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Data on the spontaneous onset of ventricular tachyarrhythmias (VTAs) in Brugada syndrome (BrS), including polymorphic ventricular tachycardia (PVT) and monomorphic ventricular tachycardia (MVT), remain limited. The goal of this study was to compare the clinical profile and mode of initiation of PVT and MVT in BrS. This retrospective multicenter registry included 154 patients with BrS from 29 centers with documented VTA initiation captured by implantable cardioverter-defibrillator (94.9%) or electrocardiogram (5.1%). A total of 234 VTAs were analyzed, and initiation patterns were classified by using predefined electrocardiographic criteria. PVT was observed in 80.5% of patients, MVT in 16.9%, and both in 2.6%. Patients with MVT tended to be older, exhibit drug-induced Brugada electrocardiogram, and were more frequently White. Pause-dependent initiation occurred in approximately 25% of PVT and approximately 33% of MVT episodes. Coupling intervals initiating PVT were nonsignificantly shorter than for MVT (median 368 milliseconds vs 395 milliseconds), with a significantly lower prematurity index and faster early arrhythmia cycle length. Antecedent premature ventricular complexes were present in approximately 43% of both VTA types, commonly sharing morphology with the initiating premature ventricular complex. The prevalence of pathogenic/likely pathogenic SCN5A mutation did not differ between groups. In this largest analysis to date of spontaneous VTA onset in BrS, MVT occurred in a substantial minority and was associated with older age, White ethnicity, drug-induced electrocardiogram pattern, and a preceding tachycardia. Initiation patterns were broadly similar across arrhythmia types, although PVT exhibited a significantly lower prematurity index and faster early cycle length despite only nonsignificant shorter coupling intervals. These findings refine the clinical and electrophysiological characterization of BrS-related arrhythmias and delineate distinct features of PVT and MVT initiation.
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Low-level tragus stimulation (LLTS) of the auricular branch of the vagus nerve at the tragus reduces atrial fibrillation burden. Its efficacy on premature ventricular complexes (PVCs) is unknown, however. The goal of this study was to evaluate the efficacy of daily LLTS on PVC burden in patients with idiopathic PVC. TREAT-PVC (LLTS to Treat Premature Ventricular Contractions) is a sham-controlled, double-blind, randomized trial. Eligible patients with >10% PVC burden were randomized 1:1 to receive LLTS vs sham stimulation to the earlobe (20 Hz, 1 mA below the discomfort threshold; 1 hour daily). The primary outcome was reduction of PVC burden at 6 months assessed by using 10-day ambulatory electrocardiographic monitoring. Among 100 randomized patients, 96 were included into final analysis (N = 48 for each group) with no significant adverse effects. Baseline characteristics were balanced between groups (PVC burden: LLTS = 18.7%; sham = 16.7%). Adherence to the study protocol was similar between the 2 groups (LLTS = 85.4%; sham = 89.6%). At 6 months, both groups showed reduced PVC burden assessed by 10-day monitoring (LLTS median value: 18.7% to 11.1% [P < 0.01]; sham median value: 16.7% to 12.6% [P < 0.01]), although with no differences between the 2 groups. Skin sympathetic nerve activity and inflammatory markers (tumor necrosis factor-α, interleukin-1, and interleukin-6) remained unchanged in both groups. Heart rate variability parameters showed similar significant changes in each group (higher low-frequency, high-frequency, and very-low-frequency power; and a lower low-frequency/high-frequency ratio), suggesting that autonomic balance shifted toward parasympathetic dominance. However, there were no differences between the 2 groups (P > 0.05 for all parameters). LLTS and sham stimulation produced parallel results, indicating the presence of significant placebo effects. Future transcutaneous neuromodulation studies should include placebo effects into sample size calculation. (LLTS to Treat Premature Ventricular Contractions [TREAT-PVC]; NCT04909528).
Catheter ablation of ventricular arrhythmias (VAs) with conventional small-tip radiofrequency ablation (RFA) catheters is limited by inadequate lesion size and small footprint design. This early U.S. experience investigated procedural and clinical outcomes of VA ablation with a lattice-tip wide footprint catheter that allows toggling between RFA and pulsed field ablation (PFA). The Cleveland Clinic VT (CLEAR-VT) Registry is a prospectively maintained registry of consecutive patients undergoing catheter ablation of VAs. Patients undergoing catheter ablation of VA with an RFA/PFA lattice-tip catheter (Sphere-9; Medtronic) between January and September 2025 were analyzed. A total of 59 patients (median age 70 years; mean left ventricular ejection fraction 36.3% ± 12.3%) underwent ablation of VA using the lattice-tip catheter during the study period. Of these, 50 (85%) had scar-related ventricular tachycardia (VT) (28 with ischemic, 19 with nonischemic, and 3 with mixed cardiomyopathy), and 9 (15%) had frequent premature ventricular contractions (PVCs). Acute procedural success, defined as non-inducibility of any VT (excluding nonclinical VTs with cycle length ≤240 milliseconds) or complete PVC suppression, was achieved in 78% and 100% of patients, respectively. After a median follow-up of 100 days (Q1-Q3: 51-172 days), VT recurred in 9 patients (18%), and death/heart transplantation/left ventricular assist device implantation occurred in 6 patients (12%). At 6 months, the Kaplan-Meier-estimated VT-free survival was 69.8% (95% CI: 54.0%-90.3%); the Fine-Gray cumulative incidence of VT recurrence, accounting for competing risks, was 28.4% (95% CI: 11.0%-45.8%). No patient with PVCs had recurrence after a median follow-up of 54 days (Q1-Q3: 40-71 days). Three major procedure-related complications occurred, including 2 major bleeding events and 1 implantable cardioverter-defibrillator system failure after PFA application approximately 7.5 mm from the tip of a left ventricular pacing lead (which required intra-operative device generator change). In this first U.S. series, catheter ablation of VAs with a lattice-tip RFA/PFA catheter appeared effective and generally safe. Caution should be exercised when applying PFA in proximity to exposed conductors of implantable cardiac devices.
Tissue contact optimizes pulsed field ablation (PFA), but existing methods - based on impedance, thermal response or contact force - remain indirect. An endoscope-enabled PFA balloon catheter allows direct, real-time visualization of the electrode-tissue interface. To evaluate the safety, lesion durability and clinical outcomes of the novel, ultra-compliant PFA balloon catheter with direct tissue visualization. VISION AF was a single-arm study of paroxysmal AF patients undergoing pulmonary vein isolation (PVI) using a morphable PFA balloon catheter with integrated endoscope, and 12 longitudinal electrodes for circumferential energy delivery using either 4 applications with a single rotation (Phase A) or 4 applications without rotation (Phase B). Invasive remapping assessed lesion durability. Clinical recurrence was assessed with 7-day Holters at 3-/6-months, and weekly trans-telephonic monitoring after a 2-month blanking period. Four operators treated 50 patients: age 61±9 years; 68% male, LVEF 63±5%, CHA2DS2-VASc 2.0±1.4, 86% deep sedation/14% anesthesia (Phases A/B = 33/17). There were no serious device-related complications. Brain MRI in 36 patients revealed 5.6% DWI+/FLAIR- and 0% DWI+/FLAIR+ lesions. Using 4.3±1.0 applications/vein, PVI was achieved in 100% of patients. Transpired PVI times were 26±10 min (Phase A) or 18±4 min (Phase B). Fluoroscopy time was 4±3 min (range 0-12). Remaps at 81±28 days revealed durable PVI in 99.4% of PVs (175 of 176), translating to 97.8% of patients (44 of 45). The 6-month freedom from atrial arrhythmias was 91.5% (95%CI 79.3-96.8%). Direct visualization of electrode-tissue contact was associated with efficient, safe and durable PVI with promising rhythm outcomes. NCT06828939.
Lead extraction procedures typically use "over-the-lead" cutting tools (sheaths) to separate leads from the surrounding fibrotic, vascular, and cardiac tissue. These methods carry significant risks of collateral damage and major bleeding complications. The goal of this study was to evaluate the safety and efficacy of a novel vibration-based lead extraction technique that eliminates the need for cutting tools. The study included comprehensive preclinical testing and initial human experience. Development included 3 phases: 1) bench experiments; 2) animal studies (N = 13) with varying lead implant durations; and 3) a first-in-human study enrolling 10 consecutive patients requiring a total of 18 lead extractions. The primary endpoints were complete procedural success and absence of major complications. The secondary endpoint was successful extraction of all leads without conventional tools. The bench experiments established optimal vibration parameters for lead extraction. The animal studies confirmed the safety of high-frequency vibration application to an implanted pacing lead. In 9 animals with long-term implants (up to 5 years), all leads (6 pacing and 3 implantable cardiac-defibrillator) were successfully extracted without significant tissue damage on anatomical and histologic examination. In the human study, complete extraction was achieved in all 10 cases (18 leads [12 pacing, 4 implantable cardiac-defibrillator, and 2 coronary sinus]) with a mean dwell time of 48.6 ± 21.74 months (21-78 months). Mean lead vibration time was 40 seconds (6-176 seconds). No device-related complications occurred during the procedure or at 1-month follow-up. This novel vibration-based extraction technique exhibited excellent safety and efficiency profiles in preclinical and initial human study, potentially offering a simple, rapid, and safe alternative to conventional extraction methods.
Clinical experience with minimally invasive hybrid ventricular tachycardia (VT) ablation remains limited, particularly regarding video-assisted thoracoscopic access. The purpose of this study was to describe procedural characteristics, feasibility, and outcomes of minimally invasive hybrid VT ablation for complex substrates. Consecutive patients undergoing minimally invasive hybrid VT ablation at a single tertiary center (2014-2025) were retrospectively analyzed. Multidisciplinary preprocedural evaluation was consistently performed, and from 2022 onward, this was formalized within the VT-TRACT (Ventricular Tachyarrhythmias: A Multidisciplinary Clinical-Translational Approach) care pathway. In total, 22 patients (86% men, median age 70 years, median PAINESD score 13, 68% VT storm) underwent minimally invasive hybrid VT ablation: left- or right-sided video-assisted thoracoscopic (n = 13 vs 1), subxiphoid access (n = 3), double access (n = 2), and anterolateral minithoracotomy (n = 3). Indications were prior cardiac surgery in 7 (32%), extensive scar in 3 (14%), concomitant left-sided sympathectomy in 2 (9%), hybrid atrial fibrillation ablation in 1 (5%), failed epicardial access in 2 (9%), and pericarditis/tamponade in 2 (9%), while 5 (23%) underwent ablation under direct visualization by preference. Pericardial adhesions (45%) were bluntly dissected. Mean procedure time was 312 ± 98 minutes. At 1 year, median VT burden decreased from 16.5 (Q1-Q3: 9.5-37.0) to 0 (Q1-Q3: 0-5.8) (-81%; P < 0.001), and ICD shocks from 2 (Q1-Q3: 0-5) to 0 (Q1-Q3: 0-0) (-90%; P < 0.001). One hemothorax required reoperation; no other major complications occurred. One-year survival was 82%. Minimally invasive, patient-tailored hybrid VT ablation-guided by multidisciplinary planning-achieves marked reductions in VT burden and ICD shocks with a favorable safety profile, even in complex post-surgical patients.
Ventricular arrhythmias from the aortic cusps (ACs) represent a subset of left ventricular outflow tract arrhythmias. Although ablation in this region can be highly effective, concerns persist regarding aortic valve injury and iatrogenic aortic regurgitation (AR). Contemporary data on AR incidence after AC mapping/ablation remain limited. This study sought to determine the incidence, severity, and clinical significance of AR in a multicenter cohort after mapping and/or radiofrequency ablation in the ACs or commissures. We retrospectively analyzed patients at 4 high-volume centers (2015-2024) who underwent AC/commissural mapping and/or ablation for ventricular arrhythmia and had paired preprocedural and postprocedural transthoracic echocardiograms (TTEs). AR was graded by using standardized criteria; procedure-related AR was defined as ≥2-grade worsening or new ≥moderate AR. Among 290 patients, 208 (218 procedures) had complete paired TTEs. Baseline AR was absent in 81% and mild in 18%. Retrograde aortic access was used in 94%, and 77% underwent radiofrequency ablation within the cusps. Clinically significant AR (≥2-grade worsening or new moderate AR) occurred in 2 procedures (0.9%), both representing progression from preexisting mild-to-moderate AR, with one of the patients having a bicuspid valve. New mild AR (1-grade increase from none to mild) occurred in 26 procedures (11.9%). Among 14 with additional follow-up imaging (median 320 days after first postprocedural TTE), AR resolved in 8 (57%) and remained mild in 6 (43%). No patient required valve intervention. Significant AR occurred in approximately 1% after AC mapping/ablation. New mild AR developed in 12.5% and improved in more than one-half during follow-up. No valve interventions were required, supporting the safety of cusp and commissural ablation at experienced centers.
Despite rapid percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), large infarcts contribute to heart failure and mortality. Left ventricular (LV) wall tension and load are major determinants of infarct size. Preclinical studies identified that delaying reperfusion to permit LV unloading with a transvalvular microaxial flow pump (TV-mAFP) reduces infarct size. We tested whether this combination reduces infarct size compared with reperfusion alone in patients with anterior STEMI without cardiogenic shock. The STEMI-Door to Unload (DTU) pivotal trial tested the central hypothesis that the combination of mechanical LV unloading plus a 30-minute delay before PCI reduces infarct size compared with immediate PCI alone in patients with anterior STEMI without cardiogenic shock. We conducted an open-label, randomized controlled trial at 55 hospitals in the United States, Germany, Italy, United Kingdom, Switzerland, and Canada. Adults aged 18 to 85 years with no prior myocardial infarction and presenting with acute anterior STEMI within 1 to 6 hours of symptom onset before hospital arrival were eligible for inclusion. Patients were randomly assigned (1:1) by study site personnel to either LV unloading with a TV-mAFP for 30 minutes before PCI (treatment group) or PCI alone (control group). The primary outcome was infarct size normalized to LV mass (IS/LVM) evaluated by cardiac magnetic resonance imaging 3 to 5 days after PCI and was evaluated in all randomized patients. The trial is closed to new participants. Between December 12, 2019 and September 3, 2024, 527 patients were randomized; 262 patients were assigned to the treatment group and 265 to the control group. Mean patient age was 61 ± 11 years, and 417 patients (79.1%) were men. Total ischemic time was longer in the treatment arm. IS/LVM was 30.8% ± 16.2% in the treatment group and 31.9% ± 16.9% in the control group (mean difference: -1.1%; 95% CI: -4.2 to 2.0; P = 0.50). Major bleeding or vascular complications at 30-day follow-up occurred more frequently in the treatment group when compared with either a prespecified performance goal or the control group. Combination of a TV-mAFP plus delayed PCI did not reduce infarct size in patients with anterior STEMI without cardiogenic shock compared with PCI alone. (Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial [DTU-STEMI]; NCT03947619).
Cardioneuroablation (CNA) is an emerging therapy for vagally mediated bradyarrhythmias. Its role in ictal asystole, a rare but severe manifestation of epilepsy, remains poorly defined. This study sought to summarize procedural characteristics and clinical outcomes of CNA performed for ictal asystole. We conducted a retrospective multicenter study across 6 international centers, identifying adult patients who underwent CNA for ictal asystole (≥4 s) from 2017 to 2025. A total of 12 patients (aged 39 ± 9 years, 50% female) were included; 9/12 had focal impaired-awareness seizures. All patients exhibited sinus arrest during the events, with a mean asystole of 16 ± 8 s, and a median number of 7 syncopal events. Biatrial CNA (75% under conscious sedation) was facilitated by 3-dimensional electroanatomic mapping. Ganglionated plexi (GPs) were identified using anatomical landmarks and fractionated electrograms. Right superior (12 of 12), right inferior (10 of 12), and left inferior (9 of 12) GPs were most frequently ablated. After CNA, the sinus rate increased by ≥25% in 10 of 12 patients, and 9 of 12 demonstrated a blunted atropine response. No procedural complications occurred. Over a median follow-up of 20.5 months, 8 of 12 patients remained free from ictal asystole. Four patients experienced recurrent syncope at 2 to 15 months and underwent repeated CNA, with one of them achieving durable freedom from syncope. Two patients ultimately required a pacemaker implant. In patients with ictal asystole, biatrial CNA appears to be safe and may substantially reduce syncope burden, although repeated ablation or permanent pacing may be required. Prospective studies are needed to better define efficacy and long-term outcomes.
Atrial fibrillation (AF) is more prevalent in endurance athletes (EAs) than in the general population, but identifying athletes at greatest risk remains challenging. This study sought to develop an AF risk assessment tool from associations between AF and electrophysiologic, imaging, and genetic markers of atrial cardiomyopathy in EAs. EAs and nonathletic control subjects (NAs) underwent comprehensive phenotyping with the use of cardiopulmonary exercise testing, echocardiography, 12-lead electrocardiography (ECG), Holter monitoring for premature atrial contractions (PACs), and biochemical analysis. A genotyping array was used to determine polygenic risk scores for AF (AF-PRS). Logistic regression was used to develop an AF probability model. EAs (n = 353; median age 41 years, 74% male) had 40% larger LA volumes (42.9 vs 29.7 mL/m2; P < 0.001) than NAs (n = 97; median age 34 years, 64% male). Of the EAs, 96 (27%) had prevalent AF and demonstrated larger LA volumes (46.2 mL/m2 vs 41.9 mL/m2; P < 0.001), reduced LA strain (reservoir 26% vs 32%; P < 0.001), prolonged P-wave duration (124 vs 111 ms; P < 0.001), abnormal P-wave terminal force velocity in lead V1 (26% vs 9%; P < 0.001), and increased PACs (118 vs 15 PACs/24 h; P < 0.001) than EAs without AF. A clinical risk model incorporating these factors demonstrated excellent discrimination (AUC = 0.84). High AF-PRS increased AF odds 2.56-fold but contributed little additional predictive value. Using the model, AF prevalence increased from 4% to 86% in low to very high risk athletes, respectively. A combination of atrial cardiomyopathy markers was associated with high AF prevalence in EAs. A resulting quantitative AF risk identification tool provides promise for interventions aimed at preventing AF and thromboembolic complications in EAs.
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