Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation.

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.).

Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial.

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.

Same-day discharge following catheter ablation and venous closure with VASCADE MVP: A postmarket registry.

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.

Contact force catheter ablation for the treatment of persistent atrial fibrillation: Results from the PERSIST-END study.

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.

The hybrid convergent procedure for persistent and long-standing persistent atrial fibrillation from an electrophysiologist's perspective.

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.

Life cycle management of Micra transcatheter pacing system: Data from a high-volume center.

BACKGROUND: Data on the management of Micra transcatheter pacing system (TPS) at the time of an upgrade or during battery depletion is limited. OBJECTIVE: We sought to evaluate the management patterns of patients implanted with a Micra TPS during long-term follow-up. METHODS: We retrospectively identified patients who underwent Micra implantation from April 2014 to November 2019. We identified patients who underwent extraction (n = 11) or had an abandoned Micra (n = 12). RESULTS: We identified 302 patients who received a Micra during the period of the study. Mean age was 72.7 ± 15.4 years, 54.6% were men, and left ventricular ejection fraction was 51.9 ± 5.2%. Mean follow-up was 1105.5 ± 529.3 days. Procedural complications included pericardial tamponade (n = 1) treated with pericardiocentesis, significant rise in thresholds (n = 6) treated with reimplantation (n = 4), and major groin complications (n = 2). Indications for extraction included an upgrade to cardiac resynchronization therapy (CRT) device (n = 3), bridging after extraction of an infected transvenous system (n = 3), elevated thresholds (n = 3), and non-Micra-related bacteremia (n = 2). The median time from implantation to extraction was 78 days (interquartile range: 14-113 days), with the longest extraction occurring at 1442 days. All extractions were successful, with no procedural or long-term complications. Indications for abandonment included the need for CRT (n = 6), battery depletion (n = 2), increasing thresholds/failure to capture (n = 3), and pacemaker syndrome (n = 1). All procedures were successful, with no procedural or long-term complications. CONCLUSION: In this large single-center study, 6% of patients implanted with a Micra required a system modification during long-term follow-up, most commonly due to the requirement for CRT pacing. These patients were managed successfully with extraction or abandonment.

Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design.

Atrial fibrillation is the most common sustained arrhythmia affecting over 33 million people worldwide. Approximately 70% of AF patients have non-paroxysmal AF. As AF progresses from paroxysmal to non-paroxysmal forms, the prevalence of comorbidities increases. The efficacy of catheter ablation for persistent and long standing persistent (LSP) AF is <40%, often requiring multiple ablation procedures with greater cost and potentially more complications. There is an unmet need to effectively treat such patients. METHODS: CONVERGE is an investigational device exempt, prospective, multi-center, open label 2:1 randomized controlled pivotal study to evaluate the overall success of the Convergent hybrid procedure compared to endocardial catheter ablation for the treatment of symptomatic persistent AF refractory or intolerant to at least one Class I and /or III anti-arrhythmic drug (AAD). A total of 153 subjects at 27 centers are treated in the study. The CONVERGE study is differentiated from other studies currently being conducted on the persistent AF population, because a) there is no time restriction on the duration of diagnosed AF in the patients being studied and b) the trial allows patients with left atrial sizes up to 6 centimeters. The ongoing trials are limited to either 6 months, 12 months or 3-years of continuous AF making CONVERGE the only ablation trial thus far to include a substantial portion of patients with longstanding persistent AF. The convergent procedure involves combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation. The primary endpoint is freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The primary safety endpoint is the incidence of major adverse events from the procedure through 30-days post procedure. CONCLUSION: CONVERGE AF compares the overall success of the Convergent hybrid procedure to endocardial catheter ablation for the treatment of persistent and longstanding persistent AF. By providing objective comparative data, the study aims to provide guidance on the treatment of such patients.

Outcomes of convergent atrial fibrillation ablation with continuous rhythm monitoring.

BACKGROUND: Outcomes of catheter ablation for persistent atrial fibrillation (PeAF) are suboptimal. The convergent procedure (CP) may offer improved efficacy by combining endocardial and epicardial ablation. METHODS: We reviewed 113 consecutive patients undergoing the CP at our institution. The cohort was divided into two groups based on the presence (n = 92) or absence (n = 21) of continuous rhythm monitoring (CM) following the CP. Outcomes were reported in two ways. First, using a conventional definition of any atrial fibrillation/atrial tachycardia (AF/AT) recurrence lasting >30 seconds, after a 90 day blanking period. Second, by determining AF/AT burden at relevant time points in the group with CM. RESULTS: Across the entire cohort, 88% had either persistent or long-standing persistent AF, mean duration of AF diagnosis before the CP was 5.1 ± 4.6 years, 45% had undergone at least one prior AF ablation, 31% had impaired left ventricle ejection fraction and 62% met criteria for moderate or severe left atrial enlargement. Mean duration of follow-up after the CP was 501 ± 355 days. In the entire cohort, survival free from any AF/AT episode >30 seconds at 12 months after the blanking period was 53%. However, among those in the CM group who experienced recurrences, mean burden of AF/AT was generally very low (<5%) and remained stable over the duration of follow-up. Ten patients (9%) required elective cardioversion outside the 90 day blanking period, 11 patients (9.7%) underwent repeat ablation at a mean of 229 ± 178 days post-CP and 64% were off AADs at the last follow-up. Procedural complications decreased significantly following the transition from transdiaphragmatic to sub-xiphoid surgical access: 23% versus 3.8% (P = .005) CONCLUSIONS: In a large, consecutive series of patients with predominantly PeAF, the CP was capable of reducing AF burden to very low levels (generally <5%), which appeared durable over time. Complication rates associated with the CP decreased significantly with the transition from transdiaphragmatic to sub-xiphoid surgical access. Future trials will be necessary to determine which patients are most likely to benefit from the convergent approach.

Clinical Performance of Magnetic Resonance Imaging Conditional and Nonconditional Cardiac Implantable Electronic Devices.

OBJECTIVES: This study compared risks associated with magnetic resonance imaging (MRI) in patients with non-MRI conditional and MRI conditional pacing and defibrillator systems with particular attention to clinically actionable outcomes. BACKGROUND: While recipients of new MRI conditional pacemaker and defibrillator systems may undergo MRI scanning with very low risk, safety and regulatory concerns persist regarding such scanning in recipients of non-MRI conditional systems. METHODS: Patients with any cardiac device who were referred for MRI were prospectively enrolled at a single center and underwent scanning at 1.5 Tesla. Pre- and postscan lead characteristic changes, system integrity, and symptoms were analyzed. A comparison was made between non-MRI conditional and MRI conditional devices. RESULTS: 105 patients were evaluated allowing for comparison of 97 scans with non-MRI conditional devices and 16 scans with MRI conditional devices. The cohort included those with pacemaker dependency, defibrillator, and cardiac resynchronization devices. Small, nonsignificant changes were observed in lead characteristics following scanning, and there was no significant difference when comparing non-MRI and MRI conditional devices. Lead parameter changes did not require lead revision or programming changes. No device reset, failures, or premature scan termination was observed. CONCLUSIONS: 1.5 T MRI scanning in patients with MRI conditional and non-MRI conditional cardiac devices was performed with similar, low clinical risk.

Predictors of Long-Term Survival Following Transvenous Extraction of Defibrillator Leads.

BACKGROUND: Little data exist on long-term outcomes following extraction of implantable cardioverter defibrillator (ICD) leads, particularly for noninfectious indications. We sought to identify predictors of long-term survival after ICD lead extraction. METHODS: We retrospectively reviewed ICD lead extractions at our institution (n = 508). Procedural outcomes and long-term survival were ascertained by medical records review. RESULTS: Indication for lead extraction was infection in 32.5% and lead failure in 61.8%. Mean dwell time of the oldest extracted lead was 5.1 ± 5.9 years. Complete procedural success was achieved in 96.5% of cases. Major procedure-related complications occurred in 1.6% with six periprocedural deaths. During a mean follow-up of 866 ± 798 days, survival was significantly worse among patients with infection as the indication for extraction. At 1 year after extraction, survival among those with infection was 88.2%, compared to 95.0% in the lead failure cohort (P < 0.001). Procedural failure was a significant predictor of long-term mortality, even after excluding periprocedural deaths. In multivariate models, the presence of chronic kidney disease, increased number of leads requiring extraction, lower ejection fraction, and procedural failure were predictors of mortality. CONCLUSION: Despite high rates of procedural success, infectious indication for ICD lead extraction is associated with increased long-term mortality. In contrast, among patients undergoing extraction for lead failure, long-term survival was excellent. The presence of procedural failure was a significant predictor of long-term mortality. Further studies will be necessary to better understand the mechanisms by which procedural failure may adversely impact long-term outcomes.

Pulse Generator Exchange Does Not Accelerate the Rate of Electrical Failure in a Recalled Small Caliber ICD Lead.

BACKGROUND: St. Jude Riata/Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) were recalled by the Food and Drug Administration in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of implantable cardioverter defibrillator (ICD) generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year. METHODS: A retrospective chart review was conducted in patients who underwent implantation of a Riata/Riata ST lead at one center. Patients with a functioning Riata lead (with/without externalized conductor) at the time of ICD exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement. RESULTS: Riata leads were implanted in 1,042 patients prior to the recall and 153 of these patients underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the ICD exchange cohort, which was not different from the control group (19.2%; P = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%; P = 0.57). At change-out, 54% received a commanded shock (18.6 ± 0.9 J) that did not result in any change in the high-voltage lead impedance (46.1 ± 1.1 ohms). CONCLUSIONS: Conductor externalization was seen frequently in our cohort of patients. ICD generator exchange did not accelerate the rate of Riata lead failure at 1 year. Although both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem.

Catheter ablation of atrial fibrillation and risk of asymptomatic cerebral embolism.

Recent studies have suggested that a significant minority of patients undergoing atrial fibrillation catheter ablation (AFCA) develop evidence of acute, asymptomatic cerebral emboli (ACE) detected by brain magnetic resonance imaging. Although the prognostic significance of ACE associated with AFCA remains unclear, given the heightened risk of dementia associated with asymptomatic chronic infarcts on brain imaging, it is imperative to understand the pathogenesis of ACE and identify methods to mitigate the risk of emboli associated with AF ablation. In this paper, we review the incidence of ACE associated with AFCA and discuss patient- and procedure-specific markers of risk for asymptomatic embolism. We also review the data to support strategies, which have been proposed to reduce the incidence of ACE.

Sex-based outcomes of subcutaneous implantable cardioverter-defibrillator and impact of surgical technique.

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.

Autonomic Effects of Pulsed Field vs Thermal Ablation for Treating Atrial Fibrillation: Subanalysis of ADVENT.

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 (The 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.

Efficacy and safety of implantable cardiac defibrillators for treatment of ventricular arrhythmias in patients with cardiac sarcoidosis.

AIMS: Implantable cardiac defibrillator (ICD) implantation is a class IIA recommendation for patients with cardiac sarcoidosis (CS). However, little is known about the efficacy and safety of ICDs in this population. The goal of this multicentre retrospective data review was to evaluate the efficacy and safety of ICDs in patients with CS. METHODS AND RESULTS: Electrophysiologists at academic medical centres were asked to identify consecutive patients with CS and an ICD. Clinical information, ICD therapy history, and device complications were collected for each patient. Data were collected on 235 patients from 13 institutions, 64.7% male with mean age 55.6 ± 11.1. Over a mean follow-up of 4.2 ± 4.0 years, 85 of 234 (36.2%) patients received an appropriate ICD therapy (shocks and/or anti-tachycardia pacing) and 67 of 226 (29.7%) received an appropriate shock. Fifty-seven of 235 patients (24.3%) received a total of 222 inappropriate shocks. Forty-six adverse events occurred in 41 of 235 patients (17.4%). Patients who received appropriate ICD therapies were more likely to be male (73.8 vs. 59.6%, P = 0.0330), have a history of syncope (40.5 vs. 22.5%, P = 0.0044), lower left ventricular ejection fraction (38.1 ± 15.2 vs. 48.8 ± 14.7%, P ≤ 0.0001), ventricular pacing on baseline electrocardiogram (16.1 vs. 2.1%, P = 0.0002), and a secondary prevention indication (60.7 vs. 24.5%, P < 0.0001) compared with those who did not receive appropriate ICD therapies. CONCLUSION: Patients with CS and ICDs are at high risk for ventricular arrhythmias. This population also has high rates of inappropriate shocks and device complications.

Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial.

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.

Hybrid epicardial-endocardial ablation for long-standing persistent atrial fibrillation: A subanalysis of the CONVERGE Trial.

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.

Hybrid Convergent Procedure for the Treatment of Persistent and Long-standing Persistent Atrial Fibrillation.

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.

Combined epicardial and endocardial ablation for atrial fibrillation: Best practices and guide to hybrid convergent procedures.

The absence of strategies to consistently and effectively address nonparoxysmal atrial fibrillation by nonpharmacological interventions has represented a long-standing treatment gap. A combined epicardial/endocardial ablation strategy, the hybrid Convergent procedure, was developed in response to this clinical need. A subxiphoid incision is used to access the pericardial space facilitating an epicardial ablation directed at isolation of the posterior wall of the left atrium. This is followed by an endocardial ablation to complete isolation of the pulmonary veins and for additional ablation as needed. Experience gained with the hybrid Convergent procedure during the last decade has led to the development and adoption of strategies to optimize the technique and mitigate risks. Additionally, a surgical and electrophysiology "team" approach including comprehensive training is believed critical to successfully develop the hybrid Convergent program. A recently completed randomized clinical trial indicated that this ablation strategy is superior to an endocardial-only approach for patients with persistent atrial fibrillation. In this review, we propose and describe best practice guidelines for hybrid Convergent ablation on the basis of a combination of published data, author consensus, and expert opinion. A summary of clinical outcomes, emerging evidence, and future perspectives is also given.