1 January 2008 to 31 December 2018. The patients were divided into AF and non-AF groups. We matched each patient with CKD and AF to two non-AF CKD controls according to propensity scores. The outcomes of interest included estimated glomerular filtration rate (eGFR) decline of ≥20%, ≥30%, ≥40% and ≥50%, and end-stage renal disease (ESRD).
Results
After propensity score matching, 6731 patients with AF and 13 462 matched controls were included in the analyses. Compared with the non-AF group, the AF group exhibited greater risks of eGFR decline ≥20% (HR 1.43; 95% CI 1.33 to 1.53), ≥30% (HR 1.50; 95% CI 1.36 to 1.66), ≥40% (HR 1.62; 95% CI 1.41 to 1.85) and ≥50% (HR 1.82; 95% CI 1.50 to 2.20), and ESRD (HR 1.22; 95% CI 1.12 to 1.34). Higher CHA2DS2-VASc scores were associated with greater risks of eGFR decline and ESRD.
Conclusions
In patients with CKD, AF was associated with greater risks of subsequent renal function decline. CHA2DS2-VASc scores may be a useful risk stratification scheme for predicting the risk of renal function decline.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 29 Jun 2021; epub ahead of print
Chen TH, Chu YC, Ou SM, Tarng DC
Heart: 29 Jun 2021; epub ahead of print | PMID: 34193464
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Impact:
Abstract

Aspirin versus P2Y inhibitors with anticoagulation therapy for atrial fibrillation.

Fukaya H, Ako J, Yasuda S, Kaikita K, ... Matsui K, Ogawa H
Objective
Patients with coronary artery disease (CAD) and atrial fibrillation (AF) can be treated with multiple antithrombotic therapies including antiplatelet and anticoagulant therapies; however, this has the potential to increase bleeding risk. Here, we aimed to evaluate the efficacy and safety of P2Y12 inhibitors and aspirin in patients also receiving anticoagulant therapy.
Methods
We evaluated patients from the Atrial Fibrillation and Ischaemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial who received rivaroxaban plus an antiplatelet agent; the choice of antiplatelet agent was left to the physician\'s discretion. The primary efficacy and safety end points, consistent with those of the AFIRE trial, were compared between P2Y12 inhibitors and aspirin groups. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation or death from any cause. The primary safety end point was major bleeding according to the International Society on Thrombosis and Haemostasis criteria.
Results
A total of 1075 patients were included (P2Y12 inhibitor group, n=297; aspirin group, n=778). Approximately 60% of patients were administered proton pump inhibitors (PPIs) and there was no significant difference in PPI use in the groups. There were no significant differences in the primary end points between the groups (efficacy: HR 1.31; 95% CI 0.88 to 1.94; p=0.178; safety: HR 0.79; 95% CI 0.43 to 1.47; p=0.456).
Conclusions
There were no significant differences in cardiovascular and bleeding events in patients with AF and stable CAD taking rivaroxaban with P2Y12 inhibitors or aspirin in the chronic phase.
Trial registration number
UMIN000016612; NCT02642419.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 13 Jul 2021; epub ahead of print
Fukaya H, Ako J, Yasuda S, Kaikita K, ... Matsui K, Ogawa H
Heart: 13 Jul 2021; epub ahead of print | PMID: 34261738
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Impact:
Abstract

Catheter ablation as first-line treatment for paroxysmal atrial fibrillation: a systematic review and meta-analysis.

Imberti JF, Ding WY, Kotalczyk A, Zhang J, ... Andrade J, Gupta D
Objective
To assess the efficacy and safety of catheter ablation (CA) compared with antiarrhythmic drugs (AADs) as first-line treatment for symptomatic paroxysmal atrial fibrillation (AF).
Methods
Systematic review and meta-analysis of randomised controlled trials identified using MEDLINE, Cochrane Library and Embase published between 01/01/2000 and 19/03/2021. The primary efficacy endpoint was the first documented recurrence of atrial arrhythmias following the blanking period. The primary safety endpoint was a composite of all serious adverse events (SAEs).
Results
From 441 records, 6 studies met the inclusion criteria. 609 patients received CA, while 603 received AAD therapy. 212/609 patients in the CA group had a recurrence of atrial arrhythmias as compared with 318/603 in the AADs group resulting in a 36% relative risk reduction (risk ratio: 0.64, 95% CI 0.51 to 0.80, p<0.01). The risk of all SAEs was not statistically different between CA and AAD (0.87, 0.58 to 1.30, p=0.49); 107/609 SAE in the CA group vs 126/603 in the AAD group. Both recurrence of symptomatic atrial arrhythmias (109/505 vs 186/504) and healthcare utilisation (126/397 vs 185/394) were significantly lower in the CA group (0.53, 0.35 to 0.79 and 0.65, 0.48 to 0.89, respectively). There was a 79% reduction in the crossover rate during follow-up among patients randomised to CA compared with AAD (0.21, 0.13 to 0.32, p<0.01).
Conclusions
First-line treatment with CA is superior to AAD therapy in patients with symptomatic paroxysmal AF, as it significantly reduces the recurrence of any atrial arrhythmias and symptomatic atrial arrhythmias, and healthcare resource utilisation with comparable safety profile.

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Heart: 13 Jul 2021; epub ahead of print
Imberti JF, Ding WY, Kotalczyk A, Zhang J, ... Andrade J, Gupta D
Heart: 13 Jul 2021; epub ahead of print | PMID: 34261737
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Impact:
Abstract

Stroke Prevention by Anticoagulants in Daily Practice Depending on Atrial Fibrillation Pattern and Clinical Risk Factors.

Grimaldi-Bensouda L, Le Heuzey JY, Ferrières J, Leys D, ... Abenhaim L, PGRx-Stroke and PGRx-Atrial Fibrillation Study Groups
Background:
and purpose
The objective of the study was to assess the effectiveness of individual direct oral anticoagulants versus vitamin K antagonists for primary prevention of stroke (ischemic and hemorrhagic) in routine clinical practice in patients with various clinical risk factors depending on their atrial fibrillation (AF) patterns.
Methods
A nested case-referent study was conducted using data from 2 national registries of patients with stroke and AF. Stroke cases with previous history of AF were matched to up to 2 randomly selected referent patients with AF and no stroke. The association of individual anticoagulant use with ischemic or hemorrhagic stroke was studied in patients with or without permanent AF using multivariable conditional logistic models, controlled for clinically significant risk factors and multiple other cardiovascular risk factors.
Results
In total, 2586 stroke cases with previous AF and 4810 nonstroke referent patients with AF were retained for the study. Direct oral anticoagulant users had lower odds of stroke of any type than vitamin K antagonist users: the adjusted-matched OR for ischemic stroke were 0.70 (95% CI, 0.50-0.98) for dabigatran, 0.68 (95% CI, 0.53-0.86) for rivaroxaban, and 0.73 (95% CI, 0.52-1.02) for apixaban while for hemorrhagic stroke they were 0.31 (95% CI, 0.14-0.68), 0.64 (95% CI, 0.39-1.06), and 0.70 (95% CI, 0.33-1.49), respectively. The effects of individual direct oral anticoagulants relative to vitamin K antagonists were similar in permanent AF and nonpermanent AF patients.
Conclusions
Similar results were observed for each direct oral anticoagulant in real life as those observed in the pivotal clinical trials. The pattern of AF did not affect the outcome.



Stroke: 12 Jul 2021:STROKEAHA120032704; epub ahead of print
Grimaldi-Bensouda L, Le Heuzey JY, Ferrières J, Leys D, ... Abenhaim L, PGRx-Stroke and PGRx-Atrial Fibrillation Study Groups
Stroke: 12 Jul 2021:STROKEAHA120032704; epub ahead of print | PMID: 34253047
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Impact:
Abstract

Clinical Outcomes in Atrial Fibrillation Patients With a History of Cancer Treated With Non-Vitamin K Antagonist Oral Anticoagulants: A Nationwide Cohort Study.

Chan YH, Chao TF, Lee HF, Chen SW, ... See LC, Lip GYH
Background:
and purpose
Data on clinical outcomes for nonvitamin K antagonist oral anticoagulant (NOACs) and warfarin in patients with atrial fibrillation and cancer are limited, and patients with active cancer were excluded from randomized trials. We investigated the effectiveness and safety for NOACs versus warfarin among patients with atrial fibrillation with cancer.
Methods
In this nationwide retrospective cohort study from Taiwan National Health Insurance Research Database, we identified a total of 6274 and 1681 consecutive patients with atrial fibrillation with cancer taking NOACs and warfarin from June 1, 2012, to December 31, 2017, respectively. Propensity score stabilized weighting was used to balance covariates across study groups.
Results
There were 1031, 1758, 411, and 3074 patients treated with apixaban, dabigatran, edoxaban, and rivaroxaban, respectively. After propensity score stabilized weighting, NOAC was associated with a lower risk of major adverse cardiovascular events (hazard ratio, 0.63 [95% CI, 0.50-0.80]; P=0.0001), major adverse limb events (hazard ratio, 0.41 [95% CI, 0.24-0.70]; P=0.0010), venous thrombosis (hazard ratio, 0.37 [95% CI, 0.23-0.61]; P<0.0001), and major bleeding (hazard ratio, 0.73 [95% CI, 0.56-0.94]; P=0.0171) compared with warfarin. The outcomes were consistent with either direct thrombin inhibitor (dabigatran) or factor Xa inhibitor (apixaban, edoxaban, and rivaroxaban) use, among patients with stroke history, and among patients with different type of cancer and local, regional, or metastatic stage of cancer (P interaction >0.05). When compared with warfarin, NOAC was associated with lower risk of major adverse cardiovascular event, and venous thrombosis in patients aged <75 but not in those aged ≥75 years (P interaction <0.05).
Conclusions
Thromboprophylaxis with NOACs rather than warfarin should be considered for the majority of the atrial fibrillation population with cancer.



Stroke: 07 Jul 2021:STROKEAHA120033470; epub ahead of print
Chan YH, Chao TF, Lee HF, Chen SW, ... See LC, Lip GYH
Stroke: 07 Jul 2021:STROKEAHA120033470; epub ahead of print | PMID: 34233467
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Impact:
Abstract

Association of Oral Anticoagulation With Stroke in Atrial Fibrillation or Heart Failure: A Comparative Meta-Analysis.

Reddin C, Judge C, Loughlin E, Murphy R, ... Canavan M, O\'Donnell MJ
Background:
and purpose
Atrial fibrillation and heart failure with reduced ejection fraction (HFrEF) are common sources of cardioembolism. While oral anticoagulation is strongly recommended for atrial fibrillation, there are marked variations in guideline recommendations for HFrEF due to uncertainty about net clinical benefit. This systematic review and meta-analysis evaluates the comparative association of oral anticoagulation with stroke and other cardiovascular risk in populations with atrial fibrillation or HFrEF in sinus rhythm and identify factors mediating different estimates of net clinical benefit.
Methods
PubMed and Embase were searched from database inception to November 20, 2019 for randomized clinical trials comparing oral anticoagulation to control. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall and within atrial fibrillation and HFrEF trials. Differences in treatment effect were assessed by estimating I2 among all trials and testing the between-trial-population P-interaction. The primary outcome measure was all stroke. Secondary outcome measures were ischemic stroke, hemorrhagic stroke, mortality, myocardial infarction, and major hemorrhage.
Results
Twenty-one trials were eligible for inclusion, 15 (n=19 332) in atrial fibrillation (mean follow-up: 23.1 months), and 6 (n=9866) in HFrEF (mean follow-up: 23.9 months). There were differences in primary outcomes between trial populations, with all-cause mortality included for 95.2% of HFrEF trial population versus 0.38% for atrial fibrillation. Mortality was higher in controls groups of HFrEF populations (19.0% versus 9.6%) but rates of stroke lower (3.1% versus 7.0%) compared with atrial fibrillation. The association of oral anticoagulation with all stroke was consistent for atrial fibrillation (odds ratio, 0.51 [95% CI, 0.42-0.63]) and HFrEF (odds ratio, 0.61 [95% CI, 0.47-0.79]; I2=12.4%; P interaction=0.31). There were no statistically significant differences in the association of oral anticoagulation with cardiovascular events, mortality or bleeding between populations.
Conclusions
The relative association of oral anticoagulation with stroke risk, and other cardiovascular outcomes, is similar for patients with atrial fibrillation and HFrEF. Differences in the primary outcomes employed by trials in HFrEF, compared with atrial fibrillation, may have contributed to differing conclusions of the relative efficacy of oral anticoagulation.



Stroke: 19 Jul 2021:STROKEAHA120033910; epub ahead of print
Reddin C, Judge C, Loughlin E, Murphy R, ... Canavan M, O'Donnell MJ
Stroke: 19 Jul 2021:STROKEAHA120033910; epub ahead of print | PMID: 34281383
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Impact:
Abstract

Blood pressure levels and risk of haemorrhagic stroke in patients with atrial fibrillation and oral anticoagulants: results from The Swedish Primary Care Cardiovascular Database of Skaraborg.

Bager JE, Hjerpe P, Schiöler L, Bengtsson Boström K, ... Manhem K, Mourtzinis G
Objective
To assess the risk of haemorrhagic stroke at different baseline SBP levels in a primary care population with hypertension, atrial fibrillation and newly initiated oral anticoagulants (OACs).
Methods
We identified 3972 patients with hypertension, atrial fibrillation and newly initiated OAC in The Swedish Primary Care Cardiovascular Database of Skaraborg. Patients were followed from 1 January 2006 until a first event of haemorrhagic stroke, death, cessation of OAC or 31 December 2016. We analysed the association between continuous SBP and haemorrhagic stroke with a multivariable Cox regression model and plotted the hazard ratio as a function of SBP with a restricted cubic spline with 130 mmHg as reference.
Results
There were 40 cases of haemorrhagic stroke during follow-up. Baseline SBP in the 145-180 mmHg range was associated with a more than doubled risk of haemorrhagic stroke, compared with a SBP of 130 mmHg.
Conclusion
In this cohort of primary care patients with hypertension and atrial fibrillation, we found that baseline SBP in the 145-180 mmHg range, prior to initiation of OAC, was associated with a more than doubled risk of haemorrhagic stroke, as compared with an SBP of 130 mmHg. This suggests that lowering SBP to below 145 mmHg, prior to initiation of OAC, may decrease the risk of haemorrhagic stroke in patients with hypertension and atrial fibrillation.

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

J Hypertens: 31 Jul 2021; 39:1670-1677
Bager JE, Hjerpe P, Schiöler L, Bengtsson Boström K, ... Manhem K, Mourtzinis G
J Hypertens: 31 Jul 2021; 39:1670-1677 | PMID: 33710172
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Abstract

Transcriptomic Profiling of Canine Atrial Fibrillation Models after One Week of Sustained Arrhythmia.

Leblanc FJA, Vahdati Hassani F, Liesinger L, Qi X, ... Lettre G, Nattel S

Background:
- Atrial fibrillation (AF), the most common sustained arrhythmia, is associated with increased morbidity, mortality, and health-care costs. AF develops over many years and is often related to substantial atrial structural and electrophysiological remodeling. AF may lack symptoms at onset and atrial biopsy samples are generally obtained in subjects with advanced disease, so it is difficult to study earlier-stage pathophysiology in humans. Methods - Here, we characterized comprehensively the transcriptomic (miRNAseq and mRNAseq) changes in the left atria of two robust canine AF-models after one week of electrically-maintained AF, without or with ventricular rate-control via atrioventricular node-ablation/ventricular pacing. Results - Our RNA-sequencing experiments identified thousands of genes that are differentially expressed, including a majority that have never before been implicated in AF. Gene-set enrichment analyses highlighted known (e.g. extracellular matrix structure organization) but also many novel pathways (e.g. muscle structure development, striated muscle cell differentiation) that may play a role in tissue remodeling and/or cellular trans-differentiation. Of interest, we found dysregulation of a cluster of non-coding RNAs, including many microRNAs but also the MEG3 long non-coding RNA orthologue, located in the syntenic region of the imprinted human DLK1-DIO3 locus. Interestingly (in the light of other recent observations), our analysis identified gene-targets of differentially expressed microRNAs at the DLK1-DIO3 locus implicating glutamate signaling in AF pathophysiology.
Conclusions:
- Our results capture molecular events that occur at an early stage of disease development using well-characterized animal models, and may therefore inform future studies that aim to further dissect the causes of AF in humans.




Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print
Leblanc FJA, Vahdati Hassani F, Liesinger L, Qi X, ... Lettre G, Nattel S
Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270327
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Abstract

Bucindolol Decreases Atrial Fibrillation Burden in Patients with Heart Failure and the Arg389Arg Genotype.

Piccini JP, Dufton C, Carroll IA, Healey JS, ... Bristow MR, Connolly SJ

Background:
- Bucindolol is a genetically targeted β-blocker/mild vasodilator with the unique pharmacologic properties of sympatholysis and ADRB1 Arg389 receptor inverse agonism. In the GENETIC-AF trial conducted in a genetically defined heart failure (HF) population at high risk for recurrent atrial fibrillation (AF), similar results were observed for bucindolol and metoprolol succinate for the primary endpoint of time to first atrial fibrillation (AF) event; however, AF burden and other rhythm control measures were not analyzed. Methods - The prevalence of ECGs in normal sinus rhythm, AF interventions for rhythm control (cardioversion, ablation and antiarrhythmic drugs), and biomarkers were evaluated in the overall population entering efficacy follow-up (N=257). AF burden was evaluated for 24 weeks in the device substudy (N=67). Results - In 257 patients with HF the mean age was 65.6 ± 10.0 years, 18% were female, mean left ventricular ejection fraction (LVEF) was 36%, and 51% had persistent AF. Cumulative 24-week AF burden was 24.4% (95% CI: 18.5, 30.2) for bucindolol and 36.7% (95% CI: 30.0, 43.5) for metoprolol (33% reduction, p < 0.001). Daily AF burden at the end of follow-up was 15.1% (95% CI: 3.2, 27.0) for bucindolol and 34.7% (95% CI: 17.9, 51.2) for metoprolol (55% reduction, p < 0.001). For the metoprolol and bucindolol respective groups the prevalence of ECGs in normal sinus rhythm was 4.20 and 3.03 events per patient (39% increase in the bucindolol group, p < 0.001), while the rate of AF interventions was 0.56 and 0.82 events per patient (32% reduction for bucindolol, p = 0.011). Reductions in plasma norepinephrine (p = 0.038) and NT-proBNP (p = 0.009) were also observed with bucindolol compared to metoprolol.
Conclusions:
- Compared with metoprolol, bucindolol reduced AF burden, improved maintenance of sinus rhythm, and lowered the need for additional rhythm control interventions in patients with HF and the ADRB1 Arg389Arg genotype.




Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print
Piccini JP, Dufton C, Carroll IA, Healey JS, ... Bristow MR, Connolly SJ
Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270905
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Abstract

Left Atrial Isolation and Appendage Occlusion in Patients with Atrial Fibrillation at End Stage Left Atrial Fibrotic Disease.

Zedda A, Huo Y, Kronborg M, Ulbrich S, ... Piorkowski J, Piorkowski C

Background:
- Atrial fibrillation (AF) ablation in an end-stage left atrial (LA) fibrotic disease is more complex, has more recurrences and may compromise transport function and stroke risk. We explored whether a total left atrial isolation procedure (TLAI) followed by left atrial appendage occlusion (LAAO) is a feasible treatment concept for rhythm and stroke risk control. Methods - Symptomatic AF patients with extended LA fibrosis were enrolled consecutively for TLAI followed by LAAO. At enrollment all patients received a sinus rhythm LA voltage map. For TLAI, LA anterior and paraseptal ablation lines were placed, combined with right atrial and epicardial line completion and right pulmonary vein isolation - as needed. Rhythm follow-up was provided through continuous monitoring using implantable cardiac devices. Results - 92 patients (71±9y, 41% male, 84% persistent AF, CHA2DS2-VASc 4) underwent 104 ablation procedures. Follow-up duration measured 48±22 months. At 12-month follow-up 70 out of 92 (76%) patients were free from any atrial arrhythmia recurrence, off antiarrhythmic drugs. All intended LAAO procedures were successfully performed 6-8 weeks after TLAI. Combination of TLAI and LAAO attenuated the native 4% annual stroke risk to <1% over the entire course of the study. Patients\' clinical AF and heart failure symptoms (EHRA and NYHA classification) significantly improved and remained stable during further follow-up. Invasive hemodynamic assessment as well as echocardiographic transport function analysis did not show evidence of detrimental hemodynamic effects of the treatment concept.
Conclusions:
- This is the first report on a structured concept of interventional electrical LA isolation and LA appendage occlusion for rhythm and stroke risk control in AF patients at an end-stage left atrial fibrotic disease. We report feasibility, safety, and efficacy of such a treatment approach.




Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print
Zedda A, Huo Y, Kronborg M, Ulbrich S, ... Piorkowski J, Piorkowski C
Circ Arrhythm Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270906
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Impact:
Abstract

Management of Congenital Long-QT Syndrome: Commentary From the Experts.

Kaufman ES, Eckhardt LL, Ackerman MJ, Aziz PF, ... A M Wilde A, Zareba W
While published guidelines are useful in the care of patients with long-QT syndrome, it can be difficult to decide how to apply the guidelines to individual patients, particularly those with intermediate risk. We explored the diversity of opinion among 24 clinicians with expertise in long-QT syndrome. Experts from various regions and institutions were presented with 4 challenging clinical scenarios and asked to provide commentary emphasizing why they would make their treatment recommendations. All 24 authors were asked to vote on case-specific questions so as to demonstrate the degree of consensus or divergence of opinion. Of 24 authors, 23 voted and 1 abstained. Details of voting results with commentary are presented. There was consensus on several key points, particularly on the importance of the diagnostic evaluation and of β-blocker use. There was diversity of opinion about the appropriate use of other therapeutic measures in intermediate-risk individuals. Significant gaps in knowledge were identified.



Circ Arrhythm Electrophysiol: 29 Jun 2021; 14:e009726
Kaufman ES, Eckhardt LL, Ackerman MJ, Aziz PF, ... A M Wilde A, Zareba W
Circ Arrhythm Electrophysiol: 29 Jun 2021; 14:e009726 | PMID: 34238011
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Abstract

Anatomical Characteristics of the Left Atrium and Left Atrial Appendage in Relation to the Risk of Stroke in Patients with Versus without Atrial Fibrillation.

Smit JM, Simon J, El Mahdiui M, Száraz L, ... Maurovich-Horvat P, Bax JJ

Background:
- The left atrial appendage (LAA) has been regarded as an important source of cardiac thrombus formation and appears important in the contribution to thrombo-embolism in patients with atrial fibrillation (AF). Our aim was to evaluate the relationship between LAA morphology and previous stroke and/or transient ischemic attack (TIA) in two large and distinct patient cohorts with and without known AF. Methods - The study population consisted of patients with and without drug-refractory AF who underwent computed tomography (CT) prior to transcatheter AF ablation, or clinically indicated for suspected coronary artery disease (CAD). The CT data were used for volumetric assessment of the left atrium (LA) and LAA and to determine LAA morphology. The LAA was classified by 3 readers in consensus as chicken wing, swan, cauliflower or windsock, based on predefined morphology classification criteria. Results - In total, 1813 patients (mean age 59 ± 11 years, 42% female) who underwent CT were included in this analysis (908 patients with AF and 905 patients without known AF). Swan LAA morphology was independently associated with prior stroke/TIA in the overall study population (OR 3.40, P <0.001), and in patients with (OR 2.88, P = 0.012) and without known AF (OR 3.96, P = 0.011).
Conclusions:
- Swan morphology of the LAA is independently associated with prior stroke and/or TIA in patients with known AF, as well as in patients not previously diagnosed with AF.




Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print
Smit JM, Simon J, El Mahdiui M, Száraz L, ... Maurovich-Horvat P, Bax JJ
Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print | PMID: 34279121
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Abstract

Propagation Vectors Facilitate Differentiation between Conduction Block, Slow Conduction and Wavefront Collision.

Yavin HD, Bubar ZP, Higuchi K, Sroubek J, Yarnitsky J, Anter E

Background:
- Differentiation between conduction block, slow conduction, and wavefront collision can be difficult using activation mapping alone, often requiring differential pacing. Therefore, a real-time method for determination of complex patterns of conduction may be desired. We hereby report a novel algorithm for displaying propagation vectors, allowing differentiation between complex patterns of conduction and facilitating real-time detection of block during ablation. Methods - In 10 swine, a chronic transcaval ablation line with an intentional gap or complete block was created, simulating conduction block, slow conduction and wavefront collision. The line was mapped during atrial pacing using Carto 3 and a novel high-resolution array that includes 48 mini-electrodes (surface area-0.9mm2, spacing 2.4mm) distributed over 6 splines (Optrell™, Biosense Webster). Propagation vectors were created from unipolar waveforms of adjacent electrodes along and across splines that were acquired at single beats. In order to examine the utility of propagation vectors for detection conduction block during ablation, a cavotricuspid isthmus line (CTI) was created during coronary sinus pacing with the array positioned lateral to the line. Results - Propagation vectors detected the gap in all 6 interrupted ablation line, while activation maps only identified gap in 3/6 lines; in the remainder, activation maps alone could not differentiate between conduction block, slow conduction or wavefront collision. Propagation vectors accurately determined block in all 4 contiguous ablation line, while activation maps suggested conduction block or was indeterminant due to wavefront collision in 2/4 lines. CTI block was detected during ablation by abrupt reversal of propagation vectors from a lateral to a septal direction and acute reconnection was detected by reversal of the propagating vectors back to a lateral direction.
Conclusions:
- Real-time propagation vectors enhance the ability of standard activation maps to differentiate between complex patterns of conduction, including determination of conduction block during ablation.




Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print
Yavin HD, Bubar ZP, Higuchi K, Sroubek J, Yarnitsky J, Anter E
Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print | PMID: 34279988
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Impact:
Abstract

Super and Non-responders To Catheter Ablation for Atrial Fibrillation: A Quality-of-Life Assessment Using Patient Reported Outcomes.

Farwati M, Wazni OM, Tarakji KG, Diab M, ... Saliba WI, Hussein AA

Background:
- Atrial fibrillation (AF) ablation targets improvement in quality of life (QoL). Data is scarce on predictors of QoL improvement following ablation. We aimed to investigate the clinical characteristics underlying differential response in QoL after AF ablation (with or without arrhythmia recurrence). Methods - All patients undergoing AF ablation (2013-2016) at our center were prospectively enrolled in a fully automated patient-reported outcomes registry. A large number of variables were collected including AF symptom severity scale (AFSSS) and AF burden (as indicated by AF frequency and duration scores). Patients were divided into 3 groups based on self-report of QoL improvement: remarkable (super responders), mild/moderate, and unchanged or worse (non-responders). Univariable and multivariable logistic regression models assessed clinical characteristics and QoL outcomes. Results - A total of 956 patients were included (25% females, mean age 63.9). Most patients (~80%) were super responders (n=761), 138 (14.4%) had mild/moderate improvement, and 57 (5.9%) were non-responders. The strongest predictors of remarkable QoL improvement were freedom of arrhythmia recurrence (OR 2.42, 95% CI 1.27-4.59, p-value = 0.007), and lower AF burden at 12 months. Similarly, higher AF burden was significantly associated with clinical \"non-response\". In patients with observed clinical recurrence-QoL mismatch, changes in AF burden at 12 months were the main predictors of QoL outcome, with lower burden predicting higher improvement in QoL and vice versa.
Conclusions:
- Most patients derive significant QoL benefit from AF ablation. Freedom from arrhythmia recurrence and lower AF burden predict remarkable QoL improvement following ablation.




Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print
Farwati M, Wazni OM, Tarakji KG, Diab M, ... Saliba WI, Hussein AA
Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print | PMID: 34279998
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Abstract

Vein of Marshall Ethanol Infusion: Feasibility, Pitfalls, and Complications in over 700 Patients.

Kamakura T, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Pambrun T

Background:
- Vein of Marshall (VOM) ethanol infusion is a relatively new therapeutic option for atrial tachyarrhythmias. We aimed to evaluate the feasibility, pitfalls, and complications associated with this procedure in a large cohort of patients. Methods - Successful ethanol infusion, VOM-related lesion extent, and serious complications were evaluated in 713 consecutive patients treated with VOM ethanol infusion. Results - While feasible in 88.9% of cases, VOM ethanol infusion failure mainly resulted from non-identification (6.2%), non-cannulation (1.5%), or ethanol infusion in the wrong vein (1.7%). The Vieussens valve was a helpful landmark and was visible in 63.2% of cases. Multivariable analysis identified previous coronary sinus ablation as the only predictor for non-identification. The mean area of VOM-related endocardial scarring was 10.2±5.3 cm2. VOM dissection (10.7%), iodine leakage (3.0%), and VOM morphology without visible branches (3.0%) were associated with smaller VOM-related scarring (5.0±3.9 cm2, 6.6±3.5 cm2 and 4.7±2.3 cm2, with a p <0.0001, p <0.044, and p <0.0001, respectively). Ethanol infusion in a wrong vein was associated with less mitral line block (72.7% vs. 95.8%, p=0.012). A total of 14 serious complications (2.0%) occurred: 7 tamponades, of which were 6 delayed and treated with pericardiocentesis (2 of these patients had per-procedural VOM perforation), 4 strokes, 1 anaphylactic shock, 1 atrioventricular block, and 1 left appendage isolation. Only 4 of these complications occurred during the procedure.
Conclusions:
- Although limited by previous coronary sinus ablation, VOM ethanol infusion is a highly feasible treatment for atrial tachyarrhythmia, with a low rate of serious complications.




Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print
Kamakura T, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Pambrun T
Circ Arrhythm Electrophysiol: 18 Jul 2021; epub ahead of print | PMID: 34280029
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Impact:
Abstract

Gender-affirming hormone treatment causes changes in gender phenotype in a 12-lead electrocardiogram.

Saito N, Nagahara D, Ichihara K, Masumori N, Miura T, Takahashi S
Background
Men and women have specific patterns in an electrocardiogram (ECG) differentiated by J-point elevation and ST-segment angle. Although gender-affirming hormone treatment is one of the treatments for gender dysphoria, its influence on an ECG has not been clarified yet.
Objective
The purpose of this study was to investigate ECG changes induced by gender-affirming hormone treatment.
Methods
The study population consisted of 29 transgender males and 8 transgender females and 37 age- and sex-matched cisgender females and males. Male pattern was defined as J-point elevation > 0.1 mV and ST-segment angle > 20° in precordial leads.
Results
In the comparison between 29 transgender males and cisgender females, the prevalence of the male pattern (89.7% vs 6.9%; P < .001), prevalence of the early repolarization pattern (51.7% vs 17.2%; P = .01), J-point elevation (leads V1-V6), T-wave amplitudes (leads V1-V6), QRS amplitudes (leads II, III, V1-V6), and P-wave amplitudes (leads V1-V3) were significantly higher in transgender males. The prevalence of the male pattern was lower in transgender females than in cisgender males (25.0% vs 87.5%; P = .04). In the analysis of transgender males for whom ECGs were available before and after gender-affirming hormone treatment (n = 13), J-point elevation and T-wave amplitudes significantly increased after gender-affirming hormone treatment, leading to a higher prevalence of the male pattern (23.1% vs 92.3%; P < .001). The prevalence of the early repolarization pattern and QRS amplitudes also significantly increased after the treatment, but the augmentation of P-wave amplitudes was modest.
Conclusion
Gender-affirming hormone treatment for gender dysphoria is accompanied by a change in ECG phenotype toward affirming gender, in which change in androgen level may be involved.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1203-1209
Saito N, Nagahara D, Ichihara K, Masumori N, Miura T, Takahashi S
Heart Rhythm: 29 Jun 2021; 18:1203-1209 | PMID: 33706005
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Abstract

Arrhythmia-induced cardiomyopathy: A potentially reversible cause of refractory cardiogenic shock requiring venoarterial extracorporeal membrane oxygenation.

Hékimian G, Paulo N, Waintraub X, Bréchot N, ... Gandjbakhch E, Luyt CE
Background
The most severe form of arrhythmia-induced cardiomyopathy in adults- refractory cardiogenic shock requiring mechanical circulatory support-has rarely been reported.
Objective
The purpose of this study was to describe the management of critically ill patients admitted for acute, nonischemic, or worsening of previously known cardiac dysfunction and recent-onset supraventricular arrhythmia who developed refractory cardiogenic shock requiring venoarterial extracorporeal membrane oxygenation (VA-ECMO).
Methods
This study is a retrospective analysis of prospectively collected data.
Results
Between 2004 and 2018, 35 patients received VA-ECMO for acute, nonischemic cardiogenic shock and recent supraventricular arrhythmia (77% atrial fibrillation [AF]). Cardiogenic shock was the first disease manifestation in 21 patients (60%). Characteristics at ECMO implantation [median (interquartile range)] were Sequential Organ Failure Assessment score 10 (7-13); inotrope score 29 (11-80); left ventricular ejection (LVEF) fraction 10% (10%-15%); and lactate level 8 (4-11) mmol/L. For 12 patients, amiodarone and/or electric cardioversion successfully reduced arrhythmia, improved LVEF, and enabled weaning off VA-ECMO; 11 had long-term survival without transplantation or long-term assist device. Eight patients experiencing arrhythmia-reduction failure underwent ablation procedures (7 atrioventricular node [AVN] with pacing, 1 atrial tachycardia) and were weaned off VA-ECMO; 7 survived. Of the remaining 15 patients without arrhythmia reduction or ablation, only the 6 bridged to heart transplantation or left ventricular (LV) assist device survived.
Conclusion
Arrhythmia-induced cardiomyopathy, mainly AF-related, is an underrecognized cause of refractory cardiogenic shock and should be considered in patients with nonischemic cardiogenic shock and recent-onset supraventricular arrhythmia. VA-ECMO support allowed safe arrhythmia reduction or rate control by AVN ablation while awaiting recovery, even among those with severe LV dilation.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1106-1112
Hékimian G, Paulo N, Waintraub X, Bréchot N, ... Gandjbakhch E, Luyt CE
Heart Rhythm: 29 Jun 2021; 18:1106-1112 | PMID: 33722763
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Impact:
Abstract

Effect of ivabradine on cardiac arrhythmias: Antiarrhythmic or proarrhythmic?

Marciszek M, Paterek A, Oknińska M, Zambrowska Z, Mackiewicz U, Mączewski M
Cardiac arrhythmias are a major source of mortality and morbidity. Unfortunately, their treatment remains suboptimal. Major classes of antiarrhythmic drugs pose a significant risk of proarrhythmia, and their side effects often outweigh their benefits. Therefore, implantable devices remain the only truly effective antiarrhythmic therapy, and new strategies of antiarrhythmic treatment are required. Ivabradine is a selective heart rate-reducing agent, an inhibitor of hyperpolarization-activated, cyclic nucleotide-gated (HCN) channels, currently approved for treatment of coronary artery disease and chronic heart failure. In this review, we focus on the clinical and basic science evidence for the antiarrhythmic and proarrhythmic effects of ivabradine. We attempt to dissect the mechanisms behind the effects of ivabradine and indicate the focus of future studies.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1230-1238
Marciszek M, Paterek A, Oknińska M, Zambrowska Z, Mackiewicz U, Mączewski M
Heart Rhythm: 29 Jun 2021; 18:1230-1238 | PMID: 33737235
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Abstract

Significance of manifest localized staining during ethanol infusion into the vein of Marshall.

Takagi T, Pambrun T, Nakashima T, Vlachos K, ... Jaïs P, Derval N
Background
Localized staining due to venule injury is attributable to ethanol infusion into the vein of Marshall (Et-VOM).
Objective
The purpose of this study was to investigate adverse outcomes of localized staining during Et-VOM in patients undergoing ablation for atrial fibrillation.
Methods
Two hundred four patients (age 64 ± 10 years; 153 male) were sorted based on the aspect of localized staining. Staining of atrial myocardium that spread uniformly along the VOM vascular tree following selective VOM venography was considered normal, in contrast to predominantly localized staining that spread concentrically from a focal point due to vascular injury. Outcomes between the 2 groups were compared.
Results
Localized staining was observed in 27% of patients. No patients developed clinically significant pericardial effusions during Et-VOM; however, 7 patients developed pericardial effusions on the first postprocedural day (3.6% in patients with vs 3.4% in patients without localized staining). No significant difference was found in achievement of acute mitral isthmus (MI) block (96% vs 98%) and size of the endocardial low-voltage area (8.5 ± 4.1 cm2 vs 9.3 ± 5.3 cm2) in patients with and without localized staining, respectively. Long-term follow-up was not impacted by localized staining. Freedom from recurrent atrial tachyarrhythmias (66% vs 76%) and durability of MI block (57% vs 54%) were not significantly different with and without localized staining. There were no cases of rehospitalization for pericarditis, chronic pericardial effusion, or heart failure.
Conclusion
In our study, localized staining was frequent but was not associated with clinically relevant impact or disadvantages.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1057-1063
Takagi T, Pambrun T, Nakashima T, Vlachos K, ... Jaïs P, Derval N
Heart Rhythm: 29 Jun 2021; 18:1057-1063 | PMID: 33741483
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Impact:
Abstract

Identification of a SCN5A Founder Mutation Causing Sudden Death, Brugada Syndrome and Conduction Blocks in Southern Italy.

Curcio A, Malovini A, Mazzanti A, Memmi M, ... Bellazzi R, Napolitano C
Background
The genetic architecture of Brugada syndrome (BrS) is emerging as an increasingly complex area of investigation. The identification of genetically homogeneous populations can provide mechanistic insights and improve genotype-phenotype correlation.
Objective
To characterize and define the clinical implications of a novel BrS founder mutation. Using a haplotype-based approach we investigated whether two SCN5A genetic variants could derive from founder events.
Methods
Single nucleotide polymorphisms were genotyped in 201 subjects, haplotypes reconstructed and mutational age estimated. Clinical phenotypes and historical records were collected.
Results
A SCN5A variant (c.3352C>T; p.Gln1118Ter) was identified in 3 probands with BrS originating from South Italy. The same mutation was identified in a proband from central Italy and in one U.S. resident subject with Italian ancestry. The five individuals carried a common core haplotype, whose frequency was extremely low in local non-carrier probands and in population controls (0%-6.06%). The clinical presentation included multi-generational dominant transmission of Brugada electrocardiographic pattern, high incidence of sudden cardiac death (SCD) and cardiac conduction defects (CCD). We reconstructed seven-generation pedigrees with common geographic origin. Variant\'s age estimates suggested that origin of the p.Gln1118Ter dates back 76 generations (95% Confidence Interval: 28-200). A second SCN5A variant (c.5350G>A; p.Glu1784Lys) identified in the region did not show similar founder signal.
Conclusions
p.Gln1118Ter is a novel BrS/CCD/SCD founder mutation. We illustrate how these findings provide insights on the inheritance patterns and phenotypes associated with SCN5A mutation.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 06 Jul 2021; epub ahead of print
Curcio A, Malovini A, Mazzanti A, Memmi M, ... Bellazzi R, Napolitano C
Heart Rhythm: 06 Jul 2021; epub ahead of print | PMID: 34245912
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Impact:
Abstract

Comparison of the effect of glucose-lowering agents on the risk of atrial fibrillation: A network meta-analysis.

Shi W, Zhang W, Zhang D, Ren G, ... Chen H, Ding C
Background
Diabetes is associated with the progression of atrial fibrillation (AF) and atrial flutter (AFL). However, whether glucose-lowering agents could reduce AF/AFL remains unclear. We hypothesized that different glucose-lowering agents exhibit different characteristic effects on the risk of AF/AFL.
Objectives
The goals of this study were to evaluate the effect of different glucose-lowering agents and identify the optimal treatment that can reduce AF/AFL events in patients with diabetes.
Methods
We searched PubMed, Embase, and the Cochrane Library from their inception to September 30, 2020. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this network meta-analysis. The primary end point of our study was AF or AFL. Only studies that reported AF/AFL as clinical end points with a follow-up period of at least 12 months were included. The results from trials were presented as odds ratios (ORs) with 95% confidence intervals (CIs). The results were pooled using a Bayesian random-effects model.
Results
Five eligible studies (9 glucose-lowering agents, including thiazolidinedione, metformin, sulfonylurea, insulin, dipeptidyl peptidase-4 inhibitor, glucagon-like peptide-1 receptor agonist [GLP-1RA], sodium-glucose cotransporter 2 inhibitor, alpha-glucosidase inhibitor, and non-sulfonylurea) consisting of 263,583 patients with type 2 diabetes mellitus were included. Based on the pooled results, GLP-1RA significantly reduced AF/AFL events compared with metformin (OR 0.17; 95% CI 0.04-0.61), sulfonylurea (OR 0.23; 95% CI 0.07-0.73), insulin (OR 0.20; 95% CI 0.07-0.86), and non-sulfonylurea (OR 0.18; 95% CI 0.04-0.66).
Conclusion
Compared with other glucose-lowering agents, GLP-1RA could reduce the risk of AF/AFL in patients with diabetes.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 29 Jun 2021; 18:1090-1096
Shi W, Zhang W, Zhang D, Ren G, ... Chen H, Ding C
Heart Rhythm: 29 Jun 2021; 18:1090-1096 | PMID: 33684547
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Impact:
Abstract

Percentage of age-predicted cardiorespiratory fitness and risk of sudden cardiac death: A prospective cohort study.

Laukkanen JA, Kurl S, Khan H, Kunutsor SK
Background
The inverse associations between cardiorespiratory fitness (CRF) and vascular outcomes have been established. However, there has been no prospective evaluation of the relationship between percentage of age-predicted cardiorespiratory fitness (%age-predicted CRF) and risk of sudden cardiac death (SCD).
Objective
The purpose of this study was to assess the association of %age-predicted CRF with SCD risk in a long-term prospective cohort study.
Methods
CRF was assessed using the gold standard respiratory gas exchange analyzer in 2276 men who underwent cardiopulmonary exercise testing. The age-predicted CRF estimated from a regression equation for age was converted to %age-predicted CRF using (Achieved CRF/Age-predicted CRF) × 100. Hazard ratios (HRs) [95% confidence intervals (CIs)] were calculated for SCD.
Results
During median follow-up of 28.2 years, 260 SCDs occurred. There was a dose-response relationship between age-predicted CRF and SCD. A 1-SD increase in %age-predicted CRF was associated with a decreased risk of SCD in analysis adjusted for established risk factors (HR 0.60; 95% CI 0.53-0.70), which remained consistent on further adjustment for several potential confounders, including alcohol consumption, physical activity, socioeconomic status, and systemic inflammation (HR 0.73; 95% CI 0.62-0.85). The corresponding adjusted HRs were 0.34 (0.23-0.50) and 0.52 (0.34-0.79), respectively, when comparing extreme quartiles of %age-predicted CRF levels. HRs for the associations of absolute CRF levels with SCD risk in the same participants were similar.
Conclusion
Percentage of age-predicted CRF is continuously, strongly, and independently associated with risk of SCD and is comparable to absolute CRF as a risk indicator for SCD.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1171-1177
Laukkanen JA, Kurl S, Khan H, Kunutsor SK
Heart Rhythm: 29 Jun 2021; 18:1171-1177 | PMID: 33689907
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Impact:
Abstract

Determinants of outcome impact of vein of Marshall ethanol infusion when added to catheter ablation of persistent atrial fibrillation: A secondary analysis of the VENUS randomized clinical trial.

Lador A, Peterson LE, Swarup V, Schurmann PA, ... Kleiman NS, Valderrábano M
Background
The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial demonstrated that adding vein of Marshall (VOM) ethanol infusion to catheter ablation (CA) improves ablation outcomes in persistent atrial fibrillation (AF). There was significant heterogeneity in the impact of VOM ethanol infusion on rhythm control.
Objective
The purpose of this study was to assess the association between outcomes and (1) achievement of bidirectional perimitral conduction block and (2) procedural volume.
Methods
The VENUS trial randomized patients with persistent AF (N = 343) to CA combined with VOM ethanol or CA alone. The primary outcome (freedom from AF or atrial tachycardia [AT] lasting longer than 30 seconds after a single procedure) was analyzed by 2 categories: (1) successful vs no perimitral block and (2) high- (>20 patients enrolled) vs low-volume centers.
Results
In patients with perimitral block, the primary outcome was reached 54.3% after VOM-CA and 37% after CA alone (P = .01). Among patients without perimitral block, freedom from AF/AT was 34.0% after VOM-CA and 37.0% after CA (P = .583). In high-volume centers, the primary outcome was reached in 56.4% after VOM-CA and 40.2% after CA (P = .01). In low-volume centers, freedom from AF/AT was 30.77% after VOM-CA and 32.61% after CA (P = .84). In patients with successful perimitral block from high-volume centers, the primary outcome was reached in 59% after VOM-CA and 39.1% after CA (P = .01). Tests for interaction were significant (P = .002 for perimitral block and P = .04 for center volume).
Conclusion
Adding VOM ethanol infusion to CA has a greater impact on outcomes when associated with perimitral block and performed in high-volume centers. Perimitral block should be part of the VOM procedure.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1045-1054
Lador A, Peterson LE, Swarup V, Schurmann PA, ... Kleiman NS, Valderrábano M
Heart Rhythm: 29 Jun 2021; 18:1045-1054 | PMID: 33482387
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Impact:
Abstract

Arrhythmias and device therapies in patients with cancer therapy-induced cardiomyopathy.

Lee C, Maan A, Singh JP, Fradley MG
Our knowledge of associated cardiotoxicities from novel therapeutics in oncology continues to expand. These include arrhythmias from cancer-therapy induced cardiomyopathy resulting from both direct and indirect effects on cardiomyocytes and other mechanisms that can adversely impact cardiovascular outcomes and overall mortality. In this review, we focus on both the arrhythmias of various classes of oncologic agents as well as the use of cardiac implantable electronic devices (cardioverter-defibrillators, permanent pacemakers, and cardiac resynchronization therapy) in cardio-oncology patients.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1223-1229
Lee C, Maan A, Singh JP, Fradley MG
Heart Rhythm: 29 Jun 2021; 18:1223-1229 | PMID: 33640446
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Impact:
Abstract

Skin sympathetic nerve activity as a biomarker for neurologic recovery during therapeutic hypothermia for cardiac arrest.

Kutkut I, Uceda D, Kumar A, Wong J, ... Chen PS, Everett TH
Background
Targeted temperature management (TTM) improves neurologic outcome after cardiac arrest. However, better neurologic prognostication is needed.
Objective
The purpose of this study was to test the hypothesis that noninvasive recording of skin sympathetic nerve activity (SKNA) and its association with heart rate (HR) during TTM may serve as a biomarker of neurologic status.
Methods
SKNA recordings were analyzed from 29 patients undergoing TTM. Patients were grouped based on Clinical Performance Category (CPC) score into group 1 (CPC 1-2) representing a good neurologic outcome and group 2 (CPC 3-5) representing a poor neurologic outcome.
Results
Of the 29 study participants, 18 (62%) were deemed to have poor neurologic outcome. At all timepoints, low average skin sympathetic nerve activity (aSKNA) was associated with poor neurologic outcome (odds ratio 22.69; P = .002) and remained significant (P = .03) even when adjusting for presenting clinical factors. The changes in aSKNA and HR during warming in group 1 were significantly correlated (ρ = 0.49; P <.001), even when adjusting for corresponding temperature and mean arterial pressure measurements (P = .017), whereas this correlation was not observed in group 2. Corresponding to high aSKNA, there was increased nerve burst activity during warming in group 1 compared to group 2 (0.739 ± 0.451 vs 0.176 ± 0.231; P = .013).
Conclusion
Neurologic recovery was retrospectively associated with SKNA. Patients undergoing TTM who did not achieve neurologic recovery were associated with low SKNA and lacked a significant correlation between SKNA and HR. These preliminary results indicate that SKNA may potentially be a useful biomarker to predict neurologic status in patients undergoing TTM.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1162-1170
Kutkut I, Uceda D, Kumar A, Wong J, ... Chen PS, Everett TH
Heart Rhythm: 29 Jun 2021; 18:1162-1170 | PMID: 33689908
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Impact:
Abstract

Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker.

Hauser RG, Gornick CC, Abdelhadi RH, Tang CY, Casey SA, Sengupta JD
Background
Leadless intracardiac pacemakers were developed to avoid the complications of transvenous pacing systems. The Medtronic Micra™ transcatheter pacemaker is one such system. We found an unexpected number of major adverse clinical events (MACE) in the Food and Drug Administration\'s Manufacturers and User Facility Device Experience (MAUDE) database associated with Micra implantation.
Objective
The purpose of this study was to describe these MACE and compare them to implant procedure MACE in MAUDE for Medtronic CapSureFix™ active-fixation transvenous pacing leads.
Methods
During January 2021, we queried the MAUDE database for reports of MACE for Micra pacemakers and CapSureFix leads using the simple search terms \"death,\" \"tamponade,\" and \"perforation.\" Reports from 2016-2020 were included.
Results
The search identified 363 MACE for Micra and 960 MACE for CapSureFix leads, including 96 Micra deaths (26.4%) vs 23 CapSureFix deaths (2.4%) (P <.001); 287 Micra tamponades (79.1%) vs 225 tamponades for CapSureFix (23.4%) (P <.001); and 99 rescue thoracotomies for Micra (27.3%) vs 50 rescue thoracotomies for CapSureFix (5.2%) (P <.001). More Micra patients required cardiopulmonary resuscitation (21.8% vs 1.1%) and suffered hypotension or shock (22.0% vs 5.8%) than CapSureFix recipients (P <.001). Micra patients were more likely to survive a myocardial perforation or tear if they had surgical repair (P = .014).
Conclusion
Micra leadless pacemaker implantation may be complicated by myocardial and vascular perforations and tears that result in cardiac tamponade and death. We estimate the incidence is low (<1%). Rescue surgery to repair perforations may be lifesaving. MACE are significantly less for implantation of CapSureFix transvenous ventricular pacing leads.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1132-1139
Hauser RG, Gornick CC, Abdelhadi RH, Tang CY, Casey SA, Sengupta JD
Heart Rhythm: 29 Jun 2021; 18:1132-1139 | PMID: 33713856
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Impact:
Abstract

Effect of preload reducing therapy on right ventricular size and function in patients with arrhythmogenic right ventricular cardiomyopathy.

Kalantarian S, Vittinghoff E, Klein L, Scheinman MM
Background
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an important cause of sudden cardiac death in young people and athletes. To date, no treatment has proven to slow the progression of the disease. Preload reducing agents such as nitrates and diuretics have shown promising results in preventing training-induced development of ARVC in a murine model.
Objective
The purpose of this study was to describe our experience with preload reducing therapy in patients with ARVC and symptomatic right ventricular (RV) dysfunction.
Methods
We performed retrospective chart review of prospectively collected registry data and included 20 patients with definite ARVC who had serial echocardiographic measurements and an implantable cardioverter-defibrillator. Six of the 20 patients with RV end-diastolic area (RVEDA) above median (>25 cm2) and New York Heart Association functional class II-IV symptoms were successfully treated with long-term isosorbide dinitrate 5-40 mg tid (at maximum tolerated dose) and hydrochlorothiazide-spironolactone 25-25 mg daily. The main outcomes of interest were RVEDA, RV fractional area change (FAC), and RV outflow tract measurements. Generalized estimating equations with repeated measures were used to identify the association between preload reducing agents and echocardiographic structural progression.
Results
Patients who received preload reducing agents (n = 6) were older and had larger RVs with lower FAC at baseline. However, treatment with preload reducing agents was associated with less RVEDA enlargement during mean 3.3 (range 1-6.7) years of treatment in multivariate analysis (% change in RVEDA associated with treatment -7.71; 95% confidence interval -13.29 to -2.13; P = .007).
Conclusion
Preload reducing agents show promising results in slowing RV enlargement in patients with ARVC and show possible disease-modifying potential.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1186-1191
Kalantarian S, Vittinghoff E, Klein L, Scheinman MM
Heart Rhythm: 29 Jun 2021; 18:1186-1191 | PMID: 33722762
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Impact:
Abstract

Atrial resting membrane potential confers sodium current sensitivity to propafenone, flecainide and dronedarone.

Holmes AP, Saxena P, Kabir SN, O\'Shea C, ... Fabritz L, Kirchhof P
Background
Although atrial fibrillation ablation is increasingly used for rhythm control therapy, antiarrhythmic drugs (AADs) are commonly used, either alone or in combination with ablation. The effectiveness of AADs is highly variable. Previous work from our group suggests that alterations in atrial resting membrane potential (RMP) induced by low Pitx2 expression could explain the variable effect of flecainide.
Objective
The purpose of this study was to assess whether alterations in atrial/cardiac RMP modify the effectiveness of multiple clinically used AADs.
Methods
The sodium channel blocking effects of propafenone (300 nM, 1 μM), flecainide (1 μM), and dronedarone (5 μM, 10 μM) were measured in human stem cell-derived cardiac myocytes, HEK293 expressing human NaV1.5, primary murine atrial cardiac myocytes, and murine hearts with reduced Pitx2c.
Results
A more positive atrial RMP delayed INa recovery, slowed channel inactivation, and decreased peak action potential (AP) upstroke velocity. All 3 AADs displayed enhanced sodium channel block at more positive atrial RMPs. Dronedarone was the most sensitive to changes in atrial RMP. Dronedarone caused greater reductions in AP amplitude and peak AP upstroke velocity at more positive RMPs. Dronedarone evoked greater prolongation of the atrial effective refractory period and postrepolarization refractoriness in murine Langendorff-perfused Pitx2c+/- hearts, which have a more positive RMP compared to wild type.
Conclusion
Atrial RMP modifies the effectiveness of several clinically used AADs. Dronedarone is more sensitive to changes in atrial RMP than flecainide or propafenone. Identifying and modifying atrial RMP may offer a novel approach to enhancing the effectiveness of AADs or personalizing AAD selection.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1212-1220
Holmes AP, Saxena P, Kabir SN, O'Shea C, ... Fabritz L, Kirchhof P
Heart Rhythm: 29 Jun 2021; 18:1212-1220 | PMID: 33737232
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Impact:
Abstract

Fasciculoventricular and atrioventricular accessory pathways in patients with Danon disease and preexcitation: A multicenter experience.

Darden D, Hsu JC, Tzou WS, von Alvensleben JC, ... Feld GK, Adler E
Background
Studies have suggested that a fasciculoventricular pathway (FVP) may be the cause of preexcitation in patients with Danon disease, a rare X-linked dominant genetic disorder of hypertrophic cardiomyopathy.
Objective
The purpose of this study was to describe the prevalence of ventricular preexcitation on resting 12-lead electrocardiogram (ECG) in patients with Danon disease and the electrophysiological study (EPS) results of those with preexcitation.
Methods
Patients with confirmed Danon disease diagnosed with preexcitation (PR ≤120 ms, delta wave, QRS >110 ms) on ECG were included from a multicenter registry. The incidence of arrhythmias, implantable cardioverter-defibrillator (ICD) procedures, ICD shocks, and EPS results were collected.
Results
Thirteen of 40 patients (32.5%) with Danon disease were found to have preexcitation (mean age 17.3 years; 38% women). EPS performed in 9 of 13 patients (69%) demonstrated FVP only in 2 (22.2%), extranodal pathway without exclusion of FVP in 2 (22.2%), and both FVP and extranodal pathway in 5 (55.6%). Two patients had malignant accessory pathway (AP) properties. Over median follow-up of 842 days (interquartile range 138-1678), 11 patients (85%) had ICD placement, and 6 (46.1%) underwent heart transplantation. No patients required therapy for ventricular tachycardia, and 2 patients (15%) had paroxysmal atrial fibrillation.
Conclusion
In a large multicenter cohort of patients with Danon disease, there was a high prevalence of FVP and extranodal pathways diagnosed on EPS in those with preexcitation. These findings suggest patients with preexcitation and Danon disease should undergo EPS to assess for FVP and potentially malignant extranodal AP.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1194-1202
Darden D, Hsu JC, Tzou WS, von Alvensleben JC, ... Feld GK, Adler E
Heart Rhythm: 29 Jun 2021; 18:1194-1202 | PMID: 33737230
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Impact:
Abstract

Low-temperature electrocautery reduces adverse effects from secondary cardiac implantable electronic device procedures: Insights from the WRAP-IT trial.

Mittal S, Wilkoff BL, Poole JE, Kennergren C, ... Holbrook R, Tarakji KG
Background
Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited.
Objective
The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event.
Methods
We evaluated patients enrolled in WRAP-IT (Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial) undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement. All adverse events were adjudicated by an independent physician committee. Data were analyzed using Cox proportional hazard regression modeling.
Results
In total, 5641 patients underwent device revision/upgrade/replacement. Electrocautery was used in 5205 patients (92.3%) (mean age 70.6 ± 12.7 years; 28.8% female), and low-temperature electrocautery was used in 1866 patients (35.9%). Compared to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure- or lead-related adverse event through 3 years of follow up (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.65-0.91; P = .002). After controlling for the number of active leads, degree of capsulectomy, degree of lead dissection, and renal dysfunction, low-temperature electrocautery was associated with a 32% lower risk of lead-related adverse events (HR 0.68; 95% CI 0.52-0.89; P = .004). These effects were consistent across a spectrum of lead-related adverse event types.
Conclusion
This study represents one of the largest assessments of electrocautery use in patients undergoing CIED revision, upgrade, or replacement procedures. Compared to standard electrocautery, low-temperature electrocautery significantly reduces adverse effects from these procedures.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1142-1150
Mittal S, Wilkoff BL, Poole JE, Kennergren C, ... Holbrook R, Tarakji KG
Heart Rhythm: 29 Jun 2021; 18:1142-1150 | PMID: 33781980
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Impact:
Abstract

Vein of Marshall ethanol infusion in the treatment of atrial fibrillation: From concept to clinical practice.

Valderrábano M
The vein of Marshall (VOM) contains innervation, myocardial connections, and arrhythmogenic foci that make it an attractive target in catheter ablation of atrial fibrillation (AF). Additionally, it co-localizes with the mitral isthmus, which is critical to sustain perimitral flutter, and is a true atrial vein that communicates with underlying myocardium. Retrograde balloon cannulation of the VOM from the coronary sinus is feasible and allows for ethanol delivery, which results in rapid ablation of neighboring myocardium and its innervation. Here we review the body of work performed over a span of 13 years, from the inception of the technique, to its preclinical validation, to demonstration of its ablative and denervation effects, and finally to completion of a randomized clinical trial demonstrating favorable outcomes, improving rhythm control in catheter ablation of persistent AF.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1074-1082
Valderrábano M
Heart Rhythm: 29 Jun 2021; 18:1074-1082 | PMID: 33781979
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Impact:
Abstract

Defining idiopathic ventricular fibrillation: A systematic review of diagnostic testing yield in apparently unexplained cardiac arrest.

Alqarawi W, Dewidar O, Tadros R, Roberts JD, ... Wells G, Krahn AD
Background
Idiopathic ventricular fibrillation (IVF) is diagnosed in patients with apparently unexplained cardiac arrest (UCA) after varying degrees of evaluation. This is largely due to the lack of a standardized approach to UCA.
Objective
We sought to develop an evidence-based diagnostic algorithm for IVF by systematically examining the yield of diagnostic testing in UCA probands.
Methods
Studies reporting the yield of diagnostic testing in UCA were identified in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and conference abstracts. Their methodological quality was assessed by the National Institutes of Health quality assessment tool. Meta-analyses were performed using the random effects model.
Results
A total of 21 studies were included. The pooled comprehensive diagnostic testing yield was 43% (95% confidence interval 39%-48%). A lower yield was seen when only definite diagnoses based on the prespecified criteria were used (32% vs 47%; P = .15). Epinephrine challenge, Holter monitoring, and family screening were associated with low yield (<5%), whereas cardiac magnetic resonance imaging, exercise treadmill test, and sodium-channel blocker challenge were associated with high yield (≥5%). Coronary spasm provocation, electrophysiology study, and systematic genetic testing were reported to be abnormal in a high proportion of UCA probands (>10%).
Conclusion
We developed a stepwise algorithm for UCA evaluation and criteria to assess the strength of IVF diagnosis on the basis of the diagnostic yield of UCA testing.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1178-1185
Alqarawi W, Dewidar O, Tadros R, Roberts JD, ... Wells G, Krahn AD
Heart Rhythm: 29 Jun 2021; 18:1178-1185 | PMID: 33781978
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Impact:
Abstract

Differentiating atrial tachycardias with centrifugal activation: Lessons from high-resolution mapping.

Takigawa M, Takagi T, Martin CA, Derval N, ... Sasano T, Jais P
Background
Centrifugal activation is not always the origin of a focal atrial tachycardia (AT) (\"true-focal\"), but passive activation from the other structures (\"pseudo-focal\").
Objective
We aimed to establish a method to differentiate true-focal from pseudo-focal.
Methods
In 49 centrifugal activations in 35 patients with AT, 12-lead electrocardiogram, activation map, atrial global activation histogram (GAH), and local electrograms were analyzed. GAH demonstrates the relation between the activation area and timing through the cycle length, displayed with a normalized value, ranging from 0 (smallest activation area) to 1.0 (largest activation area).
Results
Of 30 centrifugal activations observed in the septal region, 6/30 (20.0%) were true-focal. The remaining 24/60 (80.0%) were pseudo-focal, of which 23 (95.8%) were from the opposite chamber. P-wave/flutter-wave duration < 200 ms discriminated true-focal from pseudo-focal (sensitivity 100%; specificity 54.5%; positive predictive value 33.3%; negative predictive value 100%). Multiple breakthrough ruled out the possibility of a true-focal AT. Other differentiating factors were an activation area within the initial 20 ms of <5 mm2 and a typical QS pattern electrogram at the origin. Of 19 centrifugal activations observed outside the septal regions, 7 were true-focal and 12 were pseudo-focal exited from an epicardial structure: 10 of 12 (83.3%) were located around the left atrial appendage and ridge. Flutter wave, GAH score ≤ 0.05, and GAH score < 0.1 for >110 ms of cycle length differentiated true-focal from pseudo-focal with a sensitivity/negative predictive value of 100%. GAH score < 0.1 for >40% of the cycle length simply discriminated true-focal from pseudo-focal with 100% accuracy.
Conclusion
Centrifugal activation is not necessarily due to a focal AT but passive activation. The activation map with GAH in addition to the 12-lead electrocardiogram and local electrograms enables an accurate differentiation.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1122-1131
Takigawa M, Takagi T, Martin CA, Derval N, ... Sasano T, Jais P
Heart Rhythm: 29 Jun 2021; 18:1122-1131 | PMID: 33794392
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Impact:
Abstract

Persistent atrial fibrillation ablation in cardiac laminopathy: Electrophysiological findings and clinical outcomes.

Chauvel R, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Pambrun T
Background
Little is known about persistent atrial fibrillation (AF) ablation in patients with cardiac laminopathy (CLMNA).
Objectives
We aimed to characterize atrial electrophysiological properties and to assess the long-term outcomes of persistent AF ablation in patients with CLMNA.
Methods
All patients with CLMNA referred in our center for persistent AF ablation were retrospectively included. Left atrial (LA) volume, left atrial appendage (LAA) cycle length, interatrial conduction delay, and LA voltage amplitude were analyzed during the ablation procedure. Sinus rhythm maintenance and LA contractile function were assessed during long-term follow-up.
Results
From 2011 to 2020, 8 patients were included. The mean age was 47 ± 14 years, and 3 patients (38%) were women. The LA volume was 205.8 ± 43.7 mL; the LAA AF cycle length was 250.7 ± 85.6 ms; and the interatrial conduction delay was 296.5 ± 110.1 ms. Large low-voltage areas (>50% of the LA surface; <0.5 mV electrogram) were recorded in all 8 patients. Two patients had inadvertent LAA disconnection during ablation. All A waves recorded by pulsed Doppler in sinus rhythm were <30 cm/s before and after AF ablation. Early arrhythmia recurrence was recorded in 7 patients (87%) (time to recurrence 4 ± 4 months; 1.5 procedures per patient). After a mean follow-up of 4.4 ± 3.2 years, 4 patients underwent implantable cardioverter-defibrillator therapy for life-threatening ventricular arrhythmia and 3 patients finally underwent heart transplantation.
Conclusion
Patients with persistent AF afflicted by CLMNA exhibit severe LA impairment because of large low-voltage areas, prolonged conduction velocity, and reduced contractile function. Ablation procedures have a limited effect with a high recurrence rate.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1115-1121
Chauvel R, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Pambrun T
Heart Rhythm: 29 Jun 2021; 18:1115-1121 | PMID: 33812085
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Impact:
Abstract

Long term complications in patients implanted with subcutaneous implantable defibrillators Real-world data from the Extended ELISIR experience.

Gasperetti A, Schiavone M, Ziacchi M, Vogler J, ... Forleo G, Biffi M
Background
Recently, the Food and Drug administration issued a recall for the subcutaneous implantable cardioverter defibrillator (S-ICD) due to the possibility of lead ruptures and accelerated battery depletion.
Objective
Aim of this study is to evaluate device-related complications over time in a real-world multicentered large S-ICD cohort.
Methods
Patients implanted with S-ICD from January 2015 to June 2020 were enrolled from a 19 institution European registry (ELISIR NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.
Results
A total of 1254 patients (52.0 [41.0-62.2] years, 77.6% male, 30.9% ischemic) was enrolled. Over a follow-up of 23.2 [12.8-37.8] months, complications were observed in 117 (9.3%) patients, for a total of 127 device-related complications (23.6% managed conservatively, 76.4%) requiring reintervention). Twenty-seven (2.2%) patients had an unanticipated generator replacement, after 3.6 [3.3-3.9] years, while 4 (0.3%) had a lead rupture. BMI (HR 1.063 [1.028-1.100]; p=0.000), chronic kidney disease (HR 1.960 [1.191-3.225]; p=0.008), and oral anticoagulation (HR 1.437 [1.010-2.045]; p=0.043) were associated with an increase of overall complications whereas older age (HR 0.980 [0.967-0.994]; p=0.007) and procedure performed in high volume centers (HR 0.463 [0.300-0.715]; p=0.001) were protective factors.
Conclusion
The overall complication rate over 23.2 months of follow-up in a multicentered S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, in line with the expected rates reported from Boston Scientific.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 12 Jul 2021; epub ahead of print
Gasperetti A, Schiavone M, Ziacchi M, Vogler J, ... Forleo G, Biffi M
Heart Rhythm: 12 Jul 2021; epub ahead of print | PMID: 34271173
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Impact:
Abstract

Impact of specialized electrophysiological care on outcome of catheter ablation for supraventricular tachycardias in adults with congenital heart disease: Independent risk factors and gender aspects.

Fischer AJ, Enders D, Wasmer K, Marschall U, Baumgartner H, Diller GP
Background
Limited data exist on the impact of gender and specialized care on the requirement of repeat treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (ACHD).
Objective
The study aimed to assess independent predictors for a combined endpoint of re-CA or cardioversion at 3 years of follow-up including the impact of gender and specialized ACHD care.
Methods
All ACHD registered at a database of one of the largest German Health Insurers (≈9.2 million members) who underwent catheter ablation (CA) for SVT were analyzed.
Results
Of 38,892 ACHD ≥16 years, 485 (49.5% women, median age 58.4 years) underwent CA for SVT. Over the three-year follow-up, the number of yearly CA increased significantly particularly for treatment of atrial fibrillation (AF) (+195%) and atrial flutter (+108%). Moderate to severe complexity heart disease (Odds ratio [OR] 1.66; p=0.01), advanced age (OR 1.85 per year; p=0.02), chronic kidney disease (OR 1.70; p=0.01) and AF (OR 2.02; p=0.002) emerged as independent predictors for re-treatment. Re-treatment was significantly less often performed if the primary CA was carried out at a specialized ACHD center (p=0.009) in patients with moderate to severe complexity. Women treated at specialist centers had a 1.6-fold reduced risk of undergoing re-treatment (p=0.01).
Conclusion
CA for SVT is increasingly performed in ACHD, especially for atrial flutter and atrial fibrillation. Patients with moderate and severe complexity congenital heart defects and female ACHD benefit from upfront referral to specialized ACHD centers for CA. Centralization of care for ACHD arrhythmias should thus be advocated.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 12 Jul 2021; epub ahead of print
Fischer AJ, Enders D, Wasmer K, Marschall U, Baumgartner H, Diller GP
Heart Rhythm: 12 Jul 2021; epub ahead of print | PMID: 34271174
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Impact:
Abstract

Sex differences in the origin of Purkinje ectopy initiating idiopathic ventricular fibrillation.

Surget E, Cheniti G, Ramirez FD, Leenhardt A, ... Hocini M, Haïssaguerre M
Background
Purkinje ectopics (PurkE) are major triggers of idiopathic ventricular fibrillation (VF). Identifying clinical factors associated with specific PurkE characteristics could yield insights into the mechanisms of Purkinje-mediated arrhythmogenicity.
Objective
To examine the associations of clinical, environmental, and genetic factors with PurkE origin in patients with PurkE-initiated idiopathic VF.
Methods
Consecutive patients from four arrhythmia referral centers with PurkE-initiated idiopathic VF were included. We evaluated demographics, medical history and clinical circumstances associated with index VF events, and electrophysiologic characteristics of PurkE. An electrophysiological study was performed in most patients to confirm the Purkinje origin.
Results
Eighty three patients were included (age 38 ± 14 years, 44 women) among whom 32 had a previous history of syncope. Fourty four patients had VF at rest. PurkE originated from the right ventricle (RV) in 41 cases (49%), from the left ventricle (LV) in 36 (44%) and from the both ventricles in 6 (7%). Seasonal and circadian distributions of VF episodes were similar according to PurkE origin. Clinical characteristics of patients with RV vs. LV PurkE origins were similar except for sex. RV PurkE were more frequent in men than women (76% vs 24%) whereas LV and biventricular PurkE were more frequent in women (81% vs 19% and 83% vs 17% respectively, p<0.0001).
Conclusion
PurkE triggering idiopathic VF originate dominantly from RV in men and from LV or both ventricles in women adding to other sex-related arrhythmias as Brugada syndrome or long QT. Sex-based factors influencing Purkinje arrhythmogenicity warrant investigation.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 10 Jul 2021; epub ahead of print
Surget E, Cheniti G, Ramirez FD, Leenhardt A, ... Hocini M, Haïssaguerre M
Heart Rhythm: 10 Jul 2021; epub ahead of print | PMID: 34260987
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Impact:
Abstract

Epicardial Course of the Musculature Related to the Great Cardiac Vein: Anatomical Considerations and Clinical Implications for Mitral Isthmus Block after Vein of Marshall Ethanol Infusion.

Pambrun T, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Jaïs P
Background
Mitral isthmus gaps have been ascribed to an epicardial musculature anatomically related to the great cardiac vein (GCV) and the vein of Marshall (VOM). Their lumen offers an access for radiofrequency application or ethanol infusion, respectively.
Objective
To evaluate the frequency of mitral isthmus gaps accessible via the GCV lumen, to assess their location around the GCV circumference, and to propose an efficient ablation strategy when present.
Methods
One hundred consecutive patients underwent VOM ethanol infusion (step 1) and endocardial linear ablation from the mitral annulus to the left inferior pulmonary vein (step 2). In cases of mitral isthmus gap, endovascular ablation of the GCV anchored wall facing the left atrium was systematically performed (step 3), while the opposite GCV free wall was targeted in case of block failure only (step 4).
Results
After VOM ethanol infusion and endocardial ablation, mitral isthmus block occurred in 51 patients (51%). Pacing maneuvers and activation sequences demonstrated an epicardial gap via the VOM in 2 patients (2%), and via the GCV in 47 patients (47%). In the latter case, block was achieved at the GCV anchored wall in 42 patients (89%), and the GCV free wall in 5 patients (11%). Global success rate of mitral isthmus block was 98%. No tamponade occurred.
Conclusion
With the advent of VOM ethanol infusion, residual mitral isthmus gaps are mostly eliminated within the first centimeter of the GCV. Thorough mapping of the entire circumference of the GCV wall can help identify these epicardial gaps.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 30 Jun 2021; epub ahead of print
Pambrun T, Derval N, Duchateau J, Denis A, ... Haïssaguerre M, Jaïs P
Heart Rhythm: 30 Jun 2021; epub ahead of print | PMID: 34217842
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Impact:
Abstract

Catheter ablation of premature ventricular complexes associated with left ventricular false tendons.

Zhang J, Liang M, Wang Z, Zhang X, ... Zhang H, Huang J
Background
Clinical studies have suggested that there is a significant correlation between left ventricular(LV) false tendon and premature ventricular complexes(PVCs).
Objective
This study aimed to investigate the electrophysiological characteristics and the outcome of RFCA for this category of PVCs.
Methods
From a total of 2284 patients with idiopathic PVCs who underwent catheter ablation at six institutions in China, ICE was utilized during the procedure in 346 cases, ten patients (2.9%) with PVCs associated with false tendon were retrospectively reviewed and enrolled in the present study. Activation mapping and pace mapping were performed to localize the origin of PVCs. Intracardiac echocardiography (ICE) was used in all patients.If the false tendon was directly visualized and identified, we attempted to identify the distinct relationship with the PVC origin.
Results
The PVCs were successfully eliminated by ablation in all patients.The target sites were confirmed to be related to false tendon . The origin of PVCs was located at the attachment of the false tendon to the papillary muscle, LV septum or LV apex. At the target site, high-frequency Purkinje potentials were observed preceding local ventricular activation in seven patients.
Conclusions
LV false tendon can be associated with PVCs which can be cured by RFCA.. An ICE-guided electroanatomical approach should be considered to improve the safety and feasibility of this procedure.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 28 Jun 2021; epub ahead of print
Zhang J, Liang M, Wang Z, Zhang X, ... Zhang H, Huang J
Heart Rhythm: 28 Jun 2021; epub ahead of print | PMID: 34214648
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Impact:
Abstract

Left atrial appendage closure in patients with prohibitive anatomy: Insights from PINNACLE FLX.

Ellis CR, Jackson GG, Kanagasundram AN, Mansour M, ... Doshi S, Osorio J
Background
Watchman 2.5 (Boston Scientific Inc, Marlborough, MA) implant success approaches 95% in registries, yet many patients are not attempted because of complex left atrial appendage (LAA) anatomy. Watchman FLX can expand the range of ostium width (14-31.5 mm) and depth available for LAA closure.
Objective
The purpose of this study was to evaluate the safety and efficacy of Watchman FLX in patients with a failed Watchman 2.5 attempt or prohibitive LAA anatomy.
Methods
The roll-in (n = 58) and primary effectiveness (n = 400) cohorts of the PINNACLE FLX trial comprised the study population. Subjects were identified who previously failed implantation of Watchman 2.5 (n = 11) or were not attempted because of prohibitive LAA anatomy (n = 88). Demographic characteristics, implant procedure details, and TEE follow-up data were compared to controls composed of enrollees not meeting these criteria (n = 359).
Results
Watchman FLX LAA closure was successfully implanted in all subjects with a prior failed Watchman 2.5 attempt (n = 11 of 11). Subjects with previously failed Watchman 2.5 were more likely to receive a 35 mm FLX device than controls (27.3% vs 7.3%; P = .047). Patients with prohibitive anatomy had smaller LAA dimensions than did controls (diameter 18.0 ± 4 mm vs 20.4 ± 3 mm; P < .001 and length 23.7 ± 5 mm vs 28.9 ± 5 mm; P < .001). There was no difference in age, sex, CHA2DS2-VASc score, HAS-BLED score, or primary efficacy between cohorts. Transesophageal echocardiography (TEE) at 12 months showed zero leak in 90.9% in the failed Watchman 2.5 cohort, 91.3% in the prohibitive anatomy cohort, and 89.5% in the control cohort (P = .84). Overall and cardiovascular mortality was lower in the prohibitive anatomy cohort (1.2% vs 8.8% in controls; P = .02).
Conclusion
Watchman FLX implantation in patients with a prior failed Watchman 2.5 attempt or prohibitive LAA anatomy remained safe and highly effective. The association of reduced overall mortality with smaller LAA dimension warrants future study.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1153-1161
Ellis CR, Jackson GG, Kanagasundram AN, Mansour M, ... Doshi S, Osorio J
Heart Rhythm: 29 Jun 2021; 18:1153-1161 | PMID: 33957090
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Impact:
Abstract

The combination of coronary sinus ostial atresia/abnormalities and a small persistent left superior vena cava-Opportunity for left ventricular lead implantation and unrecognized source of thromboembolic stroke.

Zou F, Worley SJ, Steen T, McKillop M, ... Hadadi CA, Kushnir A
Background
Coronary sinus (CS) ostial atresia/abnormalities prevent access to the CS from the right atrium (RA) for left ventricular (LV) lead implantation. Some patients with CS ostial abnormalities also have a small persistent left superior vena cava (sPLSVC).
Objective
The purpose of this study was to describe CS ostial abnormalities and sPLSVC as an opportunity for LV lead implantation and unrecognized source of stroke.
Methods
Twenty patients with CS ostial abnormalities and sPLSVC were identified. Clinical information, imaging methods, LV lead implantation techniques, and complications were summarized.
Results
Forty percent had at least 1 previously unsuccessful LV lead placement. In 70%, sPLSVC was identified by catheter manipulation and contrast injection in the left brachiocephalic vein, and in 30% by levophase CS venography. In 30%, sPLSVC was associated with drainage from the CS into the left atrium (LA). When associated with CS ostial abnormalities, the sPLSVC diameter averaged 5.6 ± 3 mm. sPLSVC was used for successful LV lead implantation in 90% of cases. In 80%, the LV lead was implanted down sPLSVC, and in 20%, sPLSVC was used to access the CS from the RA. Presumably because of unrecognized drainage from the CS to the LA, 1 patient had a stroke during implantation via sPLSVC.
Conclusion
When CS ostial abnormalities prevent access to the CS from the RA, sPLSVC can be used to successfully implant LV leads. In some, the CS partially drains into the LA and stroke can occur spontaneously or during lead intervention. It is important to distinguish sPLSVC associated with CS ostial abnormalities from isolated PLSVC.

Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Heart Rhythm: 29 Jun 2021; 18:1064-1073
Zou F, Worley SJ, Steen T, McKillop M, ... Hadadi CA, Kushnir A
Heart Rhythm: 29 Jun 2021; 18:1064-1073 | PMID: 33971333
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Impact:
Abstract

Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial.

Turakhia M, Sundaram V, Smith SN, Ding V, ... Mahaffey KW, smartADHERE Investigators
Background
Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective.
Methods
SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥ 18, newly-prescribed (≤90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment.
Results
There were 139 participants (age 65±9.6 years, 30% female, median CHA2DS2-VASc score 3 with IQR 2 to 4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events.
Conclusions
The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite prescreening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am Heart J: 29 Jun 2021; 237:68-78
Turakhia M, Sundaram V, Smith SN, Ding V, ... Mahaffey KW, smartADHERE Investigators
Am Heart J: 29 Jun 2021; 237:68-78 | PMID: 33676886
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Impact:
Abstract

Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study.

Lubitz SA, Faranesh AZ, Atlas SJ, McManus DD, ... Pantelopoulos A, Foulkes AS
Background
Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment.
Methods
The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF.
Conclusions
The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Jul 2021; 238:16-26
Lubitz SA, Faranesh AZ, Atlas SJ, McManus DD, ... Pantelopoulos A, Foulkes AS
Am Heart J: 30 Jul 2021; 238:16-26 | PMID: 33865810
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Impact:
Abstract

Comparison of Low-Dose Direct Acting Anticoagulant and Warfarin in patients Aged ≥80 years With Atrial Fibrillation.

Chaudhry UA, Ezekowitz MD, Gracely EJ, George WT, ... Harper G, Harper GR
Low dose direct acting oral anticoagulants (LDDOACS) were approved for elderly atrial Fibrillation (AF) patients with limited information. A retrospective analysis collecting baseline characteristics and outcomes in AF patients ≥ 80 prescribed LDDOAC or warfarin (W), from a multidisciplinary practice between 1/1/11 (First LDDOAC available) and 5/31/17 was conducted. From 9660 AF patients, 514 ≥ 80 received a LDDOAC and 422 W. A multivariable comparison found LDDOAC patients were older (p <0.001), had lower creatinine clearance (CrCl) (p = 0.006), used more anti-platelet drugs (p <0.001), and more often had new onset AF verses those prescribed W (p <0.001). There were no clinically significant differences among those patients receiving Dabigatran 75 mgs BID (D), Rivaroxaban 15mgs (R) or Apixaban 2.5mgs BID (A). Forty-eight and 50% of the patients remained on their LDDOAC or W for the observation period (p = 0.55). Stroke/systemic embolism (SSE) and CNS bleeds were 1.16 vs 2.22%/yr., (p = 0.143) and 1.46 vs 0.93%/yr., (p = 0.24). Mortality and major bleeds were 6.26 vs 1.67%/yr., and 12.3vs 3.77%/yr. (p <0.001). SSE were 1.1%/yr for D, R, and A (p = 0.94). CNS bleeds were 2.2 for D, 1.7 for R and 0.8%/yr. for A: p = 0.53. Major bleeding was: 14.3 for D, 14.1 for R and 9.1%/yr. for A, p = 0.048 (with A < R, p = 0.01). Mortality was 5.5 for D, 4.2 for R and 9.5% for A, p = 0.031. In conclusion, half the patients remained on their assigned anti-coagulant. SSE and intracranial bleed rates were similar and low. Major bleeds and deaths were different between groups emphasizing the need for prospective randomized trials in this growing population with AF.

Copyright © 2021. Published by Elsevier Inc.

Am J Cardiol: 31 Jul 2021; 152:69-77
Chaudhry UA, Ezekowitz MD, Gracely EJ, George WT, ... Harper G, Harper GR
Am J Cardiol: 31 Jul 2021; 152:69-77 | PMID: 34162485
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Impact:
Abstract

Impact of Atrial Fibrillation on Hospitalization Outcomes of Heart Failure in Patients ≥ 60 Years with Implantable Cardioverter Defibrillator.

Abugroun A, Elawad A, Okoh AK, Abdel-Rahman ME, Ayinde H, Volgman AS
The impact of atrial fibrillation (AF) on the hospitalization outcomes in patients ≥ 60 years of age with implantable cardioverter defibrillators (ICD) is not well studied. We queried the National Inpatient Sample database for all patients aged ≥ 60 who had a history of ICD placement, and were admitted with a primary diagnosis of heart failure (HF) during the years 2016-2017. Patients were stratified into 2 groups based on their history of AF. The primary outcome of the study was all-cause in-hospital mortality. Secondary outcomes included cardiogenic shock, myocardial infarction (MI), ventricular fibrillation (VF), stroke and acute kidney injury (AKI). The association between different age strata and outcomes was investigated. The hospitalization outcomes were modeled using logistic regression. A total of 178,045 patients were included, of whom 56.2% had AF. AF correlated with increased mortality (A-OR 1.22 (95% CI: 1.06-1.4), p=0.005), cardiogenic shock (A-OR 1.21 (95%CI: 1.08-1.36), p<0.001), AKI (A-OR 1.12 (95%CI: 1.06-1.17), p<0.001 and lower risk for MI (A-OR 0.79 (95% CI: 0.68-0.9), p<0.001. There was no correlation between AF and risk for VF or stroke. A significant correlation between AF and higher risk for mortality, cardiogenic shock and AKI was demonstrated in ages ≤ 75, ≤ 75, and ≤ 80 years, respectively. In contrast, a significant correlation between AF and lower risk for MI is only demonstrated at age > 70 years. We conclude that AF is an independent predictor for increased all-cause in-hospital mortality and cardiogenic shock. Such risk is influenced by age.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:94-98
Abugroun A, Elawad A, Okoh AK, Abdel-Rahman ME, Ayinde H, Volgman AS
Am J Cardiol: 31 Jul 2021; 152:94-98 | PMID: 34090659
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Impact:
Abstract

Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT Trial Analysis.

Tarakji KG, Korantzopoulos P, Philippon F, Biffi M, ... Seshadri S, Wilkoff BL
Background
Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT trial, but its effectiveness in the presence of hematoma is not well understood.
Objective
Evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients.
Methods
All 6800 study patients were included in this analysis (control = 3429; envelope = 3371). Hematomas occurring within 30 days post-procedure (acute) were characterized and grouped by study treatment and evaluated for subsequent infection risk. Data were analyzed using Cox proportional hazard regression modeling.
Results
Acute hematoma incidence was 2.2% at 30 days and there was no significant difference between treatment groups (envelope vs. control HR: 1.15, 95% CI: 0.84-1.58, p = 0.39). Through all follow-up, the risk of major infection was significantly higher among control patients with hematoma vs those without (13.1% vs. 1.6%; HR: 11.3, 95%CI: 5.5-23.2, p < 0.001). The risk of major infection was significantly lower in the envelope vs control patients with hematoma (2.5% vs. 13.1%; HR: 0.18, 95%CI 0.04-0.85, p = 0.03).
Conclusion
The risk of hematoma was 2.2% among the WRAP-IT trial patients. Among control patients, hematoma carried >11-fold risk of developing a major CIED infection. This risk was significantly mitigated with antibacterial envelope use as there was an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control.

Copyright © 2021. Published by Elsevier Inc.

Heart Rhythm: 15 Jul 2021; epub ahead of print
Tarakji KG, Korantzopoulos P, Philippon F, Biffi M, ... Seshadri S, Wilkoff BL
Heart Rhythm: 15 Jul 2021; epub ahead of print | PMID: 34280568
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Impact:
Abstract

Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based Bavarian Alternative Detection of Atrial Fibrillation (eBRAVE-AF) trial.

Freyer L, von Stülpnagel L, Spielbichler P, Sappler N, ... Rizas KD, Bauer A
Current guidelines recommend opportunistic screening for subclinical atrial fibrillation (AF) taking advantage of e-health-based technologies. However, the efficacy of a fully scalable e-health-based strategy for AF detection in a head-to-head comparison with routine symptom-based screening is unknown. eBRAVE-AF is an investigator-initiated, digital, prospective, randomized, siteless, open-label, cross-over study to evaluate an e-health-based strategy for detection of AF in a real-world setting. 67,488 policyholders of a large German health insurance company (Versicherungskammer Bayern, Germany) selected by age ≥ 50 years and a CHA2DS2-VASc score ≥ 1 (females ≥2) are invited to participate. Subjects with known AF or on treatment with oral anticoagulation are excluded. After obtaining electronic informed consent, at least 4,400 participants will be randomly assigned to an e-health-based screening strategy or routine symptom-based screening. The e-health-based strategy consists of repetitive one-minute photoplethysmographic (PPG) pulse wave assessments using a certified smartphone app (Preventicus Heartbeats, Preventicus, Jena, Germany), followed by a confirmatory 14-day ECG patch (CardioMem CM 100 XT, Getemed, Teltow, Germany) in case of abnormal findings. After 6 months, participants are crossed over to the other study arm. Primary endpoint is the incidence of newly diagnosed AF leading to oral anticoagulation indicated by an independent physician. Clinical follow-up will be at least 12 months. In both groups, follow-up is performed by 4-week app-based questionnaires, personal contact in case of abnormal findings, and matching with claim-based insurance data and medical reports. At time of writing enrollment is completed. First results are expected to be available in mid-2021.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am Heart J: 08 Jul 2021; epub ahead of print
Freyer L, von Stülpnagel L, Spielbichler P, Sappler N, ... Rizas KD, Bauer A
Am Heart J: 08 Jul 2021; epub ahead of print | PMID: 34252387
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Impact:
Abstract

Outcomes and Resource Utilization of Atrial Fibrillation Hospitalizations With Type 2 Myocardial Infarction.

Ariss RW, Minhas AMK, Nazir S, Meenakshisundaram C, ... Kayani WT, Sheikh M
Scarce data exist on the prognostic impact of type 2 myocardial infarction (MI) in patients with AF. The Nationwide Readmission Database 2018 was queried for primary AF hospitalizations with and without type 2 MI. Complex samples multivariable logistic and linear regression models were used to determine the association between type 2 MI and outcomes (in-hospital mortality, index length of stay [LOS], hospital costs, discharge to nursing facility, and 30-day all-cause readmissions). Of 382,896 weighted primary AF hospitalizations included in this study, 7,375 (1.9%) had type 2 MI. AF with type 2 MI is associated with significantly higher in-hospital mortality (adjusted OR [aOR] 1.76; 95% CI 1.30 to 2.38), LOS (adjusted parameter estimate [aPE] 0.48; 95% CI 0.35 to 0.62), hospital costs (aPE 1307.75; 95% CI 986.05 to 1647.44), discharges to nursing facility (aOR 1.38; 95% CI 1.24 to 1.54), and 30-day all-cause readmissions (adjusted hazard ratio 1.17; 95% CI 1.07 to 1.27) compared to AF without type 2 MI. Heart failure, chronic kidney disease, neurologic disorders, and age (per year) were identified as independent predictors of mortality among AF patients with type 2 MI. In conclusion, type 2 MI in the setting of AF hospitalization is associated with high in-hospital mortality and increased resource utilization.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 31 Jul 2021; 152:27-33
Ariss RW, Minhas AMK, Nazir S, Meenakshisundaram C, ... Kayani WT, Sheikh M
Am J Cardiol: 31 Jul 2021; 152:27-33 | PMID: 34130825
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Impact:
Abstract

Patient Characteristics, Care Patterns, and Outcomes of Atrial Fibrillation Associated Hospitalizations in Patients with Chronic Kidney Disease and End-Stage Renal Disease.

Kumar N, Xu H, Garg N, Pandey A, ... Lewis WR, Fonarow GC
Introduction
Chronic Kidney Disease (CKD) and end-stage renal disease (ESRD) are associated with poor outcomes in patients with cardiovascular disease. There is a paucity of contemporary data on in-hospital outcomes and care patterns of atrial fibrillation (AF) associated hospitalizations CKD and ESRD.
Methods
Outcomes and care patterns were evaluated in GWTG-AFIB database (Jan 2013-Dec 2018), including in-hospital mortality, use of a rhythm control strategy, and oral anticoagulation (OAC) prescription at discharge among eligible patients. Generalized logistic regression models with generalized estimating equations were used to ascertain differences in outcomes. Hospital-level variation in OAC prescription and rhythm control was also evaluated.
Results
Among 50,154 patients from 105 hospitals the median age was 70 years (interquartile range 61-79) and 47.3% were women. The prevalence of CKD was 36.0% while that of ESRD was 1.6%. Among eligible patients, discharge OAC prescription rates were 93.6% for CKD and 89.1% for ESRD. After adjustment, CKD and ESRD were associated with higher in-hospital mortality (odds ratio [OR] 3.08, 95% confidence interval [CI] 1.57-6.03 for ESRD and OR 2.02, 95% CI 1.52-2.67 for CKD), lower odds of OAC prescription at discharge (OR 0.59, 95% CI 0.44-0.79 for ESRD and OR 0.84, 95% CI 0.75-0.94 for CKD) compared with normal renal function. CKD was associated with lower utilization of rhythm control strategy (OR 0.92, 95% CI 0.87-0.98) with no significant difference between ESRD and normal renal function (OR 1.32, 95% CI 0.79-1.11). There was large hospital-level variation in OAC prescription at discharge (MOR 2.34, 95% CI 2.05-2.76) and utilization of a rhythm control strategy (MOR 2.69, 95% CI 2.34-3.21).
Conclusions
CKD/ESRD is associated with higher in-hospital mortality, less frequent rhythm control, and less OAC prescription among patients hospitalized for AF. There is wide hospital-level variation in utilization of a rhythm control strategy and OAC prescription at discharge highlighting potential opportunities to improve care and outcomes for these patients, and better define standards of care in this patient population.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 29 Jun 2021; epub ahead of print
Kumar N, Xu H, Garg N, Pandey A, ... Lewis WR, Fonarow GC
Am Heart J: 29 Jun 2021; epub ahead of print | PMID: 34216572
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Impact:
Abstract

Depression as a Driving Force for Low Time in Therapeutic Range and Dementia in Patients With and Without Atrial Fibrillation.

Rizzi SA, Knight S, May HT, Woller SC, ... Knowlton KU, Bunch TJ
Both time in therapeutic range (TTR) for anticoagulation and depression are associated with dementia risk. The purposes of this study were to examine the impact of depression on TTR and to describe the partitioned contribution of depression and TTR on long-term dementia risk. We studied 14,953 patients anticoagulated with warfarin (target INR 2-3) for atrial fibrillation (AF), venous thromboembolism (VTE), or a mechanical heart valve from 2003 to 2015. We excluded patients with a diagnosis of dementia before or within 6 months of warfarin initiation. We examined the association of depression with TTR using finite mixture modeling and logistic regression and utilized multivariable Cox hazard regression to determine the association of TTR and depression with incident dementia at 3 and 13 years. Forty % (n = 6055) of patients were diagnosed with depression before or while on warfarin. Patients with depression had significantly lower TTR and were 1.37 times more likely to have TTR <50% than non-depressed patients (p <0.0001). During follow-up, 4.2% of patients received the diagnosis of dementia within 3 years as compared to 12% during all-time follow up. The 3-year risk of dementia was highest for patients with a ≤50% TTR regardless of depression status. The 3-year dementia risk was associated with TTR (p <0.0001) but not depression. However, for all-time dementia both TTR (p <0.0001) and depression (p <0.0001) as well as their interaction (p = 0.049) were associated with dementia. Depression increased the risk of long-term dementia by 1.69 fold (95% CI: 1.33, 2.15) for patients with the lowest TTR. Depression is prevalent in patients managed with warfarin and is associated with significant decreases in TTR. In conclusion, decreased TTR appears to increase 3-year dementia risk and both low TTR and depression interact to increase risk for all-time dementia in patients taking warfarin.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 14 Aug 2021; 153:58-64
Rizzi SA, Knight S, May HT, Woller SC, ... Knowlton KU, Bunch TJ
Am J Cardiol: 14 Aug 2021; 153:58-64 | PMID: 34176597
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Impact:
Abstract

Long-term prognostic outcomes and implication of oral anticoagulants in patients with new-onset atrial fibrillation following st-segment elevation myocardial infarction.

Madsen JM, Jacobsen MR, Sabbah M, Topal DG, ... Engstrøm T, Lønborg JT
Background
New-onset atrial fibrillation (NEW-AF) following ST-segment elevation myocardial infarction (STEMI) is a common complication, but the true prognostic impact of NEW-AF is unknown. Additionally, the optimal treatment of NEW-AF among patients with STEMI is warranted.
Methods
A large cohort of consecutive patients with STEMI treated with percutaneous coronary intervention were identified using the Eastern Danish Heart Registry from 1999-2016. Medication and end points were retrieved from Danish nationwide registries. NEW-AF was defined as a diagnosis of AF within 30 days following STEMI. Patients without a history of AF and alive after 30 days after discharge were included. Incidence rates were calculated and multivariate analyses performed to determine the association between NEW-AF and long-term mortality, incidence of ischemic stroke, re-MI, and bleeding leading to hospitalization, and the comparative effectiveness of OAC therapy on these outcomes.
Results
Of 7944 patients with STEMI, 296 (3.7%) developed NEW-AF. NEW-AF was associated with increased long-term mortality (adjusted HR 1.48, 95% CI 1.20-1.82, P<.001) and risk of bleeding leading to hospitalization (adjusted HR 1.36, 95% CI 1.00-1.85, P=.050), and non-significant increased risk of ischemic stroke (adjusted HR 1.45, 95% CI 0.96-2.19, P=.08) and re-MI (adjusted HR 1.14, 95% CI 0.86-1.52, P=.35) with a median follow-up of 5.8 years. In NEW-AF patients, 38% received OAC therapy, which was associated with reduced long-term mortality (adjusted HR 0.69, 95% CI 0.47-1.00, P=.049).
Conclusions
NEW-AF following STEMI is associated with increased long-term mortality. Treatment with OAC therapy in NEW-AF patients is associated with reduced long-term mortality.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am Heart J: 30 Jul 2021; 238:89-99
Madsen JM, Jacobsen MR, Sabbah M, Topal DG, ... Engstrøm T, Lønborg JT
Am Heart J: 30 Jul 2021; 238:89-99 | PMID: 33957102
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Impact:
Abstract

Batch enrollment for an artificial intelligence-guided intervention to lower neurologic events in patients with undiagnosed atrial fibrillation: rationale and design of a digital clinical trial.

Yao X, Attia ZI, Behnken EM, Walvatne K, ... Friedman PA, Noseworthy PA
Background
Clinical trials are a fundamental tool to evaluate medical interventions but are time-consuming and resource-intensive.
Objectives
To build infrastructure for digital trials to improve efficiency and generalizability and test it using a study to validate an artificial intelligence algorithm to detect atrial fibrillation (AF).
Design
We will prospectively enroll 1,000 patients who underwent an electrocardiogram for any clinical reason in routine practice, do not have a previous diagnosis of AF or atrial flutter and would be eligible for anticoagulation if AF is detected. Eligible patients will be identified using digital phenotyping algorithms, including natural language processing that runs on the electronic health records. Study invitations will be sent in batches via patient portal or letter, which will direct patients to a website to verify eligibility, learn about the study (including video-based informed consent), and consent electronically. The method aims to enroll participants representative of the general patient population, rather than a convenience sample of patients presenting to clinic. A device will be mailed to patients to continuously monitor for up to 30 days. The primary outcome is AF diagnosis and burden; secondary outcomes include patients\' experience with the trial conduct methods and the monitoring device. The enrollment, intervention, and follow-up will be conducted remotely, ie, a patient-centered site-less trial.
Summary
This is among the first wave of trials to adopt digital technologies, artificial intelligence, and other pragmatic features to create efficiencies, which will pave the way for future trials in a broad range of disease and treatment areas. Clinicaltrials.gov: NCT04208971.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 30 Aug 2021; 239:73-79
Yao X, Attia ZI, Behnken EM, Walvatne K, ... Friedman PA, Noseworthy PA
Am Heart J: 30 Aug 2021; 239:73-79 | PMID: 34033803
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Impact:
Abstract

Pre-operative atrial fibrillation and early right ventricular failure after left ventricular assist device implantation: a systematic review and meta-analysis.

Kittipibul V, Blumer V, Hernandez GA, Fudim M, ... Chaparro S, Agarwal R
Background
Right ventricular failure (RVF) remains a major cause of morbidity and mortality after left ventricular assist device (LVAD). Atrial fibrillation (AF) is known for its deleterious effects on cardiac function and hemodynamics. The association of pre-operative AF with the risk of early post-LVAD RVF has not been well described.
Method
A comprehensive literature search was performed through April, 9 2021. Cohort studies comparing the risk of post-operative RVF and/or need for right ventricular assist device (RVAD) after LVAD in patients with or without AF were included. Pooled odds ratio (OR) with 95% confidence intervals (CI) and I2 statistic were calculated using the random-effects model.
Results
Six studies were included in the analysis. Post-operative RVF was reported in 5 studies (1,841 patients) and RVAD use was reported in 4 studies (1,355 patients). There is a non-significant trend toward a higher risk of post-operative RVF in the AF group (pooled OR=1.25, 95%CI=0.99-1.58). No significant association between AF and RVAD use is noted (pooled OR=1.17, 95%CI=0.82-1.66).
Conclusions
Pre-operative AF is not significantly associated with higher risks of post-operative RVF and RVAD use after LVAD implantation, although the trend toward higher post-operative RVF is observed in patients with pre-operative AF. Additional research using a larger study population is warranted to better understand the association of pre-operative AF and the development of post-LVAD RVF.

Copyright © 2021. Published by Elsevier Inc.

Am Heart J: 30 Aug 2021; 239:120-128
Kittipibul V, Blumer V, Hernandez GA, Fudim M, ... Chaparro S, Agarwal R
Am Heart J: 30 Aug 2021; 239:120-128 | PMID: 34038705
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Impact:
Abstract

Outpatient Prescription Practices in Patients with Atrial Fibrillation (From the NCDR PINNACLE Registry).

Hsu JC, Reynolds MR, Song Y, Doros G, ... Turakhia MP, Maddox TM
This study sought to evaluate inappropriate prescribing practices in an atrial fibrillation (AF) population, as outlined by the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults with Atrial Fibrillation or Atrial Flutter document. The 2016 AF quality measures document specified medications to avoid in certain AF populations, including aspirin and anticoagulant combination therapy in patients without cardiovascular disease, and non-dihydropyridine calcium channel blockers in patients with reduced ejection fraction. Using data from the NCDR PINNACLE registry, a national outpatient cardiology practice registry, we assessed rates of inappropriate prescription of two types of medications among AF outpatients from 5/1/2008-5/1/2016. Overall rates of inappropriate prescription and variation by practice were calculated. Patient and practice factors associated with inappropriate prescription were assessed in adjusted analyses. A total of 107,759 of 658,250 (16.4%) patients without cardiovascular disease were inappropriately prescribed an antiplatelet and anticoagulant together, and 5,731 of 150,079 (3.8%) patients with reduced ejection fraction were inappropriately prescribed a non-dihydropyridine calcium channel blocker. Overall, 14.8% of AF patients were prescribed medications that were not recommended. Both patient and practice factors were associated with inappropriate prescribing, and the adjusted practice-level median odds ratio for inappropriate prescription was 1.70 (95% CI: 1.61-1.82), indicating a 70% likelihood that 2 random practices would treat identical AF patients differently. In a large registry of AF patients treated in cardiology practices, overall rates of inappropriate prescription practices, as defined by the 2016 AF quality measures, were relatively low, but significant practice variation was present.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print
Hsu JC, Reynolds MR, Song Y, Doros G, ... Turakhia MP, Maddox TM
Am J Cardiol: 16 Jul 2021; epub ahead of print | PMID: 34284863
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Impact:
Abstract

Frequency of Visit-to-Visit Variability of Resting Heart Rate and the Risk of New-Onset Atrial Fibrillation in the General Population.

Zhang S, Zhao M, Sun Y, Hou Z, ... Wu S, Xue H
Resting heart rate (RHR) has been an established predictor for atrial fibrillation (AF). However, the association of visit-to-visit heart rate variability (VVHRV) with new-onset AF risk over long term remains unclear. Our study investigates the relation of VVHRV to new-onset AF in general population in the prospective study of the Kailuan cohort. A total of 46,126 individuals without arrhythmia were included. They underwent 3 health examinations from 2006 to 2010 and performed follow up. VVHRV was measured by coefficient of variation (CV), variability independent of the mean (VIM), and standard deviation (SD). Participants were separately divided into 5 categories by quintiles of visit-to-visit RHR-CV, RHR-VIM and RHR-SD. Multivariate Cox regression and restricted cubic spline models were performed to establish the association between VVHRV and new-onset AF. 241 new-onset AF occurred during a median follow-up of 7.54 years. The incidence of new-onset AF in the group of the lowest (Q1) and highest quintiles (Q5) of RHR-CV were higher than that in other groups. The HRs for the new-onset AF were 2.07 (95% CI, 1.34-3.21, p < 0.01), in the highest quintile group(Q5) compared with group Q2, and 1.89(95% CI, 1.20-2.97, p < 0.01) in the lowest quintile group(Q1) compared with group Q2. The risk for new-onset AF showed a similar trend using RHR-VIM (p < 0.01) and RHR-SD (p < 0.05) parameters. Further sensitivity analyses indicated the consistent results in subjects without prior cardiovascular disease and without taking beta blockers or CCB. To match the covariates, analyses were also performed by propensity score matching, and prominent trends were also found in RHR-SD and RHR-VIM. In conclusion, the study indicated that higher and lower VVHRV were associated with the increasing risk of new-onset AF, which supporting a U-shaped curve existence.

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print
Zhang S, Zhao M, Sun Y, Hou Z, ... Wu S, Xue H
Am J Cardiol: 16 Jul 2021; epub ahead of print | PMID: 34284867
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Impact:
Abstract

Incidence of Left Atrial Thrombus Development and Imaging Approach in Patients Scheduled for Repeat Catheter Ablation for Atrial Fibrillation.

Yanagisawa S, Inden Y, Riku S, Suga K, ... Shibata R, Murohara T
The risk for developing left atrial (LA) thrombi after initial catheter ablation for atrial fibrillation (AF) and requirements for imaging evaluation for thrombi screening at repeat ablation is unclear. This study aimed to assess the occurrence of thrombus development and frequency of any imaging study evaluating thrombus formation during repeat ablation for AF. Of 2,066 patients undergoing initial catheter ablation for AF with uninterrupted oral anticoagulation, 615 patients underwent repeat ablation after 258.0 (105.0-882.0) days. We investigated the factors associated with safety outcomes and requirements for thrombus screening. All patients underwent at least one imaging examination to screen for thrombi in the initial session; however, the examination rate decreased to 476 patients (77%) before the repeat session. The frequency of imaging evaluations was 5.0%, 11%, 21%, 84%, and 91% for transesophageal echocardiography and 18%, 33%, 49%, 98%, and 99% for any imaging modality at repeat ablation performed ≤60 days, ≤90 days, ≤180 days, >180 days, and >1 year after the initial session, respectively. Three patients (0.5%) developed LA thrombi at repeat ablation due to identifiable causes, and no patients experienced thromboembolic events when no imaging evaluation was performed. Multivariate analysis revealed that repeat ablation performed after >180 days, non-paroxysmal atrial arrhythmias, and lower left ventricular ejection fraction were predictors of thrombus development and severe spontaneous echocardiography contrast. In conclusion, the risk for thrombus development at repeat ablation for AF was low. There needs to be a risk stratification of the imaging screening for thrombi at repeat ablation.

Copyright © 2021 Elsevier Inc. All rights reserved.

Am J Cardiol: 16 Jul 2021; epub ahead of print
Yanagisawa S, Inden Y, Riku S, Suga K, ... Shibata R, Murohara T
Am J Cardiol: 16 Jul 2021; epub ahead of print | PMID: 34281670
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Impact:
Abstract

The CHADS-VASc Score for Risk Stratification of Stroke in Heart Failure With-vs-Without Atrial Fibrillation.

Marzouka GR, Rivner H, Mehta V, Lopez J, ... Ishwaran H, Goldberger JJ
A recent study suggested that the CHA2DS2-VASc score can risk stratify heart failure (HF) patients without atrial fibrillation (AF) for stroke. We performed a retrospective analysis using the national Veteran Affairs database to externally validate the findings. Crude incidence rates of end points were calculated. A Cox proportional model was used to study the association between the CHA2DS2-VASc score and outcomes. In HF patients with AF (n = 17,481) and without AF (n = 36,935), the 1 year incidence rate for ischemic stroke, thromboembolism, thromboembolism (without MI), and death were 2.7 and 2.0%; 10.3 and 7.9%; 4.1 and 3.1%; and 19.2 and 26.0%, respectively, with higher rates with increasing CHA2DS2-VASc scores both with and without AF. CHA2DS2-VASc score predicted strokes in HF patients without AF (1-year C-statistic 0.62, 95% CI 0.60-0.64; NPV 85.4%, 95% CI 83.4-87.4%) with similar predictive ability to those with AF (C-statistic 0.59, 95% CI 0.56-0.62; NPV 86.4%, 95% CI 82.6-90.2%). Among patients with HF, there was an increased risk of stroke, thromboembolism, and death with increasing CHA2DS2-VASc scores regardless of AF status. Our findings support the use of the CHA2DS2-VASc score as a prognostic tool in HF.

Published by Elsevier Inc.

Am J Cardiol: 13 Jul 2021; epub ahead of print
Marzouka GR, Rivner H, Mehta V, Lopez J, ... Ishwaran H, Goldberger JJ
Am J Cardiol: 13 Jul 2021; epub ahead of print | PMID: 34274114
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Impact:
Abstract

Association of Left Atrial Metrics with Atrial Fibrillation Rehospitalization and Adverse Cardiovascular Outcomes in Patients with Non-valvular Atrial Fibrillation following Index Hospitalization.

Bhat A, Gan GCH, Chen HHL, Khanna S, ... MacIntyre CR, Tan TC
Background
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice with significant clinical and economic burdens, largely driven by adverse cardiovascular outcomes and AF-related hospitalization. Left atrial (LA) parameters have been shown to have prognostic value in cardiovascular disease states. We sought to evaluate the prognostic value of measures of LA size and function, as measured through LA volume index (LAVI) and LA emptying fraction (LAEF) respectively, for AF rehospitalization and long-term adverse outcomes in patients with non-valvular AF following index hospitalization.
Methods
In this retrospective study, 594 consecutive patients (mean age 67.8±13.6 years, 53% men) admitted to a tertiary referral centre with non-valvular AF were assessed. Patients who underwent transthoracic echocardiography during their index admission and had complete follow-up data were included and followed for a mean period of 33.18 ± 21.27 months for the primary outcome of AF rehospitalization. The secondary outcome was a composite of all-cause death and major adverse cardiovascular events (MACE).
Results
The primary outcome occurred in 250 (42%) patients and the secondary outcome occurred in 219 (37%) patients. On multivariable regression analysis, LAEF had an independent association with AF rehospitalization (hazard ratio [HR] 0.967, CI0.953 - 0.982, p<0.01) and time dependent receiver operating characteristic curves demonstrated LAEF to have strong diagnostic accuracy in predicting early and intermediate AF rehospitalization. Both LAVI (HR 1.014, CI 1.003 - 1.026, p=0.01) and LAEF (HR 0.982, CI 0.970 - 0.993, p<0.01) were associated with all-cause death and MACE.
Conclusions
Adverse LA remodelling, as reflected through LA enlargement and reduced LA mechanical function, is associated with AF rehospitalization and long-term adverse cardiovascular outcomes in hospitalized patients with non-valvular AF.

Copyright © 2021. Published by Elsevier Inc.

J Am Soc Echocardiogr: 06 Jul 2021; epub ahead of print
Bhat A, Gan GCH, Chen HHL, Khanna S, ... MacIntyre CR, Tan TC
J Am Soc Echocardiogr: 06 Jul 2021; epub ahead of print | PMID: 34245827
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Impact:
Abstract

The effect of cardiac rhythm on artificial intelligence-enabled ECG evaluation of left ventricular ejection fraction prediction in cardiac intensive care unit patients.

Kashou AH, Noseworthy PA, Lopez-Jimenez F, Attia ZI, ... Friedman PA, Jentzer JC
The presence of left ventricular systolic dysfunction (LVSD) alters clinical management and prognosis in most acute and chronic cardiovascular conditions. While transthoracic echocardiography (TTE) remains the most common diagnostic tool to screen for LVSD, it is operator-dependent, time-consuming, effort-intensive, and relatively expensive. Recent work has demonstrated the ability of an artificial intelligence-augment ECG (AI-ECG) model to accurately predict LVSD in critical intensive care unit (CICU) patients. We demonstrate that the AI-ECG algorithm can maintain its performance in these patients with and without AF despite their clinical differences. An AI-ECG algorithm can serve as a non-invasive, inexpensive, and rapid screening tool for early detection of LVSD in resource-limited settings, and potentially expedite clinical decision making and guideline-directed therapies in the acute care setting.

Copyright © 2021 Elsevier B.V. All rights reserved.

Int J Cardiol: 06 Jul 2021; epub ahead of print
Kashou AH, Noseworthy PA, Lopez-Jimenez F, Attia ZI, ... Friedman PA, Jentzer JC
Int J Cardiol: 06 Jul 2021; epub ahead of print | PMID: 34242690
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Impact:
Abstract

Pulmonary vein and left atrial posterior wall isolation for the treatment of atrial fibrillation: Comparable outcomes for adults with congenital heart disease.

Moore JP, Gallotti R, Su J, Nguyen HL, ... Prosper A, Buch E
Introduction
Optimal treatment strategies for ACHD with AF are unknown. This study sought to assess outcomes of pulmonary vein isolation (PVI) ± left atrial (LA), posterior wall isolation (PWI) for adults with congenital heart disease (ACHD), and atrial fibrillation (AF).
Methods
A retrospective review of all cryoballoon (CB) PVI ± PWI procedures at a single center over a 3-year period were performed. Clinical characteristics and outcomes for patients with and without ACHD were compared. The primary outcome was the occurrence of atrial tachyarrhythmia at 12-months postablation after a 90-day blanking period.
Results
Three-hundred and sixteen patients (mean: 63 ± 12 years, [63% male]) underwent CB PVI ± PWI during the study, including 31 (10%) ACHD (simple 35%, moderate 39% complex 26%; nonparoxysmal AF in 52%). ACHD was younger (51 vs. 64 years; p < .001) with a lower CHADS2 DS2 -VASc score (1.2 vs. 2.1; p = .001) but had a greater LA diameter (4.9 vs. 4.0 cm; p < .001) and a number of prior cardioversions (0.9 vs. 0.4; p < .001) versus controls. 12-month freedom from recurrent AF was similar for ACHD and controls (76% vs. 80%; p = .6) and remained nonsignificant in multivariate analysis (hazard ratio: 1.8, 95% confidence interval: 0.7-5.1; p = .22). At 12-months postablation, 75% of ACHD versus 93% of control patients were off antiarrhythmic drug therapy (p = .07).
Conclusion
This study demonstrates younger age and lower conventional stroke risk, yet clinically advanced AF for ACHD relative to controls. CB PVI ± PWI was an effective strategy for the treatment of AF among all forms of ACHD with similar 12-month outcomes as compared to controls.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1868-1876
Moore JP, Gallotti R, Su J, Nguyen HL, ... Prosper A, Buch E
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1868-1876 | PMID: 33821546
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Impact:
Abstract

The isthmus characteristics of scar-related macroreentrant atrial tachycardia in patients with and without cardiac surgery.

Liu SH, Lin YJ, Lee PT, Vicera JJ, ... Cheng WH, Chen SA
Introduction
Identifying the critical isthmus (CI) in scar-related macroreentrant atrial tachycardia (AT) is challenging, especially for patients with cardiac surgery. We aimed to investigate the electrophysiological characteristics of scar-related macroreentrant ATs in patients with and without cardiac surgery.
Methods
A prospective study of 31 patients (mean age 59.4 ± 9.81 years old) with scar-related macroreentrant ATs were enrolled for investigation of substrate properties. Patients were categorized into the nonsurgery (n = 18) and surgery group (n = 13). The CIs were defined by concealed entrainment, conduction velocity less than 0.3 m/s, and the presence of local fractionated electrograms.
Results
Among the 31 patients, a total of 65 reentrant circuits and 76 CIs were identified on the coherent map. The scar in the surgical group is larger than the nonsurgical group (18.81 ± 9.22 vs. 10.23 ± 5.34%, p = .016). The CIs in surgical group have longer CI length (15.27 ± 4.89 vs. 11.20 ± 2.96 mm, p = .004), slower conduction velocity (0.46 ± 0.19 vs. 0.69 ± 0.14 m/s, p < .001), and longer total activation time (45.34 ± 9.04 vs. 38.24 ± 8.41%, p = .016) than those in the nonsurgical group. After ablation, 93.54% of patients remained in sinus rhythm during a follow-up of 182 ± 19 days.
Conclusion
The characteristics of the isthmus in macroreentrant AT are diverse, especially for surgical scar-related AT. The identification of CIs can facilitate the successful ablation of scar-related ATs.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1921-1930
Liu SH, Lin YJ, Lee PT, Vicera JJ, ... Cheng WH, Chen SA
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1921-1930 | PMID: 33834555
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Impact:
Abstract

Prevalence and predictors of pacing-induced cardiomyopathy in young adult patients (<60 years) with pacemakers.

Li DL, Yoneda ZT, Issa TZ, Shoemaker MB, Montgomery JA
Introduction
Clinical trials and observational studies of pacing-induced cardiomyopathy (PICM) have largely included elderly patients with mean age >70 years. The prevalence and predictors of PICM in younger patients (age < 60 years) after pacemaker implantation are not known.
Methods
Adults (18-59 years) who received single-chamber ventricular or dual-chamber pacemakers at Vanderbilt University Medical Center from 1986 to 2015 were included. Patients without documented ventricular pacing burden and patients with baseline left ventricular ejection fraction (LVEF) <35% were excluded. PICM was defined as LVEF decrease of ≥ 10% and LVEF < 50% during follow-up with right ventricular pacing ≥20%, and without alternative explanations for cardiomyopathy.
Results
A total of 325 patients were included in the study. During a median follow-up duration of 11.5 (Interquartile range 7-17) years, 38 patients (11.7%) developed PICM (1.3 per 100 patient-year). Older age (HR 2.5 for age ≥50 years, p = .013), reduced baseline LVEF (HR 2.4, p = .022), and preimplant AVB (HR 2.7, p = .007) were associated with an increased risk of PICM in the multivariate analysis. Furthermore, baseline AF conferred an increased risk of PICM only in patients without preimplant AVB but not patients with pre-implant AVB.
Conclusions
The incidence of PICM in young patients was low, but PICM could occur more than a decade after pacemaker implantation. Older age, baseline reduced LVEF, and preimplant AVB were associated with an increased risk of PICM in the young patient cohort.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1961-1968
Li DL, Yoneda ZT, Issa TZ, Shoemaker MB, Montgomery JA
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1961-1968 | PMID: 33825250
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Impact:
Abstract

Predictors of clinical success after paroxysmal atrial fibrillation catheter ablation.

Osorio J, Hunter TD, Rajendra A, Zei P, Silverstein J, Morales G
Introduction
Contact force (CF) guided ablation of paroxysmal atrial fibrillation (PAF) with stable catheter-tissue contact optimizes clinical success and may increase an operator\'s ability to achieve pulmonary vein isolation (PVI) in a single encirclement. First pass PVI reduces procedure time but the relationship with long term clinical success is not well understood. This study evaluated patient characteristics and procedural details as predictors of 1-year clinical success after PAF ablation, including first pass isolation.
Methods
Consecutive de novo PAF ablations were performed with a porous tip CF catheter in 2017 and 2018. All ablations used wide-area circumferential ablation, with first pass isolation captured separately for the left and right pulmonary veins (PVs). CF was held between 10 and 20 g and the catheter was moved every 10-20 s. Radiofrequency energy was set at 40-45 W throughout the atrium. Patient characteristics and procedural details were tested for association with clinical success, defined as freedom from recurrent atrial tachyarrhythmia through 1 year.
Results
A total of 404 patients were included in the study. Clinical success at 1 year was 86.6%. Achieving first pass isolation on at least one ipsilateral PV pair was the most significant predictor of clinical success (p = .0126). After controlling for first pass isolation, only recurrence within the 90-day blanking period was independently predictive (p = .0015). First pass isolation was not associated with early recurrence (p = .2454).
Conclusion
In a real-world setting, first pass isolation was highly predictive of 12-month clinical success after CF-guided ablation in a PAF population.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1814-1821
Osorio J, Hunter TD, Rajendra A, Zei P, Silverstein J, Morales G
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1814-1821 | PMID: 33825242
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Impact:
Abstract

Focal impulse and rotor modulation guided ablation versus pulmonary vein isolation for atrial fibrillation: A meta-analysis of head-to-head comparative studies.

Romero J, Gabr M, Alviz I, Briceno D, ... Natale A, Di Biase L
Introduction
Empirical pulmonary vein isolation (PVI) remains the cornerstone for catheter ablation of atrial fibrillation (AF). Various ablation strategies and modalities are continually tested with the aim of improving ablation outcomes. Although focal impulse and rotor modulation (FIRM)-guided ablation is currently used as an adjunct to PVI, evidence supporting this strategy is conflicting. We sought to examine whether the utilization of FIRM-guided ablation with or without PVI is associated with a decrease in all-atrial arrhythmia recurrence as compared to PVI alone.
Methods
A systematic review of PubMed, Cochrane, and Embase was performed for head-to-head study designs comparing outcomes of patients who underwent FIRM-guided ablation with or without PVI to those who underwent PVI alone. The primary efficacy endpoint was all-atrial arrhythmia recurrence. The secondary endpoints were complications rates and procedural characteristics.
Results
Overall, six studies comprising 674 patients undergoing either FIRM-guided ablation ± PVI versus PVI were included (mean age 63.4 ± 9.2, male 74%, 9% paroxysmal AF, 91% nonparoxysmal AF). After a mean follow-up of 18.8 months, FIRM-guided ablation with or without PVI was not associated with improvement in all-atrial arrhythmia recurrence rate compared to PVI alone (43.4% vs. 45.9%, risk ratio [RR]: 1.06; 95% confidence interval [CI]: 0.77-1.47; p = .70). No statistically significant difference was noted in complication rates between the two groups (RR: 1.66; 95% CI: 0.08-34.54; p = .74).
Conclusion
In this meta-analysis of head-to-head comparison studies, FIRM-guided ablation with or without PVI did not provide any benefit in improving all-atrial arrhythmia recurrence at follow-up when compared to PVI alone.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1822-1832
Romero J, Gabr M, Alviz I, Briceno D, ... Natale A, Di Biase L
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1822-1832 | PMID: 33844385
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Impact:
Abstract

Uninterrupted versus interrupted direct oral anticoagulation for catheter ablation of atrial fibrillation: A systematic review and meta-analysis.

Asad ZUA, Akhtar KH, Jafry AH, Khan MH, ... Lakkireddy DR, Gopinathannair R
Introduction
To evaluate the safety of uninterrupted versus interrupted direct oral anticoagulation (DOAC) for patients undergoing catheter ablation (CA) of atrial fibrillation (AF).
Methods
We conducted a systematic search of MEDLINE and EMBASE for randomized controlled trials (RCT) and observational studies comparing uninterrupted versus interrupted DOAC for patients undergoing CA of AF. Primary outcome was major bleeding. Secondary outcomes included minor bleeding, stroke or transient ischemic attack (TIA) or thromboembolism (TE), silent cerebral ischemic events, and cardiac tamponade. Meta-analysis was stratified by study design. Risk ratios (RR) with 95% confidence intervals were calculated using random effects model and Mantel-Haenszel method was used to pool RR.
Results
A total of 13 studies (7 randomized, 6 observational) comprising 3595 patients were included. The RCT restricted analysis did not show any difference in terms of major bleeding (risk ratio [RR] = 0.79; [0.35-1.79]), minor bleeding (RR = 0.99 [0.68-1.43]), stroke or TIA or TE (RR = 0.80 [0.19-3.32]), silent cerebral ischemic events (RR = 0.64 [0.32-1.28]), and cardiac tamponade (RR = 0.61 [0.20-1.92]). Observational study restricted analysis showed a protective effect of uninterrupted DOAC on silent cerebral ischemic events (RR = 0.45 [0.31-0.67]) and no difference in other outcomes.
Conclusions
There is no difference in bleeding and thromboembolic outcomes with uninterrupted versus interrupted DOAC for CA of AF and observational data suggests that uninterrupted DOACs are protective against silent cerebral ischemic lesions.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1995-2004
Asad ZUA, Akhtar KH, Jafry AH, Khan MH, ... Lakkireddy DR, Gopinathannair R
J Cardiovasc Electrophysiol: 29 Jun 2021; 32:1995-2004 | PMID: 33861494
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Impact:
Abstract

Cardiovascular magnetic resonance-based predictors of complete left ventricular systolic functional recovery after rhythm restoration in patients with atrial tachyarrhythmia.

Stegmann C, Jahnke C, Lindemann F, Oebel S, ... Hindricks G, Paetsch I
Aims
To establish a cardiovascular magnetic resonance (CMR)-based prediction model for complete systolic left ventricular ejection fraction (LVEF) recovery for the distinction of \'arrhythmia-induced\' from \'arrhythmia-mediated\' cardiomyopathy in patients with atrial tachyarrhythmias.
Methods and results
Two hundred and fifty-three tachyarrhythmia patients referred for catheter ablation were enrolled and underwent CMR baseline imaging; patients with a reduced LVEF <50% at baseline and CMR imaging at 3-month follow-up after successful rhythm restoration constituted the final study population (n = 134). CMR at baseline consisted of standard functional cine imaging, determination of extracellular volume, and late gadolinium enhancement (LGE) imaging; follow-up CMR comprised standard functional cine imaging. Left ventricular end-diastolic volume index (LVEDVI) measurements were categorized in \'opposite\', \'normal\', and \'enlarged\'. At follow-up, 80% (107/134) presented with complete LVEF recovery, while in 20% (27/134) persistent LVEF impairment was observed. LVEDVI and LGE were independent predictors of complete LVEF recovery with LGE adding significant incremental value on logistic regression modelling. Model-derived probabilities for complete LVEF recovery in LVEDVI categories of opposite, normal, and enlarged for LGE negativity and positivity were 94%, 85%, and 29% and 77%, 55%, and 8%, respectively.
Conclusion
CMR-derived assessment of LVEDVI category and LGE allowed for identification of arrhythmia-induced cardiomyopathy with acceptable discriminative performance. Probabilities for complete LVEF recovery for the combination of opposite LVEDVI/LGE negativity and enlarged LVEDVI/LGE positivity were 94% and 8%, respectively. The CMR-based prediction model of complete LVEF recovery can be used to perform upfront stratification in atrial tachyarrhythmia-related LVEF impairment.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 18 Jul 2021; epub ahead of print
Stegmann C, Jahnke C, Lindemann F, Oebel S, ... Hindricks G, Paetsch I
Europace: 18 Jul 2021; epub ahead of print | PMID: 34279613
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Impact:
Abstract

The incidence and location of epicardial connections in the era of contact force guided ablation for pulmonary vein isolation.

Sun X, Niu G, Lin J, Suo N, ... Yao Y, Zhang S
Background
The effects of epicardial connections (ECs) involving pulmonary veins (PVs) in atrial fibrillation (AF) ablation have been revealed recently. However, no systematic approaches to identify and ablate the ECs were established.
Methods
Patients with AF undergoing radiofrequency (RF) catheter ablation were retrospectively analyzed. ECs were identified when (1) PV isolation (PVI) cannot be achieved after first-pass isolation; (2) PVI was still absent although the conduction gap was detected and ablated; (3) the earliest activation area (EAA) was revealed located within the PV antrum distant from the initial ablation line using high-density mapping (HDM) technique; (4) focal ablation at the EAA was effective to achieve PVI. Relevant pacing maneuvers were performed to elucidate ECs\' bidirectional conduction.
Results
Overall, 36 ECs were identified and ablated in 35/597 (5.86%) patients. Among the 35 patients with ECs, at least one PV insertion of ECs was located at the carina region. The most common pattern was a single breakthrough in 31 (88.6%) patients, followed by multiple breakthroughs in 3 and wide breakthroughs in 1. The median distance from EAA to the initial ablation line was 10.0 mm. The average number of RF energy delivery was 1.75 ± 1.00, and single RF delivery was adequate in 16/36 (44.4%) patients. Continuous potentials were present at the EAA in 9/34 (26.5%) patients.
Conclusion
ECs were confirmed and ablated successfully in 5.86% (35/597) AF patients using HDM. PV insertions of ECs were mainly located at the carina region. Continuous potentials might assist in the prediction of ECs.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print
Sun X, Niu G, Lin J, Suo N, ... Yao Y, Zhang S
J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270147
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Impact:
Abstract

Diagnosis, Significance, and Management of Ventricular Thrombi in Patients Referred for VT Ablation.

Beavers DL, Ghannam M, Liang J, Cochet H, ... Morady F, Bogun F
Introduction
In patients with structural heart disease presenting with VT, detection of ventricular thrombi and subsequent management can be challenging. This study aimed to assess the value of multimodality imaging with cardiac magnetic resonance imaging (CMR), contrast enhanced transthoracic echocardiography (TTE) and computed tomography (CT) for thrombus detection as well as a management algorithm geared towards anticoagulation and deferred ablation for patients referred for ventricular tachycardia (VT) ablation.
Methods and results
A total of 154 consecutive patients referred for VT ablation underwent preprocedural multimodality imaging with CMR, CT and TTE. In 9 patients (6%) a new ventricular thrombus was detected and anticoagulation was initiated. Thrombi were detected by CMR in 9 patients, by CT in 7 patients and by TTE in 2 patient. Five patients eventually underwent endocardial VT ablation procedures 6.0±2.0 months after initiation of anticoagulation with one patient also requiring epicardial approach. Two patients died while on anticoagulation, unrelated to ventricular arrhythmia. Four of five patients were rendered non-inducible and no testing was performed in 1/5 patients. Areas containing left ventricular thrombi were non-excitable with pacing. Six of thirty-two inducible VTs were mapped in close vicinity of ventricular thrombi. No clinical embolic events occurred during the ablation procedures.
Conclusions
Ventricular thrombus was detected in 6% of consecutive patients with structural heart disease undergoing VT ablation. CMR was the most sensitive modality, while contrast enhanced TTE failed to detect the majority of thrombus. Anticoagulation followed by ablation can be safely and successfully performed in patients with ventricular thrombi. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print
Beavers DL, Ghannam M, Liang J, Cochet H, ... Morady F, Bogun F
J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270148
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Impact:
Abstract

A Novel Adaptive Insertable Cardiac Monitor Algorithm Improves the Detection of Atrial Fibrillation and Atrial Tachycardia in Silico.

Saha S, Perschbacher D, Jones P, Frost K, ... Mittal S, Richards M
Introduction
Insertable cardiac monitors (ICMs) provide a minimally invasive method of continuous monitoring for abnormal heart rhythms. While the benefits of ICMs are clear, current algorithm performance can be improved. The objective of this study is to assess performance of a novel adaptive atrial fibrillation (AF) detection algorithm and separately programmable atrial tachycardia (AT) algorithm.
Methods
A dual-stage detect-and-verify AF algorithm and separately programmable AT algorithm were developed. Sensitivity and PPV across a range of settings were determined in silico by comparison to an adjudicated Holter data set (n=1966 with 229 patient days). Finally, the ability to improve performance through simulated remote programming was assessed.
Results
The dual-stage algorithm detected AF in all true AF patients (76/76) resulting in a patient-level sensitivity of 100%. Episode-level sensitivity and PPV ranged from 97.6%-100% and 79.1%-98.5%, respectively. Thirty-six false positive episodes were observed and 32 (88.9%) of these were corrected with programming changes. Decoupling of AF and AT durations improved PPV from a range of 10%-22% to a range of 95%-100%.
Conclusions
AF and AT algorithms were designed with novel features including an adaptive morphology assessment for AF detection and separately programmable durations for AT detection. In silico performance yielded improved PPVs while maintaining high sensitivity across a range of settings. Importantly, programming changes that may be made remotely with this system reduced false positives. These algorithms allow clinicians to individualize arrhythmia detection settings thereby improving data management and reducing clinic burden. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print
Saha S, Perschbacher D, Jones P, Frost K, ... Mittal S, Richards M
J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270150
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Impact:
Abstract

Leadless pacemakers in critically ill patients requiring prolonged cardiac pacing: A multicenter international study.

Clementy N, Coelho R, Veltmann C, Marijon E, ... Steinwender C, Babuty D
Background
Temporary transvenous pacing in critically ill patients requiring prolonged cardiac pacing is associated with a high risk of complications. We sought to evaluate the safety and efficacy of self-contained intracardiac leadless pacemaker (LPM) implantation in this population.
Methods and results
Consecutive patients implanted with a Micra LPM during the hospitalization in an intensive care unit were retrospectively included. Inclusion criteria were: more than or equal to 1 supracaval central venous line, or a ventilation tube, or intravenous antibiotic therapy for ongoing sepsis or bacteremia. Patients with a history of the previous implantation of a pacemaker were excluded. Out of 1016 patients implanted with an LPM, 99 met the inclusion criteria. Mean age was 75 years and Charlson comorbidity index 7. LPM implantation was successfully performed in 98% of cases, with a perioperative complication rate of 5%, mainly cardiac injuries. In-hospital mortality rate was 6%. No late (>30 days) device-related complication occurred, especially no infection.
Conclusions
LPM appears as an acceptable alternative to conventional temporary transvenous pacing in selected critically ill patients requiring prolonged cardiac pacing, especially regarding the risk of infection.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print
Clementy N, Coelho R, Veltmann C, Marijon E, ... Steinwender C, Babuty D
J Cardiovasc Electrophysiol: 15 Jul 2021; epub ahead of print | PMID: 34270153
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Impact:
Abstract

The role of posterior wall isolation in catheter ablation of persistent atrial fibrillation.

Clarke JD, Piccini JP, Friedman DJ
The left atrial posterior wall has many embryologic, anatomic, and electrophysiologic characteristics, that are important for the initiation and maintenance of persistent atrial fibrillation. The left atrial posterior wall is a potential target for ablation in patients with persistent atrial fibrillation, a population in whom pulmonary vein isolation alone has resulted in unsatisfactory recurrence rates. Published clinical studies report conflicting results on the safety and efficacy of posterior wall isolation. Emerging technologies including optimized use of radiofrequency ablation, pulse field ablation, and combined endocardial/epicardial ablation may optimize approaches to posterior wall isolation and reduce the risk of injury to nearby structures such as the esophagus. Critical evaluation of future and ongoing clinical studies of posterior wall isolation requires careful scrutiny of many characteristics, including intraprocedural definition of posterior wall isolation, concomitant extrapulmonary vein ablation, and study endpoints.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print
Clarke JD, Piccini JP, Friedman DJ
J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print | PMID: 34258794
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Impact:
Abstract

Surgical ablation supplemented by ethanol injection for ventricular tachycardia refractory to percutaneous ablation.

Yang G, Shao Y, Gu W, Ni B, ... Wu Y, Chen M
Background
A combination of endocardial and epicardial approaches has improved the overall success rate of ventricular tachycardia (VT) ablation in patients with cardiomyopathy. However, the origins of some VTs are truly intramural or close to coronary arteries, which makes this combined strategy either prone to failure or too risky.
Objectives
This observational study aimed to explore the feasibility and efficacy of direct epicardial ablation combined with intramural ethanol injection via surgical approach for inaccessible intramural VTs or VTs too close to coronary arteries.
Methods
In four canines ventricular lesions produced by direct epicardial injection of ethanol were assessed. Six consecutive patients with recurrent VT refractory to catheter endocardial and epicardial RF ablation and that remained inducible after surgical epicardial mapping and RF ablation were included. Ethanol was injected by needle at the epicardial RF ablation sites. The primary outcome was freedom of sustained VT determined by device interrogation and periodical 24-h holter recordings subsequently.
Results
In an animal study, the lesions were homogenous and increased in size with the volume of ethanol injected. In all six patients, ethanol injection at the target sites in the anterior or lateral left ventricle abolished inducible VT. Over a median follow-up of 22 months (range, 6-65), all patients remained free of sustained VT. One patient died of pulmonary infection one year after the procedure.
Conclusions
A hybrid strategy of surgical ablation combined with intramural ethanol injection is feasible and effective in patients with multiple failed percutaneous ablation attempts.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print
Yang G, Shao Y, Gu W, Ni B, ... Wu Y, Chen M
J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print | PMID: 34258807
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Impact:
Abstract

Use of a cerebral protection device to facilitate pulmonary vein isolation in a patient with left atrial mass arising from the interatrial septum.

Gopinathannair R, Elbey MA, Eshcol J, Seligson FL, Atkins D, Lakkireddy D
Sentinel cerebral embolic protection devices (CPDs) may limit periprocedural cerebrovascular events by preventing micro and macro-embolization to the brain, and has been used in many cardiology and radiology procedures. We hereby report the use of a Sentinel CPD to facilitate safe and effective atrial fibrillation ablation in a patient with a left atrial mass arising from the interatrial septum.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print
Gopinathannair R, Elbey MA, Eshcol J, Seligson FL, Atkins D, Lakkireddy D
J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print | PMID: 34258815
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Impact:
Abstract

Implantable cardioverter defibrillator shocks from ventricular tachyarrhythmias in patients with ischemic heart disease: Preventative measures, shortcomings, cost-effectiveness, and global practice perspectives.

Kantharia BK
Implantable cardioverter defibrillators (ICDs) have proven to be life-saving devices in patients with ischemic cardiomyopathy (ICM) who are prone to develop ventricular tachycardia (VT) and fibrillation (VF). Antiarrhythmic drugs (AADs) are commonly prescribed in many such patients with ICDs to treat and prevent different forms of arrhythmias in clinical practice. When these patients experience recurrent monomorphic VT despite chronic AADs therapy, or when AAD therapy is contraindicated or not tolerated, and VT storm is refractory to AAD therapy, catheter ablation constitute guideline-based class I indication of treatment. However, what should be the most appropriate strategy to prevent first ICD shock or subsequent multiple shocks from VT/VF in patients with ICM who undergo ICD implantation without prior incidence of cardiac arrest, remains debatable. The purpose of this review is to discuss preventative aspects of ICD shocks for VT and the shortcomings of these measures along with the cost-effectiveness and global perspectives based on the current knowledge of the topic.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print
Kantharia BK
J Cardiovasc Electrophysiol: 12 Jul 2021; epub ahead of print | PMID: 34258823
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Impact:
Abstract

Clinical presentation, diagnosis, and treatment of atrioesophageal fistula resulting from atrial fibrillation ablation.

Della Rocca DG, Magnocavallo M, Natale VN, Gianni C, ... Di Biase L, Natale A
Background
Atrioesophageal fistula (AEF) is a worrisome complication of atrial fibrillation (AF) ablation. Its clinical manifestations and time course are unpredictable and may contribute to diagnostic and treatment delays. We conducted a systematic review of all available cases of AEF, aiming at characterizing clinical presentation, time course, diagnostic pitfalls, and outcomes.
Methods
The digital search retrieved 150 studies containing 257 cases, 238 (92.6%) of which with a confirmed diagnosis of AEF and 19 (7.4%) of pericardioesophageal fistula.
Results
The median time from ablation to symptom onset was 21 days (interquartile range [IQR]: 11-28). Neurological abnormalities were documented in 75% of patients. Compared to patients seen by a specialist, those evaluated at a walk-in clinic or community hospital had a significantly greater delay between symptom onset and hospital admission (median: 2.5 day [IQR: 1-8] vs. 1 day [IQR: 1-5); p = .03). Overall, 198 patients underwent a chest scan (computed tomography [CT]: 192 patients and magnetic resonance imaging [MRI]: 6 patients), 48 (24.2%; 46 CT and 2 MRI) of whom had normal/unremarkable findings. Time from hospital admission to diagnostic confirmation was significantly longer in patients with a first normal/unremarkable chest scan (p < .001). Overall mortality rate was 59.3% and 26.0% survivors had residual neurological deficits at the time of discharge.
Conclusions
Since healthcare professionals of any specialty might be involved in treating AEF patients, awareness of the clinical manifestations, diagnostic pitfalls, and time course, as well as an early contact with the treating electrophysiologist for a coordinated interdisciplinary medical effort, are pivotal to prevent diagnostic delays and reduce mortality.

© 2021 Wiley Periodicals LLC.

J Cardiovasc Electrophysiol: 13 Jul 2021; epub ahead of print
Della Rocca DG, Magnocavallo M, Natale VN, Gianni C, ... Di Biase L, Natale A
J Cardiovasc Electrophysiol: 13 Jul 2021; epub ahead of print | PMID: 34260115
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Impact:
Abstract

Selective vs Exclusive: a matter of clearness in His bundle pacing.

Coluccia G, Accogli M, Palmisano P
His bundle (HB) pacing represents a progressively growing field in electrophysiology, given the great promise of offering the most physiological pacing modality in patients requiring permanent ventricular stimulation. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

J Cardiovasc Electrophysiol: 13 Jul 2021; epub ahead of print
Coluccia G, Accogli M, Palmisano P
J Cardiovasc Electrophysiol: 13 Jul 2021; epub ahead of print | PMID: 34260120
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Impact:
Abstract

Brugada syndrome and syncope: a practical approach for diagnosis and treatment.

Mascia G, Bona RD, Ameri P, Canepa M, ... Crotti L, Brignole M
Syncope in patients with Brugada electrocardiogram pattern may represent a conundrum in the decision algorithm because incidental benign forms, especially neurally mediated syncope, are very frequent in this syndrome similarly to the general population. Arrhythmic syncope in Brugada syndrome typically results from a self-terminating sustained ventricular tachycardia or paroxysmal ventricular fibrillation, potentially leading to sudden cardiac death. Distinguishing syncope due to malignant arrhythmias from a benign form is often difficult unless an electrocardiogram is recorded during the episode. We performed a review of the existing literature and propose a practical approach for diagnosis and treatment of the patients with Brugada syndrome and syncope.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:996-1002
Mascia G, Bona RD, Ameri P, Canepa M, ... Crotti L, Brignole M
Europace: 17 Jul 2021; 23:996-1002 | PMID: 33367713
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Impact:
Abstract

Arrhythmogenic potential of myocardial disarray in hypertrophic cardiomyopathy: genetic basis, functional consequences and relation to sudden cardiac death.

Finocchiaro G, Sheikh N, Leone O, Westaby J, ... Sheppard MN, Olivotto I
Myocardial disarray is defined as disorganized cardiomyocyte spatial distribution, with loss of physiological fibre alignment and orientation. Since the first pathological descriptions of hypertrophic cardiomyopathy (HCM), disarray appeared as a typical feature of this condition and sparked vivid debate regarding its specificity to the disease and clinical significance as a diagnostic marker and a risk factor for sudden death. Although much of the controversy surrounding its diagnostic value in HCM persists, it is increasingly recognized that myocardial disarray may be found in physiological contexts and in cardiac conditions different from HCM, raising the possibility that central focus should be placed on its quantity and distribution, rather than a mere presence. While further studies are needed to establish what amount of disarray should be considered as a hallmark of the disease, novel experimental approaches and emerging imaging techniques for the first time allow ex vivo and in vivo characterization of the myocardium to a molecular level. Such advances hold the promise of filling major gaps in our understanding of the functional consequences of myocardial disarray in HCM and specifically on arrhythmogenic propensity and as a risk factor for sudden death. Ultimately, these studies will clarify whether disarray represents a major determinant of the HCM clinical profile, and a potential therapeutic target, as opposed to an intriguing but largely innocent bystander.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:985-995
Finocchiaro G, Sheikh N, Leone O, Westaby J, ... Sheppard MN, Olivotto I
Europace: 17 Jul 2021; 23:985-995 | PMID: 33447843
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Impact:
Abstract

Attenuated heart rate recovery is associated with higher arrhythmia recurrence and mortality following atrial fibrillation ablation.

Donnellan E, Wazni OM, Chung MK, Elshazly MB, ... Saliba W, Jaber W
Aims
Heart rate recovery (HRR), the decrease in heart rate occurring immediately after exercise, is caused by the increase in vagal activity and sympathetic withdrawal occurring after exercise and is a powerful predictor of cardiovascular events and mortality. The extent to which it impacts outcomes of atrial fibrillation (AF) ablation has not previously been studied. The aim of this study is to investigate the association between attenuated HRR and outcomes following AF ablation.
Methods and results
We studied 475 patients who underwent EST within 12 months of AF ablation. Patients were categorized into normal (>12 b.p.m.) and attenuated (≤12 b.p.m.) HRR groups. Our main outcomes of interest included arrhythmia recurrence and all-cause mortality. During a mean follow-up of 33 months, 43% of our study population experienced arrhythmia recurrence, 74% of those with an attenuated HRR, and 30% of those with a normal HRR (P < 0.0001). Death occurred in 9% of patients in the attenuated HRR group compared to 4% in the normal HRR cohort (P = 0.001). On multivariable models adjusting for cardiorespiratory fitness (CRF), medication use, left atrial size, ejection fraction, and renal function, attenuated HRR was predictive of increased arrhythmia recurrence (hazard ratio 2.54, 95% confidence interval 1.86-3.47, P < 0.0001).
Conclusion
Heart rate recovery provides additional valuable prognostic information beyond CRF. An impaired HRR is associated with significantly higher rates of arrhythmia recurrence and death following AF ablation.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:1063-1071
Donnellan E, Wazni OM, Chung MK, Elshazly MB, ... Saliba W, Jaber W
Europace: 17 Jul 2021; 23:1063-1071 | PMID: 33463688
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Impact:
Abstract

Local catheter impedance drop during pulmonary vein isolation predicts acute conduction block in patients with paroxysmal atrial fibrillation: initial results of the LOCALIZE clinical trial.

Das M, Luik A, Shepherd E, Sulkin M, ... Ramos P, García-Bolao I
Aims
Radiofrequency ablation creates irreversible cardiac damage through resistive heating and this temperature change results in a generator impedance drop. Evaluation of a novel local impedance (LI) technology measured exclusively at the tip of the ablation catheter found that larger LI drops were indicative of more effective lesion formation. We aimed to evaluate whether LI drop is associated with conduction block in patients with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI).
Methods and results
Sixty patients underwent LI-blinded de novo PVI using a point-by-point ablation workflow. Pulmonary vein rings were divided into 16 anatomical segments. After a 20-min waiting period, gaps were identified on electroanatomic maps. Median LI drop within segments with inter-lesion distance ≤6 mm was calculated offline. The diagnostic accuracy of LI drop for predicting segment block was assessed using receiver operating characteristic analysis. For segments with inter-lesion distance ≤6 mm, acutely blocked segments had a significantly larger LI drop [19.8 (14.1-27.1) Ω] compared with segments with gaps [10.6 (7.8-14.7) Ω, P < 0.001). In view of left atrial wall thickness differences, the association between LI drop and block was further evaluated for anterior/roof and posterior/inferior segments. The optimal LI cut-off value for anterior/roof segments was 16.1 Ω (positive predictive value for block: 96.3%) and for posterior/inferior segments was 12.3 Ω (positive predictive value for block: 98.1%) where inter-lesion distances were ≤6 mm.
Conclusion
The magnitude of LI drop was predictive of acute PVI segment conduction block in patients with paroxysmal AF. The thinner posterior wall required smaller LI drops for block compared with the thicker anterior wall.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Europace: 17 Jul 2021; 23:1042-1051
Das M, Luik A, Shepherd E, Sulkin M, ... Ramos P, García-Bolao I
Europace: 17 Jul 2021; 23:1042-1051 | PMID: 33550380
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Impact:
Abstract

Age-related tilt test responses in patients with suspected reflex syncope.

Rivasi G, Torabi P, Secco G, Ungar A, ... Brignole M, Fedorowski A
Aims
Tilt testing (TT) is recognized to be a valuable contribution to the diagnosis and the pathophysiology of vasovagal syncope (VVS). This study aimed to assess the influence of age on TT responses by examination of a large patient cohort.
Methods and results
Retrospective data from three experienced European Syncope Units were merged to include 5236 patients investigated for suspected VVS by the Italian TT protocol. Tilt testing-positivity rates and haemodynamics were analysed across age-decade subgroups. Of 5236 investigated patients, 3129 (60%) had a positive TT. Cardioinhibitory responses accounted for 16.5% of positive tests and were more common in younger patients, decreasing from the age of 50-59 years. Vasodepressor (VD) responses accounted for 24.4% of positive tests and prevailed in older patients, starting from the age of 50-59. Mixed responses (59.1% of cases) declined slightly with increasing age. Overall, TT positivity showed a similar age-related trend (P = 0.0001) and was significantly related to baseline systolic blood pressure (P < 0.001). Tilt testing was positive during passive phase in 18% and during nitroglycerine (TNG)-potentiated phase in 82% of cases. Positivity rate of passive phase declined with age (P = 0.001), whereas positivity rate during TNG remained quite stable. The prevalence of cardioinhibitory and VD responses was similar during passive and TNG-potentiated TT, when age-adjusted.
Conclusions
Age significantly impacts the haemodynamic pattern of TT responses, starting from the age of 50. Conversely, TT phase-passive or TNG-potentiated-does not significantly influence the type of response, when age-adjusted. Vagal hyperactivity dominates in younger patients, older patients show tendency to vasodepression.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:1100-1105
Rivasi G, Torabi P, Secco G, Ungar A, ... Brignole M, Fedorowski A
Europace: 17 Jul 2021; 23:1100-1105 | PMID: 33564843
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Impact:
Abstract

Use of high-density activation and voltage mapping in combination with entrainment to delineate gap-related atrial tachycardias post atrial fibrillation ablation.

Vlachos K, Efremidis M, Derval N, Martin CA, ... Haïssaguerre M, Jaïs P
Aims
An incomplete understanding of the mechanism of atrial tachycardia (AT) is a major determinant of ablation failure. We systematically evaluated the mechanisms of AT using ultra-high-resolution mapping in a large cohort of patients.
Methods and results
We included 107 consecutive patients (mean age: 65.7 ± 9.2 years, males: 81 patients) with documented endocardial gap-related AT after left atrial ablation for persistent atrial fibrillation (AF). We analysed the mechanism of 134 AT (94 macro-re-entries and 40 localized re-entries) using high-resolution activation mapping in combination with high-density voltage and entrainment mapping. Voltage in the conducting channels may be extremely low, even <0.1 mV (0.14 ± 0.095 mV, 51 of 134 AT, 41%), and almost always <0.5 mV (0.03-0.5 mV, 133 of 134 AT, 99.3%). The use of multipolar Orion, HDGrid, and Pentaray catheters improved our accuracy in delineating ultra-low-voltage areas critical for maintenance of the circuit of endocardial gap-related AT. Conventional ablation catheters often do not detect any signal (noise level) even using adequate contact force, and only multipolar catheters of small electrodes and shorter interelectrode space can detect clear fractionated low-amplitude and high frequency signals, critical for re-entry maintenance. We performed a diagnosis in 112 out of 134 AT (83.6%) using only activation mapping and in 134 out of 134 AT (100%) using the combination of activation and entrainment mapping.
Conclusion 
High-resolution activation mapping in combination with high-density voltage and entrainment mapping is the ideal strategy to delineate the critical part of the circuit in endocardial gap-related re-entrant AT after AF ablation.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:1052-1062
Vlachos K, Efremidis M, Derval N, Martin CA, ... Haïssaguerre M, Jaïs P
Europace: 17 Jul 2021; 23:1052-1062 | PMID: 33564832
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Abstract

Relationship between procedural volume and complication rates for catheter ablation of atrial fibrillation: a systematic review and meta-analysis.

Tonchev IR, Nam MCY, Gorelik A, Kumar S, ... Kistler PM, Kalman JM
Aims
There are conflicting data as to the impact of procedural volume on outcomes with specific reference to the incidence of major complications after catheter ablation for atrial fibrillation. Questions regarding minimum volume requirements and whether these should be per centre or per operator remain unclear. Studies have reported divergent results. We performed a systematic review and meta-analysis of studies reporting the relationship between either operator or hospital atrial fibrillation (AF) ablation volumes and incidence of complications.
Methods and results
Databases were searched for studies describing the relationship between operator or hospital AF ablation volumes and incidence of complications which were published prior to 12 June 2020. Of 1593 articles identified, 14 (315 120 patients) were included in the meta-analysis. Almost two-thirds of the procedures were performed in low-volume centres. Both hospital volume of ≥50 and ≥100 procedures/year were associated with a significantly lower incidence of complications compared to <50/year (4.2% vs. 5.5%, OR = 0.58, 95% CI 0.50-0.66, P < 0.001) or <100/year (5.5% vs. 6.2%, OR = 0.62, 95% CI 0.53-0.73, P < 0.001), respectively. Hospitals performing ≥50 procedures/year demonstrated significantly lower mortality compared with those performing <50 procedures/year (0.16% vs. 0.55%, OR = 0.33, 95% CI 0.26-0.43, P < 0.001). A similar relationship existed between proceduralist volume of <50/year and incidence of complications [3.75% vs. 12.73%, P < 0.001; OR = 0.27 (0.23-0.32)].
Conclusion
There is an inverse relationship between both hospital and proceduralist AF ablation volume and the incidence of complications. Implementation of minimum hospital and operator AF ablation volume standards should be considered in the context of a broader strategy to identify AF ablation Centers of Excellence.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: [email protected]

Europace: 17 Jul 2021; 23:1024-1032
Tonchev IR, Nam MCY, Gorelik A, Kumar S, ... Kistler PM, Kalman JM
Europace: 17 Jul 2021; 23:1024-1032 | PMID: 33595063
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