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1.
JAMA ; 331(13): 1099-1108, 2024 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-38563835

RESUMO

Importance: Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation. Objective: To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation. Design, Setting, and Participants: This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021. Interventions: Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone. Main Outcomes and Measures: A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation. Results: Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, -4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients. Conclusions and Relevance: Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT02513797.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Compostos Organotiofosforados , Veias Pulmonares , Humanos , Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Teorema de Bayes , Estudos Prospectivos , Veias Pulmonares/cirurgia , Ablação por Cateter , Cateterismo
2.
Europace ; 26(4)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38584395

RESUMO

AIMS: A few studies have reported the effect and safety of pulsed field ablation (PFA) catheters for ablating atrial fibrillation (AF), which were mainly based on basket-shaped or flower-shaped designs. However, the clinical application of a circular-shaped multi-electrode catheter with magnetic sensors is very limited. To study the efficacy and safety of a PFA system in patients with paroxysmal AF using a circular-shaped multi-electrode catheter equipped with magnetic sensors for pulmonary vein isolation (PVI). METHODS AND RESULTS: A novel proprietary bipolar PFA system was used for PVI, which utilized a circular-shaped multi-electrode catheter with magnetic sensors and allowed for three-dimensional model reconstruction, mapping, and ablation in one map. To evaluate the efficacy, efficiency, and safety of this PFA system, a prospective, multi-centre, single-armed, pre-market clinical study was performed. From July 2021 to December 2022, 151 patients with paroxysmal AF were included and underwent PVI. The study examined procedure time, immediate success rate, procedural success rate at 12 months, and relevant complications. In all 151 patients, all the pulmonary veins were acutely isolated using the studied system. Pulsed field ablation delivery was 78.4 ± 41.8 times and 31.3 ± 16.7 ms per patient. Skin-to-skin procedure time was 74.2 ± 29.8 min, and fluoroscopy time was 13.1 ± 7.6 min. The initial 11 (7.2%) cases underwent procedures with deep sedation anaesthesia, and the following cases underwent local anaesthesia. In the initial 11 cases, 4 cases (36.4%) presented transient vagal responses, and the rest were all successfully preventatively treated with atropine injection and rapid fluid infusion. No severe complications were found during or after the procedure. During follow-up, 3 cases experienced atrial flutter, and 11 cases had AF recurrence. The estimated 12-month Kaplan-Meier of freedom from arrhythmia was 88.4%. CONCLUSION: The PFA system, comprised of a circular PFA catheter with magnetic sensors, could rapidly achieve PVI under three-dimensional guidance and demonstrated excellent safety with comparable effects.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Resultado do Tratamento , Estudos Prospectivos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Cateteres , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Fenômenos Magnéticos , Recidiva
3.
Europace ; 26(4)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38597211

RESUMO

AIMS: Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. METHODS AND RESULTS: In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. CONCLUSION: Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Feminino , Humanos , Pessoa de Meia-Idade , Masculino , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/etiologia , Veias Pulmonares/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Átrios do Coração/diagnóstico por imagem , Átrios do Coração/cirurgia , Fenótipo , Recidiva , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos
4.
PLoS One ; 19(4): e0300309, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38578781

RESUMO

Radiofrequency ablation (RFA) using the CARTO 3D mapping system is a common approach for pulmonary vein isolation to treat atrial fibrillation (AF). Linkage between CARTO procedural data and patients' electronical health records (EHR) provides an opportunity to identify the ablation-related parameters that would predict AF recurrence. The objective of this study is to assess the incremental accuracy of RFA procedural data to predict post-ablation AF recurrence using machine learning model. Procedural data generated during RFA procedure were downloaded from CARTONET and linked to deidentified Mercy Health EHR data. Data were divided into train (70%) and test (30%) data for model development and validation. Automate machine learning (AutoML) was used to predict 1 year AF recurrence, defined as a composite of repeat ablation, electrical cardioversion, and AF hospitalization. At first, AutoML model only included Patients' demographic and clinical characteristics. Second, an AutoML model with procedural variables and demographical/clinical variables was developed. Area under receiver operating characteristic curve (AUROC) and net reclassification improvement (NRI) were used to compare model performances using test data. Among 306 patients, 67 (21.9%) patients experienced 1-year AF recurrence. AUROC increased from 0.66 to 0.78 after adding procedural data in the AutoML model based on test data. For patients with AF recurrence, NRI was 32% for model with procedural data. Nine of 10 important predictive features were CARTO procedural data. From CARTO procedural data, patients with lower contact force in right inferior site, long ablation duration, and low number of left inferior and right roof lesions had a higher risk of AF recurrence. Patients with persistent AF were more likely to have AF recurrence. The machine learning model with procedural data better predicted 1-year AF recurrence than the model without procedural data. The model could be used for identification of patients with high risk of AF recurrence post ablation.


Assuntos
Técnicas de Ablação , Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Ablação por Radiofrequência , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Resultado do Tratamento , Fatores de Tempo , Ablação por Cateter/métodos , Recidiva , Veias Pulmonares/cirurgia
6.
Europace ; 26(4)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38652090

RESUMO

AIMS: Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) using very high-power short-duration (vHPSD) radiofrequency (RF) ablation proved to be safe and effective. However, vHPSD applications result in shallower lesions that might not be always transmural. Multidetector computed tomography-derived left atrial wall thickness (LAWT) maps could enable a thickness-guided switching from vHPSD to the standard-power ablation mode. The aim of this randomized trial was to compare the safety, the efficacy, and the efficiency of a LAWT-guided vHPSD PVI approach with those of the CLOSE protocol for PAF ablation (NCT04298177). METHODS AND RESULTS: Consecutive patients referred for first-time PAF ablation were randomized on a 1:1 basis. In the QDOT-by-LAWT arm, for LAWT ≤2.5 mm, vHPSD ablation was performed; for points with LAWT > 2.5 mm, standard-power RF ablation titrating ablation index (AI) according to the local LAWT was performed. In the CLOSE arm, LAWT information was not available to the operator; ablation was performed according to the CLOSE study settings: AI ≥400 at the posterior wall and ≥550 at the anterior wall. A total of 162 patients were included. In the QDOT-by-LAWT group, a significant reduction in procedure time (40 vs. 70 min; P < 0.001) and RF time (6.6 vs. 25.7 min; P < 0.001) was observed. No difference was observed between the groups regarding complication rate (P = 0.99) and first-pass isolation (P = 0.99). At 12-month follow-up, no significant differences occurred in atrial arrhythmia-free survival between groups (P = 0.88). CONCLUSION: LAWT-guided PVI combining vHPSD and standard-power ablation is not inferior to the CLOSE protocol in terms of 1-year atrial arrhythmia-free survival and demonstrated a reduction in procedural and RF times.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Átrios do Coração , Tomografia Computadorizada Multidetectores , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Veias Pulmonares/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Feminino , Masculino , Ablação por Cateter/métodos , Pessoa de Meia-Idade , Idoso , Átrios do Coração/cirurgia , Átrios do Coração/diagnóstico por imagem , Fatores de Tempo , Resultado do Tratamento , Recidiva , Frequência Cardíaca , Potenciais de Ação
7.
JACC Clin Electrophysiol ; 10(4): 685-694, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38658060

RESUMO

BACKGROUND: Reconnection after mitral isthmus (MI) block with radiofrequency ablation is common. OBJECTIVES: The aim of this study was to investigate the effects of ethanol infusion in the vein of Marshall (EIVOM) on acute reconnection after MI bidirectional block. METHODS: Patients with persistent atrial fibrillation who were scheduled to receive radiofrequency ablation for the first time were randomly assigned to the radiofrequency catheter ablation (RFCA) group (n = 44) or the EIVOM group (n = 45). The RFCA group's strategy was bilateral pulmonary vein ablation and linear ablation; in the EIVOM group, EIVOM was performed first. The primary endpoint was acute reconnection 30 minutes after MI bidirectional block. RESULTS: A total of 89 patients (average age 62.9 years; 57.3% male) were enrolled. The average duration for persistent atrial fibrillation was 2.3 years. Before observation, all patients in the EIVOM group achieved MI bidirectional block (45 of 45 [100%]), compared with 84.1% (37 of 44) in the RFCA group. After the observation, 3 cases of MI reconnection occurred in the EIVOM group and 13 cases in the RFCA group (6.7% vs 35.1%; P < 0.05). After additional ablation, the final MI block rates in the EIVOM and RFCA groups were 97.8% (44 of 45) and 72.7% (32 of 44), respectively. During a 1-year follow-up, 8 of 45 patients who underwent EIVOM had recurrent atrial fibrillation, compared with 14 of 44 in the RFCA group (17.8% vs 31.8%; P < 0.01). CONCLUSIONS: EIVOM can reduce acute reconnection after MI bidirectional block and significantly increase first-pass MI block.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Valva Mitral , Veias Pulmonares , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Idoso , Valva Mitral/cirurgia , Veias Pulmonares/cirurgia , Etanol/administração & dosagem , Recidiva , Resultado do Tratamento
8.
Europace ; 26(3)2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38516791

RESUMO

AIMS: Pulmonary vein isolation (PVI) for catheter ablation of atrial fibrillation (AF) is a time-demanding procedure. High-power short-duration (HPSD) ablation protocols and high-density mapping catheters have recently been introduced to clinical practice. We investigated the impact of high-density mapping and HPSD ablation protocols on procedural timing, efficacy, and safety by comparing different standardized set-ups. METHODS AND RESULTS: Three electrophysiology (EP) laboratory set-ups were analysed: (i) circular catheter for mapping and HPSD ablation with 30/35 W guided by an ablation index (AI); (ii) pentaspline catheter for mapping an HPSD ablation with 50 W guided by an AI; and (iii) pentaspline catheter for mapping and HPSD ablation with 90 W over 4 s using a novel ablation catheter. All patients underwent PVI without additional left atrial ablation strategies. Procedural data and operating intervals in the EP laboratory were systematically analysed. Three hundred seven patients were analysed (30/35 W AI: n = 102, 50 W AI: n = 102, 90 W/4 s: n = 103). Skin-to-skin times [105.3 ± 22.7 (30/35 W AI) vs. 81.4 ± 21.3 (50 W AI) vs. 69.5 ± 12.2 (90 W/4 s) min, P ≤ 0.001] and total laboratory times (132.8 ± 42.1 vs. 107.4 ± 25.7 vs. 95.2 ± 14.0 min, P < 0.001) significantly differed among the study groups. Laboratory interval analysis revealed significant shortening of mapping and ablation times. Arrhythmia-free survival after 12 months was not different among the study groups (log-rank P = 0.96). CONCLUSION: The integration of high-density mapping and HPSD protocols into an institutional AF ablation process resulted in reduced procedure times without compromising safety or efficacy.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fluxo de Trabalho , Átrios do Coração , Ablação por Cateter/efeitos adversos , Veias Pulmonares/cirurgia , Resultado do Tratamento , Recidiva
9.
Int Heart J ; 65(2): 363-366, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38556344

RESUMO

Congenital pulmonary lymphangiectasia (CPL) is associated with fetal pulmonary venous obstructive physiology. The precise morbidity of CPL is unknown as CPL is generally fatal in neonates. Here, we report an infant with secondary CPL in total anomalous pulmonary venous connection (TAPVC). He developed severe pulmonary hypertension (PH) after corrective surgery for TAPVC. However, cardiac catheterization showed mild left pulmonary venous obstruction (PVO), which was deemed unnecessary for re-intervention. He died at 11 months-old due to an exacerbation of PH. Autopsy revealed medial hypertrophy of the pulmonary arteries, mild left PVO, and marked dilatation and proliferation of the pulmonary lymphatics which might have been involved in the PH, although CPL was not conclusively identified based on the previous biopsy findings. We should be aware of the possibility of CPL in addition to postoperative PVO when encountering patients with fetal pulmonary venous obstructive physiology. Furthermore, a cautious approach to the interpretation of lung biopsy results is warranted.


Assuntos
Pneumopatias/congênito , Linfangiectasia/congênito , Veias Pulmonares , Pneumopatia Veno-Oclusiva , Síndrome de Cimitarra , Lactente , Recém-Nascido , Masculino , Humanos , Circulação Pulmonar , Veias Pulmonares/cirurgia , Pulmão
12.
Am J Cardiol ; 218: 43-50, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38479607

RESUMO

Low-voltage areas have been used as atrial structural substrates in estimating fibrotic degeneration in patients with atrial fibrillation (AF). The high-resolution maps obtained by recently developed mapping catheters allow the visualization of several functional abnormalities. We investigated the association between left atrial (LA) functional abnormal findings on a high-resolution substrate map and AF recurrence in patients who underwent pulmonary vein isolation without any additional LA substrate ablation. This observational study included 100 consecutive patients who underwent second ablation for AF (paroxysmal, 48%; persistent, 52%). Patients with extra-pulmonary-vein LA substrate ablation during the initial and second ablation were excluded. LA mapping was performed using a 64-pole mini-basket catheter on the RHYTHMIA mapping system (Boston Scientific, Marlborough [Cambridge] Massachusetts). Patients were followed for 2 years. AF recurrence developed in 39 (39%) patients. On the high-resolution substrate map, AF recurrence was associated with the presence of the following findings: low-voltage areas (<1.0 mV, >5 cm2; hazard ratio [HR] = 2.53; 95% confidence interval [CI] = 1.30 to 4.93; p <0.006), fractionated-electrogram areas (≥5 peaks, >5 cm2; HR = 2.15, 95% CI = 1.10 to 4.19; p = 0.025), LA conduction time of >130 ms (HR = 3.11, 95% CI = 1.65 to 5.88, p <0.0001), deceleration zone (≥5 isochrones/cm2; HR = 1.97, 95% CI = 1.04 to 3.37, p = 0.039), and multiple septal break-out points (HR = 3.27, 95% CI = 1.50 to 7.16, p = 0.003). Accumulation of these risk factors increased AF recurrence in a stepwise manner, with an HR = 1.90, 95% CI = 1.44 to 2.52, p <0.00001 for each additional risk factor. In conclusion, a high-resolution map revealed new LA functional substrates associated with AF recurrence. Implementation of functional substrates may improve the prediction of AF recurrence after ablation, and possibly aid the development of tailored AF ablation strategies.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Átrios do Coração , Frequência Cardíaca , Fatores de Risco , Ablação por Cateter/efeitos adversos , Recidiva , Resultado do Tratamento
14.
Pacing Clin Electrophysiol ; 47(5): 595-602, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38523591

RESUMO

BACKGROUND: Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. METHODS: Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). RESULTS: A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p = 0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p = 0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p = 0.03. Comparable results were observed in paroxysmal and persistent AF. CONCLUSION: CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.


Assuntos
Fibrilação Atrial , Criocirurgia , Medidas de Resultados Relatados pelo Paciente , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Masculino , Feminino , Criocirurgia/métodos , Fibrilação Atrial/cirurgia , Pessoa de Meia-Idade , Estudos Prospectivos , Átrios do Coração/cirurgia , Ablação por Cateter/métodos , Sistema de Registros , Qualidade de Vida , Idoso , Ablação por Radiofrequência/métodos
15.
J Cardiovasc Electrophysiol ; 35(5): 886-894, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38433316

RESUMO

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.


Assuntos
Fibrilação Atrial , Cateteres Cardíacos , Ablação por Cateter , Desenho de Equipamento , Veias Pulmonares , Veias Pulmonares/cirurgia , Veias Pulmonares/fisiopatologia , Humanos , Ablação por Cateter/instrumentação , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Frequência Cardíaca , Potenciais de Ação , Fluxo de Trabalho , Temperatura
16.
J Cardiovasc Electrophysiol ; 35(4): 832-842, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38448797

RESUMO

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Traumatismos Cardíacos , Veias Pulmonares , Humanos , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/epidemiologia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Traumatismos Cardíacos/etiologia , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Resultado do Tratamento
17.
J Am Heart Assoc ; 13(6): e033146, 2024 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-38471838

RESUMO

BACKGROUND: Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an interesting nonthermal alternative energy for PVI. The purpose of our study was to evaluate the safety and long-term efficacy of PVI using the pentaspline PFA catheter in comparison to cryoballoon ablation. METHODS AND RESULTS: Between January 2021 and December 2022, we included all consecutive patients of our center in whom a first PVI-only procedure was performed using PFA or cryoballoon. The choice of the energy was based on patients' preference between general anesthesia (PFA) and local anesthesia (cryoballoon). The primary end point was freedom from documented atrial arrhythmia recurrence after a 3-month blanking period. A total of 301 patients (paroxysmal atrial fibrillation in 220 patients) underwent a first PVI procedure performed using PFA (n=151) or cryoballoon (n=150). Complete short-term PVI was obtained in 144 of 150 patients (96%) in the cryoballoon group and in all patients of the PFA group (P=0.01). Procedure duration was significantly longer in the cryoballoon group. Transient and persistent phrenic nerve injuries were observed in the cryoballoon group only (13/150 and 2/150, respectively). One-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%; adjusted hazard ratio, 0.53 [95% CI, 0.30-0.96]; P=0.037). CONCLUSIONS: This prospective, comparative, real-life study suggested that PFA could overcome safety limitations of cryoballoon with optimal effectiveness. Randomized controlled studies are required to further investigate the potential superiority of PFA over cryoballoon.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Cateteres , Veias Pulmonares/cirurgia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Recidiva
18.
Kyobu Geka ; 77(3): 177-181, 2024 Mar.
Artigo em Japonês | MEDLINE | ID: mdl-38465489

RESUMO

The patient is a 77-year-old man. He was referred to our hospital after a chest computed tomography (CT) scan revealed a 6.5 cm-sized mass in the right lung apex. Bronchoscopy revealed adenocarcinoma, clinical stageⅡB, and the patient was referred for surgery. Preoperative 3D-CT revealed the presence of a displaced bronchus, probably B1a, branching from the right main bronchus centrally from the upper lobe bronchus, and an abnormal vessel (V2) running dorsal to the upper lobe bronchus and the right main bronchus, and returning directly to the left atrium. Surgery was performed by resectioning the right upper lobe through a posterolateral incision, combined resection of the wall pleura, and lymph node dissection (ND2a-2). Because lung cancer surgery is sometimes accompanied by abnormal bronchial and pulmonary vascular branches, it is essential to thoroughly examine the patient before surgery for checking abnormal branches by bronchoscopy and 3D-CT.


Assuntos
Adenocarcinoma , Cardiopatias Congênitas , Neoplasias Pulmonares , Veias Pulmonares , Masculino , Humanos , Idoso , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/cirurgia , Neoplasias Pulmonares/complicações , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Veias Pulmonares/anormalidades , Pulmão , Brônquios/diagnóstico por imagem , Brônquios/cirurgia , Adenocarcinoma/diagnóstico por imagem , Adenocarcinoma/cirurgia , Cardiopatias Congênitas/complicações
19.
Kyobu Geka ; 77(1): 9-14, 2024 Jan.
Artigo em Japonês | MEDLINE | ID: mdl-38459839

RESUMO

BACKGROUND: Maze surgery is often performed for atrial fibrillation during cardiac surgery, and a certain number of therapeutic effects are observed. However, the effectiveness of pulmonary vein isolation (PVI) remains unclear. METHODS: 329 arrhythmia surgeries was performed between 2012 and 2021. The patients were divided into three groups:paroxysmal atrial fibrillation (PAf) group, persistent atrial fibrillation group (PerAf), and long persistent atrial fibrillation( LongPerAf) group. In the PVI and maze groups, postoperative sinus rhythm rate and the rate of freedom from Af recurrence were compared. RESULTS: In PAf, PerAf cases, there was no difference between PVI and maze groups in the rate of freedom from recurrent Af and postoperative sinus rhythm rate. In LongPerAf cases, the rates of freedom from recurrent Af and postoperative sinus rhythm were significantly lower in the PVI group. CONCLUSION: PVI was considered effective in patients with atrial fibrillation of less than one year duration due to the simplicity of the procedure and low complications.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Fibrilação Atrial/cirurgia , Veias Pulmonares/cirurgia , Resultado do Tratamento , Ablação por Cateter/métodos , Átrios do Coração/cirurgia , Recidiva
20.
Kyobu Geka ; 77(1): 72-75, 2024 Jan.
Artigo em Japonês | MEDLINE | ID: mdl-38459849

RESUMO

A 67 years old male had underwent left upper division segmentectomy. On the sixth day after surgery, he had developed unconsciousness, aphasia and unilateral spatial neglect. Brain MRI revealed a cerebral infarction, and percutaneous cerebral thrombectomy was performed. Enhanced computed tomography revealed thrombus formation in the remnant superior pulmonary vein (SPV), left renal infarction and right acute limb ischemia. After starting anticoagulant therapy with apixaban the thrombus reduced and neurological symptoms improved. A thrombus in the SPV may cause serious whole body organ infarction in the same way as a left atrial thrombus. It was suggested that left upper division segmentectomy was associated with the risk of remnant pulmonary vein thrombosis.


Assuntos
Neoplasias Pulmonares , Veias Pulmonares , Tromboembolia , Trombose , Humanos , Masculino , Idoso , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Pneumonectomia/métodos , Neoplasias Pulmonares/cirurgia , Tromboembolia/cirurgia , Trombose/cirurgia , Infarto
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