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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.
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Fibrilación Atrial , Aleteo Atrial , Ablación por Catéter , Venas Pulmonares , Humanos , Femenino , Persona de Mediana Edad , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/tratamiento farmacológico , Estudios Retrospectivos , Volumen Sistólico , Función Ventricular Izquierda , Resultado del Tratamiento , Aleteo Atrial/etiología , Sistema de Registros , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , RecurrenciaRESUMEN
AIMS: Pulsed field ablation (PFA) is a novel, non-thermal, cardiac tissue-selective ablation modality. To date, radiofrequency (RF)-guided high-power short-duration (HPSD) ablation represents the gold standard besides cryo-ablation for pulmonary vein isolation (PVI). This single-centre, retrospective study investigated the efficacy of PFA-PVI vs. HPSD-RF PVI in terms of single-procedure arrhythmia-free outcome and safety in a real-world setting. METHODS AND RESULTS: Consecutive, paroxysmal atrial fibrillation (AF) patients who underwent PVI using PFA or HPSD-RF were enrolled. In group PFA, PVI was performed using a pentaspline PFA catheter. The ablation procedure in group HPSD-RF was performed with RF energy (45 W, ablation index). A total of 410 patients (group PFA, 201; group HPSD-RF, 209) were included. There was no difference between both groups regarding age, gender, and CHA2DS2-VASc score. The procedure time was significantly shorter in group PFA [61 (44-103) vs. 125 (105-143) min; P < 0.001]; fluoroscopy time and dose area product were significantly higher in group PFA [16 (13-20) vs. 4 (2-5) min; P < 0.01 and 412 (270-739) vs. 129 (58-265) µGym2; P < 0.01]. The overall complication rates were 2.9% in group PFA and 6.2% in group HPSD (P = 0.158). There was one fatal stroke in the PFA group. The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 85% with PFA and 79% with HPSD-RF (log-rank P = 0.160). In 56 repeat ablation procedures, the PV reconnection rate was 30% after PFA and 38% after HPSD-RF (P = 0.372). CONCLUSION: Both PFA and HPSD-RF were highly efficient and effective in achieving PVI in paroxysmal AF patients. The arrhythmia-free survival is comparable. The PV reconnection rate was not different.
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Fibrilación Atrial , Venas Pulmonares , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Venas Pulmonares/cirugía , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Resultado del Tratamiento , Factores de Tiempo , Ablación por Catéter/métodos , Ablación por Catéter/efectos adversos , Recurrencia , Tempo Operativo , Estudios de SeguimientoRESUMEN
AIMS: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter. METHODS AND RESULTS: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40-87) and 14 (9-21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323-386) days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated. CONCLUSION: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.
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Fibrilación Atrial , Ablación por Catéter , Poria , Venas Pulmonares , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/epidemiología , Resultado del Tratamiento , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Fluoroscopía , Venas Pulmonares/cirugía , RecurrenciaRESUMEN
Pulsed field ablation (PFA) is a promising technology for the treatment of atrial fibrillation (AF). Due to its unique tissue selectivity, PFA potentially bears superior characteristics as compared to established thermal energy sources in AF ablation procedures. Cardiovascular magnetic resonance imaging (CMR) using late gadolinium enhancement (LGE) is an established tool in the analysis of myocardial fibrosis representing atrial cardiomyopathy as well as ablation-induced atrial scar formation following catheter ablation with thermal energy. Mechanisms of atrial lesion formation differ between thermal ablation and electroporation and its impact on results of CMR imaging are not fully understood until now. In this review article, the potential of CMR imaging for PFA lesion assessment and available data are discussed. Further, additional needs to adopt imaging approaches to the cellular mechanisms of electroporation are considered.
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Fibrilación Atrial , Cardiomiopatías , Ablación por Catéter , Humanos , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Medios de Contraste , Gadolinio , Imagen por Resonancia Magnética/métodos , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/cirugía , Atrios Cardíacos/patología , Cardiomiopatías/diagnóstico por imagen , Cardiomiopatías/cirugía , Ablación por Catéter/métodosRESUMEN
INTRODUCTION: Electroporation ablation creates deep and wide myocardial lesions. No data are available on time course and characteristics of acute lesion formation. METHODS: For the acute phase of myocardial lesion development, seven pigs were investigated. Single 200 J applications were delivered at four different epicardial right ventricular sites using a linear suction device, yielding a total of 28 lesions. Timing of applications was designed to yield lesions at seven time points: 0, 10, 20, 30, 40, 50, and 60 min, with four lesions per time point. After killing, lesion characteristics were histologically investigated. For the chronic phase of myocardial lesion development, tissue samples were used from previously conducted studies where tissue was obtained at 3 weeks and 3 months after electroporation ablation. RESULTS: Acute myocardial lesions induce a necrosis pattern with contraction band necrosis and interstitial edema, immediately present after electroporation ablation. No further histological changes such as hemorrhage or influx of inflammatory cells occurred in the first hour. After 3 weeks, the lesions consisted of sharply demarcated loose connective tissue that further developed to more fibrotic scar tissue after 3 months without additional changes. Within the scar tissue, arteries and nerves were unaffected. CONCLUSION: Electroporation ablation immediately induces contraction band necrosis and edema without additional tissue changes in the first hour. After 3 weeks, a sharply demarked scar has been developed that remains stable during follow-up of 3 months. This is highly relevant for clinical application of electroporation ablation in terms of the electrophysiological endpoint and waiting period after ablation.
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Ablación por Catéter , Animales , Ablación por Catéter/efectos adversos , Electroporación , Ventrículos Cardíacos , PorcinosRESUMEN
AIMS: Catheter ablation for atrial fibrillation (AF) using thermal energy can cause collateral damage. Pulsed field ablation (PFA) is a novel non-thermal energy source. Few small clinical studies have been published. We report on the first 'real-world' experience with pulmonary vein isolation (PVI) using PFA for paroxysmal AF (PAF). METHODS AND RESULTS: Pre- and post-ablation, phrenic nerve function was assessed. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13â Fr steerable sheath and a pentaspline PFA over-the-wire catheter. After ablation, bipolar voltage mapping was repeated to assess lesion formation. In 30 PAF patients (mean 63 years; 53% female), uncomplicated PFA was performed, with all PVs acutely isolated. The median procedure time was 116â min. The median PFA catheter LA dwell time was 29â min. The median fluoroscopy time was 26â min. In one patient with roof-dependent flutter, a roof line was intentionally created. In two patients, unintentional bidirectional mitral isthmus block was created. There was no phrenic nerve or oesophageal damage. In one patient, pericardial drainage after cardiac tamponade was performed. In-hospital stay and 30-day follow-up were uneventful. After 90 days, 97% of patients were in sinus rhythm. CONCLUSION: PVI using PFA for PAF in a 'real-world' setting appears to be safe and feasible in this small patient cohort. Procedure times are homogeneous, and LA dwell time is short. Atrial ablation lines can easily be created. Unintentional ablation of atrial tissue can occur, accurate catheter alignment to the PV ostium and axis should be ensured.
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Apéndice Atrial , Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Femenino , Atrios Cardíacos , Humanos , Masculino , Venas Pulmonares/cirugía , Resultado del TratamientoRESUMEN
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 65â 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.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Accidente Cerebrovascular , Adulto , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etiología , Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Femenino , Humanos , Persona de Mediana Edad , Venas Pulmonares/cirugía , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Adulto JovenRESUMEN
AIMS: Irreversible electroporation (IRE) ablation is a non-thermal ablation method based on the application of direct current between a multi-electrode catheter and skin electrode. The delivery of current through blood leads to electrolysis. Some studies suggest that gaseous (micro)emboli might be associated with myocardial damage and/or (a)symptomatic cerebral ischaemic events. The aim of this study was to compare the amount of gas generated during IRE ablation and during radiofrequency (RF) ablation. METHODS AND RESULTS: In six 60-75 kg pigs, an extracorporeal femoral shunt was outfitted with a bubble-counter to detect the size and total volume of gas bubbles. Anodal and cathodal 200 J IRE applications were delivered in the left atrium (LA) using a 14-electrode circular catheter. The 30 and 60 s 40 W RF point-by-point ablations were performed. Using transoesophageal echocardiography (TOE), gas formation was visualized. Average gas volumes were 0.6 ± 0.6 and 56.9 ± 19.1 µL (P < 0.01) for each anodal and cathodal IRE application, respectively. Also, qualitative TOE imaging showed significantly less LA bubble contrast with anodal than with cathodal applications. Radiofrequency ablations produced 1.7 ± 2.9 and 6.7 ± 7.4 µL of gas, for 30 and 60 s ablation time, respectively. CONCLUSION: Anodal IRE applications result in significantly less gas formation than both cathodal IRE applications and RF applications. This finding is supported by TOE observations.
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Ablación por Catéter , Animales , Ablación por Catéter/efectos adversos , Catéteres , Electroporación , Gases , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/cirugía , PorcinosRESUMEN
BACKGROUND: Cardiac tamponade (CT) complicating pulmonary vein isolation (PVI) for atrial fibrillation (AF) is a complication that can increase morbidity and mortality. Radiofrequency energy is a known cause of CT. Ablation Index (AI) is a novel ablation quality marker. We hypothesized that use of AI reduces the incidence of CT. METHODS: All AF procedures between 10/2014 and 06/2019 were included. Three ablation groups were defined: group A, RF ablation with non-contact force (CF) catheter; group B, RF ablation with CF catheter; and group C, RF ablation with CF catheter using AI. All episodes of CT were analyzed. RESULTS: In total, 1222 consecutive AF patients underwent PVI. Group A consisted of 100 (8%) procedures, while group B included 432 (35%) procedures and group C 690 (57%) procedures. The overall risk for CT in all patients was 2.1% (26/1222). The risk in group A was 2.9% (3/100), in group B 2.5% (11/432), and in group C 1.7% (12/690), including all 1222 patients in the analysis (pâ¯< 0.05). Univariate analysis identified no further specific predictors for CT. With the exception of one patient (1/26; 3.8%), who needed surgical treatment, all CT could be successfully drained. CONCLUSIONS: In a high-volume center, the use of AI decreased the risk of CT in patients undergoing RF ablation for AF by 32%.
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Fibrilación Atrial , Taponamiento Cardíaco , Ablación por Catéter , Venas Pulmonares , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Taponamiento Cardíaco/diagnóstico por imagen , Taponamiento Cardíaco/epidemiología , Taponamiento Cardíaco/etiología , Humanos , Incidencia , Venas Pulmonares/diagnóstico por imagen , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
INTRODUCTION: Recent studies demonstrated that irreversible electroporation (IRE) ablation may be an alternative method for thermal ablation for pulmonary vein isolation. Development of gaseous microemboli during catheter ablation might lead to asymptomatic ischemic events and is therefore an important research topic. Gas formation during arcing with direct current catheter ablation has been studied in the past, however not for nonarcing IRE-ablation. OBJECTIVE: The aim of the present study was to visualize, quantify, and characterize gas formation during nonarcing millisecond IRE-pulses using a multielectrode circular catheter. METHODS: In vitro, gas formation during IRE-pulses was studied using a high-speed imaging, direct volume measurements, and a bubble counter. Gas formation was compared between cathodal and anodal IRE-pulses and between a small and large catheter hoop diameter. RESULTS: High-speed images showed the location and dynamics of gas formation during cathodal and anodal millisecond IRE-pulses. The direct volume measurements demonstrated a significantly larger volume for cathodal than for anodal IRE-pulses (P < .001), and no significant difference between small and large hoop diameters. A strong linear relationship was found between delivered charge and total gas volume (r = 0.99). Bubble counter measurements showed that cathodal IRE-pulses produced more and larger gas bubbles than anodal IRE-pulses. The ratio of total gas volume between cathodal and anodal IRE-pulses is different as predicted from electrolysis theory. CONCLUSION: In vitro, millisecond anodal IRE-pulses produce significantly less and smaller gas bubbles than millisecond cathodal IRE-pulses. In vivo experiments are required to investigate the clinical implication of these observations.
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Ablación por Catéter/efectos adversos , Electroporación , Embolia Aérea/etiología , Catéteres Cardíacos , Ablación por Catéter/instrumentación , Electroporación/instrumentación , Diseño de Equipo , Factores de TiempoRESUMEN
BACKGROUND: Irreversible electroporation (IRE) using direct current (DC) is an effective method for the ablation of cardiac tissue. A major drawback of the use of DC-IRE, however, are two problems: requirement of general anesthesia due to severe muscle contractions and the formation of bubbles containing gaseous products from electrolysis. The use of high-frequency alternating current (HF-IRE) is expected to solve both problems, because HF-IRE produces little to no muscle spasms and does not cause electrolysis. METHODS: In the present study, we introduce a novel asymmetric, high-frequency (aHF) waveform for HF-IRE and present the results of a first, small, animal study to test its efficacy. RESULTS: The data of the experiments suggest that the aHF waveform creates significantly deeper lesions than a symmetric HF waveform of the same energy and frequency (p = 0.003). CONCLUSION: We therefore conclude that the use of the aHF enhances the feasibility of the HF-IRE method.
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Técnicas de Ablación/métodos , Arritmias Cardíacas/terapia , Electroporación/métodos , Animales , Arritmias Cardíacas/fisiopatología , Conductividad Eléctrica , Contracción Miocárdica , PorcinosRESUMEN
Aims: With multi-electrode catheters, measuring contact force (CF) on each electrode is technically challenging. Present electrical methods, like the electrical coupling index (ECI) may yield false positive values in pulmonary veins. We developed a novel method that measures electrode-interface resistance (IR) by applying a very local electrical field between neighbouring catheter electrodes while measuring voltage between each catheter electrode and a skin patch. The aim of this study was to evaluate the new IR method to measure electrode-tissue contact. Methods and results: In vitro, effects of remote high-impedance structures were studied. In addition, both ECI and IR were directly compared with true electrode-tissue CF. In five pigs, the influence of high-impedance pulmonary tissue on ECI and IR was investigated while navigating the free floating catheter into the caval veins. Inside the left atrium (LA), IR was directly compared with CF. Finally, multi-electrode IR measurements in the LA and inferior pulmonary vein (IPV) were compared. In vitro, IR is much less affected by remote high-impedance structures than ECI (3% vs. 32%). Both IR and ECI strongly relate to electrode-tissue CF (r2 = 0.84). In vivo, and in contrast to ECI, IR was not affected by nearby pulmonary tissue. Inside the LA, a strong relation between IR and CF was found. This finding was confirmed by simultaneous multi-electrode measurements in LA and IPV. Conclusion: Data of the present study suggest that electrode-tissue contact affects the IR while being highly insensitive to remote structures. This method facilitates electrode-tissue contact measurements with circular multi-electrode ablation catheters.
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Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Ablación por Catéter/instrumentación , Atrios Cardíacos/cirugía , Venas Pulmonares/cirugía , Animales , Impedancia Eléctrica , Diseño de Equipo , Ensayo de Materiales , Modelos Animales , Sus scrofaRESUMEN
INTRODUCTION: Implantable loop recorders (ILR) are leadless subcutaneous devices that allow cardiac monitoring for up to 3â¯years and are a valuable tool in the diagnosis of arrhythmias, cryptogenic stroke and unexplained syncope. The Biotronik BioMonitor 2 is a novel, insertable ILR allowing long-term continuous monitoring with wireless telemetry options. METHODS: A single-center, prospective, observational study investigating the reliability of sensing quality and detection performance in the BioMonitor 2 ILR, as well as post-implantation patient satisfaction. R-wave amplitude was recorded immediately post implantation and 1â¯day post implantation, followed by extensive patient instruction. Follow-up was scheduled after 3â¯months, or after an event. Data from the ILR were retrieved, with documentation of all episodes, R-wave amplitude and noise burden. The anatomical position of the ILR was determined 1â¯day post implantation and after 3â¯months. A patient questionnaire was conducted after 3â¯months. RESULTS: 30 consecutive patients (mean age 71⯱â¯12â¯years, 56% male) were analyzed. Indications for ILR implantation were: unexplained syncope (nâ¯=â¯24, 80%), suspected atrial fibrillation (nâ¯=â¯4, 13%), cryptogenic stroke (nâ¯=â¯1, 3%) and palpitations (nâ¯=â¯1, 3%). Median time from skin cut to suture was 8â¯min. No complications occurred. Mean R-wave amplitude at implantation was 0.84⯱â¯0.32â¯mV, at day 1 post implantation 0.96⯱â¯0.31â¯mV, and after a mean follow-up of 85⯱â¯24â¯days 1.02⯱â¯0.47â¯mV (pâ¯=â¯0.01). The mean noise burden was 1.4⯱â¯2%. CONCLUSION: Implantation of the novel BioMonitor 2 ILR is fast and uncomplicated. Initial sensing values are good and improve over time.
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Fibrilación Atrial/diagnóstico , Electrocardiografía Ambulatoria/instrumentación , Anciano , Anciano de 80 o más Años , Bradicardia/diagnóstico , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Prótesis e Implantes , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , TelemetríaRESUMEN
Because of the close proximity of the phrenic nerve to the pericardium, phrenic nerve damage caused by epicardial ablation can easily occur. We report two cases of epicardial VT ablation where pericardial injection of saline, combined with the use of a steerable sheath, successfully prevents the phrenic nerve from being damaged.
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BACKGROUND: The role of catheter ablation in elderly patients with atrial fibrillation (AF) is unclear. Pulsed field ablation (PFA) demonstrates a favorable clinical profile, however, data on elderly patients are lacking. AIMS: We aimed to assess the safety and efficacy of PFA in the elderly, using data from the EU-PORIA registry. METHODS: Periprocedural complications and long-term safety and efficacy outcomes of AF ablation using the pentaspline PFA catheter (Farapulse™) were compared between patients older than 80â¯years old and their younger counterparts, across seven European centers. RESULTS: Among the 1233 patients in the registry, 88 (7.1â¯%) were older than 80â¯years. Elderly patients were more often females (51.1â¯% vs 37.8â¯%, pâ¯=â¯0.01) with a lower median BMI (26.0, IQR:23.5-29.2 vs 26.9, IQR:24.4-30.4â¯kg/m2, pâ¯=â¯0.02), a higher median CHA2DS2-VASc score (4, IQR:3-5 vs 2, IQR:1-3, pâ¯<â¯0.001) and a higher incidence of hypertension (73.9â¯% vs 52.7â¯%, pâ¯<â¯0.001). In both groups, most patients had paroxysmal AF (58.0â¯% vs 60.3â¯%, pâ¯=â¯0.65). Ablation in the elderly was more frequently performed with minimally interrupted anticoagulation (87.5â¯% vs 59.7â¯%, pâ¯<â¯0.001). Despite comparable rates of overall complications (5.7â¯% vs 3.5â¯%, pâ¯=â¯0.29), elderly patients had a higher incidence of stroke (2.3â¯% vs 0.3â¯%, pâ¯=â¯0.04). At 12â¯months, major adverse clinical events (4.5â¯% vs. 2.1â¯%, pâ¯=â¯0.12) and arrhythmia-free survival (70â¯% vs 74â¯%, pâ¯=â¯0.69) were comparable in both groups. None of the recurrence-free elderly patients were on antiarrhythmic drugs at the end of follow-up. CONCLUSION: In this real-world cohort, the efficacy of PFA for AF was similar in elderly and younger patients. Despite comparable complication rates, a higher incidence of stroke was observed in the elderly.
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BACKGROUND: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology with high procedural safety and efficiency for pulmonary vein isolation (PVI). Premarket data showed high PVI durability during mandatory remapping studies. Data on lesion durability in real-world patients with clinically indicated redo procedures are scarce. OBJECTIVES: This study sought to report PVI durability rates in patients undergoing a clinically indicated redo procedure after an index PVI using PFA. METHODS: Patients from 7 European centers undergoing an index PVI using PFA were included the EU-PORIA (European Real-world Outcomes With Pulsed Field Ablation in Patients With Symptomatic Atrial Fibrillation) registry. In patients with subsequent left atrial redo procedures due to arrhythmia recurrence, 3-dimensional electroanatomical maps were acquired. PVI durability was assessed on a per-vein and per-patient level, and sites of reconnections and predictors of lesion durability were identified. RESULTS: Of 1,184 patients (62% paroxysmal atrial fibrillation) undergoing an index PVI using PFA, 272 (23%) had an arrhythmia recurrence. Of these, 144 (53%) underwent a left atrial redo procedure a median of 7 (Q1-Q3: 5-10) months after the first ablation. Three-dimensional electroanatomical maps identified 404 of 567 pulmonary veins (71%) with durable isolation. In 54 patients (38%), all pulmonary veins were durably isolated. Prior operator experience with cryoballoon ablation was associated with a higher PVI durability compared to operators with only point-by-point radiofrequency experience (76% vs 60%; P < 0.001). Neither the operators' cumulative experience in atrial fibrillation ablation (≤5 vs >5 years) nor the size of the PFA device used (31 mm vs 35 mm) had an impact on subsequent lesion durability (both P > 0.50). CONCLUSIONS: In 144 patients with arrhythmia recurrence after PFA PVI, durable isolation was observed in 71% of the pulmonary veins during the redo procedure, and 38% of all patients showed durable isolation of all veins.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Sistema de Registros , Humanos , Venas Pulmonares/cirugía , Fibrilación Atrial/cirugía , Masculino , Femenino , Persona de Mediana Edad , Ablación por Catéter/métodos , Anciano , Europa (Continente) , Resultado del Tratamiento , Recurrencia , Reoperación/estadística & datos numéricosRESUMEN
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/terapia , Femenino , Masculino , Persona de Mediana Edad , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Anciano , Resultado del Tratamiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiologíaRESUMEN
BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.
RESUMEN
BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.