Shiqiang Xiong, Duan Luo, Yan Luo, Guoshu Yang, Guijun He, Yongxin Yang, Jialing He, Bao Xu, Lin Cai, Long Huang, Hao Chen, George Thomas, Tim Betts, Zhen Zhang, Hanxiong Liu
{"title":"First-in-human experience and one-year outcomes using a novel conformal pulsed-field ablation balloon catheter for pulmonary vein isolation in paroxysmal atrial fibrillation.","authors":"Shiqiang Xiong, Duan Luo, Yan Luo, Guoshu Yang, Guijun He, Yongxin Yang, Jialing He, Bao Xu, Lin Cai, Long Huang, Hao Chen, George Thomas, Tim Betts, Zhen Zhang, Hanxiong Liu","doi":"10.1007/s10840-026-02447-y","DOIUrl":"https://doi.org/10.1007/s10840-026-02447-y","url":null,"abstract":"<p><strong>Background: </strong>Thermal balloon catheters have improved the efficiency of pulmonary vein isolation (PVI) in atrial fibrillation (AF). Reports assessing additional safety and effectiveness of pulsed field ablation (PFA) balloon catheters for PVI are limited. This study aims to assess the safety and effectiveness of a conformal PFA balloon catheter for PVI in paroxysmal AF.</p><p><strong>Methods: </strong>35 patients with paroxysmal AF (PAF) were treated with a PFBalloon catheter (Biphasic, Bipolar, 750 V). The balloon was inflated with 10:1 saline/contrast, with volume adjusted for spherical wide-antral or pear-shaped ostial-junction PV ablation to ensure optimal tissue contact. The primary safety endpoint was absence of periprocedural primary adverse events. The primary effectiveness endpoint was acute PVI. The secondary effectiveness endpoint included durable PVI assessed by remapping at three months post-ablation and 1-year clinical outcomes.</p><p><strong>Results: </strong>All targeted PVs (142/142) in 35 patients were acutely isolated, with 32.3 ± 4.5 applications per patient and 7.9 ± 1.0 per vein. Procedure and left atrial dwell times were 133 ± 46 and 56 ± 25 min, respectively. No hemolysis-related acute kidney injury or severe device-related complications occurred. PVI durability was 76.0% (19/25) per patient and 93.1% (95/102) per vein. After a median follow-up of 367 (interquartile range 357-380) days, 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia) ≥30 s was 90.7% (95% CI, 81.2%-100%).</p><p><strong>Conclusions: </strong>The conformal PFBalloon catheter demonstrated favorable safety, efficiency, and effectiveness for PVI in PAF patients, achieving durable lesions and a high rate of freedom from atrial arrhythmias recurrence.</p><p><strong>Trial registration: </strong>clinicaltrials.gov NCT07320976.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149168847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adnan Ahmed, Jalaj Garg, Rajesh Kabra, Rishi Charate, Ran Eliaz, Jonathan Abraham Demma, Ziv Menshes, Or Hazan, Dhanunjaya Lakkireddy
{"title":"Feasibility and safety of a novel blunt tip concealed needle device for pericardial access in porcine models.","authors":"Adnan Ahmed, Jalaj Garg, Rajesh Kabra, Rishi Charate, Ran Eliaz, Jonathan Abraham Demma, Ziv Menshes, Or Hazan, Dhanunjaya Lakkireddy","doi":"10.1007/s10840-022-01450-3","DOIUrl":"10.1007/s10840-022-01450-3","url":null,"abstract":"<p><strong>Background: </strong>Percutaneous pericardial access is the cornerstone of various procedures in clinical cardiology. The two commonly used methods utilizing large bore (LB) and smaller micropuncture (MP) needles often lead to inadvertent RV punctures. As both of these techniques push the pericardium inward, the novel blunt tip concealed needle device (BTCND) introduces the concept of bringing a small portion of the pericardium into a tube, where needle puncture and guidewire can be passed into the pericardial space all within the safety of the tube.</p><p><strong>Methods: </strong>The BTCND (Via One®, CardioVia, Nazareth, Israel) is a tool designed to allow for safe percutaneous subxiphoid pericardial access. In this preclinical study, a total of 18 procedures were performed in 5 female pigs. All procedures were performed under general anesthesia and under fluoroscopic guidance with a team of veterinarians and cardiac electrophysiologists. A laparoscopic camera was used to demonstrate and record the procedure. The Institutional Animal Care and Use Committees approved all preclinical experiments.</p><p><strong>Results: </strong>A total of 18 procedures were performed on five female pigs. In all procedures, the physicians safely introduced guidewire into the pericardial space. Device operation was not associated with any adverse events or bleeding, nor was any damage seen to the pericardium, the heart, or other organs during the procedure.</p><p><strong>Conclusion: </strong>The result of our preclinical report demonstrates that the device is intuitive, easy to use, and effective for its intended use. Large preclinical studies are needed to validate the results of the study.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"889-894"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10826793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nathaniel A Steiger, Logan McClennen, Justin Bilenker, Carlos Patino, Carlos D Matos, Katherine M Sauer, Carolina Hoyas, Usha B Tedrow, Paul C Zei, Jorge E Romero, William H Sauer
{"title":"Evaluation of pulsed field ablation lesion characteristics using an in vitro vegetable model.","authors":"Nathaniel A Steiger, Logan McClennen, Justin Bilenker, Carlos Patino, Carlos D Matos, Katherine M Sauer, Carolina Hoyas, Usha B Tedrow, Paul C Zei, Jorge E Romero, William H Sauer","doi":"10.1007/s10840-024-01906-8","DOIUrl":"10.1007/s10840-024-01906-8","url":null,"abstract":"<p><strong>Background: </strong>In vitro models to evaluate cardiac pulsed field ablation (PFA) have not been well established. We sought to create a standardized vegetable model and staining protocol for assessing unipolar PFA using a surface electrode.</p><p><strong>Methods: </strong>We exposed potato slabs to unipolar PFA in a saline bath using a 3.5 mm electrode catheter and grounding pad connected to a custom-built high-voltage generator. Lesions were clearly visualized after staining with 2,3,5-triphenyltetrazolium chloride (TTC) using a timed protocol to reveal a necrotic center and a periphery of electroporated cells with intact mitochondria.</p><p><strong>Results: </strong>Lesion volume increased linearly with increasing voltage and logarithmically with repetitive PFA applications.</p><p><strong>Conclusion: </strong>The findings observed in this vegetable model using a TTC staining protocol are consistent with findings observed with cardiomyocytes.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"919-923"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bipolar ablation's safety and efficacy: reassurance coming from ex vivo.","authors":"Piotr Futyma, Łukasz Zarębski, Faisal M Merchant","doi":"10.1007/s10840-025-01996-y","DOIUrl":"10.1007/s10840-025-01996-y","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"821-822"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The potato model: A root of all pulsed field ablation experimentation?","authors":"Martin van Zyl, Christopher V DeSimone","doi":"10.1007/s10840-024-01924-6","DOIUrl":"10.1007/s10840-024-01924-6","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"925-926"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142372063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roberto Scacciavillani, Jackson J Liang, Piotr Futyma
{"title":"Bipolar ablation: another arrow in the electrophysiologist's quiver when targeting intramural ventricular arrhythmias.","authors":"Roberto Scacciavillani, Jackson J Liang, Piotr Futyma","doi":"10.1007/s10840-025-01984-2","DOIUrl":"10.1007/s10840-025-01984-2","url":null,"abstract":"","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"869-870"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laith Alkukhun, Uday Sandhu, James Hodovan, Yan Zhao, Kirby Chiang, Quim Castellvi, Peter Stenzel, Randy Woltjer, Xin Li, Ramon F Barajas, Babak Nazer
{"title":"Multi-modality imaging assessment of microbubbles and cerebral emboli in left ventricular pulsed field ablation.","authors":"Laith Alkukhun, Uday Sandhu, James Hodovan, Yan Zhao, Kirby Chiang, Quim Castellvi, Peter Stenzel, Randy Woltjer, Xin Li, Ramon F Barajas, Babak Nazer","doi":"10.1007/s10840-023-01529-5","DOIUrl":"10.1007/s10840-023-01529-5","url":null,"abstract":"<p><strong>Background: </strong>Pulsed field ablation (PFA) may have a superior safety profile compared to other technologies, but it has the potential to cause gaseous microbubbles (MB), which may be associated with cerebral emboli. Limited relative safety data has been published regarding PFA in the left ventricle (LV).</p><p><strong>Methods: </strong>Healthy and chronic myocardial infarction (MI) swine underwent PFA (monopolar, biphasic, 25 Amps) in the LV using an irrigated focal catheter under intra-cardiac echocardiography (ICE) guidance for MB monitoring. Two control swine received air MBs through the lumen of the ablation catheter. Swine underwent brain MRI before and after PFA (or control air MB injection). Gross pathology and histology of brains with abnormal MRI findings were performed.</p><p><strong>Results: </strong>Four healthy and 5 chronic MI swine underwent 124 left ventricular PFA applications. No PFA-related MB formation was noted on ICE. Both control swine developed multiple acute emboli in the thalamus and caudate on DWI, ADC, and FLAIR brain MRI images in response to air MB injection. Of the 9 PFA swine, there were no abnormalities on ADC or FLAIR images. There was one hyperintense focus in the left putamen on the DWI trace image, but the absence of ADC or FLAIR affirmation suggested it was artifact. Gross pathology and histopathology of this region did not detect any abnormalities.</p><p><strong>Conclusions: </strong>Focal monopolar biphasic PFA of both healthy and chronically infarcted left ventricular myocardium does not generate any MB or cerebral emboli observable on ICE and brain MRI.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":"829-835"},"PeriodicalIF":2.7,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9524730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}