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1.
Europace ; 2024 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-38743765

RESUMO

Imaging using cardiac computed tomography (CT) or magnetic resonance imaging (MR) has become an important option for anatomic and substrate delineation in complex atrial and ventricular tachycardia (VT) ablation procedures. CT more common than MR has been used to detect procedure-associated complications like esophageal, cerebral and vascular injury. This clinical consensus statement summarizes the current knowledge of CT and MR to facilitate electrophysiological procedures, the current value of real-time integration of imaging-derived anatomy and substrate information during the procedure and the current role of CT and MR in diagnosing relevant procedure-related complications. Practical advice on potential advantages of one imaging modality over the other is discussed for patients with implanted cardiac rhythm devices as well as for planning, intraprocedural integration and post-interventional management in atrial fibrillation (AF) and VT ablation patients. Establishing a team of electrophysiologists and cardiac-imaging specialists working on specific details of imaging for complex ablation procedures is key. CMR can safely be performed in most patients with implanted active cardiac devices. Standard procedures for pre- and post-scanning management of the device and potential CMR-associated device-malfunctions need to be in place. In VT patients imaging - specifically MR - may help to determine scar location and mural distribution in ischemic and non-ischemic cardiomyopathy patients beyond evaluating the underlying structural heart disease. Future directions in imaging may include the ability to register multiple imaging modalities, novel high-resolution modalities but also refinements of imaging-guided ablation strategies are expected.

2.
Europace ; 26(5)2024 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-38696675

RESUMO

AIMS: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. METHODS AND RESULTS: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. CONCLUSION: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05752487.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Masculino , Feminino , Ablação por Cateter/métodos , Ablação por Cateter/instrumentação , Pessoa de Meia-Idade , Resultado do Tratamento , Idoso , Imageamento Tridimensional , Cateteres Cardíacos , Fatores de Tempo , Desenho de Equipamento , Estudos Prospectivos , Recidiva
3.
Heart Rhythm O2 ; 5(4): 234-242, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38690147

RESUMO

Background: Cardiac radioablation is a new treatment for patients with refractory ventricular tachycardia (VT). The target for cardiac radioablation is subject to cardiorespiratory motion (CRM), the heart's movement with breathing and cardiac contraction. Data regarding the magnitude of target CRM are limited but are highly important for treatment planning. Objectives: The study sought to assess CRM amplitude by using ablation catheter geometrical data. Methods: Electroanatomic mapping data of patients undergoing catheter ablation for VT at 3 academic centers were exported. The spatial position of the ablation catheter as a function of time while in contact with endocardium was analyzed and used to quantify CRM. Results: Forty-four patients with ischemic and nonischemic cardiomyopathy and VT contributed 1364 ablation lesions to the analysis. Average cardiac and respiratory excursion were 1.62 ± 1.21 mm and 12.12 ± 4.10 mm, respectively. The average ratio of respiratory to cardiac motion was approximately 11:1. CRM was greatest along the craniocaudal axis (9.66 ± 4.00 mm). Regional variations with respect to respiratory and cardiac motion were observed: basal segments had smaller displacements vs midventricular and apical segments. Patient characteristics (previous cardiac surgery, height, weight, body mass index, and left ventricular ejection fraction) had a statistically significant, albeit clinically moderate, impact on CRM. Conclusion: CRM is primarily determined by respiratory displacement and is modulated by the location of the target and the patient's biometric characteristics. The patient-specific quantification of CRM may allow to decrease treatment volume and reduce radiation exposure of surrounding organs at risk while delivering the therapeutic dose to the target.

4.
Circ Arrhythm Electrophysiol ; : e012667, 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38655693

RESUMO

BACKGROUND: We previously presented the safety and early efficacy of inspIRE study (Pulsed-Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation by Irreversible Electroporation). 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/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.

5.
Artigo em Inglês | MEDLINE | ID: mdl-38609733

RESUMO

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society (HRS), the Asia Pacific HRS, and the Latin American HRS.

7.
Europace ; 26(4)2024 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-38587017

RESUMO

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .


Assuntos
Fibrilação Atrial , Ablação por Cateter , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , América Latina , Resultado do Tratamento , Catéteres , Ásia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos
8.
Cardiovasc Diabetol ; 23(1): 78, 2024 02 24.
Artigo em Inglês | MEDLINE | ID: mdl-38402177

RESUMO

OBJECTIVE: We aimed to assess the effect of SGLT2i on arrhythmias by conducting a meta-analysis using data from randomized controlled trials(RCTs). BACKGROUND: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have shown cardioprotective effects via multiple mechanisms that may also contribute to decrease arrhythmias risk. METHODS: We searched in databases (PubMed, Embase, Cochrane Library, and clinicaltrials.gov) up to April 2023. RCTs comparing SGLT2i with placebo were included. The effects of SGLT2i on atrial fibrillation(AF), atrial flutter(AFL), composite AF/AFL, ventricular fibrillation(VF), ventricular tachycardia(VT), ventricular extrasystoles(VES), sudden cardiac death(SCD) and composite VF/VT/SCD were evaluated. RESULTS: 33 placebo-controlled RCTs were included, comprising 88,098 patients (48,585 in SGLT2i vs. 39,513 in placebo). The mean age was 64.9 ± 9.4 years, 63.0% were male. The mean follow-up was 1.4 ± 1.1 years. The pooled-results showed that SGLT2i was associated with a significantly lower risk of AF [risk ratio(RR): 0.88, 95% confidence interval(CI) 0.78-1.00, P = 0.04] and composite AF/AFL (RR: 0.86, 95%CI 0.77-0.96, P = 0.01). This favorable effect appeared to be substantially pronounced in patients with HFrEF, male gender, dapagliflozin, and > 1 year follow-up. For SCD, only in heart failure patients, SGLT2i were found to be associated with a borderline lower risk of SCD (RR: 0.67, P = 0.05). No significant effects of SGLT2i on other ventricular arrhythmic outcomes were found. CONCLUSIONS: SGLT2i lowers the risks of AF and AF/AFL, and this favorable effect appeared to be particularly pronounced in patients with HFrEF, male gender, dapagliflozin, and longer follow-up (> 1 year). SGLT2i lowers the risk of SCD only in heart failure patients.


Assuntos
Fibrilação Atrial , Compostos Benzidrílicos , Glucosídeos , Insuficiência Cardíaca , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Volume Sistólico , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Fibrilação Ventricular
9.
J Cardiovasc Electrophysiol ; 34(12): 2599-2606, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37968834

RESUMO

Radiofrequency (RF) ablation of intramural ventricular arrhythmias (VAs) may require advanced ablation techniques to achieve effective energy transfer to the targeted tissue. As an alternative to standard RF ablation, catheter ablation can also be conducted in bipolar configuration when two ablation catheters participate in the RF circuit. This strategy has proved to result in deeper lesion formation and may be effective for eliminating arrhythmias that have been refractory to standard ablation. In this article, we provide a step-by-step guide on when and how to perform bipolar ablation of VAs.


Assuntos
Técnicas de Ablação , Ablação por Cateter , Taquicardia Ventricular , Humanos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/cirurgia , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/cirurgia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos
10.
Europace ; 25(10)2023 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-37789664

RESUMO

AIMS: Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era. METHODS AND RESULTS: An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures. CONCLUSION: There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS.


Assuntos
Fibrilação Atrial , COVID-19 , Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Humanos , Terapia de Ressincronização Cardíaca/métodos , Tempo de Internação , COVID-19/epidemiologia , Inquéritos e Questionários
11.
Europace ; 25(9)2023 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-37622592

RESUMO

The first edition of Europace journal in 1999 came right around the time of the landmark publication of the electrophysiologists from Bordeaux, establishing how elimination of ectopic activity from the pulmonary veins (PVs) resulted in a marked reduction of atrial fibrillation (AF). The past 25 years have seen an incredible surge in scientific interest to develop new catheters and energy sources to optimize durability and safety of ablation, as well as study the mechanisms for AF and devise ablation strategies. While ablation in the beginning was performed with classic 4 mm tip catheters that emitted radiofrequency (RF) energy to create tissue lesions, this evolved to using irrigation and contact force (CF) measurement while increasing power. Also, so-called single-shot devices were developed with balloons and arrays to create larger contiguous lesions, and energy sources changed from RF current to cryogenic ablation and more recently pulsed field ablation with electrical current. Although PV ablation has remained the basis for every AF ablation, it was soon recognized that this was not enough to cure all patients, especially those with non-paroxysmal AF. Standardized approaches for additional ablation targets have been used but have not been satisfactory in all patients so far. This led to highly technical mapping systems that are meant to unravel the drivers for the maintenance of AF. In the following sections, the development of energies, strategies, and tools is described with a focus on the contribution of Europace to publish the outcomes of studies that were done during the past 25 years.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Catéteres , Terapia de Eletroporação Irreversível
12.
Europace ; 25(6)2023 06 02.
Artigo em Inglês | MEDLINE | ID: mdl-37306314

RESUMO

Atrial fibrillation is associated with neurocognitive comorbidities such as stroke and dementia. Evidence suggests that rhythm control-especially if implemented early-may reduce the risk of cognitive decline. Catheter ablation is highly efficacious for restoring sinus rhythm in the setting of atrial fibrillation; however, ablation within the left atrium has been shown to result in MRI-detected silent cerebral lesions. In this state-of-the-art review article, we discuss the balance of risk between left atrial ablation and rhythm control. We highlight suggestions to lower the risk, as well as the evidence behind newer forms of ablation such as very high power short duration radiofrequency ablation and pulsed field ablation.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Ablação por Radiofrequência , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Átrios do Coração/diagnóstico por imagem , Átrios do Coração/cirurgia
14.
Eur Heart J ; 44(27): 2458-2469, 2023 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-37062040

RESUMO

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Fístula Esofágica , Humanos , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Fibrilação Atrial/diagnóstico , Resultado do Tratamento , Incidência , Fatores de Risco , Fístula Esofágica/epidemiologia , Fístula Esofágica/etiologia , Fístula Esofágica/diagnóstico , Prognóstico , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos
16.
Front Cardiovasc Med ; 10: 1112561, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36873407

RESUMO

Background: There is no clear guidance on how to implement opportunistic atrial fibrillation (AF) screening in daily clinical practice. Objectives: This study evaluated the perception of general practitioners (GPs) about value and practicalities of implementing screening for AF, focusing on opportunistic single-time point screening with a single-lead electrocardiogram (ECG) device. Methods: A descriptive cross-sectional study was conducted with a survey developed to assess overall perception concerning AF screening, feasibility of opportunistic single-lead ECG screening and implementation requirements and barriers. Results: A total of 659 responses were collected (36.1% Eastern, 33.4% Western, 12.1% Southern, 10.0% Northern Europe, 8.3% United Kingdom & Ireland). The perceived need for standardized AF screening was rated as 82.7 on a scale from 0 to 100. The vast majority (88.0%) indicated no AF screening program is established in their region. Three out of four GPs (72.1%, lowest in Eastern and Southern Europe) were equipped with a 12-lead ECG, while a single-lead ECG was less common (10.8%, highest in United Kingdom & Ireland). Three in five GPs (59.3%) feel confident ruling out AF on a single-lead ECG strip. Assistance through more education (28.7%) and a tele-healthcare service offering advice on ambiguous tracings (25.2%) would be helpful. Preferred strategies to overcome barriers like insufficient (qualified) staff, included integrating AF screening with other healthcare programs (24.9%) and algorithms to identify patients most suitable for AF screening (24.3%). Conclusion: GPs perceive a strong need for a standardized AF screening approach. Additional resources may be required to have it widely adopted into clinical practice.

18.
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
19.
Europace ; 26(1)2023 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-38193796

RESUMO

AIMS: High-power ablation is effective for ventricular arrhythmia ablation; however, it increases the risk of steam pops. The aim of this study was to define the safety and efficacy of QMODE ablation in the ventricle and the risk of steam pop. METHODS AND RESULTS: Consecutive patients undergoing ventricular ablation using QDOT were included in a prospective single-centre registry. Procedural data, complications, and follow-up were systematically analysed and compared with a historical ventricular tachycardia (VT) and premature ventricular complexes (PVC) cohort ablated using STSF. QMODE (≤50 W) ablation was performed in 107 patients [age 62 ± 13 years; 76% male; VT (n = 41); PVC (n = 66)]. A total of 2456 applications were analysed [power: 45.9 ± 5.0 W with minimal power titration (90% > 95% max power); duration 26 ± 8 s; impedance drop 9.4 ± 4.7 Ω; ablation index: 569 ± 163; mean-max temperature 44.3 ± 2.6°C]. Ventricular tachycardia ablation was associated with shorter radiofrequency (RF) time and a trend towards shorter procedure times using QDOT (QDOT vs. STSF: 20.1 ± 14.7 vs. 31 ± 17 min; P = 0.002, 151 ± 59 vs. 172 ± 48 min; P = 0.06). Complications, VT recurrence, and mortality rates were comparable (QDOT vs. STSF: 2% vs. 2%; P = 0.9, 24% vs. 27%; P = 0.82, and 2% vs. 4%; P = 0.67). Five audible steam pops (0.02%) occurred. Premature ventricular complex ablation was associated with comparable RF and procedure times (QDOT vs. STSF: 4.8 ± 4.6 vs. 3.9 ± 3.1 min; P = 0.25 and 96.1 ± 31.9 vs. 94.6 ± 24.7 min; P = 0.75). Complication and PVC recurrence were also comparable (QDOT vs. STSF: 0% vs. 3%; P = 0.17 and 19% vs. 22%; P = 0.71). CONCLUSION: Ventricular ablation using QMODE ≤ 50 W is safe and effective for both VT and PVC ablation and is associated with a low risk for steam pop.


Assuntos
Ablação por Radiofrequência , Taquicardia Ventricular , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Estudos Prospectivos , Vapor , Temperatura , Arritmias Cardíacas , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/cirurgia
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