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INTRODUCTION: During atrial fibrillation ablation (AFA), achievement of first pass isolation (FPI) reflects effective lesion formation and predicts long-term freedom from arrhythmia recurrence. We aim to determine the clinical and procedural predictors of pulmonary vein FPI. METHODS: We reviewed AFA procedures in a multicenter prospective registry of AFA (REAL-AF). A multivariate ordinal logistic regression, weighted by inverse proceduralist volume, was used to determine predictors of FPI. RESULTS: A total of 2671 patients were included with 1806 achieving FPI in both vein sides, 702 achieving FPI in one, and 163 having no FPI. Individually, age, left atrial (LA) scar, higher power usage (50 W), greater posterior contact force, ablation index >350 posteriorly, Vizigo™ sheath utilization, nonstandard ventilation, and high operator volume (>6 monthly cases) were all related to improved odds of FPI. Conversely sleep apnea, elevated body mass index (BMI), diabetes mellitus, LA enlargement, antiarrhythmic drug use, and center's higher fluoroscopy use were related to reduced odds of FPI. Multivariate analysis showed that BMI > 30 (OR 0.78 [0.64-0.96]) and LA volume (OR per mL increase = 1.00 [0.99-1.00]) predicted lower odds of achieving FPI, whereas significant left atrial scarring (>20%) was related to higher rates of FPI. Procedurally, the use of high power (50 W) (OR 1.32 [1.05-1.65]), increasing force posteriorly (OR 2.03 [1.19-3.46]), and nonstandard ventilation (OR 1.26 [1.00-1.59]) predicted higher FPI rates. At a site level, high procedural volume (OR 1.89 [1.48-2.41]) and low fluoroscopy centers (OR 0.72 [0.61-0.84]) had higher rates of FPI. CONCLUSION: FPI rates are affected by operator experience, patient comorbidities, and procedural strategies. These factors may be postulated to impact acute lesion formation.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Humanos , Venas Pulmonares/cirugía , Resultado del Tratamiento , Estudios Prospectivos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Atrios Cardíacos , Cicatriz , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Recurrencia , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Durable electrical isolation of pulmonary veins (PVs) is associated with better outcomes after atrial fibrillation (AF) ablation, but previous studies of AF recurrence have reported high rates of reconnection despite successful acute isolation. This study aims to quantify historical trends in the durability of PV isolation (PVI) as radiofrequency (RF) ablation catheters, additional ablation technologies, and associated workflows have evolved. METHODS: The study population included adult patients receiving a first repeat ablation for AF between September 2013 and July 2019 at the study site. All index ablations were performed at the same site with an RF catheter and included PVI. Three generations of irrigated RF catheters based on the same technology platform were used by the site during the timeframe of this study. RESULTS: A total of 224 patients were included in the analysis. At repeat ablation, the mean number of patients with at least one reconnected PV dropped significantly with subsequent catheter generation, from 78.3% to 56.7% to 27.0% (p < .0001). Moreover, the mean number of reconnected PVs were significantly reduced from 1.48 to 0.92 to 0.47 (p < .0001), representing a 68.3% reduction across the 3 generations of devices. CONCLUSION: Significant improvement in durable PVI was seen with successive generations of RF catheter over a 6-year period. In addition to catheter technology, ancillary advances in ablation technologies, workflows, and operator experience likely contributed to these improvements.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Adulto , Humanos , Venas Pulmonares/cirugía , Resultado del Tratamiento , Factores de Tiempo , RecurrenciaRESUMEN
INTRODUCTION: Contact force (CF) guided ablation of paroxysmal atrial fibrillation (PAF) with stable catheter-tissue contact optimizes clinical success and may increase an operator's ability to achieve pulmonary vein isolation (PVI) in a single encirclement. First pass PVI reduces procedure time but the relationship with long term clinical success is not well understood. This study evaluated patient characteristics and procedural details as predictors of 1-year clinical success after PAF ablation, including first pass isolation. METHODS: Consecutive de novo PAF ablations were performed with a porous tip CF catheter in 2017 and 2018. All ablations used wide-area circumferential ablation, with first pass isolation captured separately for the left and right pulmonary veins (PVs). CF was held between 10 and 20 g and the catheter was moved every 10-20 s. Radiofrequency energy was set at 40-45 W throughout the atrium. Patient characteristics and procedural details were tested for association with clinical success, defined as freedom from recurrent atrial tachyarrhythmia through 1 year. RESULTS: A total of 404 patients were included in the study. Clinical success at 1 year was 86.6%. Achieving first pass isolation on at least one ipsilateral PV pair was the most significant predictor of clinical success (p = .0126). After controlling for first pass isolation, only recurrence within the 90-day blanking period was independently predictive (p = .0015). First pass isolation was not associated with early recurrence (p = .2454). CONCLUSION: In a real-world setting, first pass isolation was highly predictive of 12-month clinical success after CF-guided ablation in a PAF population.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Atrios Cardíacos , Humanos , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: Most atrial fibrillation (AF) ablations are performed with general anesthesia (GA). The ideal GA protocol is unknown, but it affects ablation outcomes and laboratory utilization. We sought to report a GA protocol used at a high-volume center, with special consideration on efficiency and optimization of mapping and ablation conditions. METHODS: Our protocol consists of propofol as sole anesthetic agent and analgesia with Fentanyl. IV fluids are minimized. After transseptal access, the right phrenic nerve is tagged, rocuronium is given, and redosing avoided. Ventilation is modulated to optimize mapping and ablation. After ablation, isoproterenol is infused for 20 min. After 10 min, propofol is gradually decreased and ventilation set to SIMV 8 breaths/min to promote spontaneous breathing, and then switched to pressure support and propofol stopped. Paralysis is reversed and furosemide given. Patient is extubated once meeting standard criteria. RESULTS: A total of 1286 patients underwent AF ablation from January 2017 to December 2018 using the protocol. Mean age was 66 years (41% paroxysmal AF, CHADS2Vasc 2.6). Total procedure time was 86 min. Median time to extubation was 9 min (first and third quartile 6-16) after procedure completed, with total anesthesia time of 116 min. On average 370 mL of fluids were given by anesthesia. Only one patient who had heart failure required reintubation with no other anesthesia-related complications seen. CONCLUSION: Our GA protocol was specifically designed for AF ablation. It was safe and led to efficient recovery and extubation times. It maximizes laboratory utilization time without compromising safety.
General anesthesia (GA) has been shown to improve outcomes of atrial fibrillation (AF) ablation. However, the ideal anesthetic protocol is unknown. We describe a GA protocol developed by the anesthesiology and electrophysiology team. It considers each phase of the ablation procedure separately in choosing drugs to be used and also careful modulation of ventilator settings to improve mapping and ablation conditions. This GA protocol was then utilized in 1286 patients undergoing AF ablation and it was safe and produced very efficient median time to extubation (9 min).
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Anestesia General , Anestésicos Intravenosos , Fibrilación Atrial/cirugía , Ablación por Catéter , Protocolos Clínicos/normas , Propofol , Anciano , Procedimientos Quirúrgicos Cardíacos/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). OBJECTIVES: This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. METHODS: This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge. RESULTS: The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; P < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; P = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; P = 0.79). CONCLUSIONS: The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.
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Fibrilación Atrial , Ablación por Catéter , Ablación por Radiofrecuencia , Humanos , Estudios Prospectivos , Ablación por Catéter/métodos , Esófago/cirugíaRESUMEN
BACKGROUND: High-frequency, low tidal volume (HFLTV) ventilation increases the efficacy and efficiency of radiofrequency catheter ablation (RFCA) of paroxysmal atrial fibrillation. Whether those benefits can be extrapolated to RFCA of persistent atrial fibrillation (PeAF) is undetermined. OBJECTIVE: The purpose of this study was to evaluate whether using HFLTV ventilation during RFCA in patients with PeAF is associated with improved procedural and clinical outcomes compared to standard ventilation (SV). METHODS: In this prospective multicenter registry (REAL-AF), patients who had undergone pulmonary vein isolation (PVI) + pulmonary wall isolation (PWI) for PeAF using either HFLTV ventilation or SV were included. The primary efficacy outcome was freedom from all-atrial arrhythmias at 12 months. Secondary outcomes included procedural and long-term clinical outcomes and complications. RESULTS: A total of 210 patients were included (95 HFLTV, 115 SV) in the analysis. There was no difference in baseline characteristics between groups. Procedural time (80 [63-103.5] minutes vs110 [85-141] minutes; P <.001), total radiofrequency (RF) time (18.73 [13.93-26.53] minutes vs 26.15 [20.30-35.25] minutes; P <.001), and pulmonary vein RF time (11.35 [8.78-16.69] minutes vs 18 [13.74-24.14] minutes; P <.001) were significantly shorter using HFLTV ventilation compared with SV. Freedom from all-atrial arrhythmias was significantly higher with HFLTV ventilation compared with SV (82.1% vs 68.7%; hazard ratio 0.41; 95% confidence interval [0.21-0.82]; P = .012), indicating a 43% relative risk reduction and a 13.4% absolute risk reduction in all-atrial arrhythmias recurrence. There was no difference in long-term procedural-related complications between the groups (P = .270). CONCLUSION: In patients undergoing RFCA with PVI + PWI for PeAF, use of HFLTV ventilation was associated with higher freedom from all-atrial arrhythmias at 12-month follow-up, with significantly shorter procedural and RF times compared to SV but with similar safety profile.
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BACKGROUND: The safety and long-term efficacy of radiofrequency (RF) catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) has been well established. Contemporary techniques to optimize ablation delivery, reduce fluoroscopy use, and improve clinical outcomes have been developed. OBJECTIVE: The purpose of this study was to assess the contemporary real-world practice approach and short and long-term outcomes of RF CA for PAF through a prospective multicenter registry. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ClincalTrials.gov Identifier: NCT04088071) Registry, patients undergoing RF CA to treat PAF across 42 high-volume institutions and 79 experienced operators were evaluated. The procedures were performed using zero or reduced fluoroscopy, contact force sensing catheters, wide area circumferential ablation, and ablation index as a guide with a target of 380-420 for posterior and 500-550 for anterior lesions. The primary efficacy outcome was freedom from all-atrial arrhythmia recurrence at 12 months. RESULTS: A total of 2470 patients undergoing CA from January 2018 to December 2022 were included. Mean age was 65.2 ±11.14 years, and 44% were female. Most procedures were performed without fluoroscopy (71.5%), with average procedural and total RF times of 95.4 ± 41.7 minutes and 22.1±11.8 minutes, respectively. At 1-year follow-up, freedom from all-atrial arrhythmias was 81.6% with 89.7% of these patients off antiarrhythmic drugs. No significant difference was identified comparing pulmonary vein isolation vs pulmonary vein isolation plus ablation approaches. The complication rate was 1.9%. CONCLUSION: Refinement of RF CA to treat PAF using contemporary tools, standardized protocols, and electrophysiology laboratory workflows resulted in excellent short- and long-term clinical outcomes.
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BACKGROUND: Advances in technology and workflows have facilitated substantial reductions in fluoroscopy utilization and procedure times for atrial fibrillation (AF) ablations. A recently available steerable sheath, visualizable on a 3D electroanatomical map (EAM), may further simplify low/zero fluoroscopy ablation workflows by facilitating understanding of the relative positions of the catheter and sheath. The objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow. METHODS: Consecutive de novo paroxysmal AF procedures were performed with a porous tip contact force catheter at a high-volume site between January 2018 and May 2019. Procedures performed with and without the VIZIGO™ EAM-visualizable sheath (Vizigo) were compared. All ablations employed the same standardized low-fluoroscopy workflow. Statistical analyses employed stabilized inverse probability of treatment weights (IPTW) to balance cohorts by operator and key patient characteristics. RESULTS: Cohorts of 142 Vizigo and 173 non-Vizigo patients were similar at baseline. Use of the Vizigo sheath was associated with approximately 10% improvement in catheter stability (p = 0.0005), 16% reduction in radiofrequency time (p < 0.0001), and 7% fewer ablations that used fluoroscopy (p = 0.0030). There was one cardiac tamponade in each cohort and no deaths, atrioesophageal fistulas, or strokes. Single-procedure freedom from atrial arrhythmia recurrence through 12 months was similar between cohorts (p = 0.9556). CONCLUSIONS: Use of a 3D EAM-visualizable sheath resulted in improved catheter stability, reduced radiofrequency time, and more procedures performed without fluoroscopy, without compromise to safety or effectiveness.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Humanos , Fibrilación Atrial/cirugía , Catéteres , Resultado del Tratamiento , Factores de Tiempo , Fluoroscopía/métodos , Ablación por Catéter/métodos , Venas Pulmonares/cirugíaRESUMEN
BACKGROUND: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) has been widely adopted. Nevertheless, planned SDD has been performed by using subjective criteria rather than standardized protocols. OBJECTIVES: The goal of this study was to determine the efficacy and safety of the previously described SDD protocol in a prospective multicenter study. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation) SDD protocol eligibility criteria (stable anticoagulation, no bleeding history, left ventricular ejection fraction >40%, no pulmonary disease, no procedures within 60 days, and body mass index <35 kg/m2), operators prospectively determined whether patients undergoing ablation of AF were candidates for SDD (SDD vs non-SDD groups). Successful SDD was achieved if the patient met the protocol discharge criteria. The primary efficacy endpoint was the success rate of SDD. The primary safety endpoints were readmission rates as well as acute and subacute complications. The secondary endpoints included procedural characteristics and freedom from all-atrial arrhythmias. RESULTS: A total of 2,332 patients were included. The REAL-AF SDD protocol identified 1,982 (85%) patients as potential candidates for SDD. The primary efficacy endpoint was achieved in 1,707 (86.1%) patients. The readmission rate for SDD vs non-SDD group was similar (0.8% vs 0.9%; P = 0.924). The SDD group had a lower acute complication rate than the non-SDD group (0.8% vs 2.9%; P < 0.001), and there was no difference in the subacute complication rate between groups (P = 0.513). Freedom from all-atrial arrhythmias was comparable between groups (P = 0.212). CONCLUSIONS: In this large, multicenter prospective registry, the use of a standardized protocol showed the safety of SDD after catheter ablation of paroxysmal and persistent AF. (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation [REAL-AF]; NCT04088071).
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Fibrilación Atrial , Ablación por Catéter , Humanos , Alta del Paciente , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
BACKGROUND: High-frequency, low-tidal-volume (HFLTV) ventilation is a safe and simple strategy to improve catheter stability and first-pass isolation during pulmonary vein (PV) isolation. However, the impact of this technique on long-term clinical outcomes has not been determined. OBJECTIVES: This study sought to assess acute and long-term outcomes of HFLTV ventilation compared with standard ventilation (SV) during radiofrequency (RF) ablation of paroxysmal atrial fibrillation (PAF). METHODS: In this prospective multicenter registry (REAL-AF), patients undergoing PAF ablation using either HFLTV or SV were included. The primary outcome was freedom from all-atrial arrhythmia at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and hospitalizations at 12 months. RESULTS: A total of 661 patients were included. Compared with those in the SV group, patients in the HFLTV group had shorter procedural (66 [IQR: 51-88] minutes vs 80 [IQR: 61-110] minutes; P < 0.001), total RF (13.5 [IQR: 10-19] minutes vs 19.9 [IQR: 14.7-26.9] minutes; P < 0.001), and PV RF (11.1 [IQR: 8.8-14] minutes vs 15.3 [IQR: 12.4-20.4] minutes; P < 0.001) times. First-pass PV isolation was higher in the HFLTV group (66.6% vs 63.8%; P = 0.036). At 12 months, 185 of 216 (85.6%) in the HFLTV group were free from all-atrial arrhythmia, compared with 353 of 445 (79.3%) patients in the SV group (P = 0.041). HLTV was associated with a 6.3% absolute reduction in all-atrial arrhythmia recurrence, lower rate of AF-related symptoms (12.5% vs 18.9%; P = 0.046), and hospitalizations (1.4% vs 4.7%; P = 0.043). There was no significant difference in the rate of complications. CONCLUSIONS: HFLTV ventilation during catheter ablation of PAF improved freedom from all-atrial arrhythmia recurrence, AF-related symptoms, and AF-related hospitalizations with shorter procedural times.
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Fibrilación Atrial , Ablación por Catéter , Humanos , Estudios Prospectivos , Resultado del Tratamiento , Volumen de Ventilación Pulmonar , Recurrencia Local de Neoplasia/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodosRESUMEN
Atrial fibrillation (AF) represents a significant health care burden in the United States that will continue to increase as the population ages; thus, the introduction of cost-effective strategies to limit this burden is critical. The establishment of dedicated electrophysiology programs focusing on AF care within hospitals can improve patient care while providing added financial benefits for institutions if properly planned and delivered. This paper explains how to develop an efficient and quality-focused AF ablation program as part of a larger AF center of excellence by highlighting the experience of a single center and demonstrating how the same principles were adopted to implement a similar program at another institution.
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PURPOSE: Overnight stays associated with catheter ablation (CA) for paroxysmal atrial fibrillation (PAF) account for a significant proportion of treatment cost. Same-day discharge (SDD) after CA may be attractive to both patients and hospitals, especially in light of current restrictions on overnight stays due to COVID-19. This study reports on the selection criteria, protocol, and safety of SDD after CA of PAF. METHODS: Patients undergoing CA for PAF were evaluated to assess the risk of groin, respiratory, cardiac, or bleeding complications. SDD eligibility criteria were stable anticoagulation with no bleeding history, systolic heart failure, respiratory conditions, or interventional procedures within 60 days, and recommended BMI < 35. Patient proximity to the hospital was also considered. Anesthesia with propofol was used, and ablations were performed with a contact force catheter. Patients rested for 6 h post-procedure and then ambulated over 1-2 h. Discharge followed if they were stable without evidence of complications. A nurse called all patients the following morning to elicit evidence of complications. RESULTS: Of 44 planned SDD procedures between April 2017 and June 2018, 41 resulted in SDD after 7.2 ± 1.0 h, 2 patients stayed overnight for observation, and one by choice. Average age was 59 ± 10 years with CHA2DS2-VASc of 1.6 ± 1.1. No SDD-related complications occurred, and no return visits resulted from the follow-up calls. CONCLUSION: Appropriate low-risk patients identified by well-defined clinical criteria can be safely discharged the same day after CA for PAF. Evaluation in a larger population across different centers is required for generalizability of this SDD protocol.
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Fibrilación Atrial , COVID-19 , Ablación por Catéter , Anciano , Fibrilación Atrial/cirugía , Humanos , Persona de Mediana Edad , Alta del Paciente , Estudios Prospectivos , SARS-CoV-2 , Resultado del TratamientoRESUMEN
PURPOSE: Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. METHODS: Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. RESULTS: Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. DISCUSSION: Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019).
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Fibrilación Atrial , Ablación por Catéter , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Humanos , Estudios Prospectivos , Recurrencia , Sistema de Registros , Resultado del TratamientoRESUMEN
BACKGROUND: The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (AF) treatment led to the development of a minimally invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multicenter randomized controlled CONVERGE trial (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent AF) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for persistent and long-standing persistent AF treatment. METHODS: One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent versus CA. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia absent new/increased dosage of previously failed/intolerant class I/III antiarrhythmic drugs through 12 months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6 cm and imposed no limits on AF duration, making it the only ablation trial to substantially include long-standing persistent-AF, that is, 42% patients with long-standing persistent-AF. RESULTS: Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (P=0.036) on/off previously failed antiarrhythmic drugs and in 53.5% (53/99) versus 32.0% (16/50; P=0.0128) respectively off antiarrhythmic drugs. At 18 months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8 and 30 days postprocedure. No deaths, cardiac perforations, or atrioesophageal fistulas occurred. All but one primary safety event resolved. CONCLUSIONS: The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of persistent and long-standing persistent atrial fibrillation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01984346.
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Fibrilación Atrial/cirugía , Ablación por Catéter/métodos , Venas Pulmonares/cirugía , Anciano , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Femenino , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Venas Pulmonares/fisiopatología , Recurrencia , Factores de Tiempo , Resultado del Tratamiento , Reino Unido , Estados UnidosRESUMEN
AIM: Compare the 1-year costs of three catheter ablation technologies for the treatment of paroxysmal atrial fibrillation (PAF). MATERIALS & METHODS: A decision tree model was developed to estimate 1-year hospital costs associated with an index and potential repeat PAF ablation procedure using the Thermocool® Smarttouch® Catheter (ST), Thermocool SF Catheter (SF) or Arctic Front Advance Cryoballoon (CB). Model parameters were estimated using the results of two recently published studies. RESULTS: The ST resulted in average per-patient savings for combined inpatient and outpatient populations of US$1488 and US$4494 compared with SF and CB, respectively. These cost savings were greater in the inpatient setting. CONCLUSION: The 1-year expected hospital visit costs for PAF ablation were lower with ST than with SF or CB.
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Fibrilación Atrial/economía , Fibrilación Atrial/cirugía , Ablación por Catéter/economía , Ahorro de Costo/métodos , Costos de Hospital/estadística & datos numéricos , Adulto , Ahorro de Costo/estadística & datos numéricos , Femenino , Humanos , Masculino , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Catheter ablation technology has evolved rapidly in recent years. There is a need to understand the impact of these advances on efficiency, safety, and effectiveness in real-world populations. The objective of this study was to evaluate a standardized workflow that integrates a contact force (CF) catheter and stability module in an attempt to optimize efficiency and clinical outcomes of paroxysmal atrial fibrillation (PAF) ablation, and to compare the outcomes of this workflow with existing ablation technologies at a high-volume center. METHODS: Consecutive ablations for PAF from July 2013 - June 2016 were included. Radiofrequency (RF) ablations were performed with the ThermocoolSF Catheter (SF) through April 2014, after which a change was made to the ThermocoolSmarttouchCatheter (ST)with a standardized workflow. Cryoballoon ablations (CA) were performed with theArctic FrontAdvancebetween July 2013 and March 2016. Systematic collection of 12-month effectiveness data began in July 2014. Prior to that time, only acute outcomes and reablations were captured. RESULTS: Procedural data for 32 SF, 232 ST, and 59 CA procedures for PAF were available. Mean procedure times were similar across SF and CA, and moderately shorter with ST (p=0.0201). Fluoroscopy times were substantially reduced with ST (p<0.0001). Complication rates were low and similar across all cohorts (p=0.4744), whereas reablation rates were lowest in the ST cohort (p=0.0194). CONCLUSIONS: PAF ablation using integrated CF and catheter stability technology with a systematic ablation workflow maylead to improvements in both procedural efficiency and reablation rates, without compromising patient safety.
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INTRODUCTION: Significant improvements in catheter technology, electro-anatomic (EA) mapping and techniques to reduce fluoroscopy during radiofrequency ablation (RFA) of atrial fibrillation (AF) are on-going.However, few educational opportunities are available post fellowship for Electrophysiologists (EPs) to understand and integrate them into their practice, preventing wide spread adoption. The impact of observational learning for adoption of new technologies and techniques in the field of cardiac electrophysiology has not been studied. We sought to report the impact of a visit to a high-volume center with experience in new technologies and fluoroscopy reductionto the clinical practice of EPs. METHODS: Between 8/2014 and 10/2017 a total of 150 EPs visited 3 hospitals that perform a high volume of AF RFAs. EPs observed a minimum of 4 RFAs, primarily AF. AF RFAs were performed without fluoroscopy, using Carto 3 Version 4 (Biosense Webster) and intracardiac Echocardiography. There was ample interaction and discussion between hosting and visiting EP. RESULTS: 73 EPs (48.6% of visitors) completed an electronic survey after the visit. The majority reported a significant reduction in fluoroscopy (>50%) and procedure (>20%).68% adopted a rigorous workflow and reported an increase in their confidence level with intracardiac echo (79%), continuous mapping (52%) and the Visitag module (61%). CONCLUSIONS: Observational experience can have an immense impact on the clinical practice of EPs. Further effort should be devoted to such programs and to study in a more systematic way their ultimate impact on patient care.