bluuebunny/crossref_metadata_2025_split huggingface dataset:
Very high-power short-duration temperature-controlled ablation for pulmonary vein isolation: The Fast-and-Furious study
Authors: Heeger CH , Sano MS , Meyer-Saraei RMS , Eitel CE , Phan HL , Hatahet SH , Traub AT , Delgado Lopez LDL , Vogler JV , Kuck KH , Tilz RRT 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Catheter ablation for atrial fibrillation (AF) treatment provides effective and durable PVI associated with encouraging clinical outcome. The novel QDot ablation catheter with Qmode + ablation mode (90W/4sec, Figure 1) offers the ability to possibly improve safety and decrease ablation procedure times.

Aims
We aim to evaluate safety and efficacy of the very high-power short-duration (vHP-SD) temperature-controlled radiofrequency (RF) ablation Qmode + mode for pulmonary vein isolation (PVI) utilizing the novel QDot micro ablation catheter. The data was compared to conventional power-controlled ablation index (AI) guided PVI.

Methods
Twenty-five consecutive patients with paroxysmal or persistent AF were prospectively enrolled, underwent vHP-SD based PVI (vHP-SD group) and were compared to 25 consecutive patients treated with conventional CF-sensing catheters (control).

Results
All PVs were successfully isolated utilizing Qmode +. The total median RF ablation time was vHP-SD: 334 (282, 369) sec. vs control: 1567 (1250, 1756) sec. (p &lt; 0.0001), the median procedure time was vHP-SD: 56 (48-62) vs. control: 104 (92-122) min (p &lt; 0.0001). No differences in periprocedural complications were observed.

Conclusions
The novel Qmode + provides safe and effective PVI with impressive short RF time and short procedures times. Procedure time and RF time were substantial lower in the vHP-SD group. Abstract Figure 1
Predictive value of ten risk scores for outcomes of atrial fibrillation patients undergoing radiofrequency pulmonary vein isolation
Authors: Mulder MJ , Kemme MJB , Hopman LHGA , Kusgozoglu E , Gulcicek H , Van De Ven PM , Hauer HA , Tahapary GJM , Van Rossum AC , Allaart CP 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.
Background/Introduction:
A significant number of patients experience recurrent atrial fibrillation (AF) after ablation. Predicting who will or will not benefit from AF ablation is challenging. Although various risk scores have been designed to predict outcomes after AF ablation, comparative data are sparse and external risk score validation is often lacking.

Purpose
In this study, we aimed to compare ten previously described risk scores with regard to their predictive value for post-ablation AF recurrence and procedural complications.

Methods
A total of 482 AF patients (37% non-paroxysmal AF, 66% male, mean age 62 ± 9 years) undergoing initial radiofrequency pulmonary vein isolation (RF-PVI) were included in the present analysis. Prior to ablation, all patients underwent both transthoracic echocardiography and either cardiac computed tomography imaging or cardiac magnetic resonance imaging. The following risk scores were calculated for each patient: APPLE, ATLAS, BASE-AF2, CAAP-AF, CHADS2, CHA2DS2-VASc, DR-FLASH, HATCH, LAGO and MB-LATER. The predictive performance of the risk scores for AF recurrence and complications were assessed separately by receiver operating characteristic (ROC) curves.

Results
Median follow-up was 16 (12-31) months. AF recurrence after the 90-day blanking period was observed in 199 patients (41%), occurring after a median of 183 (124-360) days after ablation. Overall procedural adverse event rate was 6%. The HATCH score was the only score without predictive value for recurrent AF after ablation (area under curve [AUC] 0.545). All other investigated scores demonstrated statistically significant but poor predictive value for recurrent AF after ablation (AUC 0.553-0.669). CHA2DS2-VASc and CAAP-AF were the only risk scores with predictive value for procedural complications (AUC 0.616, p = 0.043; AUC 0.615, p = 0.044; respectively). ROC curve analyses of the studied risk scores for the prediction of AF recurrence and complications are shown in Figure.

Conclusion
Currently available risk scores perform poorly in predicting outcomes after RF-PVI. These data suggest that the utility of these scores for clinical decision-making is limited. Abstract Figure. ROC curve analyses of risk scores
Efficacy and safety of a high power short duration ablation-index guided protocol for pulmonary vein isolation using a single catheter
Authors: Badertscher P , Knecht S , Madaffari A , Spies F , Osswald S , Schaer B , Sticherling C , Kuehne M 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Catheter ablation for atrial fibrillation (AF) is the most common performed electrophysiological procedure. The cost of this procedure remains high.

Purpose
To improve health care utilization, we aimed to compare the efficacy and safety of a minimalistic, streamlined single radiofrequency catheter ablation approach using high power short duration ablation-index guided protocol (HPSD) vs. a standard single catheter protocol.

Methods
A circular mapping catheter free PVI with a single transseptal puncture was performed in 91 patients. A CARTO fast anatomical map was performed with the ablation catheter. Pacing maneuvers were used to confirm exit block. Procedural characteristics and success rates were compared using HPSD- vs. a standard ablation-protocol. Freedom from recurrence was defined as a 1-year absence of AF episodes &gt; 30 s, beyond the 3-month-blanking-period.

Results
Using the HPSD-protocol the median procedure, map and RF ablation time were significantly shorter in the HPSD group compared to the standard group, 84 (IQR 76-100) vs. 118 minutes (IQR 104-141), 12 (IQR 10-16) vs. 18 minutes (IQR 15-21) and 1036 (898-1184) vs. 1949 seconds (IQR 1693-2261), respectively, P &lt; .001 for all. First-pass-PVI was achieved using the HPSD-protocol in 23 patients (74%) and the standard-protocol in 30 patients (53%), p = 0.08. Localization of conduction gaps are illustrated for the HPSD-protocol and the standard-protocol in Figure 1. The residual gap was identified using the ablation catheter only in all patients. No procedural complication were observed. At 12 months follow-up, 60 (89.6%) patients remained free from AF with no differences between groups.

Conclusions
A minimalistic, CMC-free HPSD-guided PVI approach is very efficient, safe, likely cost-saving, and associated with excellent clinical outcomes at 1 year. Abstract Figure 1
Effects of pulse field and radiofrequency pulmonary vein isolation on parasympathetic cardiac innervation
Authors: Peichl P , Wichterle D , Stojadinovic P , Cihak R , Nakagawa H , Kautzner J 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Public hospital(s). Main funding source(s): IKEM

Background
Pulmonary vein isolation (PVI) is an established treatment modality for patients with atrial fibrillation (AF). PVI performed by radiofrequency (RF) energy results in parasympathetic denervation of the heart by collateral ganglionic plexi ablation. Pulse field (PF) is a novel nonthermal energy source for PVI that selectively ablates atrial myocardium while preserving cardiac autonomic nerves, which may affect the outcome after PVI.

Purpose
The study compared the effect of PVI between RF and PF ablation on cardiac autonomic function and a short-term AF recurrence rate. The resting heart rate (HR) was evaluated as a simple index of sinus nodal parasympathetic innervation.

Methods
We investigated 45 patients (aged 64 ± 7 years, 4 women) who underwent PVI by novel three-dimensional electroanatomical mapping/ablation system (lattice electrode ablation system). PVI was performed by either high-energy RF (n = 21) or PF (n = 24) energy using the identical ablation catheter. Resting HR assessed by standard ECG was recorded the day before the procedure and at the 3-month visit. Arrhythmia recurrences were analysed by 24-Holter at the 3-month visit.

Results
All PVs were acutely isolated in all patients. The HR data are shown in the Table. The baseline HR did not differ between both groups. A significant increase in HR was observed only in the RF ablation subgroup. The between-group difference remained significant even after adjustment for age, gender, and baseline HR. There was no difference in arrhythmia recurrences at the 3-month visit between study groups.

Conclusions
Parasympathetic denervation effects on HR after the PF ablation are virtually absent. Comparable AF recurrence rate at 3-month visit after RF and PF ablation suggests that preservation of autonomic innervation has no impact on AF recurrence during short-term follow-up. Table RF PVI (n = 21) PF PVI (n = 24) P Baseline HR (bpm) 60.0 ± 7.1 63.8 ± 9.4 n.s. HR change - 3-month visit (bpm) 14.4 ± 6.9 0.3 ± 8.6 P &lt;0.001 Arrhythmia recurrences 3/21 (14%) 2/24 (8%) n.s.
Defining the blanking period duration after cryoballoon pulmonary vein isolation in patients taking an antiarrhythmic drug
Authors: Musat D , Milstein NS , Saberito M , Bhatt A , Habibi M , Preminger MW , Sichrovsky T , Shaw R , Mittal S 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Cryoballoon pulmonary vein isolation (CB) is an accepted method for ablation in patients with atrial fibrillation (AF). A three-month blanking period (BP) is commonly used in clinical trials and practice. However, the actual BP duration in patients (pts) on an antiarrhythmic drug (AAD) at time of ablation remains undefined.

Objective
To objectively define the BP duration in pts undergoing CB while taking an AAD.

Methods
We enrolled consecutive pts with AF who had CB PVI while on an AAD. All pts had an implantable loop recorder (ILR). We prospectively followed all pts and determined the time to last AF episode during the 90-day post-PVI BP. This was then correlated with likelihood of having an AF recurrence between 3-12 months post-PVI.

Results
The cohort included 92 pts (66 ± 10 years; 62 [67%] male; 33 [36%] PAF; CHA2DS2-VASc 2.6 ± 1.7). AADs used included dofetilide (42), dronedarone (14), amiodarone (25), sotalol and propafenone (3 each), and flecainide (5). The AAD was stopped at a median of 80 [36, 105] days post-PVI. We defined 4 distinct groups: (1) no AF in 90-day BP (n = 45 [49%]); (2) last AF within 30 days of PVI (n = 17 [18%]); (3) last AF within 60 days of PVI (n = 13 [15%]); and (4) last AF within 90 days of PVI (n = 17 [18%]). Following the 90-day BP, 47 (51%) pts had a recurrence of AF. Once recurrent AF was observed &gt; 30 days post-ablation, patients had high likelihood of having a long term AF recurrence (p = 0.037, Figure).

Conclusion
Our data suggest that the optimal BP duration in AF patients undergoing CB PVI while taking an AAD is 30 days. An AF recurrence after 30 days is associated with a very high likelihood of recurrent AF during longer-term follow-up. Abstract Figure.
Does cardiac arrhythmia surgery improve a patient"s quality of life? a systematic review and meta-analysis
Authors: Van Der Heijden CAJ , Bidar E , Vos R , Maessen J , Athanasiou T , Maesen B 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Although one-year success of arrhythmia surgery for atrial fibrillation (AF) has long been defined as freedom from supraventricular tachyarrhythmia, patient-reported quality of life (QOL) has become increasingly important.

Purpose
We aimed to analyze current evidence of QOL following both concomitant and stand-alone arrhythmia surgery for AF.

Methods
Studies reporting on QOL of patients undergoing arrhythmia surgery for AF, stand-alone or concomitant, who provided essential data for the analysis, were included in this systematic review. A meta-analysis was performed on inter-study heterogeneity of changes in QOL in 9 of 12 included studies who used the Short-Form (SF) 36 tool. The metric standardized mean difference (SMD) was used to compare one year outcomes with baseline scores per variable of the SF-36 QOL questionnaire (total patients n = 545). Finally, meta-regression based on rhythm outcome after one year and add-on arrhythmia surgery as covariate were performed.

Results
QOL scores improved one year after surgical ablation for AF, evaluated by several questionnaires. In standalone arrhythmia procedures, meta-regression showed a significant improvement between the QOL and the procedural effectiveness after one year (Physical Functioning p = 0.015, Role Physical p = 0.006, General Health p = 0.002, Social Functioning p = 0.043. Forest plot Physical Functioning: SMD = 1.105; heterogeneity: I²=90.6%, p &lt; 0.001). While this association was also suggested in concomitant procedures, only the variable Physical Role demonstrated a significant improvement when comparing QOL of cardiac surgery with and without add-on surgical AF ablation (p = 0.037).

Conclusion
Arrhythmia surgery for AF improves QOL. Both in standalone and concomitant procedures, the improvement in QOL seems to be related to the procedural effectiveness to maintain sinus rhythm after 12 months. Abstract Figure. SF-36 variable Physical Functioning
Non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in (morbidly) obese or low body weight patients with atrial fibrillation: a meta-analysis
Authors: Grymonprez M , De Backer TL , Steurbaut S , Boussery K , Lahousse L 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Fund for Scientific Research Flanders (FWO)

Background
Oral anticoagulants are crucial for preventing systemic thromboembolism in atrial fibrillation (AF), with guidelines preferring non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) in the general AF population. However, as NOACs are administered in fixed doses, concerns of unintentional underdosing in morbidly obese patients and unintentional overdosing in underweight patients have emerged. Moreover, VKAs are still recommended in morbidly obese patients (body mass index (BMI) ≥40 kg/m², body weight &gt;120 kg) due to lack of data for NOACs in these patients.

Purpose
A critical appraisal of the benefit-risk profile of NOACs in AF patients across the body weight spectrum.

Methods
After searching the Medline database, phase III randomized controlled trials (RCTs) and longitudinal observational cohort studies on the effectiveness and safety of NOACs versus VKAs in obese (BMI ≥30 kg/m²), and class III obese (BMI ≥40 kg/m²) non-valvular AF patients, and in low body weight (≤60 kg) AF patients during a mean/median follow-up of ≥6 months were included. The meta-analyses were performed using a random effects model with the Mantel-Haenszel method.

Results
A meta-analysis based on 4 phase III RCTS and 3 longitudinal observational cohort studies demonstrated that NOAC use in obese and class III obese AF patients was associated with significantly lower stroke/systemic embolism (stroke/SE) risks (RR 0.82, 95%CI [0.71-0.96]; and RR 0.75, 95%CI [0.64-0.87], respectively), similar to lower major bleeding risks (RR 0.83, 95%CI [0.69-1.00]; and RR 0.74, 95%CI [0.57-0.95], respectively), and similar mortality risks (RR 0.92, 95%CI [0.73-1.15]; and RR 1.17, 95%CI [0.83-1.64], respectively) as compared to VKAs. In AF patients ≤60 kg, significantly lower stroke/SE (RR 0.63, 95%CI [0.56-0.71]) and major bleeding risks (RR 0.71, 95%CI [0.62-0.80]), and similar mortality risks (RR 0.68, 95%CI [0.42-1.10]) were observed for NOAC- versus VKA-treated patients in a meta-analysis based on 4 phase III RCTs and 2 longitudinal observational cohort studies.

Conclusions
The benefit-risk profile of NOACs seems preserved in (morbidly) obese AF patients and patients with low body weight of ≤60 kg. However, more data are needed in underweight AF patients (BMI &lt;18.5 kg/m²) and on differences between NOACs to further optimize management in these patient subgroups.
Kidney, limb and ophthalmic complications and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis
Authors: Costa O , Brescia CW , Vardar B , Abdelgawwad K , Sood N , Coleman CI 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Bayer AG, Berlin, Germany

INTRODUCTION
Patients with nonvalvular atrial fibrillation (NVAF) and type 2 diabetes (T2D) have a higher risk of kidney, limb, and ophthalmic complications than those without T2D.

PURPOSE
We sought to evaluate these complications and death in patients with NVAF and T2D prescribed rivaroxaban or warfarin.

METHODS
We analyzed Optum® de-Identified electronic health record (EHR) data from 11/2010-12/2019. We included adults with NVAF and T2D newly initiated on rivaroxaban or warfarin with ≥12 months of prior EHR activity. Patients with another indication for anticoagulation, valve disease, history of end-stage renal disease, major adverse limb events (MALE), diabetic retinopathy or pregnancy were excluded. We evaluated the incidence rate of developing a composite outcome of &gt;40% decrease in estimated glomerular filtration incidence rate (eGFR) from baseline, eGFR &lt; 15 mL/minute/1.73 m2, need for dialysis or kidney transplant, MALE, diabetic retinopathy or death. Overlap weighting was used to balance baseline characteristics between cohorts while preserving sample size. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted Cox regression.

RESULTS
We included 24912 rivaroxaban and 58270 warfarin users. Rivaroxaban was associated with a significant reduction in the composite endpoint versus warfarin (-19.7 events per 1000 person years) driven mostly by an &gt;40% decrease in eGFR from baseline, need for dialysis or renal transplant, MALE and death (Figure 1).

CONCLUSIONS
Rivaroxaban was associated with reduced incidence rates of kidney and limb complications, and death in NVAF patients with T2D.

FUNDING
Funding for this study was provided by Bayer AG, Berlin, Germany Abstract Figure 1. Outcomes
Role of long-term continuous cardiac monitoring in oral anticoagulation management of patients with known atrial fibrillation
Authors: Natale A , Kasner SE , Diener HC , Verma A , Amin A , Beinart SC , Del Greco M , Kusano K , Pouliot E , Franco NC , Mittal S 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Medtronic

OnBehalf
Reveal LINQ Registry Investigators

Background
Monitoring atrial fibrillation (AF) with an insertable cardiac monitor (ICM) provides objective data for clinicians to make decisions on oral anticoagulation (OAC) management, based on individual risk profiles. Whether ICM data is being used for that purpose has not been widely explored.

Purpose
To show the impact of AF burden measured by an ICM on OAC treatment initiation and discontinuation in patients with known AF.

Methods
Patients from the prospective, ongoing, multi-center Reveal LINQ Registry monitored for AF management, or pre- or post-ablation monitoring were eligible. Follow-up was scheduled every 6 months for up to 3 years. Patients were excluded if they had no AF data available within the last 6 months of follow-up (FU), or less than 6 months of FU and no change to their OAC treatment compared to baseline. AF burden was defined as the percentage of time in AF 6 months prior to last FU, excluding the first 3 months post-ablation for patients who had an ablation.

Results
The analysis included 225 patients (65 ± 10 years, 72% male, mean CHA2DS2-VASc score 2.1 ± 1.4) monitored with an ICM for 21.8 ± 7.9 months. At baseline, 164 (73%) were taking OAC therapy, 147 (65%) had a history of paroxysmal AF and 79 (35%) had persistent AF. Forty percent of patients had a history of atrial ablation prior to ICM insertion and 37% had ≥1 AF ablation procedure after ICM. Patients were grouped according to OAC status at baseline, CHA2DS2-VASc score and AF burden (Figure: bars show percentage of patients with a change in OAC status during monitoring). Patients at high risk of stroke and AF burden &gt;0.5% were more likely to initiate OAC therapy, whereas patients with higher AF burden were less likely to discontinue OAC, regardless of their risk score. Among those with no AF burden detected during the last 6 months of follow-up and on OAC at baseline, approximately half discontinued OAC, whereas 1/3 of patients with high risk score had initiated OAC, despite having no AF detected.

Conclusion
Our results derived from real-world practice show that AF detected and quantified by an ICM influences OAC therapy management in patients with known AF. Many patients with a low CHA2DS2-VASc score and no AF or low AF burden have had OAC therapy discontinuation, whereas a high proportion of patients with high AF burden have initiated OAC, regardless of their risk score. Abstract Figure. OAC according to risk and AF burden
Safety and effectiveness of edoxaban in a real-world clinical setting: Two-year follow-up of the ETNA-AF-Europe study
Authors: De Caterina R , De Groot JR , Weiss TW , Kelly P , Monteiro P , Deharo JC , De Asmundis C , Lopez-De-Sa E , Waltenberger J , Steffel J , Levy P , Bakhai A , Kirchhof P 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Europe

OnBehalf
ETNA-AF-Europe investigators

Background
Oral anticoagulation (OAC) for stroke prevention is essential in the management of patients with atrial fibrillation (AF). The assessment of OAC use in routine clinical care and the effects of this therapy on outcomes and safety are important. Purpose: We analysed two-year outcome data with adjudicated follow-up results in 13,417 patients with AF treated with edoxaban. Methods: ETNA-AF-Europe (Clinicaltrials.gov: NCT02944019) enrolled 13,417 consecutive patients with AF treated with edoxaban in 825 centres in 10 European countries and 2-year prospectively collected, real world data is presented. Results: Edoxaban was prescribed according to licence recommendations in 83.1% (n = 11,146) of patients (Table). Whilst three quarters of patients were prescribed edoxaban 60 mg (n = 10,248, 76.4%), the quarter prescribed edoxaban 30 mg were older (79.5 versus 71.8 years), had a higher stroke risk (CHA2DS2-VASc score: 3.9 versus 3.0) and a higher bleeding risk (HAS-BLED score: 2.9 versus 2.4). Thromboembolic and bleeding events were more common in patients receiving edoxaban 30 mg OD without differences in intracranial haemorrhage (ICH) (Figure). Patients prescribed a non-recommended dose of edoxaban had a numerically higher stroke risk (CHA2DS2-VASc score: 3.6 versus 3.1) with subsequent higher rates of ischemic stroke and mortality, however they also had higher bleeding rates, with the exception of ICH (table) despite a similar initial bleeding risk (HAS-BLED score: 2.7 versus 2.5). Conclusions: In this large, European data set reporting two-year outcomes on edoxaban therapy, no additional safety signals were observed and event rates were in line with those observed in ETNA-AF after 1 year and in ENGAGE AF-TIMI 48, re-affirming the safety and effectiveness of edoxaban licence recommendations in a real world setting of patients with AF. All key events of interest, other than intracranial haemorrhage, were numerically lower in patients prescribed the licenced recommended dose. Outcomes with rec. vs non-rec. dosesn (%/year [95%CI])Recommended dose (n = 11,146; 83.1%)Non-recommended dose (n = 2271; 16.9%)Any stroke/SEE138 (0.68 [0.57;0.80])31 (0.76 [0.51;1.07])Ischaemic stroke99 (0.48 [0.39;0.59])26 (0.63 [0.41; 0.93])Major bleeding189 (0.93 [0.80;1.07])49 (1.20 [0.89;1.59])Intracranial haemorrhage43 (0.21 [0.15;0.28])7 (0.17 [0.07;0.35])All-cause mortality729 (3.55 [3.30;3.82])208 (5.04 [4.38;5.78])CV mortality405 (1.97 [1.79;2.18])113 (2.74 [2.26;3.30])CI, confidence interval; CV, cardiovascular; rec., recommended; SEE, systemic embolic event.Abstract Figure. Annualised event rates at 2-year FU