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1.
Article de Anglais | MEDLINE | ID: mdl-39248361

RÉSUMÉ

BACKGROUND: Most studies of device-detected atrial fibrillation (AF) have recommended indefinite anticoagulation once a patient crosses a particular threshold for AF duration or burden. However, durations and burdens are known to fluctuate over time, but little is known about the magnitude of spontaneous fluctuations and the potential impact on anticoagulation decisions. OBJECTIVE: To quantify spontaneous fluctuations in AF duration and burden in patients with implantable loop recorders (ILRs) METHODS: We reviewed all ILR interrogations for patients with non-permanent AF at our institution from 2018 to 2023. We excluded patients treated with rhythm control. The duration of longest AF episode at each interrogation was classified as < 6, 6-24, and > 24 h, and the AF burden reported at each interrogation was classified as < 2%, 2%-11.4%, and > 11.4%. RESULTS: Out of 156 patients, the mean age at ILR implant was 70.9 ± 12.5 years, CHA2DS2-VASc score was 4.2 ± 1.8, duration of ILR follow-up was 23.4 ± 11.2 months, and number of ILR interrogations per patient was 18.0 ± 8.9. The duration of longest AF episode at any point during follow-up was < 6 , 6-24 , and > 24 h in 110, 30, and 16 patients, respectively. Among the 30 patients with a longest AF episode of 6-24 h at some point during follow-up, out of 594 total ILR interrogations, only 75 (12%) showed a longest episode of 6-24 h. In the remaining 519 interrogations, the longest episode was < 6 h. In patients with a longest episode of > 24 h at any point during follow-up (n = 16), only 47 out of 320 total ILR interrogations (15%) showed an episode of > 24 h. When evaluating AF burden, 96, 38, and 22 patients had maximum reported AF burdens of < 2%, 2%-11.4%, and > 11.4% at any point during ILR follow-up. Among those with a maximum burden of 2%-11.4% at some point during follow-up (n = 38), out of 707 ILR interrogations, only 76 (11%) showed a burden of 2%-11.4%. In the remaining 631 interrogations, the burden was < 2%. In the 22 patients with a burden > 11.4% at some point during follow-up, only 80 out of 480 interrogations (17%) showed a burden of > 11.4%. In 65% of interrogations, the burden was < 2%. CONCLUSION: Significant, spontaneous fluctuations in AF burden and duration are common in patients with ILRs. Even in patients with AF episodes of 6-24 h or > 24 h at some point during follow-up, the vast majority of interrogations show episodes of < 6 h. Similarly, in patients with burdens of 2%-11.4% or > 11.4% at some point during follow-up, the vast majority of interrogations show burdens of < 2%. More data are needed to determine whether crossing an AF burden or duration threshold once is sufficient to merit lifelong anticoagulation or whether spontaneous fluctuations in AF burden and duration should impact anticoagulation decisions.

2.
Heart Rhythm ; 2024 Jun 24.
Article de Anglais | MEDLINE | ID: mdl-38925335

RÉSUMÉ

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.

3.
JACC Clin Electrophysiol ; 10(7 Pt 2): 1634-1644, 2024 Jul.
Article de Anglais | MEDLINE | ID: mdl-38869507

RÉSUMÉ

BACKGROUND: Autonomic denervation is an ancillary phenomenon during thermal ablation of atrial fibrillation (AF), that may have synergistic effects on symptomatic improvement and long-term freedom from AF. Pulsed field ablation (PFA), a nonthermal ablation modality, was noninferior to thermal ablation in treating AF; however, PFA's relative myocardial selectivity may minimize autonomic effects. OBJECTIVES: This study sought to compare heart rate (HR) and heart rate variability (HRV) metrics as markers of autonomic function after ablation using PFA vs thermal ablation. METHODS: ADVENT (FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation) was a randomized pivotal study comparing PFA (pentaspline catheter) with thermal ablation (radiofrequency [RF] or cryoballoon [CB]) for treating paroxysmal AF. Baseline HR was acquired from a pre-ablation 12-lead electrocardiogram, whereas follow-up HRs, as well as HRV (standard deviation of all normal to normal RR intervals, standard deviation of 5-minute average RR intervals) metrics, were derived from 72-hour Holter monitors at 6 and 12 months. RESULTS: This study included 379 paroxysmal AF patients undergoing PFA (n = 194) or thermal ablation (n = 185; n = 102 RF, n = 83 CB) completing 6- and 12-month Holter monitoring. Compared with PFA, thermal patients had significantly greater increases in HR from baseline to 6 months (ΔHR; 10.1 vs 5.9 beats/min; P = 0.02) and 12 months (ΔHR; 8.8 vs 5.2 beats/min; P = 0.03). This increase in HR at 6 and 12 months was similar between CB and RF (P = 0.94 and 0.83, respectively). HRV, both standard deviation of all normal to normal RR intervals and standard deviation of 5-minute average RR intervals, were significantly lower at both 6 and 12 months after thermal ablation compared with PFA (P < 0.01). CONCLUSIONS: PFA's effect on the autonomic nervous system was attenuated compared with thermal ablation. Whether this affects long-term freedom from AF or symptomatic bradycardia/pauses after AF ablation requires further study.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Rythme cardiaque , Fibrillation auriculaire/chirurgie , Fibrillation auriculaire/physiopathologie , Fibrillation auriculaire/thérapie , Humains , Mâle , Femelle , Adulte d'âge moyen , Rythme cardiaque/physiologie , Ablation par cathéter/méthodes , Sujet âgé , Système nerveux autonome/physiopathologie , Cryochirurgie/méthodes , Électrocardiographie ambulatoire , Résultat thérapeutique
4.
Heart Rhythm ; 2024 May 05.
Article de Anglais | MEDLINE | ID: mdl-38752909

RÉSUMÉ

BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.

6.
J Cardiovasc Electrophysiol ; 35(6): 1212-1216, 2024 Jun.
Article de Anglais | MEDLINE | ID: mdl-38650520

RÉSUMÉ

BACKGROUND: Early guidance recommended a bolus of intravenous heparin at the beginning of leadless pacemaker (LP) implantation procedures. However, due to concern about bleeding complications, more recent practice has tended toward omitting the bolus and only running a continuous heparin infusion through the introducer sheath. The impact of omitting the heparin bolus on procedural outcomes is not clear. METHODS: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. The decision to bolus with heparin was at operator discretion. RESULTS: Among 621 LP implants, 326 received an intravenous heparin bolus, 243 did not, and 52 patients were excluded because heparin bolus status could not be confirmed. There was a trend toward more frequent omission of the heparin bolus with more recent implants. Median follow-up after LP implant was 14.3 (interquartile range [IQR]: 8.4-27.9) months. There was no difference between heparin bolus and no bolus groups in the number of device deployments/recaptures (1.42 ± 0.81 vs. 1.31 ± 0.66, p = .15). Implant-related adverse events were also similar between heparin bolus and no bolus groups: access-site hematoma requiring intervention (7 vs. 5, p = .99), pseudoaneurysm (1 vs. 1, p = .99), cardiac perforation (1 vs. 1, p = .99), intraprocedural device thrombus formation (2 vs. 4, p = .41), 30-day rehospitalization (21 vs. 15, p = .98), and 30-day all-cause mortality (16 vs. 14, p = .70). There was one additional nonfatal cardiac perforation in a patient who was excluded due to unknown heparin bolus status. Regarding device electrical parameters between heparin bolus and no bolus groups, there were no significant differences at the time of implant: pacing capture threshold 0.5 ± 0.4 vs. 0.5 ± 0.3, p = .10; pacing impedance 739.9 ± 226.4 vs. 719.1 ± 215.4, p = .52; R wave sensing 11.7 ± 5.7 vs. 12.0 ± 5.4, p = .34). Long-term device performance was also similar between groups. CONCLUSION: Omission of the systemic heparin bolus at the time of LP implantation appears safe in appropriately selected patients. Heparin bolus may still be considered in long cases requiring multiple device deployments or in patients at high risk for thrombotic complications.


Sujet(s)
Anticoagulants , Entraînement électrosystolique , Héparine , Pacemaker , Humains , Héparine/administration et posologie , Héparine/effets indésirables , Mâle , Sujet âgé , Femelle , Anticoagulants/administration et posologie , Anticoagulants/effets indésirables , Résultat thérapeutique , Études rétrospectives , Facteurs temps , Facteurs de risque , Sujet âgé de 80 ans ou plus , Adulte d'âge moyen , Calendrier d'administration des médicaments , Implantation de prothèse/instrumentation , Implantation de prothèse/effets indésirables , Conception de prothèse
9.
J Cardiovasc Electrophysiol ; 34(11): 2216-2222, 2023 Nov.
Article de Anglais | MEDLINE | ID: mdl-37727925

RÉSUMÉ

INTRODUCTION: Permanent pacing indications are common after cardiac surgery and transcatheter structural valve interventions. Leadless pacemakers (LPs) have emerged as a useful alternative to transvenous pacemakers. However, current commercially available LPs are unable to provide atrial pacing or cardiac resynchronization and relatively little is known about LP outcomes after cardiac surgery and transcatheter valve interventions. METHODS: This retrospective study included patients who received a Micra VR (MicraTM MC1VR01) or Micra AV (MicraTM MC1AVR1) (Medtronic) leadless pacemaker following cardiac surgery or transcatheter structural valve intervention between September 2014 and September 2022. Device performance and clinical outcomes, including ventricular pacing burden, ejection fraction, and need for conversion to transvenous pacing systems, were evaluated during follow-up. RESULTS: A total of 78 patients were included, of whom 40 received a Micra VR LP implant, and 38 received a Micra AV LP implant. The mean age of the cohort was 65.9 ± 17.9 years, and 48.1% were females. The follow-up duration for the entire cohort was 1.3 ± 1.1 years: 1.6 ± 1.3 years for the Micra VR group and 0.8 ± 0.5 years for the Micra AV group. Among the cohort, 50 patients had undergone cardiac surgery and 28 underwent transcatheter structural valve interventions. Device electrical performance was excellent during follow-up, with a small but clinically insignificant increase in ventricular pacing threshold and a slight decrease in pacing impedance. The mean right ventricle pacing (RVP) burden significantly decreased over time in the entire cohort (74.3% ± 37.2% postprocedure vs. 47.7% ± 40.6% at last follow-up, p < .001), and left ventricle ejection fraction (LVEF) showed a modest but significant downward trend during follow-up (55.0% ± 10.6% vs. 51.5% ± 11.2% p < .001). Patients with Micra VR implants had significantly reduced LVEF during follow-up (54.1% ± 11.9% vs. 48.8% ± 11.9%, p = .003), whereas LVEF appeared stable in the Micra AV group during follow-up (56.1% ± 9.0% vs. 54.6% ± 9.7%, p = .06). Six patients (7.7%) required conversion to transvenous pacing systems, four who required cardiac resynchronization for drop in LVEF with high RVP burden and two who required dual-chamber pacemakers for symptomatic sinus node dysfunction. CONCLUSION: Leadless pacemakers provide a useful alternative to transvenous pacemakers in appropriately selected patients after cardiac surgery and transcatheter structural valve interventions. Device performance is excellent over medium-term follow-up. However, a significant minority of patients require conversion to transvenous pacing systems for cardiac resynchronization or atrial pacing support, demonstrating the need for close electrophysiologic follow-up in this cohort.


Sujet(s)
Procédures de chirurgie cardiaque , Pacemaker , Femelle , Humains , Adulte d'âge moyen , Sujet âgé , Sujet âgé de 80 ans ou plus , Mâle , Études rétrospectives , Lipopolysaccharides , Résultat thérapeutique , Conception d'appareillage , Entraînement électrosystolique/effets indésirables
10.
N Engl J Med ; 389(18): 1660-1671, 2023 Nov 02.
Article de Anglais | MEDLINE | ID: mdl-37634148

RÉSUMÉ

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.).


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Veines pulmonaires , Humains , Fibrillation auriculaire/classification , Fibrillation auriculaire/chirurgie , Théorème de Bayes , Ablation par cathéter/effets indésirables , Ablation par cathéter/méthodes , Veines pulmonaires/chirurgie , Récidive , Méthode en simple aveugle , Tachycardie/étiologie , Résultat thérapeutique
11.
Heart Rhythm ; 20(9): 1238-1245, 2023 09.
Article de Anglais | MEDLINE | ID: mdl-37211146

RÉSUMÉ

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Veines pulmonaires , Humains , Qualité de vie , Résultat thérapeutique , Ablation par cathéter/méthodes , Acceptation des soins par les patients , Récidive , Veines pulmonaires/chirurgie
12.
Heart Rhythm O2 ; 4(2): 111-118, 2023 Feb.
Article de Anglais | MEDLINE | ID: mdl-36873309

RÉSUMÉ

Background: Favorable clinical outcomes are difficult to achieve in long-standing persistent atrial fibrillation (LSPAF) with catheter ablation (CA). The CONVERGE (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent Atrial FIbrillation) trial evaluated the effectiveness of hybrid convergent (HC) ablation vs endocardial CA. Objective: The study sought to evaluate the safety and effectiveness of HC vs CA in the LSPAF subgroup from the CONVERGE trial. Methods: The CONVERGE trial was a prospective, multicenter, randomized trial that enrolled 153 patients at 27 sites. A post hoc analysis was performed on LSPAF patients. The primary effectiveness was freedom from atrial arrhythmias off new or increased dose of previously failed or intolerant antiarrhythmic drugs (AADs) through 12 months. The primary safety endpoint was major adverse event incidence through 30 days with HC. Key secondary effectiveness measures included (1) percent of patients achieving ≥90% AF burden reduction vs baseline and (2) AF freedom. Results: Sixty-five patients (42.5% of total enrollment) had LSPAF; 38 in HC and 27 in CA. Primary effectiveness was 65.8% (95% confidence interval [CI] 50.7%-80.9%) with HC vs 37.0% (95% CI 5.1%-52.4%) with CA (P = .022). Through 18 months, these rates were 60.5% (95% CI 50.0%-76.1%) with HC vs 25.9% (95% CI 9.4%-42.5%) with CA (P = .006). Secondary effectiveness rates were higher than CA with HC at 12 and 18 months. Freedom from atrial arrhythmias off AADs was 52.6% (95% CI 36.8%-68.5%) and 47.4% (95% CI 31.5%-63.2%) with HC at 12 and 18 months vs 25.9% (95% CI 9.4%-42.5%) and 22.2% (95% CI 6.5%-37.9%) with CA, respectively (12 months: P = .031; 18 months: P = .038). Three (7.9%) major adverse events occurred within 30 days of HC. Conclusion: Post hoc analysis demonstrated effectiveness and acceptable safety of HC compared with CA in LSPAF.

13.
Circulation ; 147(19): 1422-1432, 2023 05 09.
Article de Anglais | MEDLINE | ID: mdl-36877118

RÉSUMÉ

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.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Veines pulmonaires , Humains , Fibrillation auriculaire/chirurgie , Fibrillation auriculaire/traitement médicamenteux , Études prospectives , Résultat thérapeutique , Antiarythmiques/usage thérapeutique , Électrocardiographie , Ablation par cathéter/effets indésirables , Ablation par cathéter/méthodes , Récidive
14.
J Cardiovasc Electrophysiol ; 34(2): 348-355, 2023 02.
Article de Anglais | MEDLINE | ID: mdl-36448428

RÉSUMÉ

INTRODUCTION: Early and safe ambulation can facilitate same-day discharge (SDD) following catheter ablation, which can reduce resource utilization and healthcare costs and improve patient satisfaction. This study evaluated procedure success and safety of the VASCADE MVP venous vascular closure system in patients with atrial fibrillation (AF). METHODS: The AMBULATE SDD Registry is a two-stage series of postmarket studies in patients with paroxysmal or persistent AF undergoing catheter ablation followed by femoral venous access-site closure with VASCADE MVP. Efficacy endpoints included SDD success, defined as the proportion of patients discharged the same day who did not require next-day hospital intervention for procedure/access site-related complications, and access site sustained success within 15 days of the procedure. RESULTS: Overall, 354 patients were included in the pooled study population, 151 (42.7%) treated for paroxysmal AF and 203 (57.3%) for persistent AF. SDD was achieved in 323 patients (91.2%) and, of these, 320 (99.1%) did not require subsequent hospital intervention based on all study performance outcomes. Nearly all patients (350 of 354; 98.9%) achieved total study success, with no subsequent hospital intervention required. No major access-site complications were recorded. Patients who had SDD were more likely to report procedure satisfaction than patients who stayed overnight. CONCLUSION: In this study, 99.7% of patients achieving SDD required no additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients after catheter ablation for paroxysmal or persistent AF in which the VASCADE MVP is used for venous access-site closure.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Humains , Sortie du patient , Fibrillation auriculaire/diagnostic , Fibrillation auriculaire/chirurgie , Fibrillation auriculaire/étiologie , Satisfaction des patients , Ablation par cathéter/effets indésirables , Ablation par cathéter/méthodes , Enregistrements , Résultat thérapeutique
15.
J Cardiovasc Electrophysiol ; 34(2): 279-290, 2023 02.
Article de Anglais | MEDLINE | ID: mdl-36352771

RÉSUMÉ

INTRODUCTION: Use of a novel magnetic sensor enabled optical contact force ablation catheter has been established to be safe and effective for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF) but has yet to be demonstrated in the persistent AF (PersAF) population. METHODS: PERSIST-END was a multicenter, prospective, nonrandomized, investigational study designed to demonstrate the safety and effectiveness of TactiCath™ Ablation Catheter, Sensor Enabled™(SE) (TactiCath SE) for use in the treatment of subjects with documented PersAF refractory or intolerant to at least one Class I/III AAD. The ablation strategy included pulmonary vein isolation and additional targets at physician discretion. Follow-up through 15-months, including a 3-month blanking period and 3-month therapy consolidation period, was performed with cardiac event and Holter monitoring. Primary safety, primary effectiveness, clinical success, and quality of life (QOL) endpoints were analyzed. RESULTS: Of 224 subjects enrolled at 21 investigational sites in the United States and Australia, 223 underwent ablation with the investigational catheter. The primary safety event rate was 3.1% (seven events in seven subjects). The Kaplan-Meier estimate of freedom from AF/atrial flutter/atrial tachycardia recurrence at 15-months was 61.6% and clinical success at 15 months was 89.8%. Subject QOL significantly improved following ablation as assessed via AFEQT (31.6 point increase, p < .0001) and EQ-5D-5L (10.7 point increase, p < .0001) and was met with a 53% reduction in all cause cardiovascular healthcare utilization. CONCLUSION: The sensor-enabled force-sensing catheter is safe and effective for the treatment of drug refractory recurrent symptomatic PersAF, reducing arrhythmia recurrence while improving QOL and healthcare utilization.


Sujet(s)
Fibrillation auriculaire , Flutter auriculaire , Ablation par cathéter , Veines pulmonaires , Humains , Fibrillation auriculaire/diagnostic , Fibrillation auriculaire/chirurgie , Fibrillation auriculaire/traitement médicamenteux , Qualité de vie , Études prospectives , Système de conduction du coeur , Ablation par cathéter/effets indésirables , Ablation par cathéter/méthodes , Veines pulmonaires/chirurgie , Résultat thérapeutique , Récidive
16.
J Cardiovasc Electrophysiol ; 33(8): 1954-1960, 2022 08.
Article de Anglais | MEDLINE | ID: mdl-35420730

RÉSUMÉ

In atrial fibrillation (AF), the pulmonary veins (PVs) are central to arrhythmogenicity and are targeted by PV isolation (PVI). As AF progresses, triggers become more prevalent in non-PV areas including the left atrial posterior wall (LAPW). Reported benefits of LAPW isolation in Cox-maze IV led to exploration of ablation strategies using endocardial catheters. However, no single approach to endocardial LAPW isolation exists. Relative success in comparison to PVI alone has been mixed. The hybrid convergent procedure was developed to combine minimally invasive surgical and electrophysiology techniques to accomplish effective PVI and LAPW isolation. Epicardial LAPW isolation is performed by a cardiothoracic surgeon followed by endocardial ablation by an electrophysiologist who ensures PVI completion and targets any remaining gaps. Safety and effectiveness of hybrid convergent were evaluated in the prospective, multicenter, randomized controlled trial, Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE). CONVERGE compared the effectiveness of the hybrid convergent procedure to endocardial catheter ablation for treatment of drug-refractory persistent and long-standing persistent AF and demonstrated primary effectiveness of higher freedom from atrial arrhythmias absent new/increased dose previously failed/intolerant antiarrhythmic drugs through 12 months compared to endocardial catheter ablation. Greater freedom from AF and proportion of patients experiencing ≥90% burden reduction with hybrid convergent ablation were seen through 18 months of follow-up. Improved electrophysiology lab efficiency was demonstrated by the reduction in endocardial ablation time with addition of epicardial ablation. This multidisciplinary heart team procedure may improve outcomes in difficult-to-treat patients with advanced AF.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Veines pulmonaires , Fibrillation auriculaire/diagnostic , Fibrillation auriculaire/étiologie , Fibrillation auriculaire/chirurgie , Ablation par cathéter/effets indésirables , Ablation par cathéter/méthodes , Humains , Études multicentriques comme sujet , Études prospectives , Veines pulmonaires/chirurgie , Récidive , Résultat thérapeutique
17.
Curr Opin Cardiol ; 37(1): 54-61, 2022 Jan 01.
Article de Anglais | MEDLINE | ID: mdl-34508033

RÉSUMÉ

PURPOSE OF REVIEW: Patients with persistent forms of atrial fibrillation are seeking treatments based on the promise of better restoration of sinus rhythm with newer therapies. Successful catheter ablation and maintenance of atrial fibrillation in this subgroup is negatively impacted by the presence of epicardial adipose tissue (EAT) associated with the posterior left atrium. RECENT FINDINGS: EAT is now understood to be hormonally active and promotes adverse atrial remodelling, including fibrosis and myopathy. Despite being dominantly adipose tissue, it is known to be electrically active, comprising ganglia, neural tissue and ectopic atrial myocardium that may contribute to endo-epicardial dissociation and persistent electrical activity and atrial fibrillation despite good endocardial electrical silencing. Hybrid procedures that include direct epicardial ablation of the posterior wall, including the EAT, are associated with superior outcomes in nonparoxysmal atrial fibrillation. SUMMARY: Therapies for persistent atrial fibrillation that also ablate the EAT as part of a well tolerated transmural posterior wall ablation may improve outcomes in this challenging subset of patients.


Sujet(s)
Fibrillation auriculaire , Ablation par cathéter , Tissu adipeux/chirurgie , Ablation par cathéter/méthodes , Atrium du coeur/chirurgie , Humains , Péricarde/chirurgie , Technologie , Résultat thérapeutique
18.
Cardiovasc Revasc Med ; 40S: 225-230, 2022 07.
Article de Anglais | MEDLINE | ID: mdl-34893444

RÉSUMÉ

We present a case of recurrent coronary artery spasm induced ventricular arrhythmias. A 73-year-old female developed a syncopal episode requiring brief cardiopulmonary resuscitation (CPR) with later spontaneous resolution and bradycardia. During admission, the patient had a recurrent syncopal episode while in supine position. Upon reviewing cardiac monitor, it was noted that the syncope coincided with a series of recorded arrhythmias. Invasive cardiac angiogram revealed a non-obstructive lesion at the right coronary artery with no other abnormalities suggesting spastic activity as the source of the arrhythmia. Subsequently, the patient successfully underwent an Implantable Cardioverter- Defibrillator (ICD) placement and stenting in the right coronary. Patient symptoms resolved and no further arrhythmias were detected in the ICD recording.


Sujet(s)
Spasme coronaire , Défibrillateurs implantables , Sujet âgé , Troubles du rythme cardiaque/diagnostic , Spasme coronaire/diagnostic , Spasme coronaire/imagerie diagnostique , Vaisseaux coronaires , Femelle , Humains , Spasme , Syncope/diagnostic , Syncope/étiologie , Syncope/thérapie
19.
Arrhythm Electrophysiol Rev ; 10(3): 198-204, 2021 Oct.
Article de Anglais | MEDLINE | ID: mdl-34777825

RÉSUMÉ

Recent advances have been made in AF treatment, including the role of early rhythm control and landmark clinical trials using ablation therapy. However, some treatment gaps remain, including the creation of durable lesions outside the pulmonary veins and effective treatment of longstanding persistent AF. A novel epicardial-endocardial ablation approach - the hybrid convergent procedure - was developed to combine surgical and catheter ablation techniques into a collaborative, multidisciplinary approach to managing AF. In this review, the authors discuss recently published data on hybrid convergent ablation, including results of the CONVERGE clinical trial, in the context of current challenges to treatment of persistent and long-standing persistent AF. The review also aims to provide perspective on outstanding questions and future directions in this area.

20.
Heart Rhythm ; 18(7): 1045-1054, 2021 07.
Article de Anglais | MEDLINE | ID: mdl-33482387

RÉSUMÉ

BACKGROUND: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial demonstrated that adding vein of Marshall (VOM) ethanol infusion to catheter ablation (CA) improves ablation outcomes in persistent atrial fibrillation (AF). There was significant heterogeneity in the impact of VOM ethanol infusion on rhythm control. OBJECTIVE: The purpose of this study was to assess the association between outcomes and (1) achievement of bidirectional perimitral conduction block and (2) procedural volume. METHODS: The VENUS trial randomized patients with persistent AF (N = 343) to CA combined with VOM ethanol or CA alone. The primary outcome (freedom from AF or atrial tachycardia [AT] lasting longer than 30 seconds after a single procedure) was analyzed by 2 categories: (1) successful vs no perimitral block and (2) high- (>20 patients enrolled) vs low-volume centers. RESULTS: In patients with perimitral block, the primary outcome was reached 54.3% after VOM-CA and 37% after CA alone (P = .01). Among patients without perimitral block, freedom from AF/AT was 34.0% after VOM-CA and 37.0% after CA (P = .583). In high-volume centers, the primary outcome was reached in 56.4% after VOM-CA and 40.2% after CA (P = .01). In low-volume centers, freedom from AF/AT was 30.77% after VOM-CA and 32.61% after CA (P = .84). In patients with successful perimitral block from high-volume centers, the primary outcome was reached in 59% after VOM-CA and 39.1% after CA (P = .01). Tests for interaction were significant (P = .002 for perimitral block and P = .04 for center volume). CONCLUSION: Adding VOM ethanol infusion to CA has a greater impact on outcomes when associated with perimitral block and performed in high-volume centers. Perimitral block should be part of the VOM procedure.


Sujet(s)
Fibrillation auriculaire/thérapie , Ablation par cathéter/méthodes , Éthanol/administration et posologie , Système de conduction du coeur/physiopathologie , Rythme cardiaque/physiologie , Veines pulmonaires/chirurgie , Adolescent , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Fibrillation auriculaire/physiopathologie , Femelle , Humains , Perfusions veineuses , Mâle , Adulte d'âge moyen , Récidive , Résultat thérapeutique , Jeune adulte
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