Pub Date : 2026-02-01Epub Date: 2025-11-25DOI: 10.1016/j.hroo.2025.11.013
Ilaria My MD, PhD , Moritz Nies MD , Fabian Moser MD , Marc D. Lemoine MD , Laura Rottner MD , Katharina Govorov MD , Niklas Schenker MD , Alexander Zarfelder MD , Lauritz Schoof MD , Paulus Kirchhof MD , Bruno Reissmann MD , Feifan Ouyang MD , Andreas Metzner MD , Andreas Rillig MD
Background
A new large-footprint catheter that switches between pulsed field ablation (PFA) and radiofrequency ablation (RFA) and integrates with a novel 3-dimensional (3D) mapping platform has been introduced.
Objective
This study aimed to evaluate the safety, efficacy, and procedural characteristics of the large-footprint dual-energy catheter in patients undergoing catheter ablation for atrial fibrillation or atrial tachycardia.
Methods
Consecutive patients undergoing left (LA) and right atrial ablation for atrial fibrillation or atrial tachycardias were analyzed. All patients were enrolled in the prospective TRUST Registry (NCT05521451).
Results
102 patients (37 women [36%]; median age 68 years [60–75]; median left ventricular ejection fraction 60% [53–60]) were included; 42 (41%) underwent first pulmonary vein isolation (PVI), and 57 (56%) repeat PVI. Median procedure and mapping times were 91 minutes (78–114) and 15 minutes (11.9–21.7), respectively; median 3D LA volume was 165 mL (142–199).
In 75 patients (42 index, 33 repeat procedures), pulmonary veins were targeted, and first-pass isolation was achieved in all using PFA only (median ablation 25 minutes [16–34]). Additional LA lines were applied in 87 of 102 (85%): anterior (34, 25 of 34 [73%] PFA + RFA), mitral isthmus (27, 18 of 27 [67%] PFA + RFA; 5 of 27 [18%] with PFA in the coronary sinus), posterior box (45, PFA only), and roof (23, PFA only). All lines were bidirectionally blocked, and posterior boxes isolated. A cavotricuspid isthmus line was created in 36 of 102 (35%; 30 of 36 [83%] RFA only). Procedural complications occurred in 3 of 102 (2.9%).
Conclusion
The large-footprint dual-energy catheter enables safe and effective PVI, repeat PVI, and creation of complex left and right atrial lesion sets.
{"title":"Pulmonary vein isolation and beyond: Feasibility and acute outcomes of the lattice-tip dual-energy catheter for complex ablations","authors":"Ilaria My MD, PhD , Moritz Nies MD , Fabian Moser MD , Marc D. Lemoine MD , Laura Rottner MD , Katharina Govorov MD , Niklas Schenker MD , Alexander Zarfelder MD , Lauritz Schoof MD , Paulus Kirchhof MD , Bruno Reissmann MD , Feifan Ouyang MD , Andreas Metzner MD , Andreas Rillig MD","doi":"10.1016/j.hroo.2025.11.013","DOIUrl":"10.1016/j.hroo.2025.11.013","url":null,"abstract":"<div><h3>Background</h3><div>A new large-footprint catheter that switches between pulsed field ablation (PFA) and radiofrequency ablation (RFA) and integrates with a novel 3-dimensional (3D) mapping platform has been introduced.</div></div><div><h3>Objective</h3><div>This study aimed to evaluate the safety, efficacy, and procedural characteristics of the large-footprint dual-energy catheter in patients undergoing catheter ablation for atrial fibrillation or atrial tachycardia.</div></div><div><h3>Methods</h3><div>Consecutive patients undergoing left (LA) and right atrial ablation for atrial fibrillation or atrial tachycardias were analyzed. All patients were enrolled in the prospective TRUST Registry (NCT05521451).</div></div><div><h3>Results</h3><div>102 patients (37 women [36%]; median age 68 years [60–75]; median left ventricular ejection fraction 60% [53–60]) were included; 42 (41%) underwent first pulmonary vein isolation (PVI), and 57 (56%) repeat PVI. Median procedure and mapping times were 91 minutes (78–114) and 15 minutes (11.9–21.7), respectively; median 3D LA volume was 165 mL (142–199).</div><div>In 75 patients (42 index, 33 repeat procedures), pulmonary veins were targeted, and first-pass isolation was achieved in all using PFA only (median ablation 25 minutes [16–34]). Additional LA lines were applied in 87 of 102 (85%): anterior (34, 25 of 34 [73%] PFA + RFA), mitral isthmus (27, 18 of 27 [67%] PFA + RFA; 5 of 27 [18%] with PFA in the coronary sinus), posterior box (45, PFA only), and roof (23, PFA only). All lines were bidirectionally blocked, and posterior boxes isolated. A cavotricuspid isthmus line was created in 36 of 102 (35%; 30 of 36 [83%] RFA only). Procedural complications occurred in 3 of 102 (2.9%).</div></div><div><h3>Conclusion</h3><div>The large-footprint dual-energy catheter enables safe and effective PVI, repeat PVI, and creation of complex left and right atrial lesion sets.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 212-220"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-21DOI: 10.1016/j.hroo.2025.11.011
Roland Richard Tilz MD, FHRS , Jan-Per Wenzel MD , Charlotte Eitel MD , Sorin Popescu MD , Julius Nikorowitsch MD , Karl-Heinz Kuck MD , Sascha Hatahet MD
Background
Pulsed field ablation (PFA) is a novel technique for pulmonary vein isolation (PVI) in atrial fibrillation, offering myocardial selectivity and a favorable safety profile. The balloon-in-basket (BiB)-PFA system enables circumferential PVI with optimized tissue contact. PFA is typically performed under deep sedation or general anesthesia, increasing procedural risk and logistical burden.
Objective
This study evaluated the safety, feasibility, and patient experience of BiB-PVI under conscious sedation, keeping patients awake and avoiding routine use of propofol.
Methods
Consecutive patients undergoing de novo PVI were prospectively enrolled. Conscious sedation included fentanyl, midazolam, metamizole, and lidocaine; propofol was used for direct-current cardioversion only. Patient experience was assessed via structured questionnaires at 3 time points: during ablation and 1 hour and 1 day after the procedure. Pain, dyspnea, and anxiety were rated on numeric rating scales (0–10); satisfaction and recommendation were rated on visual analog scales (0%–100%).
Results
14 patients (86% male; age 70.6 ± 9.8 years; BMI 27.7 ± 3.7 kg/m2) were included. Procedure duration was 54.5 minutes (38.3, 60.8); LA dwell time was 23 minutes (19.5, 34.8). 2.5 PFA applications (2.0, 4.0) were delivered per vein (left superior pulmonary vein 2.5; left inferior pulmonary vein 2.5; right inferior pulmonary vein 2.5; right superior pulmonary vein 2.5). Additional ablation strategies were performed owing to the interventionist’s preference. No escalation to deep sedation was required. Pain was 6.5 (4.3, 8.0), decreasing to 2.0 after ablation and on day 1 (P = .002/.001). Dyspnea and anxiety remained low. Satisfaction reached 95% (90, 100) and recommendation 100% (90, 100), remaining high throughout follow-up.
Conclusion
PFA using the BiB-PFA system under conscious sedation is safe, feasible, and well tolerated, enabling streamlined workflows with high patient satisfaction.
{"title":"“Awake and Ablated”: First experience with a balloon-in-basket PFA system without propofol","authors":"Roland Richard Tilz MD, FHRS , Jan-Per Wenzel MD , Charlotte Eitel MD , Sorin Popescu MD , Julius Nikorowitsch MD , Karl-Heinz Kuck MD , Sascha Hatahet MD","doi":"10.1016/j.hroo.2025.11.011","DOIUrl":"10.1016/j.hroo.2025.11.011","url":null,"abstract":"<div><h3>Background</h3><div>Pulsed field ablation (PFA) is a novel technique for pulmonary vein isolation (PVI) in atrial fibrillation, offering myocardial selectivity and a favorable safety profile. The balloon-in-basket (BiB)-PFA system enables circumferential PVI with optimized tissue contact. PFA is typically performed under deep sedation or general anesthesia, increasing procedural risk and logistical burden.</div></div><div><h3>Objective</h3><div>This study evaluated the safety, feasibility, and patient experience of BiB-PVI under conscious sedation, keeping patients awake and avoiding routine use of propofol.</div></div><div><h3>Methods</h3><div>Consecutive patients undergoing de novo PVI were prospectively enrolled. Conscious sedation included fentanyl, midazolam, metamizole, and lidocaine; propofol was used for direct-current cardioversion only. Patient experience was assessed via structured questionnaires at 3 time points: during ablation and 1 hour and 1 day after the procedure. Pain, dyspnea, and anxiety were rated on numeric rating scales (0–10); satisfaction and recommendation were rated on visual analog scales (0%–100%).</div></div><div><h3>Results</h3><div>14 patients (86% male; age 70.6 ± 9.8 years; BMI 27.7 ± 3.7 kg/m<sup>2</sup>) were included. Procedure duration was 54.5 minutes (38.3, 60.8); LA dwell time was 23 minutes (19.5, 34.8). 2.5 PFA applications (2.0, 4.0) were delivered per vein (left superior pulmonary vein 2.5; left inferior pulmonary vein 2.5; right inferior pulmonary vein 2.5; right superior pulmonary vein 2.5). Additional ablation strategies were performed owing to the interventionist’s preference. No escalation to deep sedation was required. Pain was 6.5 (4.3, 8.0), decreasing to 2.0 after ablation and on day 1 (<em>P</em> = .002/.001). Dyspnea and anxiety remained low. Satisfaction reached 95% (90, 100) and recommendation 100% (90, 100), remaining high throughout follow-up.</div></div><div><h3>Conclusion</h3><div>PFA using the BiB-PFA system under conscious sedation is safe, feasible, and well tolerated, enabling streamlined workflows with high patient satisfaction.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 204-211"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sexual health is a vital but often overlooked aspect of quality of life in patients living with an implantable cardioverter-defibrillator (ICD). Although the absolute risk of malignant ventricular arrhythmias during sexual activity is low, fear of shocks, anxiety, and partner concerns frequently lead to avoidance of intimacy and psychological distress. Both men and women experience sexual dysfunction after ICD implantation, driven by a complex interplay of physiological, psychological, and relational factors, with women remaining underrepresented in research. Pharmacologic effects, altered body image, and insufficient counseling further contribute to diminished sexual satisfaction. Evidence supports a multimodal approach encompassing individualized counseling, integration of sexual health into cardiac rehabilitation, partner involvement, management of medication side effects, and interventions aimed at restoring perceived control and self-efficacy. Cognitive behavioral therapy and structured exercise programs are particularly effective in reducing fear and improving adjustment. However, high-quality, gender-inclusive trials are scarce, and standardized outcome measures are lacking. Normalizing sexual-health discussions within ICD follow-up is essential to bridge the gap between evidence and practice, ensuring holistic care that not only prolongs life but also enhances its quality.
{"title":"Sexual health in patients with an implantable cardioverter-defibrillator: A narrative review","authors":"Patricia Poels MSc , Noah Stuyck MSc , Alexander Dorrestijn MSc , Tomas Robyns MD, PhD , Philip Moons MSc, PhD , Rik Willems MD, PhD , Bert Vandenberk MD, PhD, MSc","doi":"10.1016/j.hroo.2025.11.024","DOIUrl":"10.1016/j.hroo.2025.11.024","url":null,"abstract":"<div><div>Sexual health is a vital but often overlooked aspect of quality of life in patients living with an implantable cardioverter-defibrillator (ICD). Although the absolute risk of malignant ventricular arrhythmias during sexual activity is low, fear of shocks, anxiety, and partner concerns frequently lead to avoidance of intimacy and psychological distress. Both men and women experience sexual dysfunction after ICD implantation, driven by a complex interplay of physiological, psychological, and relational factors, with women remaining underrepresented in research. Pharmacologic effects, altered body image, and insufficient counseling further contribute to diminished sexual satisfaction. Evidence supports a multimodal approach encompassing individualized counseling, integration of sexual health into cardiac rehabilitation, partner involvement, management of medication side effects, and interventions aimed at restoring perceived control and self-efficacy. Cognitive behavioral therapy and structured exercise programs are particularly effective in reducing fear and improving adjustment. However, high-quality, gender-inclusive trials are scarce, and standardized outcome measures are lacking. Normalizing sexual-health discussions within ICD follow-up is essential to bridge the gap between evidence and practice, ensuring holistic care that not only prolongs life but also enhances its quality.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 414-423"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285538","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-10DOI: 10.1016/j.hroo.2025.12.002
Jon Magne Letnes MD, PhD , Andreas Berg Sellevold MD , Turid Apelland MD , Fedelix Phetogo Brown MD , Rune Byrkjeland MD, PhD , Marius Flasnes MD , Jan Pål Loennechen MD, PhD , Bjarne Martens Nes PhD , Marius Myrstad MD, PhD , NEXAF Investigators
Background
Implantable cardiac monitors (ICMs) enable continuous arrhythmia detection and quantification of atrial fibrillation (AF) burden. However, the influence of an athletic lifestyle on the positive predictive value (PPV) of ICM-detected AF episodes, and the accuracy of automated AF burden estimation, remain uncertain.
Objective
This study aimed to compare the PPV of ICM-detected AF episodes between athletes and non-athletes with known AF, and to evaluate the accuracy of automatic AF burden estimation.
Methods
During a 4-week pre-randomization phase of 2 randomized trials, 3041 AF episodes lasting ≥30 seconds were detected by ICMs in 32 endurance athletes and 159 non-athletes with non-permanent AF, totaling 4202 monitored days. All episodes were manually adjudicated to determine true AF.
Results
The patient-averaged PPV was 0.59 (95% confidence interval [CI] 0.42–0.74) for athletes and 0.51 (95% CI 0.45–0.58) for non-athletes (P = .24). PPV increased significantly with longer episode duration, reaching 0.89 (95% CI 0.83–0.94) for episodes >60 minutes vs 0.42 (95% CI 0.35–0.48) for episodes <6 minutes. Findings were consistent across groups. Correlation between automatic and validated AF burden was 0.67 (95% CI 0.56–0.77), improving to 0.85 (95% CI 0.80–0.92) after excluding episodes shorter than 6 minutes.
Conclusion
The PPV of ICM-detected AF episodes is similar in athletes and non-athletes. Longer AF episode duration enhances accuracy, and excluding short episodes improves automated AF burden estimation. ICMs may serve as good alternatives for AF monitoring also in athletic subpopulations.
背景：植入式心脏监护仪（ICMs）能够连续检测心律失常并量化心房颤动（AF）负担。然而，运动生活方式对icm检测到的AF发作阳性预测值（PPV）以及自动AF负担估计的准确性的影响仍不确定。目的：本研究旨在比较已知AF的运动员和非运动员icm检测AF发作的PPV，并评估自动估计AF负担的准确性。方法：在2项随机试验的4周预随机化阶段，在32名耐力运动员和159名非运动员的非永久性房颤中，ICMs检测到3041次房颤发作持续≥30秒，总计4202监测天。结果：运动员患者平均PPV为0.59(95%可信区间[CI] 0.42-0.74)，非运动员患者平均PPV为0.51(95%可信区间[CI] 0.45-0.58) （P = 0.24）。随着发作时间的延长，PPV显著增加，在bbb60分钟时达到0.89 (95% CI 0.83-0.94)，而在发作时达到0.42 （95% CI 0.35-0.48）。结论：icm检测的AF发作PPV在运动员和非运动员中相似。较长的AF发作持续时间提高了准确性，排除短发作可提高自动AF负担估计。在运动亚群中，ICMs也可作为房颤监测的良好选择。
{"title":"Atrial fibrillation detection in endurance athletes vs non-athletes: Positive predictive value and burden estimation using implantable cardiac monitors","authors":"Jon Magne Letnes MD, PhD , Andreas Berg Sellevold MD , Turid Apelland MD , Fedelix Phetogo Brown MD , Rune Byrkjeland MD, PhD , Marius Flasnes MD , Jan Pål Loennechen MD, PhD , Bjarne Martens Nes PhD , Marius Myrstad MD, PhD , NEXAF Investigators","doi":"10.1016/j.hroo.2025.12.002","DOIUrl":"10.1016/j.hroo.2025.12.002","url":null,"abstract":"<div><h3>Background</h3><div>Implantable cardiac monitors (ICMs) enable continuous arrhythmia detection and quantification of atrial fibrillation (AF) burden. However, the influence of an athletic lifestyle on the positive predictive value (PPV) of ICM-detected AF episodes, and the accuracy of automated AF burden estimation, remain uncertain.</div></div><div><h3>Objective</h3><div>This study aimed to compare the PPV of ICM-detected AF episodes between athletes and non-athletes with known AF, and to evaluate the accuracy of automatic AF burden estimation.</div></div><div><h3>Methods</h3><div>During a 4-week pre-randomization phase of 2 randomized trials, 3041 AF episodes lasting ≥30 seconds were detected by ICMs in 32 endurance athletes and 159 non-athletes with non-permanent AF, totaling 4202 monitored days. All episodes were manually adjudicated to determine true AF.</div></div><div><h3>Results</h3><div>The patient-averaged PPV was 0.59 (95% confidence interval [CI] 0.42–0.74) for athletes and 0.51 (95% CI 0.45–0.58) for non-athletes (<em>P</em> = .24). PPV increased significantly with longer episode duration, reaching 0.89 (95% CI 0.83–0.94) for episodes >60 minutes vs 0.42 (95% CI 0.35–0.48) for episodes <6 minutes. Findings were consistent across groups. Correlation between automatic and validated AF burden was 0.67 (95% CI 0.56–0.77), improving to 0.85 (95% CI 0.80–0.92) after excluding episodes shorter than 6 minutes.</div></div><div><h3>Conclusion</h3><div>The PPV of ICM-detected AF episodes is similar in athletes and non-athletes. Longer AF episode duration enhances accuracy, and excluding short episodes improves automated AF burden estimation. ICMs may serve as good alternatives for AF monitoring also in athletic subpopulations.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 284-292"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-02DOI: 10.1016/j.hroo.2025.11.019
Jay W. Mason MD , Suzanne J. Romano PhD , Gary T. Elliott RPh, PharmD, PhD , Boaz Mendzelevski MD , Stephanie H. Stanworth MS , Martino Vaglio MS , Fabio Badilini PhD , Mireille Gillings PhD , Jerome B. Riebman MD
Background
HBI-3000 (sulcardine sulfate) inhibits multiple cardiac ion channels in vitro including peak sodium current, late sodium current, L-type calcium current, and the rapid component of the delayed rectifier potassium channel current.
Objective
This study aimed to determine electrocardiographic effects, pharmacokinetics, safety, and tolerability of escalating doses of intravenously administered sulcardine in healthy volunteers.
Methods
In this first-in-human, randomized, double-blind, placebo-controlled, serial-cohort, dose-escalation study, 47 subjects were randomized to 6 cohorts of 8, each receiving 1 of 5 single ascending 30-minute intravenous infusions (20–600 mg) of HBI-3000 (sulcardine sulfate) or placebo in a 6:2 ratio.
Results
Clinically and statistically significant electrocardiographic effects were seen at the higher dose levels (180 mg, 360 mg, and 600 mg). At the probable therapeutic dose (360 mg), concentration-effect modeling predicted the following changes at the time of maximum plasma concentration (30 minutes): Fridericia-corrected QT interval, 13.50 ms; heart rate (HR), 7.70 beats per minute; PR, 17.53 ms; QRS, 7.81 ms; P-wave duration, 9.93 ms; HR corrected J to T peak interval (JTpc), −9.65 ms; and T peak to T end interval, 5.07 ms.
Peak plasma concentrations fell rapidly to negligible levels at 2 hours, associated with rapid redistribution from the central compartment. No significant adverse effects were observed, and no serious adverse events were reported.
Conclusion
Sulcardine increased the QTc and PR intervals, QRS and P-wave durations, and HR dose dependently. The T-wave segment JTpc was significantly decreased, whereas the T peak to T end interval was significantly increased. These findings predict an anti–atrial fibrillation effect via inhibition of 1 or more cardiac ion channels. The strong block of the rapid component of the delayed rectifier potassium channel current was partially mitigated by JTp shortening, probably owing to late sodium current and L-type calcium current inhibition, reducing the risk of proarrhythmia by decreasing repolarization time.
{"title":"Electrocardiographic effects of HBI-3000 (sulcardine sulfate), a new drug for termination of atrial fibrillation","authors":"Jay W. Mason MD , Suzanne J. Romano PhD , Gary T. Elliott RPh, PharmD, PhD , Boaz Mendzelevski MD , Stephanie H. Stanworth MS , Martino Vaglio MS , Fabio Badilini PhD , Mireille Gillings PhD , Jerome B. Riebman MD","doi":"10.1016/j.hroo.2025.11.019","DOIUrl":"10.1016/j.hroo.2025.11.019","url":null,"abstract":"<div><h3>Background</h3><div>HBI-3000 (sulcardine sulfate) inhibits multiple cardiac ion channels in vitro including peak sodium current, late sodium current, L-type calcium current, and the rapid component of the delayed rectifier potassium channel current.</div></div><div><h3>Objective</h3><div>This study aimed to determine electrocardiographic effects, pharmacokinetics, safety, and tolerability of escalating doses of intravenously administered sulcardine in healthy volunteers.</div></div><div><h3>Methods</h3><div>In this first-in-human, randomized, double-blind, placebo-controlled, serial-cohort, dose-escalation study, 47 subjects were randomized to 6 cohorts of 8, each receiving 1 of 5 single ascending 30-minute intravenous infusions (20–600 mg) of HBI-3000 (sulcardine sulfate) or placebo in a 6:2 ratio.</div></div><div><h3>Results</h3><div>Clinically and statistically significant electrocardiographic effects were seen at the higher dose levels (180 mg, 360 mg, and 600 mg). At the probable therapeutic dose (360 mg), concentration-effect modeling predicted the following changes at the time of maximum plasma concentration (30 minutes): Fridericia-corrected QT interval, 13.50 ms; heart rate (HR), 7.70 beats per minute; PR, 17.53 ms; QRS, 7.81 ms; P-wave duration, 9.93 ms; HR corrected J to T peak interval (JTpc), −9.65 ms; and T peak to T end interval, 5.07 ms.</div><div>Peak plasma concentrations fell rapidly to negligible levels at 2 hours, associated with rapid redistribution from the central compartment. No significant adverse effects were observed, and no serious adverse events were reported.</div></div><div><h3>Conclusion</h3><div>Sulcardine increased the QTc and PR intervals, QRS and P-wave durations, and HR dose dependently. The T-wave segment JTpc was significantly decreased, whereas the T peak to T end interval was significantly increased. These findings predict an anti–atrial fibrillation effect via inhibition of 1 or more cardiac ion channels. The strong block of the rapid component of the delayed rectifier potassium channel current was partially mitigated by JTp shortening, probably owing to late sodium current and L-type calcium current inhibition, reducing the risk of proarrhythmia by decreasing repolarization time.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 264-272"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-11DOI: 10.1016/j.hroo.2025.11.002
Robert G. Hauser MD, FHRS, Mariam Desouki MD, Larissa I. Stanberry PhD, Kerollos Abdelsayed MD, Melanie Kapphahn-Bergs RN, CCDS, Dawn Witt PhD, MPH, Jay N. Sengupta MD, FHRS
Background
The subcutaneous implantable cardioverter-defibrillator (S-ICD) has been shown to be safe and effective for preventing sudden cardiac death. Clinical trial and registry data suggest that the incidence of S-ICD inappropriate shocks (IAS) is similar to or slightly higher than IAS from transvenous implantable cardioverter-defibrillators. However, little data exist for S-ICD IAS in everyday practice.
Objective
This study aimed to assess IAS events reported by Boston Scientific (BSC) to the Food and Drug Administration (FDA) for its Emblem S-ICDs and transvenous single-chamber implantable cardioverter-defibrillators (TV-VR ICDs).
Methods
We searched for reports of Emblem S-ICD and TV-VR ICD adverse events (AEs) in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database that were received by the FDA from BSC during 2020–2024.
Results
In 2024, BSC estimated 153,000 Emblem S-ICDs and 353,000 of its TV-VR ICDs were distributed worldwide. During 2020–2024, BSC submitted 22,957 MAUDE AE reports for Emblem S-ICDs and 6791 MAUDE AE reports for TV-VR ICDs. Of these, 5363 (23.4%) involved IAS for S-ICDs and 813 IAS (11.7%) for TV-VR ICDs. The most common cause of S-ICD IAS was oversensing of physiological and nonphysiological signals (91.1%; 4885 of 5363), whereas rapid atrial fibrillation or supraventricular tachycardia caused 69.5% of TV-VR ICD IAS. Emblem S-ICD IAS induced ventricular fibrillation or ventricular tachycardia in 69 patients and failed to defibrillate/convert 4 of them.
Conclusion
These real-word data suggest that S-ICD IAS may be more common than previously reported. The incidence, root causes, and consequences of these IAS in the general population of S-ICD recipients should be investigated.
{"title":"Inappropriate shocks from subcutaneous and transvenous implantable cardioverter-defibrillators: Reports from the FDA MAUDE database","authors":"Robert G. Hauser MD, FHRS, Mariam Desouki MD, Larissa I. Stanberry PhD, Kerollos Abdelsayed MD, Melanie Kapphahn-Bergs RN, CCDS, Dawn Witt PhD, MPH, Jay N. Sengupta MD, FHRS","doi":"10.1016/j.hroo.2025.11.002","DOIUrl":"10.1016/j.hroo.2025.11.002","url":null,"abstract":"<div><h3>Background</h3><div>The subcutaneous implantable cardioverter-defibrillator (S-ICD) has been shown to be safe and effective for preventing sudden cardiac death. Clinical trial and registry data suggest that the incidence of S-ICD inappropriate shocks (IAS) is similar to or slightly higher than IAS from transvenous implantable cardioverter-defibrillators. However, little data exist for S-ICD IAS in everyday practice.</div></div><div><h3>Objective</h3><div>This study aimed to assess IAS events reported by Boston Scientific (BSC) to the Food and Drug Administration (FDA) for its Emblem S-ICDs and transvenous single-chamber implantable cardioverter-defibrillators (TV-VR ICDs).</div></div><div><h3>Methods</h3><div>We searched for reports of Emblem S-ICD and TV-VR ICD adverse events (AEs) in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database that were received by the FDA from BSC during 2020–2024.</div></div><div><h3>Results</h3><div>In 2024, BSC estimated 153,000 Emblem S-ICDs and 353,000 of its TV-VR ICDs were distributed worldwide. During 2020–2024, BSC submitted 22,957 MAUDE AE reports for Emblem S-ICDs and 6791 MAUDE AE reports for TV-VR ICDs. Of these, 5363 (23.4%) involved IAS for S-ICDs and 813 IAS (11.7%) for TV-VR ICDs. The most common cause of S-ICD IAS was oversensing of physiological and nonphysiological signals (91.1%; 4885 of 5363), whereas rapid atrial fibrillation or supraventricular tachycardia caused 69.5% of TV-VR ICD IAS. Emblem S-ICD IAS induced ventricular fibrillation or ventricular tachycardia in 69 patients and failed to defibrillate/convert 4 of them.</div></div><div><h3>Conclusion</h3><div>These real-word data suggest that S-ICD IAS may be more common than previously reported. The incidence, root causes, and consequences of these IAS in the general population of S-ICD recipients should be investigated.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 293-298"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-29DOI: 10.1016/j.hroo.2025.11.020
Marine Arnaud MD , Thomas Pambrun MD , Xavier Bouteiller PhD , Benjamin Sacristan MD , Nicolas Johner MD, PhD , Geoffroy Ditac MD , Laurens Verhaeghe MD , Francesco Notaristefano MD , John L. Fitzgerald MBBS, PhD , Cinzia Monaco MD, PhD , Konstantinos Vlachos MD , Marianne Tétreault-Langlois MD , Romain Tixier MD , Josselin Duchateau MD , Frederic Sacher MD, PhD , Meleze Hocini MD , Pierre Jaïs MD, PhD , Michel Haissaguerre MD, PhD , Nicolas Derval MD
Background
The anatomic ablation set that comprises pulmonary vein isolation, roof line, posterior mitral line with vein of Marshall alcohol ablation, and cavotricuspid isthmus line spares the anterior wall to preserve left atrial (LA) physiology. The outcome of patients with persistent atrial fibrillation (AF) and spontaneous LA anterior scar ablated with this strategy is not known.
Objective
This study aimed to evaluate patients presenting with spontaneous LA anterior scar and persistent AF in terms of clinical characteristics and ablation outcome using this ablation set.
Methods
Patients with persistent AF referred for AF ablation from June 2018 to June 2023 were screened. Patients presenting spontaneous LA anterior scar were compared with patients with no scar. The ablation strategy consisted of pulmonary vein isolation, vein of Marshall alcohol ablation, roof line, posterior mitral line, and cavotricuspid isthmus line.
Results
111 consecutive patients were evaluated: 35 patients in the scar group (SCAR group) and 76 patients in the control group. After propensity weighting, the population resulted in 101 patients: 34 patients in the SCAR group and 67 patients in the control group. There were significantly more female patients in the SCAR group (18 [23.4%] vs 20 [69%]; P < .001). The mean follow-up was 17 ± 11 months. The lesion set could be accomplished in all. After a first procedure, the AT-AF-free survival was significantly lower in the SCAR group (82.9% vs 65.7%; P = .005).
Conclusion
After a Marshall-plan ablation procedure, the presence of spontaneous LA anterior scar is associated with more AT/AF recurrence during the follow-up. These results suggest that additional ablation may be necessary to complement the initial ablation set during the first procedure in these patients.
背景：解剖消融组包括肺静脉隔离、顶线、二尖瓣后线和马歇尔酒精消融静脉，以及三尖瓣峡线，保留前壁以保持左房（LA）生理。持续性心房颤动（AF）和自发性LA前瘢痕消融患者的结果尚不清楚。目的：本研究旨在评估自发性LA前部瘢痕和持续性房颤患者的临床特征和使用该消融装置的消融结果。方法：筛选2018年6月至2023年6月间接受房颤消融治疗的持续性房颤患者。出现自发性前路瘢痕的患者与无瘢痕的患者进行比较。消融策略包括肺静脉隔离、马歇尔酒精消融静脉、顶线、二尖瓣后线和三尖瓣峡线。结果：连续评估111例患者：疤痕组（scar组）35例，对照组76例。倾向加权后，共有101例患者：SCAR组34例，对照组67例。SCAR组女性患者明显多于对照组（18例[23.4%]vs 20例[69%]；P < 0.001）。平均随访17±11个月。病灶设置全部完成。第一次手术后，SCAR组无at - af生存率显著降低（82.9% vs 65.7%; P = 0.005）。结论：马歇尔计划消融手术后，自发性LA前部瘢痕的存在与随访期间更多的AT/AF复发相关。这些结果表明，在这些患者的第一次手术中，可能需要额外的消融来补充初始消融集。
{"title":"Left atrial anterior scar in persistent atrial fibrillation: Results with pulmonary vein isolation and linear ablation including posterior mitral line","authors":"Marine Arnaud MD , Thomas Pambrun MD , Xavier Bouteiller PhD , Benjamin Sacristan MD , Nicolas Johner MD, PhD , Geoffroy Ditac MD , Laurens Verhaeghe MD , Francesco Notaristefano MD , John L. Fitzgerald MBBS, PhD , Cinzia Monaco MD, PhD , Konstantinos Vlachos MD , Marianne Tétreault-Langlois MD , Romain Tixier MD , Josselin Duchateau MD , Frederic Sacher MD, PhD , Meleze Hocini MD , Pierre Jaïs MD, PhD , Michel Haissaguerre MD, PhD , Nicolas Derval MD","doi":"10.1016/j.hroo.2025.11.020","DOIUrl":"10.1016/j.hroo.2025.11.020","url":null,"abstract":"<div><h3>Background</h3><div>The anatomic ablation set that comprises pulmonary vein isolation, roof line, posterior mitral line with vein of Marshall alcohol ablation, and cavotricuspid isthmus line spares the anterior wall to preserve left atrial (LA) physiology. The outcome of patients with persistent atrial fibrillation (AF) and spontaneous LA anterior scar ablated with this strategy is not known.</div></div><div><h3>Objective</h3><div>This study aimed to evaluate patients presenting with spontaneous LA anterior scar and persistent AF in terms of clinical characteristics and ablation outcome using this ablation set.</div></div><div><h3>Methods</h3><div>Patients with persistent AF referred for AF ablation from June 2018 to June 2023 were screened. Patients presenting spontaneous LA anterior scar were compared with patients with no scar. The ablation strategy consisted of pulmonary vein isolation, vein of Marshall alcohol ablation, roof line, posterior mitral line, and cavotricuspid isthmus line.</div></div><div><h3>Results</h3><div>111 consecutive patients were evaluated: 35 patients in the scar group (SCAR group) and 76 patients in the control group. After propensity weighting, the population resulted in 101 patients: 34 patients in the SCAR group and 67 patients in the control group. There were significantly more female patients in the SCAR group (18 [23.4%] vs 20 [69%]; <em>P</em> < .001). The mean follow-up was 17 ± 11 months. The lesion set could be accomplished in all. After a first procedure, the AT-AF-free survival was significantly lower in the SCAR group (82.9% vs 65.7%; <em>P</em> = .005).</div></div><div><h3>Conclusion</h3><div>After a Marshall-plan ablation procedure, the presence of spontaneous LA anterior scar is associated with more AT/AF recurrence during the follow-up. These results suggest that additional ablation may be necessary to complement the initial ablation set during the first procedure in these patients.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 241-247"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147285513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-21DOI: 10.1016/j.hroo.2025.11.008
Peng-Sheng Chen MD, FHRS , Xiao Liu MD, PhD , Tiffany G. Perry MD , Robert J. Siegel MD , Alexander Tuchman MD , Anxhela Kote MS , Jewel N. Reaso BS , Kathleen A. Lane MS , Carine Rosenberg BS , K. Taiga Andersson MSHS , Susan Straka RN , Lan S. Chen MD , Thomas H. Everett IV PhD, FHRS , Michael M. Shehata MD, FHRS , Ashkan Ehdaie MD, FHRS , Xunzhang Wang MD , Eugenio Cingolani MD , Archana Ramireddy MD, FHRS , Eric D. Braunstein MD, FHRS , Xiaochun Li PhD
Background
Subcutaneous nerve stimulation (ScNS) can reduce atrial arrhythmia in canine models.
Objective
This study aimed to test the hypothesis that ScNS can reduce the burden of paroxysmal atrial fibrillation (AF) by a randomized, sham-controlled clinical trial.
Methods
Patients with drug-resistant symptomatic paroxysmal AF were randomized to receive ScNS (10 Hz, 3.5 mA output, 20 s on, and 1 min off) for 2 weeks. The AF burden was determined by ePatch recordings.
Results
Of the 46 patients who consented, 12 patients (8 men and 4 women, 60.9 ± 10.2 years) were randomized. The change in AF burden at week 1 from eligibility week was not significantly different between the groups (P = .8102). The proportion of AF-free patients was 16.7% for each group (P = 1.000). The difference-in-difference (DID) estimates for weeks 1, 2, 3, and 12 (estimate ± SE) were -2.04 ± 10.84 (P = .8516), -2.44 ± 10.84 (P = .8228), -0.20 ± 10.84 (P = .986), and -18.11 ± 11.16 (P = .1126), respectively. The Stimulation Group shows a slower increase in %AF burden over time than the Sham Group (P = .027 for group and time interaction) when time is modeled linearly as a continuous variable in the mixed model. In Week 3, the ventricular rate (VR) during AF in the Stimulation Group was faster than in the Sham Group (P = .026).
Conclusion
2 weeks of ScNS did not reduce the AF burden or control the VR in patients with paroxysmal AF. However, there was a slower increase in %AF burden over time in the Stimulation Group than in the Sham Group.
{"title":"Using subcutaneous nerve stimulation to control atrial fibrillation","authors":"Peng-Sheng Chen MD, FHRS , Xiao Liu MD, PhD , Tiffany G. Perry MD , Robert J. Siegel MD , Alexander Tuchman MD , Anxhela Kote MS , Jewel N. Reaso BS , Kathleen A. Lane MS , Carine Rosenberg BS , K. Taiga Andersson MSHS , Susan Straka RN , Lan S. Chen MD , Thomas H. Everett IV PhD, FHRS , Michael M. Shehata MD, FHRS , Ashkan Ehdaie MD, FHRS , Xunzhang Wang MD , Eugenio Cingolani MD , Archana Ramireddy MD, FHRS , Eric D. Braunstein MD, FHRS , Xiaochun Li PhD","doi":"10.1016/j.hroo.2025.11.008","DOIUrl":"10.1016/j.hroo.2025.11.008","url":null,"abstract":"<div><h3>Background</h3><div>Subcutaneous nerve stimulation (ScNS) can reduce atrial arrhythmia in canine models.</div></div><div><h3>Objective</h3><div>This study aimed to test the hypothesis that ScNS can reduce the burden of paroxysmal atrial fibrillation (AF) by a randomized, sham-controlled clinical trial.</div></div><div><h3>Methods</h3><div>Patients with drug-resistant symptomatic paroxysmal AF were randomized to receive ScNS (10 Hz, 3.5 mA output, 20 s on, and 1 min off) for 2 weeks. The AF burden was determined by ePatch recordings.</div></div><div><h3>Results</h3><div>Of the 46 patients who consented, 12 patients (8 men and 4 women, 60.9 ± 10.2 years) were randomized. The change in AF burden at week 1 from eligibility week was not significantly different between the groups (<em>P =</em> .8102). The proportion of AF-free patients was 16.7% for each group (<em>P =</em> 1.000). The difference-in-difference (DID) estimates for weeks 1, 2, 3, and 12 (estimate ± SE) were -2.04 ± 10.84 (<em>P =</em> .8516), -2.44 ± 10.84 (<em>P =</em> .8228), -0.20 ± 10.84 (<em>P =</em> .986), and -18.11 ± 11.16 (<em>P =</em> .1126), respectively. The Stimulation Group shows a slower increase in %AF burden over time than the Sham Group (<em>P =</em> .027 for group and time interaction) when time is modeled linearly as a continuous variable in the mixed model. In Week 3, the ventricular rate (VR) during AF in the Stimulation Group was faster than in the Sham Group (<em>P =</em> .026).</div></div><div><h3>Conclusion</h3><div>2 weeks of ScNS did not reduce the AF burden or control the VR in patients with paroxysmal AF. However, there was a slower increase in %AF burden over time in the Stimulation Group than in the Sham Group.</div></div>","PeriodicalId":29772,"journal":{"name":"Heart Rhythm O2","volume":"7 2","pages":"Pages 255-263"},"PeriodicalIF":2.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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