Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Pulsed-field versus cryoballoon ablation for atrial fibrillation-Impact of energy source on sedation and analgesia requirement.

INTRODUCTION: Pulsed field ablation (PFA) represents a novel, nonthermal energy modality that can be applied for single-shot pulmonary vein isolation (PVI) in atrial fibrillation (AF). Comparative data with regard to deep sedation to established single-shot modalities such as cryoballoon (CB) ablation are scarce. The aim of this study was to compare a deep sedation protocol in patients receiving PVI with either PFA or CB. METHODS: Prospective, consecutive AF patients undergoing PVI with a pentaspline PFA catheter were compared to a retrospective CB-PVI cohort of the same timeframe. Study endpoints were the requirements of analgesics, cardiorespiratory stability, and sedation-associated complications. RESULTS: A total of 100 PVI patients were included (PFA n = 50, CB n = 50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). Requirement of propofol, midazolam, and sufentanyl was significantly higher in the PFA group compared to CB [propofol 0.14 ± 0.04 mg/kg/min in PFA vs. 0.11 ± 0.04 mg/kg/min in CB (p = .001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA vs. 0.0006295 ± 0.0003 mg/kg/min in CB (p = .002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA vs. 0.0008 ± 0.0004 µg/kg/min in CB (p < .0001)]. Sedation-associated complications did not differ between both groups (PFA n = 1/50 mild aspiration pneumonia, CB n = 0/50, p > .99). Nonsedation-associated complications (PFA: n = 2/50, 4%, CB: n = 1/50, 2%, p > .99) and procedure times (PFA 75 ± 31, CB 84 ± 32 min, p = .18) did not differ between groups. CONCLUSIONS: PFA is associated with higher sedation and especially analgesia requirements. However, the safety of deep sedation does not differ to CB ablation.

Contemporary catheter ablation of complex atrial tachycardias after prior atrial fibrillation ablation: pulsed field vs. radiofrequency current energy ablation guided by high-density mapping.

AIMS: Catheter ablation (CA) of post-ablation left atrial tachycardias (LATs) can be challenging. So far, pulsed field ablation (PFA) has not been compared to standard point-by-point radiofrequency current (RFC) energy for LAT ablation. To compare efficacy of PFA vs. RFC in patients undergoing CA for LAT. METHODS AND RESULTS: Consecutive patients undergoing LAT-CA were prospectively enrolled (09/2021-02/2023). After electro-anatomical high-density mapping, ablation with either a pentaspline PFA catheter or RFC was performed. Patients were matched 1:1. Ablation was performed at the assumed critical isthmus site with additional ablation, if necessary. Right atrial tachycardia (RAT) was ablated with RFC. Acute and chronic success were assessed. Fifty-six patients (n = 28 each group, age 70 ± 9 years, 75% male) were enrolled.A total of 77 AT (n = 67 LAT, n = 10 RAT; 77% macroreentries) occurred with n = 32 LAT in the PFA group and n = 35 LAT in the RFC group. Of all LAT, 94% (PFA group) vs. 91% (RFC group) successfully terminated to sinus rhythm or another AT during ablation (P = 1.0). Procedure times were shorter (PFA: 121 ± 41 vs. RFC: 190 ± 44 min, P < 0.0001) and fluoroscopy times longer in the PFA group (PFA: 15 ± 9 vs. RFC: 11 ± 6 min, P = 0.04). There were no major complications. After one-year follow-up, estimated arrhythmia free survival was 63% (PFA group) and 87% (RFC group), [hazard ratio 2.91 (95% CI: 1.11-7.65), P = 0.0473]. CONCLUSION: Pulsed field ablation of post-ablation LAT using a pentaspline catheter is feasible, safe, and faster but less effective compared to standard RFC ablation after one year of follow-up. Future catheter designs and optimization of the electrical field may further improve practicability and efficacy of PFA for LAT.

Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study.

AIMS: Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF. METHODS AND RESULTS: FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure. CONCLUSION: In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety. REGISTRATION: Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).

A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

A novel wide-band dielectric imaging system to guide radiofrequency ablation for pulmonary vein isolation.

INTRODUCTION: Recently, the wide-band dielectric mapping system Kodex-EPD was introduced. This study reports the first clinical experience using a novel system to guide pulmonary vein isolation (PVI) with radiofrequency (RF) ablation. METHODS AND RESULTS: The study included 20 consecutive patients undergoing de-novo PVI for symptomatic paroxysmal or persistent atrial fibrillation guided by Kodex-EPD. The primary efficacy endpoint was successful PVI. Secondary endpoints included procedural parameters and complications. In all 20 patients (mean age 68 ± 8 years, 12 male patients, paroxysmal fibrillation in 14/20 [70%] patients), PVI was successfully completed. One patient underwent additional cavo-tricuspid isthmus ablation for concomitant typical atrial flutter and one patient required additional ablation of a focal atrial tachycardia. A conventional three-dimensional image of the left atrium as well as the innovative endocardial panoramic view were used to guide catheter manipulation and ablation. Median procedure time was 115 [1st; 3rd quartile 93,75; 140] min and median total fluoroscopy time was 9.9 [9.7; 11.2] min, of which a median of 0.8 [0.6; 0.9] min was required to create left atrial maps. Complete left atrial imaging using Kodex-EPD was achieved within a median of 7.1 [5.7; 8.3] min. Median RF ablation time was 45.1 [34.6; 58.7] min. No major complications were observed. CONCLUSION: RF ablation PVI guided by Kodex-EPD seems safe and feasible. The system provides effective three-dimensional guidance for PVI.

Pulsed field ablation in patients with complex consecutive atrial tachycardia in conjunction with ultra-high density mapping: Proof of concept.

INTRODUCTION: Catheter-ablation (CA) of consecutive left atrial tachycardias (LAT) can be challenging. Pulsed field ablation (PFA) yields a novel nonthermal CA technology for treatment of atrial fibrillation (AF). There is no data regarding PFA of LAT. This study sought to investigate PFA of consecutive LAT following prior CA of AF. METHODS: Consecutive patients with LAT underwent ultrahigh-density (UHDx) mapping. Subsequent to identification of the AT mechanism, PFA was performed at the assumed critical sites for LAT maintenance. Continuous ablation lines were performed if required and evaluated with pre- and post-PFA HDx-mapping. RESULTS: Fifteen patients (age 70 ± 10, male 73%) who underwent 3.6 ± 2 prior AF-CA procedures were included. The total mean procedure and fluoroscopy times were 141 ± 43 and 18 ± 10 min, respectively. All 19 of 19 (100%) LAT were successfully ablated with PFA. Two AT located at the right atria required RF-ablation. LAT were identified as localized reentry (n = 1) and macro-reentry LAT (n = 18) and targeted with PFA. All LAT terminated with PFA either to sinus rhythm (9/15) or a secondary AT (6/15 and subsequently to SR); 63% (12/19) terminated with the first PFA-application. All lines (13 roof, 11 anterior, 1 mitral) were blocked. LA-posterior-wall isolation (LAPWI) was successfully achieved when performed (10/10). AF/AT free survival was 80% (12/15) after 153 [88-207] days of follow-up. No procedure-related complications occurred. CONCLUSION: PFA of consecutive LAT is feasible and safe. Successful creation of ablation lines and LAPWI can be achieved in a short time. PFA may offer the opportunity for effective ablation of atrial arrhythmias beyond AF.

Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations.

BACKGROUND: Pulsed-field ablation (PFA) yields a novel ablation technology for atrial fibrillation (AF). PFA lesions promise to be highly durable, however clinical data on lesion characteristics are still limited. OBJECTIVE: This study sought to investigate PFA lesion creation with ultrahigh-density (UHDx) mapping. METHODS: Consecutive AF patients underwent PFA-based pulmonary vein isolation (PVI) using a multispline catheter (Farwave, Farapulse Inc.). Additional ablation, including left atrial posterior wall isolation (LAPWI) and mitral isthmus ablation (MI) were performed in a subset of persistent AF patients. The extent of PFA-lesions and decrease of LA-voltage were assessed with pre- and post PFA UHDx-mapping (Orion™ catheter and Rhythmia™ 3D-mapping system, Boston Scientific). RESULTS: In 20 patients, acute PVI was achieved in 80/80 PVs, LAPW isolation in 9/9 patients, MI ablation in 2/2 (procedure time: 123 ± 21.6 min, fluoroscopy time: 19.2 ± 5.5 min). UHDx-mapping subsequent to PVI revealed early PV-reconnection in five case (5/80, 6.25%). Gaps were located at the anterior-superior PV ostia and were successfully targeted with additional PFA. Repeat UHDx mapping after PFA revealed a significant decrease of voltage along the PV ostia (1.67 ± 1.36 mV vs. 0.053 ± 0.038 mV, p < .0001) with almost no complex electrogram-fractionation at the lesion border zones. PFA-catheter visualization within the mapping system was feasible in 17/19 (84.9%) patients and adequate in 92.9% of ablation sites. CONCLUSION: For the first time illustrated by UHDx mapping, PFA creates wide antral circumferential lesions and homogenous LAPW isolation with depression of tissue voltage to a minimum. Although with a low incidence, early PV reconnection can still occur also in the setting of PFA.

Atrial fibrillation progression and the importance of early treatment for improving clinical outcomes.

Over time, atrial fibrillation (AF) naturally progresses from initially paroxysmal to persistent/permanent AF caused by structural and electrical remodelling with a complex underlying pathogenesis. It has been demonstrated that this progression of AF itself is linked to negative cardiovascular outcomes (stroke, systemic embolism, and hospitalization due to heart failure). Consequently, there is a profound rationale for early treatment of AF as a cornerstone of AF management. Recent randomized trials produced evidence that early rhythm control is effective in maintaining sinus rhythm, lower the risk of cardiovascular outcomes, and that catheter ablation of AF is effective to delay AF progression. This review will illuminate current evidence regarding the hypothesis of early AF treatment to prevent AF progression and improve clinical outcomes.

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Comparison of machine learning methods with logistic regression analysis in creating predictive models for risk of critical in-hospital events in COVID-19 patients on hospital admission.

BACKGROUND: Machine learning (ML) algorithms have been trained to early predict critical in-hospital events from COVID-19 using patient data at admission, but little is known on how their performance compares with each other and/or with statistical logistic regression (LR). This prospective multicentre cohort study compares the performance of a LR and five ML models on the contribution of influencing predictors and predictor-to-event relationships on prediction model´s performance. METHODS: We used 25 baseline variables of 490 COVID-19 patients admitted to 8 hospitals in Germany (March-November 2020) to develop and validate (75/25 random-split) 3 linear (L1 and L2 penalty, elastic net [EN]) and 2 non-linear (support vector machine [SVM] with radial kernel, random forest [RF]) ML approaches for predicting critical events defined by intensive care unit transfer, invasive ventilation and/or death (composite end-point: 181 patients). Models were compared for performance (area-under-the-receiver-operating characteristic-curve [AUC], Brier score) and predictor importance (performance-loss metrics, partial-dependence profiles). RESULTS: Models performed close with a small benefit for LR (utilizing restricted cubic splines for non-linearity) and RF (AUC means: 0.763-0.731 [RF-L1]); Brier scores: 0.184-0.197 [LR-L1]). Top ranked predictor variables (consistently highest importance: C-reactive protein) were largely identical across models, except creatinine, which exhibited marginal (L1, L2, EN, SVM) or high/non-linear effects (LR, RF) on events. CONCLUSIONS: Although the LR and ML models analysed showed no strong differences in performance and the most influencing predictors for COVID-19-related event prediction, our results indicate a predictive benefit from taking account for non-linear predictor-to-event relationships and effects. Future efforts should focus on leveraging data-driven ML technologies from static towards dynamic modelling solutions that continuously learn and adapt to changes in data environments during the evolving pandemic. TRIAL REGISTRATION NUMBER: NCT04659187.

A Simplified Approach to Pulmonary Vein Visualization during Cryoballoon Ablation of Atrial Fibrillation.

Background and Objectives: Selective pulmonary vein (PV) angiography has been established as the gold standard for PV visualization in cryoballoon (CB)-based pulmonary vein isolation (PVI). We sought to simplify this approach to reduce procedural complexity and radiation exposure. Materials and Methods: Patients with paroxysmal and recently diagnosed persistent AF undergoing CB-based PVI from January 2015 to December 2017 were retrospectively analyzed. Patients underwent either selective PV angiography or conventional left atrial (LA) angiography for PV visualization. Results: A total of 336 patients were analyzed. A total of 87 patients (26%) received PV angiography and 249 (74%) LA angiography. LA angiography required fewer cine-sequences for PV visualization, translating into a significant reduction in procedure duration, fluoroscopy time and dose area product. Additionally, less contrast medium was utilized. PV occlusion by the CB, CB temperature and time to isolation showed no significant differences. The number of CB applications and total application time (LA angiography: 1.4 ± 0.02 vs. PV Angiography: 1.6 ± 0.05; p < 0.0001; LA angiography: 297.9 ± 4.62 vs. PV-Angiography: 348.9 ± 11.03; p < 0.001, respectively) per vein were slightly but significantly higher in the PV angiography group. We observed no difference in late AF recurrence (24.7% LA angiography vs. 21.3% PV angiography; p = 0.2657). Conclusions: A simplified protocol, using LA angiography for PV visualization, entails a reduction in procedure time and radiation exposure while equally maintaining procedural efficiency and safety in both groups.

Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial.

AIMS: Weight management seems to be beneficial for obese atrial fibrillation (AF) patients; however, randomized data are sparse. Thus, this study aimed to investigate the influence of weight reduction on AF ablation outcomes. METHODS AND RESULTS: SORT-AF is an investigator-sponsored, prospective, randomized, multicentre, and clinical trial. Patients with symptomatic AF (paroxysmal or persistent) and body mass index (BMI) 30-40 kg/m2 underwent AF ablation and were randomized to either weight-reduction (group 1) or usual care (group 2), after sleep-apnoea-screening and loop recorder (ILR) implantation. The primary endpoint was defined as AF burden between 3 and 12 months after AF ablation. Overall, 133 patients (60 ± 10 years, 57% persistent AF) were randomized to group 1 (n = 67) and group 2 (n = 66), respectively. Complications after AF-ablation were rare (one stroke and no tamponade). The intervention led to a significant reduction of BMI (34.9 ± 2.6-33.4 ± 3.6) in group 1 compared to a stable BMI in group 2 (P < 0.001). Atrial fibrillation burden after ablation decreased significantly (P < 0.001), with no significant difference regarding the primary endpoint between the groups (P = 0.815, odds ratio: 1.143, confidence interval: 0.369-3.613). Further analyses showed a significant correlation between BMI and AF recurrence for patients with persistent AF compared with paroxysmal AF patients (P = 0.032). CONCLUSION: The SORT-AF study shows that AF ablation is safe and successful in obese patients using continuous monitoring via ILR. Although the primary endpoint of AF burden after ablation did not differ between the two groups, the effects of weight loss and improvement of exercise activity were beneficial for obese patients with persistent AF demonstrating the relevance of life-style management as an important adjunct to AF ablation in this setting. TRIAL REGISTRATION NUMBER: NCT02064114.

Ultra-high-density mapping of conduction gaps and atrial tachycardias: Distinctive patterns following pulmonary vein isolation with cryoballoon or contact-force-guided radiofrequency current.

INTRODUCTION: The aim of this study was to investigate electrophysiological findings in patients with arrhythmia recurrence undergoing a repeat ablation procedure using ultra-high-density (UHDx) mapping following an index procedure using either contact-force (CF)-guided radiofrequency current (RFC) pulmonary vein isolation (PVI) or second-generation cryoballoon (CB) PVI for treatment of atrial fibrillation (AF). METHODS AND RESULTS: Fifty consecutive patients with recurrence of AF and/or atrial tachycardia (AT) following index CF-RFC PVI (n = 21) or CB PVI (n = 29) were included. A 64-pole mini-basket mapping catheter in combination with an UHDx-mapping system-guided ablation was used. RFC was applied using a catheter tip with three incorporated mini-electrodes. PV reconnection rates were higher after CF-RFC PVI (CF-RFC: 2.5 ± 1.3 PVs vs CB: 1.4 ± 0.9 PVs; P = .0025) and left PVs were more frequently reconnected (CF-RFC: 64% PVs vs CB: 35% PVs; P = .0077). Fractionated signals along the antral index ablation line (FS) were found in 30% of CB-PVI patients (CF-RFC: 9.5% vs CB:30%; P = .098) targeted for ablation. In five cases, FS were a critical part of maintaining consecutive AT. The main AT mechanism found during reablation (n = 45 ATs) was macroreentry (80% [36/45], CF-RFC: 78.9% vs CB: 80.8%; P = 1.0) with a variety of circuits throughout both atria. CONCLUSION: UHDx mapping is sensitive in detecting conduction gaps along the index ablation line. Left PVs are more frequently reconnected after initial CF-RFC PVI. FS are a common finding after CB PVI and can maintain certain forms of ATs. ATs after index PVI are mostly macroreentries with a broad spectrum of entities.

Outcome after tailored catheter ablation of atrial tachycardia using ultra-high-density mapping.

INTRODUCTION: Tailored catheter ablation of atrial tachycardias (ATs) is increasingly recommended as a potentially easy treatment strategy in the era of high-density mapping (HDM). As follow-up data are sparse, we here report outcomes after HDM-guided ablation of ATs in patients with prior catheter ablation or cardiac surgery. METHODS AND RESULTS: In 250 consecutive patients (age 66.5 ± 0.7 years, 58% male) with ATs (98% prior catheter ablation, 13% prior cardiac surgery) an HDM-guided catheter ablation was performed with the support of a 64-electrode mini-basket catheter. A total of 354 ATs (1.4 ± 0.1 ATs per patient; mean cycle length 304 ± 4.3 ms; 64% macroreentry, 27% localized reentry, and 9% focal) with acute termination of 95% were targeted in the index procedure. A similar AT as in the index procedure recurred in five patients (2%) after a median follow-up time of 535 days (interquartile range (IQR) 25th-75th percentile: 217-841). Tailored ablation of reentry ATs with freedom from any arrhythmia was obtained in 53% after a single procedure and in 73% after 1.4 ± 0.4 ablation procedures (range: 1-4). A total of 228 patients (91%) were free from any arrhythmia recurrence after 210 days (IQR: 152-494) when including optimal usual care. CONCLUSIONS: Tailored catheter ablation of ATs guided by HDM has a high acute success rate. The recurrence rate of the index AT is low. In patients with extensive atrial scaring further ablation procedures need to be considered to achieve freedom from any arrhythmia.

Local impedance guides catheter ablation in patients with ventricular tachycardia.

AIMS: Catheter contact and local tissue characteristics are relevant information for successful radiofrequency current (RFC)-ablation. Local impedance (LI) has been shown to reflect tissue characteristics and lesion formation during RFC-ablation. Using a novel ablation catheter incorporating three mini-electrodes, we investigated LI in relation to generator impedance (GI) in patients with ventricular tachycardia (VT) and its applicability as an indicator of effective RFC-ablation. METHODS AND RESULTS: Baseline impedance, Δimpedance during ablation and drop rate (Δimpedance/time) were analyzed for 625 RFC-applications in 28 patients with recurrent VT undergoing RFC-ablation. LI was lower in scarred (87.0 Ω [79.0-95.0]) compared to healthy myocardium (97.5 Ω ([82.75-111.50]; P = .03) while GI did not differ between scarred and healthy myocardium. ΔLI was higher (18 Ω [9.4-26.0]) for VT-terminating as compared to non-terminating RFC-ablation (ΔLI 13 Ω [8.85-18.0]; P = .03), but did not differ for ΔGI between terminating vs nonterminating RFC-ablation. Correspondingly, LI drop rate was higher for RFC-ablation terminating the VT compared with RFC-ablation not terminating the VT (0.63 Ω/s [0.52-0.76] vs 0.32 Ω [0.20-0.58]; P = .008) while there was no difference for GI drop rate. ΔLI was higher in patients with nonischemic cardiomyopathy vs patients with ischemic cardiomyopathy (16 Ω [11.0-20.0] vs 11.0 Ω [7.85-17.00]; P = .003). CONCLUSION: Our findings suggest that LI is a sensitive parameter to guide RFC-ablation in patients with VT. LI indicates differences in tissue characteristics and generally is higher in patients with nonischemic cardiomyopathy. Hence, the etiology of the underlying cardiomyopathy needs to be considered when adopting LI for monitoring catheter ablation of VT.

Long-term efficacy and safety of radiofrequency catheter ablation of atrial fibrillation in patients with cardiac implantable electronic devices and transvenous leads.

INTRODUCTION: Long-term efficacy and safety are uncertain in patients with cardiac implantable electronic devices (CIED) and transvenous leads (TVL) undergoing radiofrequency catheter ablation of atrial fibrillation (AF). Thus, we assessed the outcome of AF ablation in those patients during long-term follow-up using continuous atrial rhythm monitoring (CARM). METHODS AND RESULTS: A total of 190 patients (71.3 ± 10.7 years; 108 (56.8% men) were included in this study. At index procedure 81 (42.6%) patients presented with paroxysmal AF and 109 (57.4%) with persistent AF. The ablation strategy included pulmonary vein isolation in all patients and biatrial ablation of complex fractionated electrograms with additional ablation lines, if appropriate. AF recurrences were assessed by CARM- and CIED-related complications by device follow-up. After a mean follow-up of 55.4 ± 38.1 months, freedom of AF was found in 86 (61.4%) and clinical success defined as an AF burden less than or equal to 1% in 101 (72.1%) patients. Freedom of AF was reported in 74.6% and 51.9% (P = 0.006) and clinical success in 89.8% and 59.3% (P < 0.001) of patients with paroxysmal and persistent AF, respectively. In 3 of 408 (0.7%) ablation procedures, a TVL malfunction occurred within 90 days after catheter ablation. During long-term follow-up 9 (4.7%) patients showed lead dislodgement, 2 (1.1%) lead fracture, and 2 (1.1%) lead insulation defect not related to the ablation procedure. CONCLUSION: Our findings using CARM demonstrate long-term efficacy and safety of radiofrequency catheter ablation of AF in patients with CIED and TVL.

A novel assessment of local impedance during catheter ablation: initial experience in humans comparing local and generator measurements.

AIMS: A novel measure of local impedance (LI) has been found to predict lesion formation during radiofrequency current (RFC) catheter ablation. The aim of this study was to investigate the utility of this novel approach, while comparing LI to the well-established generator impedance (GI). METHODS AND RESULTS: In 25 consecutive patients with a history of atrial fibrillation, catheter ablation was guided by a 3D-mapping system measuring LI in addition to GI via an ablation catheter tip with three incorporated mini-electrodes. Local impedance and GI before and during RFC applications were studied. In total, 381 RFC applications were analysed. The baseline LI was higher in high-voltage areas (>0.5 mV; LI: 110.5 ± 13.7 Ω) when compared with intermediate-voltage sites (0.1-0.5 mV; 90.9 ± 10.1 Ω, P < 0.001), low-voltage areas (<0.1 mV; 91.9 ± 16.4 Ω, P < 0.001), and blood pool LI (91.9 ± 9.9 Ω, P < 0.001). During ablation, mean LI drop (△LI; 13.1 ± 9.1 Ω) was 2.15 times higher as mean GI drop (△GI) (6.1 ± 4.2 Ω, P < 0.001). Baseline LI correlated with △LI: a mean LI of 99.9 Ω predicted a △LI of 12.9 Ω [95% confidence interval (12.1-13.6), R2 0.41; P < 0.001]. This relationship was weak for baseline GI predicting △GI (R2 0.06, P < 0.001). Catheter movements were represented by rapid LI changes. The duration of an RFC application was not predictive for catheter-tissue coupling with no further change of △LI (P = 0.247) nor △GI (P = 0.376) during prolonged ablation. CONCLUSION: Local impedance can be monitored during ablation. Compared with the sole use of GI, baseline LI is a better predictor of impedance drops during ablation and may provide useful insights regarding lesion formation. However, further studies are needed to investigate if this novel approach is useful to guide catheter ablation.

Influence of energy source on early atrial fibrillation recurrences: a comparison of cryoballoon vs. radiofrequency current energy ablation with the endpoint of unexcitability in pulmonary vein isolation.

Introduction: Comparative data of early recurrence rates of atrial fibrillation (ERAF) following second-generation cryoballoon (CB-G2) and radiofrequency current (RFC) ablation for pulmonary vein isolation (PVI) in paroxysmal AF (PAF) are rare. We randomized PAF patients into either PVI with CB-G2 (group 1) or PVI with a combined RFC-approach applying contact force (CF) with the endpoint of unexcitability (group 2) to investigate ERAF. Methods and results: In group 1 (n = 30), CB-G2-PVI was performed. After CF-PVI in group 2 (n = 30), bipolar pacing on the ablation line and additional ablation until unexcitability was conducted. Follow-up included 48 h of in-hospital monitoring followed by 5-day Holter ECGs 1, 2, 3, 6, 12 months postablation to evaluate ERAF. Acute PVI was reached in 100% of group 2 and in 99% of group 1. Shorter procedure durations (98.0 ± 21.9 vs. 114.3 ± 18.7 min, P < 0.05) but extended fluoroscopy times (15.4 ± 3.9 vs. 10.0 ± 4.3 min, P < 0.05) were found in the CB-G2 group. Ten non-severe complications occurred (6 vs. 4 in group 1 and 2, P = 0.73). In group 2, five patients suffered from ERAF vs. seven patients in group 1 (P = 0.67). The time until the occurrence of ERAF was shorter in group 2 (1 day (q1-q3: 1-4.5)) when compared with group 1 (22 (q1-q3: 6-54) days, P = 0.025). Conclusion: ERAF rates were equal among groups; however, they occurred earlier in the initial phase after RFC ablation when compared with CB-G2. PVI utilizing cryoablation is associated with shorter procedure durations but extended fluoroscopy time while being similarly secure.

Risk stratification of patients with left atrial appendage thrombus prior to catheter ablation of atrial fibrillation: An approach towards an individualized use of transesophageal echocardiography.

INTRODUCTION: The need for transesophageal echocardiography (TEE) before catheter ablation of atrial fibrillation (CA-AF) is still being questioned. The aim of this study is to analyze patients' (patients) risk factors of left atrial appendage thrombus (LAAT) prior to CA-AF in daily clinical practice, according to oral anticoagulation (OAC) strategies recommended by current guidelines. METHODS AND RESULTS: All patients scheduled for CA-AF from 01/2015 to 12/2016 in our center were included and either treated with NOACs (novel-OAC; paused 24-hours preablation) or continuous vitamin K antagonists (INR 2.0-3.0). All patients received a preprocedural TEE at the day of ablation. Two groups were defined: (1) patients without LAAT, (2) patients with LAAT. The incidence of LAAT was 0.78% (13 of 1,658 patients). No LAAT was detected in patients with a CHA2 DS2 -VASc score of ≤1 (n = 640 patients) irrespective of the underlying AF type. Independent predictors for LAAT are: higher CHA2 DS2 -VASc scores (odds ratio [OR] 1.54, 95%-confidence interval [CI]: 1.07-2.23, P = 0.0019), a history of nonparoxysmal AF (OR 7.96, 95%-CI: 1.52-146.64, P = 0.049), hypertrophic cardiomyopathy (HCM; OR 9.63, 95% CI: 1.36-43.05, P = 0.007), and a left ventricular ejection fraction (LVEF) < 30% (OR 8.32, 95% CI: 1.18-36.29, P = 0.011). The type of OAC was not predictive (P = 0.70). CONCLUSIONS: The incidence of LAAT in patients scheduled for CA-AF is low. Therefore, periprocedural OAC strategies recommended by current guidelines seem feasible. Preprocedural TEE may be dispensed in patients with a CHA2 DS2 -VASc score ≤1. However, a CHA2 DS2 -VASc score ≥2, reduced LVEF, HCM, or history of nonparoxysmal AF are independently associated with an increased risk for LAAT.