Validation of a machine learning algorithm to identify pulmonary vein isolation during ablation procedures for the treatment of atrial fibrillation: results of the PVISION study.

AIMS: Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation. Confirmation of PVI can be challenging due to the presence of far-field electrograms (EGMs) and sometimes requires additional pacing manoeuvres or mapping. This prospective multicentre study assessed the agreement between a previously trained automated algorithm designed to determine vein isolation status with expert opinion in a real-world clinical setting. METHODS AND RESULTS: Consecutive patients scheduled for PVI were recruited at four centres. The ECGenius electrophysiology (EP) recording system (CathVision ApS, Copenhagen, Denmark) was connected in parallel with the existing system in the laboratory. Electrograms from a circular mapping catheter were annotated during sinus rhythm at baseline pre-ablation, time of isolation, and post-ablation. The ground truth for isolation status was based on operator opinion. The algorithm was applied to the collected PV signals off-line and compared with expert opinion. The primary endpoint was a sensitivity and specificity exceeding 80%. Overall, 498 EGMs (248 at baseline and 250 at PVI) with 5473 individual PV beats from 89 patients (32 females, 62 ± 12 years) were analysed. The algorithm performance reached an area under the curve (AUC) of 92% and met the primary study endpoint with a sensitivity and specificity of 86 and 87%, respectively (P = 0.005; P = 0.004). The algorithm had an accuracy rate of 87% in classifying the time of isolation. CONCLUSION: This study validated an automated algorithm using machine learning to assess the isolation status of pulmonary veins in patients undergoing PVI with different ablation modalities. The algorithm reached an AUC of 92%, with both sensitivity and specificity exceeding the primary study endpoints.

Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience.

AIMS: The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. METHODS AND RESULTS: This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). Kaplan-Meier curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1-95.4%) vs. 83.7% (76.0%-89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9-2.8), P = 0.12]. CONCLUSION: PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.

Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison.

AIMS: Pulsed field ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We describe a multicentre experience on pulmonary vein isolation (PVI) via the pentaspline Farapulse™ PFA system vs. thermal-based technologies in a propensity score-matched population of paroxysmal atrial fibrillation (PAF) patients. METHODS AND RESULTS: Propensity score matching was adopted to compare PVI-only ablation outcomes via the Farawave™ system (Group PFA), cryoballoon (Group CRYO), or focal radiofrequency (Group RF) (PFA:CRYO:RF ratio = 1:2:2). Among 1572 (mean age: 62.4 ± 11.3 years; 42.5% females) PAF patients undergoing first time PVI with either PFA (n = 174), CRYO (n = 655), or RF (n = 743), propensity score matching yielded 174 PFA, 348 CRYO, and 348 RF patients. First-pass isolation was achieved in 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CRYO, and 73.1% with RF (P < 0.001). Procedural and dwell times were significantly shorter with PFA, whereas the availability of a 3D mapping system led to a significant reduction in X-ray exposure with RF. Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CRYO, and 5.5% (n = 19) with RF (P = 0.052). The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CRYO, and 72.4% with RF (log-rank P-value: 0.24). Among 145 repeat ablation procedures, PV reconnection rate was 19.1% after PFA, 27.5% after CRYO, and 34.8% after RF (P = 0.01). CONCLUSION: Pulsed field ablation contributed to significantly shorter procedural times. Follow-up data showed a similar arrhythmia freedom, although a higher rate of PV reconnection was documented in post-CRYO and post-RF redo procedures.

Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation.

INTRODUCTION: Multiple groups have reported on the usefulness of ablating in atrial regions exhibiting abnormal electrograms during atrial fibrillation (AF). Still, previous studies have suggested that ablation outcomes are highly operator- and center-dependent. This study sought to evaluate a novel machine learning software algorithm named VX1 (Volta Medical), trained to adjudicate multipolar electrogram dispersion. METHODS: This study was a prospective, multicentric, nonrandomized study conducted to assess the feasibility of generating VX1 dispersion maps. In 85 patients, 8 centers, and 17 operators, we compared the acute and long-term outcomes after ablation in regions exhibiting dispersion between primary and satellite centers. We also compared outcomes to a control group in which dispersion-guided ablation was performed visually by trained operators. RESULTS: The study population included 29% of long-standing persistent AF. AF termination occurred in 92% and 83% of the patients in primary and satellite centers, respectively, p = 0.31. The average rate of freedom from documented AF, with or without antiarrhythmic drugs (AADs), was 86% after a single procedure, and 89% after an average of 1.3 procedures per patient (p = 0.4). The rate of freedom from any documented atrial arrhythmia, with or without AADs, was 54% and 73% after a single or an average of 1.3 procedures per patient, respectively (p < 0.001). No statistically significant differences between outcomes of the primary versus satellite centers were observed for one (p = 0.8) or multiple procedures (p = 0.4), or between outcomes of the entire study population versus the control group (p > 0.2). Interestingly, intraprocedural AF termination and type of recurrent arrhythmia (i.e., AF vs. AT) appear to be predictors of the subsequent clinical course. CONCLUSION: VX1, an expertise-based artificial intelligence software solution, allowed for robust center-to-center standardization of acute and long-term ablation outcomes after electrogram-based ablation.

Easily available ECG and echocardiographic parameters for prediction of left atrial remodeling and atrial fibrillation recurrence after pulmonary vein isolation: A multicenter study.

BACKGROUND: The assessment of noninvasive markers of left atrial (LA) low-voltage substrate (LVS) enables the identification of atrial fibrillation (AF) patients at risk for arrhythmia recurrence after pulmonary vein isolation (PVI). METHODS: In this prospective multicenter study, 292 consecutive AF patients (72% male, 62 ± 11 years, 65% persistent AF) underwent high-density LA voltage mapping in sinus rhythm. LA-LVS (<0.5 mV) was considered as significant at 2 cm2  or above. Preprocedural clinical electrocardiogram and echocardiographic data were assessed to identify predictors of LA-LVS. The role of the identified LA-LVS markers in predicting 1-year arrhythmia freedom after PVI was assessed in 245 patients. RESULTS: Significant LA-LVS was identified in 123 (42%) patients. The amplified sinus P-wave duration (APWD) best predicted LA-LVS, with a 148-ms value providing the best-balanced sensitivity (0.81) and specificity (0.88). An APWD over 160 ms was associated with LA-LVS in 96% of patients, whereas an APWD under 145 ms in 15%. Remaining gray zones improved their accuracy by introduction of systolic pulmonary artery pressure (sPAP) of 35 mmHg or above, age, and sex. According to COX regression, the risk of arrhythmia recurrence 12 months following PVI was twofold and threefold higher in patients with APWD 145-160 and over 160 ms, compared to APWD under 145 ms. Integration of pulmonary hypertension further improved the outcome prediction in the intermediate APWD group: Patients with APWD 145-160 ms and normal sPAP had similar outcome than patients with APWD under 145 ms (hazard ratio [HR] 1.62, p = .14), whereas high sPAP implied worse outcome (HR 2.56, p < .001). CONCLUSIONS: The APWD identifies LA-LVS and risk for arrhythmia recurrence after PVI. Our prediction model becomes optimized by means of integration of the pulmonary artery pressure.

Catheter ablation of atrial fibrillation in patients with heart failure with reduced ejection fraction: Real world experience from six European centers.

INTRODUCTION: Catheter ablation of atrial fibrillation (AF) has been recently shown to have an impact on the outcome of patients with heart failure and reduced LV ejection fraction (LVEF). We aimed to assess patients with reduced LVEF referred to catheter ablation of AF, and the efficacy and safety of this procedure compared with healthier patients. METHODS: 2083 consecutive procedures of catheter ablation of AF in six centers were divided into two groups on the basis of LVEF (≤ vs >35%) and comparisons were performed regarding procedural safety and efficacy. RESULTS: Only 51 (2.4%) of patients had low LVEF. Complication rate was comparable: 8.0% vs 6.9% (P = .760). Low LVEF patients are more frequently in persistent AF at the time of the procedure, have a higher degree of left atrial dilation, and higher CHA2 DS2 VASc score. The rate of atrial arrhythmia relapse post-blanking period in the first 12 months was higher in the low LVEF group: 58.0% vs 37.6% (P < .001). During a median follow-up of 14 months (IQR 5-24), after adjusting for all baseline differences, AF duration, paroxysmal AF, CHA2 DS2 VASc score, BMI, and indexed LA volume were independent predictors of relapse. LVEF and LVEF ≤ 35% were not identified as predictors of relapse. CONCLUSIONS: Patients with reduced LVEF account for only a minority of patients undergoing catheter ablation of AF. However, ablation appears to be as safe as for the general population, and albeit the efficacy seems lower, this appears to be driven by other comorbidities or features, which are more frequent in this population.

Multicentre evaluation of non-invasive biatrial mapping for persistent atrial fibrillation ablation: the AFACART study.

AIMS: Non-invasive electrocardiogram (ECG) mapping allows the activation of the entire atrial epicardium to be recorded simultaneously, potentially identifying mechanisms critical for atrial fibrillation (AF) persistence. We sought to evaluate the utility of ECG mapping as a practical tool prior to ablation of persistent AF (PsAF) in centres with no practical experience of the system. METHODS AND RESULTS: A total of 118 patients with continuous AF duration <1 year were prospectively studied at 8 European centres. Patients were on a median of 1 antiarrhythmic drug (AAD) that had failed to restore sinus rhythm. Electrocardiogram mapping (ECVUE™, CardioInsight, USA) was performed prior to ablation to map AF drivers (local re-entrant circuits or focal breakthroughs). Ablation targeted drivers depicted by the system, followed by pulmonary vein (PV) isolation, and finally left atrial linear ablation if AF persisted. The primary endpoint was AF termination. Totally, 4.9 ± 1.0 driver sites were mapped per patient with a cumulative mapping time of 16 ± 2 s. Of these, 53% of drivers were located in the left atrium, 27% in the right atrium, and 20% in the anterior interatrial groove. Driver-only ablation resulted in AF termination in 75 of the 118 patients (64%) with a mean radiofrequency (RF) duration of 46 ± 28 min. Acute termination rates were not significantly different amongst all 8 centres (P = 0.672). Ten additional patients terminated with PV isolation and lines resulting in a total AF termination rate of 72%. Total RF duration was 75 ± 27 min. At 1-year follow-up, 78% of the patients were off AADs and 77% of the patients were free from AF recurrence. Of the patients with no AF recurrence, 49% experienced at least one episode of atrial tachycardia (AT) which required either continued AAD therapy, cardioversion, or repeat ablation. CONCLUSION: Non-invasive mapping identifies biatrial drivers that are critical in PsAF. This is validated by successful AF termination in the majority of patients treated in centres with no experience of the system. Ablation targeting these drivers results in favourable AF-free survival at 1 year, albeit with a significant rate of AT recurrence requiring further management.

Higher contact-force values associated with better mid-term outcome of paroxysmal atrial fibrillation ablation using the SmartTouch™ catheter.

AIMS: Real-time measurement of contact force (CF) during catheter ablation of atrial fibrillation (AF) has been recently suggested to potentially impact procedural outcome. However, the role of CF intensity on mid-term results using the SmartTouch™ catheter has not been investigated so far. METHODS AND RESULTS: Pulmonary vein isolation (PVI) using the SmartTouch™ catheter was performed in 100 eligible patients (age 62 ± 8; 79% men) undergoing a first procedure of paroxysmal AF catheter ablation. Continuous CF monitoring during catheter ablation allowed calculation of mean CF per patient. Patients were dichotomized into high CF (≥22 g, upper quartile) and low CF (<22 g, remaining) and enroled in a standardized follow-up programme (after a 3-month blanking period), free from antiarrhythmic therapy, with regular evaluations including 24 h Holter recordings at 1, 3, 6, 9, 12, 18, and 24 months. Atrial fibrillation relapse was defined as any symptomatic or asymptomatic atrial arrhythmia lasting >30 s. The average CF among all procedures was 19.6 ± 3.7 g. Though complete PVI was eventually achieved in all cases in both groups, success using an exclusively anatomical approach was higher in the high CF group (92.0 vs. 72.0%; P = 0.04). During a mean follow-up of 19 ± 5 months, a lower incidence of AF relapse was observed in higher CF patients (4.0 vs. 20.0%; log rank P = 0.04). Pericardial tamponade occurred in one patient in the higher CF group. No thromboembolism or procedure-associated deaths were observed. CONCLUSION: Higher values of CF overall during antral PVI appear to be associated with a higher likelihood of sinus rhythm maintenance without significantly increasing the complication rate.

Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation.

AIMS: In the setting of paroxysmal atrial fibrillation (AF), there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation (PVI) catheter ablation using contact-force (CF)-guided radiofrequency (RF) vs. second-generation balloon cryotherapy. METHODS AND RESULTS: Prospective single-centre evaluation, carried out from March 2011 to February 2013, comparing CF radiofrequency (Thermocool(®) SmartTouch™, Biosense Webster, Inc.) (CF group) with cryoballoon ablation (Arctic Front Advance™ 28 mm cryoballoon, Medtronic, Inc.) (CB group), in regards to procedural safety and efficacy, as well as recurrence at 12 months. Overall, 150 consecutive patients were enrolled (75 in each group). The characteristics of patients of both the groups were similar (61.2 ± 9.9 years, women 25.3%, mean AF duration 4.1 ± 4.0 years, mean CHA2DS2-VASc score 1.4 ± 1.3, mean HAS-BLED 1.4 ± 0.6). Duration of the procedure was significantly lower in the CF group (110.7 ± 32.5 vs. 134.5 ± 48.3 min, P = 0.001), with a lower duration of fluoroscopy (21.5 ± 8.5 vs. 25.3 ± 9.9 min, P = 0.017) and X-ray exposure (4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm², P = 0.001). In contrast, no significant difference was found regarding significant procedural complication (2.7 vs. 1.3% in CF and CB groups, respectively; P = 0.56), and PVI was eventually achieved in all cases. At 12 months, AF recurrence occurred in 11 patients (14.7%) in the CB group and in 9 patients (12.0%) in the CF group (HR = 1.20 95% CI 0.50-2.90; log rank P = 0.682). CONCLUSIONS: Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation.

Lack of Correlations between Electrophysiological and Anatomical-Mechanical Atrial Remodeling in Patients with Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) progressively leads to electrical remodeling (ER) and anatomical-mechanical remodeling (AR), whose relationships in humans remain poorly known. METHODS: ER and AR were compared in patients undergoing percutaneous radiofrequency (RF) ablation for AF. ER was defined by right and left appendage activation rates as a surrogate for atrial refractory periods. AR was approached by left atrial (LA) diameters and area and left atrial appendage (LAA) area and contractile function (mean emptying flow velocity) (LAAFV) before RF ablation. Mean duration between successive LAA contractions was considered as LAA mechanical rate. RESULTS: Forty-one patients (31 men, age: 64 ± 9 years) with paroxysmal (27%), persistent (61%), or long-persistent AF (12%) were prospectively included (ejection fraction: 44 ± 16%). Parameters exploring AR were highly correlated to each other: LA area (28 ± 7 cm(2) ), LAA area (5.7 ± 2.25 cm(2) ), LA transverse (49 ± 7 mm), and anteroposterior diameter (59 ± 13 mm) or LAAFV (29 ± 13 cm/s; P < 0.05 for each comparison). Parameters exploring ER were also highly correlated: right atrial appendage (RAA; 181 ± 39 ms) and LAA (176 ± 33 ms) activation rates (P < 0.0001). There was no significant correlation between any ER and AR parameter. Only LAA mechanical rate (174 ± 36 ms) was correlated to LAA or RAA activations rates (P ≤ 0.01). CONCLUSION: ER and AR are not mutually related, atrial activation rate being not correlated to LA or LAA size or function. Thus, the mechanisms leading to AF-induced atrial remodeling may differ for anatomical and electrophysiological aspects.

Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results.

INTRODUCTION: The additional benefit of contact force (CF) technology during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) to improve mid-term clinical outcome is unclear. METHODS AND RESULTS: Eligible patients with symptomatic paroxysmal AF were enrolled in this prospective trial, comparing circular antral catheter ablation (guided by Carto 3 System, Biosense Webster) using either a new open-irrigated CF catheter (SmartTouch Thermocool, Biosense Webster) (CF group) or a non-CF open-irrigated catheter (EZ Steer Thermocool, Biosense Webster) (control group). Overall, 30 patients were enrolled in each group, with a standardized 12-month follow-up, free of antiarrhythmic therapy. Demographic, cardiovascular and anatomic characteristics were similar in both groups. Though complete PVI was eventually achieved in all cases in both groups, success using an exclusive anatomic approach was 80.0% in CF group versus 36.7% in control group (P < 0.0001). CF use was associated with significant reductions in fluoroscopy exposure (P < 0.01) and radiofrequency time (P = 0.01). The incidence rates of AF recurrence were 10.5% (95% CI, 1.38-22.4) in the CF group, and 35.9% (95% CI, 12.4-59.4) in the control group (log rank test, P = 0.04). After adjustment on potential confounders, the use of CF catheter was found to be associated with a lower AF recurrence (OR 0.18, 95% CI 0.04-0.94, P = 0.04). CONCLUSION: Our findings suggest a potential benefit of real-time CF sensing technology, in reducing AF recurrence during the first year after PVI.

Rivaroxaban and dabigatran in patients undergoing catheter ablation of atrial fibrillation.

AIMS: The recent availability of the novel oral anticoagulants (NOACs) may have led to a change in the anticoagulation regimens of patients referred to catheter ablation of atrial fibrillation (AF). Preliminary data exist concerning dabigatran, but information regarding the safety and efficacy of rivaroxaban in this setting is currently scarce. METHODS AND RESULTS: Of the 556 consecutive eligible patients (age 61.0 ± 9.6; 74.6% men; 61.2% paroxysmal AF) undergoing AF catheter ablation in our centre (October 2012 to September 2013) and enroled in a systematic standardized 30-day follow-up period: 192 patients were under vitamin K antagonists (VKAs), 188 under rivaroxaban, and 176 under dabigatran. Peri-procedural mortality and significant systemic or pulmonary thromboembolism (efficacy outcome), as well as bleeding events (safety outcome) during the 30 days following the ablation were evaluated according to anticoagulation regimen. During a 12-month time interval, the use of the NOACs in this population rose from <10 to 70%. Overall, the rate of events was low with no significant differences regarding: thrombo-embolic events in 1.3% (VKA 2.1%; rivaroxaban 1.1%; dabigatran 0.6%; P = 0.410); major bleeding in 2.3% (VKA 4.2%; rivaroxaban 1.6%; dabigatran 1.1%; P = 0.112), and minor bleeding 1.4% (VKA 2.1%; rivaroxaban 1.6%; dabigatran 0.6%; P = 0.464). No fatal events were observed. CONCLUSION: The use of the NOAC in patients undergoing catheter ablation of AF has rapidly evolved (seven-fold) over 1 year. These preliminary data suggest that rivaroxaban and dabigatran in the setting of catheter ablation of AF are efficient and safe, compared with the traditional VKA.

Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases?

AIM: Real-time assessment of pulmonary vein (PV) disconnection is possible using an inner circular mapping catheter during cryoablation of atrial fibrillation (AF). However, it has been recently demonstrated that such continuous monitoring may only be possible in <50% of PVs. We hypothesized that a stepwise mapping approach, including pacing manoeuvres, could optimize monitoring of real-time PV disconnection during ablation. METHODS AND RESULTS: Single-centre, prospective observational study (NCT01843465) including 34 consecutive eligible patients (128 PVs) undergoing a first procedure of cryoballoon ablation of AF using the Artic Front Advance(®) 28 mm catheter and a 20 mm diameter Achieve(®) catheter (AC) in all cases. Monitoring of real-time entrance block was possible, when AC was maintained in the standard position (distal to the tip of the Artic Front Advance(®) catheter) in 47 (36.7%) PVs. In an additional 63 cases (49.2%), such monitoring was possible after moving AC to a more proximal position and using different torqueing movements. Finally, using supplemental systematic pacing manoeuvres to test exit block, real-time assessment of PV disconnection was possible in 15 (11.7%) more PVs. Overall, real-time assessment of PV disconnection was possible in 97.7% of cases, after a mean duration of 48.6 ± 33.0 s. CONCLUSION: Our results suggest that optimal use of the AC, with a systematic stepwise mapping approach, may dramatically improve the real-time monitoring of PV disconnection during AF cryoablation.

Optimized workflow for pulmonary vein isolation using 90-W radiofrequency applications: a comparative study.

BACKGROUND: Ninety-watt applications are more sensitive to catheter instability and produce lesions that are shallower and smaller in diameter than 50-W applications. These characteristics were considered for the development of a combined (90-50 W) pulmonary vein isolation (PVI) strategy which was prospectively compared to a 50 W-only ablation index (AI)-guided PVI strategy. METHODS: One hundred fifty consecutive paroxysmal AF patients underwent PVI under general anesthesia using CARTO. In the first 75 patients, PVI was performed with a combined (90-50 W) strategy using the QDOT-MICRO catheter in a temperature-controlled mode. This strategy consisted of 90 W-4 s applications on the posterior LA wall (at sites of catheter stability and expectedly thin atrial tissue) with an interlesion distance (ILD) ≤ 4 mm and 50-W applications elsewhere (at sites of catheter instability or expectedly thick atrial tissue) with ILD < 6 mm. In the subsequent 75 patients, PVI was performed with a 50 W-only AI-guided strategy using the SmartTouch-SF catheter in a power-controlled mode. RESULTS: Both groups of patients had similar clinical characteristics and LA dimensions (123.1 ± 24.9 ml vs 119 ± 26.8 ml, P = 0.33). Total procedural times (61 [56-70] vs 65 [60-75] min, P = 0.12), first-pass PVI (82.6 vs 80%, P = 0.81), acute PV reconnection (0 vs 6.6%, P = 0.05), and 1-year SR maintenance (93.3 vs 90.6%, P = 0.57) rates were also similar in both groups of patients. There were no complications in the combined (90-50 W) group while only 2 groin hematomas were reported in the 50 W group. CONCLUSIONS: In paroxysmal AF patients, a combined (90-50 W) strategy for PVI did not improve safety, efficiency, or effectiveness compared to a 50 W-only AI-guided strategy.

Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience.

BACKGROUND: Pulsed field ablation has recently emerged as an interesting non-thermal energy for atrial fibrillation ablation. At a time of rapid spread of this technology, there is still a lack of prospective real-life data. AIM: To describe multicentre prospective safety and 1-year efficacy data in three of the first French centres to use pulsed field ablation. METHODS: All consecutive patients undergoing a first pulsed field ablation were included prospectively. The primary outcome was freedom from documented atrial arrhythmia. The safety endpoint was a composite of major adverse events. Univariate and multivariable analyses, including patient and procedural characteristics, were performed to identify factors predictive of recurrence. RESULTS: Between May 2021 and June 2022, 311 patients were included (paroxysmal atrial fibrillation in 53%, persistent atrial fibrillation in 35% and long-standing persistent atrial fibrillation in 11%). Additional non-pulmonary vein pulsed field ablation applications were performed in 104/311 patients. One-year freedom from arrhythmia recurrence was 77.6% in the overall population and was significantly higher in patients with paroxysmal atrial fibrillation (88.4%) compared with patients with persistent atrial fibrillation (69.7%; P<0.001) and those with long-standing persistent atrial fibrillation (49.0%; P<0.001). The major complication rate was 2.6% (tamponade in four patients, stroke in two patients and coronary spasm in one patient). Besides the usual predictors of recurrences (left atrium size, CHA2DS2-VASc score, type of atrial fibrillation), the presence of atrial fibrillation at procedure start was independently associated with arrhythmia recurrence (hazard ratio: 2.04, 95% confidence interval: 1.10-3.77). CONCLUSION: In this prospective multicentre real-world study, pulsed field ablation for atrial fibrillation ablation seems to be associated with a good safety profile and rather favourable acute and 1-year success rates.

Characterization and Clinical Significance of Hemolysis After Pulsed Field Ablation for Atrial Fibrillation: Results of a Multicenter Analysis.

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.

Case Report: A leadless and endovascular pacemaker teamwork.

Background: Cardiac Implantable Electronic Device infections increase short- and long-term mortality, along with healthcare costs. Leadless pacemakers (PM) were developed to overcome pocket- and minimize lead-related complications in selected high-risk patients. Recent advancements enable leadless devices to mechanically detect atrial activity, facilitating atrioventricular (AV) synchronous stimulation. Case summary: A 90-year-old woman, implanted with a dual-chamber pacemaker eight years ago due to sinus node dysfunction, presented with syncope. A diagnosis of complete AV block, in the setting of ventricular lead dysfunction was made. Due to a high risk of infection, the patient was implanted with a leadless PM capable of maintaining AV synchrony in VDD mode (MICRA™ model MC1AVR1). The transvenous PM was programmed to AAI-R mode to drive the atria, which, in turn, triggered the leadless PM to stimulate the ventricles. At six month follow-up, the AV synchrony rate was 85%. Conclusion: The combination of classic atrial pacing with leadless ventricular stimulation can be used in high-risk patients to reduce the risk of complications, in the setting of ventricular lead dysfunction. In this manner, AV synchrony can be maintained, improving hemodynamic parameters and quality of life. Low sinus rate variability at rest is essential to achieve a high AV synchrony rate in such cases.