bluuebunny/crossref_metadata_2025_split huggingface dataset:
Zero x-ray pulmonary vein isolation with heliostar radiofrequency balloon: efficacy and safety
Authors: Martinez Gomez E , Salgado Aranda R , Calvo Cuervo D , Gonzalez Ferrer J J , Canadas Godoy V , Filgueiras Rama D , Chavez Ortiz I , La Rosa G , Sanchez Vallejo C , Perez-Villacastin Dominguez J , Perez Castellano N 
Published: November 2023

Abstract

Introduction
Single shot pulmonary vein isolation techniques are currently an attractive and effective alternative to point-by-point ablation. The Heliostar® radiofrequency balloon is capable of producing single shot isolation with reduced procedure times and high efficacy and safety. A particular feature of this new balloon is its ability to be visualized on the Carto 3® navigation system, which makes it possible to reduce or even eliminate the use of X-rays (XR) in this type of procedure.

Objectives
Our objective was to demonstrate the efficacy and safety of pulmonary vein isolation with Heliostar® radiofrequency balloon without the use of XR.

Methods
Twenty-five patients with paroxysmal (68%) or persistent (32%) atrial fibrillation were prospectively included in our centre and underwent pulmonary vein isolation with radiofrequency balloon. Ten cases were performed without XR (40%), and the remaining 15 (60%) using fluoroscopy. All cases were performed under general anaesthesia and using the Carto 3® navigation system. Electroanatomical mapping was performed pre and post ablation in all cases. Mapping was performed in sinus rhythm. In cases without XR, intracardiac echocardiography was used to guide the transseptal puncture and the rest of the procedure. Technical and clinical data were collected. Cases with and without XR were compared.

Results
There were no complications in either group. All veins were successfully isolated, with 56% first pass isolation in the non-XR group versus 68% in the XR group (non-significant difference). The vein with the highest percentage of first pass isolations was the left inferior vein in both groups. Procedure times were similar (median left atrial dwell time of 34 minutes in the non-XR group and 36 minutes in the XR group, non-significant difference). There was also no difference in the median time to isolation from the start of radiofrequency application in each vein (10 seconds in both groups). Left atrial size was normal in most patients, and ventricular function was preserved, with no differences between the two groups. The non-XR group had a higher number of patients with left main trunk, but the XR group had a higher percentage of patients with persistent forms of atrial fibrillation.

Conclusion
Zero-XR pulmonary vein isolation with Heliostar® balloon is possible and safe, with similar efficacy and first pass isolation rate, similar procedure time and no relevant complications in our series.
Predicting success of atrial fibrillation ablation: comparing machine learning approaches of intracardiac electrograms
Authors: Feng R , Ganesan P , Deb B , Ruiperez-Campillo S , Chang H J , Clopton P , Rogers A J , Rodrigo M , Tjong F V Y , Zaharia M , Narayan S M 
Published: November 2023

Abstract

Introduction
Machine learning (ML) and Deep learning (DL) neural networks have been used to predict which patients will respond to atrial fibrillation (AF) ablation. However, the predictive results of DL are modest compared to traditional statistical models of clinical features with or without intracardiac electrograms.

Purpose
To test the hypothesis that optimized ML architectures will better identify patients who respond to AF ablation using intracardiac EGM than other DL architectures in our large registry of 320 consecutive patients.

Methods
Our patients had age 65.1±10.4Y, were 25% women, 61.6% non-paroxysmal, with intracardiac EGM recorded from multipolar catheters and 64-pole baskets (Fig A). Patients were propensity matched into those in whom ablation terminated by ablation (N=160, "Term") and those without termination (N=160, "Non-Term"). Using a proven DL architecture, ResNet, we systematically varied the depth (i.e., number of residual layers (D)) and width (i.e., number of nodes per layer (W)). We predicted termination (Fig C), presenting EGMs to training cohorts and testing in separate cohorts in a 6-fold cross-validation which we repeated 10 times for each fold with different randomization.

Results
Fig B illustrates that the prediction accuracy is generally negatively correlated with the network depth but positively correlated with the width. Specifically, the deep architecture (D=4, W=256, with 265M trainable parameters, blue-circled in Fig B) predicted with AUC = 0.61±0.08. However, a shallow-narrow architecture (D=1, W=16, green-circled in Fig B) achieved same AUC (0.61±0.09, p=0.65), while reducing the number of parameters by 97% compared to the DL architecture (79K vs. 265M). Additionally, a shallow-wide architecture (D=1, W=2048, red-circled in Fig B) achieved higher AUC (0.74±0.08; p&lt;0.0001), while saving 44% of the parameters (148M vs 265M) and 26% training time compared to the deep architecture.

Conclusion
Shallow neural network classification of raw EGMs predicted ablation response with better accuracy than other architectures. Future work should determine if deep architectures ultimately ‘overfit’ detailed EGM data, which may explain their lower success.Figure
Revisiting pulmonary vein stenosis after high-power short-duration radiofrequency ablation in patients with atrial fibrillation
Authors: Kim J , Kim D , Park J , Yu H , Kim T , Uhm J , Joung B , Lee M , Park H 
Published: November 2023

Abstract

Background
High-power short-duration atrial fibrillation catheter ablation (HPSD-AFCA) of pulmonary vein (PV) isolation reduces the procedure time without a difference in the efficacy as compared to conventional power AFCA (ConvP-AFCA). PV stenosis (PVS) after AFCA is a rare complication.

Purpose
We compared the frequency of symptomatic PVS as a long-term complication between the ConvP-AFCA and HPSD-AFCA groups.

Methods
We included 3,851 patients undergoing AFCA between 2009 and 2022 prospectively. We evaluated the characteristics of patients diagnosed with clinically symptomatic PVS, ascertained using computed tomography during the follow-up period. The risk of PVS was compared between the ConvP-AFCA and HPSD-AFCA groups using propensity overlap weighting.

Results
Symptomatic PVS was diagnosed in 14 (0.4%) patients at a mean of 342.9 days after the procedure. After overlap weighting, PVS was significantly more frequent in the HPSD-AFCA group (incidence: HPSD-AFCA, 0.8% vs. ConvP-AFCA, 0.2%; weighted hazard ratio [HR] 6.27, 95% confidence interval [CI] 2.15-18.28; P&lt;0.001). In the multivariable Cox regression analyses, repeat AFCA procedures (HR 3.52, 95% CI 1.18-10.55; P=0.024) and paroxysmal AF (HR 8.29, 95% CI 1.08-63.82; P=0.042) were also independently associated with PVS after AFCA. Among the PVs of patients with PVS, stenotic PVs had shorter antral diameters and a smaller cross-sectional area than non-stenotic PVs on preprocedural computed tomographic evaluations.

Conclusion
HPSD-AFCA, compared to ConvP-AFCA, was associated with a 6-fold increased risk of symptomatic PVS. Caution is required, especially in patients with plans for a repeated AFCA, paroxysmal AF, or small PV antrum.
High efficacy and safety of pulsed electrical field ablation via contact force-controlled radiofrequency catheters for atrial fibrillation ablation with linear lesions in the left atrium
Authors: Schreieck J , Scheckenbach C , Kranert M , Gawaz M , Heinzmann D 
Published: November 2023

Abstract

Background
Pulsed Field Ablation have been shown to be efficient and safe for Pulmonary vein isolation (PVI) in catheter ablation of atrial fibrillation (AF). The bipolar application of pulsed electrical energy for electroporation of myocardium has been established with specially designed catheters, which are not used for linear ablation.

Purpose
We evaluated a novel monophasic PEF ablation technique applied by commercially available CF-controlled catheters for linear ablation lines beyond PVI for treatment of complex AF patients.

Methods
Patients (n=31, age 64±12 years, 29% females, BMI 29±4) referred for re-ablation of AF and presented with recurrence of persistent AF (n=13) or atypical atrial flutter (n=14) after a PVI procedure, or patients with longstanding persistent AF and severe enlarged atrium (n=4) were included in our patient cohort for additional AF substrate ablation with PEF applications. After high density voltage mapping of the left atrium with multipolar microelectrode catheters, and PVI, or re-PVI was completed (8 patients), additional left atrial linear lesions were performed according to the atrial flutter mechanism or as fibrosis-guided substrate ablation. All but one patient showed low voltage areas (bipolar electrograms &lt;0.5mV) in 35±31% of the left atrial surface. Using contact force sensing catheters, maximal PEF energy pulses were applied with a minimum of 5g contact force and an interlesion distance ≤6mm. Performed linear lesions were left atrial roof line, lateral mitral isthmus line, anterior mitral line, left posterior wall isolation, and cavotricuspid isthmus (CTI) line. Before PEF application close-by a coronary artery (lateral mitral line, CTI) nitroglycerie 0.2mg i.v. was injected.

Results
Complete lines with exclusively PEF applications and proofed bidirectional conduction block were 100% for roof lines (n=20), posterior wall isolation (n=8), anterior mitral lines (n=10). Exclusively endocardial PEF applications blocked the lateral mitral line in 14 out of 16 cases (88%). Only in two cases additional epicardial RF applications via coronary sinus and endocardial additional RF applications were necessary to complete the mitral isthmus block. In 7 out of 8 cases CTI were blocked by linear PEF applications (88%), however, in one case additional RF applications became necessary. No ECG ST segment elevation was recorded. No serious complications occurred throughout all procedures.
Follow up will be available at presentation time.

Conclusion
Catheter ablation of complex AF patients with linear lesions is performd very efficient and safe with PEF applications by CF-sensing RF ablation catheters. Especially the high efficacy of exclusively endocardial PEF applications for creation of a lateral mitral isthmus block is very promising. However, the long term permanence of the linear lines have to be awaited.
Development and validation of the DOAC Score: a novel bleeding risk prediction tool for patients with atrial fibrillation
Authors: Aggarwal R , Ruff C , Virdone S , Perreault S , Kakkar A , Palazzolo M , Dorais M , Kayani G , Singer D , Secemsky E , Piccini J , Tahir U , Shen C , Yeh R 
Published: November 2023

Abstract

Background
Clinicians and patients must balance the ischemic benefits and bleeding risks when deciding to anticoagulate patients with atrial fibrillation (AF). Current clinical decision tools for assessing bleeding risk have limited performance and were developed for individuals anticoagulated with warfarin.

Purpose
This study develops and validates a clinical risk score to personalize estimates of bleeding risk for individuals with AF taking direct-acting oral anticoagulants (DOACs).

Methods
Among individuals taking dabigatran 150mg twice per day from 44 countries and 951 centers in this secondary analysis of the RE-LY trial, a risk score was developed to determine the probability for bleeding, based on covariates derived in a Cox proportional hazards model. The risk prediction model was internally validated with bootstrapping. We then refined the model in the GARFIELD-AF registry, with individuals taking dabigatran, edoxaban, rivaroxaban, and apixaban. To determine generalizability in external cohorts and among individuals on different DOACS, the risk prediction model was validated in the COMBINE-AF pooled clinical trial cohort and the RAMQ administrative database. The primary outcome was major bleeding. The risk score, termed the DOAC Score, was compared to the HAS-BLED score.

Results
Of the 5684 patients in RE-LY, 386 experienced a major bleeding event, within a median follow-up of 1.74-years. The prediction model was well-calibrated (goodness-of-fit P = 0.57) and had an optimism-corrected C statistic of 0.73 after internal validation with bootstrapping. The DOAC Score assigned points for age, creatinine clearance/glomerular filtration rate, underweight status, stroke/transient ischemic attack/embolism history, diabetes, hypertension, antiplatelet use, non-steroidal anti-inflammatory use, liver disease, and bleeding history, with each additional point scored associated with a 48.7% (95% CI: 38.9%-59.3%, P&lt;0.001) increase in major bleeding in RE-LY. The score had superior performance to the HAS-BLED score in RE-LY (C Statistic: 0.73 vs 0.60, P for difference &lt;0.001) and among 12,296 individuals in GARFIELD-AF (C statistic: 0.71 vs 0.66, P for Difference = 0.025). The DOAC Score had stronger predictive performance than the HAS-BLED score in both validation cohorts, including 25,586 individuals in COMBINE-AF (C statistic: 0.67 vs 0.63, P for Difference &lt;0.001) and 11,945 individuals in RAMQ (C statistic: 0.65 vs 0.58, P for Difference &lt;0.001).

Conclusion
In individuals with AF on DOAC therapy, the DOAC Score can help stratify patients based on expected bleeding risk.
Anticoagulation-associated bleeding in patients randomised to screening for atrial fibrillation or usual care
Authors: Kongebro E , Diederichsen S , Xing L , Haugan K , Graff C , Hoejberg S , Olesen M , Brandes A , Koeber L , Svendsen J 
Published: November 2023

Abstract

Background
Atrial fibrillation (AF) prevalence is rising, strongly aided by population ageing and increased awareness. Detection and treatment of subclinical AF may help mitigate stroke risk, but could increase iatrogenic complications.

Purpose
To evaluate whether detection of subclinical AF using implantable loop recorder (ILR) and subsequent initiation of oral anticoagulant (OAC) enhances the risk of major bleeding in elderly individuals with stroke risk factors.

Methods
This was a post-hoc analysis of a trial which randomised 6004 participants without known AF but with stroke risk factors in a 1:3 ratio to either ILR-screening for AF and OAC initiation upon AF episodes lasting ≥6 minutes or usual care (Control group). We examined the risk of major bleeding using OAC initiation as a time-varying exposure (figure 1) in Cox regression models, and similarly for the use of antiplatelets. Further, we estimated the incidence rates of OAC/antiplatelet initiation and discontinuation along with the distribution of major bleeding events according to drug exposure and subgroups.

Results
A total of 1019 participants (17%) initiated OAC; 578 (12.8%) in Control group vs. 441 (29.4%) in ILR group, with a mean age of 78.8 (±4.7) years in Control vs. 77.0 (±4.8) in ILR group, p&lt;0.0001. Major bleeding events totalled 221 (3.7%) with 47 of these occurring after OAC initiation (4.6% of all OAC-users); 26 (4.5%) vs. 21 (4.8%) in Control and ILR group, respectively. Without the use of OAC or antiplatelets the overall rate of major bleeding was 0.44 (0.33-0.57) per 100-perosn years compared to 1.54 (1.13-2.05) after OAC initiation. For the individual person, the hazard ratio for major bleeding after OAC initiation was 2.08 (1.50-2.90) p&lt;0.0001 compared to before initiation (Control: 2.81 (1.82-4.34) p&lt;0.0001, ILR: 1.32 (0.78-2.23) p=0.31, p=0.07 for interaction)(table 1), similarly was usage of antiplatelet associated with a hazard ratio of 1.3 (0.96-1.75) p=0.09. For OAC users ≥75 years, the rate of major bleeding was 1.96 (1.30-2.83)(Control: 2.20 (1.23-3.63), ILR: 1.73 (0.92-2.96)), compared to 1.17 (0.70-1.83) among users &lt;75 years (Control: 1.64 (0.82-2.93), ILR: 0.84 (0.36-1.66)). After OAC initiation, the discontinuation rate in the Control and ILR group was 9.60 (7.9-11.6) and 6.15 (4.95-7.55), respectively, while the rate of antiplatelet discontinuation was 7.44 (6.92-7.99) and 12.24 (10.9-13.4) in the Control and ILR group.

Conclusion
This post-hoc study of a randomised study found a two-fold risk increase of major bleeding after OAC initiation on individual basis compared with before, but this increase did not seem augmented by AF screening and treatment. A weaker signal was seen for antiplatelets. The OAC-associated bleeding risk was markedly higher in the elderly population. Finally, discontinuations of OAC and antiplatelets were common throughout follow-up.
Impact of oral anticoagulants in frail atrial fibrillation patients: a report from an observational registry of european patients
Authors: Proietti M , Romiti G F , Corica B , Mei D A , Bonini N , Vitolo M , Fawzy A M , Ding W Y , Imberti J F , Boriani G , Lip G Y H 
Published: November 2023

Abstract

Background
The last years showed a substantial increase of interest about the clinical issue of frailty among patients with cardiovascular diseases. Impact of frailty in atrial fibrillation (AF) has been examined in terms of management, quality of life and increased risk of outcomes; nonetheless, the impact of treatment with oral anticoagulants (OAC) remains suboptimally understood.

Purpose
To analyse the impact of OAC in a cohort of frail AF patients.

Methods
We used data from a European-wide prospective observational AF registry. Frailty was evaluated with a 40-items frailty index (FI) built according to the cumulative deficit method proposed by Rockwood and Mitnitski. OAC treatment was evaluated at baseline. A net clinical outcome (NCO) of all-cause death, major adverse cardiovascular outcomes, and major bleeding, as well as the single components were the study outcomes.

Results
Among 10,172 patients available for this analysis, 2,171 (21.3%) were frail. AF frail patients had a mean (SD) age of 71.7 (9.8) years and were 1,073 (49.4%) females. Overall, 1,801 (83.0%) were treated with OAC, of which 1,232 (68.4%) prescribed with vitamin K antagonist (VKA) and 569 (31.6%) prescribed with non-vitamin K antagonist oral anticoagulants (NOACs). Over a mean (SD) follow-up time of 1.56 (0.74) years there were 571 (26.3%) NCO events. Frail patients prescribed with OAC had a lower rate of NCO compared to those not prescribed (27.1% vs. 44.6%, p&lt;0.001). After adjustments, use of OAC was associated with lower risk of NCO and all the other secondary outcomes (Table 1). Regarding the type of OAC, patients prescribed with NOACs reported a lower rate of NCO compared to those prescribed with VKAs (22.7% vs. 29.1%). After adjustments, use of NOACs was associated with a lower risk of NCO and all the other secondary outcomes, except for major bleeding (Table 1). When comparing patients with FI &lt;80th percentile with those with FI ≥80th percentile, adjusted analysis showed that in the FI &lt;80th group the use of OAC was consistently associated with lower risk of all outcomes (except for major bleeding), with a non-statistically significant trend seen in those with FI ≥80th percentile treated with OAC (Table 1).

Conclusions
In frail AF patients, use of OAC was associated with a lower risk of outcomes, as well as the use of NOACs compared with VKAs. In patients with a very high frailty burden the benefits of OAC may be attenuated.
The predictive value of compression rate on residual leak after left atrial appendage occlusion with watchman FLX
Authors: La Fazia V , Gianni C , Pierucci N , Della Rocca D G , Mohanty S , Macdonald B , Mayedo A , Torlapati G , Bassiouny M , Al-Ahmad A , Gallinghouse G J , Burkhardt J D , Horton R , Di Biase L , Natale A 
Published: November 2023

Abstract

Background
Incomplete left atrial appendage (LAA) occlusion due to residual leaks may occur after percutaneous closure procedure with Watchman FLX. Before release of device PASS (position, anchor, size and seal) criteria must be verified. Optimal compression rate for watchman FLX device is between 10-30% according to company recommendations.

Purpose
The aim of this study is to evaluate the correlation between compression rate and leak presence after left atrial appendage closure.

Methods
This is an observational retrospective study including patients that underwent LAA closure under transesophageal echocardiography (TEE) with at least one follow-up where complete LAA closure was assessed by TEE in our center between January 2021 and August 2022. TEE images were reviewed by the first author. Compression rate was calculated based on intraprocedural TEE images using the following formula: (original device size—size after deployment)/original device size*100. Patients were divided into 2 groups based on the compression rate: group 1: 10-30%; group 2: &gt;30%. The rate of leak between groups was compared using the Chi-square test.

Results
203 patients (mean age 79± 8 years) were included in the study. The implanted device size was 20 mm in 7 (3.4%), 24 mm in 30 (14.8%), 27 mm in 49 (24.1%), 31 mm in 75 (36.9%) and 35 mm in 42 (20.7%) patients.
Based on the compression rate, patients were classified into group 1: &gt;30% [n=37 (18.2%)] and group 2: ≤30% [n=166 (81.8%)]. Mean compression rate was 38.5% and 21.3% in group 1 and 2 respectively. At follow-up TEE, 1 (2.7%) patient in group 1 and 32 (19.3%) patients in group 2 were found to have a residual leak of &gt;1 mm.
When comparing leaks between the two groups, there was 1 leak in group 1 whereas in group 2 there were 32 leaks (1/37 vs 32/166, p value 0.01, RR 0.14, 95% CI, 0.02-0.74).

Conclusion
Devices with compression rate ≤30% were associated with significantly higher risk of residual leak.
Gastrointestinal bleeding and cardiovascular events in patients with atrial fibrillation: results from the SAKURA AF registry and RAFFINE registry
Authors: Abe K , Wada H W , Miyauchi K M , Suwa S S , Miyazaki S M , Hayashi H H , Nishizaki Y N , Sumiyoshi M S , Nakazato Y N , Minamino T M , Okumura Y O , Daida H D 
Published: November 2023

Abstract

Background
Anticoagulants for patients with atrial fibrillation (AF) reduce cardiovascular events but increase gastrointestinal bleeding. However, the association between gastrointestinal bleeding and cardiovascular events is unclear. The present study aimed to evaluate the association between bleeding and major adverse cardiac and cerebrovascular events (MACCE) among patients with AF.

Methods
We analyzed the data of 2 Japanese multicenter registries (the SAKURA AF registry and RAFFINE registry). Primary endpoint was MACCE, which was defined as a composite of death, myocardial infarction and stroke. The association of gastrointestinal bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding.

Results
Among 7,133 AF patients, 192 (2.7%) had gastrointestinal bleeding events during follow-up. Multivariate logistic regression analysis showed that age (Odds ratio (OR) 1.02, 95% CI 1.00-1.05, p=0.046), hypertension (OR 1.52, 95% CI 1.04-2.21, p=0.03), diabetes mellitus (OR 1.38, 95% CI 1.02-1.88, p=0.04) and lower hemoglobin level (OR 0.84, 95% CI 0.76-0.92, p=0.0002) were independent predictors of gastrointestinal bleeding. Incidence of MACCE was significantly higher in patients with gastrointestinal bleeding than those without (13.93% versus 3.54% per patient-year; p&lt;0.0001, Figure). Even after adjusted for other risk factors, patients who experienced gastrointestinal bleeding had significantly higher risk of MACCE (hazard ratio, 3.09; 95% CI, 2.20-4.33; p&lt;0.0001).

Conclusions
In patients with AF, gastrointestinal bleeding was strongly associated with incidence of MACCE. Thus, it is important to prevent gastrointestinal bleeding to avoid adverse cardiovascular events.Figure