Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study.

AIMS: High-power-short-duration (HPSD) ablation is an effective treatment for atrial fibrillation but poses risks of thermal injuries to the oesophagus and vagus nerve. This study aims to investigate incidence and predictors of thermal injuries, employing machine learning. METHODS AND RESULTS: A prospective observational study was conducted at Leipzig Heart Centre, Germany, excluding patients with multiple prior ablations. All patients received Ablation Index-guided HPSD ablation and subsequent oesophagogastroduodenoscopy. A machine learning algorithm categorized ablation points by atrial location and analysed ablation data, including Ablation Index, focusing on the posterior wall. The study is registered in clinicaltrials.gov (NCT05709756). Between February 2021 and August 2023, 238 patients were enrolled, of whom 18 (7.6%; nine oesophagus, eight vagus nerve, one both) developed thermal injuries, including eight oesophageal erythemata, two ulcers, and no fistula. Higher mean force (15.8 ± 3.9 g vs. 13.6 ± 3.9 g, P = 0.022), ablation point quantity (61.50 ± 20.45 vs. 48.16 ± 19.60, P = 0.007), and total and maximum Ablation Index (24 114 ± 8765 vs. 18 894 ± 7863, P = 0.008; 499 ± 95 vs. 473 ± 44, P = 0.04, respectively) at the posterior wall, but not oesophagus location, correlated significantly with thermal injury occurrence. Patients with thermal injuries had significantly lower distances between left atrium and oesophagus (3.0 ± 1.5 mm vs. 4.4 ± 2.1 mm, P = 0.012) and smaller atrial surface areas (24.9 ± 6.5 cm2 vs. 29.5 ± 7.5 cm2, P = 0.032). CONCLUSION: The low thermal lesion's rate (7.6%) during Ablation Index-guided HPSD ablation for atrial fibrillation is noteworthy. Machine learning based ablation data analysis identified several potential predictors of thermal injuries. The correlation between machine learning output and injury development suggests the potential for a clinical tool to enhance procedural safety.

Patient perspectives on same-day discharge following catheter ablation for atrial fibrillation: results from a patient survey as part of the monocentric FAST AFA trial.

AIMS: Same-day discharge (SDD) following catheter ablation (CA) of atrial fibrillation (AF) was already introduced in selected facilities in Europe, but a widespread implementation has not yet succeeded. Data on patients' perspectives are lacking. Therefore, we conducted a survey to address patients' beliefs towards SDD and identify variables that are associated with their evaluation. METHODS AND RESULTS: As part of the prospective, monocentric FAST AFA trial, patients aged ≥20 years undergoing left atrial CA for AF were asked to participate in the survey consisting of a study-specific questionnaire, the AF knowledge scale, and pre-defined patient-reported outcome measures. The study cohort was stratified based on SDD willingness, and a logistic regression analysis was used to identify predictors for patients' valuation. Between 26 July 2021 and 01 July 2022, 256 of 376 screened patients consented to study participation of whom 248 (mean age 61.8 years, 33.9% female) completed the SDD survey. Of them, 50.0% were willing to have SDD concepts integrated into their clinical course with increased patient comfort (27.5%), shorter waiting times (14.6%), and a cost-efficient treatment (14.0%) being imaginable benefits. In contrast, expressed concerns included uncertainties with occurring complaints (50.6%), the insufficient recognition (47.8%), and treatment (48.9%) of complications. European Heart Rhythm Association class at baseline and inpatient treatments within the preceding year were predictors for SDD willingness whereas comorbidity burden or AF knowledge were not. CONCLUSION: We provide a detailed survey expressing patients' beliefs towards SDD following left atrial CA. Our findings may facilitate adequate patient selection to improve the future implementation of SDD programs in suitable cohorts.

P-wave duration and interatrial block as predictors of new-onset atrial fibrillation: A systematic review and meta-analysis.

BACKGROUND: Early detection of atrial fibrillation (AF) could improve patient outcomes. P-wave duration (PWD) and interatrial block (IAB) are known predictors of new-onset AF and could improve selection for AF screening. This meta-analysis reviews the published evidence and offers practical implications. METHODS: Publication databases were systematically searched, and studies reporting PWD and/or morphology at baseline and new-onset AF during follow-up were included. IAB was defined as partial (pIAB) if PWD≥120 ms or advanced (aIAB) if the P-wave was biphasic in the inferior leads. After quality assessment and data extraction, random-effects analysis calculated odds ratio (OR) and confidence intervals (CI). Subgroup analysis was performed for those with implantable devices (continuous monitoring). RESULTS: Among 16,830 patients (13 studies, mean 66 years old), 2,521 (15%) had new-onset AF over a median of 44 months. New-onset AF was associated with a longer PWD (mean pooled difference: 11.5 ms, 13 studies, p < 0.001). The OR for new-onset AF was 2.05 (95% CI: 1.3-3.2) for pIAB (5 studies, p = 0.002) and 3.9 (95% CI: 2.6-5.8) for aIAB (7 studies, p < 0.001). Patients with pIAB and devices had higher AF-detection risk (OR: 2.33, p < 0.001) than those without devices (OR: 1.36, p = 0.56). Patients with aIAB had similarly high risk regardless of device presence. There was significant heterogeneity but no publication bias. CONCLUSION: Interatrial block is an independent predictor of new-onset AF. The association is stronger for patients with implantable devices (close monitoring). Thus, PWD and IAB could be used as selection criteria for intensive screening, follow-up or interventions.

Subject-specific factors affecting particle residence time distribution of left atrial appendage in atrial fibrillation: A computational model-based study.

Background: Atrial fibrillation (AF) is a prevalent arrhythmia, that causes thrombus formation, ordinarily in the left atrial appendage (LAA). The conventional metric of stroke risk stratification, CHA2DS2-VASc score, does not account for LAA morphology or hemodynamics. We showed in our previous study that residence time distribution (RTD) of blood-borne particles in the LAA and its associated calculated variables (i.e., mean residence time, tm , and asymptotic concentration, C ∞) have the potential to improve CHA2DS2-VASc score. The purpose of this research was to investigate the effects of the following potential confounding factors on LAA tm and C ∞: (1) pulmonary vein flow waveform pulsatility, (2) non-Newtonian blood rheology and hematocrit level, and (3) length of the simulation. Methods: Subject-Specific data including left atrial (LA) and LAA cardiac computed tomography, cardiac output (CO), heart rate, and hematocrit level were gathered from 25 AF subjects. We calculated LAA tm and C ∞ based on series of computational fluid dynamics (CFD) analyses. Results: Both LAA tm and C ∞ are significantly affected by the CO, but not by temporal pattern of the inlet flow. Both LAA tm and C ∞ increase with increasing hematocrit level and both calculated indices are higher for non-Newtonian blood rheology for a given hematocrit level. Further, at least 20,000 s of CFD simulation is needed to calculate LAA tm and C ∞ values reliably. Conclusions: Subject-specific LA and LAA geometries, CO, and hematocrit level are essential to quantify the subject-specific proclivity of blood cell tarrying inside LAA in terms of the RTD function.

P-wave duration as a marker of atrial remodeling in patients referred to ablation for atrial fibrillation: A new stratification tool emerging?

Ablation of atrial fibrillation is one of the most widely applied invasive procedures in cardiovascular medicine, and populations with atrial fibrillation continuously rise. Recurrence rates are, however, consistently high, even in patients without severe comorbidities. Robust stratification algorithms to distinguish patients suitable for ablation are generally lacking. This is a fact caused by the inability to incorporate evidence of atrial remodeling and fibrosis, e.g., atrial remodeling, in the decision pathways. Cardiac magnetic resonance is a powerful tool in identifying fibrosis; however, it is costly and not routinely used. Electrocardiography has been generally underutilized in clinical practice during pre-ablative screening. One of the characteristics of the electrocardiogram that can give us valuable data depicting the existence and the extent of atrial remodeling and fibrosis is the duration of the P-wave. Currently, many studies support the implementation of P-wave duration in the routine practice of patient evaluation as a surrogate marker of existing atrial remodeling, that in turn predicts recurrence after ablation of atrial fibrillation. Further research is guaranteed to establish this electrocardiographic characteristic in our stratification quiver.

Perioperative complications after pacemaker implantation: higher complication rates with subclavian vein puncture than with cephalic vein cutdown.

PURPOSE: The cephalic vein cutdown (CVC) and the subclavian puncture (SP) is the most common access for pacemaker implantation. The purpose of this study was to compare the peri-/postoperative complications of these approaches. METHODS: A retrospective analysis of the quality assurance data of the state of North Rhine-Westphalia was performed to evaluate the peri-/postoperative complications of first pacemaker implantation according to the venous access. The primary endpoint was defined as the occurrence of one of the following: asystole, ventricular fibrillation, pneumothorax, hemothorax, pericardial effusion, pocket hematoma, lead dislocation, lead dysfunction, postoperative wound infection or other complication requiring intervention. Descriptive analysis was done via absolute, relative frequencies and Odds Ratio. Fisher's exact test was used for comparison of the both study groups. RESULTS: From 139,176 pacemaker implantations from 2010 to 2014, 15,483 cases were excluded due to other/double access. The median age was 78 years and the access used was CVC for 75,251 cases (60.8%) and SP for 48,442 cases (39.2%). The implanted devices were mainly dual-chamber pacemakers (73.9% in the CVC group and 78.4% in the SP group), followed by single-chamber pacemakers VVI (24.9% and 19.9% in the CVC and SP group respectively). There were significantly fewer peri/postoperative complications in the CVC group compared to the SP group (2.49% vs. 3.64%, p = 0.0001, OR 1.47; 95% CI 1.38-1.57). CONCLUSIONS: CVC as venous access for pacemaker implantation has significantly fewer peri/postoperative complications than SP and appears to be an advantageous technique.

Management of patients with electrical storm: an educational review.

Electrical storm (ES) is a medical emergency that is defined as ≥ 3 separate ventricular tachycardia (VT) episodes causing ICD therapy within 24 h. Patients with ES have high risk for hospitalization, heart failure (HF) decompensation, in-hospital death. Furthermore, it is associated with significant anxiety and distress for the patients. Frequent triggers of ES are myocardial ischaemia, acute decompensation of HF, metabolic and electrolyte disorders, drug side-effects, increased sympathetic tone. Acute management of ES requires sedation, antiarrhythmic drugs and correction of the precipitating factors; although, in severe refractory cases, intubation, mechanical ventilation, and circulatory support might be necessary. Radiofrequency catheter ablation is superior than antiarrhythmic drugs to suppress the ES and is also frequently required to terminate the ES, as well as to achieve acute and long-term freedom of VT. Optimization of the ICD programming is crucial to reduce the burden of further appropriate and inappropriate shocks. Use of appropriate discrimination criteria and algorithms, ATPs and extending the detection times are important measures to reduce the burden of ES. In patients with end-stage HF, ES can be a sign of failing heart and can be refractory of treatment. In such cases, deactivation of the ICD therapy should be considered and discussed with patients and their care givers.

P-wave duration and atrial fibrillation recurrence after catheter ablation: a systematic review and meta-analysis.

AIMS: Atrial fibrillation (AF) is a global health problem with high morbidity and mortality. Catheter ablation (CA) can reduce AF burden and symptoms, but AF recurrence (AFr) remains an issue. Simple AFr predictors like P-wave duration (PWD) could help improve AF therapy. This updated meta-analysis reviews the increasing evidence for the association of AFr with PWD and offers practical implications. METHODS AND RESULTS: Publication databases were systematically searched and cohort studies reporting PWD and/or morphology at baseline and AFr after CA were included. Advanced interatrial block (aIAB) was defined as PWD ≥ 120 ms and biphasic morphology in inferior leads. Random-effects analysis was performed using the Review Manager 5.3 and R programs after study selection, quality assessment, and data extraction, to report odds ratio (OR) and confidence intervals. : Among 4175 patients in 22 studies, 1138 (27%) experienced AFr. Patients with AFr had longer PWD with a mean pooled difference of 7.8 ms (19 studies, P < 0.001). Pooled OR was 2.04 (1.16-3.58) for PWD > 120 ms (13 studies, P = 0.01), 2.42 (1.12-5.21) for PWD > 140 ms (2 studies, P = 0.02), 3.97 (1.79-8.85) for aIAB (5 studies, P < 0.001), and 10.89 (4.53-26.15) for PWD > 150 ms (4 studies, P < 0.001). There was significant heterogeneity but no publication bias detected. CONCLUSION: P-wave duration is an independent predictor for AF recurrence after left atrium ablation. The AFr risk is increasing exponentially with PWD prolongation. This could facilitate risk stratification by identifying high-risk patients (aIAB, PWD > 150 ms) and adjusting follow up or interventions.

Outcomes following cardiac sympathetic denervation in patients with structural heart disease and refractory ventricular arrhythmia.

AIM: Cardiac sympathetic denervation (CSD) has been introduced as a bailout therapy in patients with structural heart disease and refractory ventricular arrhythmias (VAs), but available data are scarce. Purpose of this study was to estimate immediate results, complications, and mid-term outcomes of CSD following recurrent VA after catheter ablation. METHODS AND RESULTS: Adult patients who underwent CSD in the Heart Center Leipzig from March 2017 to February 2021 were retrospectively analysed. Follow-up (FU) was executed via implantable cardioverter defibrillator (ICD) interrogation, telephone interviews, and reviewing medical records. Twenty-one patients (age 63.7 ± 14.4 years, all men, 71.4% non-ischaemic cardiomyopathy, left ventricular ejection fraction 31.6 ± 12.6%) received CSD via video-assisted thoracoscopic surgery (90.5% bilateral, 9.5% left-sided only). Indication for CSD was monomorphic ventricular tachycardia in 76.2% and ventricular fibrillation in 23.8 with 71.4% of patients presenting with electrical storm before index hospitalization. Procedure-related major complications occurred in 9.5% of patients. In-hospital adverse events not related to surgery were common (28.6%) and two patients died during the index hospital stay. During FU (mean duration 9.1 ± 6.5 months), five more patients died. Of the remaining patients, 38.5 and 76.9% were free from any VA or ICD shocks, respectively. CONCLUSIONS: The CSD showed additional moderate efficacy to suppress VAs, when performed as a bailout therapy after previously unsuccessful catheter ablation. At 9 months, it was associated with freedom of ICD shocks in two-thirds of patients. In a population with many comorbidities, the rate of CSD-related complications was acceptable, although there was an overall high risk of procedure unrelated adverse events and death.

A randomized trial of non-fasting vs. fasting for cardiac implantable electronic device procedures (Fast-CIED Study).

AIMS: Data on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient's well-being and safety in elective cardiac implantable electronic device (CIED) procedures. METHODS AND RESULTS: In this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients' well-being scores (based on numeric rating scale, 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients' well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) -6.35 to -0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD -2.86 to -1.42, P < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD -1.68 to -0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. CONCLUSION: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient's well-being and comparable in terms of safety for CIED procedures (NCT04389697).

Big Data in electrophysiology.

The quantity of data produced and captured in medicine today is unprecedented. Technological improvements and automation have expanded the traditional statistical methods and enabled the analysis of Big Data. This has permitted the discovery of new associations with a granularity that was previously hidden to human eyes. In the first part of this review, the authors would like to provide an overview of basic Machine Learning (ML) principles and techniques in order to better understand their application in recent publications about cardiac arrhythmias. In the second part, ML-enabled advances in disease detection and diagnosis, outcome prediction, and novel disease characterization in topics like electrocardiography, atrial fibrillation, ventricular arrhythmias, and cardiac devices are presented. Finally, the limitations and challenges of applying ML in clinical practice, such as validation, replication, generalizability, and regulatory issues, are discussed. More carefully designed studies and collaborations are needed for ML to become feasible, trustworthy, accurate, and reproducible and to reach its full potential for patient-oriented precision medicine.

Biatrial volume ratio predicts low voltage areas in atrial fibrillation.

BACKGROUND: Left atrial volume (LAV) and low voltage areas (LVAs) are acknowledged markers for worse rhythm outcome after ablation of atrial fibrillation (AF). Some studies reported the importance of increased right atrial volume (RAV) as a predictor for arrhythmia recurrences in AF patients. OBJECTIVE: To investigate association between the LAV/RAV ratio and LVAs presence. METHODS: Patients undergoing first AF ablation were included. LVAs were assessed peri-procedurally using high-density 3D maps and defined as <0.5 mV. All patients underwent pre-procedural cardiovascular magnetic resonance imaging. LAV (biplane) and RAV (monoplane 4-chamber) were assessed prior to ablation, and the LAV/RAV ratio was calculated. RESULTS: The study population included 189 patients (age mean 63 ± 10 years, 33% women, 57% persistent AF, 22% LVAs). There were 149 (79%) patients with LAV > RAV. In univariable analysis LAV > RAV was associated with LVAs (OR 6.803, 95%CI 1.395-26.514, p = .016). The association remained robust in multivariable model after adjustment for persistent AF, CHA2 DS2 -VASc score, and heart rate (OR 5.981, 95%CI 1.256-28.484, p = .025). Using receiver operator curve analysis, LAV > RAV (AUC 0.668, 95%CI 0.585-0.751, p = .001) was significant predictor for LVAs. In multivariable analysis, after adjustment for age, persistent AF, and renal function, RAV≥LAV was threefold higher in males (OR 3.040, 95%CI 1.050-8.802, p = .04). CONCLUSIONS: LAV > RAV is useful for the prediction of electro-anatomical substrate in AF. LAV > RAV was associated with LVAs presence, while male sex remained associated with RAV≥LAV and less LVAs.

Atrial remodeling and atrial fibrillation recurrence after catheter ablation : Past, present, and future developments.

The term "atrial remodeling" is used to describe the electrical, mechanical, and structural changes associated with the presence of an arrhythmogenic substrate for atrial fibrillation. Rhythm control therapy may slow down or even reverse progressive atrial remodeling. Atrial remodeling has long been recognized as an important predictor of clinical outcomes and therapeutic success, but recent advances have highlighted its clinical relevance and revealed the implications of specific anatomical changes such as atrial asymmetry or shape. This has opened the path to computational precision medicine that captures these data in detail and combines them with other factors, to provide patient-specific solutions. The goal of precision medicine lies in improving clinical outcomes, reducing costs, and avoiding unnecessary procedures. In this article, we review the history of atrial remodeling and we summarize the insights from our research on anatomical atrial remodeling and its association with rhythm outcomes after catheter ablation. Finally, we present recent advances in the field, reflecting the beginning of a new technological era that will enable us to improve patient care by personalized patient-specific medicine.