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.

RESUMO

BACKGROUND: No data regarding subcutaneous-ICD (S-ICD) technology in patients actively engaging in sports activities is available. OBJECTIVE: To compare S-ICD performance between athletes and non-athletes. METHODS: The primary outcome of the study was the comparison of overall device-related complications between athletes and non-athletes. Appropriate shocks, inappropriate shocks, and individual device-related complications were secondary outcomes. RESULTS: A total of 1493 patients were extracted from the iSUSI registry, of which 152 (10.2%) were athletes, mostly engaging in dynamic sports (54.2%). Brugada syndrome, myocarditis, and ARVC were more common in athletes (11.2%vs.3.3%, p<0.001; 19.1%vs.9.0%, p<0.001; 8.6%vs.2.8%, p<0.001, respectively). During a median follow-up time of 25.5 [12.0-41.2] months, athletes were more likely to experience appropriate shocks (yearly-rate: 7.2 [4.9-10.7]% vs. 4.3 [3.6-5.1]%, p=0.028), occurring more frequently during exercise (3.9%vs.0.6%, p < 0.001). This finding lost significance when adjusting for confounders (aHR=1.440[0.909-2.281], p=0.120). No differences were found in overall device-related complications (yearly-rate: 3.3%vs.3.4%, p=0.448) and inappropriate shocks (yearly-rate: 5.3% vs. 3.7%, p=0.111). Myopotential oversensing (4.0%vs.1.3%, p=0.011) was more common in athletes, as were lead infections (3.3%vs.0.9%, p=0.008), with the latter clustering in the early post-implantation period. CONCLUSION: The S-ICD is a valid therapeutic option for preventing sudden cardiac death in athletes. Sports practice was not associated with an increased risk of complications or inappropriate shocks, although athletes are exposed to a higher risk of S-ICD infections in the early post-operative period.

RESUMO

The role of antithrombotic therapy in the prevention of ischemic stroke after non-cardiac surgery is unclear. In this study, we tested the hypothesis that the association of new-onset postoperative atrial fibrillation (POAF) on ischemic stroke can be mitigated by postoperative oral anticoagulation therapy. Of 251,837 adult patients (155,111 female (61.6%) and 96,726 male (38.4%)) who underwent non-cardiac surgical procedures at two sites, POAF was detected in 4,538 (1.8%) patients. The occurrence of POAF was associated with increased 1-year ischemic stroke risk (3.6% versus 2.3%; adjusted risk ratio (RRadj) = 1.60 (95% confidence interval (CI): 1.37-1.87), P < 0.001). In patients with POAF, the risk of developing stroke attributable to POAF was 1.81 (95% CI: 1.44-2.28; P < 0.001) without oral anticoagulation, whereas, in patients treated with anticoagulation, no significant association was observed between POAF and stroke (RRadj = 1.04 (95% CI: 0.71-1.51), P = 0.847, P for interaction = 0.013). Furthermore, we derived and validated a computational model for the prediction of POAF after non-cardiac surgery based on demographics, comorbidities and procedural risk. These findings suggest that POAF is predictable and associated with an increased risk of postoperative ischemic stroke in patients who do not receive postoperative anticoagulation.

RESUMO

AIMS: Pulsed-field ablation (PFA) is a novel, myocardial-selective, non-thermal ablation modality used to target cardiac arrhythmias. Although prompt electrogram (EGM) signal disappearance is observed immediately after PFA application in the pulmonary veins, whether this finding results in adequate transmural lesions is unknown. The aim of this study is to check whether application repetition and catheter-tissue contact impact lesion formation during PFA. METHODS AND RESULTS: A circular loop PFA catheter was used to deliver repeated energy applications with various levels of contact force. A benchtop vegetal potato model and a beating heart ventricular myocardial model were utilized to evaluate the impact of application repetition, contact force, and catheter repositioning on contiguity and lesion depth. Lesion development occurred over 18 h in the vegetal model and over 6 h in the porcine model. Lesion formation was found to be dependent on application repetition and contact. In porcine ventricles, single and multiple stacked applications led to a lesion depth of 3.5 ± 0.7 and 4.4 ± 1.3 mm, respectively (P = 0.002). Furthermore, the greater the catheter-tissue contact, the more contiguous and deeper the lesions in the vegetal model (1.0 ± 0.9 mm with no contact vs. 5.4 ± 1.4 mm with 30 g of force; P = 0.0001). CONCLUSION: Pulsed-field ablation delivered via a circular catheter showed that both repetition and catheter contact led independently to deeper lesion formation. These findings indicate that endpoints for effective PFA are related more to PFA biophysics than to mere EGM attenuation.

Assuntos

RESUMO

BACKGROUND: Recurrence during the 3-month blanking period after radiofrequency ablation of atrial fibrillation (AF) is typically not considered as a predictor for late recurrence. OBJECTIVE: We investigated the significance of early recurrence as a risk factor for late recurrence in patients with AF receiving pulsed-field ablation (PFA). METHODS: Consecutive patients undergoing PFA were prospectively followed up for 1 year. All patients received isolation of pulmonary veins. Additional ablation procedures were performed per operator's discretion. After the procedure, all remained on their previously ineffective antiarrhythmic drugs (AADs) during the 2-month blanking period after which the AADs were discontinued. Early recurrence was defined as atrial arrhythmia of >30-second duration during the 3-month blanking period, and any recurrence beyond 3 months was considered as late recurrence. RESULTS: A total of 337 patients undergoing PFA for AF were included. Early recurrence was recorded in 53 patients (15.7%): 10 in the first month, 12 in the second month, and 31 in the third month. Of the 10 patients having recurrence during the first month, 7 (70%) remained in sinus rhythm after cardioversion whereas 3 (30%) underwent a redo procedure because of late recurrence. At 1 year, all patients with recurrence in the second and third months experienced late recurrence; among these patients, 10 (83.3%) of 12 and 27 (87%) of 31 underwent a redo procedure and the remaining 6 patients were in sinus rhythm on AADs. CONCLUSION: In this consecutive series of patients with AF, early recurrence in the second or third month after the PFA procedure was associated with a high risk of late recurrence. Thus, blanking period could be redefined as 1 month after PFA.

Assuntos

RESUMO

Cardioneuroablation has emerged as a potential alternative to cardiac pacing in selected cases with vasovagal reflex syncope, extrinsic vagally induced sinus bradycardia-arrest or atrioventricular block. The technique was first introduced decades ago, and its use has risen over the past decade. However, as with any intervention, proper patient selection and technique are a prerequisite for a safe and effective use of cardioneuroablation therapy. This document aims to review and interpret available scientific evidence and provide a summary position on the topic.

Assuntos

RESUMO

BACKGROUND: After a cryptogenic stroke, patients often will require prolonged cardiac monitoring; however, the subset of patients who would benefit from long-term rhythm monitoring is not clearly defined. OBJECTIVE: The purpose of this study was to create a risk score by identifying significant predictors of atrial fibrillation (AF) using age, sex, comorbidities, baseline 12-lead electrocardiogram, short-term rhythm monitoring, and echocardiographic data and to compare it to previously published risk scores. METHODS: Patients admitted to Montefiore Medical Center between May 2017 and June 2022 with a primary diagnosis of cryptogenic stroke or transient ischemic attack who underwent long-term rhythm monitoring with an implantable cardiac monitor were retrospectively analyzed. RESULTS: Variables positively associated with a diagnosis of clinically significant AF include age (P <.001), race (P = .022), diabetes status (P = .026), chronic obstructive pulmonary disease status (P = .012), presence of atrial runs (P = .003), number of atrial runs per 24 hours (P <.001), total number of atrial run beats per 24 hours (P <.001), number of beats in the longest atrial run (P <.001), left atrial enlargement (P = .007), and at least mild mitral regurgitation (P = .009). We created a risk stratification score for our population, termed the ACL score. The ACL score demonstrated superiority to the CHA2DS2-VASc score and comparability to the C2HEST score for predicting device-detected AF. CONCLUSION: The ACL score enables clinicians to better predict which patients are more likely to be diagnosed with device-detected AF after a cryptogenic stroke.

RESUMO

OBJECTIVE: Pregnancy can trigger maternal tachycardias, and the onset of recurrent or incessant focal atrial tachycardia (AT) can lead to tachycardia-induced cardiomyopathy. Medical interventions are commonly employed, but they carry potential fetal and maternal risks. Catheter ablation (CA), particularly with non-fluoroscopic navigation systems, may be considered as an alternative. This systematic review aims to explore the feasibility and outcomes of CA for focal AT during pregnancy. METHODS: A thorough literature search was conducted until September 30th, 2023, on PubMed, Embase, and Cochrane databases. Included articles described maternal focal ATs diagnosed through electrophysiological studies and treated with CA. Data derived from these studies were organized into tables and subsequently analyzed. RESULTS: Out of 278 papers reviewed, 15 articles involving 24 patients were retrieved. CA, utilizing radiofrequency energy achieved acute success in 95.8% of cases. Sixteen patients (66.7%) underwent complete fluoroless procedures, with two adverse events directly related to the procedure reported. Long-term follow-up revealed minimal AT recurrences, with a 0.06% arrhythmia burden in one case. CONCLUSION: Focal ATs during pregnancy can be incessant and refractory to medical intervention, precipitating an acute decline in left ventricular ejection fraction. In this setting, CA emerges as an efficacious treatment modality, particularly in cases of tachycardia-induced cardiomyopathies. Whenever feasible, it is advisable to perform these procedures with minimal or no fluoroscopy guidance. Larger studies are needed to establish the safety and the efficacy of CA for focal ATs during pregnancy, as current research consists of case reports or small case series.

Assuntos

RESUMO

Cardioneuroablation has emerged as a potential alternative to cardiac pacing in selected cases with vasovagal reflex syncope, extrinsic vagally induced sinus bradycardia-arrest or atrioventricular block. The technique was first introduced decades ago, and its use has risen over the past decade. However, as with any intervention, proper patient selection and technique are a prerequisite for a safe and effective use of cardioneuroablation therapy. This document aims to review and interpret available scientific evidence and provide a summary position on the topic.

Assuntos

Assuntos

RESUMO

BACKGROUND: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). OBJECTIVE: The purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function. METHODS: Consecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes. RESULTS: Of the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18-59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25-2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35-0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38-0.81 V] vs G4/G5 group 0.51 V [0.38-0.84 V] @ 0.24 ms; P < .001). CONCLUSION: In a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up.

RESUMO

BACKGROUND: Purkinje fibers play an important role in initiation and maintenance of ventricular fibrillation (VF) and polymorphic ventricular tachycardia (PMVT). Fascicular substrate modification (FSM) approaches have been suggested to treat recurrent VF in case reports and small case series. OBJECTIVES: The aim of this study was to investigate outcomes of catheter-based FSM to treat VF and PMVT. METHODS: Of 2,212 consecutive patients with ventricular arrhythmia undergoing catheter ablation, 18 (0.81%) underwent FSM of the Purkinje fibers as identified with high-density mapping during sinus rhythm. Fascicular substrate and VF initiation were mapped using a multipolar catheter. The endpoint of the ablation was noninducibility of VF and PMVT. In select patients, remapping revealed elimination of the targeted Purkinje potentials. Demographic, clinical, and follow-up characteristics were prospectively collected in our institutional database. RESULTS: A total of 18 patients (mean age 56 ± 3.8 years, 22% women) were included in the study. Of those, 11 (61.1%) had idiopathic VF, 3 (16.7%) had nonischemic cardiomyopathy, and 4 (22.2%) had mixed cardiomyopathy. The average left ventricular ejection fraction was 42.5%. At least 2 antiarrhythmic drugs had failed preablation. At baseline, all patients had inducible VF or PMVT. At the end of the procedure, no patient demonstrated new evidence of fascicular block or bundle branch block. There were no procedure-related complications. After a median follow-up period of 24 months, 16 patients (88.9%) were arrhythmia free on or off drugs: 11 of 11 patients (100%) with idiopathic VF vs 5 of 7 patients (71.4%) with underlying cardiomyopathy (P = 0.06). CONCLUSIONS: Catheter ablation of human VF and PMVT with FSM is feasible and safe and appears highly effective, with high rates of acute VF noninducibility and long-term freedom from recurrent VF.

Assuntos

RESUMO

BACKGROUND: Early recurrence of atrial tachyarrhythmias (ERAT) within 3 months of thermal ablation for atrial fibrillation (AF) is common and often considered transient. Pulsed field ablation (PFA) is a nonthermal energy source in which ERAT is not well described. OBJECTIVE: The purpose of this study was to analyze ERAT in patients with AF undergoing PFA in the Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF) trial. METHODS: This analysis included 154 (52.4%) paroxysmal AF and 140 (47.6%) persistent AF who had ≥10 rhythm assessments during the 90-day blanking period. ERAT was defined as any instance of ≥30 seconds of AF, atrial flutter, or atrial tachycardia on transtelephonic monitoring (weekly and symptomatic) or ≥10 seconds on electrocardiography (at 3 months), both within 90 days. Late recurrence of atrial tachyarrhythmias (LRAT) was defined as observed atrial tachyarrhythmias between 90 days and 12 months. RESULTS: The overall prevalence of ERAT was 27.1% in patients with paroxysmal AF and 31.6% in patients with persistent AF. In patients with ERAT, 73% had ERAT onset within the first month of the procedure. The presence of ERAT was associated with LRAT in patients with paroxysmal AF (hazard ratio 6.4; 95% confidence interval 3.6-11.3) and patients with persistent AF (hazard ratio 3.8; 95% confidence interval 2.2-6.6). Yet, in 29.4% of patients with paroxysmal AF and 34.3% of patients with persistent AF with ERAT, LRAT was not observed. LRAT was positively correlated with the number of ERAT observations. CONCLUSION: ERAT after PFA predicted LRAT in patients with paroxysmal and persistent AF. However, the concept of a blanking period after PFA is still valid, as approximately one-third of patients with ERAT did not continue to have LRAT during follow-up and may not need reablation.

RESUMO

The complexity of cardiac electrophysiology procedures has increased significantly during the past 3 decades. Anesthesia requirements of these procedures can differ on the basis of patient- and procedure-specific factors. This manuscript outlines various anesthesia strategies for cardiac implantable electronic devices and electrophysiology procedures, including preprocedural, procedural, and postprocedural management. A team-based approach with collaboration between cardiac electrophysiologists and anesthesiologists is required with careful preprocedural and intraprocedural planning. Given the recent advances in electrophysiology, there is a need for specialized cardiac electrophysiology anesthesia care to improve the efficacy and safety of the procedures.

Assuntos

Assuntos