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.

Systematic use of half normal saline during ablation of ventricular tachycardia in structural heart disease.

BACKGROUND: Efficiency and safety of ablation using half normal saline (HNS) has been shown in refractory ventricular tachycardia (VT), but no evaluation in unselected larger populations has been made. OBJECTIVE: To evaluate the efficiency and safety of systematic HNS ablation in VT ablation. METHODS: All successive VT ablations in patients with structural heart disease from 2018 to 2021 used HNS in our center and were retrospectively included. RESULTS: One hundred seventy-seven successive VT ablation procedures using HNS have been performed in 148 patients (91% males, mean 64 ± 12 years, ischemic cardiomyopathy 64%, left ventricular ejection fraction 38 ± 13%). A mean of 19 ± 7.5 min of RF was delivered, with a mean power of 44 ± 7 W. Relevant complications happened in 9% (strokes 2%, tamponades 3%, atrioventricular block during septal ablations 5%). Over a mean follow-up of 15 ± 9 months, VT recurred in 46%. Final recurrence rate after one or several procedures was 36% (18 months follow-up). Number of VT episodes decreased from 14 ± 35 before to 2.5 ± 10 after ablation (p < .0001) and number of ICD shocks decreased from 4.8 ± 6.8 to 1.5 ± 0.8 (p = .027). CONCLUSION: Systematic use of HNS during VT ablations in patients with structural heart disease leads to long-term recurrences rates and complications in the range of what is reported using normal saline. Although controlled studies are needed for demonstrating the superiority of such attitude, the use of HNS in every scar-related VT ablation seems safe for standard cases and may be furthermore useful in case of refractory arrhythmias due to difficult-to-ablate substrates.

Phase analysis for ventricular arrhythmia prediction: A retrospective monocentric cohort study.

BACKGROUND: Prediction of ventricular arrhythmias (VA) mostly relies on left ventricular ejection fraction (LVEF), but with limited performance. New echocardiographic parameters such as mechanical dispersion have emerged, but acoustic window sometimes precludes this measurement. Nuclear imaging may be an alternative. We aimed to assess the ability of mechanical dispersion, measured with phase standard deviation (PSD) on radionuclide angiocardiography (RNA), to predict VAs. METHODS: This retrospective monocentric observational study included all patients who underwent a tomographic RNA from 2015 to 2019. Phase analysis yielded PSD and follow-up was examined to identify VAs, heart transplantation, and death. RESULTS: The study population consisted of 937 patients, mainly with LVEF ≤ 35% (425, 45%). Most had ischemic (334, 36%) or dilated cardiomyopathies (245, 26%). We identified 86 (9%) VAs. PSD was strongly associated with the occurrence of VA [hazard ratio per 10 ms increase (HR10) 1.12 (1.09-1.16)], heart transplantation [HR10 1.09 (1.06-1.12)], and death [HR10 1.03 (1.00-1.05)]. The association between PSD and VA persisted after adjustment for age, sex, QRS duration, LVEF, global longitudinal strain (GLS), and echocardiography-assessed mechanical dispersion. CONCLUSION: The occurrence of ventricular arrhythmias was predicted by mechanical dispersion assessed by RNA, even after adjustment for LVEF and GLS.

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.

The prevalence of left and right bundle branch block morphology ventricular tachycardia amongst patients with arrhythmogenic cardiomyopathy and sustained ventricular tachycardia: insights from the European Survey on Arrhythmogenic Cardiomyopathy.

AIMS: In arrhythmogenic cardiomyopathy (ACM), sustained ventricular tachycardia (VT) typically displays a left bundle branch block (LBBB) morphology while a right bundle branch block (RBBB) morphology is rare. The present study assesses the VT morphology in ACM patients with sustained VT and their clinical and genetic characteristics. METHODS AND RESULTS: Twenty-six centres from 11 European countries provided information on 954 ACM patients who had ≥1 episode of sustained VT spontaneously documented during patients' clinical course. Arrhythmogenic cardiomyopathy was defined according to the 2010 Task Force Criteria, and VT morphology according to the QRS pattern in V1. Overall, 882 (92.5%) patients displayed LBBB-VT alone and 72 (7.5%) RBBB-VT [alone in 42 (4.4%) or in combination with LBBB-VT in 30 (3.1%)]. Male sex prevalence was 79.3%, 88.1%, and 56.7% in the LBBB-VT, RBBB-VT, and LBBB + RBBB-VT groups, respectively (P = 0.007). First RBBB-VT occurred 5 years after the first LBBB-VT (46.5 ± 14.4 vs 41.1 ± 15.8 years, P = 0.011). An implanted cardioverter-defibrillator was more frequently implanted in the RBBB-VT (92.9%) and the LBBB + RBBB-VT groups (90%) than in the LBBB-VT group (68.1%) (P < 0.001). Mutations in PKP2 predominated in the LBBB-VT (65.2%) and the LBBB + RBBB-VT (41.7%) groups while DSP mutations predominated in the RBBB-VT group (45.5%). By multivariable analysis, female sex was associated with LBBB + RBBB-VT (P = 0.011) while DSP mutations were associated with RBBB-VT (P < 0.001). After a median follow-up of 103 (51-185) months, death occurred in 106 (11.1%) patients with no intergroup difference (P = 0.176). CONCLUSION: RBBB-VT accounts for a significant proportion of sustained VTs in ACM. Sex and type of pathogenic mutations were associated with VT type, female sex with LBBB + RBBB-VT, and DSP mutation with RBBB-VT.

Accuracy of automatic abnormal potential annotation for substrate identification in scar-related ventricular tachycardia.

INTRODUCTION: Ultrahigh-density mapping for ventricular tachycardia (VT) is increasingly used. However, manual annotation of local abnormal ventricular activities (LAVAs) is challenging in this setting. Therefore, we assessed the accuracy of the automatic annotation of LAVAs with the Lumipoint algorithm of the Rhythmia system (Boston Scientific). METHODS AND RESULTS: One hundred consecutive patients undergoing catheter ablation of scar-related VT were studied. Areas with LAVAs and ablation sites were manually annotated during the procedure and compared with automatically annotated areas using the Lumipoint features for detecting late potentials (LP), fragmented potentials (FP), and double potentials (DP). The accuracy of each automatic annotation feature was assessed by re-evaluating local potentials within automatically annotated areas. Automatically annotated areas matched with manually annotated areas in 64 cases (64%), identified an area with LAVAs missed during manual annotation in 15 cases (15%), and did not highlight areas identified with manual annotation in 18 cases (18%). Automatic FP annotation accurately detected LAVAs regardless of the cardiac rhythm or scar location; automatic LP annotation accurately detected LAVAs in sinus rhythm, but was affected by the scar location during ventricular pacing; automatic DP annotation was not affected by the mapping rhythm, but its accuracy was suboptimal when the scar was located on the right ventricle or epicardium. CONCLUSION: The Lumipoint algorithm was as/more accurate than manual annotation in 79% of patients. FP annotation detected LAVAs most accurately regardless of mapping rhythm and scar location. The accuracy of LP and DP annotations varied depending on mapping rhythm or scar location.

Incidence, epidemiology, diagnosis and prognosis of atrio-oesophageal fistula following percutaneous catheter ablation: a French nationwide survey.

AIMS: Rate, incidence, risk factors, and optimal management of atrio-oesophageal fistula (AOF) after catheter ablation for atrial fibrillation (AF) remain obscure. METHODS AND RESULTS: All French centres performing AF ablation were identified and surveys were sent concerning the number of procedures, eventual cases of AOF, and characteristics of such cases. Eighty-two of the 103 centres (80%) performing AF ablation in France were included, with a total of 129 286 AF ablations since 2006 (93% of the whole procedures in France). Thirty-three AOF were reported (reported rate 0.026% per procedure) with a stable reported annual incidence despite the increasing number of procedures. Sensitivity of computed tomography (CT) scan for AOF was 81%. Mortality was 60%, significantly lower in case of surgical corrective therapy (31 vs. 93%, P = 0.001). CONCLUSION: The reported rate of AOF after AF ablation in this nationwide survey was 0.026%, with a stable reported annual incidence over time. A normal CT scan does not rule out the diagnosis and should be repeated in case of suspicion. Prognosis remains poor with a mortality of 60% and crucially dependant of immediate surgical correction. No clear protective strategy has been proven effective.

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

AIMS: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. METHODS AND RESULTS: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). CONCLUSION: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

Chest pain in Brugada syndrome: Prevalence, correlations, and prognosis role.

BACKGROUND: Brugada syndrome (BrS) is sometimes diagnosed because of chest pain. Prevalence and characteristics of such BrS patients are unknown. METHODS: A total of 200 BrS probands were retrospectively included. BrS diagnosis made because of chest pain (n = 34, 17%) was compared to the other ones. RESULTS: BrS probands with diagnosis because of chest pain had significantly more often smoker habits, increased body mass index, and familial history of coronary artery disease but less frequently previous resuscitated sudden death/syncope or atrial fibrillation. Presence of coronary spasm and familial coronary artery disease were independently associated with BrS diagnosed because of chest pain. They presented more often with spontaneous type 1 ST elevation (59% vs 26%, P = .0004) and higher ST elevation during the episode of chest pain compared to other patients or compared to baseline electrocardiogram after chest pain resumption. ST elevation during chest pain was lower compared to ajmaline test. A total of 20% of them had significant coronary artery disease and four (11%) had coronary spasm, and they experienced more often recurrent chest pain episodes (24% vs 5%, P = .0002). Presence of chest pain at BrS diagnosis was not correlated to future arrhythmic events in univariate analysis. Only previous sudden cardiac death (SD)/syncope and familial SD were still significantly associated with outcome in multivariate analysis. CONCLUSION: Chest pain is a common cause for BrS diagnosis, although major part is not apparently explained by ischemic heart disease. Mechanisms leading to chest main remain unknown in the other ones. ST elevation is higher in this situation but does not seem to carry poor prognosis.

Feasibility of fast ventricular tachycardia mapping using the Rhythmia ™ system in a patient with an Impella ™.

Use of 3D navigation systems may be sometimes impossible in patients with left ventricular assist devices because of major electromagnetical interferences with some 3D systems based on magnetic localization. Mapping with the Rhythmia ™ system in patients implanted with an Impella ™ is described to be non feasible. We relate how to overcome this technical issues in this case.

Correlations between arrhythmogenic substrate and noninvasive risk stratification in ischemic heart disease patients modifications by radiofrequency ablation.

INTRODUCTION: Several noninvasive risk factors for ventricular arrhythmias have been described in postmyocardial infarction (MI) patients, whose relationships with scar characteristics and modifications by ablation are unknown. METHODS: Twenty-two patients with previous MI referred for ventricular tachycardia ablation were prospectively included. ECG, heart rate variability (HRV), signal-averaged ECG (SA-ECG), and T wave alternans (TWA) were performed before and after radiofrequency ablation. Scar areas were correlated to preablation parameters. Pre and postablation parameters were furthermore compared. RESULTS: Left ventricular ejection fraction and some spectral and time-domain HRV parameters were significantly correlated to the scar areas. QRS duration was larger after vs before ablation (120 ± 29 vs 105 ± 22 msec, P = .01). No significant modification in time or spectral domain of HRV was observed. There was no significant change in TWA and SA-ECG before and after ablation. Borderline decreases in quantitative TWA parameters were noted in patients with positive TWA and successful ablation procedure. CONCLUSION: Some noninvasive risk factors were linked to the scar areas, but few were significantly modified after ablation. Larger populations are needed to demonstrate significant differences or correlations.

Comparison between novel and standard high-density 3D electro-anatomical mapping systems for ablation of atrial tachycardia.

Ultra-high-density mapping allows very accurate characterization of circuits/mechanisms in atrial tachycardia (AT). Whether these advantages will translate into a better procedural or long-term clinical outcome is unknown. Sixty consecutive AT ablation procedures using ultra-high-density mapping (Rhythmia™, group 1) were retrospectively compared to 60 consecutive procedures using standard high-density mapping (Carto/NavX™, group 2) (total 209 AT, 79% left AT). A higher number of maps were performed in group 1 (4.8 ± 2.5 vs 3.2 ± 1.7, p = 0.0001) with similar acquisition duration (12 ± 5 vs 13 ± 6 min per map, p = ns), although with a greater number of activation points (10,543 ± 5854 vs 689 ± 1827 per map, p < 0.0001). AT location remained undetermined in 5 AT in group 1 vs 10 (p = 0.1). Mechanism remained undetermined in 5 AT from group 1 vs 11 (p = 0.06). Acute complete success was achieved in 77%, in both groups. At 1-year follow-up, AT recurred in 37% in group 1 vs 50% in group 2 (p = 0.046). There are less long-term recurrences after AT ablation using ultra-high-density mapping system compared to standard high-density 3D mapping, possibly because of a better comprehensive approach of AT mechanisms.

Prevalence and long-term prognosis of patients with 'narrower than normal' QRS complexes.

Aims: Very narrow QRS have been reported in sudden death survivors but prevalence and prognosis role of narrow QRS is unknown. Methods and results: 546 healthy men between 50 and 60 years (group 1) and 373 similar patients with coronary artery disease (368 men, group 2) underwent signal averaged ECG (SA-ECG) allowing precise measurement of QRS duration. All cause-mortality was determined after 18 ± 3 years follow-up. Mean QRS duration was 97 ± 13 ms in group 1 and 103 ± 16 ms in group 2. Tenth percentile was 84 ms in group 1 and 85 ms in group 2. All cause-mortality in group 1 was 10.4% (57/546): 6/85 in case of QRS <85 ms (7%) and 2/23 (9%) in case of QRS >120 ms (ns). HR for all-cause mortality was 0.75 (95% CI 0.32-1.76, P = 0.52) for QRS <85 ms and 0.86 (95% CI 0.21-3.53, P = 0.84) for QRS >120 ms. All cause mortality in group 2 was 29% (109/373): 7/44 in case of QRS <85 ms (16%) and 22/44 (50%) in case of QRS >120 ms (P = 0.002). HR for all-cause mortality was 0.65 (95% CI 0.29-1.45, P = 0.29) for QRS <85 ms and 1.73 (95% CI 1.02-2.94, P = 0.05) for QRS >120 ms. Conclusion: QRS duration <80-85 ms can be observed in a significant proportion of middle-aged healthy males and in similar patients with ischemic heart disease. Narrow QRS were not linked to prognosis in any group.

Crossroads or "Flyovers" novel insights into ventricular tachycardia mechanisms: The path is twisting.

Diverging channels of activation may be observed in some ventricular tachycardia (VT) using ultra-high-density mapping. We present here cases of such diverging activation patterns as observed from 60 consecutive VT activation maps using the Rhythmia system™ (Boston Scientific, Marlborough, MA, USA). Diverging directions of activation in the same area with "crossroads" or "flyover" pattern can be traced, implying recording of independent multilayer channels. Adaptation of current automated recording by the 3D mapping system is mandatory for better investigating this phenomenon.

High density mapping of inappropriate sinus tachycardia further looks into potential mechanisms.

Inappropriate sinus tachycardia (IST) is an incompletely understood condition associating unexpectedly fast sinus rates and debilitating symptoms whose management by sinus node modification/ablation demonstrated limited long-term success. We report about a case of IST who underwent two RF procedures using high density mapping system, highlighting some possibly specific features and discussing potential mechanisms.

Sudden QRS morphology change during ventricular pacing in a scar-related isthmus What is the mechanism?

We present an example of sudden modification in QRS morphology during ventricular pacing inside a scar-related isthmus. This is explained by a "concealed" sudden block in both the orthodromic and antidromic wavefront directions, allowing then the activation to proceed through a now overt antidromic conduction.

Impact of Substrate-Based Ablation of Ventricular Tachycardia on Cardiac Mortality in Patients With Implantable Cardioverter-Defibrillators.

INTRODUCTION: This study sought to determine if the acute procedural outcome of ventricular tachycardia (VT) substrate ablation is associated with a mortality benefit in patients with implantable cardioverter-defibrillators (ICD). METHODS AND RESULTS: A total of 195 ICD recipients (65 ± 11years) with ischemic or nonischemic dilated cardiomyopathy underwent substrate-based ablation targeting elimination of local abnormal ventricular activities (LAVA). Acute procedural success, which was defined as elimination of all identified LAVA in addition to the lack of VT inducibility, was achieved in 95 (49%) patients. During a median follow-up of 23 months, patients with acute procedure success had a significantly lower incidence of ICD shocks compared to those with ablation failure (8% vs. 30%, P < 0.001). In multivariate analysis, acute procedural success was associated with a lower risk of VT recurrence (hazard ratio [HR] 0.30, 95% confidence interval [CI] 0.18-0.49, P < 0.001) and all-cause mortality (HR 0.32, 95% CI 0.17-0.60, P < 0.001). While the impact of ablation success on mortality was not statistically significant in patients with LVEF > 35% (HR 0.45, 95% CI 0.15-1.34, P = 0.15) and those with NYHA class I/II (HR 0.63, 95% CI 0.29-1.40, P = 0.26), it was marked in patients with LVEF ≤ 35% (HR 0.30, 95% CI 0.14-0.62, P = 0.001) and NYHA class III/IV (HR 0.17, 95% CI 0.05-0.57, P = 0.004). CONCLUSIONS: LAVA elimination in addition to VT noninducibility as a procedural outcome for substrate-based ablation is associated with reduced mortality and better VT-free survival during follow-up. This prognostic benefit may be most pronounced in patients with severe heart failure as indicated by severely depressed LV function and NYHA class III/IV symptoms.