Comparative Analysis of Real-World Clinical Outcomes of a Novel Pulsed Field Ablation System for Pulmonary Vein Isolation: The Prospective CIRCLE-PVI Study

被引:0
|
作者
Katov, Lyuboslav [1 ]
Teumer, Yannick [1 ]
Bothner, Carlo [1 ]
Rottbauer, Wolfgang [1 ]
Weinmann-Emhardt, Karolina [1 ]
机构
[1] Ulm Univ, Heart Ctr, Dept Cardiol, Albert Einstein Allee 23, D-89081 Ulm, Germany
关键词
atrial fibrillation; pulsed field ablation; pulmonary vein isolation; circular pulsed field ablation catheter; ATRIAL-FIBRILLATION;
D O I
10.3390/jcm13237040
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Pulsed field ablation (PFA) represents a novel non-thermal approach for treating atrial fibrillation (AF) through pulmonary vein isolation (PVI). By utilizing irreversible electroporation, PFA creates lesions with minimal impact on adjacent tissues. This study investigates the procedural outcomes and safety of a novel circular PFA catheter in comparison to an established PFA system in a real-world clinical setting. Methods: This prospective, single-center study enrolled 125 consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with PFA at Ulm University Heart Center. Twenty-five patients underwent PFA PVI using a novel PFA system (PulseSelectTM, Medtronic, Dublin, Ireland) which incorporates a new circular catheter design and additional features such as ECG-triggered energy application and phrenic nerve capture testing. In comparison, 100 patients were treated using the established PFA system (FarapulseTM, Boston Scientific, Marlborough, MA, USA). Results: Acute PVI was achieved in 100% of the patients. Procedure duration, total left atrial (LA) time and fluoroscopy time remained comparable between both groups. The total number of energy deliveries was higher with the novel circular PFA catheter (34.0 vs. 32.0; p < 0.001). No procedure-related complications, including pericardial tamponade, phrenic nerve injury, atrial-esophageal fistula, vascular complications, embolisms, malignant cardiac arrhythmias, or coronary spasms were observed. Conclusions: The novel and the established PFA systems demonstrated comparable results in terms of procedure duration, fluoroscopy time, and LA time. In the hands of experienced operators, the novel circular PFA system enables an effective, consistent, and safe approach to successful PFA PVI.
引用
收藏
页数:13
相关论文
共 34 条
  • [31] Using a Novel Connected Device for the Collection of Puffing Topography Data for the Vuse Solo Electronic Nicotine Delivery System in a Real-World Setting: Prospective Ambulatory Clinical Study
    Underly, Robert
    Dull, Gary M.
    Nudi, Evan
    Pionk, Timothy
    Prevette, Kristen
    Smith, Jeffrey
    JMIR FORMATIVE RESEARCH, 2023, 7
  • [32] The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes (TROPHIES): Final, 24-month analysis of time to first significant treatment change, treatment persistence and clinical outcomes
    Giorgino, Francesco
    Guerci, Bruno
    Fuechtenbusch, Martin
    Lebrec, Jeremie
    Boye, Kristina
    Federici, Marco Orsini
    Heitmann, Elke
    Dib, Anne
    Yu, Maria
    Sapin, Helene
    Garcia-Perez, Luis-Emilio
    DIABETES OBESITY & METABOLISM, 2023, 25 (12): : 3465 - 3477
  • [33] Sustained Low Clinical Event Rates in Real-World Patients Receiving Everolimus-Eluting Coronary Stent System from a Large, Prospective, Condition of Approval Study: 2-Year Clinical Outcomes from the XIENCE V® USA Study
    Hermiller, James B.
    Rutledge, David R.
    Gruberg, Luis
    Katopodis, John N.
    Lombardi, William
    Mao, Vivian W.
    Zhao, Weiying
    Sharma, Samin K.
    Tamboli, Hoshedar P.
    Wang, Jin
    Jonnavithula, Lalitha
    Sudhir, Krishnankutty
    Krucoff, Mitchell W.
    JOURNAL OF INTERVENTIONAL CARDIOLOGY, 2012, 25 (06) : 565 - 575
  • [34] Real-world treatment patterns and outcomes in chronic lymphocytic leukemia (CLL) patients on novel agents in the US Veterans Health Administration (VHA) system: preliminary analysis of a retrospective electronic medical record (EMR) and chart review study
    Nooruddin, Zohra
    Le, Hannah
    McHugh, Daniel
    Elesinmogun, Cynthia
    Galley, Samantha
    Franklin, Kathleen
    Tavera, Juan
    Gregorio, David
    Ananth, Snegha
    Uribe, Ricardo
    Surapaneni, Prathibha
    Espinoza-Gutarra, Manuel
    Song, Michael
    Jones, Xavier
    Frei, Christopher
    LEUKEMIA & LYMPHOMA, 2020, 61 : 61 - 63