Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

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.

Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results.

AIMS: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. METHODS AND RESULTS: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. CONCLUSION: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05752487.

A simple method for radiation exposure reduction during atrial fibrillation ablation: the lead-apron-free approach.

BACKGROUND: Radiofrequency catheter ablation (RFCA) is a well-established treatment for atrial fibrillation (AF). Fluoroscopy, a widely used imaging method for RFCA, has significant implications for human health. Although no fluoroscopy or near-zero fluoroscopy strategies have gained popularity, they have limitations, such as long procedure times, additional equipment, and expertise. A simple and cost-effective radiation reduction method is needed for treating AF and is compatible with the daily workflow. We aimed to compare the efficacy and safety of fluoroscopy-free and lead apron-free (LAF) after transseptal puncture AF ablation with conventional ablation (CON). METHODS: This retrospective study included all patients who underwent RF catheter AF ablation. The lead apron used for protection was removed immediately before 3D reconstruction of the left atrium (LA) after transseptal puncture (TSP), while fluoroscopy was performed on stand-by and locked-in. The pulmonary vein isolation (PVI) was performed using a 3D mapping system, a multielectrode catheter, and a Smart Touch contact force (CF) sensing catheter, via the lead-apron-free (LAF) method, which is similar to the conventional ablation (CON) method. RESULTS: This study enrolled 152 consecutive patients, with 72 and 80 patients in the LAF and CON groups, respectively. The LAF group demonstrated significantly lower values in total fluoroscopy time (6.9 vs. 14 min, P<0.001) and dose area product (DAP) values (15.4±12.1 vs. 31.5±17.4 G/m2, P<0.001) than the CON group. However, there was no significant difference in the total procedure time (83.6±21.1 vs. 77.2±11.4 min, P=0.12) between the two groups. Only four procedures (5.5%) required repositioning of the apron, and no complications were observed with the LAF method. Pulmonary vein isolation was achieved in all patients. CONCLUSIONS: The LAF method reduced fluoroscopy use compared with CON, with no change in procedure time or efficacy.

Machine-Learning-Based Prediction of 1-Year Arrhythmia Recurrence after Ventricular Tachycardia Ablation in Patients with Structural Heart Disease.

BACKGROUND: Ventricular tachycardia (VT) recurrence after catheter ablation remains a concern, emphasizing the need for precise risk assessment. We aimed to use machine learning (ML) to predict 1-month and 1-year VT recurrence following VT ablation. METHODS: For 337 patients undergoing VT ablation, we collected 31 parameters including medical history, echocardiography, and procedural data. 17 relevant features were included in the ML-based feature selection, which yielded six and five optimal features for 1-month and 1-year recurrence, respectively. We trained several supervised machine learning models using 10-fold cross-validation for each endpoint. RESULTS: We observed 1-month VT recurrence was observed in 60 (18%) cases and accurately predicted using our model with an area under the receiver operating curve (AUC) of 0.73. Input features used were hemodynamic instability, incessant VT, ICD shock, left ventricular ejection fraction, TAPSE, and non-inducibility of the clinical VT at the end of the procedure. A separate model was trained for 1-year VT recurrence (observed in 117 (35%) cases) with a mean AUC of 0.71. Selected features were hemodynamic instability, the number of inducible VT morphologies, left ventricular systolic diameter, mitral regurgitation, and ICD shock. For both endpoints, a random forest model displayed the highest performance. CONCLUSIONS: Our ML models effectively predict VT recurrence post-ablation, aiding in identifying high-risk patients and tailoring follow-up strategies.

Picking the Locked Door: Experiences and Techniques in Transseptal Puncture Post-Atrial Septal Defect Occlusion.

The management of atrial septal defects (ASDs) has been revolutionized by the advent of percutaneous transvenous occlusion devices. This case series describes techniques required to perform a transeptal puncture safely and effectively in patients postimplantation of an atrial septal defect occluder to facilitate catheter ablation of atrial arrhythmias. (Level of Difficulty: Intermediate.).

The impact of steerable sheath visualization during catheter ablation for atrial fibrillation.

AIMS: Incorporating a steerable sheath that can be visualized using an electroanatomical mapping (EAM) system may allow for more efficient mapping and catheter placement, while reducing radiation exposure, during ablation procedures for atrial fibrillation (AF). This study evaluated fluoroscopy usage and procedure times when a visualizable steerable sheath was used compared with a non-visualizable steerable sheath for catheter ablation for AF. METHODS AND RESULTS: In this retrospective, observational, single-centre study, patients underwent catheter ablation for AF using a steerable sheath that is visualizable using the CARTO EAM (VIZIGO; n = 57) or a non-visualizable steerable sheath (n = 34). The acute procedural success rate was 100%, with no acute complications in either group. Use of the visualizable sheath vs. the non-visualizable sheath was associated with a significantly shorter fluoroscopy time [median (first quartile, third quartile), 3.4 (2.1, 5.4) vs. 5.8 (3.8, 8.6) min; P = 0.003], significantly lower fluoroscopy dose [10.0 (5.0, 20.0) vs. 18.5 (12.3, 34.0) mGy; P = 0.015], and significantly lower dose area product [93.0 (48.0, 197.9) vs. 182.2 (124.5, 355.0) µGy·m2; P = 0.017] but with a significantly longer mapping time [12.0 (9.0, 15.0) vs. 9.0 (7.0, 11.0) min; P = 0.004]. There was no significant difference between the visualizable and non-visualizable sheaths in skin-to-skin time [72.0 (60.0, 82.0) vs. 72.0 (55.5, 80.8) min; P = 0.623]. CONCLUSION: In this retrospective study, use of a visualizable steerable sheath for catheter ablation of AF significantly reduced radiation exposure vs. a non-visualizable steerable sheath. Although mapping time was longer with the visualizable sheath, the overall procedure time was not increased.

High incidence of newly diagnosed obstructive coronary artery disease regardless of chest pain detected on pre-procedural cardiac computed tomography angiography in patients undergoing atrial fibrillation ablation.

BACKGROUND: Cardiac computed tomography (CT) is often performed before catheter ablation of atrial fibrillation to map atrial and pulmonary anatomy. Incident coronary artery disease (CAD) may also be diagnosed during cardiac CT angiography (CTA). Our aim was to assess whether coronary CTA might be able to identify a significant proportion of patients with obstructive CAD prior to their catheter ablation procedure event, even in asymptomatic patients. METHODS: Consecutive patients undergoing pre-ablation coronary CTA for atrial fibrillation between 2013 and 2020 were retrospectively selected. Patients with previously diagnosed CAD were excluded. Obstructive CAD was defined as ≥50% luminal stenosis. We analyzed the relationship between obstructive CAD, any chest pain, and traditional risk factors. RESULTS: Overall, 2321 patients [median age 63.0 (54.4-69.2), 1052/2321 (45.3%) female] underwent coronary CTA and 488/2321 (21.0%) were diagnosed with obstructive CAD. There was no difference regarding the rate of obstructive CAD in patients with any chest pain compared to patients without any chest pain [91/404 (22.5%) vs. 397/1917 (20.7%), P = 0.416, respectively). The following parameters were associated with obstructive CAD: age > 65 years [odds ratio (OR) = 2.51; 95% confidence interval (CI), 2.02-3.13; P < 0.001), male sex (OR = 1.59; 95% CI, 1.28-1.98; P < 0.001), hypertension (OR = 1.40; 95% CI, 1.08-1.81; P = 0.012), diabetes (OR = 1.50; 95% CI, 1.13-1.99; P = 0.006), dyslipidaemia (OR = 1.33; 95% CI, 1.07-1.66; P = 0.011) and history of smoking (OR = 1.34; 95% CI, 1.07-1.68; P = 0.011). CONCLUSIONS: The high prevalence of obstructive CAD even in patients without chest pain highlights the importance of additional coronary artery diagnostics in patients undergoing left atrial CTA awaiting catheter ablation for atrial fibrillation. These patients regardless of chest pain thus may require further risk modification to decrease their potential ischemic and thromboembolic risk.

Sex differences in one-year recurrence and all-cause mortality following catheter ablation of ventricular tachycardia in structural heart disease.

Aims: We aimed to establish sex-specific predictors for 1-year VT recurrence and 1-year all-cause mortality in patients with structural heart disease undergoing catheter ablation. Methods: We analyzed data of 299 patients recorded in our structured registry. These included medical history, echocardiography parameters, laboratory results, VT properties, procedural data. Results: Out of the 299 patients, 34 (11%) were female. No significant difference was found between women and men in terms of VT recurrence (p = 0.74) or mortality (p = 0.07). In females, severe mitral regurgitation (MR), tricuspid regurgitation (TR), presentation with incessant VT, and preprocedural electrical storm (ES) were associated with increased risk of VT recurrence. Diabetes, implanted CRT, VT with hemodynamic instability, ES and advanced MR were the risk factors of mortality in women. ACEi/ARB use predicted a favorable outcome in both endpoints among females. In men, independent predictors of VT recurrence were the composite parameter of ES and multiple ICD therapies, presentation with incessant VT, severe MR, while independent predictors of mortality were age, LVEF, creatinine and previously implanted CRT. Conclusion: According to our investigation, there are pronounced sex differences in predictors of recurrence and mortality following VT ablation.

Selection of an impedance- or magnetic field-based electro-anatomical mapping platform does not affect outcomes of outflow tract premature ventricular complex manual ablation.

Comparative data are virtually missing about the performance of different electro-anatomical mapping (EAM) system platforms on outflow tract (OT) premature ventricular complex (PVC) ablation outcomes with manual ablation catheters. We aimed to compare the acute success-, complication-, and long-term recurrence rates of impedance-based (IMP) and magnetic field-based (MAG) EAM platforms in manual OT PVC ablation. Single-centre, propensity score matched data of 39-39 patients ablated for OT PVCs in 2015-17 with IMP or MAG platforms were analysed. Acute success rate, peri-procedural complications, post-ablation daily PVC burden, and long-term recurrence rates were compared on intention-to-treat basis. Acute success rate was similar in the IMP and MAG group (77 vs. 82%, p = 0.78). There was a single case of femoral pseudo-aneurysm and no cardiac tamponade occurred. PVC burden fell significantly from baseline 24.0% [15.0-30.0%] to 3.3% [0.25-10.5%] (p < 0.001) post-ablation, with no difference between EAM platforms (IMP: 2.6% [0.5-12.0%] vs. MAG: 4.0% [2.0-6.5%]; p = 0.60). There was no significant difference in recurrence-free survival of the intention-to-treat cohort of the IMP and MAG groups (54 vs. 60%, p = 0.82, respectively) during 12 months of follow-up. Ablation with the aid of both impedance- and magnetic field-based EAM platforms can considerably reduce OT PVC burden and give similar acute- and long-term freedom from arrhythmia.

Abutting Left Atrial Appendage and Left Superior Pulmonary Vein Predicts Recurrence of Atrial Fibrillation After Point-by-Point Pulmonary Vein Isolation.

INTRODUCTION: The role of the spatial relationship between the left superior pulmonary vein (LSPV) and left atrial appendage (LAA) is unknown. We sought to evaluate whether an abutting LAA and LSPV play a role in AF recurrence after catheter ablation for paroxysmal AF. METHODS: Consecutive patients, who underwent initial point-by-point radiofrequency catheter ablation for paroxysmal AF at the Heart and Vascular Center of Semmelweis University, Budapest, Hungary, between January of 2014 and December of 2017, were enrolled in the study. All patients underwent pre-procedural cardiac CT to assess left atrial (LA) and pulmonary vein (PV) anatomy. Abutting LAA-LSPV was defined as cases when the minimum distance between the LSPV and LAA was less than 2 mm. RESULTS: We included 428 patients (60.7 ± 10.8 years, 35.5% female) in the analysis. AF recurrence rate was 33.4%, with a median recurrence-free time of 21.2 (8.8-43.0) months. In the univariable analysis, female sex (HR = 1.45; 95%CI = 1.04-2.01; p = 0.028), LAA flow velocity (HR = 1.01; 95%CI = 1.00-1.02; p = 0.022), LAA orifice area (HR = 1.00; 95%CI = 1.00-1.00; p = 0.028) and abutting LAA-LSPV (HR = 1.53; 95%CI = 1.09-2.14; p = 0.013) were associated with AF recurrence. In the multivariable analysis, abutting LAA-LSPV (adjusted HR = 1.55; 95%CI = 1.04-2.31; p = 0.030) was the only independent predictor of AF recurrence. CONCLUSION: Abutting LAA-LSPV predisposes patients to have a higher chance for arrhythmia recurrence after catheter ablation for paroxysmal AF.

Orientation of the right superior pulmonary vein affects outcome after pulmonary vein isolation.

AIMS: Controversial results have been published regarding the influence of pulmonary vein (PV) anatomical variations on outcomes after pulmonary vein isolation (PVI). However, no data are available on the impact of PV orientation on the long-term success rates of point-by-point PVI. We sought to determine the impact of PV anatomy and orientation on atrial fibrillation (AF)-free survival in patients undergoing PVI using the radiofrequency point-by-point technique. METHODS AND RESULTS: We retrospectively included 448 patients who underwent initial point-by-point radiofrequency ablation for AF at our department. Left atrial computed tomography angiography was performed before each procedure. PV anatomical variations, ostial parameters (area, effective diameter, and eccentricity), orientation, and their associations with 24-month AF-free survival were analysed. PV anatomical variations and ostial parameters were not predictive for AF-free survival (all P > 0.05). Univariate analysis showed that female sex (P = 0.025) was associated with higher rates of AF recurrence, ventral-caudal (P = 0.002), dorsal-cranial (P = 0.034), and dorsal-caudal (P = 0.042) orientation of the right superior PV (RSPV), on the other hand, showed an association with lower rates of AF recurrence, when compared with the reference ventral-cranial orientation. On multivariate analysis, both female sex [odds ratio (OR) 1.83, 95% CI 1.15-2.93, P = 0.011] and ventral-caudal RSPV orientation, compared with ventral-cranial orientation, proved to be independent predictors of 24-month AF recurrence (OR 0.37, 95% CI 0.19-0.71, P = 0.003). CONCLUSION: Female sex and ventral-caudal RSPV orientation have an impact on long-term arrhythmia-free survival. Assessment of PV orientation may be a useful tool in predicting AF-free survival and may contribute to a more personalized management of AF.

Risk scores in cardiac resynchronization therapy-A review of the literature.

Cardiac resynchronization therapy (CRT) for selected heart failure (HF) patients improves symptoms and reduces morbidity and mortality; however, the prognosis of HF is still poor. There is an emerging need for tools that might help in optimal patient selection and provide prognostic information for patients and their families. Several risk scores have been created in recent years; although, no literature review is available that would list the possible scores for the clinicians. We identified forty-eight risk scores in CRT and provided the calculation methods and formulas in a ready-to-use format. The reviewed score systems can predict the prognosis of CRT patients; some of them have even provided an online calculation tool. Significant heterogeneity is present between the various risk scores in terms of the variables incorporated and some variables are not yet used in daily clinical practice. The lack of cross-validation of the risk scores limits their routine use and objective selection. As the number of prognostic markers of CRT is overwhelming, further studies might be required to analyze and cross-validate the data.

Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures.

OBJECTIVE: Pulmonary vein isolation (PVI) is the cornerstone of the interventional treatment of atrial fibrillation (AF). Traditionally, during these procedures the catheters are guided by fluoroscopy, which poses a risk to the patient and staff by ionizing radiation. Our aim was to describe our experience in the implementation of an intracardiac echocardiography (ICE) guided zero fluoroscopic (ZF) ablation approach to our routine clinical practice. METHODS: We developed a simplified ICE guided technique to perform ablation procedures for AF, with the aid of a 3D electroanatomical mapping system. The workflow was implemented in two phases: (1) the Introductory phase, where the first 16 ZF PVIs were compared with 16 cases performed with fluoroscopy and (2) the Extension phase, where 71 consecutive patients (including repeat procedures) with ZF approach were included. Standard PVI (and redoPVI) procedures were performed, data on feasibility of the ZF approach, complications, acute and 1-year success rates were collected. RESULTS: In the Introductory phase, 94% of the procedures could be performed with complete ZF with a median procedure time of 77.5 (73.5-83) minutes. In one case fluoroscopy was used to guide the ICE catheter to the atrium. There was no difference in the complication, acute and 1-year success rates, compared with fluoroscopy guided procedures. In the Extension phase, 97% of the procedures could be completed with complete ZF. In one case fluoroscopy was used to guide the transseptal puncture and in another to position the ICE catheter. Acute success of PVI was achieved in all cases, 64.4% patients were arrhythmia free at 1-year. Acute major complications were observed in 4 cases, all of these occurred in the redo PVI group and consisted of 2 tamponades, 1 transient ischemic attack and 1 pseudoaneurysm at the puncture site. The procedures were carried out by all members of the electrophysiology unit in the Extension phase, including less experienced operators and electrophysiology fellows (3 physicians) under the supervision of the senior electrophysiologist. Consequently, procedure times became longer [90 (75-105) vs 77.5 (73.5-85) min, p = 0.014]. CONCLUSIONS: According to our results, a ZF workflow of AF ablations can be successfully implemented into the routine practice of an electrophysiology laboratory, without compromising safety and effectivity.

Classification of Left Atrial Diseased Tissue Burden Determined by Automated Voltage Analysis Predicts Outcomes after Ablation for Atrial Fibrillation.

BACKGROUND: The burden and persistence of atrial fibrillation (AF) have been associated with the presence and extent of left atrial (LA) fibrosis. Recent reports have implicated an association between the extent of LA fibrosis and the outcome of pulmonary vein isolation (PVI). We aimed to analyse the value of an automated scar quantification method in the prediction of success following PVI. METHODS: One hundred and nine consecutive patients undergoing PVI for paroxysmal or persistent AF were included in our observational study with a 2-year follow-up. Prior to PVI, patients underwent high-definition LA electroanatomical mapping, and scar burden was quantified by automated software (Voltage Histogram Analysis, CARTO 3, Biosense Webster), then classified into 4 subgroups (Dublin Classes I-IV). Recurrence rates were analysed on and off antiarrhythmic drug therapy (AAD), respectively. RESULTS: The overall success rate was 74% and 67% off AAD at 1- and 2-year follow-up, respectively. Patients with Dublin Class IV had significantly lower success rates (p = 0.008, off AAD). Dublin Class IV (OR = 2.27, p = 0.022, off AAD) and the presence of arrhythmia in the blanking period (OR = 3.28, p = 0.001, off AAD) were the only significant predictors of recurrence. The use of AAD did not affect these results. CONCLUSIONS: We propose a classification of low voltage areas based on automated quantification by software during 3D mapping prior to PVI. Patients with high burden of low voltage areas (>31% of <0.5 mV, Dublin Class IV) have a higher risk of recurrence following PVI. Information gathered during electroanatomical mapping may have important prognostic value.

Quality of life and healthcare utilisation improvements after atrial fibrillation ablation.

OBJECTIVE: Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement. METHODS: CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05. RESULTS: Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1-37.5 points and 33.3%-50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA2DS2-VASc scores at baseline, and higher AF burden following PVI. CONCLUSIONS: QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation. TRIAL REGISTRATION NUMBER: NCT03062046.

Similar outcomes with manual contact force ablation catheters and traditional catheters in the treatment of outflow tract premature ventricular complexes.

AIMS: Unlike in atrial fibrillation ablation, there is a lack of appropriately sized and properly designed studies regarding outflow tract (OT) premature ventricular complex (PVC) ablation outcomes with contact force sensing (CFS) catheters. We aimed to compare the acute success-, complication-, and long-term recurrence rates of manual CFS catheters with traditional irrigated catheters (T) in OT PVC ablation. METHODS AND RESULTS: Single-centre, propensity-matched data of 75-75 patients ablated for right-sided OT (RVOT) or left-sided OT (LVOT) PVCs in 2015-17 with CFS or T catheters were compared. Acute success rate, peri-procedural complications, post-procedural daily PVC burden, and long-term recurrence rates were compared on intention-to-treat basis. Acute success rate equalled 80% in both groups, with no difference in force values in the CFS group comparing successful or failed cases [12.0 (8.75-17.0) vs. 16.0 (10.25-22.25) g, P = 0.21]. There were three cases of pseudo-aneurysm and one cardiac tamponade. PVC burden fell significantly from baseline 22 (15-30)% to 2 (0-10)% (P < 0.0001), with no difference between catheter types [CFS: 1 (0-7)% vs. T: 4 (1-12) %; P = 0.21]. There was no significant difference in recurrence-free survival of CFS and T catheters (58 vs. 59%, P = 0.29) during 12 months of follow-up, respectively. Recurrence in the CFS group did not differ either by the force exerted below or above the median value of 12 g (P = 0.66). CONCLUSION: Both types of catheters can effectively reduce OT PVC burden with minimal serious complication rates. Ablation with CFS or T catheters gives similar acute- and long-term results.

Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial.

AIMS: To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. METHODS AND RESULTS: This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4-86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8-82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8-87.0%). Freedom fromrepeat ablations by the Kaplan-Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9-6.3%). CONCLUSIONS: The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres.Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.

The Value of Voltage Histogram Analysis Derived Right Atrial Scar Burden in the Prediction of Left Atrial Scar Burden.

INTRODUCTION: Growing evidence suggests that fibrotic changes can be observed in atrial fibrillation (AF) in both atria. Quantification of the scar burden during electroanatomical mapping might have important therapeutic and prognostic consequences. However, as the current invasive treatment of AF is focused on the left atrium (LA), the role of the right atrium (RA) is less well understood. We aimed to characterize the clinical determinates of the RA low-voltage burden and its relation to the LA scaring. METHODS: We have included 36 patients who underwent catheter ablation for AF in a prospective observational study. In addition to LA mapping and ablation, high-density RA bipolar voltage maps (HD-EAM) were also reconstructed. The extent of the diseased RA tissue (≤0.5 mV) was quantified using the voltage histogram analysis tool (CARTO®3, Biosense Webster). RESULTS: The percentage of RA diseased tissue burden was significantly higher in patients with a CHA2DS2-VASc score ≥ 2 (p = 0.0305), higher indexed LA volume on the CTA scan and on the HD-EAM (p = 0.0223 and p = 0.0064, respectively), or higher indexed RA volume on the HD-EAM (p = 0.0026). High RA diseased tissue burden predicted the presence of high LA diseased tissue burden (OR = 7.1, CI (95%): 1.3-38.9, p = 0.0145), and there was a significant correlation of the same (r = 0.6461, p < 0.0001). CONCLUSIONS: Determining the extent of the right atrial low-voltage burden might give useful clinical information. According to our results, the diseased tissue burden correlates well between the two atria: the right atrium mirrors the left atrium.

Machine learning-based mortality prediction of patients undergoing cardiac resynchronization therapy: the SEMMELWEIS-CRT score.

AIMS: Our aim was to develop a machine learning (ML)-based risk stratification system to predict 1-, 2-, 3-, 4-, and 5-year all-cause mortality from pre-implant parameters of patients undergoing cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Multiple ML models were trained on a retrospective database of 1510 patients undergoing CRT implantation to predict 1- to 5-year all-cause mortality. Thirty-three pre-implant clinical features were selected to train the models. The best performing model [SEMMELWEIS-CRT score (perSonalizEd assessMent of estiMatEd risk of mortaLity With machinE learnIng in patientS undergoing CRT implantation)], along with pre-existing scores (Seattle Heart Failure Model, VALID-CRT, EAARN, ScREEN, and CRT-score), was tested on an independent cohort of 158 patients. There were 805 (53%) deaths in the training cohort and 80 (51%) deaths in the test cohort during the 5-year follow-up period. Among the trained classifiers, random forest demonstrated the best performance. For the prediction of 1-, 2-, 3-, 4-, and 5-year mortality, the areas under the receiver operating characteristic curves of the SEMMELWEIS-CRT score were 0.768 (95% CI: 0.674-0.861; P < 0.001), 0.793 (95% CI: 0.718-0.867; P < 0.001), 0.785 (95% CI: 0.711-0.859; P < 0.001), 0.776 (95% CI: 0.703-0.849; P < 0.001), and 0.803 (95% CI: 0.733-0.872; P < 0.001), respectively. The discriminative ability of our model was superior to other evaluated scores. CONCLUSION: The SEMMELWEIS-CRT score (available at semmelweiscrtscore.com) exhibited good discriminative capabilities for the prediction of all-cause death in CRT patients and outperformed the already existing risk scores. By capturing the non-linear association of predictors, the utilization of ML approaches may facilitate optimal candidate selection and prognostication of patients undergoing CRT implantation.