Journal of Cardiovascular Electrophysiology最新文献_第8页

Acute Procedural Results of Pulsed Field Cryoablation for Persistent Atrial Fibrillation: Multicenter First-in-Human PARALELL Trial. 脉冲场冷冻消融治疗持续性心房颤动的急性过程结果：多中心首次人体平行试验。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-16 DOI: 10.1111/jce.16680

Vidal Essebag, Lucas Boersma, Jan Petru, Mark M Gallagher, Vivek Y Reddy, Tom De Potter, Pawel Derejko, Petr Neuzil, Ilya Grigorov, Atul Verma

{"title":"Acute Procedural Results of Pulsed Field Cryoablation for Persistent Atrial Fibrillation: Multicenter First-in-Human PARALELL Trial.","authors":"Vidal Essebag, Lucas Boersma, Jan Petru, Mark M Gallagher, Vivek Y Reddy, Tom De Potter, Pawel Derejko, Petr Neuzil, Ilya Grigorov, Atul Verma","doi":"10.1111/jce.16680","DOIUrl":"https://doi.org/10.1111/jce.16680","url":null,"abstract":"Introduction: Pulsed Field Cryoablation (PFCA) is a dual-energy cardiac ablation modality consisting of short-duration ultra-low temperature cryoablation (ULTC) followed immediately by pulsed field ablation (PFA) delivered from the same catheter. It is hypothesized that PFCA may improve contact stability during PFA, while maintaining lesion depth and effectiveness of ULTC.Methods: PARALELL is a first-in-human multicenter study evaluating safety and effectiveness of a novel PFCA catheter and system in patients with persistent atrial fibrillation (PsAF) using the combination of pulmonary vein (PVI) and posterior wall (PWI) isolation.Results: Sixty-six patients were ablated at six sites. One groin hematoma and one intubation-related hospitalization were the only serious procedure- or device-related adverse events recorded in the study. Per protocol, acute effectiveness was evaluated in 46 patients, including 31 patients with post-hoc analysis of cryogenic energy per lesion. After an average of 21.1 ± 9.3 lesions per patient the rates of PVI and PWI were 95.7% (176/184) and 97.7% (42/43), respectively. The average cryogenic energy per patient was highly predictive of acute isolation success with ROC AUC = 0.944% and 100% rates of both PVI and PWI in 24 patients in the optimal energy cohort. Grade I microbubbles and faint muscle contractions were detected in 1.1% and 0.5% of ablations, respectively.Conclusion: This initial multi-center experience suggests that PFCA can be efficiently performed for PVI and PWI using a single versatile catheter system, with high acute success and good early safety profile. The evaluation of the chronic 12-month effectiveness of PFCA is ongoing.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Sotalol: The Antiarrhythmic Drug With a Winding and Still-Continuing Clinical Course. 索他洛尔：具有曲折和持续临床过程的抗心律失常药物。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-10 DOI: 10.1111/jce.16686

James A Reiffel

引用次数: 0

Safety Reporting in Trials on Atrial Fibrillation: An Observational Study of ClinicalTrials.gov Registry and Corresponding Publications. 心房颤动试验的安全性报告：临床试验注册和相应出版物的观察性研究。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-10 DOI: 10.1111/jce.16682

Viktoria Lišnić, Fran Šaler, Marin Viđak, Ana Marušić

{"title":"Safety Reporting in Trials on Atrial Fibrillation: An Observational Study of ClinicalTrials.gov Registry and Corresponding Publications.","authors":"Viktoria Lišnić, Fran Šaler, Marin Viđak, Ana Marušić","doi":"10.1111/jce.16682","DOIUrl":"https://doi.org/10.1111/jce.16682","url":null,"abstract":"Background: Adverse events (AE) in clinical trials should be reported fully and transparently as inconsistent reporting endangers patients and can lead to incorrect conclusions about medical procedures. Atrial fibrillation (AF) is a highly prevalent disease with different therapeutic options available. With an increasing incidence of AF, potential AEs are important factor in the choice of treatment. The aim of our study was to assess the completeness of AE reporting for the registered trials of interventions for AF treatment in a clinical trial registry and the consistency of their reporting in corresponding publications.Methods: This was an observational, cross-sectional study of clinical trials of AF registered in ClinicalTrials.gov, as well as of corresponding publications.Findings: Out of 340 registry items retrieved by our search, 130 items reported on the treatment of AF, and 75 corresponding publications were identified (39.2%) and included in the analysis. Both number of serious AEs (SAE) and other AEs (OAE) as well as the number of patients affected were underreported in corresponding publications when compared with trial registry. For trials reporting nonpharmacological interventions (e.g., medical devices and procedures) there was a higher number of discrepancies in the number of SAEs and the number of patients affected, and information on SAEs or OAEs were more often omitted from publication.Interpretation: The reporting of AEs in AF trials is inconsistent and incomplete and presents a serious problem for patients' safety. Inadequate reporting raises concerns for the credibility of trials results as well as for clinical practice guidelines and justifies the calls for improvements in reporting and regulations of clinical trials of interventions for AF.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Case of Recurrent Transient Upper Airway Disturbance During Pulsed Field Ablation. 脉冲场消融过程中复发性短暂性上呼吸道障碍1例。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-10 DOI: 10.1111/jce.16675

Iwanari Kawamura, Masateru Takigawa, Takahiro Tsunoda, Kazunori Tobino, Shinsuke Miyazaki, Tetsuo Sasano

引用次数: 0

Comparative Analysis of Leadless Versus Transvenous Pacemakers in Non-Heart Failure Patients: A Multicenter US Retrospective Study. 无导线与经静脉起搏器在非心力衰竭患者中的比较分析：一项美国多中心回顾性研究。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-10 DOI: 10.1111/jce.16672

Michele Fouad, Kerollos Abdelsayed, Shehroze Tabassum, Mohamed Hatem Ellabban, Sittinun Thangjui, Basel Abdelazeem, Sandeep Arora

{"title":"Comparative Analysis of Leadless Versus Transvenous Pacemakers in Non-Heart Failure Patients: A Multicenter US Retrospective Study.","authors":"Michele Fouad, Kerollos Abdelsayed, Shehroze Tabassum, Mohamed Hatem Ellabban, Sittinun Thangjui, Basel Abdelazeem, Sandeep Arora","doi":"10.1111/jce.16672","DOIUrl":"https://doi.org/10.1111/jce.16672","url":null,"abstract":"Background: Despite leadless pacemakers (LPMs) showing promise, real-world data comparing them to transvenous pacemakers (TV-VVI) are insufficient and often contradictory, especially in patients without major comorbidities like heart failure.Objectives: Comparing LPMs with TV-VVIs in real-world patients without HF.Methods: The TriNetX database (Jan 2015-June 2023) was queried to include adults receiving their first single-chamber ventricular pacemaker for heart block, bradycardia, sick sinus syndrome, atrial fibrillation, or syncope, excluding those with prior pacemakers, heart failure or enrolled for research settings. Propensity score matching (PSM) was done on 90 covariates. Primary outcomes were assessed after 1 week, 6 months, and 12 months and included mechanical complications, need for re-intervention, cardiac-related hemodynamic instability (CRHI), hospitalizations, and mortality. The risk ratio (RR) with a 95% confidence interval (CI) was reported. An E-sensitivity analysis assessed the impact of unmeasured confounders.Results: Each group had 1,158 patients after PSM; 58.4% versus 58.9% were males, with mean ages of 74.9 versus 77.4 years. LPMs showed lower mechanical complications at all follow-up points (RR 0.16, 0.18, 0.21, p < 0.0001). CRHI was lower in the LPM group at 1 week and 6 months (RR 0.72, 0.85, p < 0.05) but higher mortality at 6 and 12 months (RR 1.436, 1.314, p < 0.05). Hospitalization rates and re-intervention rates were comparable between both groups. The E-value was satisfactory.Conclusion: In the absence of HF, LPM was associated with fewer rates of mechanical complications and CRHI. However, late mortality was higher with LPMs. Randomized trials comparing the two devices are crucial.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Sotalol Dosing and Outcomes Among Patients Undergoing Intravenous Loading for Atrial Arrhythmias-A PEAKS Registry Substudy. 心房心律失常静脉负荷患者的索他洛尔剂量和结局——峰值登记亚研究。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-09 DOI: 10.1111/jce.16677

Benjamin A Steinberg, Richard Holubkov, T Jared Bunch, Thomas F Deering, Christopher A Groh, Robert Kennedy, Marco Perez, Jonathan P Piccini, Parash Pokharel, Salvatore J Savona, Nishant Verma, Kevin Watt, Suneet Mittal

{"title":"Sotalol Dosing and Outcomes Among Patients Undergoing Intravenous Loading for Atrial Arrhythmias-A PEAKS Registry Substudy.","authors":"Benjamin A Steinberg, Richard Holubkov, T Jared Bunch, Thomas F Deering, Christopher A Groh, Robert Kennedy, Marco Perez, Jonathan P Piccini, Parash Pokharel, Salvatore J Savona, Nishant Verma, Kevin Watt, Suneet Mittal","doi":"10.1111/jce.16677","DOIUrl":"https://doi.org/10.1111/jce.16677","url":null,"abstract":"Background: Sotalol is used for the maintenance of sinus rhythm among patients with atrial fibrillation. However, there is discretion regarding dosing of chronic therapy, and the target oral dose dictates infusion doses for intravenous sotalol loading. To date, use and outcomes by dose are not well-described.Methods: In the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry, we analyzed outcomes among patients undergoing elective IV sotalol load for atrial arrhythmias (AT/AF). Baseline characteristics, changes in ECG parameters, in-hospital adverse events, and arrhythmia outcomes were compared based on target oral dose (80 mg vs. 120 mg).Results: Among 163 total patients, 85 (52%) of patients underwent loading anticipating target oral dose of 80 mg, compared with 78 (48%) for 120 mg. Those targeting 80 mg were older (median age 70 vs. 66, p < 0.001), with similar proportion female (24% vs. 21%, p = 0.71), and without significant differences in comorbidities or renal function. Patients targeted for 80 mg were less frequently kept in-hospital for 2 oral doses after intravenous infusion (45% vs. 89%, p < 0.001). There were no significant differences in rates of sinus rhythm or adverse events during loading.Conclusions: Selection of target oral sotalol dose (120 vs. 80 mg) does not appear to be driven by patient characteristics, and may represent an opportunity for improved treatment. In-hospital adverse events are low overall without differences between dose.Trial registration: Clinicaltrials. gov # NCT05247320.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Is It Time to Think Beyond the Generator in Subcutaneous Implantable Defibrillator Generator Replacements?

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-09 DOI: 10.1111/jce.16676

Majd A. El-Harasis, Sharon T. Shen

引用次数: 0

Bilirubin Elevation Associated With Pulsed Field Ablation Induced Hemolysis in Patients With Paroxysmal Atrial Fibrillation. 阵发性心房颤动患者胆红素升高与脉冲场消融引起的溶血相关。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-09 DOI: 10.1111/jce.16664

Fengqi Xuan, Mingying Ding, Ming Liang, Huimin Chu, Jing Xu, Zhiqing Jin, Jian Ding, Mingyu Sun, Wei Ma, Zulu Wang

{"title":"Bilirubin Elevation Associated With Pulsed Field Ablation Induced Hemolysis in Patients With Paroxysmal Atrial Fibrillation.","authors":"Fengqi Xuan, Mingying Ding, Ming Liang, Huimin Chu, Jing Xu, Zhiqing Jin, Jian Ding, Mingyu Sun, Wei Ma, Zulu Wang","doi":"10.1111/jce.16664","DOIUrl":"https://doi.org/10.1111/jce.16664","url":null,"abstract":"Background and aims: Hemolysis-related renal failure after pulsed field ablation (PFA) has been described in recently published cases, we reported the incidence of bilirubin elevation after PFA utilizing a novel hexaspline PFA catheter.Methods: PFA was performed in patients with paroxysmal atrial fibrillation using novel hexaspline PFA catheter, and serum bilirubin, hemoglobin and renal function were measured at baseline and the next day post ablation.Results: A total of 94 patients were analyzed, and 30 of 94 (31.9%) patients had obvious total bilirubin elevation the next day post PFA. In the 30 patients, 26 (86.7%) patients had a predominantly indirect hyperbilirubinemia, suggesting a likely presence of PFA-induced hemolysis. The liver enzyme contents post ablation were normal in all patients and no signs of hemolytic anemia and renal function injury were detected. The impact factors associated with indrect hyperbilirubinemia were also analyzed and higher number of applications tented to produce PFA-induced hemolysis. More than 86.5 applications seem to have a better sensivity and specificity to predict hemolysis.Conclusion: Intravascular hemolysis can occur after utilizing novel hexaspline catheter, but the severity of hemolysis was mild and temporary. The number of applications appears to be a determining factor leading to hemolysis.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144020308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Personalized Implantable Defibrillators. 个性化植入式除颤器。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-09 DOI: 10.1111/jce.16679

Moied M Al Sakan, Marwan M Refaat

引用次数: 0

Pacemaker Indications and Long-Term Stability of Pacing Indices in Heart Transplant Recipients. 心脏移植受者起搏器适应症和起搏指标的长期稳定性。

IF 2.3 3区医学

Journal of Cardiovascular Electrophysiology Pub Date : 2025-04-07 DOI: 10.1111/jce.16671

Pablo Fernández de-Aspe, Raquel Vázquez-García, Alejandro Used-Gavín, Jorge L Rodríguez-Garrido, Ignacio Mosquera-Pérez, María J Paniagua-Martín, Eduardo Barge-Caballero, Gonzalo Barge-Caballero, David Couto-Mallón, Daniel Enríquez-Vázquez, María García-Vieites, José Manuel Vázquez-Rodríguez, María G Crespo-Leiro, Enrique Ricoy-Martínez

{"title":"Pacemaker Indications and Long-Term Stability of Pacing Indices in Heart Transplant Recipients.","authors":"Pablo Fernández de-Aspe, Raquel Vázquez-García, Alejandro Used-Gavín, Jorge L Rodríguez-Garrido, Ignacio Mosquera-Pérez, María J Paniagua-Martín, Eduardo Barge-Caballero, Gonzalo Barge-Caballero, David Couto-Mallón, Daniel Enríquez-Vázquez, María García-Vieites, José Manuel Vázquez-Rodríguez, María G Crespo-Leiro, Enrique Ricoy-Martínez","doi":"10.1111/jce.16671","DOIUrl":"https://doi.org/10.1111/jce.16671","url":null,"abstract":"Background: Approximately 10% of heart transplant (HT) recipients require a pacemaker (PM) implant. Despite graft-related complications such as rejection, cardiac allograft vasculopathy and fibrosis, there is no evidence on the long-term stability of pacing indices. Moreover, one of the most common indications for PM implant is early post-transplant sinus node dysfunction (SND), although this is reversible in many cases.Methods and results: A retrospective observational study including all HT recipients at our institution who underwent permanent PM implantation between April 1991 and January 2023 was conducted. The incidence of PM implantation, indications for PM implantation and changes in pacing indices were evaluated. A total of 861 adult HT were performed (92.1% using bicaval anastomosis technique), and 46 received a permanent pacemaker (cumulative incidence 5.3%) over a median follow-up of 7.9 years (IQR 2.5-15.1 years). Only one patient (2%) received a PM due to early post-HT SND. The median PM follow-up time was 5.4 years (IQR 2.0-8.1 years). Atrial and ventricular leads showed an initial impedance drop (p < 0.001 both) and an initial capture threshold increase (p < 0.001 and p = 0.003, respectively) with subsequent stabilization. R-wave amplitude remained stable, but there was a drop in P-wave amplitude (p = 0.026).Conclusions: Pacing indices remained stable and showed a behavior similar to that of native hearts except for a progressive decrease in P-wave amplitude, suggesting the need to aim for the highest possible P-wave amplitude during implantation.","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0