{
  "abstract": "Background: The balloon-in-basket(BiB) pulsed field ablation(PFA) system integrates real-time electroanatomic mapping and contact sensing to streamline workflows, but clinical experience remain limited. The aim was to descriptively evaluate procedural performance, acute safety, and feasibility of the BiB-PFA-system in consecutive atrial fibrillation(AF) patients treated at a high-volume electrophysiology center.\n\nMethods: This prospective study included the first 100 consecutive patients undergoing pulmonary vein isolation(PVI) with the BiB-PFA-system between 01/2024 and 10/2025. The initial 30 patients were part of VOLTTM-CE-Mark-study and 25 of VOLTTM-CE-Mark-extended-study. It included a 20-minute waiting periode, pre-/postablation left-atrial mapping and phrenic nerve pacing; subsequent procedures relied solely on BiB-PFA-system. Additional linear or extra-pulmonary ablations were performed at operator discretion. Follow-up(≥ 6 months) as per institutional standart was available in 52 patients.\n\nResults: Patients were 68[62;76] years old, 41% were female, and 47% had paroxysmal AF. Median procedure duration was 59[48.0;71.0] and BiB-dwell time 26.0[21.0; 37.5] min. For VOLT™-CE-Mark-study patients, procedure and BiB-dwell times were 72.5[67.3;85.0] and 25.0[21.0;28.2] min, compared with 48.5[36.5;59.0] and 23.5[18.3;36.3] min in non-study patients. All PVs were successfully isolated with 100% first-shot success using a median of 4 applications. Additional ablations included posterior wall(41%), anterior line(5%), CTI(3%), and SVC isolation(6%). One groin complication(1%) requirng intervention occured. Same-day discharge was conducted in 8%, limited primarily by institutional policy. Freedom from atrial tachyarrhythmia was 86% at median follow-up of 293[184;364]days.\n\nConclusion: The BiB-PFA system enabled PVI with consistent first-shot success and a low rate of periprocedural complications. Follow-up available in a subset of patients suggested favorable early rhythm outcomes.\n\nTake home message: • This study provides the first clinical experience with the BiB-PFA-system, characterizing procedural workflows and acute safety in routine practice\n\n• This study reports the first mid-term follow-up data for the BiB-PFA system, demonstrating an 86% freedom from atrial tachyarrhythmia after a 60-day blanking period at a median follow-up of 293 [184-364] days.\n\n• The integrated mapping-and-ablation design enabled efficient PVI with consistent first-shot success and short procedure times.\n\n• Ablation strategies beyond PVI—including posterior wall ablation, anterior line ablation, CTI ablation, and SVC isolation—were feasible and could be performed safely within the same workflow.\n\n• A low rate of periprocedural complications was observed in this cohort, including one vascular complication requiring intervention, supporting a favorable acute safety profile in a high-volume electrophysiology center.\n\nGraphical abstract:",
  "abstract_shown": true,
  "affiliations": [
    "Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany",
    "German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 10,
  "authors": [
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        0,
        1
      ],
      "name": "Roland Richard Tilz"
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    {
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        0
      ],
      "name": "Sascha Hatahet"
    },
    {
      "affs": [
        0
      ],
      "name": "Charlotte Eitel"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Sorin Popescu"
    },
    {
      "affs": [
        0
      ],
      "name": "Roman Mamaev"
    },
    {
      "affs": [
        0
      ],
      "name": "Kohei Ukita"
    },
    {
      "affs": [
        0
      ],
      "name": "Mirco Küchler"
    },
    {
      "affs": [
        0
      ],
      "name": "Suzanne de Waha"
    },
    {
      "affs": [
        0
      ],
      "name": "Karl-Heinz Kuck"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Jan-Per Wenzel"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/7h1tbjvyzpffa.bib",
  "cited_by": 0,
  "doi": "10.1007/s10840-026-02357-z",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13739958/",
  "id": "7h1tbjvyzpffa",
  "issns": [
    "1383-875X",
    "1572-8595"
  ],
  "landing_url": "https://doi.org/10.1007/s10840-026-02357-z",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
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      "2705|Cardiac Arrhythmias and Treatments"
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  "pdf_url": "https://link.springer.com/content/pdf/10.1007/s10840-026-02357-z.pdf",
  "pmcid": "PMC13739958",
  "pmid": "42234368",
  "published": "2026-06-03",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/7h1tbjvyzpffa.ris",
  "sources": [
    {
      "first_seen": "2026-11-10T12:21:18Z",
      "native_id": "PMC13739958",
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      "origin": "openalex:2705|Cardiac Arrhythmias and Treatments",
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  ],
  "title": "Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center",
  "title_text": "Safety and performance of the novel balloon-in-basket pulsed field ablation system: initial 100-patient experience at a high-volume electrophysiology center",
  "type": "peer-reviewed",
  "updated_at": "2026-11-10T12:21:18Z",
  "url": "https://research.draconitic.com/paper/7h1tbjvyzpffa",
  "venue": "Journal of Interventional Cardiac Electrophysiology",
  "versions": []
}