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1.
Thorac Cancer ; 2024 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-39257073

RESUMO

A 41 year-old female with a medical history of Turner syndrome underwent a chest computed tomography (CT) scan which revealed a varicose left pulmonary vein and an endobronchial tumor of the left lower lobe. As venous drainage of each lobe seemed to be respected, surgical resection was considered. During surgical exploration, the absence of fissure and a unique venous trunk was observed. Surgical resection was aborted as only pneumonectomy was possible in this context. Endobronchial resection was performed. To better understand this particular anatomy, a three-dimensional (3D) reconstruction was performed a posteriori. This technique is already commonly used in the preoperative planning of pulmonary segmentectomy. Here, we have shown its interest in a lung malformative context.

2.
Circulation ; 2024 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-39258362

RESUMO

BACKGROUND: Evidence from clinical trials of early pulsed field ablation (PFA) systems in treating atrial fibrillation has demonstrated their promising potential to reduce complications associated with conventional thermal modalities while maintaining efficacy. However, the lack of a fully integrated mapping system, a staple technology of most modern electrophysiology procedures, poses limitations in lesion creation and workflow options. A novel variable-loop PFA catheter integrated with an electroanatomic mapping system has been developed that allows for real-time nonfluoroscopic procedural guidance and lesion indexing as well as feedback of tissue-to-catheter proximity. ADMIRE (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Bosense-Webster Irreversible Electroporation Ablation System), a multicenter, single-arm, Food and Drug Administration investigational device exemption study, evaluated the long-term safety and effectiveness of this integrated PFA system in a large United States-based drug-refractory symptomatic paroxysmal atrial fibrillation patient population. METHODS: Using the PFA catheter with a compatible electroanatomic mapping system, patients with drug-refractory symptomatic paroxysmal atrial fibrillation underwent pulmonary vein isolation. The primary safety end point was primary adverse event within 7 days of ablation. The primary effectiveness end point was a composite end point that included 12-month freedom from documented atrial tachyarrhythmia (ie, atrial fibrillation, atrial tachycardia, atrial flutter) episodes, failure to achieve pulmonary vein isolation, use of a nonstudy catheter for pulmonary vein isolation, repeat procedure (except for one redo during blanking), taking a new or previously failed class I or III antiarrhythmic drug at higher dose after blanking, or direct current cardioversion after blanking. RESULTS: At 30 centers, 277 patients with paroxysmal atrial fibrillation (61.5±10.3 years of age; 64.3% male) in the pivotal cohort underwent PFA. More than 25% of the procedures were performed without fluoroscopy. Median (Q1, Q3) pulmonary vein isolation procedure, fluoroscopy, and transpired PFA application times were 81.0 (61.0, 112.0), 7.1 (0.00, 14.3), and 31.0 (24.8, 40.9) minutes, respectively. The primary adverse event rate was 2.9% (8 of 272), with the most common complication being pericardial tamponade. The 12-month primary effectiveness end point was 74.6%. The 1-year freedom from atrial fibrillation, atrial tachycardia, or atrial flutter recurrence rate after blanking was 75.4%. Substantial improvements in quality of life were observed as early as 3 months after the procedure, concurrent with a reduction in multiple health care use measures. CONCLUSIONS: ADMIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05293639.

3.
Circ Cardiovasc Qual Outcomes ; : e010877, 2024 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-39212048

RESUMO

BACKGROUND: Arrhythmia recurrence after pulmonary vein isolation (PVI) is common. We conducted a multicenter, randomized trial to determine the impact of increased physical activity on atrial fibrillation recurrence after PVI. METHODS: From 2018 to 2020, we randomly assigned 200 patients with atrial fibrillation to the ACTION or NO-ACTION group in 4 different centers in the local country of Brandenburg, Germany. Patients were eligible if they were scheduled to undergo PVI, aged ≥50 to ≤77 years, body mass index ≥23 to ≤35 kg/m2, and accepted wearing an activity tracker allowing 24-hour activity monitoring via mobile app. Patients in the ACTION group were actively remote-controlled via transmitted activity data by a physiotherapist, and individual motivational interviewing call sessions were scheduled with each ACTION patient every 2 weeks. The primary end point was the composite of recurrence of any atrial arrhythmia >30 seconds, additional ablation procedure, cardioversion, and new onset of antiarrhythmic drugs earliest after 90 days after index PVI over 12 months. RESULTS: Overall, the median age of patients was 66 (interquartile range, 61-71) years, 33.5% were women, and 52% had persistent atrial fibrillation. The number of steps per day increased in both groups of patients from baseline to 12 months (P<0.001). The absolute increase in steps per day did not differ between patients in the ACTION group with +3205 steps (597-4944) compared with those in the NO-ACTION group +2423 steps (17-4284), P=0.325. Unadjusted intention-to-treat analysis showed no difference in the primary composite end point in the ACTION group (27.3%) versus the NO-ACTION group (32.7%), P=0.405. CONCLUSIONS: Physical activity improved in patients after PVI. The present randomized controlled trial shows that activity tracker and motivational calls to increase physical activity versus activity tracker alone did not reduce the occurrence of the primary composite end point of atrial fibrillation recurrence or the absolute increase in steps per day. REGISTRATION: URL: https://www.cochranelibrary.com; Unique identifier: DRKS00012914.

4.
Front Pediatr ; 12: 1436608, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39165488

RESUMO

Background: Anomalous pulmonary venous connection with malposition of septum primum (MSP) is a rare pediatric cardiovascular malformation. Although reports in the literature are scarce, accurate pre-operative imaging diagnosis is crucial for selecting the appropriate clinical intervention and determining the prognosis for affected children. Case description: In both case reports, the cardiovascular malformations were incidental findings. In the second case, an enlarged cardiac silhouette was observed on chest x-ray due to pneumonia, which was subsequently confirmed by ultrasound. Combined with computed tomography angiography examination, the diagnosis of MSP-type anomalous pulmonary venous connection was established. Conclusions: Comprehensive imaging examinations are essential in reducing misdiagnosis and achieving an accurate diagnosis of MSP-type anomalous pulmonary venous connection. The typical imaging findings for MSP-type anomalous pulmonary venous connection include absence or hypoplasia of the superior limbic band of the septum secundum, leftward displacement of the septum primum, and partial or total pulmonary vein drainage into the anatomical right atrium.

5.
Healthcare (Basel) ; 12(15)2024 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-39120212

RESUMO

Cryoablation is a well-established medical procedure for surgically treating atrial fibrillation. Cryothermal catheter therapy induces cellular necrosis by freezing the insides of pulmonary veins, with the goal of disrupting abnormal electrical heart signals. Nevertheless, tissue damage induced by cold temperatures may also lead to other complications after cardiac surgery. In this sense, the simulation of catheter ablation can provide safer environments for training and the performance of cryotherapy interventions. Therefore, in this paper, we propose a novel approach to help better understand how temperature rates can affect this procedure by using computer tools to develop a simulation framework to predict lesion size and determine optimal temperature conditions for reducing the risk of major complications. The results showed that a temperature profile of around -40 °C caused less penetration, reduced necrotic damage, and smaller lesion size in the tissue. Instead, cryotherapy close to -60 °C achieved a greater depth of temperature flow inside the tissue and a larger cross-section area of the lesion. With further development and validation, the framework could represent a cost-effective strategy for providing personalized modeling, better planning of cryocatheter-based treatment, and preventing surgical complications.

6.
J Arrhythm ; 40(4): 1029-1034, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39139891

RESUMO

Epicardial connections provided the anatomical substrate for the biatrial reentry circuit. The connections between the right atrium and right pulmonary vein were called "intercaval bundle," and there are few reports of atrial flutter related to this bundle. We present a case of a biatrial tachycardia, involving the intercaval bundle.

7.
Bull Exp Biol Med ; 177(1): 57-62, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38954299

RESUMO

We studied the effect of Refralon on the electrophysiological properties of the supraventricular myocardium against the background of adrenergic (epinephrine) influence in the zone of the pulmonary veins, the area where 50-90% of atrial arrhythmias is triggered. The experiments were carried out on isolated tissue preparations of Wistar rats. The multichannel microelectrode array technique was used to record action potentials simultaneously in the atrium and in the ostium and distal parts of the pulmonary veins. Epinephrine application (12-50 nM) led to depolarization of the resting potential and the conduction block in the distal part of the pulmonary veins. Refralon (30 µg/kg) restored the resting potential in the distal part of the pulmonary veins. Against the background of epinephrine, Refralon did not significantly change the duration of the action potential at 90% repolarization in comparison with control. At the same time, the comparison drug E-4031 against the background of epinephrine significantly increased the duration of action potential in the atrium and in the ostium of the pulmonary veins, and sotalol increased it only in the ostium. Neither E-4031, nor sotalol restored conduction in their distal part. Refralon has a biphasic effect under conditions of adrenergic stimulation: the fast component is responsible for stabilizing the resting potential in the pulmonary vein and reduces the dispersion of action potential duration in the atrium and pulmonary vein and is also quickly washed away, and the slow component is responsible for the increase of the action potential duration and is slowly washed away.


Assuntos
Potenciais de Ação , Antiarrítmicos , Epinefrina , Átrios do Coração , Veias Pulmonares , Ratos Wistar , Animais , Ratos , Epinefrina/farmacologia , Potenciais de Ação/efeitos dos fármacos , Antiarrítmicos/farmacologia , Veias Pulmonares/efeitos dos fármacos , Masculino , Átrios do Coração/efeitos dos fármacos , Átrios do Coração/fisiopatologia , Arritmias Cardíacas/fisiopatologia , Arritmias Cardíacas/tratamento farmacológico
8.
Cryobiology ; 116: 104945, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39053755

RESUMO

Our objective was to investigate the predictive value of monocyte-related inflammatory factors, including monocyte to high-density lipoprotein cholesterol ratio (MHR) and monocyte to lymphocyte ratio (MLR), for the recurrence of atrial fibrillation (AF) after cryoablation in AF patients. The 570 patients who underwent cryoablation were divided into AF recurrence group and non-recurrence group based on follow-up results. The multivariable logistic regression analysis was used to evaluate the effect of MHR and MLR on AF patients. The AF-free survival status of patients was tested by Kaplan-Meier method. ROC analysis was performed to assess the predictive value of MHR and MLR for post-ablation recurrence of AF. A total of 113 (19.8 %) patients relapsed, while 457 patients (80.2 %) had no AF recurrence during follow up. Patients with AF recurrence had higher MHR values (0.37 ± 0.14 vs. 0.33 ± 0.14; P = 0.004) and higher MLR values (0.49 ± 0.32 vs. 0.18 ± 0.07; P < 0.001) compared to those without AF recurrence. MHR≥0.34 combined with MLR≥0.24 (HR = 9.979, 95 % CI: 6.070-16.407, P < 0.001) was an independent factor for predicting AF recurrence after cryoablation in patients by logistic regression analysis. The ROC analysis showed that the AUC for the combination of the MHR and MLR variables was 0.974 (95 % CI: 0.962-0.985) and had the highest diagnostic sensitivity (97.4 %). Elevated baseline values of the monocyte-related inflammatory factors, MHR and MLR, have a certain predictive value for increased AF recurrence after cryoablation.


Assuntos
Fibrilação Atrial , Criocirurgia , Monócitos , Recidiva , Humanos , Fibrilação Atrial/cirurgia , Masculino , Criocirurgia/efeitos adversos , Feminino , Pessoa de Meia-Idade , Idoso , Linfócitos , HDL-Colesterol/sangue , Inflamação/etiologia , Valor Preditivo dos Testes , Curva ROC
9.
Circ Arrhythm Electrophysiol ; 17(8): e012829, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39051110

RESUMO

BACKGROUND: The clinical outcome of pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) is suboptimal. Mapping studies have demonstrated atrial sites outside of the pulmonary veins displaying focal activation patterns during AF. We sought to determine whether adding catheter ablation of focal activation sites to PVI improves clinical outcomes of catheter ablation for persistent AF. METHODS: In this multicenter, randomized, single-blinded trial, we assigned patients with persistent AF to either PVI alone or to mapping-guided ablation of focal activation sites in addition to PVI in a 1:1 ratio. In the mapping-guided group, both atria were mapped after PVI using a Pentaray catheter (Biosense-Webster) and focal activation sites identified by CARTOFINDER (Biosense-Webster) were ablated. The primary end point was freedom from AF or atrial tachycardia without antiarrhythmic drugs beyond a 90-day blanking period. RESULTS: A total of 98 patients were assigned to the mapping-guided group and 102 to the PVI alone group. In the mapping-guided group, focal activation sites were identified at 2.6±0.3 and 2.5±0.2 sites per patient in the left and right atrium, respectively. Patients were followed up for 768.5 (interquartile range, 723.75-915.75) and 755.5 days (interquartile range, 728.5-913.75) in the mapping-guided ablation and the PVI alone groups, respectively. Freedom from AF/atrial tachycardia without antiarrhythmic drugs at 2-year follow-up was 66.8% and 75.2% in the mapping-guided ablation and the PVI alone groups, respectively (hazard ratio, 1.26 [95% CI, 0.76-2.10]; P=0.37). Adverse events occurred in 3 patients (3.0%) and none (0%) in the mapping-guided ablation and the PVI alone groups, respectively (P=0.12). CONCLUSIONS: In patients with persistent AF, the addition of mapping-guided ablation of focal activation sites to PVI did not improve clinical outcomes compared with PVI alone. REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02; Unique identifier: UMIN000037569.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Masculino , Feminino , Ablação por Cateter/métodos , Ablação por Cateter/efeitos adversos , Veias Pulmonares/cirurgia , Veias Pulmonares/fisiopatologia , Método Simples-Cego , Pessoa de Meia-Idade , Idoso , Frequência Cardíaca , Fatores de Tempo , Recidiva , Resultado do Tratamento , Técnicas Eletrofisiológicas Cardíacas , Potenciais de Ação
10.
Adv Exp Med Biol ; 1441: 587-591, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38884734

RESUMO

Total anomalous pulmonary venous return (TAPVR) is rare (accounting for about 1% of all CHD) and can occur as a single lesion or in combination with other types of CHD (such as heterotaxy or HLHS). TAPVR is defined as an abnormal connection where all pulmonary veins do not drain into the left atrium but into the right atrium either directly or through a vein that is connected to the right atrium. TAPVR can be divided into four anatomic groups (Fig. 32.1): (1) supracardiac (about 55%), (2) cardiac (about 30%), (3) infracardiac (about 13%), and (4) mixed (very rare). In addition, it can be divided into two physiological types: nonobstructed and obstructed. Embryologically, all pulmonary veins usually connect to a pulmonary venous confluence that connects to the left atrium. If this connection does not occur, the pulmonary venous confluence connects to a systemic vein instead.


Assuntos
Cardiopatias Congênitas , Veias Pulmonares , Doenças Vasculares , Cardiopatias Congênitas/patologia , Veias Pulmonares/anormalidades , Veias Pulmonares/embriologia , Doenças Vasculares/patologia
11.
Bull Exp Biol Med ; 176(6): 761-766, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38896318

RESUMO

A number of pharmacological drugs have side effects that contribute to the occurrence of atrial fibrillation, the most common type of cardiac rhythm disorders. The clinical use of antihistamines is widespread; however, information regarding their anti- and/or proarrhythmic effects is contradictory. In this work, we studied the effects and mechanisms of the potential proarrhythmic action of the first-generation antihistamine chloropyramine (Suprastin) in the atrial myocardium and pulmonary vein (PV) myocardial tissue. In PV, chloropyramine caused depolarization of the resting potential and led to reduction of excitation wave conduction. These effects are likely due to suppression of the inward rectifier potassium current (IK1). In presence of epinephrine, chloropyramine induced spontaneous automaticity in the PV and could not be suppressed by atrial pacing. Chloropyramine change functional characteristics of PV and contribute to occurrence of atrial fibrillation. It should be noted that chloropyramine does not provoke atrial tachyarrhythmias, but create conditions for their occurrence during physical exercise and sympathetic stimulation.


Assuntos
Fibrilação Atrial , Veias Pulmonares , Veias Pulmonares/efeitos dos fármacos , Veias Pulmonares/fisiopatologia , Animais , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/induzido quimicamente , Átrios do Coração/efeitos dos fármacos , Átrios do Coração/fisiopatologia , Clorfeniramina/farmacologia , Epinefrina/farmacologia , Antagonistas dos Receptores Histamínicos H1/farmacologia , Miocárdio/metabolismo , Miocárdio/patologia , Masculino , Potenciais de Ação/efeitos dos fármacos , Sistema de Condução Cardíaco/efeitos dos fármacos , Sistema de Condução Cardíaco/fisiopatologia
12.
Artigo em Inglês | MEDLINE | ID: mdl-38890232

RESUMO

PURPOSE: Variations in the anatomy of pulmonary veins can influence selection of approaches of atrial fibrillation catheter ablation. Therefore, preprocedural evaluation and knowledge of pulmonary veins anatomy is crucial for proper mapping and the successful ablation of atrial fibrillation. The aim of this observational study was to assess CT angiography scans and perform detailed analysis of pulmonary veins morphology in patients scheduled for catheter ablation of atrial fibrillation. METHODS: CT angiography was performed in 771 individuals (223 females, 548 males, mean age 58.4 ± 10.7 years). Pulmonary veins anatomy was evaluated using 3D models. The patterns used for evaluation included typical anatomy with four separate pulmonary veins, a common left ostium, and various types of accessory veins either alone or in combination with common left ostia. RESULTS: An anatomical variant with common left ostium was observed as the most prevalent anatomy (44%). The typical variant was observed in 34.8% of patients. Accessory pulmonary veins were observed predominantly on the right side. The prevalence of anatomical variants did not differ between sexes with the exception of the unclassifiable category U (4.4% vs. 9%, p < 0.05). CONCLUSIONS: Our study shows that a considerable number of atypical anatomies is present in patients undergoing AF catheter ablation. This knowledge may influence the choice of instrumentation. The data could be possibly helpful also in development of new ablation techniques.

13.
Clin Case Rep ; 12(6): e9058, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38868116

RESUMO

This case illustrates the safety and efficacy of pulse field ablation (PFA) in the short and medium term. It could be used to isolate extra pulmonary sites including the posterior wall. PFA could be used in the treatment of atrial tachycardias both focal and reentrant in combination with ultrahigh density electroanatomic mapping. It is also important to understand that different catheter shapes are available and their use can be tailored to the targeted anatomical site.

14.
J Med Ultrasound ; 32(2): 104-109, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38882613

RESUMO

This article comprehensively reviews the literature concerning prenatal ultrasound findings of isolated total anomalous pulmonary venous return (TAPVR) and the application of specific sonographic markers to differentiate among the TAPVR types. These markers can be categorized as direct and indirect, based on either morphological features or hemodynamic changes in TAPVR. Indirect markers include the ventricular disproportion, an increased distance between the left atrium (LA) and the descending aorta, as well as the dilatation of superior vena cava or coronary sinus for supracardiac or cardiac TAPVR, along with abnormal pulmonary venous spectral Doppler patterns. Direct markers predominantly focus on the absence of a connection between the pulmonary veins and the LA. Some direct markers are specific to certain TAPVR types, such as the vertical vein. Diagnosing isolated TAPVR can pose challenges, but following a sequential approach can improve detection rates and outcomes. In cases with equivocal findings, additional follow-ups are recommended. The sequential approach described in the current article provides a step-wise methodology and sonographic markers for prenatal diagnosis of TAPVR, which can be utilized by fetal-maternal medicine specialists, obstetricians, and radiological technicians to ensure timely interventions.

16.
Heart Rhythm ; 21(9): 1669-1676, 2024 09.
Artigo em Inglês | MEDLINE | ID: mdl-38762134

RESUMO

BACKGROUND: Autonomic nerve activity is important in the mechanisms of paroxysmal atrial fibrillation (PAF). OBJECTIVE: The purpose of this study was to test the hypothesis that a single burst of skin sympathetic nerve activity (SKNA) can toggle on and off PAF or premature atrial contraction (PAC) clusters. METHODS: Simultaneous recording of SKNA and electrocardiogram (neuECG) recording was performed over 7 days in patients with PAF. RESULTS: In study 1, 8 patients (7 men and 1 woman; age 62 ± 8 years) had 124 episodes of PAF. An SKNA burst toggled both on and off PAF in 8 episodes (6.5%) (type 1), toggled on but not off in 12 episodes (9.7%) (type 2), and toggled on a PAC cluster followed by PAF in 4 episodes (3.2%) (type 3). The duration of these PAF episodes was <10 minutes. The remaining 100 episodes (80.6%) were associated with active SKNA bursts throughout PAF (type 4) and lasted longer than type 1 (P = .0185) and type 2 (P = .0027) PAF. There were 47 PAC clusters. Among them, 24 (51.1%) were toggled on and off, and 23 (48.9%) were toggled on but not off by an SKNA burst. In study 2, 17 patients (9 men and 8 women; age 58 ± 12 years) had <10 minutes of PAF (4, 8, 0, and 31 of types 1, 2, 3, and 4, respectively). There were significant circadian variations of all types of PAF. CONCLUSION: A single SKNA burst can toggle short-duration PAF and PAC cluster episodes on and off. The absence of continued SKNA after the onset might have affected the maintenance of these arrhythmias.


Assuntos
Fibrilação Atrial , Complexos Atriais Prematuros , Eletrocardiografia , Sistema Nervoso Simpático , Humanos , Feminino , Masculino , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Pessoa de Meia-Idade , Complexos Atriais Prematuros/fisiopatologia , Complexos Atriais Prematuros/diagnóstico , Sistema Nervoso Simpático/fisiopatologia , Idoso , Recidiva , Frequência Cardíaca/fisiologia , Pele/inervação , Seguimentos
18.
J Am Coll Cardiol ; 83(22): 2179-2192, 2024 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-38811095

RESUMO

BACKGROUND: Transcatheter correction of sinus venosus defects (SVDs) using balloon-mounted covered stents provides an attractive surgical alternative. Surgery may be complicated by superior vena caval or right upper pulmonary vein (RUPV) stenosis, sinus nodal dysfunction, and residual additional pulmonary veins. OBJECTIVES: Being a new intervention, technical modifications would simplify the procedure, improve universal applicability, and reduce or tackle complications. METHODS: Patients were included if balloon interrogation of cavoatrial junction confirmed closure of SVD and redirected RUPV to the left atrium. A single-center experience was analyzed to summarize the procedural modifications over 8 years. Transesophageal echocardiogram (TEE) on follow-up was done to identify residual shunt, RUPV flows, and stent thrombosis. RESULTS: A total of 100 patients including 9 children with a median age of 35 years (range, 4-69 years) underwent SVD closure after balloon interrogation. Among 57 patients balloon interrogated in the first 5 years, 70% underwent transcatheter closure, with 2 failures. RUPV occlusion caused the exclusions. Inclusions improved to 94% among the subsequent 65 balloon interrogations when RUPV protection was implemented, with 1 failure. Stent embolization caused the 3 failures warranting surgery. Recent modifications included limited transesophageal echocardiogram without anesthesia, avoiding venovenous circuit, interrogation with semicompliant balloons, trans-septal RUPV protection, overlapping stents to permit additional vein drainage to superior vena cava and tackle embolizations. There were no deaths. Minor complications included stent embolizations stabilized in catheterization laboratory in 2 patients, left innominate vein jailing in 2 patients, insignificant residual flows, and nonocclusive asymptomatic stent thrombosis in 4 patients. CONCLUSIONS: Procedural success was 97%. Recent modifications increased patient inclusions, decreased complications, and simplified the intervention.


Assuntos
Cateterismo Cardíaco , Stents , Humanos , Criança , Adolescente , Pré-Escolar , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Idoso , Adulto Jovem , Cateterismo Cardíaco/métodos , Ecocardiografia Transesofagiana/métodos , Comunicação Interatrial/cirurgia , Comunicação Interatrial/diagnóstico por imagem , Estudos Retrospectivos , Resultado do Tratamento , Seguimentos
20.
Circ Arrhythm Electrophysiol ; 17(5): e012667, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38655693

RESUMO

BACKGROUND: We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed-field Ablation [PFA] System With Irreversible Electroporation [IRE]). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success. METHODS: InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success. RESULTS: The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA2DS2-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications. CONCLUSIONS: The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Veias Pulmonares/fisiopatologia , Feminino , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Masculino , Pessoa de Meia-Idade , Ablação por Cateter/instrumentação , Ablação por Cateter/métodos , Ablação por Cateter/efeitos adversos , Estudos Prospectivos , Idoso , Fatores de Tempo , Frequência Cardíaca , Potenciais de Ação , Eletrocardiografia Ambulatorial/instrumentação , Recidiva , Cateteres Cardíacos , Valor Preditivo dos Testes , Resultado do Tratamento , Imageamento Tridimensional , Fatores de Risco , Desenho de Equipamento , Técnicas Eletrofisiológicas Cardíacas
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