Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing最新文献

{"title":"Clinical and experimental evaluation of averaged impedance drop during radiofrequency catheter ablation.","authors":"Nobuhiro Nakamura, Satoshi Oka, Akinori Wakamiya, Nobuhiko Ueda, Kenzaburo Nakajima, Tsukasa Kamakura, Mitsuru Wada, Yuko Inoue, Koji Miyamoto, Hideaki Morita, Kengo Kusano","doi":"10.1007/s10840-026-02427-2","DOIUrl":"https://doi.org/10.1007/s10840-026-02427-2","url":null,"abstract":"<p><strong>Background: </strong>Real-time monitoring of myocardial tissue response during radiofrequency applications using a mesh-shaped flexible irrigation tip ablation catheter (TactiFlex) remains challenging. This study assessed the dynamics of averaged impedance drop percentage (AID%), a novel ablation parameter, and its association with conduction gaps and lesion characteristics.</p><p><strong>Methods: </strong>We retrospectively analyzed 1,423 radiofrequency applications in 30 patients undergoing initial pulmonary vein isolation using TactiFlex to examine the relationship between AID% and radiofrequency applications within conduction gap segments. Mechanistic validation was performed using an ex-vivo porcine myocardial model (152 lesions).</p><p><strong>Results: </strong>Among 1,423 radiofrequency applications, 138 were located within conduction gap segments. AID% was lower in radiofrequency applications in conduction gap segments than in non-conduction gap segments, although the difference was modest (10.2 [8.3-12.2] % vs. 10.9 [9.0-13.1] %, p = 0.002). The overall discriminative performance was limited (area under the curve, 0.58; 95% confidence interval, 0.53-0.63). In mixed-effects logistic regression accounting for within-patient clustering, AID% <10% was not significantly associated with radiofrequency applications in conduction gap segments (odds ratio, 1.560; 95% confidence interval, 0.970-2.500; p = 0.065), whereas average radiofrequency power was significant. In the ex vivo study, lesion characteristics varied according to radiofrequency power, contact force, and duration, even under fixed target AID% conditions.</p><p><strong>Conclusions: </strong>AID% reflects a composite impedance-based tissue response to radiofrequency delivery that is influenced by multiple ablation parameters. Its limited ability to discriminate conduction-gap segments, together with the variability in lesion characteristics across radiofrequency delivery conditions, suggests that AID% should be interpreted as a marker of tissue response rather than as a stand-alone lesion-quality metric. The averaged impedance drop percentage (AID%) reflects a composite impedance-based tissue response to radiofrequency delivery that is influenced by multiple ablation parameters. Its limited ability to discriminate conduction gap segments, together with the variability in lesion characteristics across radiofrequency delivery conditions, suggests that AID% should be interpreted as a marker of tissue response rather than as a stand-alone lesion-quality metric.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889875","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}

{"title":"Procedural performance and safety of a helix locking tool for left bundle branch pacing: a prospective multicenter study.","authors":"Diego Menéndez, Ermengol Vallès, Álvaro Marco Del Castillo, Haritz Arrizabalaga, Teresa Moraleda, Pablo Elpidio, Guillermo Gutierrez, Eduardo Franco, Cristina Lozano-Granero","doi":"10.1007/s10840-026-02423-6","DOIUrl":"https://doi.org/10.1007/s10840-026-02423-6","url":null,"abstract":"<p><strong>Purpose: </strong>Helix retraction during septal lead deployment can complicate left bundle branch pacing (LBBP) procedures performed with extendable-retractable helix leads. A helix locking tool (HLT) has been developed to stabilize the helix of a stylet-driven lead during implantation, but clinical performance data remain limited. This study aimed to evaluate the acute safety and procedural performance of this tool in a multicenter setting.</p><p><strong>Methods: </strong>In this prospective multicenter registry, 87 consecutive patients who underwent LBBP were enrolled in eight centers in Spain. Implantation was performed using a stylet-driven Tendril STS lead and CPS Direct 3D sheath, with the HLT used during septal deployment. The primary endpoint was freedom from acute adverse events related to the HLT. Secondary endpoints included procedural success, lead repositioning, and acute electrical parameters.</p><p><strong>Results: </strong>LBBP was successfully achieved in 79 of 87 patients (90.8%). Lead repositioning was required in 36 cases (41.4%), with a mean of 2.3 ± 1.3 attempts. No cases of helix retraction were observed. Three intraprocedural lead dislodgements (3.4%) occurred and were managed without clinical consequences. No acute complications related to the HLT were reported. Electrical parameters were compatible with conduction system capture.</p><p><strong>Conclusions: </strong>In this prospective multicenter registry, left bundle branch capture was achieved in 79 of 87 patients (90.8%). No helix retraction or acute adverse events considered related to the HLT by site investigators were observed during 24-hour follow-up. In the absence of a comparator group, the study cannot determine whether the HLT reduces helix retraction or improves procedural outcomes.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889894","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}

{"title":"Multicenter study on electrical performance and predictive indicators in aveir VR pacemaker recipients.","authors":"Xin Zhang, Yongmei Hu, Lin Tong, Qiang Ye, Lingyun Jiang, Yuanning Xu, Xingbin Liu","doi":"10.1007/s10840-026-02429-0","DOIUrl":"https://doi.org/10.1007/s10840-026-02429-0","url":null,"abstract":"<p><strong>Background: </strong>There is limited evidence regarding the Aveir VR leadless pacemaker in mainland China, and the intraoperative electrical indicators linked to a favorable chronic pacing capture threshold (PCT) are not clearly defined.</p><p><strong>Methods: </strong>This retrospective study across multiple centers involved 100 patients from Sichuan Province who received Aveir VR implants between January 2023 and December 2025, with electrical data available for evaluation at least one month after implantation.Chronic PCT was considered excellent if it was ≤ 0.5 V at 0.4 ms during the first device check after at least one month.Intraoperative predictors were identified using multivariable logistic regression.Receiver Operating Characteristic(ROC) analysis with bootstrap validation (500 replicates) was used to assess discrimination, and generalized additive models (GAMs) were employed to evaluate nonlinearity.</p><p><strong>Results: </strong>In 100 patients, the device implantation was successful with no significant complications, and 66 of them (66%) achieved excellent chronic PCT after a median follow-up period of 134 days. PCT improved from 0.76 ± 0.49 V at end of procedure to 0.63 ± 0.24 V at follow-up.Tether-phase R-wave sensing was independently associated with excellent chronic PCT (adjusted OR 1.27, 95% CI 1.06-1.51; P = 0.009). Tether-phase sensing showed modest discrimination (bias-corrected AUC 0.64, 95% CI 0.52-0.75). The 5.85 mV cutoff yielded sensitivity 68.3%, specificity 68.8%, PPV 80.4%, and NPV 53.7%. GAM indicated a nonlinear association (P for nonlinearity = 0.009).</p><p><strong>Conclusions: </strong>In this cohort from mainland China, the implantation of Aveir VR was both feasible and safe, demonstrating stable short-term electrical performance. The sensing amplitude of the R-wave in the tether phase appears to be an additional intraoperative marker connected to excellent chronic PCT. Before recommending a specific cutoff for regular use, standardized long-term follow-up and external validation are necessary. Among 100 Aveir VR recipients in Chinese mainland, tether-phaseR-wave sensing was associated with excellent chronic PCT and demonstrated modestdiscriminative ability, indicating its potential role as a complementary intraoperativemarke.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148883392","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}

{"title":"Takotsubo cardiomyopathy after aveir ^TM DR leadless pacemaker implantation.","authors":"Nithi Tokavanich, Takumi Yamada, Stephen Keim, Aditya Saini","doi":"10.1007/s10840-026-02425-4","DOIUrl":"https://doi.org/10.1007/s10840-026-02425-4","url":null,"abstract":"","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868843","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}

{"title":"Post-market individual-report phenotypes after pulsed-field ablation for atrial fibrillation in a food and drug administration database.","authors":"Joyce Gu, Lucy Zheng, Hsiao-Man Chang, Daniel Yow, Hyungwoo Kim, Samuel Tan","doi":"10.1007/s10840-026-02431-6","DOIUrl":"https://doi.org/10.1007/s10840-026-02431-6","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize individual-case medical device reports submitted to the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database for commercially available pulsed-field ablation systems during early postmarket use.</p><p><strong>Methods: </strong>We analyzed reports received from February 1, 2024, through April 30, 2026. Master event, device, patient, patient problem code, device problem code, and narrative files were merged by report key. Literature-derived, clinical study-derived, false-positive, indeterminate, and exact duplicate narrative reports were excluded from the primary individual-case cohort. A prespecified hierarchy and targeted narrative review classified reporting phenotypes, reported clinical event categories, and device problem code categories. Duplicate-removal sensitivity analyses were performed.</p><p><strong>Results: </strong>Of 11,563 potential reports, 10,976 individual-case reports formed the primary cohort. Device malfunction without identified patient injury accounted for 7,323 reports (66.7%), patient injury for 3,554 (32.4%), and unclear/no coded clinical event for 99 (0.9%). The most commonly reported clinical event categories were tamponade/perforation/pericardial effusion (n = 1,014), arrhythmia/cardioversion/hemodynamic events (n = 444), stroke/TIA/neurovascular events (n = 383), coronary spasm/injury/ischemia (n = 324), death (n = 197), hemolysis/renal injury (n = 114), phrenic/diaphragm injury (n = 42), and plausible esophageal or upper gastrointestinal concerns (n = 6). Duplicate removal did not materially change the report-category hierarchy.</p><p><strong>Conclusions: </strong>The value of this report-level surveillance analysis is characterization of report and event categories rather than incidence estimation. Future pulsed-field ablation registries should capture anticoagulation-related variables, patient-reported outcomes, lesion set and application burden, and adjudicated neurologic, coronary, renal, esophageal, and phrenic outcomes. PFA MAUDE reports identify electroporation-and workflow-relevant surveillance domains that should be prospectively captured, including anticoagulation variables, patient-reported outcomes, lesion set, application burden, and adjudicated clinical outcomes.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868856","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}

{"title":"Pulsed field ablation of atrial arrhythmias in patients with cardiac implantable electronic devices: a multicenter evaluation of electrical integrity and device safety.","authors":"Alvise Del Monte, Antonio Bisignani, Domenico Giovanni Della Rocca, Vincenzo Schillaci, Cinzia Monaco, Marco Bergonti, Vedran Velagić, Sara Poggi, Wael Zaher, Antonio Sorgente, Lorenzo Marcon, Luigi Pannone, Roberto Menè, Giampaolo Vetta, Ivan Eltsov, Gezim Bala, Erwin Ströker, Juan Sieira, Alexandre Almorad, Andrea Sarkozy, Ingrid Overeinder, Giuseppe Stabile, Giulio Conte, Stefano Bianchi, Serge Boveda, Pierre Jaïs, Carlo de Asmundis, Gian-Battista Chierchia","doi":"10.1007/s10840-026-02426-3","DOIUrl":"https://doi.org/10.1007/s10840-026-02426-3","url":null,"abstract":"<p><strong>Purpose: </strong>Pulsed field ablation (PFA) uses high-intensity electric fields to create myocardial lesions and may potentially interact with cardiac implantable electronic devices (CIEDs). This multicenter study evaluated the effects of different PFA technologies on electrical integrity and device-related complications in patients undergoing left- and right-sided atrial ablation.</p><p><strong>Methods: </strong>Consecutive patients with CIEDs undergoing catheter ablation with 4 PFA technologies were included. CIED interrogation was performed at baseline, after ablation, and at ≥ 3-month follow-up. Study endpoints were electrical integrity, defined as changes in sensing, pacing threshold, or impedance, and clinically relevant PFA-related CIED malfunction. Real-time device monitoring was performed in a subgroup to assess electromagnetic interference (EMI).</p><p><strong>Results: </strong>A total of 157 patients were included. PFA was performed using a pentaspline catheter in 110 patients, a lattice-tip catheter in 26, a variable-loop circular catheter in 16, and a circular array catheter in 5. No significant changes in lead parameters were observed immediately after ablation or at 3-month follow-up, including in patients undergoing right atrial PFA. PFA was frequently associated with EMI-related oversensing (93%). Two patients (1.3%) experienced clinically relevant PFA-related CIED malfunction, consisting of transient reset of a leadless pacemaker and increase of atrial pacing threshold requiring lead revision, both occurring after right atrial lattice-tip PFA.</p><p><strong>Conclusions: </strong>PFA for left- and right-sided atrial arrhythmias was associated with preservation of CIED electrical integrity at acute and 3-month follow-up despite frequent EMI-related oversensing. Clinically relevant PFA-related CIED malfunctions were uncommon; however, caution is warranted when delivering PFA in close proximity to CIED components. In this multicenter study, PFA of left- and right-sided atrial arrhythmias using four contemporary technologies demonstrated preserved CIED electrical integrity at acute and 3-month follow-up despite frequent EMI-related oversensing. Clinically relevant PFA-related CIED malfunctions were uncommon (1.3%), although caution is warranted when delivering PFA in close proximity to CIED components.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868899","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}

{"title":"Efficacy of closed loop stimulation in left bundle branch area pacing.","authors":"Hirad Yarmohammadi, Bobak Salehi, Margaret Shea, Camden Harrell, Crystal Miller, David Hayes","doi":"10.1007/s10840-026-02430-7","DOIUrl":"https://doi.org/10.1007/s10840-026-02430-7","url":null,"abstract":"<p><strong>Background: </strong>Closed-Loop Stimulation (CLS) adjusts pacing rate based on beat-to-beat impedance changes reflecting myocardial contractility and autonomic tone. While early studies focused on right ventricular apical leads, conduction system pacing, particularly left bundle branch area pacing (LBBAP) offers a more physiologic approach. The effect of septal lead position on CLS performance remains unclear.</p><p><strong>Objective: </strong>To investigate the impact of LBBAP versus alternative right ventricular lead positions on CLS performance.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using the CERTITUDE registry, which includes longitudinal remote monitoring data from over 55,000 U.S. patients with Biotronik devices. Patients with dual-chamber pacemakers implanted starting January 1, 2021, with ≥ 1 year of follow-up were included, excluding those who were > 110 years old at implant, with ≥ 20% atrial fibrillation burden, < 50% transmission rate, mode switch > 7 days, or initial programming mode besides DDD-CLS/DDD. Pacing characteristics were compared across DDD and DDD-CLS modes and between LBBAP and non-LBBAP lead locations.</p><p><strong>Results: </strong>A total of 5,395 patients were included. Baseline mean thoracic impedance was higher in non-LBBAP groups (P < 0.001), though changes over time were not significant (P = 0.336). Mean ventricular rate increased in the non-LBBAP DDD-CLS group but decreased in the DDD group (P < 0.001). Atrial arrhythmia burden was similar across pacing modes and lead locations, except for a higher burden in the non-LBBAP DDD-CLS group compared with non-LBBAP DDD.</p><p><strong>Conclusions: </strong>In this large real-world cohort, CLS maintained stable physiological rate adaptation across pacing modes and lead locations. Minor differences in ventricular rate and thoracic impedance were observed, but overall CLS performance was consistent between LBBAP and non-LBBAP configurations, supporting its use in conduction system pacing.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868904","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}

{"title":"When 95% Atrial Pacing Does Not Mean Pacemaker Dependency.","authors":"Tolga Aksu, Emrah Ermis, Ahmad Huraibat, Mehdi Onac, Ali Hamza, Mohamed Niang, Mehmet Akif Vatankulu, Kıvanç Yalin, Hakan Uçar","doi":"10.1007/s10840-026-02421-8","DOIUrl":"https://doi.org/10.1007/s10840-026-02421-8","url":null,"abstract":"","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148805280","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}

{"title":"The use of high-density electroanatomic mapping catheter (Advisor™ HD Grid) in detecting critical Purkinje potentials (P1-P2) in patients with left posterior fascicular VT.","authors":"Fadime Koca, Mustafa Lutfullah Ardic, Hasan Koca, Hazar Harbalioglu, Yahya Kemal Icen, Hilmi Erdem Sumbul, Durmus Yildiray Sahin, Mevlut Koc","doi":"10.1007/s10840-026-02420-9","DOIUrl":"https://doi.org/10.1007/s10840-026-02420-9","url":null,"abstract":"<p><strong>Background: </strong>In patients with left posterior fascicular ventricular tachycardia (LPF-VT), the most critical determinant of successful radiofrequency ablation (RFA) is the accurate identification of the antegrade and retrograde pathways (P1-P2) within the reentrant circuit. The aim of this study was to evaluate the impact of HD Grid-guided RFA on P1 potential detection, procedural duration, acute procedural success, and arrhythmic recurrence in patients with LPF-VT.</p><p><strong>Methods: </strong>In this retrospective-cohort study, 25-patients with inducible tachycardia during electrophysiological study and a confirmed diagnosis of LPF-VT were included. Patients were divided into two-groups according to the use of the HD Grid Mapping Catheter during RFA: standard RFA group (Group-I) and standard RFA + HD Grid group (Group-II). Patients were followed for a mean duration of 24.8 ± 14.8 months after RFA.</p><p><strong>Results: </strong>In Group-II, the frequency of P1 recording during VT and, consequently, P1-targeted RF applications was significantly higher than in Group-I (92% vs 39%, and, p = 0.008). Acute procedural success was achieved in all 12-patients (100%) in Group-II and in 9-patients (69%) in Group-I (p < 0.047). During follow-up, LPF-VT recurrence occurred in 7-patients (54%) in Group-I and 1-patient (8%) in Group-II (p < 0.020).</p><p><strong>Conclusion: </strong>In this study, the use of the HD Grid Mapping Catheter during RFA for LPF-VT was associated with a higher detection rate of P1 potentials compared with the standard RFA approach. Given the critical role of P1 potentials in determining procedural success, this finding may suggest a potential relationship with shorter procedural and fluoroscopy times, higher acute procedural success rates, and lower LPF-VT recurrence rates in this patient population.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148805236","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}

{"title":"Safety and feasibility of a balloon-based pulsed field ablation system for the catheter ablation of paroxysmal atrial fibrillation.","authors":"Peize Wang, Kun Zhang, Jinlong Bai, Xiuhong Dong, Shuai Yang, Lichao Tian, Zhaoqian Zhang, Zhi Li, Yuhao Miao, Jingjing Liu","doi":"10.1007/s10840-026-02417-4","DOIUrl":"https://doi.org/10.1007/s10840-026-02417-4","url":null,"abstract":"<p><strong>Aims: </strong>Pulsed field ablation (PFA) is a ablation modality that is increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients. This study assessed the safety and effectiveness of a balloon-based PFA system at 6 months after treatment.</p><p><strong>Methods and results: </strong>This study is a prospective, single-center, premarket study. A total of 56 patients with drug-refractory paroxysmal atrial fibrillation (PAF) were enrolled between November 2024 and September 2025 and underwent PVI with a balloon-based PFA system. The study endpoints were the rate of primary serious adverse events, acute procedural effectiveness and 6-month freedom from recurrence. Acute effectiveness was achieved in 100% (231/231) of the treated PVs (100% of patients, 56/56), with 33 ± 5.5 PFA applications/patient. The procedure, fluoroscopy, and transpired ablation times were 89.0 ± 30.7, 24.2 ± 8.3, and 20.0 ± 12.0 min, respectively. One (1.8%; 1/56) primary serious adverse event occurred: one patient developed intraoperative gastrointestinal bleeding due to TEE-induced mechanical injury. One patient developed a cerebral infarction on postoperative Day 28. The rate of freedom from documented atrial arrhythmias was 92.9% through 6 months after the index procedure.</p><p><strong>Conclusion: </strong>The primary results of this study demonstrate the safety and effectiveness of the balloon-based PFA system for performing PVI in patients with PAF.</p>","PeriodicalId":520675,"journal":{"name":"Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148805229","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}