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BACKGROUND: Pulsed field ablation (PFA) is a novel technology for catheter-based atrial arrhythmia treatment. Evidence of its application for ventricular arrhythmia ablation is still limited. In this study, we describe the feasibility and efficacy of focal PFA for premature ventricular contraction (PVC) ablation. METHODS: A prospective cohort of 20 patients referred for PVC ablation at 2 centers was enrolled, regardless of the presence of structural heart disease, PVC morphology, or previous ablation attempts. All procedures were performed using the CENTAURI System in combination with contact force sensing catheters and 3-dimensional electroanatomical mapping systems. Energy output and the number of applications were left to the operator's discretion. RESULTS: Eleven (55%) procedures were conducted under general anesthesia, 6 (30%) under deep sedation, and 3 (15%) under light sedation. Muscular contraction was observed in one case (5%). Median procedural and fluoroscopy times were 95.5 and 6.55 minutes, respectively. The median number of PFA applications was 8 with a median contact force of 10g. A statistically significant (76%) reduction was observed in mean peak-to-peak bipolar electrogram voltage before and after ablation (0.707 versus 0.098 mV; P=0.008). Ventricular irritative firing was observed in 11 (55%) patients after PFA. The median follow-up was 120 days. Acute procedural success was achieved in 17 of 20 (85% [95% CI, 0.70-1]) patients. Two of the patients with procedural failure had late success with >80% clinical PVC burden suppression during follow-up, and 2 of 17 patients with acute success had late PVC recurrence, which accounts for a total of 17 of 20 (85% [95% CI, 0.70-1]) patients with chronic success. Transient ST-segment depression occurred in 1 patient, and the right bundle branch block was induced in 2 others (permanently only in one case). CONCLUSIONS: PVC ablation using a focal PFA is feasible, effective, and safe, with promising acute and long-term results in several ventricular locations. Irritative firing is frequently observed. Coronary evaluation should be considered when targeting the outflow tract.

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BACKGROUND: Previous clinical studies on pulmonary vein isolation (PVI) with a radiofrequency balloon (RFB) reported safe and effective procedures using Conventional ablation settings with 20/60-second RF delivery via posterior/anterior (PST/ANT) electrodes. The latest evidence suggests that reducing the application time to 15 seconds (s) on the posterior wall when facing the esophageal region is as effective as applying 20 s. OBJECTIVE: To prospectively assess whether reducing RF time on PST/ANT segments to 15/45 s can ensure sufficient quality of lesion metrics and compare the new Shortened ablation settings with the Conventional one in terms of safety, and effectiveness at 1-year. METHODS: A total of 641 patients from 7 European centers were enrolled in a collaborative registry, with 374 in the conventional RF delivery group and 267 in the shortened RF delivery group. Procedural outcomes, lesion metrics, and safety profiles were assessed and compared between the groups. RESULTS: Freedom of any atrial tachycarrythmias at one year were 85.4% and 88.2% in the SHRT and CONV groups, respectively. The shortened RF delivery strategy was associated with significantly shorter procedure times (median 63.5 vs. 96.5 minutes, P < 0.001) and shortened fluoroscopy exposure (median 10.0 vs. 14.0 minutes, P < 0.001) compared to conventional delivery. Efficacy metrics, including first-pass isolation rates and time to isolation, were comparable between groups. Shortened RF delivery was associated with a lower incidence of procedural complications (1.4% vs. 5.3%, P = 0.04) and optimized thermal characteristics. CONCLUSION: Analyses from the COLLABORATE Registry demonstrate that shortening RF energy delivery times to 15/45s (PST/ANT) during PVI with the RFB resulted in comparable freedom from recurrent atrial tachyarrhythmia compared to conventional delivery times with comparable efficiency and safety.

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BACKGROUND: Several algorithms can differentiate inferior axis premature ventricular contractions (PVCs) originating from the right side and left side on 12-lead electrocardiograms (ECGs). However, it is unclear whether distinguishing the origin should rely solely on PVC or incorporate sinus rhythm (SR). AIMS: We compared the Dual-Rhythm model (incorporating both SR and PVC) to the PVC model (using PVC alone), and quantified the contribution of each ECG lead in predicting the PVC origin for each cardiac rotation. METHODS: This multicenter study enrolled 593 patients from 11 centers-493 from Japan and Germany, and 100 from Belgium, which used as the external validation dataset. Using a hybrid approach combining a Resnet50-based convolutional neural network and a Transformer model, we developed two variants-the PVC and Dual-Rhythm models-to predict PVC origin. RESULTS: In the external validation dataset, the Dual-Rhythm model outperformed the PVC model in accuracy (0.84 vs. 0.74, respectively; p < 0.01), precision (0.73 vs. 0.55, respectively; p < 0.01), specificity (0.87 vs. 0.68, respectively; p < 0.01), area under the receiver operating characteristic curve (0.91 vs. 0.86, respectively; p = 0.03), and F1-Score (0.77 vs. 0.68, respectively; p = 0.03). The contributions to PVC origin prediction were 77.3% for PVC and 22.7% for the SR. However, in patients with counterclockwise rotation, SR had a greater contribution in predicting the origin of right-sided PVC. CONCLUSIONS: Our deep learning-based model, incorporating both PVC and SR morphologies, resulted in a higher prediction accuracy for PVC origin. Considering SR is particularly important for predicting right-sided origin in patients with counterclockwise rotation.

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BACKGROUND: Recurrence during the 3-month blanking period after radiofrequency ablation of atrial fibrillation (AF) is typically not considered as a predictor for late recurrence. OBJECTIVE: We investigated the significance of early recurrence as a risk factor for late recurrence in patients with AF receiving pulsed-field ablation (PFA). METHODS: Consecutive patients undergoing PFA were prospectively followed up for 1 year. All patients received isolation of pulmonary veins. Additional ablation procedures were performed per operator's discretion. After the procedure, all remained on their previously ineffective antiarrhythmic drugs (AADs) during the 2-month blanking period after which the AADs were discontinued. Early recurrence was defined as atrial arrhythmia of >30-second duration during the 3-month blanking period, and any recurrence beyond 3 months was considered as late recurrence. RESULTS: A total of 337 patients undergoing PFA for AF were included. Early recurrence was recorded in 53 patients (15.7%): 10 in the first month, 12 in the second month, and 31 in the third month. Of the 10 patients having recurrence during the first month, 7 (70%) remained in sinus rhythm after cardioversion whereas 3 (30%) underwent a redo procedure because of late recurrence. At 1 year, all patients with recurrence in the second and third months experienced late recurrence; among these patients, 10 (83.3%) of 12 and 27 (87%) of 31 underwent a redo procedure and the remaining 6 patients were in sinus rhythm on AADs. CONCLUSION: In this consecutive series of patients with AF, early recurrence in the second or third month after the PFA procedure was associated with a high risk of late recurrence. Thus, blanking period could be redefined as 1 month after PFA.

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Traditional classifications categorize atrial fibrillation (AF) into paroxysmal, persistent, or permanent, but recent advancements in monitoring have revealed AF as a continuous variable, challenging existing paradigms. AF burden, defined basically as the amount of time spent in AF during a monitored period, has emerged as a crucial metric. This review assesses the evolving landscape of AF burden and its measurement methods, diagnostic modalities, and impact on outcomes. Guidelines suggest individualized approaches, combining AF burden with clinical scores (CHA2DS2-VASc), but studies have challenged this. Addressing the impact of AF burden on patients' quality of life before or after ablation is also crucial. Although continuous monitoring technologies offer promising avenues, the field faces challenges, such as defining clinically relevant thresholds. Future research should focus on refining these, designing trials centered around AF burden, and evaluating the efficacy of interventions in reducing AF burden, ultimately paving the way for personalized management strategies.

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INTRODUCTION: Thermal atrial fibrillation (AF) ablation exerts an additive treatment effect on the cardiac autonomic nervous system (CANS). This effect is mainly reported during ablation of the right superior pulmonary vein (RSPV), modulating the right anterior ganglionated plexus (RAGP), which contains parasympathetic innervation to the sinoatrial node in the epicardial fat pad between RSPV and superior vena cava (SVC). However, a variable response to neuromodulation after ablation is observed, with little to no effect in some patients. Our objective was to assess clinical and anatomic predictors of thermal ablation-induced CANS changes, as assessed via variations in heart rate (HR) postablation. METHODS: Consecutive paroxysmal AF patients undergoing first-time PV isolation by the cryoballoon (CB) or radiofrequency balloon (RFB) within a 12-month time frame and with preprocedural cardiac computed tomography (CT), were evaluated. Preablation and 24-h postablation electrocardiograms in sinus rhythm were collected and analyzed to assess HR. Anatomic evaluation by CT included the measurement of the shortest distance between the SVC and RSPV ostium (RSPV-SVC distance). RESULTS: A total of 97 patients (CB, n = 50 vs. RFB, n = 47) were included, with similar baseline characteristics between both groups. A significant HR increase postablation (ΔHR ≥ 15 bpm) occurred in a total of 37 patients (38.1%), without difference in number of patients between both thermal ablation technologies (CB, 19 [51%]), RFB, 18 [49%]). Independent predictors for increased HR were RSPV-SVC distance (odds ratio [OR]: 0.49, CI: 0.34-0.71, p value < .001), and age (OR: 0.94, CI: 0.89-0.98, p value = .003). CONCLUSIONS: Thermal balloon-based PV isolation influences the CANS through its effect on the RAGP, especially in younger patients and patients with shorter RSPV-SVC distance.

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BACKGROUND: Pulsed field ablation (PFA) is increasingly used in clinical practice for the treatment of atrial fibrillation. While the susceptibility of erythrocytes to electroporation is well established, the effect of cardiac PFA technologies on hemolysis has remained underreported. The aim of this study was to investigate the incidence, severity, and clinical impact of PFA-induced hemolysis. METHODS: We included n=145 patients undergoing atrial fibrillation catheter ablation with a pentaspline PFA catheter (biphasic, bipolar pulses of 2 kV) and n=70 patients receiving radiofrequency ablation (40-90 W) at 4 high-volume European centers. The lesion set comprised pulmonary vein isolation for paroxysmal atrial fibrillation and pulmonary vein isolation±additional lesions for persistent atrial fibrillation. Hemolysis and renal function biomarkers were analyzed in blood samples at baseline, at the end of ablation, and 24 hours after the procedure. RESULTS: Baseline characteristics were well balanced between groups (overall mean, 65.7±9.4 years; 69.3% male). The ablation procedures comprised a mean of 61.6±27.4 PFA deliveries and 26.3±15.0 minute RF duration. Hemolysis was detected in 94.3% versus 6.8% of patients after PFA versus radiofrequency ablation (P<0.001): PFA was associated with significantly lower haptoglobin levels (0.5±0.4 versus 1.0±0.4 g/L), while free plasma hemoglobin (592.8±330.6 versus 147.8±183.0 mg/L), bilirubin (21.3±11.3 versus 14.8±8.8 µmol/L), and LDH (lactate dehydrogenase, 352.7±115.7 versus 253.2±56.5 U/L) were significantly higher after PFA versus radiofrequency ablation (all P<0.001). Hemolysis correlated with the number of PFA deliveries (r=0.62 [95% CI, 0.33-0.80]; P<0.001), with the highest severity occurring ≥54 PFA deliveries. After PFA, hemoglobinuria occurred in 36.4%, while creatinine increase was higher in patients with baseline glomerular filtration rate <50 mL/min versus baseline glomerular filtration rate >50 mL/min (Δcrea, 27.0±103.1 versus -0.2±12.1 µmol/L; P=0.010). CONCLUSIONS: Intravascular hemolysis is a frequent finding after PFA and increases with the number of PFA deliveries. Until the clinical impact of PFA-associated hemolysis is fully elucidated, a careful titration of PFA deliveries during the ablation procedure is warranted.

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BACKGROUND: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). OBJECTIVE: The purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function. METHODS: Consecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes. RESULTS: Of the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18-59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25-2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35-0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38-0.81 V] vs G4/G5 group 0.51 V [0.38-0.84 V] @ 0.24 ms; P < .001). CONCLUSION: In a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up.

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INTRODUCTION: Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. METHODS: Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. RESULTS: First-line cryoablation is dominant, meaning it results in lower costs (-€2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of €23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive ∼ 1.2 ablation procedures over a lifetime horizon. CONCLUSION: First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.

Asunto(s)

Antiarrítmicos , Fibrilación Atrial , Análisis Costo-Beneficio , Criocirugía , Costos de los Medicamentos , Cadenas de Markov , Modelos Económicos , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/economía , Fibrilación Atrial/terapia , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/fisiopatología , Humanos , Criocirugía/economía , Criocirugía/efectos adversos , Dinamarca , Antiarrítmicos/uso terapéutico , Antiarrítmicos/economía , Resultado del Tratamiento , Factores de Tiempo , Masculino , Femenino , Persona de Mediana Edad , Técnicas de Apoyo para la Decisión , Anciano , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Ahorro de Costo , Árboles de Decisión

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Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Asunto(s)

Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/terapia , Femenino , Masculino , Persona de Mediana Edad , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Anciano , Resultado del Tratamiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología

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Background: This study was conducted to evaluate compliance with guideline-directed optimal medical therapy (OMT) and its association with early implantable cardioverter-defibrillator (ICD) activation in patients with heart failure and reduced ejection fraction (HFrEF). Methods: Retrospective data from 307 patients who underwent ICD implantation for primary prevention from 2011 to 2017 were collected and analyzed. Results: Among the study participants, only 23.8% received the maximum tolerated dose of OMT prior to ICD implantation, with 59.0% receiving all three OMT medication groups. No significant difference in OMT compliance was found between patients with ischemic cardiomyopathy (ICM) and those with non-ischemic dilated cardiomyopathy (DCM). However, DCM patients received ICDs more frequently at the time of diagnosis than ICM patients (13.8% vs. 0.7%). Early ICD activation (within 3 months) occurred in only one patient who had not received appropriate OMT, representing 0.7% of all ICM patients. Furthermore, early activation was also infrequent in patients who received OMT (2.9% of ICM patients and 2.6% of DCM patients). Echocardiography follow-up data revealed that 20.4% of ICM patients and 29.8% of DCM patients who did not receive OMT before ICD implantation showed improvement in the left ventricular ejection fraction (EF) to 35% or more. Conclusions: This study found suboptimal compliance with OMT prior to ICD implantation in HFrEF patients. The results showed that early ICD activation was rare in all patient groups, especially those who did not receive the prescribed 3 months of OMT. More research is needed to investigate longer waiting periods for the evaluation of potential EF improvement, and to better evaluate the eligibility of HFrEF patients for ICD. The current findings have potential implications for clinical practice and patient outcomes.

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Ablación por Catéter , Taquicardia Ventricular , Humanos , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/fisiopatología , Taquicardia Ventricular/terapia , Ablación por Catéter/métodos , Resultado del Tratamiento , Catéteres Cardíacos , Masculino , Diseño de Equipo , Persona de Mediana Edad , Femenino

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BACKGROUND AND AIMS: Cardiac ablation is a well-established method for treating atrial fibrillation (AF). Pulsed field ablation (PFA) is a non-thermal therapeutic alternative to radiofrequency ablation (RFA) and cryoballoon ablation (CRYO). PFA uses high-voltage electric pulses to target cells. The present analysis aims to quantify the costs, outcomes, and resources associated with these three ablation strategies for paroxysmal AF. METHODS: Real-world clinical data were prospectively collected during index hospitalization by three European medical centers (Belgium, Germany, the Netherlands) specialized in cardiac ablation. These data included procedure times (pre-procedural, skin-to-skin and post-procedural), resource use, and staff burden. Data regarding complications associated with each of the three treatment options and redo procedures were extracted from the literature. Costs were collected from hospital economic formularies and published cost databases. A cost-consequence model from the hospital perspective was built to estimate the impact of the three treatment options in terms of effectiveness and costs. RESULTS: Across the three centers, N = 91 patients were included over a period of 12 months. A significant difference was seen in pre-procedural time (mean ± SD, PFA: 13.6 ± 3.7 min, CRYO: 18.8 ± 6.6 min, RFA: 20.4 ± 6.4 min; p < .001). Procedural time (skin-to-skin) was also different across alternatives (PFA: 50.9 ± 22.4 min, CRYO: 74.5 ± 24.5 min, RFA: 140.2 ± 82.4 min; p < .0001). The model reported an overall cost of €216,535 per 100 patients treated with PFA, €301,510 per 100 patients treated with CRYO and €346,594 per 100 patients treated with RFA. Overall, the cumulative savings associated with PFA (excluding kit costs) were €850 and €1,301 per patient compared to CRYO and RFA, respectively. CONCLUSION: PFA demonstrated shorter procedure time compared to CRYO and RFA. Model estimates indicate that these time savings result in cost savings for hospitals and reduce outlay on redo procedures. Clinical practice in individual hospitals varies and may impact the ability to transfer the results of this analysis to other settings.

Asunto(s)

Fibrilación Atrial , Ablación por Catéter , Análisis Costo-Beneficio , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/economía , Masculino , Femenino , Persona de Mediana Edad , Ablación por Catéter/economía , Ablación por Catéter/métodos , Anciano , Tempo Operativo , Estudios Prospectivos , Europa (Continente) , Criocirugía/economía , Criocirugía/métodos , Complicaciones Posoperatorias/economía , Recursos en Salud/estadística & datos numéricos , Recursos en Salud/economía

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Catheter ablation of septal ventricular tachycardia (VT) is challenging. Pulsed field ablation is a promising technology, potentially reaching deep substrates. We report the first sequential unipolar biventricular pulsed field ablation targeting refractory septal VT. Besides, we illustrate the importance of searching underlying cardiomyopathy in patients with recurrent multiple morphology VTs and normal magnetic resonance imaging.

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BACKGROUND: Brugada Syndrome (BrS) is a life-threatening cardiac arrhythmia disorder associated with an increased risk ventricular arrhythmias (VAs) and sudden cardiac death (SCD). Current management primarily relies on implantable cardioverter-defibrillators (ICDs), but patients may experience ICD shocks. Catheter ablation (CA) has emerged as a potential intervention to target the arrhythmogenic substrate. This systematic review aims to evaluate the safety and efficacy of catheter ablation in BrS patients. METHODS AND RESULTS: Studies with BrS patients undergoing catheter ablation for VAs were included. 14 studies that involved a total population of 709 BrS patients, with catheter ablation performed in 528 of them, were included. Catheter ablation resulted in non-inducibility of VAs in 91% (95% CI: 83-99, I2 = 76%) and resolution of Type 1 ECG Brugada pattern in 88% (95% CI: 81-96.2, I2 = 91%) of the patients. After a mean follow-up of 30.7 months, 87% (95% CI: 80-94, I2 = 82%) of patients remained free from VAs. The incidence of VAs during follow-up was significantly lower in the ablation cohort in comparison to the group receiving only ICD therapy (OR = 0.03, 95% CI: 0.01-0.12, I2 = 0%). CONCLUSION: Catheter ablation shows potential as a therapeutic approach to reduce VAs and improve outcomes in BrS patients. While further research with long follow-up period is required to confirm these findings, it represents a valuable tool as an add-on intervention to ICD implantation in BrS patients with high burden of VAs.Protocol registration: CRD42024506439.

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BACKGROUND: Brugada syndrome (BrS) has been associated with sudden cardiac death in otherwise healthy subjects, and drug-induced BrS accounts for 55% to 70% of all patients with BrS. This study aims to develop a deep convolutional neural network and evaluate its performance in recognizing and predicting BrS diagnosis. METHODS AND RESULTS: Consecutive patients who underwent ajmaline testing for BrS following a standardized protocol were included. ECG tracings from baseline and during ajmaline were transformed using wavelet analysis and a deep convolutional neural network was separately trained to (1) recognize and (2) predict BrS type I pattern. The resultant networks are referred to as BrS-Net. A total of 1188 patients were included, of which 361 (30.3%) patients developed BrS type I pattern during ajmaline infusion. When trained and evaluated on ECG tracings during ajmaline, BrS-Net recognized a BrS type I pattern with an AUC-ROC of 0.945 (0.921-0.969) and an AUC-PR of 0.892 (0.815-0.939). When trained and evaluated on ECG tracings at baseline, BrS-Net predicted a BrS type I pattern during ajmaline with an AUC-ROC of 0.805 (0.845-0.736) and an AUC-PR of 0.605 (0.460-0.664). CONCLUSIONS: BrS-Net, a deep convolutional neural network, can identify BrS type I pattern with high performance. BrS-Net can predict from baseline ECG the development of a BrS type I pattern after ajmaline with good performance in an unselected population.

Asunto(s)

Ajmalina , Síndrome de Brugada , Aprendizaje Profundo , Electrocardiografía , Humanos , Síndrome de Brugada/diagnóstico , Síndrome de Brugada/fisiopatología , Síndrome de Brugada/inducido químicamente , Electrocardiografía/efectos de los fármacos , Masculino , Femenino , Ajmalina/efectos adversos , Persona de Mediana Edad , Adulto , Valor Predictivo de las Pruebas , Estudios Retrospectivos

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To date, studies assessing the safety profile of 3D printing materials for application in cardiac ablation are sparse. Our aim is to evaluate the safety and feasibility of two biocompatible 3D printing materials, investigating their potential use for intra-procedural guides to navigate surgical cardiac arrhythmia ablation. Herein, we 3D printed various prototypes in varying thicknesses (0.8 mm-3 mm) using a resin (MED625FLX) and a thermoplastic polyurethane elastomer (TPU95A). Geometrical testing was performed to assess the material properties pre- and post-sterilization. Furthermore, we investigated the thermal propagation behavior beneath the 3D printing materials during cryo-energy and radiofrequency ablation using an in vitro wet-lab setup. Moreover, electron microscopy and Raman spectroscopy were performed on biological tissue that had been exposed to the 3D printing materials to assess microparticle release. Post-sterilization assessments revealed that MED625FLX at thicknesses of 1 mm, 2.5 mm, and 3 mm, along with TPU95A at 1 mm and 2.5 mm, maintained geometrical integrity. Thermal analysis revealed that material type, energy source, and their factorial combination with distance from the energy source significantly influenced the temperatures beneath the 3D-printed material. Electron microscopy revealed traces of nitrogen and sulfur underneath the MED625FLX prints (1 mm, 2.5 mm) after cryo-ablation exposure. The other samples were uncontaminated. While Raman spectroscopy did not detect material release, further research is warranted to better understand these findings for application in clinical settings.