The Ablate-by-LAWT multicentre prospective study: Personalized paroxysmal atrial fibrillation ablation with ablation index adapted to local left atrial wall thickness.

BACKGROUND: Personalized radiofrequency (RF) ablation for paroxysmal atrial fibrillation (PAF), adapting the ablation index (AI) to local left atrial wall thickness (LAWT), proved to be highly efficient maintaining high arrhythmia-free survival rates. However, multicentre data are lacking. This multicentre, prospective, non-randomized study was conducted at 5 tertiary hospitals and sought to assess the safety, efficacy, and reproducibility of the LAWT-guided ablation for PAF. METHODS: Consecutive patients referred for first-time PAF were prospectively enrolled. The LAWT maps were obtained from preprocedural multidetector computed tomography and integrated into the navigation system. AI was titrated according to the local LAWT, and the ablation line was personalized to avoid the thickest regions while encircling the pulmonary veins (PVs). RESULTS: A total 109 patients (60.1 ± 9.4 years, 64.2% male) were enrolled. Median procedure time was 61.7 min (48.4-83.8), fluoroscopy time was 1.0 min (0.4-3.3), and RF time was 13.9 min (12.3-16.8). Median AI tailored to the local LAWT was 393 (374-412) for the anterior wall and 340 (315-378) for the posterior wall. Right and left PVs first-pass isolation was achieved in 89% and 91.7% of the patients, respectively. At 12-month follow-up, freedom from any atrial arrhythmia was 93.4% (95% CI 88.7-98.1), without differences across centres (P = 0.169). One patient experienced femoral artery pseudoaneurysm, with no other serious procedural-related complication. CONCLUSION: The Ablate-by-LAWT study proved that LAWT-guided PV isolation for PAF is safe, effective, and efficient in a multicentre setting. Twelve-month recurrence-free survival exceeded 90% (NCT04218604).

Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting.

BACKGROUND: The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). OBJECTIVE: We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting. METHODS: Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1 year and were included in the primary analysis. RESULTS: The mean procedure duration was 115 ± 47 min, and the mean fluoroscopy time was 9.9 ± 6 min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1 year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6 months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences. CONCLUSION: An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Feasibility of carbon dioxide insufflation and impact on epicardial approach utilization for ventricular tachycardia ablation in a midvolume referral center.

BACKGROUND: Epicardial access is often crucial for successful ventricular tachycardia (VT) ablation, but it is often burdened by significant procedural risk. Intentional coronary vein exit and intrapericardial CO2 insufflation (EpiCO2) can facilitate subxiphoid pericardial access. OBJECTIVE: This prospective study aimed to assess procedural feasibility, safety, and impact of the introduction of intrapericardial CO2 insufflation for epicardial access in a referral center for VT ablation. METHODS: All consecutive patients treated with epicardial VT ablation between November 2022 and January 2024 with the EpiCO2 technique at Pisa University Hospital were prospectively enrolled and compared in terms of feasibility, efficiency, and safety with a local retrospective cohort of patients treated with subxiphoid dry puncture between July 2018 and October 2022. RESULTS: Twenty-two consecutive patients (90.9% male; mean age, 54.3 years) underwent VT ablation with EpiCO2 during the study period. Epicardial access was achieved in all patients; median time from coronary sinus (CS) cannulation to epicardial access was 33 minutes. Intentional vein exit was successful in all cases, whereas CO2 insufflation was not feasible in 1 patient. There were no major complications and no significant bleeding. Since EpiCO2 introduction, epicardial approach utilization increased from 17.8% to 40% of all VT procedures. Comparison with 20 standard dry approach epicardial ablations showed no significant differences in terms of total procedural duration (322.5 [interquartile range, 296.75-363.75] minutes vs 359 [interquartile range, 323-409] minutes; P = .08). CONCLUSION: In our single-center experience, EpiCO2 was feasible and safe and led to significant increase in procedural volume without affecting total procedural time compared with standard dry puncture.

Transcatheter options for atrial fibrillation treatment: an overview of the ablative techniques currently available and future perspectives.

Atrial fibrillation (AF) is the most common arrhythmia in the adult population and catheter ablation has emerged as an important rhythm-control strategy and is the most common cardiac ablation procedure performed worldwide. The antiarrhythmic drugs have demonstrated moderate efficacy in long-term maintenance of sinus rhythm; moreover, they are often not tolerated and are associated with adverse events. Catheter ablation has proven to be effective in treating AF, although long-term outcomes have been significantly less favorable in persistent AF than in paroxysmal. The current guidelines recommend catheter ablation as class I indication for patients whom antiarrhythmic drugs have failed or are not tolerated, and as first-line rhythm-control therapy in selected patients with symptomatic AF. Advances in technology and innovative ablation protocols resulted in a remarkable improvement of the efficacy outcomes after pulmonary vein isolation. This review seeks to provide an updated report of the current practices and approaches, and to describe the latest advances in technology that aim to improve procedural safety, efficacy and to reduce procedural requirements in terms of duration and fluoroscopy exposure.

Echo state networks for the recognition of type 1 Brugada syndrome from conventional 12-LEAD ECG.

Artificial Intelligence (AI) applications and Machine Learning (ML) methods have gained much attention in recent years for their ability to automatically detect patterns in data without being explicitly taught rules. Specific features characterise the ECGs of patients with Brugada Syndrome (BrS); however, there is still ambiguity regarding the correct diagnosis of BrS and its differentiation from other pathologies. This work presents an application of Echo State Networks (ESN) in the Recurrent Neural Networks (RNN) class for diagnosing BrS from the ECG time series. 12-lead ECGs were obtained from patients with a definite clinical diagnosis of spontaneous BrS Type 1 pattern (Group A), patients who underwent provocative pharmacological testing to induce BrS type 1 pattern, which resulted in positive (Group B) or negative (Group C), and control subjects (Group D). One extracted beat in the V2 lead was used as input, and the dataset was used to train and evaluate the ESN model using a double cross-validation approach. ESN performance was compared with that of 4 cardiologists trained in electrophysiology. The model performance was assessed in the dataset, with a correct global diagnosis observed in 91.5 % of cases compared to clinicians (88.0 %). High specificity (94.5 %), sensitivity (87.0 %) and AUC (94.7 %) for BrS recognition by ESN were observed in Groups A + B vs. C + D. Our results show that this ML model can discriminate Type 1 BrS ECGs with high accuracy comparable to expert clinicians. Future availability of larger datasets may improve the model performance and increase the potential of the ESN as a clinical support system tool for daily clinical practice.

Arrhythmic risk profile in mitral valve prolapse: A systematic review and metanalysis of 1715 patients.

INTRODUCTION: Mitral valve prolapse (MVP) is a common clinical condition in the general population. A subgroup of patients with MVP may experience ventricular arrhythmias and sudden cardiac death ("arrhythmic mitral valve prolapse" [AMVP]) but how to stratify arrhythmic risk is still unclear. Our meta-analysis aims to identify predictive factors for arrhythmic risk in patients with MVP. METHODS: We systematically searched Medline, Cochrane, Journals@Ovid, Scopus electronic databases for studies published up to December 28, 2022 and comparing AMVP and nonarrhythmic mitral valve prolapse (NAMVP) for what concerns history, electrocardiographic, echocardiographic and cardiac magnetic resonance features. The effect size was estimated using a random-effect model as odds ratio (OR) and mean difference (MD). RESULTS: A total of 10 studies enrolling 1715 patients were included. Late gadolinium enhancement (LGE) (OR: 16.67; p = .005), T-wave inversion (TWI) (OR: 2.63; p < .0001), bileaflet MVP (OR: 1.92; p < .0001) and mitral anulus disjunction (MAD) (OR: 2.60; p < .0001) were more represented among patients with AMVP than in NAMVP. Patients with AMVP were shown to have longer anterior mitral leaflet (AML) (MD: 2.63 mm; p < .0001), posterior mitral leaflet (MD: 2.96 mm; p < .0001), thicker AML (MD: 0.49 mm; p < .0001), longer MAD length (MD: 1.24 mm; p < .0001) and higher amount of LGE (MD: 1.41%; p < .0001) than NAMVP. AMVP showed increased mechanical dispersion (MD: 8.04 ms; 95% confidence interval: 5.13-10.96; p < .0001) compared with NAMVP. CONCLUSIONS: Our meta-analysis proved that LGE, TWI, bileaflet MVP, and MAD are predictive factors for arrhythmic risk in MVP patients.

Transvenous lead extraction: Efficacy and safety of the procedure in female patients.

Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited. Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients. Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required. Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24). Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes.

Short and Long-Term Outcomes of Lesion Index-Guided High-Power Short-Duration Approach for Atrial Fibrillation Ablation.

High-power short-duration (HPSD) ablation is an increasingly used ablation strategy for pulmonary vein isolation (PVI) procedures, but Lesion Index (LSI)-guided HPSD radiofrequency (RF) applications have not been described in this clinical setting. We evaluated the procedural efficiency and safety of an LSI-guided HPSD strategy for atrial fibrillation (AF) ablation. Paroxysmal and persistent AF patients scheduled for AF ablation were prospectively enrolled and divided into two groups, according to the ablation power used (≥45 W for the LSI-HP Group and ≤40 W for the LSI-LP group). All patients underwent only PVI LSI-guided ablation (5.5 to 6 anteriorly; 5 to 5.5 superiorly, 4.5 to 5 posteriorly) with a point-by-point strategy and an inter-lesion distance <6 mm. Forty-six patients with AF (25 in the LSI-HP Group vs 21 in the LSI-LP Group)-59% paroxysmal, 78% male, with low-intermediate CHA2DS2-Vasc scores (2 [1-3]), a preserved ejection fraction (65 ± 6%) and a mean left atrial index volume of 39 ± 13 mL/m2 were prospectively enrolled. Baseline clinical characteristics were comparable between groups. PVI was successful in all patients. The RF time (29 (23-37) vs. 49 (41-53) min, p < 0.001), total procedure time (131 (126-145) vs. 155 (139-203) min, p = 0.007) and fluoroscopy time (12 (10-18) vs. 21 (16-26) min, p = 0.001) were significantly lower in the LSI-HP Group. No complications or steam pops were seen in either group. LSI-HP AF ablation significantly improved procedural efficiency-reducing ablation time, total procedural duration, and fluoroscopy use, while maintaining a comparable safety profile to lower-power procedures.

Safety and Efficacy of a Single Procedure of Extraction and Reimplantation of Infected Cardiovascular Implantable Electronic Device (CIED) in Comparison with Deferral Timing: An Observational Retrospective Multicentric Study.

(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. (3) Results: Considering those lost to follow-up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single-procedure group and 84.6% in the SoC group (p = 0.075). (4) Conclusions: Single-procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED-dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single-procedure reimplantation.

Procedure, management, and outcome of subcutaneous implantable cardioverter-defibrillator extraction in clinical practice.

AIMS: Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. METHODS AND RESULTS: We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th-75th percentile: 20-55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9-32) months vs. 30 (22-41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1-2) days] and infectious indications [3 (1-6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10-14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months. CONCLUSION: The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.

Feasibility and Accuracy of Noninvasive Continuous Arterial Pressure Monitoring during Transcatheter Atrial Fibrillation Ablation.

INTRODUCTION: Transcatheter atrial fibrillation (AF) ablation is still carried out with continuous invasive radial arterial blood pressure (IBP) monitoring in many centers. Continuous noninvasive blood pressure (CNBP) measurement using the volume-clamp method is a noninvasive alternative method used in ICU. No data on CNBP reliability are available in the electrophysiology lab during AF ablation, where rhythm variations are common. BACKGROUND: The objective of the present study was to compare continuous noninvasive arterial pressure measured with the ClearSight device (Edwards Lifesciences, Irvine, CA, USA) with invasive radial artery pressure used as the reference method during AF ablation. METHODS: We prospectively enrolled 55 consecutive patients (age 62 ± 11 years, 80% male) undergoing transcatheter AF ablation (62% paroxysmal, 38% persistent) at our center. Standard of care IBP monitoring via a radial cannula and a contralateral noninvasive finger volume-clamp CNBP measurement device were positioned simultaneously in all patients for the entire procedure. Bland-Altman analysis was used to analyze the agreement between the two techniques. RESULTS: A total of 1219 paired measurements for systolic, diastolic, and mean arterial pressure were obtained in 55 subjects, with a mean (SD) of 22 (9) measurements per patient. The mean bias (SD) was -12.97 (13.89) mmHg for systolic pressure (level of agreement -14.24-40.20; correlation coefficient 0.84), -1.85 (8.52) mmHg for diastolic pressure (level of agreement -18.54-14.84; correlation coefficient 0.77) and 2.31 (8.75) mmHg for mean pressure (level of agreement -14.84-19.46; correlation coefficient 0.85). CONCLUSION: In patients undergoing AF ablation, CNBP monitoring with the ClearSight device showed acceptable agreement with IBP monitoring. Larger studies are needed to confirm the potential clinical implications of continuous noninvasive BP monitoring during AF ablation.

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test.

AIMS: Permanent pacemaker implantation (PPM-I) remains nowadays the most important drawback of transcatheter aortic valve replacement (TAVR) procedure and the optimal strategy of delayed conduction disturbances (CDs) in these patients is unclear. The study aimed to validate an ambulatory electrocardiogram (ECG) monitoring through a 30 s spot ambulatory digital mobile ECG (AeECG), by using KardiaMobile-6L device in a 30-day period after TAVR procedure. METHODS AND RESULTS: Between March 2021 and February 2022, we consecutively enrolled all patients undergoing TAVR procedure, except pacemaker (PM) carriers. At discharge, all patients were provided of a KardiaMobile-6L device and a spot digital ECG (eECG) recording 1 month schedule. Clinical and follow-up data were collected, and eECG schedule compliance and recording quality were explored. Among 151 patients without pre-existing PM, 23 were excluded for pre-discharge PPM-I, 18 failed the KardiaMobile-6L training phase, and 10 refused the device. Delayed CDs with a Class I/IIa indication for PPM-I occurred in eight patients (median 6 days). Delayed PPM-I vs. non-delayed PPM-I patients were more likely to have longer PR and QRS intervals at discharge. PR interval at discharge was the only independent predictor for delayed PPM-I at multivariate analysis. The overall eECG schedule compliance was 96.5%. None clinical adverse events CDs related were documented using this new AeECG monitoring modality. CONCLUSION: A strategy of 30 s spot AeECG is safe and efficacious in delayed CDs monitoring after TAVR procedure with a very high eECG schedule level of compliance.

Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry.

BACKGROUND: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA. METHODS: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms. RESULTS: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HRunadj 0.64 (95% CI 0.47-0.88); p < 0.01) regardless of the centers' CBA experience; when controlling for baseline characteristics, the difference was not significant (HRadj 0.87 (95% CI 0.56-1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29). CONCLUSIONS: In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.