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1.
Circ Arrhythm Electrophysiol ; 16(3): e011780, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36735937

RESUMO

BACKGROUND: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. METHODS: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up. RESULTS: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively. CONCLUSIONS: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; unique identifier: NCT04524364.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Estenose de Veia Pulmonar , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/etiologia , Constrição Patológica/etiologia , Constrição Patológica/cirurgia , Resultado do Tratamento , Catéteres , Europa (Continente) , Veias Pulmonares/cirurgia , Estenose de Veia Pulmonar/etiologia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Recidiva
2.
Front Cardiovasc Med ; 9: 928974, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36620626

RESUMO

Aims: Atrial fibrillation (AF) occurs frequently after mitral valve (MV) surgery. This study aims to evaluate the efficacy and long-term clinical outcomes after the first AF ablation in patients with prior MV surgery. Methods: Sixty consecutive patients with a history of MV surgery without MAZE referred to three European centers for a first AF ablation between 2007 and 2017 (group 1) were retrospectively enrolled. They were matched (propensity score match) with 60 patients referred for AF ablation without prior MV surgery (group 2). Results: After the index ablation, 19 patients (31.7%) from group 1 and 24 (40%) from group 2 had no recurrence of atrial arrhythmias (ATa) (p = 0.3). After 62 (48-84) months of follow-up and 2 (2-2) procedures, 90.0% of group 1 and 95.0% of group 2 patients were in sinus rhythm (p = 0.49). In group 1, 19 (31.7%) patients had mitral stenosis, and 41 (68.3%) had mitral regurgitation. Twenty-seven (45.0%) patients underwent mechanical valve replacement and 33 (55.0%) MV annuloplasty. At the final follow-up, 28 (46.7%) and 33 (55.0%) patients were off antiarrhythmic drugs (p = 0.46). ATa recurrence was seen more commonly in patients with prior MV surgery (54 vs. 22%, respectively, p < 0.05). No major complication occurred. Conclusion: Long-term freedom of atrial arrhythmias after atrial fibrillation catheter ablation is achievable and safe in patients with a history of mitral valve surgery. In AF patients without a history of mitral valve surgery, repeated procedures are needed to maintain sinus rhythm.

3.
JAMA Cardiol ; 6(10): 1177-1186, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34232254

RESUMO

Importance: Mitral annular disjunction (MAD) has received particular interest in patients with mitral valve prolapse, ventricular tachycardia, and sudden cardiac death. The clinical significance of MAD for patients with Marfan syndrome (MFS) remains largely unexplored. Objective: To define the prevalence of MAD and examine its association with cardiovascular outcomes and arrhythmia among patients with MFS. Design, Setting, and Participants: This retrospective, single-center cohort study included 142 patients with a diagnosis of MFS based on the revised Ghent criteria and a confirmed (likely) pathogenic variant in the FBN1 gene who underwent regular follow-up between January 1, 2004, and December 31, 2019. Main Outcomes and Measures: The presence of MAD was assessed by echocardiography, and the extent of MAD was categorized in tertiles. Patients also underwent resting electrocardiography and 24-hour Holter monitoring. Outcomes included aortic events (aortic dissection or prophylactic aortic surgery), arrhythmic events (defined as sustained ventricular tachycardia or sudden cardiac death), and mitral valve surgery. Results: A total of 142 patients (72 female patients [51%]; median age at first examination, 25 years [range, 2-64 years]) were evaluated. Forty-eight patients (34%) had MAD. Patients with MAD had larger aortic root z scores than patients without MAD (4.1 [interquartile range, 2.8-5.7] vs 3.0 [interquartile range, 1.8-4.0]; P < .001) and more often had mitral valve prolapse (34 of 48 [71%] vs 14 of 94 [15%]; P < .001), ventricular ectopy (14 of 33 [42%] vs 15 of 70 [21%]; P = .03), and nonsustained ventricular tachycardia (13 of 33 [39%] vs 12 of 70 [17%]; P = .01). During follow-up, aortic events occurred at similar rates among patients with vs without MAD (15 of 43 [35%] vs 21 of 84 [25%]; P = .24), but patients in the upper MAD tertile (>10 mm) showed a higher occurrence of aortic events compared with patients with MAD of 10 mm or smaller (9 of 15 [60%] vs 6 of 28 [21%]; P = .01). Patients with arrhythmic events (n = 5) and patients requiring mitral valve surgery (n = 7) were observed exclusively in the group displaying MAD. Conclusions and Relevance: This study suggests that MAD among patients with MFS is associated with the occurrence of arrhythmic events, a higher need for mitral valve intervention, and, among patients with extensive MAD, more aortic events. Cardiac imaging for patients with MFS should consider the assessment of MAD as a potential marker for adverse outcomes.


Assuntos
Arritmias Cardíacas/epidemiologia , Procedimentos Cirúrgicos Cardíacos/métodos , Síndrome de Marfan/complicações , Prolapso da Valva Mitral/etiologia , Valva Mitral/diagnóstico por imagem , Adolescente , Adulto , Arritmias Cardíacas/etiologia , Arritmias Cardíacas/fisiopatologia , Bélgica/epidemiologia , Criança , Pré-Escolar , Ecocardiografia , Eletrocardiografia Ambulatorial/métodos , Feminino , Seguimentos , Humanos , Incidência , Masculino , Síndrome de Marfan/diagnóstico , Pessoa de Meia-Idade , Prolapso da Valva Mitral/diagnóstico , Prolapso da Valva Mitral/cirurgia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
4.
Circ Arrhythm Electrophysiol ; 14(1): e009112, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33300809

RESUMO

BACKGROUND: CLOSE-guided atrial fibrillation (AF) ablation is based on contiguous (intertag distance ≤6 mm), optimized (Ablation Index >550 anteriorly and >400 posteriorly) point-by-point radiofrequency lesions. The optimal radiofrequency power remains unknown. METHODS: The POWER-AF study is a prospective, randomized controlled monocentric study including patients with paroxysmal AF, planned for first CLOSE-guided pulmonary vein isolation using a contact force radiofrequency catheter (Thermocool SmartTouch, Biosense Webster, Inc, Irvine, CA). A total of 100 patients were randomized into 2 groups (1:1). The control group received AF ablation using the standard CLOSE protocol (35 W), whereas in the experimental group, pulmonary vein isolation was performed using high power (45 W). Endoscopic evaluation was performed in patients with intraesophageal temperature rise >38.5 °C. RESULTS: The resulting sample size was 96 (48+48) patients. In the high power group, shorter procedure time (80 versus 102 minutes, P<0.001), shorter total radiofrequency application time (16 versus 26 minutes, P<0.001), and radiofrequency time per application (26 versus 37 s anteriorly, P<0.001 and 13 versus 17 s posteriorly, P<0.001) were observed. Endoscopic evaluation (performed in 19/48 versus 25/48 patients respectively, P=0.31) showed an ulcerative perforation in a high power group patient (treated by endoscopic stenting and normalization after ≈4 months) and a superficial ulcerative lesion in a control group patient (conservative treatment). Both occurred following excessive Ablation Index applications (up to 460 and 480, respectively) with excessive contact force (30 g on average, with peaks up to 50 g). Six-months AF recurrence was not significantly different (10% in high power versus 8% in control, P=0.74). CONCLUSIONS: This randomized controlled study shows that a 45 W radiofrequency power CLOSE protocol in patients with paroxysmal AF significantly increases the global procedural efficiency with similar midterm efficacy. However, our study showed a narrower safety margin and a limited increased efficiency at the posterior wall using high power. This advocates against the use of high power in the region neighboring the esophagus.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Sistema de Condução Cardíaco/fisiopatologia , Frequência Cardíaca/fisiologia , Veias Pulmonares/cirurgia , Cirurgia Assistida por Computador/métodos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Prospectivos , Recidiva , Fatores de Tempo , Resultado do Tratamento
5.
Europace ; 22(11): 1645-1652, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-32879974

RESUMO

AIMS: To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. METHODS AND RESULTS: This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4-86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8-82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8-87.0%). Freedom fromrepeat ablations by the Kaplan-Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9-6.3%). CONCLUSIONS: The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres.Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Humanos , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Reprodutibilidade dos Testes , Resultado do Tratamento , Fluxo de Trabalho
6.
J Cardiovasc Electrophysiol ; 31(5): 1091-1098, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32147899

RESUMO

AIMS: "CLOSE"-guided pulmonary vein isolation (PVI) is based on contiguous (≤6 mm) and optimized radiofrequency (RF) ablation lesions (ablation index [AI] ≥ 400 posteriorly and ≥ 550 anteriorly]. However, the optimal RF power to reach the desired AI is unknown. Therefore we evaluated the efficiency of an ablation strategy using higher power (40 W) during a first "CLOSE"-guided PVI. METHODS: Eighty consecutive patients undergoing "CLOSE"-guided PVI for symptomatic paroxysmal atrial fibrillation were ablated with 40 W (group A). Results were compared with 105 consecutive patients enrolled in the "CLOSE to CURE"-study and were ablated using the same protocol with 35 W (group B). RESULTS: In group A, ablation was associated with shorter ablation procedure time (91 vs 111 minutes; P < .001), shorter fluoroscopy time (5 vs 11 minutes; P < .001), shorter PVI time (48 vs 64 minutes; P < .001), shorter RF time (20 vs 28 minutes; P < .001), lower RF time per application (22 vs 29 seconds; P < .001), less RF applications (52 vs 58; P < .001), and less catheter dislocations (1 vs 2; P = .002). The impedance drop (12 vs 13 Ω; P = .192), first-pass isolation rate (99% vs 93%; P = .141) and acute reconnection rate (6% vs 4%; P > .733) were similar in both groups (groups A and B, respectively). No complications occurred. In group A, a gastroscopy-performed in five patients with esophageal temperature rise more than 42°C-did not reveal any esophageal lesion. Postprocedural recurrence of atrial tachyarrhythmia at 1 year was not significantly different between both groups. CONCLUSIONS: Using the "CLOSE"-protocol, increased power increases the efficiency of PVI without compromising patients' safety.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Veias Pulmonares/cirurgia , Potenciais de Ação , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Projetos Piloto , Complicações Pós-Operatórias/etiologia , Veias Pulmonares/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
7.
JACC Clin Electrophysiol ; 5(7): 778-786, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31320006

RESUMO

OBJECTIVES: This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation. BACKGROUND: The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions. METHODS: QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation. RESULTS: A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits. CONCLUSIONS: This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).


Assuntos
Ablação por Cateter , Veias Pulmonares/cirurgia , Idoso , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/instrumentação , Ablação por Cateter/métodos , Catéteres/efeitos adversos , Desenho de Equipamento , Feminino , Fluoroscopia , Humanos , Masculino , Microeletrodos , Pessoa de Meia-Idade , Estudos Prospectivos , Irrigação Terapêutica/instrumentação , Resultado do Tratamento
8.
Europace ; 21(8): 1185-1192, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31056640

RESUMO

AIMS: We sought to evaluate the efficacy and the safety of a simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement in patients ablated for paroxysmal atrial fibrillation. This consisted of bending the ablation catheter in the left atrium, creating a loop that was cautiously advanced together with the long sheath at the ostium and then within the left superior PV. The curve was then progressively released to reach a stable contact with the anterior part of the left PVs. METHODS AND RESULTS: Eighty consecutive patients (age 64 ± 11 years, left atrial diameter 43 ± 8 mm) undergoing 'CLOSE'-guided PV isolation were prospectively randomized into two groups depending on whether the loop technique was used or not. When using the loop technique, the encirclement of the left PVs was shorter [20 min (interquartile range, IQR 17-24) vs. 26 min (IQR 18-33), P < 0.01] with a high rate of first pass isolation [(100%) vs. (97%), P = 0.9] and adenosine proof isolation [(93%) vs. (95%), P = 0.67]. Most specifically, at the anterior part of the left PVs, there were less dislocations [0 (IQR 0-0) vs. 1 (IQR 0-4), P < 0.001], radiofrequency duration was shorter (272 ± 85 s vs. 378 ± 122 s, P < 0.001), force-time integral was higher [524 gs (IQR 427-687) vs. 398 gs (IQR 354-451), P < 0.001], average contact force was higher [20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14), P < 0.001]. CONCLUSION: This study describes a simple technique to facilitate catheter stability at the anterior part of the left PVs, resulting in more efficient left PV encirclement without compromising safety.


Assuntos
Fibrilação Atrial , Ablação por Cateter/métodos , Átrios do Coração , Veias Pulmonares/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/cirurgia , Cateteres Cardíacos , Técnicas Eletrofisiológicas Cardíacas , Feminino , Átrios do Coração/patologia , Átrios do Coração/fisiopatologia , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Tamanho do Órgão , Recidiva , Resultado do Tratamento
9.
JACC Clin Electrophysiol ; 5(3): 295-305, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30898231

RESUMO

OBJECTIVES: This study sought to determine the prevalence of patients with 4 isolated veins at repeat ablation after "CLOSE" -guided pulmonary vein isolation (PVI), a strategy based on delivery of contiguous and optimized radiofrequency lesions. BACKGROUND: The likelihood of finding 4 isolated veins at a repeat ablation for atrial fibrillation (AF) recurrence after a first PVI is low. METHODS: Patients undergoing repeat ablation for AF recurrence after first CLOSE-guided PVI were included. At repeat: 1) the status of the PV was evaluated; and 2) high-density voltage mapping was performed. In case of pulmonary vein reconnection (PVR), veins were reisolated. In patients with 4 isolated veins, empirical trigger or substrate ablation was performed. RESULTS: Of 326 patients undergoing CLOSE-guided PVI for paroxysmal AF, 45 patients underwent repeat ablation for AF recurrence (11 ± 7 months after first PVI). In 28 patients, all veins were still isolated (62%). They showed similar clinical characteristics and similar time from first PVI to AF recurrence (8 ± 7 vs. 6 ± 6 months, respectively, p = 0.453) compared with patients with PVR. In contrast, they were characterized by a higher incidence of low voltage (57% vs. 17%, p = 0.033). Patients with 4 isolated veins, compared with patients treated for PVR, showed a lower 12-month freedom from AF after repeat ablation (61% vs. 88%, p = 0.045). CONCLUSIONS: After CLOSE-guided ablation, PVR is no longer the rule in patients with AF recurrence. Patients with AF recurrence and 4 isolated veins present with a similar clinical profile and time to recurrence as patients with PVR.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Veias Pulmonares/cirurgia , Idoso , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Ablação por Cateter/estatística & dados numéricos , Técnicas Eletrofisiológicas Cardíacas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Reoperação , Resultado do Tratamento
10.
Heart Rhythm ; 16(7): 1013-1020, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30710736

RESUMO

BACKGROUND: The incidence of endoscopically detected esophageal lesions after pulmonary vein isolation (PVI) is as high as 18%. Intraesophageal temperature rise (ITR) during ablation is a predictor of esophageal injury. OBJECTIVE: The purpose of this study was to describe an ablation strategy aiming to enclose the pulmonary veins with contiguous, stable, and optimized radiofrequency applications (referred to as CLOSE-PVI). We evaluated esophageal and periesophageal injury with endoscopy in patients revealing ITR during CLOSE-PVI. METHODS: Eighty-five patients with ITR during CLOSE-PVI underwent endoscopy of the esophagus (with ultrasound in 38 patients). PVI consisted of contact force (CF)-guided encircling of the veins using 35-W applications, respecting strict criteria of intertag distance (≤6 mm) and ablation index (AI; 550 arbitrary unit [au] anterior wall, 400 au posterior wall, 300 au if ITR >38.5°C). RESULTS: Endoscopy was performed 9 ± 4 days after PVI. At the posterior wall, median power was 35 W [interquartile range (IQR) 35-35], application time 18 ± 5 seconds, CF 13 ± 6g, and AI 403 ± 38 au. A median of 5 applications [IQR 4-7] per patient over a length of 21.8 ± 6.8 mm resulted in ITR >38.5°C (median 39.9°C, IQR 39.2°C-41.2°C, range 38.6°C-50.0°C). For these applications, median power was 35 W [IQR 30-35], application time 14 ± 3 seconds, CF 12 ± 5g, and AI 351 ± 38 au. The incidence of esophageal erythema/erosion on endoscopy was 1 of 85 (1.2%) and of ulceration was 0 of 85 (0%). The incidence of mediastinal or esophageal injury on ultrasound was 0 of 38 (0%). CONCLUSION: The occurrence of esophageal or periesophageal injury after CLOSE-PVI is markedly low (1.2%). Absence of esophageal ulceration in patients with ITR suggests that this strategy of delivering contiguous, relatively high-power, and short-duration radiofrequency applications at the posterior wall is safe.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Esofagoscopia , Esôfago/lesões , Veias Pulmonares/cirurgia , Adulto , Idoso , Ecocardiografia , Endossonografia , Feminino , Humanos , Doença Iatrogênica , Masculino , Pessoa de Meia-Idade
11.
JACC Clin Electrophysiol ; 4(1): 99-108, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29600792

RESUMO

OBJECTIVES: This study sought to evaluate the safety and the acute and 1 year outcomes of an ablation protocol aiming to enclose the PV with a contiguous and optimized RF circle by targeting region-specific criteria for lesion depth assessed by ablation index and interlesion distance. BACKGROUND: Reconnections after pulmonary vein (PV) isolation are explained by insufficient lesion depth and/or discontiguity of radiofrequency (RF) lesions. METHODS: A total of 130 consecutive patients with paroxysmal atrial fibrillation (AF) underwent PV encircling using a contact force-sensing catheter. RF was delivered targeting interlesion distance ≤6 mm and ablation index ≥400 at posterior wall and ≥550 at anterior wall. Recurrence was defined as any AF, atrial tachycardia (AT), or atrial flutter (AFL) (AF/AT/AFL >30 s) on Holter electrocardiographs at 3, 6, and 12 months. RESULTS: Procedure and RF time per circle were 155 ± 28 min and 17 ± 5 min, respectively. Incidence of first-pass and adenosine-proof isolation were 98% and 98%, respectively. One short-lived transient ischemic attack was observed. At 12 months, single-procedure freedom from AF/AT/AFL was 91.3% in those 104 patients off antiarrhythmic drug therapy and 96.2% in those 26 patients on antiarrhythmic drug therapy. Single-procedure freedom from both AF/AT/AFL and antiarrhythmic drug therapy was 73.1%. CONCLUSIONS: This study suggests that an ablation protocol respecting strict criteria for lesion depth and contiguity results in acute durable PV isolation followed by a high single-procedure arrhythmia-free survival at 1 year. A prospective, multicenter trial is ongoing.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Idoso , Intervalo Livre de Doença , Eletrocardiografia Ambulatorial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto
12.
Europace ; 20(FI_3): f419-f427, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-29315411

RESUMO

Aims: We have recently shown that a contact force (CF)-guided ablation protocol respecting region-specific criteria of lesion contiguity and lesion depth ('CLOSE' protocol) is associated with high incidence of acute durable pulmonary vein (PV) isolation (PVI) and a high single-procedure arrhythmia-free survival at 1 year. In the present study, we compared efficiency, safety, and efficacy of 'CLOSE'-guided PVI to conventional CF-guided PVI (CONV-CF). Methods and results: Fifty consecutive paroxysmal atrial fibrillation (AF) patients underwent PV encircling using a CF-sensing catheter targeting an interlesion distance (ILD) ≤6 mm and ablation index (AI) ≥400 and ≥550 at posterior and anterior wall ('CLOSE' group). Results were compared to the last 50 patients undergoing 'CONV-CF'. All patients underwent adenosine testing after PVI. Arrhythmia recurrence was defined as any atrial tachyarrhythmia (ATA) >30 s on Holter at 3, 6, and 12 months. Clinical characteristics did not differ. Contact force variability was comparable in between both groups (proportion of applications with intermittent contact 2% in 'CLOSE' vs. 1% in CONV-CF, P = 0.67). In the 'CLOSE' group, procedure time and radiofrequency (RF) time per circle were shorter (respectively 149 ± 33 min vs. 192 ± 42 min, P < 0.0001 and 18 ± 4 min vs 28 ± 7.5 min, P < 0.0001) and incidence of adenosine-proof isolation was higher (97% vs. 82%, P < 0.001). No complications were observed in the 'CLOSE' group, one tamponade in the 'CONV-CF' group. At 12 months, single-procedure freedom from ATA was 94% in 'CLOSE' vs. 80% in 'CONV-CF' group (P < 0.05). In both groups, the majority of reconnections at repeat were associated with either ILD > 6 mm and/or AI < 400/550 (100% vs. 83%, P = 0.99). Conclusion: 'CLOSE'-guided PVI improves procedural and 1 year outcome in CF-guided PVI while shortening procedure time. Improvement cannot be explained by differences in CF variability and is most likely due to the strict application of criteria for contiguity and ablation index. A randomized controlled trial is needed to exclude the possible contribution of a learning curve.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Potenciais de Ação , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Cateteres Cardíacos , Ablação por Cateter/efeitos adversos , Ablação por Cateter/instrumentação , Bases de Dados Factuais , Eletrocardiografia Ambulatorial , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Intervalo Livre de Progressão , Veias Pulmonares/fisiopatologia , Recidiva , Fatores de Risco , Fatores de Tempo , Transdutores de Pressão
15.
Heart ; 104(7): 588-593, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-28883032

RESUMO

OBJECTIVES: To assess whether daily short-term rhythm strip recordings on top of routine clinical care could increase the atrial fibrillation (AF) detection rate in the hospitalised elderly. METHODS: A hand-held device storing a bipolar ECG during 1 min was used for daily rhythm recording in hospitalised elderly patients. RESULTS: During 2 months, all patients admitted to the Department of Geriatric Medicine were screened (n=327). Five patients refused to participate in the study and 70 patients were unable to hold the device due to severe mental (n=46) or motor impairment (n=24). In the remaining 252 patients, 1582 recordings were successfully obtained after 1624 attempts with a median acquisition time of 1 min (min 1, max 9, IQR 1-2 min). The rhythm strips were not reliable interpretable due to artefacts in three patients or an implantable cardiac pulse generator in another 28 patients. Detailed clinical information was available in 214/221 patients. Mean age was 84±6 years. On top of 71 (33%) patients with AF identified by routine clinical care (history, n=64 or de novo detected during current hospitalisation, n=7), review of all rhythm strips identified another 28 patients (13%) with AF. All these patients had a CHA2DS2VASc score ≥2. A contraindication for anticoagulation was present in only 8/28 (25%) of identified patients. CONCLUSIONS: On top of routine clinical care, daily short-term rhythm strip recordings identified another 13% of elderly hospitalised patients with AF, leading to an overall prevalence of 46% in hospitalised patients. This can have significant therapeutic implications with respect to initiation of anticoagulation.


Assuntos
Fibrilação Atrial , Eletrocardiografia , Programas de Rastreamento/métodos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Bélgica/epidemiologia , Eletrocardiografia/instrumentação , Eletrocardiografia/métodos , Feminino , Avaliação Geriátrica/métodos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Prevalência , Reprodutibilidade dos Testes
16.
Pacing Clin Electrophysiol ; 40(7): 779-787, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28543788

RESUMO

BACKGROUND: Verification of pulmonary vein isolation (PVI) can be challenging due to the coexistence of pulmonary vein potentials and far-field potentials. This study aimed to prospectively validate a novel algorithm for automated verification of PVI in radiofrequency (RF)-guided and cryoballoon (CB)-guided ablation strategies. METHODS: A data set of 620 (RF: 516 EGMs and CB: 104 EGMs) bipolar electrograms (EGM), recorded by circular mapping catheter placed at the left atrium-pulmonary vein (PV) junction, were prospectively analyzed by a two-step algorithm. The algorithm differentiates isolated from nonisolated EGMs based on typology and specific parameters of the bipolar EGMs. EGMs were recorded at baseline and after proven isolation in RF- and CB-guided procedures. Additionally, in the RF group, EGMs during encircling of the PVs were analyzed. RESULTS: In the RF and CB group, the algorithm correctly identifies EGMs as isolated or nonisolated with respectively 93% and 96% sensitivity and 86% and 90% specificity. In the RF subgroups of (1) baseline and proven isolated EGMs, (2) EGMs during encircling, and (3) EGMs in redo procedures sensitivity was 96%, 88%, and 100%, respectively, with specificity of 81%, 91%, and 100%. Fourteen out of 14 (100%) reconnected PVs were correctly identified as containing PVPs. Eleven out of 12 (92%) failed freeze attempts were correctly identified as being nonisolated. CONCLUSION: We validated a two-step algorithm for automated PVI verification, applicable both for RF- and CB-guided PVI. The algorithm automatically differentiates isolated from nonisolated PVs with high accuracy and without the need for pacing maneuvers.


Assuntos
Algoritmos , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Criocirurgia/métodos , Veias Pulmonares/cirurgia , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Ondas de Rádio , Sensibilidade e Especificidade , Resultado do Tratamento
17.
Artigo em Inglês | MEDLINE | ID: mdl-28381417

RESUMO

BACKGROUND: Pulmonary vein reconnection (PVR) still determines recurrences of atrial fibrillation after contact force (CF)-guided pulmonary vein isolation. We studied whether acute PVR (adenosine and waiting time) and late PVR (at repeat) are explained by incomplete transmurality and contiguity within the deployed radiofrequency circle. METHODS AND RESULTS: We analyzed 42 CF-guided ipsilateral pulmonary vein isolation procedures. For each radiofrequency tag within the circle, we collected data reflecting lesion depth (time of application, power, impedance drop [Δ-Imp], CF, force-time integral [FTI], and ablation index [AI]) and contiguity (automated interlesion distance [ILD]). Ablation line contiguity index (ALCI) was developed as a novel automated algorithm combining depth and contiguity into one single criterion. Each circle was subdivided into 10 segments. For each segment, we determined its weakest link by annotating timemin, powermin, Δ-Impmin, CFmin, FTImin, AImin, ILDmax, and ALCImin. Compared with segments without PVR (n=758), PVR segments (n=44) were characterized by lower Δ-Impmin (4.8 versus 7.4 Ω), CFmin (8.5 versus 11.8 g), FTImin (351 versus 473 gs), AImin (367 versus 408 arbitrary unit [au]), and higher ILDmax (6.8 versus 5.5 mm). ALCImin was significantly lower in segments with PVR (74% versus 104%; P<0.001) and was associated with the highest accuracy to predict durable segments (area under the curve=0.73). CONCLUSIONS: In CF-guided pulmonary vein isolation, PVR is explained by lack of both lesion depth and contiguity within the deployed radiofrequency circle. ALCI, a novel measure combing contiguity and depth, is the most accurate predictor for durable segments. By avoiding weak links in the ablation chain, ALCI-guided ablation is expected to improve success rate of point-by-point radiofrequency ablation.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Eletrocardiografia , Veias Pulmonares/cirurgia , Idoso , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Ablação por Cateter/efeitos adversos , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Recidiva , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida , Resultado do Tratamento
18.
Europace ; 17(9): 1435-40, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25662983

RESUMO

AIMS: To assess in young athletes (i) the variability in the percentage of abnormal electrocardiograms (ECGs) using different criteria and (ii) the variability in ECG interpretation among cardiologists and sport physicians. METHODS AND RESULTS: Electrocardiograms of 138 athletes were categorized by seven cardiologists according to the original European Society of Cardiology (ESC) criteria by Corrado (C), subsequently modified by Uberoi (U), Marek (M), and the Seattle criteria (S); seven sports physicians only used S criteria. The percentage of abnormal ECGs for each physician was calculated and the percentage of complete agreement was assessed. For cardiologists, the median percentage of abnormal ECGs was 14% [interquartile range (IQR) 12.5-20%] for C, 11% (IQR 9.5-12.5%) for U [not significant (NS) compared with C], 11% (IQR 10-13%) for M (NS compared with C), and 7% (IQR 5-8%) for S (P < 0.005 compared with C); complete agreement in interpretation was 64.5% for C, 76% for U (P < 0.05 compared with C), 74% for M (NS compared with C), and 84% for S (P < 0.0005 compared with C). Sport physicians classified a median of 7% (IQR 7-11%) of ECGs as abnormal by S (P = NS compared with cardiologists using S); complete agreement was 72% (P < 0.05 compared with cardiologists using S). CONCLUSION: Seattle criteria reduced the number of abnormal ECGs in athletes and increased agreement in classification. However, variability in ECG interpretation by cardiologists and sport physicians remains high and is a limitation for ECG-based screening programs.


Assuntos
Atletas/estatística & dados numéricos , Eletrocardiografia , Cardiopatias/prevenção & controle , Adolescente , Interpretação Estatística de Dados , Europa (Continente) , Humanos , Masculino , Programas de Rastreamento , Sociedades Médicas
19.
Europace ; 15(6): 805-12, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23275474

RESUMO

AIMS: Prior reports using pacing manoeuvres, demonstrated an up to 42% prevalence of residual pulmonary vein to left atrium (PV-LA) exit conduction after apparent LA-PV entry block. We aimed to determine in a two-centre study the prevalence of residual PV-LA exit conduction in the presence of unambiguously proven entry block and without pacing manoeuvres. METHODS AND RESULTS: Of 378 patients, 132 (35%) exhibited spontaneous pulmonary vein (PV) potentials following circumferential PV isolation guided by three-dimensional mapping and a circular mapping catheter. Pulmonary vein automaticity was regarded as unambiguous proof of LA-PV entry block. We determined the prevalence of spontaneous exit conduction of the spontaneous PV potentials toward the LA. Pulmonary vein automaticity was observed in 171 PVs: 61 right superior PV, 33 right inferior PV, 47 left superior PV, and 30 left inferior PV. Cycle length of the PV automaticity was >1000 ms in all cases. Spontaneous PV-LA exit conduction was observed in one of 171 PVs (0.6%). In a subset of 69 PVs, pacing from within the PV invariably confirmed PVLA exit block. CONCLUSION: Unidirectional block at the LA-PV junction is unusual (0.6%). This observation is supportive of LA-PV entry block as a sufficient electrophysiological endpoint for PV isolation.


Assuntos
Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Estimulação Cardíaca Artificial/estatística & dados numéricos , Ablação por Cateter/estatística & dados numéricos , Bloqueio Cardíaco/diagnóstico , Bloqueio Cardíaco/etiologia , Veias Pulmonares/cirurgia , Bélgica/epidemiologia , Mapeamento Potencial de Superfície Corporal/estatística & dados numéricos , Estimulação Cardíaca Artificial/métodos , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Medição de Risco , Cirurgia Assistida por Computador/estatística & dados numéricos , Resultado do Tratamento
20.
J Cardiovasc Electrophysiol ; 24(3): 290-6, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23110335

RESUMO

OBJECTIVE: The objective was to study the impact of radiofrequency (RF) characteristics on acute pulmonary vein reconnection (PVR) and outcome after PVAC ablation. PVI with additional ablation of PVR (PVI + PVR) was compared to PVI-only. METHODS: In 40 consecutive patients, after PVAC-guided PVI, adenosine and a 1-hour waiting time were used to unmask and ablate acute PVR (PVI + PVR group). RF-characteristics and 1-year AF freedom were compared post hoc to 40 clinically matched patients undergoing PVI only (PVI-only group). Custom-made software was used to assess RF characteristics of the PVAC applications needed to obtain baseline PVI. RESULTS: There was no difference in clinical characteristics or baseline RF-profile between both groups. Acute PVR was observed and ablated in 38 of 160 veins (24%). AF-freedom after PVI + PVR was higher than PVI (85% vs 65%, P < 0.05). Within the PVI group, comparing patients with and without AF-recurrence, the percentage of PVAC applications with high T° (>48°) but low power (<3W) was higher (28 ± 18% vs 11 ± 11%, P < 0.0001). Within the PVI + PVR group, when comparing PVs with and without PVR, the percentage of low power/high T° PVAC applications was also higher (27 ± 13% vs 13 ± 15%, P < 0.0001). CONCLUSIONS: (1) After PVAC ablation, 24% of PVs exhibit acute reconnection. Additional ablation of reconnection improves clinical outcome. (2) Acute reconnection as well as clinical recurrence of AF are characterized by PVAC ablation with a considerable number of applications with high temperature but low power. (3) If PV isolation is obtained with low power applications, a consistent use of both adenosine and waiting time is required.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Veias Pulmonares/cirurgia , Adenosina , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Intervalo Livre de Doença , Técnicas Eletrofisiológicas Cardíacas , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Veias Pulmonares/fisiopatologia , Recidiva , Processamento de Sinais Assistido por Computador , Software , Fatores de Tempo , Resultado do Tratamento
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