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1.
N Engl J Med ; 389(18): 1660-1671, 2023 Nov 02.
Article in English | MEDLINE | ID: mdl-37634148

ABSTRACT

BACKGROUND: Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation are not known. METHODS: In this randomized, single-blind, noninferiority trial, we assigned patients with drug-refractory paroxysmal atrial fibrillation in a 1:1 ratio to undergo pulsed field ablation or conventional radiofrequency or cryoballoon ablation. The primary efficacy end point was freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation. The primary safety end point included acute and chronic device- and procedure-related serious adverse events. RESULTS: A total of 305 patients were assigned to undergo pulsed field ablation, and 302 were assigned to undergo thermal ablation. At 1 year, the primary efficacy end point was met (i.e., no events occurred) in 204 patients (estimated probability, 73.3%) who underwent pulsed field ablation and 194 patients (estimated probability, 71.3%) who underwent thermal ablation (between-group difference, 2.0 percentage points; 95% Bayesian credible interval, -5.2 to 9.2; posterior probability of noninferiority, >0.999). Primary safety end-point events occurred in 6 patients (estimated incidence, 2.1%) who underwent pulsed field ablation and 4 patients (estimated incidence, 1.5%) who underwent thermal ablation (between-group difference, 0.6 percentage points; 95% Bayesian credible interval, -1.5 to 2.8; posterior probability of noninferiority, >0.999). CONCLUSIONS: Among patients with paroxysmal atrial fibrillation receiving a catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation with respect to freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation and with respect to device- and procedure-related serious adverse events at 1 year. (Funded by Farapulse-Boston Scientific; ADVENT ClinicalTrials.gov number, NCT04612244.).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/classification , Atrial Fibrillation/surgery , Bayes Theorem , Catheter Ablation/adverse effects , Catheter Ablation/methods , Pulmonary Veins/surgery , Recurrence , Single-Blind Method , Tachycardia/etiology , Treatment Outcome
2.
N Engl J Med ; 389(15): 1380-1389, 2023 Oct 12.
Article in English | MEDLINE | ID: mdl-37634135

ABSTRACT

BACKGROUND: The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. METHODS: We conducted a single-center, open-label trial in Germany that involved patients with symptomatic atrial fibrillation and end-stage heart failure who were referred for heart transplantation evaluation. Patients were assigned to receive catheter ablation and guideline-directed medical therapy or medical therapy alone. The primary end point was a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation. RESULTS: A total of 97 patients were assigned to the ablation group and 97 to the medical-therapy group. The trial was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed. Catheter ablation was performed in 81 of 97 patients (84%) in the ablation group and in 16 of 97 patients (16%) in the medical-therapy group. After a median follow-up of 18.0 months (interquartile range, 14.6 to 22.6), a primary end-point event had occurred in 8 patients (8%) in the ablation group and in 29 patients (30%) in the medical-therapy group (hazard ratio, 0.24; 95% confidence interval [CI], 0.11 to 0.52; P<0.001). Death from any cause occurred in 6 patients (6%) in the ablation group and in 19 patients (20%) in the medical-therapy group (hazard ratio, 0.29; 95% CI, 0.12 to 0.72). Procedure-related complications occurred in 3 patients in the ablation group and in 1 patient in the medical-therapy group. CONCLUSIONS: Among patients with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone. (Funded by Else Kröner-Fresenius-Stiftung; CASTLE-HTx ClinicalTrials.gov number, NCT04649801.).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Failure , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Germany , Heart Failure/complications , Heart Failure/surgery , Heart Transplantation , Heart-Assist Devices , Referral and Consultation , Treatment Outcome
3.
N Engl J Med ; 388(2): 105-116, 2023 01 12.
Article in English | MEDLINE | ID: mdl-36342178

ABSTRACT

BACKGROUND: Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation. METHODS: We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected. RESULTS: A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group. CONCLUSIONS: Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).


Subject(s)
Anti-Arrhythmia Agents , Atrial Fibrillation , Catheter Ablation , Cryosurgery , Humans , Anti-Arrhythmia Agents/adverse effects , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Recurrence , Tachycardia/etiology , Treatment Outcome , Disease Progression , Follow-Up Studies
4.
Eur Heart J ; 45(7): 510-518, 2024 Feb 16.
Article in English | MEDLINE | ID: mdl-37624879

ABSTRACT

BACKGROUND AND AIMS: Atrial fibrillation (AF) is a chronic progressive disorder. Persistent forms of AF are associated with increased rates of thromboembolism, heart failure, and death. Catheter ablation modifies the pathogenic mechanism of AF progression. No randomized studies have evaluated the impact of the ablation energy on progression to persistent atrial tachyarrhythmia. METHODS: Three hundred forty-six patients with drug-refractory paroxysmal AF were enrolled and randomly assigned to contact-force-guided RF ablation (CF-RF ablation, 115), 4 min cryoballoon ablation (CRYO-4, 115), or 2 min cryoballoon ablation (CRYO-2, 116). Implantable cardiac monitors placed at study entry were used for follow-up. The main outcome was the first episode of persistent atrial tachyarrhythmia. Secondary outcomes included atrial tachyarrhythmia recurrence and arrhythmia burden on the implantable monitor. RESULTS: At a median of 944.0 (interquartile range [IQR], 612.5-1104) days, 0 of 115 patients (0.0%) randomly assigned to CF-RF, 8 of 115 patients (7.0%) assigned to CRYO-4, and 5 of 116 patients (4.3%) assigned to CRYO-2 experienced an episode of persistent atrial tachyarrhythmia (P = .03). A documented recurrence of any atrial tachyarrhythmia ≥30 s occurred in 56.5%, 53.9%, and 62.9% of those randomized to CF-RF, CRYO-4, and CRYO-2, respectively; P = .65. Compared with that of the pre-ablation monitoring period, AF burden was reduced by a median of 99.5% (IQR 94.0%, 100.0%) with CF-RF, 99.9% (IQR 93.3%-100.0%) with CRYO-4, and 99.1%% (IQR 87.0%-100.0%) with CRYO-2 (P = .38). CONCLUSIONS: Catheter ablation of paroxysmal AF using radiofrequency energy was associated with fewer patients developing persistent AF on follow-up.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Treatment Outcome , Catheter Ablation/adverse effects , Tachycardia , Recurrence , Pulmonary Veins/surgery
5.
Eur Heart J ; 45(7): 522-534, 2024 Feb 16.
Article in English | MEDLINE | ID: mdl-38117227

ABSTRACT

BACKGROUND AND AIMS: Few recent large-scale studies have evaluated the risks and benefits of continuing oral anticoagulant (OAC) therapy after catheter ablation (CA) for atrial fibrillation (AF). This study evaluated the status of continuation of OAC therapy and the association between continuation of OAC therapy and thromboembolic and bleeding events according to the CHADS2 score. METHODS: This retrospective study included data from the Japanese nationwide administrative claims database of patients who underwent CA for AF between April 2014 and March 2021. Patients without AF recurrence assessed by administrative data of the treatment modalities were divided into two groups according to continuation of OAC therapy 6 months after the index CA. The primary outcomes were thromboembolism and major bleeding after a landmark period of 6 months. After inverse probability of treatment weighting analysis, the association between OAC continuation and outcomes was determined according to the CHADS2 score. RESULTS: Among 231 374 patients included, 69.7%, 21.6%, and 8.7% had CHADS2 scores of ≤1, 2, and ≥3, respectively. Of these, 71% continued OAC therapy at 6 months. The OAC continuation rate was higher in the high CHADS2 score group than that in the low CHADS2 score group. Among all patients, 2451 patients (0.55 per 100 person-years) had thromboembolism and 2367 (0.53 per 100 person-years) had major bleeding. In the CHADS2 score ≤1 group, the hazard ratio of the continued OAC group was 0.86 [95% confidence interval (CI): 0.74-1.01, P = .06] for thromboembolism and was 1.51 (95% CI: 1.27-1.80, P < .001) for major bleeding. In the CHADS2 score ≥3 group, the hazard ratio of the continued OAC group was 0.61 (95% CI: 0.46-0.82, P = .001) for thromboembolism and was 1.05 (95% CI: 0.71-1.56, P = 0.81) for major bleeding. CONCLUSIONS: This observational study suggests that the benefits and risks of continuing OAC therapy after CA for AF differ based on the patient's CHADS2 score. The risk of major bleeding due to OAC continuation seems to outweigh the risk reduction of thromboembolism in patients with lower thromboembolic risk.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Thromboembolism , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Retrospective Studies , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Anticoagulants/adverse effects , Catheter Ablation/adverse effects , Thromboembolism/epidemiology , Thromboembolism/etiology , Thromboembolism/prevention & control , Administration, Oral , Risk Assessment , Risk Factors
6.
Circulation ; 147(19): 1422-1432, 2023 05 09.
Article in English | MEDLINE | ID: mdl-36877118

ABSTRACT

BACKGROUND: Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications. METHODS: The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points. RESULTS: Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts. CONCLUSIONS: PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04198701.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/drug therapy , Prospective Studies , Treatment Outcome , Anti-Arrhythmia Agents/therapeutic use , Electrocardiography , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence
7.
Circulation ; 147(21): 1568-1578, 2023 05 23.
Article in English | MEDLINE | ID: mdl-36960730

ABSTRACT

BACKGROUND: Treatment options for high-risk Brugada syndrome (BrS) with recurrent ventricular fibrillation (VF) are limited. Catheter ablation is increasingly performed but a large study with long-term outcome data is lacking. We report the results of the multicenter, international BRAVO (Brugada Ablation of VF Substrate Ongoing Registry) for treatment of high-risk symptomatic BrS. METHODS: We enrolled 159 patients (median age 42 years; 156 male) with BrS and spontaneous VF in BRAVO; 43 (27%) of them had BrS and early repolarization pattern. All but 5 had an implantable cardioverter-defibrillator for cardiac arrest (n=125) or syncope (n=34). A total of 140 (88%) had experienced numerous implantable cardioverter-defibrillator shocks for spontaneous VF before ablation. All patients underwent a percutaneous epicardial substrate ablation with electroanatomical mapping except for 8 who underwent open-thoracotomy ablation. RESULTS: In all patients, VF/BrS substrates were recorded in the epicardial surface of the right ventricular outflow tract; 45 (29%) patients also had an arrhythmic substrate in the inferior right ventricular epicardium and 3 in the posterior left ventricular epicardium. After a single ablation procedure, 128 of 159 (81%) patients remained free of VF recurrence; this number increased to 153 (96%) after a repeated procedure (mean 1.2±0.5 procedures; median=1), with a mean follow-up period of 48±29 months from the last ablation. VF burden and frequency of shocks decreased significantly from 1.1±2.1 per month before ablation to 0.003±0.14 per month after the last ablation (P<0.0001). The Kaplan-Meier VF-free survival beyond 5 years after the last ablation was 95%. The only variable associated with a VF-free outcome in multivariable analysis was normalization of the type 1 Brugada ECG, both with and without sodium-channel blockade, after the ablation (hazard ratio, 0.078 [95% CI, 0.008 to 0.753]; P=0.0274). There were no arrhythmic or cardiac deaths. Complications included hemopericardium in 4 (2.5%) patients. CONCLUSIONS: Ablation treatment is safe and highly effective in preventing VF recurrence in high-risk BrS. Prospective studies are needed to determine whether it can be an alternative treatment to implantable cardioverter-defibrillator implantation for selected patients with BrS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04420078.


Subject(s)
Brugada Syndrome , Catheter Ablation , Defibrillators, Implantable , Humans , Male , Adult , Ventricular Fibrillation , Electrocardiography/methods , Heart Ventricles , Brugada Syndrome/surgery , Brugada Syndrome/complications , Defibrillators, Implantable/adverse effects , Catheter Ablation/adverse effects , Catheter Ablation/methods , Registries
8.
Circulation ; 148(1): 35-46, 2023 07 04.
Article in English | MEDLINE | ID: mdl-37199171

ABSTRACT

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Pulmonary Veins , Humans , Female , Middle Aged , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/drug therapy , Retrospective Studies , Stroke Volume , Ventricular Function, Left , Treatment Outcome , Atrial Flutter/etiology , Registries , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence
9.
Circulation ; 148(22): 1797-1811, 2023 11 28.
Article in English | MEDLINE | ID: mdl-38011245

ABSTRACT

Atrial fibrillation (AF) is the most common sustained arrhythmia in hypertrophic cardiomyopathy (HCM) with clinical and subclinical episodes occurring in nearly one-half of patients. AF in HCM historically has been characterized as a decisive disease complication associated with substantial risk for thromboembolic stroke and increased morbidity and mortality. However, there have been many advances in treatment strategy resulting in improved outcomes for this patient group. For example, stroke risk in HCM has been greatly reduced by using systemic oral anticoagulation initiated after the first clinical (symptomatic) AF episode, usually with preference given to direct anticoagulants over warfarin. In contrast, stroke risk scoring systems (such as CHA2DS2-VASc score) are not informative in HCM given the substantial potential for stroke events in patients with low scores, and therefore should not be used for anticoagulation decisions in this disease. A novel risk score specifically designed for HCM (HCM-AF score) can reliably identify most patients with HCM at risk for future AF. Although a strategy focused on controlling ventricular rate is effective in asymptomatic (or minimally symptomatic) patients with AF, restoring and maintaining sinus rhythm is required for most patients with marked AF symptom burden and impaired quality of life. Several antiarrhythmic drugs such as sotalol, disopyramide, and amiodarone, can be effective in suppressing AF episodes; albeit safe, long-term efficacy is supported by only limited data. Catheter AF ablation has emerged as an important treatment option for some patients, although freedom from AF after a single ablation is relatively low (35% at 3 years), multiple ablations and the concomitant use of antiarrhythmic drugs can control AF with more than two-thirds of patients maintaining sinus rhythm at 5 years. Surgical AF ablation with biatrial Cox-Maze IV performed as an adjunctive procedure during myectomy can reduce symptomatic AF episodes (70% of patients free from AF at 5 years). For the vast majority of patients who have HCM with AF, the implementation of contemporary therapies has allowed for improved quality of life and low HCM-related mortality.


Subject(s)
Atrial Fibrillation , Cardiomyopathy, Hypertrophic , Catheter Ablation , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Anti-Arrhythmia Agents/therapeutic use , Quality of Life , Risk Factors , Anticoagulants/therapeutic use , Stroke/etiology , Cardiomyopathy, Hypertrophic/complications , Cardiomyopathy, Hypertrophic/diagnosis , Cardiomyopathy, Hypertrophic/therapy , Catheter Ablation/adverse effects , Treatment Outcome
10.
N Engl J Med ; 384(4): 316-324, 2021 01 28.
Article in English | MEDLINE | ID: mdl-33197158

ABSTRACT

BACKGROUND: In patients with symptomatic paroxysmal atrial fibrillation that has not responded to medication, catheter ablation is more effective than antiarrhythmic drug therapy for maintaining sinus rhythm. However, the safety and efficacy of cryoballoon ablation as initial first-line therapy have not been established. METHODS: We performed a multicenter trial in which patients 18 to 80 years of age who had paroxysmal atrial fibrillation for which they had not previously received rhythm-control therapy were randomly assigned (1:1) to receive treatment with antiarrhythmic drugs (class I or III agents) or pulmonary vein isolation with a cryoballoon. Arrhythmia monitoring included 12-lead electrocardiography conducted at baseline and at 1, 3, 6, and 12 months; patient-activated telephone monitoring conducted weekly and when symptoms were present during months 3 through 12; and 24-hour ambulatory monitoring conducted at 6 and 12 months. The primary efficacy end point was treatment success (defined as freedom from initial failure of the procedure or atrial arrhythmia recurrence after a 90-day blanking period to allow recovery from the procedure or drug dose adjustment, evaluated in a Kaplan-Meier analysis). The primary safety end point was assessed in the ablation group only and was a composite of several procedure-related and cryoballoon system-related serious adverse events. RESULTS: Of the 203 participants who underwent randomization and received treatment, 104 underwent ablation, and 99 initially received drug therapy. In the ablation group, initial success of the procedure was achieved in 97% of patients. The Kaplan-Meier estimate of the percentage of patients with treatment success at 12 months was 74.6% (95% confidence interval [CI], 65.0 to 82.0) in the ablation group and 45.0% (95% CI, 34.6 to 54.7) in the drug-therapy group (P<0.001 by log-rank test). Two primary safety end-point events occurred in the ablation group (Kaplan-Meier estimate of the percentage of patients with an event within 12 months, 1.9%; 95% CI, 0.5 to 7.5). CONCLUSIONS: Cryoballoon ablation as initial therapy was superior to drug therapy for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation. Serious procedure-related adverse events were uncommon. (Supported by Medtronic; STOP AF First ClinicalTrials.gov number, NCT03118518.).


Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation , Cryosurgery , Adult , Aged , Anti-Arrhythmia Agents/administration & dosage , Anti-Arrhythmia Agents/adverse effects , Catheter Ablation/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Quality of Life , Recurrence , Secondary Prevention/methods , Single-Blind Method , Surveys and Questionnaires
11.
N Engl J Med ; 384(4): 305-315, 2021 01 28.
Article in English | MEDLINE | ID: mdl-33197159

ABSTRACT

BACKGROUND: Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm. METHODS: We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life. RESULTS: At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs. CONCLUSIONS: Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).


Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation , Cryosurgery , Adult , Aged , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/prevention & control , Atrial Flutter , Catheter Ablation/adverse effects , Female , Heart Rate , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Monitoring, Physiologic , Proportional Hazards Models , Quality of Life , Recurrence , Secondary Prevention , Single-Blind Method , Tachycardia
12.
J Cardiovasc Electrophysiol ; 35(3): 530-537, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37548071

ABSTRACT

A vast amount of now well-established clinical and epidemiological data indicates a close, interdependent, and symbiotic association between atrial fibrillation (AF) and heart failure (HF). Both AF and HF, when co-exist in a patient, have serious treatment and prognostic implications. Based on the prevailing knowledge of the topic, various societies have issued a number of guidelines regarding the management of patients with AF and HF. Overall, it is the rhythm control strategy that has shown beneficial effect over the rate control strategy with improvement in symptoms of AF and HF. While antiarrhythmic drugs (AADs) and catheter ablation (CA) may be utilized as rhythm control strategy for AF, both AADs and CA have limitations of their own. Furthermore, with the progress made in various pharmacotherapeutic agents in HF, one could question the utility of CA in HF (i.e., whether ablation is mandatory or pointless in patients who have HF). The purpose of this review is to discuss this very point, focusing on the beneficial, neutral, or detrimental outcome of CA based on the category and class of HF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Failure , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Heart Failure/diagnosis , Heart Failure/surgery , Anti-Arrhythmia Agents/therapeutic use , Catheter Ablation/adverse effects
13.
J Cardiovasc Electrophysiol ; 35(1): 130-135, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37975539

ABSTRACT

INTRODUCTION: Cavo-tricuspid isthmus (CTI) dependent atrial flutter (AFL) is one of the most common atrial arrhythmias involving the right atrium (RA) for which radiofrequency catheter ablation has been widely used as a therapy of choice. However, there is limited data on the effect of this intervention on cardiac size and function. METHODS: A retrospective study was conducted on 468 patients who underwent ablation for CTI dependent typical AFL at a single institution between 2010 and 2019. After excluding patients with congenital or rheumatic heart disease, heart transplant recipients, or those without baseline echocardiogram, a total of 130 patients were included in the analysis. Echocardiographic data were analyzed at baseline before ablation, and at early follow-up within 1-year postablation. Follow-up echocardiographic data was available for 55 patients. RESULTS: Of the 55 patients with CTI-AFL, the mean age was 64.2 ± 14.8 years old with 14.5% (n = 8) female. The average left ventricular ejection fraction (LVEF) significantly improved on follow-up echo (40.2 ± 16.9 to 50.4 ± 14.9%, p < .0001), of which 50% of patients had an improvement in LVEF of at least 10%. There was a significant reduction in left atrial volume index (82.74 ± 28.5 to 72.96 ± 28 mL/m2 , p = .008) and RA volume index (70.62 ± 25.6 to 64.15 ± 31 mL/m2 , p = .046), and a significant improvement in left atrial reservoir strain (13.04 ± 6.8 to 19.10 ± 7.7, p < .0001). CONCLUSIONS: Patients who underwent CTI dependent AFL ablation showed an improvement in cardiac size and function at follow-up evaluation. While long-term results are still unknown, these findings indicate that restoration of sinus rhythm in patients with typical AFL is associated with improvement in atrial size and left ventricular function.


Subject(s)
Atrial Flutter , Catheter Ablation , Humans , Female , Middle Aged , Aged , Atrial Flutter/diagnostic imaging , Atrial Flutter/surgery , Retrospective Studies , Stroke Volume , Ventricular Function, Left , Catheter Ablation/adverse effects , Catheter Ablation/methods , Treatment Outcome
14.
J Cardiovasc Electrophysiol ; 35(1): 111-119, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37962236

ABSTRACT

INTRODUCTION: The circular catheter compatible with current cryoballoon system for atrial fibrillation (AF) ablation is exclusively sensed by impedance-based electro-anatomical mapping (EAM) system, limiting the accuracy of maps. We aim to investigate the feasibility and safety of a magnetic-based circular mapping catheter for AF ablation with cryoballoon. METHODS: Nineteen consecutive patients who underwent pulmonary vein isolation (PVI) with cryoballoon for paroxysmal or persistent AF were included. EAMs of left atrium (LA) created by the LASSOSTAR™NAV catheter (Lassostar map) before and after PVI were compared to that generated by a high-density mapping catheter (Pentaray map) from different aspects including structural similarity, PV angle, LA posterior wall (LAPW) and low voltage areas (LVAs), and the amplitude of far field electrograms (FFEs) recorded by catheters. RESULTS: All patients had successful PVI without major complications. With similar mapping time and density, the LA volume calculated from the Pentaray map and Lassostar map were comparable. There were no significant differences in PV angle of all PVs and PW area (16.8 ± 3.2 vs. 17.1 ± 2.8, p = .516) between Pentaray map and Lassostar map. High structural similarity score was observed between two maps (0.783 in RAO/LAO view and 0.791 in PA view). Lassostar map detected lesser but not statistically significant extension of LVA (13.9% vs. 18.3%, p = .07). Amplitude of FFE was larger at the right superior PV on Lassostar map (0.21 ± 0.16 vs. 0.14 ± 0.11 mV, p = .041) compared to that on the Pentaray map. CONCLUSION: In our initial experience, PVI with cryoballoon and magnetic-based circular LASSOSTAR™NAV catheter was safe and effective based on the accurate LA geometry it created.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Treatment Outcome , Catheters , Catheter Ablation/adverse effects , Pulmonary Veins/surgery , Magnetic Phenomena , Recurrence
15.
J Cardiovasc Electrophysiol ; 35(1): 60-68, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37888200

ABSTRACT

INTRODUCTION: Carina breakthrough (CB) at the right pulmonary vein (RPV) can occur after circumferential pulmonary vein isolation (PVI) due to epicardial bridging or transient tissue edema. High-power short-duration (HPSD) ablation may increase the incidence of RPV CB. Currently, the surrogate of ablation parameters to predict RPV CB is not well established. This study investigated predictors of RPV CB in patients undergoing ablation index (AI)-guided PVI with HPSD. METHODS: The study included 62 patients with symptomatic atrial fibrillation (AF) who underwent AI-guided PVI using HPSD. Patients were categorized into two groups based on the presence or absence of RPV CB. Lesions adjacent to the RPV carina were assessed, and CB was confirmed through residual voltage, low voltage along the ablation lesions, and activation wavefront propagation. RESULTS: Out of the 62 patients, 21 (33.87%) experienced RPV CB (Group 1), while 41 (66.13%) achieved first-pass RPV isolation (Group 2). Despite similar AI and HPSD, patients with RPV CB had lower contact force (CF) at lesions adjacent to the RPV carina. Receiver operating characteristic (ROC) curve analysis identified CF < 10.5 g as a predictor of RPV CB, with 75.7% sensitivity and 56.2% specificity (area under the curve: 0.714). CONCLUSION: In patients undergoing AI-guided PVI with HPSD, lower CF adjacent to the carina was associated with a higher risk of RPV CB. These findings suggest that maintaining higher CF during ablation in this region may reduce the occurrence of RPV CB.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Pulmonary Veins/surgery , Catheter Ablation/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Recurrence
16.
J Cardiovasc Electrophysiol ; 35(1): 7-15, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37794818

ABSTRACT

INTRODUCTION: High-power short-duration (HPSD) ablation at 50 W, guided by ablation index (AI) or lesion size index (LSI), and a 90 W/4 s very HSPD (vHPSD) setting are available for atrial fibrillation (AF) treatment. Yet, tissue temperatures during ablation with different catheters around venoatrial junction and collateral tissues remain unclear. METHODS: In this porcine study, we surgically implanted thermocouples on the epicardium near the superior vena cava (SVC), right pulmonary vein, and esophagus close to the inferior vena cava. We then compared tissue temperatures during 50W-HPSD guided by AI 400 or LSI 5.0, and 90 W/4 s-vHPSD ablation using THERMOCOOL SMARTTOUCH SF (STSF), TactiCath ablation catheter, sensor enabled (TacthCath), and QDOT MICRO (Qmode and Qmode+ settings) catheters. RESULTS: STSF produced the highest maximum tissue temperature (Tmax ), followed by TactiCath, and QDOT MICRO in Qmode and Qmode+ (62.7 ± 12.5°C, 58.0 ± 10.1°C, 50.0 ± 12.1°C, and 49.2 ± 8.4°C, respectively; p = .005), achieving effective transmural lesions. Time to lethal tissue temperature ≥50°C (t-T ≥ 50°C) was fastest in Qmode+, followed by TacthCath, STSF, and Qmode (4.3 ± 2.5, 6.4 ± 1.9, 7.1 ± 2.8, and 7.7 ± 3.1 s, respectively; p < .001). The catheter tip-to-thermocouple distance for lethal temperature (indicating lesion depth) from receiver operating characteristic curve analysis was deepest in STSF at 5.2 mm, followed by Qmode at 4.3 mm, Qmode+ at 3.1 mm, and TactiCath at 2.8 mm. Ablation at the SVC near the phrenic nerve led to sudden injury at t-T ≥ 50°C in all four settings. The esophageal adventitia injury was least deep with Qmode+ ablation (0.4 ± 0.1 vs. 0.8 ± 0.4 mm for Qmode, 0.9 ± 0.3 mm for TactiCath, and 1.1 ± 0.5 mm for STSF, respectively; p = .005), correlating with Tmax . CONCLUSION: This study revealed distinct tissue temperature patterns during HSPD and vHPSD ablations with the three catheters, affecting lesion effectiveness and collateral damage based on Tmax and/or t-T ≥ 50°C. These findings provide key insights into the safety and efficacy of AF ablation with these four settings.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Swine , Animals , Temperature , Vena Cava, Superior/surgery , Catheters , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Hot Temperature , Catheter Ablation/adverse effects , Pulmonary Veins/surgery , Treatment Outcome
17.
J Cardiovasc Electrophysiol ; 35(3): 557-568, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37870146

ABSTRACT

RETRO-mapping was developed to automate activation mapping of atrial fibrillation (AF). We used the algorithm to study the effect of pulmonary vein isolation (PVI) on the frequency of focal, planar, and colliding wavefronts in persistent AF. An AFocusII catheter was placed on the left atrial endocardium to record 3 s of AF at six sites pre and post-PVI in patients undergoing wide circumferential PVI for persistent AF. RETRO-mapping analyzed each segment in 2 ms time windows for evidence of focal, planar, and colliding waveforms and the automated categorizations manually validated. Ten patients were recruited. A total of 360 s of data in 120 segments of 3 s from 60 left atrial locations were analyzed. RETRO-map was highly effective at identifying focal waves and collisions during AF. PVI significantly reduced collision frequency but not focal and planar activation frequency. However, there was a significant reduction in the dispersion of activation directions. Larger studies may help determine factors associated with successful clinical outcome.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Pulmonary Veins/surgery , Catheter Ablation/adverse effects , Heart Atria , Algorithms , Treatment Outcome , Recurrence
18.
J Cardiovasc Electrophysiol ; 35(1): 182-197, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38031313

ABSTRACT

INTRODUCTION: Multiple analysis techniques evaluate electrograms during atrial fibrillation (AF), but none have been established to guide catheter ablation. This study compares electrogram properties recorded from multiple right (RA) and left atrial (LA) sites. METHODS: Multisite LA/RA mapping (281 ± 176/239 ± 166 sites/patient) was performed in 42 patients (30 males, age 63 ± 9 years) undergoing first (n = 32) or redo-AF ablation (n = 10). All electrogram recordings were visually reviewed and artifactual signals were excluded leaving a total of 21 846 for analysis. Electrogram characteristics evaluated were cycle length (CL), amplitude, Shannon's entropy (ShEn), fractionation interval, dominant frequency, organizational index, and cycle length of most recurrent morphology (CLR ) from morphology recurrence plot analysis. RESULTS: Electrogram characteristics were correlated to each other. All pairwise comparisons were significant (p < .001) except for dominant frequency and CLR (p = .59), and amplitude and dominant frequency (p = .38). Only ShEn and fractionation interval demonstrated a strong negative correlation (r = -.94). All other pairwise comparisons were poor to moderately correlated. The relationships are highly conserved among patients, in the RA versus LA, and in those undergoing initial versus redo ablations. Antiarrhythmic drug therapy did not have a significant effect on electrogram characteristics, except minimum ShEn. Electrogram characteristics associated with ablation outcome were shorter minimum CLR , lower minimum ShEn, and longer mimimum CL. There was minimal overlap between the top 10 sites identified by one electrogram characteristic and the top 10 sites identified by the other 10 characteristics. CONCLUSION: Multiple techniques can be employed for electrogram analysis in AF. In this analysis of eight different electrogram characteristics, seven were poorly to moderately correlated and do not identify similar locations. Only some characteristics were predictive of ablation outcome. Further studies to consider electrogram properties, perhaps in combination, for categorizing and/or mapping AF are warranted.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Male , Humans , Middle Aged , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Heart Atria , Catheter Ablation/adverse effects , Catheter Ablation/methods
19.
J Cardiovasc Electrophysiol ; 35(1): 25-34, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37890043

ABSTRACT

BACKGROUND: Despite the potential benefits of ethanol infusion into the vein of Marshall (EIVOM) for atrial fibrillation (AF) ablation, concerns about its reversible and unpredictable effects persist. OBJECTIVE: To assess the effectiveness of EIVOM in the vein of Marshall (VOM) with collateral veins (CVs) during mitral isthmus and AF ablation. METHODS: We included 142 AF patients. EIVOM was performed before radiofrequency ablation, and low-voltage areas (<0.5 mV) were measured before, immediately after, and 1 h after EIVOM. RESULTS: Among the 142 patients, 93 (65%) underwent EIVOM, and among these, 35 (37%) were found to have CVs. In the VOM with CVs group, areas with low voltage measured 0 (0-1.85) cm2 before EIVOM, 6.9 (4.1-11.2) cm2 immediately after EIVOM, and 5.7 (3.5-10.6) cm2 1 h after EIVOM. Conversely, in the group designated as VOM without CVs-from which the nine leakage cases were excluded-the areas measured 0 (0-1.35) cm2 , 5.5 (2.6-11.8) cm2 , and 4.7 (1.8-13.5) cm2 at the respective time points. MI line block was fully achieved in 89% (31/35) of cases in the VOM with CVs group and 88% (44/49) in the VOM without CVs groups (p = .94). There was no significant difference in the outcome of AF ablation between these groups (log-rank p = .73). Additionally, no significant difference was observed between EIVOM (+) and EIVOM (-) groups (log-rank p = .59). CONCLUSION: EIVOM effectively creates MI line block, and its beneficial effects are sustained for at least 1 h after the procedure despite the low-voltage areas showing a slight reduction in size.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Radiofrequency Ablation , Humans , Ethanol/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Coronary Vessels , Catheter Ablation/adverse effects , Catheter Ablation/methods , Pulmonary Veins/surgery
20.
J Cardiovasc Electrophysiol ; 35(3): 547-556, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37855621

ABSTRACT

The QDOT MICRO™ Catheter is a novel open-irrigated contact force-sensing radiofrequency ablation catheter. It offers very high-power short-duration (vHPSD) ablation with 90 W for 4 s to improve safety and efficacy of catheter ablation procedures. Although the QDOT MICRO™ Catheter was mainly designed for pulmonary vein isolation (PVI) its versatility to treat atrial fibrillation (AF) and other types of arrhythmias was recently evaluated by the FAST and FURIOUS study series and other studies and will be presented in this article. Available study and registry data as well as case reports concerning utilization of the QDOT MICRO™ Catheter for the treatment of cardiac arrhythmias including AF, focal and macroreentry atrial tachycardia, typical atrial flutter by cavotricuspid isthmus block, premature ventricular contractions, and accessory pathways were reviewed and summarized. In summary, the QDOT MICRO™ Catheter showed safety and efficacy for PVI and is able to treat also other types of arrhythmias as is was recently evaluated by case reports and the FAST and FURIOUS studies.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Pulmonary Veins , Tachycardia, Supraventricular , Humans , Treatment Outcome , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Flutter/diagnosis , Atrial Flutter/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Pulmonary Veins/surgery
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