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BACKGROUND: Diffuse coronary artery disease affects the safety and efficacy of percutaneous coronary intervention (PCI). Pathophysiologic coronary artery disease patterns can be quantified using fractional flow reserve (FFR) pullbacks incorporating the pullback pressure gradient (PPG) calculation. This study aimed to establish the capacity of PPG to predict optimal revascularization and procedural outcomes. METHODS: This prospective, investigator-initiated, single-arm, multicenter study enrolled patients with at least one epicardial lesion with an FFR ≤0.80 scheduled for PCI. Manual FFR pullbacks were used to calculate PPG. The primary outcome of optimal revascularization was defined as an FFR ≥0.88 after PCI. RESULTS: A total of 993 patients with 1044 vessels were included. The mean FFR was 0.68±0.12, PPG 0.62±0.17, and the post-PCI FFR was 0.87±0.07. PPG was significantly correlated with the change in FFR after PCI (r=0.65 [95% CI, 0.61-0.69]; P<0.001) and demonstrated excellent predictive capacity for optimal revascularization (area under the receiver operating characteristic curve, 0.82 [95% CI, 0.79-0.84]; P<0.001). FFR alone did not predict revascularization outcomes (area under the receiver operating characteristic curve, 0.54 [95% CI, 0.50-0.57]). PPG influenced treatment decisions in 14% of patients, redirecting them from PCI to alternative treatment modalities. Periprocedural myocardial infarction occurred more frequently in patients with low PPG (<0.62) compared with those with focal disease (odds ratio, 1.71 [95% CI, 1.00-2.97]). CONCLUSIONS: Pathophysiologic coronary artery disease patterns distinctly affect the safety and effectiveness of PCI. PPG showed an excellent predictive capacity for optimal revascularization and demonstrated added value compared with an FFR measurement. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04789317.
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Enfermedad de la Arteria Coronaria , Reserva del Flujo Fraccional Miocárdico , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/terapia , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Atrial secondary tricuspid regurgitation (A-STR) is a distinct phenotype of secondary tricuspid regurgitation with predominant dilation of the right atrium and normal right and left ventricular function. Atrial secondary tricuspid regurgitation occurs most commonly in elderly women with atrial fibrillation and in heart failure with preserved ejection fraction in sinus rhythm. In A-STR, the main mechanism of leaflet malcoaptation is related to the presence of a significant dilation of the tricuspid annulus secondary to right atrial enlargement. In addition, there is an insufficient adaptive growth of tricuspid valve leaflets that become unable to cover the enlarged annular area. As opposed to the ventricular phenotype, in A-STR, the tricuspid valve leaflet tethering is typically trivial. The A-STR phenotype accounts for 10%-15% of clinically relevant tricuspid regurgitation and has better outcomes compared with the more prevalent ventricular phenotype. Recent data suggest that patients with A-STR may benefit from more aggressive rhythm control and timely valve interventions. However, little is mentioned in current guidelines on how to identify, evaluate, and manage these patients due to the lack of consistent evidence and variable definitions of this entity in recent investigations. This interdisciplinary expert opinion document focusing on A-STR is intended to help physicians understand this complex and rapidly evolving topic by reviewing its distinct pathophysiology, diagnosis, and multi-modality imaging characteristics. It first defines A-STR by proposing specific quantitative criteria for defining the atrial phenotype and for discriminating it from the ventricular phenotype, in order to facilitate standardization and consistency in research.
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Fibrilación Atrial , Insuficiencia Cardíaca , Insuficiencia de la Válvula Tricúspide , Humanos , Femenino , Anciano , Insuficiencia de la Válvula Tricúspide/etiología , Insuficiencia de la Válvula Tricúspide/complicaciones , Atrios Cardíacos/diagnóstico por imagen , Válvula Tricúspide/diagnóstico por imagen , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etiología , Fibrilación Atrial/terapiaRESUMEN
The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.
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Desfibriladores Implantables , Marcapaso Artificial , Cardiopatía Reumática , Insuficiencia de la Válvula Tricúspide , Humanos , Marcapaso Artificial/efectos adversos , Desfibriladores Implantables/efectos adversos , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/complicaciones , Cardiopatía Reumática/complicaciones , Estudios RetrospectivosRESUMEN
INTRODUCTION: The VARIPULSE™ variable-loop circular catheter (VLCC) is a bidirectional, multielectrode catheter that can perform electrophysiological mapping and deliver pulsed field energy through the TRUPULSE™ Generator for the treatment of atrial fibrillation. This ablation system, including the CARTO 3™ three-dimensional electroanatomical mapping system, represents a fully integrated system. METHODS: Pulsed field ablation (PFA) is a novel, primarily cardiac tissue-selective ablation technology with a minimal thermal effect, potentially eliminating the collateral tissue damage associated with radiofrequency ablation or cryoablation. Integration of a mapping system may lead to shorter fluoroscopy times and improve the usability of the system, allowing tracking of energy density and placement to confirm no areas around the vein are left untreated. RESULTS: This step-by-step review covers patient selection, mapping, the step-by-step ablation workflow, details on catheter repositioning and ensuring contact, considerations for ablation of specific anatomical variations, and discussion of ablation without fluoroscopy based on our initial clinical experience. CONCLUSIONS: The VLCC is part of the fully integrated PFA system designed for pulmonary vein isolation, using mapping to guide catheter placement and lesion set creation. The current workflow, which is based on our initial clinical experience, may be further refined as the PFA system is used in real-world settings.
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INTRODUCTION: Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm. There has been increased adoption of a high-power and very high-power short-duration ablation practice propelled by the availability of the temperature-controlled radiofrequency QDOT MICRO catheter. METHODS: There are fundamental differences in biophysics between very high-powered temperature guided ablation and conventional ablation strategy that may impact patient outcomes. The catheter's design and ablation modes offer flexibility in technique while accommodating the individual operator's clinical discretion and preference to deliver a durable, transmural, and contiguous lesion set. RESULTS: Here, we provide recommendations for 3 different workflows using the QDOT MICRO catheter in a step-by-step manner for pulmonary vein isolation based on our cumulative experience as early adopters of the technology and the data available in the scientific literature. CONCLUSIONS: With standardization, temperature-controlled ablation with the QDOT MICRO catheter provides operators the flexibility of implementing different ablation strategies to ensure durable contiguous pulmonary vein isolation depending on patient characteristics.
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Fibrilación Atrial , Catéteres Cardíacos , Ablación por Catéter , Diseño de Equipo , Venas Pulmonares , Humanos , Potenciales de Acción , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Ablación por Catéter/instrumentación , Frecuencia Cardíaca , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Temperatura , Factores de Tiempo , Resultado del Tratamiento , Flujo de TrabajoRESUMEN
AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10â mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.
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Cardiomiopatías , Ablación por Catéter , Criocirugía , Taquicardia Ventricular , Anciano , Humanos , Persona de Mediana Edad , Cardiomiopatías/complicaciones , Cardiomiopatías/diagnóstico , Cardiomiopatías/cirugía , Ablación por Catéter/efectos adversos , Cicatriz/complicaciones , Criocirugía/efectos adversos , Estudios Prospectivos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/etiología , Taquicardia Ventricular/cirugía , Temperatura , Resultado del TratamientoRESUMEN
AIMS: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. METHODS AND RESULTS: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3â mm; an inter-tag distance ≤6â mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72â h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. CONCLUSION: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05752487.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Humanos , Venas Pulmonares/cirugía , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Masculino , Femenino , Ablación por Catéter/métodos , Ablación por Catéter/instrumentación , Persona de Mediana Edad , Resultado del Tratamiento , Anciano , Imagenología Tridimensional , Catéteres Cardíacos , Factores de Tiempo , Diseño de Equipo , Estudios Prospectivos , RecurrenciaRESUMEN
AIMS: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. METHODS AND RESULTS: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. CONCLUSION: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. CLINICAL TRIAL REGISTRATION: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.
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Apéndice Atrial , Fibrilación Atrial , Sistema de Registros , Accidente Cerebrovascular , Humanos , Apéndice Atrial/cirugía , Masculino , Femenino , Fibrilación Atrial/mortalidad , Fibrilación Atrial/cirugía , Anciano , Incidencia , Factores de Riesgo , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/etiología , Anciano de 80 o más Años , Cateterismo Cardíaco , Medición de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Causas de Muerte , Persona de Mediana EdadRESUMEN
A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.
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Apéndice Atrial , Fibrilación Atrial , Médicos , Accidente Cerebrovascular , Tromboembolia , Adulto , Humanos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/complicaciones , Cierre del Apéndice Auricular Izquierdo , Consenso , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Anticoagulantes/efectos adversos , Tromboembolia/etiología , Tromboembolia/prevención & control , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Vitamina K , Apéndice Atrial/cirugía , Resultado del TratamientoRESUMEN
AIMS: Prior case series showed promising results for cardioneuroablation in patients with vagally induced atrioventricular blocks (VAVBs). We aimed to examine the acute procedural characteristics and intermediate-term outcomes of electroanatomical-guided cardioneuroablation (EACNA) in patients with VAVB. METHODS AND RESULTS: This international multicentre retrospective registry included data collected from 20 centres. Patients presenting with symptomatic paroxysmal or persistent VAVB were included in the study. All patients underwent EACNA. Procedural success was defined by the acute reversal of atrioventricular blocks (AVBs) and complete abolition of atropine response. The primary outcome was occurrence of syncope and daytime second- or advanced-degree AVB on serial prolonged electrocardiogram monitoring during follow-up. A total of 130 patients underwent EACNA. Acute procedural success was achieved in 96.2% of the cases. During a median follow-up of 300 days (150, 496), the primary outcome occurred in 17/125 (14%) cases with acute procedural success (recurrence of AVB in 9 and new syncope in 8 cases). Operator experience and use of extracardiac vagal stimulation were similar for patients with and without primary outcomes. A history of atrial fibrillation, hypertension, and coronary artery disease was associated with a higher primary outcome occurrence. Only four patients with primary outcome required pacemaker placement during follow-up. CONCLUSION: This is the largest multicentre study demonstrating the feasibility of EACNA with encouraging intermediate-term outcomes in selected patients with VAVB. Studies investigating the effect on burden of daytime symptoms caused by the AVB are required to confirm these findings.
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Bloqueo Atrioventricular , Sistema de Registros , Humanos , Masculino , Femenino , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Bloqueo Atrioventricular/fisiopatología , Bloqueo Atrioventricular/terapia , Bloqueo Atrioventricular/cirugía , Ablación por Catéter/métodos , Factores de Tiempo , Estimulación del Nervio Vago/métodos , Técnicas Electrofisiológicas Cardíacas , Síncope/etiología , Recurrencia , Nodo Atrioventricular/cirugía , Nodo Atrioventricular/fisiopatologíaRESUMEN
AIMS: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). METHODS AND RESULTS: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF. CONCLUSIONS: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF.
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Fibrilación Atrial , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Riesgo , Hemorragia , Anticoagulantes/uso terapéuticoRESUMEN
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .
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Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , América Latina , Resultado del Tratamiento , Catéteres , Asia , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodosRESUMEN
BACKGROUND: Clinical studies have demonstrated the safety, efficacy, and efficiency of VISITAG SURPOINT® (VS), which provides important lesion markers during catheter ablation (CA) of atrial fibrillation (AF). The present study evaluated the cost-effectiveness of CA with VS compared to CA without VS in AF from the publicly-funded German and Belgium healthcare perspectives. METHODS: We constructed a two-stage cost utility model that included a decision tree to simulate clinical events, costs, and utilities during the first year after the index procedure and a Markov model to simulate transitions between health states throughout a patient's lifetime. Model inputs included published literature, a meta-analysis of randomized controlled trials AF outcomes, and publicly available administrative data on costs. Deterministic and probabilistic sensitivity analyses were conducted to determine the robustness of the model. RESULTS: CA with VS was associated with lower per patient costs vs CA without VS (Germany: 3295 vs. 3936, Belgium: 3194 vs. 3814) and similar quality-adjusted life-years (QALYs) per patient (Germany: 5.35 vs. 5.34, Belgium: 5.68 vs. 5.67). CA with VS was the dominant ablation strategy (incremental cost-effectiveness ratios: Germany: -52,455/QALY, Belgium: -50,676/QALY). The model results were robust and not highly sensitive to variation to individual parameters with regard to QALYs or costs. Freedom from AF and procedure time had the greatest impact on model results, highlighting the importance of these outcomes in ablation. CONCLUSIONS: CA with VS resulted in cost savings and QALY gains compared to CA without VS, supporting the increased adoption of VS in CA in Germany and Belgium.
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Fibrilación Atrial , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Bélgica , Ablación por Catéter/métodos , Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de VidaRESUMEN
BACKGROUND: Combining pulsed field ablation (PFA) with ultra-low temperature cryoablation (ULTC) represents a novel energy source which may create more transmural cardiac lesions. We sought to assess the feasibility of lesions created by combined cryoablation and pulsed field ablation (PFCA) versus PFA alone. METHODS: Ablations were performed using a custom PFA generator, ULTC console, and an ablation catheter with insertable stylets. PFA was delivered in a biphasic, bipolar train. PFCA precooled the tissue for 30 s followed by a concurrent PFA train. Benchtop testing using Schlieren imaging and microbubble volume assessment were used to compare PFA and PFCA. PFA and PFCA lesions using pre-optimized and optimized ablation protocols were studied in 6 swine. Pre and post-ECGs were recorded for each ablation and a gross necropsy was performed at 14 days. RESULTS: Consistent with benchtop comparisons of heat and microbubble generation, PFA deliveries in the animals were accompanied by muscle contractions and significant microbubbles (Grade 2-3) visible on intracardiac echo while neither occurred during PFCA at higher voltage levels. Both PFA and PFCA acutely eliminated or highly attenuated (>80%) local atrial electrograms. Histology of PFA and PFCA lesions indicated depth up to 6-7 mm and nearly all lesions were transmural. Optimized PFCA produced wider cavotricuspid isthmus lesions with evidence of tissue selectivity. CONCLUSION: A novel technology combining PFA and ULTC into one energy source demonstrated in-vivo feasibility for PFCA ablation. PFCA had a more favorable thermal profile and did not produce muscle contraction or microbubbles while extending lesion depth beyond cryoablation.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Porcinos , Animales , Criocirugía/efectos adversos , Criocirugía/métodos , Temperatura , Frío , Atrios Cardíacos , Ablación por Catéter/métodos , Venas Pulmonares/cirugía , Fibrilación Atrial/cirugíaRESUMEN
AIMS: The leading reason for delayed discharge after pulmonary vein isolation (PVI) is vascular complications. This study aimed to evaluate feasibility, safety, and efficacy of the Perclose Proglide™ suture-mediated vascular closure in ambulatory PVI, report complications, patient satisfaction, and cost of this approach. METHODS AND RESULTS: Patients scheduled for PVI were enrolled prospectively in an observational design. Feasibility was assessed as % discharged the day of procedure. Efficacy was analysed as acute access site closure rate, time to reach haemostasis, time to ambulate, and time to discharge. Safety analysis consisted of vascular complications at 30 days. Cost analysis was reported using direct and indirect cost analysis. A 1:1 propensity matched control cohort was used for comparing time to discharge to usual workflow. Of 50 enrolled patients, 96% were discharged on the same day. 100% of devices were successfully deployed. Immediate (<1 min) haemostasis was reached in 30 patients (62.5%). Mean time to discharge was 5:48 ± 1:03 h (vs. 10:16 ± 1:21 h in the matched cohort, P < 0.0001). Patients reported high level of satisfaction with the post-operative time. No major vascular complication occurred. Cost analysis showed a neutral impact compared to the standard of care. CONCLUSION: The use of the closure device for femoral venous access after PVI led to safe discharge of patients within 6 h from the intervention in 96% of the population. This approach could minimize the overcrowding of healthcare facilities. The gain in post-operative recovery time improved patients' satisfaction and balanced the economic cost of the device.
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Venas Pulmonares , Dispositivos de Cierre Vascular , Humanos , Venas Pulmonares/cirugía , Suturas , Resultado del Tratamiento , Flujo de TrabajoRESUMEN
AIMS: Left atrial catheter ablation is well established in patients with symptomatic atrial fibrillation (AF) but associated with risk of embolism to the brain. The present analysis aims to assess the impact of diffusion-weighted imaging (DWI) slice thickness on the rate of magnetic resonance imaging (MRI)-detected ischaemic brain lesions after ablation. METHODS AND RESULTS: AXAFA-AFNET 5 trial (NCT02227550) participants underwent MRI using high-resolution (hr) DWI (slice thickness: 2.5-3â mm) and standard DWI (slice thickness: 5-6â mm) within 3-48â h after ablation. In 321 patients with analysable brain MRI (mean age 64 years, 33% female, median CHA2DS2-VASc 2), hrDWI detected at least one acute brain lesion in 84 (26.2%) patients and standard DWI in 60 (18.7%; P < 0.01) patients. High-resolution diffusion-weighted imaging detected more lesions compared to standard DWI (165 vs. 104; P < 0.01). The degree of agreement for lesion confirmation using hrDWI vs. standard DWI was substantial (κ = 0769). Comparing the proportion of DWI-detected lesions, lesion distribution, and total lesion volume per patient, there was no difference in the cohort of participants undergoing MRI at 1.5â T (n = 52) vs. 3â T (n = 269). CONCLUSION: The pre-specified AXAFA-AFNET 5 sub-analysis revealed significantly increased rates of MRI-detected acute brain lesions using hrDWI instead of standard DWI in AF patients undergoing ablation. In comparison to DWI slice thickness, MRI field strength had a no significant impact in the trial. Comparing the varying rates of ablation-related MRI-detected brain lesions across previous studies has to consider these technical parameters. Future studies should use hrDWI, as feasibility was demonstrated in the multicentre AXAFA-AFNET 5 trial.
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Fibrilación Atrial , Ablación por Catéter , Humanos , Femenino , Persona de Mediana Edad , Masculino , Imagen por Resonancia Magnética/métodos , Imagen de Difusión por Resonancia Magnética/métodos , Encéfalo/diagnóstico por imagen , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversosRESUMEN
BACKGROUND: The study is intended to evaluate the acute and long-term effectiveness and peri-procedural safety in ablation of persistent atrial fibrillation (PsAF) using the CartoFinder algorithm guided ablation (CFGA) targeting on repetitive activation patterns (RAPs) and focal impulses (FIs) identified in dynamic maps. METHODS: This is a prospective, single-arm, multicenter study. A 64-pole multielectrode basket catheter was used for intracardiac global electrogram (EGM) mapping. The RAPs or FIs were repeatedly mapped and ablated for up to five iterations by the CartoFinder algorithm to achieve sinus rhythm (SR) or organized atrial tachycardia (AT), which were followed by PVI. All patients were followed up for 12 months after procedure. RESULTS: Sixty-four PsAF patients (age, 60.7 ± 9.1 years; male, 76.6%; median PsAF duration, 6.0 months) underwent CFGA on RAPs/FIs. Six patients (9.4%) reported primary adverse event (PAE) including groin hematoma (2), complete heart block (1), tamponade (1), pericarditis (1), and pseudoaneurysm (1). Repeated mapping and ablation on RAPs/FIs resulted in the cycle length (CL) increase from 191.0 ± 167.6 ms at baseline to 365.7 ± 296.7 ms in the LA and from 167.8 ± 41.6 ms to 379.4 ± 293.5 ms in the RA and 30.2% (19/63) AF termination to SR or organized AT. The 12-month arrhythmia-free and symptomatic AF-free rates were 60.9% and 75.0%, respectively. Patients with acute AF termination showed a higher 12-month arrhythmia-free rate (76.9%) than those without (50.0%, p = .04). CONCLUSIONS: The study demonstrated that the CartoFinder algorithm can be used for global activation mapping during PsAF ablation. Patients with acute AF termination had a lower 12-month AF recurrence rate compared to patients without.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Taquicardia Supraventricular , Humanos , Masculino , Persona de Mediana Edad , Anciano , Estudios Prospectivos , Resultado del Tratamiento , Recurrencia , Ablación por Catéter/métodos , Venas Pulmonares/cirugíaRESUMEN
INTRODUCTION: Single-center observational studies have shown promising results with fragmented electrogram (FE)-guided ganglionated plexus (GP) ablation in patients with vagally mediated bradyarrhythmia (VMB). We aimed to compare the acute procedural characteristics during FE-guided GP ablation in patients with VMB performed by first-time operators and those of a single high-volume operator. METHODS AND RESULTS: This international multicenter cohort study included data collected over 2 years from 16 cardiac hospitals. The primary operators were classified according to their prior GP ablation experience: a single high-volume operator who had performed > 50 GP ablation procedures (Group 1), and operators performing their first GP ablation cases (Group 2). Acute procedural characteristics and syncope recurrence were compared between groups. Forty-seven consecutive patients with VMB who underwent FE-guided GP ablation were enrolled, n = 31 in Group 1 and n = 16 in Group 2. The mean number of ablation points in each GP was comparable between groups. The ratio of positive vagal response during ablation on the left superior GP was higher in Group 1 (90.3% vs. 62.5%, p = .022). Ablation of the right superior GP increased heart rate acutely without any vagal response in 45 (95.7%) cases. The procedure time was longer in group 2 (83.4 ± 21 vs. 118.0 ± 21 min, respectively, p < .001). Over a mean follow-up duration of 8.0 ± 3 months (range 2-24 months), none of the patients suffered from syncope. CONCLUSION: This multi-center pilot study shows for the first time the feasibility of FE-guided GP ablation across a large group of procedure-naïve operators.
Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Fibrilación Atrial/cirugía , Bradicardia/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Estudios de Cohortes , Humanos , Proyectos Piloto , Resultado del Tratamiento , Nervio Vago/cirugíaRESUMEN
Background: Atrial fibrillation (AF) is considered the most common human arrhythmia. In nonvalvular AF, around 99% of thrombi are formed in the left atrial appendage (LAA). Nevertheless, there is not a consensus in the community about the relevant factors to stratify the AF population according to thrombogenic risk. Objective: To demonstrate the need for combining left atrial morphological and haemodynamics indices to improve the thrombogenic risk assessment in nonvalvular AF patients. Methods: A cohort of 71 nonvalvular AF patients was analysed. Statistical analysis, regression models, and random forests were used to analyse the differences between morphological and haemodynamics parameters, extracted from computational simulations built on 3D rotational angiography images, between patients with and without transient ischemic attack (TIA) or cerebrovascular accident (CVA). Results: The analysis showed that models composed of both morphological and haemodynamic factors were better predictors of TIA/CVA compared with models based on either morphological or haemodynamic factors separately. Maximum ostium diameter, length of the centreline, blood flow velocity within the LAA, oscillatory shear index, and time average wall shear stress parameters were found to be key risk factors for TIA/CVA prediction. In addition, TIA/CVA patients presented more flow stagnation within the LAA. Conclusion: Thrombus formation in the LAA is the result of multiple factors. Analyses based only on morphological or haemodynamic parameters are not precise enough to predict such a phenomenon, as demonstrated in our results; a better patient stratification can be obtained by jointly analysing morphological and haemodynamic features.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/complicaciones , Velocidad del Flujo Sanguíneo , Ecocardiografía Transesofágica/métodos , Humanos , Medición de RiesgoRESUMEN
We aim to provide a critical appraisal of basic concepts underlying signal recording and processing technologies applied for (i) atrial fibrillation (AF) mapping to unravel AF mechanisms and/or identifying target sites for AF therapy and (ii) AF detection, to optimize usage of technologies, stimulate research aimed at closing knowledge gaps, and developing ideal AF recording and processing technologies. Recording and processing techniques for assessment of electrical activity during AF essential for diagnosis and guiding ablative therapy including body surface electrocardiograms (ECG) and endo- or epicardial electrograms (EGM) are evaluated. Discussion of (i) differences in uni-, bi-, and multi-polar (omnipolar/Laplacian) recording modes, (ii) impact of recording technologies on EGM morphology, (iii) global or local mapping using various types of EGM involving signal processing techniques including isochronal-, voltage- fractionation-, dipole density-, and rotor mapping, enabling derivation of parameters like atrial rate, entropy, conduction velocity/direction, (iv) value of epicardial and optical mapping, (v) AF detection by cardiac implantable electronic devices containing various detection algorithms applicable to stored EGMs, (vi) contribution of machine learning (ML) to further improvement of signals processing technologies. Recording and processing of EGM (or ECG) are the cornerstones of (body surface) mapping of AF. Currently available AF recording and processing technologies are mainly restricted to specific applications or have technological limitations. Improvements in AF mapping by obtaining highest fidelity source signals (e.g. catheter-electrode combinations) for signal processing (e.g. filtering, digitization, and noise elimination) is of utmost importance. Novel acquisition instruments (multi-polar catheters combined with improved physical modelling and ML techniques) will enable enhanced and automated interpretation of EGM recordings in the near future.